<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/NCT04449432</url>
  </required_header>
  <id_info>
    <org_study_id>1399548</org_study_id>
    <secondary_id>1R01NR017659-01A1</secondary_id>
    <nct_id>NCT04449432</nct_id>
  </id_info>
  <brief_title>Goals for Reaching Optimal Wellness: GROWell</brief_title>
  <official_title>Goals for Reaching Optimal Wellness: GROWell</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pattern Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite the negative consequences to maternal-child health from women gaining too much weight&#xD;
      during pregnancy, up to 62% of overweight and obese women gain more pregnancy weight than is&#xD;
      recommended. This project will establish the efficacy of Goals for Reaching Optimal Wellness&#xD;
      (GROWell), an mHealth tool for achieving appropriate pregnancy weight gain and promoting&#xD;
      postpartum weight loss among women who enter pregnancy overweight or obese. GROWell will fill&#xD;
      a gap in research and clinical care by providing a validated, standalone mHealth tool for&#xD;
      weight control during pregnancy and postpartum, which is a currently lacking resource.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research attempts to prevent excess gestational weight gain, defined as gaining more weight&#xD;
      during pregnancy than Institute of Medicine (IOM) guidelines for prepregnancy body mass index&#xD;
      (BMI), have largely been unsuccessful. Roughly 62% of overweight and 45% of obese women still&#xD;
      gain more weight than recommended, increasing risk for postpartum weight retention. Few&#xD;
      mobile health (mHealth) interventions have been trialed to address pregnancy-associated&#xD;
      weight gain, which is a missed opportunity. Adult women are high users of technology for&#xD;
      general and pregnancy-specific health information seeking and sharing. To fill this gap, the&#xD;
      long-term goal of this research is to disseminate into clinical practice a standalone mHealth&#xD;
      tool that is effective for overweight and obese pregnant women to achieve gestational weight&#xD;
      gain within IOM recommendations and return to prepregnancy weight after childbirth. The goal&#xD;
      of this application is to test GROWell: Goals for Reaching Optimal Wellness, an innovative,&#xD;
      mHealth tool based on Self-regulation Theory that investigators designed in pilot work to&#xD;
      achieve appropriate gestational weight gain and safe postpartum weight loss. The&#xD;
      investigators propose a blinded, randomized controlled trial to test the efficacy of GROWell&#xD;
      compared to an attention control also developed in a pilot. Investigators will recruit 480&#xD;
      women ages 18-44 with prepregnancy BMI 25-&lt;40 and 10-16 weeks gestation of a singleton,&#xD;
      uncomplicated pregnancy. Block randomization based on BMI, race, and recruitment clinic will&#xD;
      be used to assign participants equally to arm 1, GROWell (n=240), or arm 2, the attention&#xD;
      control (n=240). Upon study enrollment and through 6 months postpartum, GROWell participants&#xD;
      will receive daily text messages that provide tailored education, problem-solving skills, and&#xD;
      support to aid their personalized dietary goals. Once weekly, participants self-monitor&#xD;
      overall adherence to their goals using text messages that prompt them to report on how they&#xD;
      did in the past week. When users respond to this prompt, they immediately receive a text with&#xD;
      tailored feedback on their adherence and long-term progress toward their goals. Control&#xD;
      participants will receive weekly texts that provide personalized self-care, pregnancy, labor,&#xD;
      delivery, and early infancy education. The specific aims are to: (1) Compare the efficacy of&#xD;
      GROWell to the attention control in reducing the proportion of women who gain excess&#xD;
      gestational weight based on IOM guidelines (&gt;25 lbs for overweight and &gt;20 lbs for obese)&#xD;
      controlling for demographics, parity, physical activity, diet quality, and&#xD;
      depression/anxiety; and (2) Compare the efficacy of GROWell to the attention control in&#xD;
      reducing postpartum weight retention at 6 months post-birth as measured by the proportion of&#xD;
      women who are within 5% of their prepregnancy weight, controlling for demographics, parity,&#xD;
      physical activity, diet quality, breastfeeding, and depression/anxiety. This research&#xD;
      addresses PA 18-135 (Maternal Nutrition and Pre-pregnancy Obesity) and will provide an&#xD;
      innovative, evidence-based, standalone mHealth tool to reduce excess gestational weight gain&#xD;
      and postpartum weight retention among overweight and obese women, currently an unavailable&#xD;
      resource.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 14, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Comparing intervention to active control</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gestational Weight Gain</measure>
    <time_frame>Mid-study (25-30 weeks)</time_frame>
    <description>Gestational weight gain will be calculated as: [weight(delivery) - weight(preconception)]. Women will be categorized as gaining excess gestational weight if they started pregnancy as overweight and gained more than 25 pounds or started pregnancy as obese and gained more than 20 pounds.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postpartum Weight Retention</measure>
