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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03042208
Other study ID # H14-260
Secondary ID
Status Completed
Phase N/A
First received January 31, 2017
Last updated February 1, 2017
Start date January 2, 2015
Est. completion date October 30, 2015

Study information

Verified date February 2017
Source University of Connecticut
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 260
Est. completion date October 30, 2015
Est. primary completion date October 30, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Self guided handout
Written handout with basic weight management strategies
Behavioral:
Weight Watchers
Access to Weight Watchers in-person meetings and online tools

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Connecticut Weight Watchers International

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Weight body weight measured in kg 0, 3, and 6 months
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