<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03834194</url>
  </required_header>
  <id_info>
    <org_study_id>18-06293-XP</org_study_id>
    <nct_id>NCT03834194</nct_id>
  </id_info>
  <brief_title>Gestational Weight and Incentive Research Study</brief_title>
  <acronym>Bloom</acronym>
  <official_title>Effect of Incentives for Self-weighing, Weight Management Goals and Physical Activity Goals on Gaining Weight Healthily During Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Tennessee</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Tennessee</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bloom is a research study that examines whether incentives for daily self-weighing, weekly&#xD;
      physical activity, monthly weight management or overall (from enrollment up to 36 weeks&#xD;
      pregnancy) weight management could help pregnant mothers manage a health weight gain during&#xD;
      pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gestational weight gain (GWG) is a serious public health concern, and 37% of normal weight,&#xD;
      64% of overweight, and 49-64% of obese women exceed the Institute of Medicine's GWG&#xD;
      guidelines. [Deputy 2015] Excessive GWG increases the risk for illnesses, such as gestational&#xD;
      diabetes mellitus (GDM) [Cheng 2008, Tovar 2009] which has a long-term impact on the health&#xD;
      of both the mother (i.e., increased likelihood of developing metabolic syndrome, [Vohr 2008]&#xD;
      type 2 diabetes, [Vambergue 2007, Bellamy 2009] and GDM in subsequent pregnancies [Bottalico&#xD;
      2007] and child [Vohr 2008].&#xD;
&#xD;
      For weight loss, research has found that modest financial incentives are a promising&#xD;
      pragmatic strategy for an intervention. Yet, most previous weight management research that&#xD;
      has utilized incentives has targeted weight outcomes rather than the behaviors necessary to&#xD;
      achieve them. [Paul-Ebhohimhen 2008, Burns 2012] For self-weighing, research has found that&#xD;
      daily self-weighing is an important component that supplements behavioral interventions'&#xD;
      effort in monitoring and managing gestational weight. [Phelan 2011, Olson 2017, Harrison&#xD;
      2013, Harrison 2014] For physical activity, research has found that physical activity may&#xD;
      successfully manage GWG, and a greater adherence to the exercise program is linked to&#xD;
      interventions that resulted in weight management success. [McDonald 2016] Thus, a strategy to&#xD;
      increase adherence, like financial incentives, may be beneficial.&#xD;
&#xD;
      Consistent with recent research, [Leahey 2015] the investigators will incentivize daily&#xD;
      self-weighing and participation in physical activity (i.e., the behaviors) in addition to GWG&#xD;
      within the guidelines (i.e., the outcome). Behaviors that negatively impact health often&#xD;
      involve immediate benefits and delayed costs (i.e., &quot;eating for two&quot; provides immediate&#xD;
      gratification but may lead to excessive GWG), and many interventions involve immediate costs&#xD;
      (i.e., the inconvenience and time of an intervention) with delayed and often uncertain&#xD;
      benefits of better health years later. [Volpp 2011] Researchers also hypothesize that an&#xD;
      approach that offers frequent chances to win small lotteries based on meeting short-term&#xD;
      goals will be more effective than a straight pay-for-performance approach (of equal expected&#xD;
      value) because people are emotionally attracted to the possibility of winning a lottery.&#xD;
      [Loewenstein 2007, Volpp 2008] Therefore, the current study proposes to examine the impact of&#xD;
      frequent chances to win small, proximal incentives for meeting short-term goals of&#xD;
      self-weighing and physical activity and larger incentives for meeting overall GWG goals by&#xD;
      the end of the 36-week gestational period.&#xD;
&#xD;
      To our knowledge, the study is the first to use financial incentives to reduce the likelihood&#xD;
      of excessive GWG. This project will support evaluation of the feasibility of this promising&#xD;
      approach to decreasing excessive GWG. The incentive strategy is based in theory and focuses&#xD;
      on behaviors that has a strong link with gestational weight management (i.e., self-weighing&#xD;
      and physical activity) and on an outcome (i.e., achievement of GWG goals), thereby moving the&#xD;
      field forward in identifying promising approaches to incorporating financial incentives into&#xD;
      gestational weight management. The study design is also pragmatic and has a strong potential&#xD;
      for scalability and sustainability within the health care setting.&#xD;
&#xD;
      Pregnant participants (N=40) in their first trimester at an obstetric clinic in Memphis, TN&#xD;
      will be randomized in a factorial experiment. Three intervention components will be&#xD;
      randomized using a 2 x 2 x 2 factorial design: 1) daily incentives for self-weighing on an&#xD;
      electronic scale that will transmit data to the study team (lottery/certain loss), 2)&#xD;
      incentives for adhering to the Institute of Medicine's gestational weight gain guidelines&#xD;
      based on BMI category (monthly/overall), and 3) incentives for reaching physical activity&#xD;
      goals to manage gestational weight gain (yes/no).&#xD;
&#xD;
      Potential participants will be identified by the clinics' health professionals (i.e., nurses,&#xD;
      obstetricians) at their pregnancy confirmation visit or will be self-identified through&#xD;
      recruitment materials posted in the obstetric clinic (e.g., exam rooms, lobby and bathrooms).&#xD;
      They will encouraged to contact the study team if they wish to learn more about the study and&#xD;
      potentially enroll in the study. Upon recruitment, individuals who are interested in learning&#xD;
      more about the study will be directed to the Way to Health web portal. Upon reaching the&#xD;
      portal, potential participants will be asked to create an account and will then be informed&#xD;
      of the details of the study, including its objectives, duration, requirements, and financial&#xD;
      payments. If participants are still interested in participating, the Way to Health portal&#xD;
      will take them through an automated online informed consent. Potential participants who click&#xD;
      a clearly delineated button stating that they agree to participate in the study will be&#xD;
      considered to have consented to enroll. After consenting, participants will complete an&#xD;
      online questionnaire to determine their eligibility. Eligible participants will first answer&#xD;
      a few questions about the number of pregnancies they have prior to the current one, age,&#xD;
      annual household income, marital status, employment status, household size, education level,&#xD;
      race, and ethnicity. Then, they will be randomized to one of the study arms and led through&#xD;
      an automated description of the details specific to that arm. Participants will be provided&#xD;
      with details regarding how to contact the research team via email or phone at any time if&#xD;
      they subsequently wish to withdraw from the study. This contact information will remain&#xD;
      easily accessible via the participants' individual Way to Health web portal dashboards&#xD;
      throughout the study.&#xD;
&#xD;
      Participants will be randomized to one of 8 conditions, with combinations of 3 different&#xD;
      components of incentive for GWG management and physical activity. Participants will be asked&#xD;
      to complete daily self-weighing using the scale provided by the study, as well as wear a&#xD;
      physical activity tracker.&#xD;
&#xD;
      Participants randomized to an arm that contains the self-weighing (lottery) component will be&#xD;
      asked to pick a number between 00 and 99 at randomization, and will be informed that there&#xD;
      will be a daily lottery, for which they will be eligible if they have weighed themselves in&#xD;
      the previous day on the Withings e-scale. Then, for each day of their pregnancy, participants&#xD;
      will be informed of the study's randomly-generated winning lottery number. Participants will&#xD;
      be notified about the results of the lottery.&#xD;
&#xD;
      Participants randomized to an arm that contains the self-weighing (certain loss) component&#xD;
      will have a portion of their incentives deducted from a weekly total.&#xD;
&#xD;
      Participants randomized to an arm that contains the monthly GWG incentive component will&#xD;
      receive incentives for each month that they have gained within the recommended monthly range&#xD;
      for their BMI category for the full months they are enrolled.&#xD;
&#xD;
      Participants randomized to an arm that contains the overall GWG incentive component will&#xD;
      receive incentives for weight gain within the recommended range according to the Institute of&#xD;
      Medicine gestational weight gain recommendation (based on their body mass index at&#xD;
      randomization, adjusted for data collection at 36 weeks).&#xD;
&#xD;
      Participants randomized to an arm that contains the physical activity component will receive&#xD;
      a weekly incentive if they achieved a 150 minute physical activity goal for each week based&#xD;
      on the guideline from the American College of Obstetricians and Gynecologists (ACOG) [The&#xD;
      American College of Obstetricians and Gynecologists 2015].&#xD;
&#xD;
      Measures will be obtained by trained research staff who are blinded to treatment assignment&#xD;
      and who will be located within the obstetric clinic.&#xD;
&#xD;
      Baseline measures will be obtained in the first trimester. In-person follow-up data&#xD;
      collection visits will be scheduled at gestational week 32 and week 36 (for those still&#xD;
      pregnant at 36 weeks). Incentives ($30 for each follow-up visit) will be used to obtain high&#xD;
      retention at all follow-up data collection visits. In addition, the research staff will&#xD;
      attempt to schedule the data collection visits before or after regular office visits, in&#xD;
      order to facilitate retention.&#xD;
&#xD;
      Weekly study meetings, which include retention as a standing agenda item, are also a&#xD;
      component of this systematic and comprehensive approach. However, as the investigators will&#xD;
      be recruiting participants at &lt;12 weeks gestation (and miscarriage rates are highest in the&#xD;
      first trimester), the investigators may lose up to 15% of participants due to miscarriage.&#xD;
      [The American College of Obstetricians and Gynecologists 2015] Thus, the investigators&#xD;
      project 20% attrition at the final data collection point (36 weeks gestation).&#xD;
&#xD;
      As this is a novel intervention, no related data exist to inform the effect size that might&#xD;
      be expected, and as a pilot study, the trial is not powered to detect a significant&#xD;
      difference between conditions.&#xD;
&#xD;
      Analyses of GWG (in kg) will be performed using mixed model longitudinal methods. Analyses of&#xD;
      the proportion of women with excessive GWG will use logistic regression models to estimate&#xD;
      the odds of an intervention participant's GWG falling below or above the guidelines, relative&#xD;
      to staying within the recommendations. All of these analyses will inform effect size&#xD;
      estimation for the full-scale trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 26, 2019</start_date>
