<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/NCT03042208</url>
  </required_header>
  <id_info>
    <org_study_id>H14-260</org_study_id>
    <nct_id>NCT03042208</nct_id>
  </id_info>
  <brief_title>Weight Watchers and Families</brief_title>
  <official_title>Ripple Effect of a Nationally Available Weight Loss Program on Untreated Family Members</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Connecticut</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Weight Watchers International</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Connecticut</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Research suggests that when one spouse loses weight, the other spouse does too. This study&#xD;
      will examine whether a ripple effect is observed in untreated spouses and children of&#xD;
      individuals participating in a nationally available weight loss program. Participants will be&#xD;
      randomly assigned to either receive Weight Watchers immediately or at the end of a 6-month&#xD;
      waiting period. Participants and untreated spouses (and any children in the home) will be&#xD;
      assessed at baseline, 3, and 6 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2015</start_date>
  <completion_date type="Actual">October 30, 2015</completion_date>
  <primary_completion_date type="Actual">October 30, 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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Weight</measure>
    <time_frame>0, 3, and 6 months</time_frame>
    <description>body weight measured in kg</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">260</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Access to Weight Watchers in-person meetings and online tools.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-Guided Control Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Received handout with basic weight management advice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self guided handout</intervention_name>
    <description>Written handout with basic weight management strategies</description>
    <arm_group_label>Self-Guided Control Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Weight Watchers</intervention_name>
    <description>Access to Weight Watchers in-person meetings and online tools</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  body mass index between 27.0-40.0 kg/m2&#xD;
&#xD;
          -  married or living with a significant other who had a BMI &gt; 25 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  currently in a weight loss program, dieting, or taking medications that might affect&#xD;
             weight&#xD;
&#xD;
          -  had participated in a weight loss program in the past year&#xD;
&#xD;
          -  lost &gt; 5% of their body weight in the past 6 months&#xD;
&#xD;
          -  were planning to or had undergone weight loss surgery&#xD;
&#xD;
          -  had any orthopedic limitations or contraindications to physical activity&#xD;
&#xD;
          -  were pregnant, lactating, or less than 6 months postpartum, or were planning to become&#xD;
             pregnant in the next year&#xD;
&#xD;
          -  reported uncontrolled hypertension, history of coronary heart disease, stroke, or&#xD;
             peripheral arterial disease; reported chronic gastrointestinal disease&#xD;
&#xD;
          -  endorsed having hepatitis B or C, cirrhosis, or HIV&#xD;
&#xD;
          -  had a history of cancer within the past 5 years&#xD;
&#xD;
          -  reported a significant psychiatric illness that might interfere with completion of the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03042208
org study id: H14-260
nct id: NCT03042208
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Research suggests that when one spouse loses weight, the other spouse does too. This study
      will examine whether a ripple effect is observed in untreated spouses and children of
      individuals participating in a nationally available weight loss program. Participants will be
      randomly assigned to either receive Weight Watchers immediately or at the end of a 6-month
      waiting period. Participants and untreated spouses (and any children in the home) will be
      assessed at baseline, 3, and 6 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Weight
time frame: 0, 3, and 6 months
description: body weight measured in kg
arm group label: Intervention
arm group type: Experimental
description: Access to Weight Watchers in-person meetings and online tools.
arm group label: Self-Guided Control Group
arm group type: Other
description: Received handout with basic weight management advice.
intervention type: Other
intervention name: Self guided handout
description: Written handout with basic weight management strategies
arm group label: Self-Guided Control Group
intervention type: Behavioral
intervention name: Weight Watchers
description: Access to Weight Watchers in-person meetings and online tools
arm group label: Intervention
criteria: 
gender: All
minimum age: 25 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Overweight
sharing ipd: No