- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05796141
Becoming United in Lifestyle Decisions (BUILD)
June 5, 2026 updated by: Amy Gorin, University of Connecticut
Optimizing a Couples-Based mHealth Intervention for Weight Management
The goal of this project is to investigate how to enhance the effects of an online-only (mHealth) couples weight loss program.
This study will use an innovative methodological framework, the Multiphase Optimization Strategy (MOST), to test four different strategies for weight loss and partner support in addition to a core intervention (i.e., dyadic action planning, joint feedback on goal progress, autonomy support training, and home environment modifications).
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Actual)
762
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
Hartford, Connecticut, United States, 06103
- UConn's Weight Management Research Group
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Married/cohabitating couple - both partners must be eligible
- BMI between 25-55kg/m2
- English speaking/reading
- Have a smartphone and reliable internet access
- Have active email address
- Willing to videoconference
Exclusion Criteria:
- Report being unable to walk 2 blocks without stopping
- Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months
- Are pregnant or plan to become pregnant during the study period
- Report chest pain or loss of consciousness on the Physical Activity Readiness Questionnaire
- Report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines
- Report conditions that, in the judgment of the PI, would render them unlikely to follow the protocol (e.g. dementia)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Condition 1
1) Core BWL Intervention
|
Behavioral weight loss core (lessons, self weighing, self-monitoring, individual action planning, feedback and progress check ins)
|
|
Experimental: Condition 2
1) Core BWL Intervention; 2) Home Environment Modifications
|
Behavioral weight loss core (lessons, self weighing, self-monitoring, individual action planning, feedback and progress check ins)
Participants will be trained in how to structure their home environment to support health behavior.
|
|
Experimental: Condition 3
1) Core BWL Intervention; 2) Autonomy Support Training
|
Behavioral weight loss core (lessons, self weighing, self-monitoring, individual action planning, feedback and progress check ins)
Participants will receive training in how to create an autonomy supportive environment within their marriage/partnership.
|
|
Experimental: Condition 4
1) Core BWL Intervention; 2) Autonomy Support Training; 3) Home Environment Modifications
|
Behavioral weight loss core (lessons, self weighing, self-monitoring, individual action planning, feedback and progress check ins)
Participants will be trained in how to structure their home environment to support health behavior.
Participants will receive training in how to create an autonomy supportive environment within their marriage/partnership.
|
|
Experimental: Condition 5
1) Core BWL Intervention; 2) Joint Feedback
|
Behavioral weight loss core (lessons, self weighing, self-monitoring, individual action planning, feedback and progress check ins)
Participants will see data on their partner's progress, in addition to their own weight and behavioral data.
|
|
Experimental: Condition 6
1) Core BWL Intervention; 2) Joint Feedback; 3) Home Environment Modifications
|
Behavioral weight loss core (lessons, self weighing, self-monitoring, individual action planning, feedback and progress check ins)
Participants will be trained in how to structure their home environment to support health behavior.
Participants will see data on their partner's progress, in addition to their own weight and behavioral data.
|
|
Experimental: Condition 7
1) Core BWL Intervention; 2) Joint Feedback; 3) Autonomy Support Training
|
Behavioral weight loss core (lessons, self weighing, self-monitoring, individual action planning, feedback and progress check ins)
Participants will receive training in how to create an autonomy supportive environment within their marriage/partnership.
Participants will see data on their partner's progress, in addition to their own weight and behavioral data.
|
|
Experimental: Condition 8
1) Core BWL Intervention; 2) Joint Feedback; 3) Autonomy Support Training; 4) Home Environment Modifications
|
Behavioral weight loss core (lessons, self weighing, self-monitoring, individual action planning, feedback and progress check ins)
Participants will be trained in how to structure their home environment to support health behavior.
Participants will receive training in how to create an autonomy supportive environment within their marriage/partnership.
Participants will see data on their partner's progress, in addition to their own weight and behavioral data.
|
|
Experimental: Condition 9
1) Core BWL Intervention; 2) Dyadic Action Planning
|
Behavioral weight loss core (lessons, self weighing, self-monitoring, individual action planning, feedback and progress check ins)
Participants will develop dyadic action plans together.
|
|
Experimental: Condition 10
1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Home Environment Modifications
|
Behavioral weight loss core (lessons, self weighing, self-monitoring, individual action planning, feedback and progress check ins)
Participants will be trained in how to structure their home environment to support health behavior.
