<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/NCT02260518</url>
  </required_header>
  <id_info>
    <org_study_id>R01HD078407</org_study_id>
    <secondary_id>R01HD078407</secondary_id>
    <nct_id>NCT02260518</nct_id>
  </id_info>
  <brief_title>Promoting Health in Pregnancy and Postpartum</brief_title>
  <acronym>HIPP</acronym>
  <official_title>Promoting Health in Pregnancy and Postpartum Among Overweight/Obese Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of South Carolina</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the impact of a lifestyle intervention on gestational&#xD;
      weight gain, postpartum weight loss, and other secondary outcomes relative to a usual care&#xD;
      control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our study will address the following specific aims: (1) examine the impact of a lifestyle&#xD;
      intervention on gestational weight gain and postpartum weight loss in overweight and obese&#xD;
      women, (2) examine the impact of the intervention on physical activity (PA), dietary intake,&#xD;
      and quality of life (QOL), (3) examine race differences in total gestational weight gain, PA,&#xD;
      dietary intake, and QOL; and (4) examine the impact of the intervention on offspring&#xD;
      adiposity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">November 1, 2020</completion_date>
  <primary_completion_date type="Actual">November 1, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gestational weight gain in pounds</measure>
    <time_frame>Delivery</time_frame>
    <description>Defined as delivery room weight minus pre-pregnancy weight</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gestational weight gain category</measure>
    <time_frame>Delivery</time_frame>
    <description>Based on delivery room weight minus pre-pregnancy weight and categorized as Inadequate, adequate, excessive</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postpartum weight retention</measure>
    <time_frame>Weight retained at the 6 month postpartum visit</time_frame>
    <description>Defined as weight during 6 month postpartum visit minus pre-pregnancy weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postpartum weight retention</measure>
    <time_frame>Weight retained at the 12 month postpartum visit</time_frame>
    <description>Defined as weight during 12 month postpartum visit minus pre-pregnancy weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>32 weeks gestation</time_frame>
    <description>Sense Wear Armband and self-report measure will assess physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>6 months postpartum</time_frame>
    <description>Sense Wear Armband and self-report measure will assess physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>12 months postpartum</time_frame>
    <description>Sense Wear Armband and self-report measure will assess physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary intake</measure>
    <time_frame>32 weeks gestation</time_frame>
    <description>Two 24-hour dietary recalls using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA-24) will assess dietary intake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary intake</measure>
    <time_frame>6 months postpartum</time_frame>
    <description>Two 24-hour dietary recalls using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA-24) will assess dietary intake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary intake</measure>
    <time_frame>12 months postpartum</time_frame>
    <description>Two 24-hour dietary recalls using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA-24) will assess dietary intake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive Symptoms</measure>
    <time_frame>32 weeks gestation</time_frame>
    <description>Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive Symptoms</measure>
    <time_frame>6 months postpartum</time_frame>
    <description>Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive Symptoms</measure>
    <time_frame>12 months postpartum</time_frame>
    <description>Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-Related Quality of Life</measure>
    <time_frame>32 weeks gestation</time_frame>
    <description>The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-Related Quality of Life</measure>
    <time_frame>6 months postpartum</time_frame>
    <description>The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-Related Quality of Life</measure>
    <time_frame>12 months postpartum</time_frame>
    <description>The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Adiposity</measure>
    <time_frame>6 months postpartum</time_frame>
    <description>Z-scores and skinfolds will be used to measure child adiposity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Adiposity</measure>
    <time_frame>12 months postpartum</time_frame>
    <description>Z-scores and skinfolds will be used to measure child adiposity.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Self-efficacy for diet and physical activity</measure>
    <time_frame>32 weeks gestation</time_frame>
    <description>Self-report measure</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-efficacy for diet and physical activity</measure>
    <time_frame>6 months postpartum</time_frame>
    <description>Self-report measure</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-efficacy for diet and physical activity</measure>
    <time_frame>12 months postpartum</time_frame>
    <description>Self-report measure</description>
  </other_outcome>
  <other_outcome>
    <measure>Social support for diet and physical activity</measure>
    <time_frame>32 weeks gestation</time_frame>
    <description>Self-report measure</description>
  </other_outcome>
  <other_outcome>
    <measure>Social support for diet and physical activity</measure>
    <time_frame>6 months postpartum</time_frame>
    <description>Self-report measure</description>
  </other_outcome>
  <other_outcome>
    <measure>Social support for diet and physical activity</measure>
