- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02570009
Weight Loss for Couples
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
-
Storrs, Connecticut, United States, 06269
- University of Connecticut
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
18-70 years old interested in receiving free weight loss treatment with their spouse have a body mass index (BMI) between 25 and 45 kg/m2. Individuals who respond to the advertisement will be screened for eligibility by phone. Eligibility will be limited to married/cohabitating couples (n=64) in which each spouse is 18-70 years old with a BMI between 25-45 kg/m2.
Exclusion Criteria:
currently in a weight loss program, dieting, or taking medications that might affect weight participated in a weight loss program in the past year have lost > 10% of body weight during past 6 months are currently participating in any other research study that may interfere with this study are pregnant, lactating, < 6 months postpartum, or plan to become pregnant during the study have undergone cancer treatment within the past year, not including skin cancer treatment have substance abuse, dependence, average more than 14 drinks per week, or are currently being treated for alcohol or substance abuse have a heart condition, chest pain during periods of activity or rest, or loss of consciousness report uncontrolled hypertension, history of coronary heart disease, stroke, peripheral arterial disease or have a blood pressure ≥160/100 mmHG as measured by study staff at baseline report chronic gastrointestinal disease endorse having hepatitis B or C, cirrhosis, or HIV; or report a significant psychiatric illness that may interfere with completion of the study deemed by study staff to be unlikely to adhere to study protocol (e.g. moving in the next 12 months).
Study Plan
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 |
|---|---|
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Active Comparator: TEAMS
|
|
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Active Comparator: TEAMS+
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Weight loss
Time Frame: One year
|
One year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Denes A, Crowley JP, Ponivas ALP, Cornelius T, Allred RJ, Gettens KM, Powers TA, Gorin AA. Evidence of the Associations between Individual and Partner Autonomy Support and Physiological Stress in the Context of Conversations about Weight among Couples Who are Overweight or Obese during a 6-Month Intervention. Health Commun. 2022 Jul;37(8):1013-1021. doi: 10.1080/10410236.2021.1880685. Epub 2021 Feb 9.
- Gorin AA, Powers TA, Gettens K, Cornelius T, Koestner R, Mobley AR, Pescatello L, Medina TH. Project TEAMS (Talking about Eating, Activity, and Mutual Support): a randomized controlled trial of a theory-based weight loss program for couples. BMC Public Health. 2017 Sep 29;17(1):749. doi: 10.1186/s12889-017-4732-7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HL125157
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