    <time_frame>End of study (50-55 weeks)</time_frame>
    <description>Postpartum weight retention will be calculated as: [weight(6 months postpartum) - weight(preconception)]. Women will be categorized as experiencing postpartum weight retention if postpartum weight at 6 months is greater than 1.05*preconception weight.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence to text-based self- monitoring</measure>
    <time_frame>mid-study (25-30 weeks) and post-study (50-55 weeks)</time_frame>
    <description>Measured cumulatively by week as the number of times a participant responds to weekly prompts to report on her progress to the number of times she was prompted, calculated to a percent separately for prenatal and postnatal periods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to prescribed goals</measure>
    <time_frame>mid-study (25-30 weeks) and post-study (50-55 weeks)</time_frame>
    <description>Measured cumulatively by week as the proportion of goals for which a participant has &quot;good adherence&quot; during the previous week, defined as adhering to the goal 5/7 days, or &gt;70%, calculated to a percent and separately for prenatal and postpartum periods.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Delivery type</measure>
    <time_frame>mid-study (25-30 weeks)</time_frame>
    <description>Categorical as cesarean or vaginal delivery</description>
  </other_outcome>
  <other_outcome>
    <measure>Fetal growth abnormalities</measure>
    <time_frame>mid-study (25-30 weeks)</time_frame>
    <description>categorical as small-for-gestational age, large-for- gestational-age, macrosomia, or none.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pregnancy complications</measure>
    <time_frame>mid-study (25-30 weeks)</time_frame>
    <description>categorical as gestational diabetes, hypertension, preeclampsia/eclampsia, placental abruption, fetal death, antepartum admission, preterm birth with and without NICU admission, none</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">480</enrollment>
  <condition>Pregnancy Related</condition>
  <condition>Gestational Weight Gain</condition>
  <condition>Postpartum Weight Retention</condition>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>GROWell (Interactive Obesity Treatment Approach)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>With Self-regulation Theory as the framework, the Interactive Obesity Treatment Approach Adapted for Pregnancy/Postpartum includes four components: (1) personalized goal setting, (2) daily support and educational messages, (3) self-monitoring of behavior with tailored feedback, and (4) skills training. Each component aligns with the self- regulatory processes shown in previous studies to be necessary for behavior change. All interactions with participants are via text using a cell phone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attention Support Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The attention control will be delivered using text messaging to reduce the potential placebo effect that interacting with our mHealth system may have on pregnancy weight gain and postpartum weight loss. Information will be provided to control group participants that is specific to pregnancy, labor, delivery, and early infancy, but not to diet. Texts are specific to the participant's partner, pregnancy, employment, and breastfeeding plans/status.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>GROWell (Interactive Obesity Treatment Approach)</intervention_name>
    <description>Personalized messaging via cell phone to support healthy eating behaviors during pregnancy and through 6 months postpartum</description>
    <arm_group_label>GROWell (Interactive Obesity Treatment Approach)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Attention Support Control</intervention_name>
    <description>Personalized messaging via cell phone to support healthy behaviors during pregnancy and through 6 months postpartum</description>
    <arm_group_label>Attention Support Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  10-16 weeks gestation of a confirmed pregnancy (i.e., ultrasound/heartbeat detected)&#xD;
&#xD;
          -  Nulliparous or &gt;12 months since previous birth&#xD;
&#xD;
          -  Receive care at one of eight UC Davis Obstetric Clinics and plan to deliver at UC&#xD;
             Davis Medical Center&#xD;
&#xD;
          -  BMI &gt;25 and &lt;40 who are willing to receive and respond to texts using their own cell&#xD;
             phone or a study-provided phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known pregnancy or fetal complications/high-risk status&#xD;
&#xD;
          -  Multiple gestation&#xD;
&#xD;
          -  Unable to read/write English&#xD;
&#xD;
          -  BMI &gt;40&#xD;
&#xD;
          -  Current smokers&#xD;
&#xD;
          -  Quit smoking &lt;6 months prior to enrollment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leigh Ann Simmons, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>William Pacuilla</last_name>
    <phone>(530) 754-8280</phone>
    <email>bpacuilla@ucdavis.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Grace Liu</last_name>
    <phone>(530) 754-8323</phone>
    <email>proposals@ucdavis.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UC Davis</name>
      <address>
        <city>Davis</city>
        <state>California</state>
        <zip>95616</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Grace Liu, JD</last_name>