    <time_frame>12 months postpartum</time_frame>
    <description>Self-report measure</description>
  </other_outcome>
  <other_outcome>
    <measure>Decisional balance for diet and physical activity</measure>
    <time_frame>32 weeks gestation</time_frame>
    <description>Self-report measure</description>
  </other_outcome>
  <other_outcome>
    <measure>Decisional balance for diet and physical activity</measure>
    <time_frame>6 months postpartum</time_frame>
    <description>Self-report measure</description>
  </other_outcome>
  <other_outcome>
    <measure>Decisional balance for diet and physical activity</measure>
    <time_frame>12 months postpartum</time_frame>
    <description>Self-report measure</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-regulation for diet and physical activity</measure>
    <time_frame>32 weeks gestation</time_frame>
    <description>Self-report measure</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-regulation for diet and physical activity</measure>
    <time_frame>6 months postpartum</time_frame>
    <description>Self-report measure</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-regulation for diet and physical activity</measure>
    <time_frame>12 months postpartum</time_frame>
    <description>Self-report measure</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">228</enrollment>
  <condition>Obesity</condition>
  <condition>Pregnancy</condition>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>Lifestyle Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention will focus on women gaining the recommended amount of weight, increasing physical activity to 150 minutes per week, and meeting healthy eating guidelines.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Women in the standard care group will attend their regularly scheduled obstetric (OB) visits with their prenatal care providers and will receive monthly mailings and matched number of podcasts.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle Intervention</intervention_name>
    <description>During pregnancy, participants complete one face-to-face counseling session, receive 10 behavioral podcasts, and receive weekly phone calls until delivery. Participants will be asked to attend one group session on breastfeeding. Participants will have the opportunity to participate in a private Facebook group during pregnancy and postpartum. During postpartum, participants complete one face-to-face counseling session, receive 16 behavioral podcasts, receive brief weekly check-in telephone calls for six weeks, and receive up to 8 telephone counseling calls through 6 months after delivery.</description>
    <arm_group_label>Lifestyle Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>Women will receive standard nutrition counseling provided by physicians, nurses, nutritionists, and counselors from the Women, Infants, and Children (WIC) program (if applicable). They will receive a monthly study mailing that is educational in nature as well as podcasts related to a healthy pregnancy. During pregnancy, the mailings will focus on tips for a healthy pregnancy and on fetal development. During postpartum the mailings will focus on infant development and parenting. We will select a matched number of podcasts from Pea in the Podcast, commercially available podcasts. All mailings and podcasts will avoid discussion of weight, PA, or diet (except for foods to avoid in pregnancy for safety reasons).</description>
    <arm_group_label>Standard Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  White or African American woman&#xD;
&#xD;
          -  Overweight or obese (prepregnancy BMI: 25-45 kg/m2)&#xD;
&#xD;
          -  ≤ 16 wks gestation at screening&#xD;
&#xD;
          -  Age 18-44 years&#xD;
&#xD;
          -  No plan to move out of the greater Columbia area in next 18 months&#xD;
&#xD;
          -  Regular and consistent telephone access&#xD;
&#xD;
          -  Availability for telephone calls&#xD;
&#xD;
          -  Willing to accept random assignment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Fetal anomaly&#xD;
&#xD;
          -  Taking insulin for diabetes&#xD;
&#xD;
          -  Uncontrolled or untreated thyroid disease&#xD;
&#xD;
          -  Mental health or substance-abuse hospitalization in last 6 months&#xD;
&#xD;
          -  Multiple gestation&#xD;
&#xD;
          -  Persistent bleeding in the first trimester&#xD;
&#xD;
          -  History of more than 3 miscarriages&#xD;
&#xD;
          -  History of an eating disorder or current eating disorder&#xD;
&#xD;
          -  History of an incompetent cervix&#xD;
&#xD;
          -  Physical disability that prevents exercise&#xD;
&#xD;
          -  Told by health care provider not to exercise&#xD;
&#xD;
          -  Any other medical conditions that might be a contraindication to exercise or dietary&#xD;
             change&#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>Sara Wilcox, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of South Carolina</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jihong Liu, Sc.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of South Carolina Prevention Research Center</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of South Carolina</investigator_affiliation>
    <investigator_full_name>Sara Wilcox</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Gestational weight gain</keyword>
  <keyword>Lifestyle intervention</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>Postpartum</keyword>
  <keyword>Physical activity</keyword>
  <keyword>Nutrition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</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/NCT02260518
org study id: R01HD078407
secondary id: R01HD078407
nct id: NCT02260518
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to examine the impact of a lifestyle intervention on gestational
      weight gain, postpartum weight loss, and other secondary outcomes relative to a usual care
      control group.
