<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/NCT01693666</url>
  </required_header>
  <id_info>
    <org_study_id>22009</org_study_id>
    <secondary_id>8485</secondary_id>
    <secondary_id>22009</secondary_id>
    <nct_id>NCT01693666</nct_id>
  </id_info>
  <brief_title>Lifestyle Intervention Forever: Healthy Weight for Pregnancy and Birth (Pilot Study)</brief_title>
  <official_title>Lifestyle Intervention Forever: Healthy Weight for Pregnancy and Birth (Pilot Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gaining too much weight in pregnancy is associated with adverse pregnancy complications and&#xD;
      can have a long-term impact on maternal and offspring health, including increased risk for&#xD;
      obesity and metabolic disease. Preventing excessive gestational weight gain could reduce&#xD;
      adverse pregnancy outcomes and improve long-term health of mothers and offspring. Thirty&#xD;
      obese (BMI ≥30) pregnant women will be recruited for this pilot study and randomly assigned&#xD;
      to the Lifestyle Intervention ForEver (LIFE) program or routine care (RC). Participants will&#xD;
      be enrolled before 18 weeks gestation and will be followed until 12 weeks after delivery.&#xD;
      Women in the LIFE program will be given guidance on healthy eating and exercise at their&#xD;
      regularly scheduled obstetric visits. To increase adherence to the program, a contingency&#xD;
      management (CM) intervention offering incentives will be used to establish and maintain&#xD;
      healthy nutrition and physical activity habits, working towards the goal of restricted weight&#xD;
      gain (± 10lb) during their pregnancy. Three study testing visits will be scheduled for all&#xD;
      participants: at study entry, 34-36 weeks gestation, and 12 weeks after delivering. Primary&#xD;
      outcomes include adherence to the LIFE program, weight change in pregnancy and postpartum,&#xD;
      and objective measures of maternal and offspring health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ultimate goal of this research is to examine the impact of a healthy lifestyle&#xD;
      intervention, targeting weight gain restriction during pregnancy in obese women&#xD;
      (BMI≥30kg/m2), on maternal and fetal outcomes.&#xD;
&#xD;
      The overarching research program has 3 main objectives:&#xD;
&#xD;
        1. To establish an effective contingency management behavioral program (LIFE), increasing&#xD;
           adherence to nutritional recommendations and exercise guidelines during pregnancy.&#xD;
&#xD;
        2. To examine the impact of the LIFE program on weight gain restriction during pregnancy&#xD;
           and postpartum weight loss in obese women in comparison to the RC group.&#xD;
&#xD;
        3. To examine the impact of the LIFE program on short- and long-term maternal and offspring&#xD;
           outcomes at study enrollment, 34-36 weeks gestation and 3 months postpartum in obese&#xD;
           women in comparison to the RC group.&#xD;
&#xD;
             -  Maternal Outcomes: body composition; peak aerobic capacity; maternal&#xD;
                hormonal/metabolic profiles (fasted blood sample); obstetric parameters (incidence&#xD;
                of GDM, preeclampsia, cesarean deliveries, obstetric trauma and neonatal&#xD;
                complications)&#xD;
&#xD;
             -  Offspring Outcomes: fetal growth pattern (fetal ultrasound); neonatal anthropometry&#xD;
                assessed ≤ 48 h of birth (crown-heel length, weight, head, chest and waist&#xD;
                circumferences, skinfold analyses); metabolic markers at birth (cord blood); and&#xD;
                infant anthropometry at 12 weeks of age (as above).&#xD;
&#xD;
      The experimental hypotheses to be tested are that participation in the LIFE intervention in&#xD;
      obese pregnant women will prevent excessive weight gain and/or achieve weight maintenance (±&#xD;
      10 lb) during pregnancy and will result in 7-10% weight loss at 12 weeks postpartum.&#xD;
      Secondly, we hypothesize that participation in the LIFE intervention in obese pregnant women&#xD;
      will be associated with improved aerobic capacity, reduced incidence of obstetric&#xD;
      complications and reduced rates of LGA as a result of beneficial alterations to metabolic&#xD;
      intrauterine environment for fetal growth.&#xD;
&#xD;
      With regard to this IRB application, we will be conducting a pilot and feasibility trial to&#xD;
      address the following specific aims:&#xD;
&#xD;
        1. To establish the feasibility of the LIFE program as a large-scale funded project,&#xD;
           including participant engagement in the intervention and all study visits.&#xD;
&#xD;
        2. To evaluate the feasibility of the LIFE program in achieving weight maintenance and&#xD;
           postpartum weight loss targets in obese pregnant women across all three obesity classes.&#xD;
&#xD;
        3. To develop and refine the study materials for the LIFE program and assessment battery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of Gestational weight gain from study entry to delivery</measure>
    <time_frame>Approx. 20-25 weeks</time_frame>
    <description>Maternal weight (lb) will be measured at program entry and at the time of delivery to determine weight gain during the study period.&#xD;
Pre-pregnancy body weight will be self-reported and used to estimate total gestational weight gain (lb).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure Change from baseline in maternal body composition</measure>
    <time_frame>16-21 weeks</time_frame>