  <completion_date type="Actual">April 9, 2020</completion_date>
  <primary_completion_date type="Actual">April 9, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intervention Satisfaction Observed From Follow-up Survey</measure>
    <time_frame>Up to 32 weeks</time_frame>
    <description>At 32 weeks gestation participants will be asked to offer insight into program acceptability in each condition, as well as satisfaction to the program in general by answering an internet-based survey, that was developed for this study (not a standardized scale). The investigators will examine participants' survey responses regarding participants' satisfaction of the program (items are scored on a scale from 1 to 5, with 5 being the most positive).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recruitment Yields Observed From Enrollment Survey</measure>
    <time_frame>Up to 36 weeks</time_frame>
    <description>The number of participants initially recruited for the study will be closely monitored.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Program Retention Observed From Enrollment and Followup Surveys</measure>
    <time_frame>Up to 36 weeks</time_frame>
    <description>The number of participants stayed in the study within the time frame of the study will be closely monitored.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gestational Weight Gain Observed From Weight Recorded at Baseline and up to 36 Weeks</measure>
    <time_frame>Up to 36 weeks</time_frame>
    <description>At all measurement visits, weight will be recorded in kilograms on a calibrated research-grade scale. Weight will be measured on a calibrated digital scale in duplicate, with the participant wearing light clothing and no shoes. While we will obtain the mother's weight at baseline, we will also obtain self-reported preconception weight (before the last menstrual period). We will calculate the participant's GWG goal based on self-reported preconception BMI. The difficulty of anticipating when a final weight should be obtained to capture the fullest extent of GWG was considered, and we elected to use an approach that afforded two possible weights that would be available for analytic purposes. The Week 36 weight will be the primary outcome except for mothers who deliver prior to 36 weeks, in which case we will use the Week 32 weight.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Gestational Weight Gain Within IOM Recommendation</measure>
    <time_frame>Up to 36 weeks pregnancy</time_frame>
    <description>We will evaluate whether participants' final gestational weight gain at Week 32 or Week 36 pregnancy would be under, within, or above IOM's recommendation. The Week 36 weight will be the primary outcome except for mothers who deliver prior to 36 weeks, in which case we will use the Week 32 weight. This is to determine the effect of the intervention on prevention of excess gestational weight gain.</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Gestational Weight Gain</condition>
  <arm_group>
    <arm_group_label>Lottery + Monthly Weight</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lottery + Overall Weight + Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lottery + Overall Weight</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lottery + Monthly Weight + Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Loss + Monthly Weight</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Loss + Overall Weight + Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Loss + Overall Weight</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Loss + Monthly Weight + Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lottery + Monthly Weight</intervention_name>
    <description>Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.</description>
    <arm_group_label>Lottery + Monthly Weight</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lottery + Overall Weight + Exercise</intervention_name>
    <description>Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
    <arm_group_label>Lottery + Overall Weight + Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lottery + Overall Weight</intervention_name>
    <description>Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.</description>
    <arm_group_label>Lottery + Overall Weight</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Loss + Overall Weight</intervention_name>
    <description>Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.</description>
    <arm_group_label>Loss + Overall Weight</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Loss + Overall Weight + Exercise</intervention_name>
    <description>Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
    <arm_group_label>Loss + Overall Weight + Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lottery + Monthly Weight + Exercise</intervention_name>
    <description>Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
    <arm_group_label>Lottery + Monthly Weight + Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Loss + Monthly Weight</intervention_name>
    <description>Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.</description>
    <arm_group_label>Loss + Monthly Weight</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Loss + Monthly Weight + Exercise</intervention_name>
    <description>Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
    <arm_group_label>Loss + Monthly Weight + Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  no greater than 12 weeks gestation upon recruitment (based on the date of their last&#xD;
             menstrual period)&#xD;
&#xD;
          -  have regular access to Wi-Fi or Bluetooth&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Greater than 12 week gestation up on recruitment (based on the health care provider's&#xD;
             assessment)&#xD;
&#xD;
          -  Underweight (BMI &lt; 18.5) at baseline&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rebecca A Krukowski, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Tennessee</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Tennessee Health Science Center</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.tn.gov/content/dam/tn/health/documents/2011_TN_PRAMS_Summary_Report.pdf</url>
    <description>Tennessee Pregnancy Risk Assessment Monitoring System 2011</description>
  </link>
  <reference>
    <citation>Deputy NP, Sharma AJ, Kim SY, Hinkle SN. Prevalence and characteristics associated with gestational weight gain adequacy. Obstet Gynecol. 2015 Apr;125(4):773-781. doi: 10.1097/AOG.0000000000000739.</citation>
    <PMID>25751216</PMID>
  </reference>
  <reference>
    <citation>Cheng YW, Chung JH, Kurbisch-Block I, Inturrisi M, Shafer S, Caughey AB. Gestational weight gain and gestational diabetes mellitus: perinatal outcomes. Obstet Gynecol. 2008 Nov;112(5):1015-22. doi: 10.1097/AOG.0b013e31818b5dd9.</citation>
    <PMID>18978100</PMID>
  </reference>
  <reference>
    <citation>Tovar A, Must A, Bermudez OI, Hyatt RR, Chasan-Taber L. The impact of gestational weight gain and diet on abnormal glucose tolerance during pregnancy in Hispanic women. Matern Child Health J. 2009 Jul;13(4):520-30. doi: 10.1007/s10995-008-0381-x. Epub 2008 Jul 3. Erratum In: Matern Child Health J. 2009 Jul;13(4):434.</citation>
    <PMID>18597166</PMID>
  </reference>
  <reference>
    <citation>Vohr BR, Boney CM. Gestational diabetes: the forerunner for the development of maternal and childhood obesity and metabolic syndrome? J Matern Fetal Neonatal Med. 2008 Mar;21(3):149-57. doi: 10.1080/14767050801929430.</citation>
    <PMID>18297569</PMID>
  </reference>
  <reference>
    <citation>Vambergue A, Dognin C, Boulogne A, Rejou MC, Biausque S, Fontaine P. Increasing incidence of abnormal glucose tolerance in women with prior abnormal glucose tolerance during pregnancy: DIAGEST 2 study. Diabet Med. 2008 Jan;25(1):58-64. doi: 10.1111/j.1464-5491.2007.02306.x. Epub 2007 Nov 19.</citation>
    <PMID>18028442</PMID>
  </reference>
  <reference>
    <citation>Bellamy L, Casas JP, Hingorani AD, Williams D. Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis. Lancet. 2009 May 23;373(9677):1773-9. doi: 10.1016/S0140-6736(09)60731-5.</citation>
    <PMID>19465232</PMID>
  </reference>
  <reference>
    <citation>Bottalico JN. Recurrent gestational diabetes: risk factors, diagnosis, management, and implications. Semin Perinatol. 2007 Jun;31(3):176-84. doi: 10.1053/j.semperi.2007.03.006.</citation>
    <PMID>17531899</PMID>
  </reference>
  <reference>
    <citation>Paul-Ebhohimhen V, Avenell A. Systematic review of the use of financial incentives in treatments for obesity and overweight. Obes Rev. 2008 Jul;9(4):355-67. doi: 10.1111/j.1467-789X.2007.00409.x. Epub 2007 Oct 23.</citation>
    <PMID>17956546</PMID>
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    <citation>Burns RJ, Donovan AS, Ackermann RT, Finch EA, Rothman AJ, Jeffery RW. A theoretically grounded systematic review of material incentives for weight loss: implications for interventions. Ann Behav Med. 2012 Dec;44(3):375-88. doi: 10.1007/s12160-012-9403-4.</citation>
    <PMID>22907712</PMID>
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    <citation>Phelan S, Jankovitz K, Hagobian T, Abrams B. Reducing excessive gestational weight gain: lessons from the weight control literature and avenues for future research. Womens Health (Lond). 2011 Nov;7(6):641-61. doi: 10.2217/whe.11.70.</citation>
    <PMID>22040207</PMID>
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    <citation>Olson CM, Strawderman MS, Graham ML. Association between consistent weight gain tracking and gestational weight gain: Secondary analysis of a randomized trial. Obesity (Silver Spring). 2017 Jul;25(7):1217-1227. doi: 10.1002/oby.21873. Epub 2017 Jun 2.</citation>
    <PMID>28573669</PMID>
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    <citation>Harrison CL, Lombard CB, Strauss BJ, Teede HJ. Optimizing healthy gestational weight gain in women at high risk of gestational diabetes: a randomized controlled trial. Obesity (Silver Spring). 2013 May;21(5):904-9. doi: 10.1002/oby.20163. Erratum In: Obesity (Silver Spring). 2016 Jan;24(1):268.</citation>
    <PMID>23784892</PMID>
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    <citation>Harrison CL, Teede HJ, Lombard CB. How effective is self-weighing in the setting of a lifestyle intervention to reduce gestational weight gain and postpartum weight retention? Aust N Z J Obstet Gynaecol. 2014 Aug;54(4):382-5. doi: 10.1111/ajo.12207. Epub 2014 Apr 16.</citation>
    <PMID>24738837</PMID>
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    <citation>McDonald SM, Liu J, Wilcox S, Lau EY, Archer E. Does dose matter in reducing gestational weight gain in exercise interventions? A systematic review of literature. J Sci Med Sport. 2016 Apr;19(4):323-35. doi: 10.1016/j.jsams.2015.03.004. Epub 2015 Mar 26.</citation>
    <PMID>25846125</PMID>
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    <citation>Leahey TM, Subak LL, Fava J, Schembri M, Thomas G, Xu X, Krupel K, Kent K, Boguszewski K, Kumar R, Weinberg B, Wing R. Benefits of adding small financial incentives or optional group meetings to a web-based statewide obesity initiative. Obesity (Silver Spring). 2015 Jan;23(1):70-6. doi: 10.1002/oby.20937. Epub 2014 Nov 11.</citation>
    <PMID>25384463</PMID>
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    <citation>Volpp KG, Asch DA, Galvin R, Loewenstein G. Redesigning employee health incentives--lessons from behavioral economics. N Engl J Med. 2011 Aug 4;365(5):388-90. doi: 10.1056/NEJMp1105966. No abstract available.</citation>
    <PMID>21812669</PMID>