Our study will address the following specific aims: (1) examine the impact of a lifestyle
      intervention on gestational weight gain and postpartum weight loss in overweight and obese
      women, (2) examine the impact of the intervention on physical activity (PA), dietary intake,
      and quality of life (QOL), (3) examine race differences in total gestational weight gain, PA,
      dietary intake, and QOL; and (4) examine the impact of the intervention on offspring
      adiposity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Gestational weight gain in pounds
time frame: Delivery
description: Defined as delivery room weight minus pre-pregnancy weight
measure: Gestational weight gain category
time frame: Delivery
description: Based on delivery room weight minus pre-pregnancy weight and categorized as Inadequate, adequate, excessive
measure: Postpartum weight retention
time frame: Weight retained at the 6 month postpartum visit
description: Defined as weight during 6 month postpartum visit minus pre-pregnancy weight
measure: Postpartum weight retention
time frame: Weight retained at the 12 month postpartum visit
description: Defined as weight during 12 month postpartum visit minus pre-pregnancy weight
measure: Physical Activity
time frame: 32 weeks gestation
description: Sense Wear Armband and self-report measure will assess physical activity
measure: Physical Activity
time frame: 6 months postpartum
description: Sense Wear Armband and self-report measure will assess physical activity
measure: Physical Activity
time frame: 12 months postpartum
description: Sense Wear Armband and self-report measure will assess physical activity
measure: Dietary intake
time frame: 32 weeks gestation
description: Two 24-hour dietary recalls using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA-24) will assess dietary intake.
measure: Dietary intake
time frame: 6 months postpartum
description: Two 24-hour dietary recalls using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA-24) will assess dietary intake.
measure: Dietary intake
time frame: 12 months postpartum
description: Two 24-hour dietary recalls using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA-24) will assess dietary intake.
measure: Depressive Symptoms
time frame: 32 weeks gestation
description: Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.
measure: Depressive Symptoms
time frame: 6 months postpartum
description: Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.
measure: Depressive Symptoms
time frame: 12 months postpartum
description: Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.
measure: Health-Related Quality of Life
time frame: 32 weeks gestation
description: The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.
measure: Health-Related Quality of Life
time frame: 6 months postpartum
description: The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.
measure: Health-Related Quality of Life
time frame: 12 months postpartum
description: The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.
measure: Child Adiposity
time frame: 6 months postpartum
description: Z-scores and skinfolds will be used to measure child adiposity.
measure: Child Adiposity
time frame: 12 months postpartum
description: Z-scores and skinfolds will be used to measure child adiposity.
measure: Self-efficacy for diet and physical activity
time frame: 32 weeks gestation
description: Self-report measure
measure: Self-efficacy for diet and physical activity
time frame: 6 months postpartum
description: Self-report measure
measure: Self-efficacy for diet and physical activity
time frame: 12 months postpartum
description: Self-report measure
measure: Social support for diet and physical activity
time frame: 32 weeks gestation
description: Self-report measure
measure: Social support for diet and physical activity
time frame: 6 months postpartum
description: Self-report measure
measure: Social support for diet and physical activity
time frame: 12 months postpartum
description: Self-report measure
measure: Decisional balance for diet and physical activity
time frame: 32 weeks gestation
description: Self-report measure
measure: Decisional balance for diet and physical activity
time frame: 6 months postpartum
description: Self-report measure
measure: Decisional balance for diet and physical activity
time frame: 12 months postpartum
description: Self-report measure
measure: Self-regulation for diet and physical activity
time frame: 32 weeks gestation
description: Self-report measure
measure: Self-regulation for diet and physical activity
time frame: 6 months postpartum
description: Self-report measure
measure: Self-regulation for diet and physical activity
time frame: 12 months postpartum
description: Self-report measure
arm group label: Lifestyle Intervention
arm group type: Experimental
description: The intervention will focus on women gaining the recommended amount of weight, increasing physical activity to 150 minutes per week, and meeting healthy eating guidelines.
arm group label: Standard Care
arm group type: Other
description: Women in the standard care group will attend their regularly scheduled obstetric (OB) visits with their prenatal care providers and will receive monthly mailings and matched number of podcasts.
intervention type: Behavioral
intervention name: Lifestyle Intervention
description: During pregnancy, participants complete one face-to-face counseling session, receive 10 behavioral podcasts, and receive weekly phone calls until delivery. Participants will be asked to attend one group session on breastfeeding. Participants will have the opportunity to participate in a private Facebook group during pregnancy and postpartum. During postpartum, participants complete one face-to-face counseling session, receive 16 behavioral podcasts, receive brief weekly check-in telephone calls for six weeks, and receive up to 8 telephone counseling calls through 6 months after delivery.
arm group label: Lifestyle Intervention
intervention type: Behavioral
intervention name: Standard Care
description: Women will receive standard nutrition counseling provided by physicians, nurses, nutritionists, and counselors from the Women, Infants, and Children (WIC) program (if applicable). They will receive a monthly study mailing that is educational in nature as well as podcasts related to a healthy pregnancy. During pregnancy, the mailings will focus on tips for a healthy pregnancy and on fetal development. During postpartum the mailings will focus on infant development and parenting. We will select a matched number of podcasts from Pea in the Podcast, commercially available podcasts. All mailings and podcasts will avoid discussion of weight, PA, or diet (except for foods to avoid in pregnancy for safety reasons).
arm group label: Standard Care
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 44 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sara Wilcox, PhD
role: Principal Investigator
affiliation: University of South Carolina
last name: Jihong Liu, Sc.D
role: Principal Investigator
affiliation: University of South Carolina
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of South Carolina
investigator full name: Sara Wilcox
investigator title: Professor
mesh term: Overweight