    <description>Changes in lean and fat mass will be examined at study entry, in late pregnancy (34-36 weeks gestation) and at 12 weeks postpartum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure Change from baseline in maternal aerobic capacity</measure>
    <time_frame>16-21 weeks</time_frame>
    <description>Peak aerobic capacity will be examined via a standard maximal oxygen consumption (VO2max) test performed on a stationary cycle ergometer at study entry, in late pregnancy (34-36 weeks gestation), and at 12 weeks postpartum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure Maternal hormonal/metabolic changes from baseline</measure>
    <time_frame>16-21 weeks</time_frame>
    <description>A fasted blood sample will be collected at study entry, in late pregnancy (34-36 weeks gestation) and at 12 weeks postpartum to examine changes in lipid profile and adipokines (TNF-alpha, leptin). Fasting glucose, insulin and C-peptide will also be measured and entered into the homeostatic model (HOMA) to estimate changes in insulin sensitivity and beta cell function during the study period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Obstetric complications</measure>
    <time_frame>1-25 weeks</time_frame>
    <description>Parameters examined will include:&#xD;
incidence rates of pregnancy complications (gestational diabetes mellitus, preeclampsia, gestational hypertension)&#xD;
examination of obstetric parameters (mode of delivery, incidence of obstetric trauma, neonatal complications)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in maternal dietary intake</measure>
    <time_frame>16-21 weeks</time_frame>
    <description>Dietary intake will be examined at study entry (15-18 weeks gestation), in late pregnancy (34-36 weeks gestation) and at 12 weeks postpartum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure Change from baseline in maternal psychometric outcomes</measure>
    <time_frame>16-21 weeks</time_frame>
    <description>Psychometric outcomes examined at study entry, in late pregnancy (34-36 weeks gestation) and at 12 weeks postpartum include:&#xD;
Quality of life&#xD;
Depression and mood&#xD;
Physical activity social support&#xD;
Exercise self-efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure Offspring - fetal growth</measure>
    <time_frame>10-25 weeks</time_frame>
    <description>Fetal growth and abdominal circumference will be examined by fetal ultrasound at approximately 28-30, 34-36 and 38-40 weeks gestation and/or as part of routine care after 28 weeks gestation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure Neonatal size at birth</measure>
    <time_frame>Within 48 hours of birth</time_frame>
    <description>Between group comparisons of birth size will include birth weight (g), crown-heel length (mm), head circumference (mm), body mass index (kg/m2), ponderal index. Population-specific standard deviation (SD) scores will be calculated and the incidence of small for gestational age, appropriate for gestational age and large for gestational age will be compared between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure Neonatal body composition at birth</measure>
    <time_frame>Within 48 hours of birth</time_frame>
    <description>Neonatal lean and fat mass (g) will be calculated based on anthropometric measurements performed within 48 hours after birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure Offspring metabolic markers</measure>
    <time_frame>20-25 weeks</time_frame>
    <description>Concentrations of insulin-like growth factor (IGF)-I, IGF-II, IGF binding protein-1, IGF binding protein-3, glucose, insulin, leptin and triglyceride will be examined from cord blood samples taken at the time of delivery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure Pilot study outcomes</measure>
    <time_frame>32-37 weeks</time_frame>
    <description>The following pilot and feasibility outcomes will be assessed:&#xD;
Participant recruitment rate (number of participants recruited per week)&#xD;
Participant retention rate (percentage of participants completing all outcomes)&#xD;
Adherence to the study program (completion of study data, food records, exercise sessions)&#xD;
Success of the study program (percentage of participants achieving target gestational weight gain of plus/minus 10 lb)&#xD;
Intervention dose (total intervention time in hours).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure Postpartum weight retention at 12 weeks postpartum</measure>
    <time_frame>12 weeks</time_frame>
    <description>Maternal weight (lb) will be measured at 6 &amp; 12 weeks postpartum and compared to delivery weight (lb) to determine postpartum weight retention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure Change from baseline in maternal physical activity levels</measure>
    <time_frame>16-21 weeks</time_frame>
    <description>Physical activity levels will be examined at study entry (15-18 weeks gestation), in late pregnancy (34-36 weeks gestation) and at 12 weeks postpartum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure Infant size at 12 weeks of age</measure>
    <time_frame>12 weeks</time_frame>
    <description>Between group comparisons of body weight (g), length (mm), head circumference (mm), body mass index (kg/m2), and ponderal index. Population-specific SD scores will be calculated and compared between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure Infant body composition at 12 weeks of age</measure>
    <time_frame>12 weeks</time_frame>
    <description>Infant lean and fat mass (g) will be calculated based on anthropometric measurements performed at 12 weeks of age.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Pregnancy</condition>