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    <citation>Loewenstein G, Brennan T, Volpp KG. Asymmetric paternalism to improve health behaviors. JAMA. 2007 Nov 28;298(20):2415-7. doi: 10.1001/jama.298.20.2415. No abstract available.</citation>
    <PMID>18042920</PMID>
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    <citation>Volpp KG, John LK, Troxel AB, Norton L, Fassbender J, Loewenstein G. Financial incentive-based approaches for weight loss: a randomized trial. JAMA. 2008 Dec 10;300(22):2631-7. doi: 10.1001/jama.2008.804.</citation>
    <PMID>19066383</PMID>
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    <citation>Gardner B, Wardle J, Poston L, Croker H. Changing diet and physical activity to reduce gestational weight gain: a meta-analysis. Obes Rev. 2011 Jul;12(7):e602-20. doi: 10.1111/j.1467-789X.2011.00884.x. Epub 2011 Apr 27.</citation>
    <PMID>21521451</PMID>
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    <citation>Oken E, Taveras EM, Kleinman KP, Rich-Edwards JW, Gillman MW. Gestational weight gain and child adiposity at age 3 years. Am J Obstet Gynecol. 2007 Apr;196(4):322.e1-8. doi: 10.1016/j.ajog.2006.11.027.</citation>
    <PMID>17403405</PMID>
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    <citation>Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Mathews TJ. Births: final data for 2011. Natl Vital Stat Rep. 2013 Jun 28;62(1):1-69, 72.</citation>
    <PMID>24974591</PMID>
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    <citation>Finkelstein EA, Linnan LA, Tate DF, Birken BE. A pilot study testing the effect of different levels of financial incentives on weight loss among overweight employees. J Occup Environ Med. 2007 Sep;49(9):981-9. doi: 10.1097/JOM.0b013e31813c6dcb.</citation>
    <PMID>17848854</PMID>
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    <citation>Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626-9. doi: 10.1016/j.jpsychires.2010.10.008. Epub 2010 Oct 28.</citation>
    <PMID>21035130</PMID>
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    <citation>Yancy WS Jr, Shaw PA, Wesby L, Hilbert V, Yang L, Zhu J, Troxel A, Huffman D, Foster GD, Wojtanowski AC, Volpp KG. Financial incentive strategies for maintenance of weight loss: results from an internet-based randomized controlled trial. Nutr Diabetes. 2018 May 25;8(1):33. doi: 10.1038/s41387-018-0036-y.</citation>
    <PMID>29795365</PMID>
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    <citation>Shaw PA, Yancy WS Jr, Wesby L, Ulrich V, Troxel AB, Huffman D, Foster GD, Volpp K. The design and conduct of Keep It Off: An online randomized trial of financial incentives for weight-loss maintenance. Clin Trials. 2017 Feb;14(1):29-36. doi: 10.1177/1740774516669679. Epub 2016 Sep 23.</citation>
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    <citation>Patel MS, Asch DA, Rosin R, Small DS, Bellamy SL, Heuer J, Sproat S, Hyson C, Haff N, Lee SM, Wesby L, Hoffer K, Shuttleworth D, Taylor DH, Hilbert V, Zhu J, Yang L, Wang X, Volpp KG. Framing Financial Incentives to Increase Physical Activity Among Overweight and Obese Adults: A Randomized, Controlled Trial. Ann Intern Med. 2016 Mar 15;164(6):385-94. doi: 10.7326/M15-1635. Epub 2016 Feb 16.</citation>
    <PMID>26881417</PMID>
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  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <results_first_submitted>March 28, 2022</results_first_submitted>
  <results_first_submitted_qc>October 3, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 8, 2023</results_first_posted>
  <last_update_submitted>October 3, 2022</last_update_submitted>
  <last_update_submitted_qc>October 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>excessive weight gain</keyword>
  <keyword>pregnancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Gain</mesh_term>
    <mesh_term>Gestational Weight Gain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD are protected by the Institutional Review Board (IRB) at the University of Tennessee Health Science Center (UTHSC). No individual without the IRB of UTHSC will have access to IDP.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03834194/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Lottery + Monthly Weight</title>
          <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating.&#xD;
Lottery + Monthly Weight: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.</description>
        </group>
        <group group_id="P2">
          <title>Lottery + Overall Weight + Exercise</title>
          <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Lottery + Overall Weight + Exercise: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
        </group>
        <group group_id="P3">
          <title>Lottery + Overall Weight</title>
          <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit.&#xD;
Lottery + Overall Weight: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.</description>
        </group>
        <group group_id="P4">
          <title>Lottery + Monthly Weight + Exercise</title>
          <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Lottery + Monthly Weight + Exercise: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
        </group>
        <group group_id="P5">
          <title>Loss + Monthly Weight</title>
          <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating.&#xD;
Loss + Monthly Weight: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.</description>
        </group>
        <group group_id="P6">
          <title>Loss + Overall Weight + Exercise</title>
          <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Loss + Overall Weight + Exercise: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
        </group>
        <group group_id="P7">
          <title>Loss + Overall Weight</title>
          <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit.&#xD;
Loss + Overall Weight: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.</description>
        </group>
        <group group_id="P8">
          <title>Loss + Monthly Weight + Exercise</title>
          <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Loss + Monthly Weight + Exercise: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4">5 participants were not started with the intervention with this condition, because 1 participant was immediately withdrawn (without orientation to the condition) because of a staff member's error in assessing this participant's age eligibility</participants>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="5"/>
                <participants group_id="P8" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="5"/>
                <participants group_id="P8" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Lottery + Monthly Weight</title>
          <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating.&#xD;
Lottery + Monthly Weight: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.</description>
        </group>
        <group group_id="B2">
          <title>Lottery + Overall Weight + Exercise</title>
          <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Lottery + Overall Weight + Exercise: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
        </group>
        <group group_id="B3">
          <title>Lottery + Overall Weight</title>
          <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit.&#xD;
Lottery + Overall Weight: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.</description>
        </group>
        <group group_id="B4">
          <title>Lottery + Monthly Weight + Exercise</title>
          <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Lottery + Monthly Weight + Exercise: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
        </group>
        <group group_id="B5">
          <title>Loss + Monthly Weight</title>
          <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating.&#xD;
Loss + Monthly Weight: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.</description>
        </group>
        <group group_id="B6">
          <title>Loss + Overall Weight + Exercise</title>
          <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Loss + Overall Weight + Exercise: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
        </group>
        <group group_id="B7">
          <title>Loss + Overall Weight</title>
          <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit.&#xD;
Loss + Overall Weight: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.</description>
        </group>
        <group group_id="B8">
          <title>Loss + Monthly Weight + Exercise</title>
          <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Loss + Monthly Weight + Exercise: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
        </group>
        <group group_id="B9">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="5"/>
            <count group_id="B4" value="5"/>
            <count group_id="B5" value="5"/>
            <count group_id="B6" value="5"/>
            <count group_id="B7" value="5"/>
            <count group_id="B8" value="5"/>
            <count group_id="B9" value="39"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.5" lower_limit="20" upper_limit="33"/>
                    <measurement group_id="B2" value="27.2" lower_limit="20" upper_limit="31"/>
                    <measurement group_id="B3" value="29.6" lower_limit="23" upper_limit="36"/>
                    <measurement group_id="B4" value="26.5" lower_limit="22" upper_limit="33"/>
                    <measurement group_id="B5" value="25.6" lower_limit="20" upper_limit="35"/>
                    <measurement group_id="B6" value="25.4" lower_limit="20" upper_limit="30"/>
                    <measurement group_id="B7" value="29.2" lower_limit="25" upper_limit="33"/>
                    <measurement group_id="B8" value="29.4" lower_limit="21.0" upper_limit="40"/>
                    <measurement group_id="B9" value="29.1" lower_limit="20" upper_limit="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="3"/>
                    <measurement group_id="B9" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index category (proportion with overweight and obesity)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Intervention Satisfaction Observed From Follow-up Survey</title>
        <description>At 32 weeks gestation participants will be asked to offer insight into program acceptability in each condition, as well as satisfaction to the program in general by answering an internet-based survey, that was developed for this study (not a standardized scale). The investigators will examine participants' survey responses regarding participants' satisfaction of the program (items are scored on a scale from 1 to 5, with 5 being the most positive).</description>
        <time_frame>Up to 32 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lottery + Monthly Weight</title>
            <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating.&#xD;
Lottery + Monthly Weight: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.</description>
          </group>
          <group group_id="O2">
            <title>Lottery + Overall Weight + Exercise</title>
            <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Lottery + Overall Weight + Exercise: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
          </group>
          <group group_id="O3">
            <title>Lottery + Overall Weight</title>
            <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit.&#xD;
Lottery + Overall Weight: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.</description>
          </group>
          <group group_id="O4">
