<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/NCT03249324</url>
  </required_header>
  <id_info>
    <org_study_id>NHCL.2012.0011</org_study_id>
    <nct_id>NCT03249324</nct_id>
  </id_info>
  <brief_title>Preventing Obesity in Military Communities: Mother-Baby</brief_title>
  <official_title>Preventing Obesity in Military Communities: Mother-Baby</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry M. Jackson Foundation for the Advancement of Military Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Naval Hospital Camp Lejeune</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Henry M. Jackson Foundation for the Advancement of Military Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Women with pre-pregnancy obesity, women who exceed recommended weight gain during pregnancy,&#xD;
      and children who experience rapid and excess growth during the first year of life are all at&#xD;
      risk for subsequent obesity. The purpose of this study is to examine creative cognitive&#xD;
      strategies to promote healthy weight gain during pregnancy, creating a sound substrate of&#xD;
      metabolic programming for the critical first six months of life. A trans-disciplinary&#xD;
      approach utilizing a patient- and family-centered intervention and active patient engagement&#xD;
      with counseling for positive gain will work with women to shape lifestyle during pregnancy&#xD;
      and postpartum, and when feeding their infants in the first 6 months of life. It is&#xD;
      hypothesized patient engagement with counseling for positive gains will successfully mitigate&#xD;
      excess weight gain in both pregnancy and infancy compared to usual care. Moreover, data will&#xD;
      be examined to assess whether psychological variables, work and school climate, and social&#xD;
      support factors influence body weight gain trajectories and/or weight loss during and after&#xD;
      pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity is increasingly common among reproductive aged women and women presenting for their&#xD;
      first pregnancy. Women with overweight and obesity are more likely to exceed recommended&#xD;
      weight gain during pregnancy and retain excess weight after delivery. Women with&#xD;
      pre-pregnancy obesity, women who exceed recommended weight gain during pregnancy, and&#xD;
      children who experience rapid and excess growth during the first year of life are all at risk&#xD;
      for subsequent obesity. Additionally, maternal obesity is a significant risk factor for&#xD;
      pregnancy complications (i.e., hypertensive disorders of pregnancy, gestational diabetes) and&#xD;
      is associated with adverse pregnancy outcomes, including excess fetal weight at birth. The&#xD;
      goal of this study is to test the effectiveness of active patient engagement with counseling&#xD;
      for positive gain to mitigate excess weight gain in women during pregnancy and postpartum,&#xD;
      and in the first six months of life. Pregnant women eligible to receive care in the Military&#xD;
      Health System (MHS) will be randomized to receive either the positive-gain counseling (PGC)&#xD;
      prevention program or usual care (UC). PGC is designed to empower women to examine food&#xD;
      choices and activity patterns during pregnancy to help them adhere to the Institute of&#xD;
      Medicine (IOM) recommended weight gain standards. PGC patients will be paired with counselors&#xD;
      who follow their pregnancy from start to finish, as well as providing neonatal and infant&#xD;
      support in a continuous fashion as part of team-based care. Women in the usual care (UC)&#xD;
      group will receive prenatal care in accordance with the VA/DoD Guideline for the Management&#xD;
      of Pregnancy. Both groups will receive routine well-child care in accordance with established&#xD;
      guidelines from the American Academy of Pediatrics and the American Academy of Family&#xD;
      Physicians. Routine well-child care appointments (UC) take place at 2-3 days after birth, 2&#xD;
      weeks of life, 2 months of life, 4 months, 6 months, 9 months and 12 months. Participants'&#xD;
      weight status, food intake, and mood will be assessed once during each trimester and at 2&#xD;
      weeks, 2 months, 4 months, and 6 months postpartum. Individuals enrolled in the PGC group&#xD;
      will receive specific counseling once during each trimester and at 2 weeks, 2 months, 4&#xD;
      months and 6 months postpartum. Well-child sessions will focus on positive-gain-based&#xD;
      cognitive strategies to promote breastfeeding, recognition of satiety cues and other healthy&#xD;
      food choices. It is hypothesized that participants who receive the positive-gains counseling&#xD;
      program will show significantly less weight gain in both pregnancy and infancy relative to&#xD;
      those randomized to usual care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2017</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>Maternal weight gain</measure>
    <time_frame>Pre-pregnancy to delivery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Infant birth weight</measure>
    <time_frame>Birth</time_frame>