  <condition>Obesity</condition>
  <condition>Weight Gain</condition>
  <condition>Obstetric Complications</condition>
  <arm_group>
    <arm_group_label>Lifestyle intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The LIFE program emphasizes improved nutritional quality, moderate physical activity, and weight maintenance (±10 lb) in obese pregnant women using a contingency management (CM) approach to reinforce behavior change. Participants will meet with the study dietitian and exercise physiologist every 2-4 weeks to develop and maintain individualized nutrition and physical activity plans, reinforced by CM. When the subject meets with the interventionists at their regular appointments, they will review the diet and exercise requirements, and provide vouchers earned as reinforcement from the previous study period. Diet requirements include at least 5 days of food logs each week. Exercise requirements include objective verification of up to 5 exercise sessions per week (as prescribed).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine care group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the Routine Care (RC) control group will receive no additional intervention beyond standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle intervention</intervention_name>
    <description>To establish an effective contingency management behavioral program (LIFE), increasing adherence to nutritional recommendations and exercise guidelines during pregnancy.&#xD;
To examine the impact of the LIFE program on weight gain restriction during pregnancy and postpartum weight loss in obese women in comparison to the RC group.&#xD;
To examine the impact of the LIFE program on short- and long-term maternal and offspring outcomes at study enrollment, 34-36 weeks gestation and 3 months postpartum in obese women in comparison to the RC group.</description>
    <arm_group_label>Lifestyle intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 18-40 years with a confirmed singleton pregnancy of up to 18 weeks&#xD;
             gestation&#xD;
&#xD;
          -  Pre-pregnancy or early pregnancy BMI greater than or equal to 30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aged &lt; 18 years or &gt; 40 years&#xD;
&#xD;
          -  BMI &lt; 30 kg/m2 at study screening&#xD;
&#xD;
          -  Multiple gestations&#xD;
&#xD;
          -  Previously diagnosed with type 1 or type 2 diabetes mellitus&#xD;
&#xD;
          -  Subjects will be excluded from the study if they present with any absolute or relative&#xD;
             contraindications to exercise in pregnancy (as defined by ACOG); determined by&#xD;
             completion of medical questionnaire by supervising physician&#xD;
&#xD;
          -  Any evidence of:&#xD;
&#xD;
             i. Drug or alcohol abuse ii. Presence of any unstable psychiatric disorder iii. Plans&#xD;
             to move away from the geographical area within the next nine months iv. Other medical&#xD;
             or behavioral factors that, in the judgement of the supervising physician, may&#xD;
             interfere with their ability to take part in a lifestyle intervention program during&#xD;
             pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rosemary Catanzaro</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint Louis University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>September 30, 2015</last_update_submitted>
  <last_update_submitted_qc>September 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Rosemary Catanzaro, RD</investigator_full_name>
    <investigator_title>Registered Dietician</investigator_title>
  </responsible_party>
  <keyword>Pregnancy</keyword>
  <keyword>Obesity</keyword>
  <keyword>Weight gain</keyword>
  <keyword>Obstetric complications</keyword>
  <keyword>Lifestyle intervention</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>
  </condition_browse>
  <!-- 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/NCT01693666
org study id: 22009
secondary id: 8485
secondary id: 22009
nct id: NCT01693666
lead sponsor: 
has dmc: No
Gaining too much weight in pregnancy is associated with adverse pregnancy complications and
      can have a long-term impact on maternal and offspring health, including increased risk for
      obesity and metabolic disease. Preventing excessive gestational weight gain could reduce
      adverse pregnancy outcomes and improve long-term health of mothers and offspring. Thirty
      obese (BMI ≥30) pregnant women will be recruited for this pilot study and randomly assigned
      to the Lifestyle Intervention ForEver (LIFE) program or routine care (RC). Participants will
      be enrolled before 18 weeks gestation and will be followed until 12 weeks after delivery.
      Women in the LIFE program will be given guidance on healthy eating and exercise at their
      regularly scheduled obstetric visits. To increase adherence to the program, a contingency
      management (CM) intervention offering incentives will be used to establish and maintain
      healthy nutrition and physical activity habits, working towards the goal of restricted weight
      gain (± 10lb) during their pregnancy. Three study testing visits will be scheduled for all
      participants: at study entry, 34-36 weeks gestation, and 12 weeks after delivering. Primary
      outcomes include adherence to the LIFE program, weight change in pregnancy and postpartum,
      and objective measures of maternal and offspring health.
The ultimate goal of this research is to examine the impact of a healthy lifestyle
      intervention, targeting weight gain restriction during pregnancy in obese women
      (BMI≥30kg/m2), on maternal and fetal outcomes.