            <title>Lottery + Monthly Weight + Exercise</title>
            <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Lottery + Monthly Weight + Exercise: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
          </group>
          <group group_id="O5">
            <title>Loss + Monthly Weight</title>
            <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating.&#xD;
Loss + Monthly Weight: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.</description>
          </group>
          <group group_id="O6">
            <title>Loss + Overall Weight + Exercise</title>
            <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Loss + Overall Weight + Exercise: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
          </group>
          <group group_id="O7">
            <title>Loss + Overall Weight</title>
            <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit.&#xD;
Loss + Overall Weight: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.</description>
          </group>
          <group group_id="O8">
            <title>Loss + Monthly Weight + Exercise</title>
            <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Loss + Monthly Weight + Exercise: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
          </group>
        </group_list>
        <measure>
          <title>Intervention Satisfaction Observed From Follow-up Survey</title>
          <description>At 32 weeks gestation participants will be asked to offer insight into program acceptability in each condition, as well as satisfaction to the program in general by answering an internet-based survey, that was developed for this study (not a standardized scale). The investigators will examine participants' survey responses regarding participants' satisfaction of the program (items are scored on a scale from 1 to 5, with 5 being the most positive).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="5"/>
                <count group_id="O8" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>How much would you recommend using an e-scale for managing GWG to a friend?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="5" upper_limit="5"/>
                    <measurement group_id="O2" value="4.25" lower_limit="3" upper_limit="5"/>
                    <measurement group_id="O3" value="4.25" lower_limit="2" upper_limit="5"/>
                    <measurement group_id="O4" value="5" lower_limit="5" upper_limit="5"/>
                    <measurement group_id="O5" value="4.8" lower_limit="4" upper_limit="5"/>
                    <measurement group_id="O6" value="4.75" lower_limit="4" upper_limit="5"/>
                    <measurement group_id="O7" value="4.8" lower_limit="4" upper_limit="5"/>
                    <measurement group_id="O8" value="4.8" lower_limit="4" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How much would you recommend using a fitness tracker for managing GWG to a friend?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.67" lower_limit="4" upper_limit="5"/>
                    <measurement group_id="O2" value="3.5" lower_limit="2" upper_limit="5"/>
                    <measurement group_id="O3" value="5" lower_limit="5" upper_limit="5"/>
                    <measurement group_id="O4" value="5" lower_limit="5" upper_limit="5"/>
                    <measurement group_id="O5" value="4.4" lower_limit="2" upper_limit="5"/>
                    <measurement group_id="O6" value="4.25" lower_limit="3" upper_limit="5"/>
                    <measurement group_id="O7" value="4.6" lower_limit="4" upper_limit="5"/>
                    <measurement group_id="O8" value="4.4" lower_limit="3" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How much would you recommend setting a weight gain goal for managing GWG to a friend?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.67" lower_limit="4" upper_limit="5"/>
                    <measurement group_id="O2" value="4.25" lower_limit="3" upper_limit="5"/>
                    <measurement group_id="O3" value="4.5" lower_limit="3" upper_limit="5"/>
                    <measurement group_id="O4" value="5" lower_limit="5" upper_limit="5"/>
                    <measurement group_id="O5" value="4.4" lower_limit="3" upper_limit="5"/>
                    <measurement group_id="O6" value="4.75" lower_limit="4" upper_limit="5"/>
                    <measurement group_id="O7" value="4.8" lower_limit="4" upper_limit="5"/>
                    <measurement group_id="O8" value="4.6" lower_limit="4" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How much would you recommend setting a physical activity goal for managing GWG to a friend?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="3" upper_limit="5"/>
                    <measurement group_id="O2" value="4.25" lower_limit="3" upper_limit="5"/>
                    <measurement group_id="O3" value="4.5" lower_limit="3" upper_limit="5"/>
                    <measurement group_id="O4" value="5" lower_limit="5" upper_limit="5"/>
                    <measurement group_id="O5" value="5" lower_limit="5" upper_limit="5"/>
                    <measurement group_id="O6" value="4.25" lower_limit="3" upper_limit="5"/>
                    <measurement group_id="O7" value="4.8" lower_limit="4" upper_limit="5"/>
                    <measurement group_id="O8" value="4.8" lower_limit="4" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Recruitment Yields Observed From Enrollment Survey</title>
        <description>The number of participants initially recruited for the study will be closely monitored.</description>
        <time_frame>Up to 36 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lottery + Monthly Weight</title>
            <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating.&#xD;
Lottery + Monthly Weight: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.</description>
          </group>
          <group group_id="O2">
            <title>Lottery + Overall Weight + Exercise</title>
            <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Lottery + Overall Weight + Exercise: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
          </group>
          <group group_id="O3">
            <title>Lottery + Overall Weight</title>
            <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit.&#xD;
Lottery + Overall Weight: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.</description>
          </group>
          <group group_id="O4">
            <title>Lottery + Monthly Weight + Exercise</title>
            <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Lottery + Monthly Weight + Exercise: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
          </group>
          <group group_id="O5">
            <title>Loss + Monthly Weight</title>
            <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating.&#xD;
Loss + Monthly Weight: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.</description>
          </group>
          <group group_id="O6">
            <title>Loss + Overall Weight + Exercise</title>
            <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Loss + Overall Weight + Exercise: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
          </group>
          <group group_id="O7">
            <title>Loss + Overall Weight</title>
            <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit.&#xD;
Loss + Overall Weight: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.</description>
          </group>
          <group group_id="O8">
            <title>Loss + Monthly Weight + Exercise</title>
            <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Loss + Monthly Weight + Exercise: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
          </group>
        </group_list>
        <measure>
          <title>Recruitment Yields Observed From Enrollment Survey</title>
          <description>The number of participants initially recruited for the study will be closely monitored.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="5"/>
                <count group_id="O8" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="5"/>
                    <measurement group_id="O7" value="5"/>
                    <measurement group_id="O8" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Program Retention Observed From Enrollment and Followup Surveys</title>
        <description>The number of participants stayed in the study within the time frame of the study will be closely monitored.</description>
        <time_frame>Up to 36 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lottery + Monthly Weight</title>
            <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating.&#xD;
Lottery + Monthly Weight: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.</description>
          </group>
          <group group_id="O2">
            <title>Lottery + Overall Weight + Exercise</title>
            <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Lottery + Overall Weight + Exercise: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
          </group>
          <group group_id="O3">
            <title>Lottery + Overall Weight</title>
            <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit.&#xD;
Lottery + Overall Weight: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.</description>
          </group>
          <group group_id="O4">
            <title>Lottery + Monthly Weight + Exercise</title>
            <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Lottery + Monthly Weight + Exercise: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
          </group>
          <group group_id="O5">
            <title>Loss + Monthly Weight</title>
            <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating.&#xD;
Loss + Monthly Weight: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.</description>
          </group>
          <group group_id="O6">
            <title>Loss + Overall Weight + Exercise</title>
            <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Loss + Overall Weight + Exercise: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
          </group>
          <group group_id="O7">
            <title>Loss + Overall Weight</title>
            <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit.&#xD;
Loss + Overall Weight: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.</description>
          </group>
          <group group_id="O8">
            <title>Loss + Monthly Weight + Exercise</title>
            <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Loss + Monthly Weight + Exercise: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
          </group>
        </group_list>
        <measure>
          <title>Program Retention Observed From Enrollment and Followup Surveys</title>
          <description>The number of participants stayed in the study within the time frame of the study will be closely monitored.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="5"/>
                <count group_id="O8" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="5"/>
                    <measurement group_id="O8" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Gestational Weight Gain Observed From Weight Recorded at Baseline and up to 36 Weeks</title>