    <description>Data will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of gestational diabetes</measure>
    <time_frame>Gestation</time_frame>
    <description>Data will be collected for all participants from the outpatient electronic medical records (AHLTA) at Naval Hospital Camp Lejeune</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for induction of labor and methods of labor induction used</measure>
    <time_frame>Labor and delivery</time_frame>
    <description>Data will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mode of Delivery</measure>
    <time_frame>Birth</time_frame>
    <description>Mode of delivery (e.g., vaginal or Caesarean section) will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Labor</measure>
    <time_frame>Onset of latent phase of labor to delivery of the placenta and fetal membranes</time_frame>
    <description>The length of labor will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for anesthesia or analgesics and forms of anesthesia or analgesics used during labor</measure>
    <time_frame>Labor and delivery</time_frame>
    <description>Data will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Pregnancy</condition>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Positive-Gain Counseling (PGC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Positive-gain-based health promotion interventions capitalize on the basic human desire to maintain consistency between one's words and actions for beneficial outcomes. Participants will discuss potential costs of unhealthy behaviors and the benefits of healthier lifestyle choices, and how they apply not only to adults, but also to developing children. Theoretically, discussing these perspectives will make the mothers more likely to make healthier lifestyle choices in the future.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care (UC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>UC includes regular clinic visits, routine blood and urine screening tests, and anticipatory guidance from a primary care provider in accordance with the VA/DoD Guideline for the Management of Pregnancy. After delivery, participants receive routine well-child care in accordance with established guidelines from the American Academy of Pediatrics and the American Academy of Family Physicians.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Positive-Gain Counseling (PGC)</intervention_name>
    <description>Positive-gain-based health promotion interventions capitalize on the basic human desire to maintain consistency between one's words and actions for beneficial outcomes. Participants will be asked to discuss potential adverse effects of obesity, an unhealthy diet, and sedentary behavior, as well as the benefits of maintaining a physically fit body, eating a healthy diet, and regular physical activity. They will also discuss the costs and benefits as they apply to developing children. Theoretically, discussing and reviewing these perspectives will make the mothers more apt to make healthier lifestyle choices in the future. Women randomized to the positive-gains counseling (PGC) group will have PGC sessions once during each trimester and at 2 weeks, 2 months, 4 months and 6 months postpartum. PGC participants will also receive prenatal care in accordance with the VA/DoD Guideline for the Management of Pregnancy.</description>
    <arm_group_label>Positive-Gain Counseling (PGC)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Women in the usual care (UC) group will receive prenatal care in accordance with the VA/DoD Guideline for the Management of Pregnancy. This entails regular clinic visits, routine blood and urine screening tests, and anticipatory guidance. Routine well-child care appointments will take place at 2-3 days, 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after birth. During routine well-child visits, height, weight, and vital signs are measured, developmental milestones are reviewed, and a thorough physical examination is performed. Age-appropriate immunizations are provided as is parental anticipatory guidance, including the importance of breastfeeding. Participants enrolled in the UC group will receive anticipatory guidance from their primary care provider in the usual fashion. Providers will deliver this anticipatory guidance with no external cues or counseling provided by the research team.</description>
    <arm_group_label>Usual Care (UC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 35 years&#xD;
&#xD;
          -  Absence of underlying medical conditions that would place the pregnancy in the&#xD;
             high-risk category (e.g., hypertension, pre-existing diabetes mellitus, thyroid&#xD;
             disease, multiple gestations)&#xD;
&#xD;
          -  Baseline BMI (on determination of pregnancy) &gt;18 kg/m2 and ≤29.9 kg/m2&#xD;
&#xD;
          -  Plan to reside in the study area (Jacksonville, NC area) for at least 18 months&#xD;
&#xD;
          -  Eligible for care within the Military Health System (MHS)&#xD;
&#xD;
          -  No planned surgeries, medical interventions, or other procedures that would place&#xD;
             participants in the high-risk pregnancy category&#xD;
&#xD;
          -  No involvement in a commercial or military weight management program in the past 3&#xD;
