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Weight Loss for Couples

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TEAMS (Talking about Eating, Activity, Mutual Support)
Need Support Training
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring couples, weight loss treatment, home environment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • University of Connecticut

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TEAMS

TEAMS+

Arm Description

Outcomes

Primary Outcome Measures

Weight loss

Secondary Outcome Measures

Full Information

First Posted
October 5, 2015
Last Updated
November 10, 2018
Sponsor
University of Connecticut
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1. Study Identification

Unique Protocol Identification Number
NCT02570009
Brief Title
Weight Loss for Couples
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
September 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
couples, weight loss treatment, home environment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TEAMS
Arm Type
Active Comparator
Arm Title
TEAMS+
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
TEAMS (Talking about Eating, Activity, Mutual Support)
Intervention Type
Behavioral
Intervention Name(s)
Need Support Training
Primary Outcome Measure Information:
Title
Weight loss
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Facility Information:
Facility Name
University of Connecticut
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33563035
Citation
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.
Results Reference
derived
PubMed Identifier
28962602
Citation
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.
Results Reference
derived

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Weight Loss for Couples

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