        <description>At all measurement visits, weight will be recorded in kilograms on a calibrated research-grade scale. Weight will be measured on a calibrated digital scale in duplicate, with the participant wearing light clothing and no shoes. While we will obtain the mother's weight at baseline, we will also obtain self-reported preconception weight (before the last menstrual period). We will calculate the participant's GWG goal based on self-reported preconception BMI. The difficulty of anticipating when a final weight should be obtained to capture the fullest extent of GWG was considered, and we elected to use an approach that afforded two possible weights that would be available for analytic purposes. The Week 36 weight will be the primary outcome except for mothers who deliver prior to 36 weeks, in which case we will use the Week 32 weight.</description>
        <time_frame>Up to 36 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lottery + Monthly Weight</title>
            <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating.&#xD;
Lottery + Monthly Weight: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.</description>
          </group>
          <group group_id="O2">
            <title>Lottery + Overall Weight + Exercise</title>
            <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Lottery + Overall Weight + Exercise: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
          </group>
          <group group_id="O3">
            <title>Lottery + Overall Weight</title>
            <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit.&#xD;
Lottery + Overall Weight: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.</description>
          </group>
          <group group_id="O4">
            <title>Lottery + Monthly Weight + Exercise</title>
            <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Lottery + Monthly Weight + Exercise: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
          </group>
          <group group_id="O5">
            <title>Loss + Monthly Weight</title>
            <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating.&#xD;
Loss + Monthly Weight: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.</description>
          </group>
          <group group_id="O6">
            <title>Loss + Overall Weight + Exercise</title>
            <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Loss + Overall Weight + Exercise: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
          </group>
          <group group_id="O7">
            <title>Loss + Overall Weight</title>
            <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit.&#xD;
Loss + Overall Weight: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.</description>
          </group>
          <group group_id="O8">
            <title>Loss + Monthly Weight + Exercise</title>
            <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Loss + Monthly Weight + Exercise: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
          </group>
        </group_list>
        <measure>
          <title>Gestational Weight Gain Observed From Weight Recorded at Baseline and up to 36 Weeks</title>
          <description>At all measurement visits, weight will be recorded in kilograms on a calibrated research-grade scale. Weight will be measured on a calibrated digital scale in duplicate, with the participant wearing light clothing and no shoes. While we will obtain the mother's weight at baseline, we will also obtain self-reported preconception weight (before the last menstrual period). We will calculate the participant's GWG goal based on self-reported preconception BMI. The difficulty of anticipating when a final weight should be obtained to capture the fullest extent of GWG was considered, and we elected to use an approach that afforded two possible weights that would be available for analytic purposes. The Week 36 weight will be the primary outcome except for mothers who deliver prior to 36 weeks, in which case we will use the Week 32 weight.</description>
          <units>kilograms gained</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="5"/>
                <count group_id="O8" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.2" lower_limit="10.0" upper_limit="18.0"/>
                    <measurement group_id="O2" value="6.8" lower_limit="0.9" upper_limit="11.2"/>
                    <measurement group_id="O3" value="8.4" lower_limit="-3.7" upper_limit="14.2"/>
                    <measurement group_id="O4" value="9.4" lower_limit="8.1" upper_limit="11.2"/>
                    <measurement group_id="O5" value="9.6" lower_limit="-2.1" upper_limit="20.1"/>
                    <measurement group_id="O6" value="8.9" lower_limit="-0.2" upper_limit="13.3"/>
                    <measurement group_id="O7" value="11.8" lower_limit="3.4" upper_limit="18.8"/>
                    <measurement group_id="O8" value="11.8" lower_limit="6.9" upper_limit="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Gestational Weight Gain Within IOM Recommendation</title>
        <description>We will evaluate whether participants' final gestational weight gain at Week 32 or Week 36 pregnancy would be under, within, or above IOM's recommendation. The Week 36 weight will be the primary outcome except for mothers who deliver prior to 36 weeks, in which case we will use the Week 32 weight. This is to determine the effect of the intervention on prevention of excess gestational weight gain.</description>
        <time_frame>Up to 36 weeks pregnancy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lottery + Monthly Weight</title>
            <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating.&#xD;
Lottery + Monthly Weight: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.</description>
          </group>
          <group group_id="O2">
            <title>Lottery + Overall Weight + Exercise</title>
            <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Lottery + Overall Weight + Exercise: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
          </group>
          <group group_id="O3">
            <title>Lottery + Overall Weight</title>
            <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit.&#xD;
Lottery + Overall Weight: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.</description>
          </group>
          <group group_id="O4">
            <title>Lottery + Monthly Weight + Exercise</title>
            <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Lottery + Monthly Weight + Exercise: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
          </group>
          <group group_id="O5">
            <title>Loss + Monthly Weight</title>
            <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating.&#xD;
Loss + Monthly Weight: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.</description>
          </group>
          <group group_id="O6">
            <title>Loss + Overall Weight + Exercise</title>
            <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Loss + Overall Weight + Exercise: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
          </group>
          <group group_id="O7">
            <title>Loss + Overall Weight</title>
            <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit.&#xD;
Loss + Overall Weight: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.</description>
          </group>
          <group group_id="O8">
            <title>Loss + Monthly Weight + Exercise</title>
            <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Loss + Monthly Weight + Exercise: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Gestational Weight Gain Within IOM Recommendation</title>
          <description>We will evaluate whether participants' final gestational weight gain at Week 32 or Week 36 pregnancy would be under, within, or above IOM's recommendation. The Week 36 weight will be the primary outcome except for mothers who deliver prior to 36 weeks, in which case we will use the Week 32 weight. This is to determine the effect of the intervention on prevention of excess gestational weight gain.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="5"/>
                <count group_id="O8" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to 36 weeks gestation</time_frame>
      <desc>Data on adverse events, consistent with the clinicaltrials.gov definition, were collected at data collection visits and as reported by participants in the interim</desc>
      <group_list>
        <group group_id="E1">
          <title>Lottery + Monthly Weight</title>
          <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating.&#xD;
Lottery + Monthly Weight: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.</description>
        </group>
        <group group_id="E2">
          <title>Lottery + Overall Weight + Exercise</title>
          <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Lottery + Overall Weight + Exercise: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
        </group>
        <group group_id="E3">
          <title>Lottery + Overall Weight</title>
          <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit.&#xD;
Lottery + Overall Weight: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.</description>
        </group>
        <group group_id="E4">
          <title>Lottery + Monthly Weight + Exercise</title>
          <description>Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Lottery + Monthly Weight + Exercise: Lottery for daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
        </group>
        <group group_id="E5">
          <title>Loss + Monthly Weight</title>
          <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating.&#xD;
Loss + Monthly Weight: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.</description>
        </group>
        <group group_id="E6">
          <title>Loss + Overall Weight + Exercise</title>
          <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Loss + Overall Weight + Exercise: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
        </group>
        <group group_id="E7">
          <title>Loss + Overall Weight</title>
          <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit.&#xD;
Loss + Overall Weight: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.</description>
        </group>
        <group group_id="E8">
          <title>Loss + Monthly Weight + Exercise</title>
          <description>Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.&#xD;
Loss + Monthly Weight + Exercise: Certain loss for not engaging in daily self-weighing.&#xD;
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.&#xD;
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Premature birth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Miscarriage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Rebecca Krukowski</name_or_title>
      <organization>University of Virginia, School of Medicine</organization>
      <phone>9014482426</phone>
      <email>wae4mq@virginia.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03834194
org study id: 18-06293-XP
nct id: NCT03834194
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Bloom is a research study that examines whether incentives for daily self-weighing, weekly
      physical activity, monthly weight management or overall (from enrollment up to 36 weeks
      pregnancy) weight management could help pregnant mothers manage a health weight gain during
      pregnancy.
Gestational weight gain (GWG) is a serious public health concern, and 37% of normal weight,
      64% of overweight, and 49-64% of obese women exceed the Institute of Medicine's GWG
      guidelines. [Deputy 2015] Excessive GWG increases the risk for illnesses, such as gestational
      diabetes mellitus (GDM) [Cheng 2008, Tovar 2009] which has a long-term impact on the health
      of both the mother (i.e., increased likelihood of developing metabolic syndrome, [Vohr 2008]
      type 2 diabetes, [Vambergue 2007, Bellamy 2009] and GDM in subsequent pregnancies [Bottalico
      2007] and child [Vohr 2008].