      The overarching research program has 3 main objectives:

        1. To establish an effective contingency management behavioral program (LIFE), increasing
           adherence to nutritional recommendations and exercise guidelines during pregnancy.

        2. To examine the impact of the LIFE program on weight gain restriction during pregnancy
           and postpartum weight loss in obese women in comparison to the RC group.

        3. To examine the impact of the LIFE program on short- and long-term maternal and offspring
           outcomes at study enrollment, 34-36 weeks gestation and 3 months postpartum in obese
           women in comparison to the RC group.

             -  Maternal Outcomes: body composition; peak aerobic capacity; maternal
                hormonal/metabolic profiles (fasted blood sample); obstetric parameters (incidence
                of GDM, preeclampsia, cesarean deliveries, obstetric trauma and neonatal
                complications)

             -  Offspring Outcomes: fetal growth pattern (fetal ultrasound); neonatal anthropometry
                assessed ≤ 48 h of birth (crown-heel length, weight, head, chest and waist
                circumferences, skinfold analyses); metabolic markers at birth (cord blood); and
                infant anthropometry at 12 weeks of age (as above).

      The experimental hypotheses to be tested are that participation in the LIFE intervention in
      obese pregnant women will prevent excessive weight gain and/or achieve weight maintenance (±
      10 lb) during pregnancy and will result in 7-10% weight loss at 12 weeks postpartum.
      Secondly, we hypothesize that participation in the LIFE intervention in obese pregnant women
      will be associated with improved aerobic capacity, reduced incidence of obstetric
      complications and reduced rates of LGA as a result of beneficial alterations to metabolic
      intrauterine environment for fetal growth.

      With regard to this IRB application, we will be conducting a pilot and feasibility trial to
      address the following specific aims:

        1. To establish the feasibility of the LIFE program as a large-scale funded project,
           including participant engagement in the intervention and all study visits.

        2. To evaluate the feasibility of the LIFE program in achieving weight maintenance and
           postpartum weight loss targets in obese pregnant women across all three obesity classes.

