<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/NCT02229708</url>
  </required_header>
  <id_info>
    <org_study_id>22201</org_study_id>
    <secondary_id>R40MC26818</secondary_id>
    <nct_id>NCT02229708</nct_id>
  </id_info>
  <brief_title>Targeting Pregnancy-related Weight Gain to Reduce Disparities in Obesity</brief_title>
  <official_title>Targeting Pregnancy-related Weight Gain to Reduce Disparities in Obesity: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Temple University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>HRSA/Maternal and Child Health Bureau</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Temple University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out whether a technology-base healthy lifestyle program&#xD;
      is an acceptable and effective way for African-American mothers to improve their eating and&#xD;
      activity during pregnancy, compared to usual obstetric care. The goal of the program is to&#xD;
      enhance the health of African-American mothers and their babies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Black women are in particular need for obesity prevention and treatment. The childbearing&#xD;
      period represents a critical life stage of heightened vulnerability for new or persistent&#xD;
      obesity, especially among Black women, who retain 2-3 times more weight after pregnancy than&#xD;
      White women. Pregnancy weight gain is the strongest identified risk factor for retaining a&#xD;
      substantial amount of weight after pregnancy, yet few published interventions have been&#xD;
      effective in reducing excessive weight gain in pregnancy, particularly among low-income Black&#xD;
      mothers.&#xD;
&#xD;
      The proposed research aims to meets the needs of low-income, Black mothers by developing a&#xD;
      novel pregnancy intervention that 1) focuses solely on Black women, 2) incorporates Black&#xD;
      mothers' information needs, values, and social context, and 3) uses technology to facilitate&#xD;
      participant engagement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">July 17, 2019</completion_date>
  <primary_completion_date type="Actual">July 16, 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>Change in maternal weight from early pregnancy to 6 months and 1 year postpartum</measure>
    <time_frame>Approximately 18 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in maternal cardiometabolic risk factors (glucose tolerance, blood pressure) from early pregnancy to 6 months and 1 year postpartum</measure>
    <time_frame>Approximately 18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in infant weight and length from birth to 6 months and 1 year of age</measure>
    <time_frame>Approximately 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">262</enrollment>
  <condition>Pregnancy</condition>
  <condition>Body Weight Changes</condition>
  <condition>Behavioral</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The Usual Obstetric Care group will receive usual advice about nutrition and activity during pregnancy from their obstetrician along with some additional information about pregnancy and childbirth through readings from The American College of Obstetricians and Gynecologists. In addition, participants will receive weekly text messages to maintain contact and ensure follow-up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Lifestlye Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Healthy Lifestyle Group will take part in an individual, technology-based behavioral intervention program which will include specific information about nutrition and physical activity, and strategies for helping them make changes to their diet, physical activity, and weight-related behaviors during pregnancy. Participants will receive information through print materials, text messages, a private Facebook group, and in-person visits and phone calls from a health coach who is part of our research team.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy Lifestyle Group</intervention_name>
    <arm_group_label>Healthy Lifestlye Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant African-American women at least 18 years of age&#xD;
&#xD;
          -  BMI at recruitment between 25.0-44.9 kg/m2&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Gestational age of ≤ 20 weeks as determined by last menstrual period&#xD;
&#xD;
          -  Plan to carry the pregnancy to term and keep the baby&#xD;
&#xD;
          -  Own a cell phone with a text messaging plan&#xD;
&#xD;
          -  Member of Facebook social networking site&#xD;
&#xD;
          -  Able to participate in physical activity&#xD;
&#xD;
          -  Participants must be willing to comply with all study-related procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. BMI ≤ 24.9 or ≥ 45.0&#xD;
&#xD;
          -  Uncontrolled hypertension (systolic blood pressure &gt; 160 or diastolic blood pressure &gt;&#xD;
             95 mmHg). Participants with controlled hypertension on medication for at least three&#xD;
             months are allowable.&#xD;
&#xD;
          -  Known atherosclerotic cardiovascular disease&#xD;
&#xD;