      For weight loss, research has found that modest financial incentives are a promising
      pragmatic strategy for an intervention. Yet, most previous weight management research that
      has utilized incentives has targeted weight outcomes rather than the behaviors necessary to
      achieve them. [Paul-Ebhohimhen 2008, Burns 2012] For self-weighing, research has found that
      daily self-weighing is an important component that supplements behavioral interventions'
      effort in monitoring and managing gestational weight. [Phelan 2011, Olson 2017, Harrison
      2013, Harrison 2014] For physical activity, research has found that physical activity may
      successfully manage GWG, and a greater adherence to the exercise program is linked to
      interventions that resulted in weight management success. [McDonald 2016] Thus, a strategy to
      increase adherence, like financial incentives, may be beneficial.

      Consistent with recent research, [Leahey 2015] the investigators will incentivize daily
      self-weighing and participation in physical activity (i.e., the behaviors) in addition to GWG
      within the guidelines (i.e., the outcome). Behaviors that negatively impact health often
      involve immediate benefits and delayed costs (i.e., "eating for two" provides immediate
      gratification but may lead to excessive GWG), and many interventions involve immediate costs
      (i.e., the inconvenience and time of an intervention) with delayed and often uncertain
      benefits of better health years later. [Volpp 2011] Researchers also hypothesize that an
      approach that offers frequent chances to win small lotteries based on meeting short-term
      goals will be more effective than a straight pay-for-performance approach (of equal expected
      value) because people are emotionally attracted to the possibility of winning a lottery.
      [Loewenstein 2007, Volpp 2008] Therefore, the current study proposes to examine the impact of
      frequent chances to win small, proximal incentives for meeting short-term goals of
      self-weighing and physical activity and larger incentives for meeting overall GWG goals by
      the end of the 36-week gestational period.