      <phone>530-754-7700</phone>
      <email>proposals@ucdavis.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://studypages.com/s/healthy-pregnancy-study-720304/</url>
    <description>Learn more or sign up for the study here!</description>
  </link>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pregnancy</keyword>
  <keyword>gestational weight gain</keyword>
  <keyword>postpartum weight retention</keyword>
  <keyword>overweight</keyword>
  <keyword>obesity</keyword>
  <keyword>diet</keyword>
  <keyword>mHealth</keyword>
  <keyword>digital health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <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>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04449432
org study id: 1399548
secondary id: 1R01NR017659-01A1
nct id: NCT04449432
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Despite the negative consequences to maternal-child health from women gaining too much weight
      during pregnancy, up to 62% of overweight and obese women gain more pregnancy weight than is
      recommended. This project will establish the efficacy of Goals for Reaching Optimal Wellness
      (GROWell), an mHealth tool for achieving appropriate pregnancy weight gain and promoting
      postpartum weight loss among women who enter pregnancy overweight or obese. GROWell will fill
      a gap in research and clinical care by providing a validated, standalone mHealth tool for
      weight control during pregnancy and postpartum, which is a currently lacking resource.
Research attempts to prevent excess gestational weight gain, defined as gaining more weight
      during pregnancy than Institute of Medicine (IOM) guidelines for prepregnancy body mass index
      (BMI), have largely been unsuccessful. Roughly 62% of overweight and 45% of obese women still
      gain more weight than recommended, increasing risk for postpartum weight retention. Few
      mobile health (mHealth) interventions have been trialed to address pregnancy-associated
      weight gain, which is a missed opportunity. Adult women are high users of technology for
      general and pregnancy-specific health information seeking and sharing. To fill this gap, the
      long-term goal of this research is to disseminate into clinical practice a standalone mHealth
      tool that is effective for overweight and obese pregnant women to achieve gestational weight
      gain within IOM recommendations and return to prepregnancy weight after childbirth. The goal
      of this application is to test GROWell: Goals for Reaching Optimal Wellness, an innovative,
      mHealth tool based on Self-regulation Theory that investigators designed in pilot work to
      achieve appropriate gestational weight gain and safe postpartum weight loss. The
      investigators propose a blinded, randomized controlled trial to test the efficacy of GROWell
      compared to an attention control also developed in a pilot. Investigators will recruit 480
      women ages 18-44 with prepregnancy BMI 25-<40 and 10-16 weeks gestation of a singleton,
      uncomplicated pregnancy. Block randomization based on BMI, race, and recruitment clinic will
      be used to assign participants equally to arm 1, GROWell (n=240), or arm 2, the attention
      control (n=240). Upon study enrollment and through 6 months postpartum, GROWell participants
      will receive daily text messages that provide tailored education, problem-solving skills, and
      support to aid their personalized dietary goals. Once weekly, participants self-monitor
      overall adherence to their goals using text messages that prompt them to report on how they
      did in the past week. When users respond to this prompt, they immediately receive a text with
      tailored feedback on their adherence and long-term progress toward their goals. Control
      participants will receive weekly texts that provide personalized self-care, pregnancy, labor,
      delivery, and early infancy education. The specific aims are to: (1) Compare the efficacy of
      GROWell to the attention control in reducing the proportion of women who gain excess
      gestational weight based on IOM guidelines (>25 lbs for overweight and >20 lbs for obese)
      controlling for demographics, parity, physical activity, diet quality, and
      depression/anxiety; and (2) Compare the efficacy of GROWell to the attention control in
      reducing postpartum weight retention at 6 months post-birth as measured by the proportion of
      women who are within 5% of their prepregnancy weight, controlling for demographics, parity,
      physical activity, diet quality, breastfeeding, and depression/anxiety. This research
      addresses PA 18-135 (Maternal Nutrition and Pre-pregnancy Obesity) and will provide an
      innovative, evidence-based, standalone mHealth tool to reduce excess gestational weight gain
      and postpartum weight retention among overweight and obese women, currently an unavailable
      resource.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Comparing intervention to active control
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Gestational Weight Gain
time frame: Mid-study (25-30 weeks)
description: Gestational weight gain will be calculated as: [weight(delivery) - weight(preconception)]. Women will be categorized as gaining excess gestational weight if they started pregnancy as overweight and gained more than 25 pounds or started pregnancy as obese and gained more than 20 pounds.
