Back to resultsWeight Watchers and Families
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Self guided handout
Weight Watchers
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Self-Guided Control Group
Arm Description
Access to Weight Watchers in-person meetings and online tools.
Received handout with basic weight management advice.
Outcomes
Primary Outcome Measures
Change in Weight
body weight measured in kg
Secondary Outcome Measures
Full Information
NCT ID
NCT03042208
First Posted
January 31, 2017
Last Updated
February 1, 2017
Sponsor
University of Connecticut
Collaborators
Weight Watchers International
1. Study Identification
Unique Protocol Identification Number
NCT03042208
Brief Title
Weight Watchers and Families
Official Title
Ripple Effect of a Nationally Available Weight Loss Program on Untreated Family Members
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2, 2015 (Actual)
Primary Completion Date
October 30, 2015 (Actual)
Study Completion Date
October 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Connecticut
Collaborators
Weight Watchers International
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Access to Weight Watchers in-person meetings and online tools.
Arm Title
Self-Guided Control Group
Arm Type
Other
Arm Description
Received handout with basic weight management advice.
Intervention Type
Other
Intervention Name(s)
Self guided handout
Intervention Description
Written handout with basic weight management strategies
Intervention Type
Behavioral
Intervention Name(s)
Weight Watchers
Intervention Description
Access to Weight Watchers in-person meetings and online tools
Primary Outcome Measure Information:
Title
Change in Weight
Description
body weight measured in kg
Time Frame
0, 3, and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29388385
Citation
Gorin AA, Lenz EM, Cornelius T, Huedo-Medina T, Wojtanowski AC, Foster GD. Randomized Controlled Trial Examining the Ripple Effect of a Nationally Available Weight Management Program on Untreated Spouses. Obesity (Silver Spring). 2018 Mar;26(3):499-504. doi: 10.1002/oby.22098. Epub 2018 Feb 1.
Results Reference
derived
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Weight Watchers and Families
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