<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/NCT02205281</url>
  </required_header>
  <id_info>
    <org_study_id>72514</org_study_id>
    <nct_id>NCT02205281</nct_id>
  </id_info>
  <brief_title>Partners in Health: A Couples-based Approach to Obesity Prevention</brief_title>
  <acronym>PIH</acronym>
  <official_title>Partners in Health: A Couples-based Approach to Obesity Prevention.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>California Polytechnic State University-San Luis Obispo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dignity Health- French Hospital Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>California Polytechnic State University-San Luis Obispo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this pilot study is to test the feasibility of an innovative, couples based&#xD;
      approach to weight management during pregnancy. The primary hypothesis is that a&#xD;
      couples-based behavioral weight management program will reduce the rate of gestational weight&#xD;
      gain compared to standard care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2014</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">May 2018</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</measure>
    <time_frame>16 weeks gestation, 35 weeks gestation</time_frame>
    <description>Rate of gestational weight gain will be computed as difference between weights measured at study entry and gestational week 35; this difference will be divided by the number of weeks of observation during pregnancy (i.e., weeks between study entry and final pregnancy assessment). If gestational week 35 is unavailable, most proximal clinic visit weight will be used.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Partner's weight loss</measure>
    <time_frame>study entry, when pregnant partner reaches 35 weeks gestation</time_frame>
    <description>Weight lost by the non-pregnant partner during the study will be assessed by subtracting their weight at the 35 week gestation visit from their study entry weight.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Lifestyle Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle Intervention</intervention_name>
    <description>The intervention is a multi-component program designed to prevent excessive gestational weight gain in overweight and obese women and to promote weight loss in their non-pregnant overweight and obese partners through modifications of diet, exercise, and behavioral strategies during pregnancy.</description>
    <arm_group_label>Lifestyle Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Pregnant Women&#xD;
&#xD;
          -  &gt;18 years old&#xD;
&#xD;
          -  15-22 weeks gestation&#xD;
&#xD;
          -  BMI &gt;= 25&#xD;
&#xD;
          -  cohabitating with partner for at least 3 months or recently married&#xD;
&#xD;
          -  willing to consent&#xD;
&#xD;
        Non-pregnant Partner&#xD;
&#xD;
          -  BMI &gt;= 25&#xD;
&#xD;
          -  cohabitating with partner for at least 3 months or recently married&#xD;
&#xD;
          -  willing to consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Untreated medical or psychological problem&#xD;
&#xD;
          -  Inability to be physically active&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Suzanne Phelan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cal Poly</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cal Poly</name>
      <address>
        <city>San Luis Obispo</city>
        <state>California</state>
        <zip>93401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>August 27, 2020</last_update_submitted>
  <last_update_submitted_qc>August 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>California Polytechnic State University-San Luis Obispo</investigator_affiliation>
    <investigator_full_name>Suzanne Phelan</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Overweight</keyword>
  <keyword>Obese</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>Weight Gain</keyword>
  <keyword>Weight Loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT02205281
org study id: 72514
nct id: NCT02205281
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this pilot study is to test the feasibility of an innovative, couples based
      approach to weight management during pregnancy. The primary hypothesis is that a
      couples-based behavioral weight management program will reduce the rate of gestational weight
      gain compared to standard care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Gestational weight gain
time frame: 16 weeks gestation, 35 weeks gestation
description: Rate of gestational weight gain will be computed as difference between weights measured at study entry and gestational week 35; this difference will be divided by the number of weeks of observation during pregnancy (i.e., weeks between study entry and final pregnancy assessment). If gestational week 35 is unavailable, most proximal clinic visit weight will be used.
measure: Partner's weight loss
time frame: study entry, when pregnant partner reaches 35 weeks gestation
description: Weight lost by the non-pregnant partner during the study will be assessed by subtracting their weight at the 35 week gestation visit from their study entry weight.
arm group label: Standard Care
arm group type: No Intervention
arm group label: Lifestyle Intervention
arm group type: Experimental
intervention type: Behavioral
intervention name: Lifestyle Intervention
description: The intervention is a multi-component program designed to prevent excessive gestational weight gain in overweight and obese women and to promote weight loss in their non-pregnant overweight and obese partners through modifications of diet, exercise, and behavioral strategies during pregnancy.
arm group label: Lifestyle Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Suzanne Phelan, PhD
role: Principal Investigator
affiliation: Cal Poly
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: California Polytechnic State University-San Luis Obispo
investigator full name: Suzanne Phelan
investigator title: Associate Professor
mesh term: Obesity