- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03042208
Weight Watchers and Families
February 1, 2017 updated by: University of Connecticut
Ripple Effect of a Nationally Available Weight Loss Program on Untreated Family Members
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
260
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- body mass index between 27.0-40.0 kg/m2
- married or living with a significant other who had a BMI > 25 kg/m2
Exclusion Criteria:
- currently in a weight loss program, dieting, or taking medications that might affect weight
- had participated in a weight loss program in the past year
- lost > 5% of their body weight in the past 6 months
- were planning to or had undergone weight loss surgery
- had any orthopedic limitations or contraindications to physical activity
- were pregnant, lactating, or less than 6 months postpartum, or were planning to become pregnant in the next year
- reported uncontrolled hypertension, history of coronary heart disease, stroke, or peripheral arterial disease; reported chronic gastrointestinal disease
- endorsed having hepatitis B or C, cirrhosis, or HIV
- had a history of cancer within the past 5 years
- reported a significant psychiatric illness that might interfere with completion of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Access to Weight Watchers in-person meetings and online tools.
|
Access to Weight Watchers in-person meetings and online tools
|
|
Other: Self-Guided Control Group
Received handout with basic weight management advice.
|
Written handout with basic weight management strategies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Weight
Time Frame: 0, 3, and 6 months
|
body weight measured in kg
|
0, 3, and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2015
Primary Completion (Actual)
October 30, 2015
Study Completion (Actual)
October 30, 2015
Study Registration Dates
First Submitted
January 31, 2017
First Submitted That Met QC Criteria
February 1, 2017
First Posted (Estimate)
February 3, 2017
Study Record Updates
Last Update Posted (Estimate)
February 3, 2017
Last Update Submitted That Met QC Criteria
February 1, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H14-260
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.