             months&#xD;
&#xD;
          -  Fluent command of the English language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current involvement in a structured weight loss program&#xD;
&#xD;
          -  BMI of ≤18 kg/m2 or ≥30 kg/m2&#xD;
&#xD;
          -  Potential participants with high-risk pregnancies. Participants will be placed in the&#xD;
             high risk pregnancy category if they have any underlying medical conditions (e.g.&#xD;
             hypertension, diabetes, thyroid disease, multiple gestations) placing the subject into&#xD;
             a high-risk category by American College of Obstetrics and Gynecology (ACOG) standards&#xD;
&#xD;
          -  Planned surgeries or other procedures that would place participants in the high-risk&#xD;
             pregnancy category&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Stephens, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Uniformed Services University of the Health Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Linda Chan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Naval Hospital Camp Lejeune</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Naval Hospital Camp Lejeune</name>
      <address>
        <city>Camp Lejeune</city>
        <state>North Carolina</state>
        <zip>28547</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>June 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>August 10, 2017</last_update_submitted>
  <last_update_submitted_qc>August 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pregnancy</keyword>
  <keyword>Overweight</keyword>
  <keyword>Obesity</keyword>
  <keyword>Prevention</keyword>
  <keyword>Positive-gain counseling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</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/NCT03249324
org study id: NHCL.2012.0011
nct id: NCT03249324
lead sponsor: 
collaborator: 
has dmc: No
Women with pre-pregnancy obesity, women who exceed recommended weight gain during pregnancy,
      and children who experience rapid and excess growth during the first year of life are all at
      risk for subsequent obesity. The purpose of this study is to examine creative cognitive
      strategies to promote healthy weight gain during pregnancy, creating a sound substrate of
      metabolic programming for the critical first six months of life. A trans-disciplinary
      approach utilizing a patient- and family-centered intervention and active patient engagement
      with counseling for positive gain will work with women to shape lifestyle during pregnancy
      and postpartum, and when feeding their infants in the first 6 months of life. It is
      hypothesized patient engagement with counseling for positive gains will successfully mitigate
      excess weight gain in both pregnancy and infancy compared to usual care. Moreover, data will
      be examined to assess whether psychological variables, work and school climate, and social
      support factors influence body weight gain trajectories and/or weight loss during and after
      pregnancy.
Obesity is increasingly common among reproductive aged women and women presenting for their
      first pregnancy. Women with overweight and obesity are more likely to exceed recommended
      weight gain during pregnancy and retain excess weight after delivery. Women with
      pre-pregnancy obesity, women who exceed recommended weight gain during pregnancy, and
      children who experience rapid and excess growth during the first year of life are all at risk
      for subsequent obesity. Additionally, maternal obesity is a significant risk factor for
      pregnancy complications (i.e., hypertensive disorders of pregnancy, gestational diabetes) and
      is associated with adverse pregnancy outcomes, including excess fetal weight at birth. The
      goal of this study is to test the effectiveness of active patient engagement with counseling
      for positive gain to mitigate excess weight gain in women during pregnancy and postpartum,
      and in the first six months of life. Pregnant women eligible to receive care in the Military
      Health System (MHS) will be randomized to receive either the positive-gain counseling (PGC)
      prevention program or usual care (UC). PGC is designed to empower women to examine food
      choices and activity patterns during pregnancy to help them adhere to the Institute of
      Medicine (IOM) recommended weight gain standards. PGC patients will be paired with counselors
      who follow their pregnancy from start to finish, as well as providing neonatal and infant
      support in a continuous fashion as part of team-based care. Women in the usual care (UC)
      group will receive prenatal care in accordance with the VA/DoD Guideline for the Management
      of Pregnancy. Both groups will receive routine well-child care in accordance with established
      guidelines from the American Academy of Pediatrics and the American Academy of Family
      Physicians. Routine well-child care appointments (UC) take place at 2-3 days after birth, 2
      weeks of life, 2 months of life, 4 months, 6 months, 9 months and 12 months. Participants'
      weight status, food intake, and mood will be assessed once during each trimester and at 2