        3. To develop and refine the study materials for the LIFE program and assessment battery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Measurement of Gestational weight gain from study entry to delivery
time frame: Approx. 20-25 weeks
description: Maternal weight (lb) will be measured at program entry and at the time of delivery to determine weight gain during the study period.
Pre-pregnancy body weight will be self-reported and used to estimate total gestational weight gain (lb).
measure: Measure Change from baseline in maternal body composition
time frame: 16-21 weeks
description: Changes in lean and fat mass will be examined at study entry, in late pregnancy (34-36 weeks gestation) and at 12 weeks postpartum
measure: Measure Change from baseline in maternal aerobic capacity
time frame: 16-21 weeks
description: Peak aerobic capacity will be examined via a standard maximal oxygen consumption (VO2max) test performed on a stationary cycle ergometer at study entry, in late pregnancy (34-36 weeks gestation), and at 12 weeks postpartum
measure: Measure Maternal hormonal/metabolic changes from baseline
time frame: 16-21 weeks
description: A fasted blood sample will be collected at study entry, in late pregnancy (34-36 weeks gestation) and at 12 weeks postpartum to examine changes in lipid profile and adipokines (TNF-alpha, leptin). Fasting glucose, insulin and C-peptide will also be measured and entered into the homeostatic model (HOMA) to estimate changes in insulin sensitivity and beta cell function during the study period.
measure: Number of participants with Obstetric complications
time frame: 1-25 weeks
description: Parameters examined will include:
incidence rates of pregnancy complications (gestational diabetes mellitus, preeclampsia, gestational hypertension)
examination of obstetric parameters (mode of delivery, incidence of obstetric trauma, neonatal complications)
measure: Change from baseline in maternal dietary intake
time frame: 16-21 weeks
description: Dietary intake will be examined at study entry (15-18 weeks gestation), in late pregnancy (34-36 weeks gestation) and at 12 weeks postpartum.
measure: Measure Change from baseline in maternal psychometric outcomes
time frame: 16-21 weeks
description: Psychometric outcomes examined at study entry, in late pregnancy (34-36 weeks gestation) and at 12 weeks postpartum include:
Quality of life
Depression and mood
Physical activity social support
Exercise self-efficacy
measure: Measure Offspring - fetal growth
time frame: 10-25 weeks
description: Fetal growth and abdominal circumference will be examined by fetal ultrasound at approximately 28-30, 34-36 and 38-40 weeks gestation and/or as part of routine care after 28 weeks gestation.
measure: Measure Neonatal size at birth
time frame: Within 48 hours of birth
description: Between group comparisons of birth size will include birth weight (g), crown-heel length (mm), head circumference (mm), body mass index (kg/m2), ponderal index. Population-specific standard deviation (SD) scores will be calculated and the incidence of small for gestational age, appropriate for gestational age and large for gestational age will be compared between groups.
measure: Measure Neonatal body composition at birth
time frame: Within 48 hours of birth
description: Neonatal lean and fat mass (g) will be calculated based on anthropometric measurements performed within 48 hours after birth
measure: Measure Offspring metabolic markers
time frame: 20-25 weeks
description: Concentrations of insulin-like growth factor (IGF)-I, IGF-II, IGF binding protein-1, IGF binding protein-3, glucose, insulin, leptin and triglyceride will be examined from cord blood samples taken at the time of delivery.
measure: Measure Pilot study outcomes
time frame: 32-37 weeks
description: The following pilot and feasibility outcomes will be assessed:
Participant recruitment rate (number of participants recruited per week)
Participant retention rate (percentage of participants completing all outcomes)
Adherence to the study program (completion of study data, food records, exercise sessions)
Success of the study program (percentage of participants achieving target gestational weight gain of plus/minus 10 lb)
Intervention dose (total intervention time in hours).
measure: Measure Postpartum weight retention at 12 weeks postpartum
time frame: 12 weeks
description: Maternal weight (lb) will be measured at 6 & 12 weeks postpartum and compared to delivery weight (lb) to determine postpartum weight retention.
measure: Measure Change from baseline in maternal physical activity levels
time frame: 16-21 weeks
description: Physical activity levels will be examined at study entry (15-18 weeks gestation), in late pregnancy (34-36 weeks gestation) and at 12 weeks postpartum.
measure: Measure Infant size at 12 weeks of age
time frame: 12 weeks
description: Between group comparisons of body weight (g), length (mm), head circumference (mm), body mass index (kg/m2), and ponderal index. Population-specific SD scores will be calculated and compared between groups.
measure: Measure Infant body composition at 12 weeks of age
time frame: 12 weeks
description: Infant lean and fat mass (g) will be calculated based on anthropometric measurements performed at 12 weeks of age.
arm group label: Lifestyle intervention group
arm group type: Experimental
description: The LIFE program emphasizes improved nutritional quality, moderate physical activity, and weight maintenance (±10 lb) in obese pregnant women using a contingency management (CM) approach to reinforce behavior change. Participants will meet with the study dietitian and exercise physiologist every 2-4 weeks to develop and maintain individualized nutrition and physical activity plans, reinforced by CM. When the subject meets with the interventionists at their regular appointments, they will review the diet and exercise requirements, and provide vouchers earned as reinforcement from the previous study period. Diet requirements include at least 5 days of food logs each week. Exercise requirements include objective verification of up to 5 exercise sessions per week (as prescribed).
arm group label: Routine care group
arm group type: No Intervention
description: Participants in the Routine Care (RC) control group will receive no additional intervention beyond standard of care.
intervention type: Behavioral
intervention name: Lifestyle intervention
description: To establish an effective contingency management behavioral program (LIFE), increasing adherence to nutritional recommendations and exercise guidelines during pregnancy.
To examine the impact of the LIFE program on weight gain restriction during pregnancy and postpartum weight loss in obese women in comparison to the RC group.
To examine the impact of the LIFE program on short- and long-term maternal and offspring outcomes at study enrollment, 34-36 weeks gestation and 3 months postpartum in obese women in comparison to the RC group.
arm group label: Lifestyle intervention group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rosemary Catanzaro
role: Principal Investigator
affiliation: St. Louis University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Rosemary Catanzaro, RD
investigator title: Registered Dietician
mesh term: Body Weight
mesh term: Weight Gain