Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Weight Loss for Couples

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02570009
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Amy Gorin, University of Connecticut

Brief Summary:
Obesity risk is shared within married couples yet most existing weight loss programs focus on individuals and not the marital dyad. This project will test the effects of a couples weight loss program that teaches spouses how to provide each other with autonomy support and create an interpersonal environment that promotes sustained behavior change.

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: TEAMS (Talking about Eating, Activity, Mutual Support) Behavioral: Need Support Training Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : June 2015
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: TEAMS Behavioral: TEAMS (Talking about Eating, Activity, Mutual Support)
Active Comparator: TEAMS+ Behavioral: TEAMS (Talking about Eating, Activity, Mutual Support)
Behavioral: Need Support Training



Primary Outcome Measures :
  1. Weight loss [ Time Frame: One year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570009


Locations
Layout table for location information
United States, Connecticut
University of Connecticut
Storrs, Connecticut, United States, 06269
Sponsors and Collaborators
University of Connecticut

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Amy Gorin, Associate Professor, University of Connecticut
ClinicalTrials.gov Identifier: NCT02570009     History of Changes
Other Study ID Numbers: HL125157
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Keywords provided by Amy Gorin, University of Connecticut:
couples
weight loss treatment
home environment
Additional relevant MeSH terms:
Layout table for MeSH terms
Overweight
Body Weight
Signs and Symptoms