      weeks, 2 months, 4 months, and 6 months postpartum. Individuals enrolled in the PGC group
      will receive specific counseling once during each trimester and at 2 weeks, 2 months, 4
      months and 6 months postpartum. Well-child sessions will focus on positive-gain-based
      cognitive strategies to promote breastfeeding, recognition of satiety cues and other healthy
      food choices. It is hypothesized that participants who receive the positive-gains counseling
      program will show significantly less weight gain in both pregnancy and infancy relative to
      those randomized to usual care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Maternal weight gain
time frame: Pre-pregnancy to delivery
measure: Infant birth weight
time frame: Birth
description: Data will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune
measure: Development of gestational diabetes
time frame: Gestation
description: Data will be collected for all participants from the outpatient electronic medical records (AHLTA) at Naval Hospital Camp Lejeune
measure: Need for induction of labor and methods of labor induction used
time frame: Labor and delivery
description: Data will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune
measure: Mode of Delivery
time frame: Birth
description: Mode of delivery (e.g., vaginal or Caesarean section) will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune
measure: Length of Labor
time frame: Onset of latent phase of labor to delivery of the placenta and fetal membranes
description: The length of labor will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune
measure: Need for anesthesia or analgesics and forms of anesthesia or analgesics used during labor
time frame: Labor and delivery
description: Data will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune
arm group label: Positive-Gain Counseling (PGC)
arm group type: Experimental
description: Positive-gain-based health promotion interventions capitalize on the basic human desire to maintain consistency between one's words and actions for beneficial outcomes. Participants will discuss potential costs of unhealthy behaviors and the benefits of healthier lifestyle choices, and how they apply not only to adults, but also to developing children. Theoretically, discussing these perspectives will make the mothers more likely to make healthier lifestyle choices in the future.
arm group label: Usual Care (UC)
arm group type: Active Comparator
description: UC includes regular clinic visits, routine blood and urine screening tests, and anticipatory guidance from a primary care provider in accordance with the VA/DoD Guideline for the Management of Pregnancy. After delivery, participants receive routine well-child care in accordance with established guidelines from the American Academy of Pediatrics and the American Academy of Family Physicians.
intervention type: Behavioral
intervention name: Positive-Gain Counseling (PGC)
description: Positive-gain-based health promotion interventions capitalize on the basic human desire to maintain consistency between one's words and actions for beneficial outcomes. Participants will be asked to discuss potential adverse effects of obesity, an unhealthy diet, and sedentary behavior, as well as the benefits of maintaining a physically fit body, eating a healthy diet, and regular physical activity. They will also discuss the costs and benefits as they apply to developing children. Theoretically, discussing and reviewing these perspectives will make the mothers more apt to make healthier lifestyle choices in the future. Women randomized to the positive-gains counseling (PGC) group will have PGC sessions once during each trimester and at 2 weeks, 2 months, 4 months and 6 months postpartum. PGC participants will also receive prenatal care in accordance with the VA/DoD Guideline for the Management of Pregnancy.
arm group label: Positive-Gain Counseling (PGC)
intervention type: Other
intervention name: Usual Care
description: Women in the usual care (UC) group will receive prenatal care in accordance with the VA/DoD Guideline for the Management of Pregnancy. This entails regular clinic visits, routine blood and urine screening tests, and anticipatory guidance. Routine well-child care appointments will take place at 2-3 days, 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after birth. During routine well-child visits, height, weight, and vital signs are measured, developmental milestones are reviewed, and a thorough physical examination is performed. Age-appropriate immunizations are provided as is parental anticipatory guidance, including the importance of breastfeeding. Participants enrolled in the UC group will receive anticipatory guidance from their primary care provider in the usual fashion. Providers will deliver this anticipatory guidance with no external cues or counseling provided by the research team.
arm group label: Usual Care (UC)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mark Stephens, MD
role: Principal Investigator
affiliation: Uniformed Services University of the Health Sciences
last name: Linda Chan, MD
role: Principal Investigator
affiliation: Naval Hospital Camp Lejeune
facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity
mesh term: Overweight
sharing ipd: No