      To our knowledge, the study is the first to use financial incentives to reduce the likelihood
      of excessive GWG. This project will support evaluation of the feasibility of this promising
      approach to decreasing excessive GWG. The incentive strategy is based in theory and focuses
      on behaviors that has a strong link with gestational weight management (i.e., self-weighing
      and physical activity) and on an outcome (i.e., achievement of GWG goals), thereby moving the
      field forward in identifying promising approaches to incorporating financial incentives into
      gestational weight management. The study design is also pragmatic and has a strong potential
      for scalability and sustainability within the health care setting.

      Pregnant participants (N=40) in their first trimester at an obstetric clinic in Memphis, TN
      will be randomized in a factorial experiment. Three intervention components will be
      randomized using a 2 x 2 x 2 factorial design: 1) daily incentives for self-weighing on an
      electronic scale that will transmit data to the study team (lottery/certain loss), 2)
      incentives for adhering to the Institute of Medicine's gestational weight gain guidelines
      based on BMI category (monthly/overall), and 3) incentives for reaching physical activity
      goals to manage gestational weight gain (yes/no).

      Potential participants will be identified by the clinics' health professionals (i.e., nurses,
      obstetricians) at their pregnancy confirmation visit or will be self-identified through
      recruitment materials posted in the obstetric clinic (e.g., exam rooms, lobby and bathrooms).
      They will encouraged to contact the study team if they wish to learn more about the study and
      potentially enroll in the study. Upon recruitment, individuals who are interested in learning
      more about the study will be directed to the Way to Health web portal. Upon reaching the
      portal, potential participants will be asked to create an account and will then be informed
      of the details of the study, including its objectives, duration, requirements, and financial
      payments. If participants are still interested in participating, the Way to Health portal
      will take them through an automated online informed consent. Potential participants who click
      a clearly delineated button stating that they agree to participate in the study will be
      considered to have consented to enroll. After consenting, participants will complete an
      online questionnaire to determine their eligibility. Eligible participants will first answer
      a few questions about the number of pregnancies they have prior to the current one, age,
      annual household income, marital status, employment status, household size, education level,
      race, and ethnicity. Then, they will be randomized to one of the study arms and led through
      an automated description of the details specific to that arm. Participants will be provided
      with details regarding how to contact the research team via email or phone at any time if
      they subsequently wish to withdraw from the study. This contact information will remain
      easily accessible via the participants' individual Way to Health web portal dashboards
      throughout the study.

