NCT02570009

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

2.3 years

First QC Date

October 5, 2015

Last Update Submit

November 10, 2018

Conditions

OverweightObesity

Keywords

couplesweight loss treatmenthome environment

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    One year

Study Arms (2)

TEAMS

ACTIVE COMPARATOR
Behavioral: TEAMS (Talking about Eating, Activity, Mutual Support)

TEAMS+

ACTIVE COMPARATOR
Behavioral: TEAMS (Talking about Eating, Activity, Mutual Support)Behavioral: Need Support Training

Interventions

TEAMS (Talking about Eating, Activity, Mutual Support)BEHAVIORAL
TEAMSTEAMS+
Need Support TrainingBEHAVIORAL
TEAMS+

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

Related Publications (3)

  • Gorin AA, Leahey TM, Cornelius T, Bourgea K, Powers TA. Self-control and grit: associations with weight management and healthy habits. J Behav Med. 2024 Feb;47(1):160-167. doi: 10.1007/s10865-023-00431-9. Epub 2023 Jul 13.

    PMID: 37440156DERIVED

  • 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.

    PMID: 33563035DERIVED

  • 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.

    PMID: 28962602DERIVED

MeSH Terms

Conditions

OverweightObesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 5, 2015

First Posted

October 7, 2015

Study Start

June 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2018

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

US(1)