          -  Known congestive heart failure&#xD;
&#xD;
          -  Known diabetes mellitus (type 1 or type 2)&#xD;
&#xD;
          -  Uncontrolled thyroid disease. Participants with controlled thyroid disease on&#xD;
             medication for at least three months are allowable.&#xD;
&#xD;
          -  Known cancer&#xD;
&#xD;
          -  Any major active rheumatologic, pulmonary, hepatic, dermatologic disease or&#xD;
             inflammatory condition requiring steroids or immune modulating medications&#xD;
&#xD;
          -  History of testing HIV positive&#xD;
&#xD;
          -  Current smoker or tobacco user&#xD;
&#xD;
          -  Current or recent history (past 6 months) of drug or alcohol abuse or dependence&#xD;
&#xD;
          -  Participation in any weight control or investigational drug study within 6 weeks of&#xD;
             screening&#xD;
&#xD;
          -  Serious or unstable medical or psychological conditions that, in the opinion of the&#xD;
             investigator, would compromise the subject's safety for successful participation in&#xD;
             the study&#xD;
&#xD;
          -  Gastrointestinal Disorders (gallbladder disease, Crohn's disease, etc)&#xD;
&#xD;
          -  Previous weight loss surgery&#xD;
&#xD;
          -  History of bulimia or anorexia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sharon J Herring, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Temple University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Temple University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>October 15, 2019</last_update_submitted>
  <last_update_submitted_qc>October 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pregnancy</keyword>
  <keyword>Weight control</keyword>
  <keyword>Behavioral</keyword>
  <keyword>technology-based intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Gain</mesh_term>
    <mesh_term>Body Weight Changes</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/NCT02229708
org study id: 22201
secondary id: R40MC26818
nct id: NCT02229708
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to find out whether a technology-base healthy lifestyle program
      is an acceptable and effective way for African-American mothers to improve their eating and
      activity during pregnancy, compared to usual obstetric care. The goal of the program is to
      enhance the health of African-American mothers and their babies.
Black women are in particular need for obesity prevention and treatment. The childbearing
      period represents a critical life stage of heightened vulnerability for new or persistent
      obesity, especially among Black women, who retain 2-3 times more weight after pregnancy than
      White women. Pregnancy weight gain is the strongest identified risk factor for retaining a
      substantial amount of weight after pregnancy, yet few published interventions have been
      effective in reducing excessive weight gain in pregnancy, particularly among low-income Black
      mothers.

      The proposed research aims to meets the needs of low-income, Black mothers by developing a
      novel pregnancy intervention that 1) focuses solely on Black women, 2) incorporates Black
      mothers' information needs, values, and social context, and 3) uses technology to facilitate
      participant engagement.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in maternal weight from early pregnancy to 6 months and 1 year postpartum
time frame: Approximately 18 months
measure: Change in maternal cardiometabolic risk factors (glucose tolerance, blood pressure) from early pregnancy to 6 months and 1 year postpartum
time frame: Approximately 18 months
measure: Change in infant weight and length from birth to 6 months and 1 year of age
time frame: Approximately 12 months
arm group label: Usual Care
arm group type: No Intervention
description: The Usual Obstetric Care group will receive usual advice about nutrition and activity during pregnancy from their obstetrician along with some additional information about pregnancy and childbirth through readings from The American College of Obstetricians and Gynecologists. In addition, participants will receive weekly text messages to maintain contact and ensure follow-up.
arm group label: Healthy Lifestlye Group
arm group type: Experimental
description: The Healthy Lifestyle Group will take part in an individual, technology-based behavioral intervention program which will include specific information about nutrition and physical activity, and strategies for helping them make changes to their diet, physical activity, and weight-related behaviors during pregnancy. Participants will receive information through print materials, text messages, a private Facebook group, and in-person visits and phone calls from a health coach who is part of our research team.
intervention type: Behavioral
intervention name: Healthy Lifestyle Group
arm group label: Healthy Lifestlye Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sharon J Herring, MD, MPH
role: Principal Investigator
affiliation: Temple University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity
mesh term: Body Weight
mesh term: Weight Gain
mesh term: Body Weight Changes