measure: Postpartum Weight Retention
time frame: End of study (50-55 weeks)
description: Postpartum weight retention will be calculated as: [weight(6 months postpartum) - weight(preconception)]. Women will be categorized as experiencing postpartum weight retention if postpartum weight at 6 months is greater than 1.05*preconception weight.
measure: Adherence to text-based self- monitoring
time frame: mid-study (25-30 weeks) and post-study (50-55 weeks)
description: Measured cumulatively by week as the number of times a participant responds to weekly prompts to report on her progress to the number of times she was prompted, calculated to a percent separately for prenatal and postnatal periods.
measure: Adherence to prescribed goals
time frame: mid-study (25-30 weeks) and post-study (50-55 weeks)
description: Measured cumulatively by week as the proportion of goals for which a participant has "good adherence" during the previous week, defined as adhering to the goal 5/7 days, or >70%, calculated to a percent and separately for prenatal and postpartum periods.
measure: Delivery type
time frame: mid-study (25-30 weeks)
description: Categorical as cesarean or vaginal delivery
measure: Fetal growth abnormalities
time frame: mid-study (25-30 weeks)
description: categorical as small-for-gestational age, large-for- gestational-age, macrosomia, or none.
measure: Pregnancy complications
time frame: mid-study (25-30 weeks)
description: categorical as gestational diabetes, hypertension, preeclampsia/eclampsia, placental abruption, fetal death, antepartum admission, preterm birth with and without NICU admission, none
arm group label: GROWell (Interactive Obesity Treatment Approach)
arm group type: Experimental
description: With Self-regulation Theory as the framework, the Interactive Obesity Treatment Approach Adapted for Pregnancy/Postpartum includes four components: (1) personalized goal setting, (2) daily support and educational messages, (3) self-monitoring of behavior with tailored feedback, and (4) skills training. Each component aligns with the self- regulatory processes shown in previous studies to be necessary for behavior change. All interactions with participants are via text using a cell phone.
arm group label: Attention Support Control
arm group type: Active Comparator
description: The attention control will be delivered using text messaging to reduce the potential placebo effect that interacting with our mHealth system may have on pregnancy weight gain and postpartum weight loss. Information will be provided to control group participants that is specific to pregnancy, labor, delivery, and early infancy, but not to diet. Texts are specific to the participant's partner, pregnancy, employment, and breastfeeding plans/status.
intervention type: Behavioral
intervention name: GROWell (Interactive Obesity Treatment Approach)
description: Personalized messaging via cell phone to support healthy eating behaviors during pregnancy and through 6 months postpartum
arm group label: GROWell (Interactive Obesity Treatment Approach)
intervention type: Behavioral
intervention name: Attention Support Control
description: Personalized messaging via cell phone to support healthy behaviors during pregnancy and through 6 months postpartum
arm group label: Attention Support Control
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 44 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Leigh Ann Simmons, PhD
role: Principal Investigator
affiliation: University of California, Davis
last name: William Pacuilla
phone: (530) 754-8280
email: bpacuilla@ucdavis.edu
last name: Grace Liu
phone: (530) 754-8323
email: proposals@ucdavis.edu
facility: 
status: Recruiting
contact: 
country: United States
url: https://studypages.com/s/healthy-pregnancy-study-720304/
description: Learn more or sign up for the study here!
responsible party type: Sponsor
mesh term: Overweight
mesh term: Body Weight
mesh term: Weight Gain
mesh term: Gestational Weight Gain
sharing ipd: No