      Participants will be randomized to one of 8 conditions, with combinations of 3 different
      components of incentive for GWG management and physical activity. Participants will be asked
      to complete daily self-weighing using the scale provided by the study, as well as wear a
      physical activity tracker.

      Participants randomized to an arm that contains the self-weighing (lottery) component will be
      asked to pick a number between 00 and 99 at randomization, and will be informed that there
      will be a daily lottery, for which they will be eligible if they have weighed themselves in
      the previous day on the Withings e-scale. Then, for each day of their pregnancy, participants
      will be informed of the study's randomly-generated winning lottery number. Participants will
      be notified about the results of the lottery.

      Participants randomized to an arm that contains the self-weighing (certain loss) component
      will have a portion of their incentives deducted from a weekly total.

      Participants randomized to an arm that contains the monthly GWG incentive component will
      receive incentives for each month that they have gained within the recommended monthly range
      for their BMI category for the full months they are enrolled.

      Participants randomized to an arm that contains the overall GWG incentive component will
      receive incentives for weight gain within the recommended range according to the Institute of
      Medicine gestational weight gain recommendation (based on their body mass index at
      randomization, adjusted for data collection at 36 weeks).

      Participants randomized to an arm that contains the physical activity component will receive
      a weekly incentive if they achieved a 150 minute physical activity goal for each week based
      on the guideline from the American College of Obstetricians and Gynecologists (ACOG) [The
      American College of Obstetricians and Gynecologists 2015].

      Measures will be obtained by trained research staff who are blinded to treatment assignment
      and who will be located within the obstetric clinic.

      Baseline measures will be obtained in the first trimester. In-person follow-up data
      collection visits will be scheduled at gestational week 32 and week 36 (for those still
      pregnant at 36 weeks). Incentives ($30 for each follow-up visit) will be used to obtain high
      retention at all follow-up data collection visits. In addition, the research staff will
      attempt to schedule the data collection visits before or after regular office visits, in
      order to facilitate retention.

      Weekly study meetings, which include retention as a standing agenda item, are also a
      component of this systematic and comprehensive approach. However, as the investigators will
      be recruiting participants at <12 weeks gestation (and miscarriage rates are highest in the
      first trimester), the investigators may lose up to 15% of participants due to miscarriage.
      [The American College of Obstetricians and Gynecologists 2015] Thus, the investigators
      project 20% attrition at the final data collection point (36 weeks gestation).

      As this is a novel intervention, no related data exist to inform the effect size that might
      be expected, and as a pilot study, the trial is not powered to detect a significant
      difference between conditions.

      Analyses of GWG (in kg) will be performed using mixed model longitudinal methods. Analyses of
      the proportion of women with excessive GWG will use logistic regression models to estimate
      the odds of an intervention participant's GWG falling below or above the guidelines, relative
      to staying within the recommendations. All of these analyses will inform effect size
      estimation for the full-scale trial.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Intervention Satisfaction Observed From Follow-up Survey
time frame: Up to 32 weeks
description: At 32 weeks gestation participants will be asked to offer insight into program acceptability in each condition, as well as satisfaction to the program in general by answering an internet-based survey, that was developed for this study (not a standardized scale). The investigators will examine participants' survey responses regarding participants' satisfaction of the program (items are scored on a scale from 1 to 5, with 5 being the most positive).
measure: Recruitment Yields Observed From Enrollment Survey
time frame: Up to 36 weeks
description: The number of participants initially recruited for the study will be closely monitored.
measure: Program Retention Observed From Enrollment and Followup Surveys
time frame: Up to 36 weeks
description: The number of participants stayed in the study within the time frame of the study will be closely monitored.
measure: Gestational Weight Gain Observed From Weight Recorded at Baseline and up to 36 Weeks
time frame: Up to 36 weeks
description: At all measurement visits, weight will be recorded in kilograms on a calibrated research-grade scale. Weight will be measured on a calibrated digital scale in duplicate, with the participant wearing light clothing and no shoes. While we will obtain the mother's weight at baseline, we will also obtain self-reported preconception weight (before the last menstrual period). We will calculate the participant's GWG goal based on self-reported preconception BMI. The difficulty of anticipating when a final weight should be obtained to capture the fullest extent of GWG was considered, and we elected to use an approach that afforded two possible weights that would be available for analytic purposes. The Week 36 weight will be the primary outcome except for mothers who deliver prior to 36 weeks, in which case we will use the Week 32 weight.
measure: Number of Participants With Gestational Weight Gain Within IOM Recommendation
time frame: Up to 36 weeks pregnancy
description: We will evaluate whether participants' final gestational weight gain at Week 32 or Week 36 pregnancy would be under, within, or above IOM's recommendation. The Week 36 weight will be the primary outcome except for mothers who deliver prior to 36 weeks, in which case we will use the Week 32 weight. This is to determine the effect of the intervention on prevention of excess gestational weight gain.
arm group label: Lottery + Monthly Weight
arm group type: Experimental
description: Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating.
arm group label: Lottery + Overall Weight + Exercise
arm group type: Experimental
description: Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.
arm group label: Lottery + Overall Weight
arm group type: Experimental
description: Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit.
arm group label: Lottery + Monthly Weight + Exercise
arm group type: Experimental
description: Participants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.
arm group label: Loss + Monthly Weight
arm group type: Experimental
description: Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating.
arm group label: Loss + Overall Weight + Exercise
arm group type: Experimental
description: Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.
arm group label: Loss + Overall Weight
arm group type: Experimental
description: Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit.
arm group label: Loss + Monthly Weight + Exercise
arm group type: Experimental
description: Participants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.
intervention type: Behavioral
intervention name: Lottery + Monthly Weight
description: Lottery for daily self-weighing.
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.
arm group label: Lottery + Monthly Weight
intervention type: Behavioral
intervention name: Lottery + Overall Weight + Exercise
description: Lottery for daily self-weighing.
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.
arm group label: Lottery + Overall Weight + Exercise
intervention type: Behavioral
intervention name: Lottery + Overall Weight
description: Lottery for daily self-weighing.
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.
arm group label: Lottery + Overall Weight
intervention type: Behavioral
intervention name: Loss + Overall Weight
description: Certain loss for not engaging in daily self-weighing.
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.
arm group label: Loss + Overall Weight
intervention type: Behavioral
intervention name: Loss + Overall Weight + Exercise
description: Certain loss for not engaging in daily self-weighing.
Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.
arm group label: Loss + Overall Weight + Exercise
intervention type: Behavioral
intervention name: Lottery + Monthly Weight + Exercise
description: Lottery for daily self-weighing.
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.
arm group label: Lottery + Monthly Weight + Exercise
intervention type: Behavioral
intervention name: Loss + Monthly Weight
description: Certain loss for not engaging in daily self-weighing.
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.
arm group label: Loss + Monthly Weight
intervention type: Behavioral
intervention name: Loss + Monthly Weight + Exercise
description: Certain loss for not engaging in daily self-weighing.
Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.
Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.
arm group label: Loss + Monthly Weight + Exercise
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rebecca A Krukowski, PhD
role: Principal Investigator
affiliation: University of Tennessee
facility: 
country: United States
url: https://www.tn.gov/content/dam/tn/health/documents/2011_TN_PRAMS_Summary_Report.pdf
description: Tennessee Pregnancy Risk Assessment Monitoring System 2011
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PMID: 18978100
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responsible party type: Sponsor
mesh term: Body Weight
mesh term: Weight Gain
mesh term: Gestational Weight Gain
sharing ipd: No
ipd description: IPD are protected by the Institutional Review Board (IRB) at the University of Tennessee Health Science Center (UTHSC). No individual without the IRB of UTHSC will have access to IDP.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 