Participants will develop dyadic action plans together.
|
|
Experimental: Condition 11
1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Autonomy Support Training
|
Behavioral weight loss core (lessons, self weighing, self-monitoring, individual action planning, feedback and progress check ins)
Participants will receive training in how to create an autonomy supportive environment within their marriage/partnership.
Participants will develop dyadic action plans together.
|
|
Experimental: Condition 12
1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Autonomy Support Training 4) Home Environment Modifications
|
Behavioral weight loss core (lessons, self weighing, self-monitoring, individual action planning, feedback and progress check ins)
Participants will be trained in how to structure their home environment to support health behavior.
Participants will receive training in how to create an autonomy supportive environment within their marriage/partnership.
Participants will develop dyadic action plans together.
|
|
Experimental: Condition 13
1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback
|
Behavioral weight loss core (lessons, self weighing, self-monitoring, individual action planning, feedback and progress check ins)
Participants will see data on their partner's progress, in addition to their own weight and behavioral data.
Participants will develop dyadic action plans together.
|
|
Experimental: Condition 14
1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Home Environment Modifications
|
Behavioral weight loss core (lessons, self weighing, self-monitoring, individual action planning, feedback and progress check ins)
Participants will be trained in how to structure their home environment to support health behavior.
Participants will see data on their partner's progress, in addition to their own weight and behavioral data.
Participants will develop dyadic action plans together.
|
|
Experimental: Condition 15
1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Autonomy Support Training
|
Behavioral weight loss core (lessons, self weighing, self-monitoring, individual action planning, feedback and progress check ins)
Participants will receive training in how to create an autonomy supportive environment within their marriage/partnership.
Participants will see data on their partner's progress, in addition to their own weight and behavioral data.
Participants will develop dyadic action plans together.
|
|
Experimental: Condition 16
1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Autonomy Support Training; 5) Home Environment Modifications
|
Behavioral weight loss core (lessons, self weighing, self-monitoring, individual action planning, feedback and progress check ins)
Participants will be trained in how to structure their home environment to support health behavior.
Participants will receive training in how to create an autonomy supportive environment within their marriage/partnership.
Participants will see data on their partner's progress, in addition to their own weight and behavioral data.
Participants will develop dyadic action plans together.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Weight (kg)
Time Frame: Baseline to 6 months
|
Weight change from baseline to 6 months.
Weight will be objectively measured on a digital scale in the participant's home and weight change will be calculated.
|
Baseline to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Goal Coordination (Wingrove Goal Coordination Scale)
Time Frame: Baseline, 3 months, 6 months
|
Goal coordination (the extent to which partners integrate and align their weight management goals) will be measured with the Wingrove Goal Coordination Scale at baseline, 3, and 6 months.
|
Baseline, 3 months, 6 months
|
|
Transactive Density
Time Frame: Baseline, 3 months, 6 months
|
Interdependence of partners will be measured with the Inclusion of Others in the Self Scale at baseline, 3, and 6 months.
|
Baseline, 3 months, 6 months
|
|
Shared Goal Representation
Time Frame: Baseline, 3 months, 6 months
|
The Important Others Questionnaire will be used to capture shared goal representation at baseline, 3, and 6 months.
|
Baseline, 3 months, 6 months
|
|
Home Food Environment (Household Food Inventory)
Time Frame: Baseline, 3 months, 6 months
|
The home food environment will be measured with the Household Food Inventory, administered at baseline, 3, and 6 months.
|
Baseline, 3 months, 6 months
|
|
Home Exercise Environment (Exercise Environment Questionnaire)
Time Frame: Baseline, 3 months, 6 months
|
The home exercise environment will be measured with the Exercise Environment Questionnaire, administered at baseline, 3, and 6 months.
|
Baseline, 3 months, 6 months
|
|
Dietary Intake
Time Frame: Baseline, 3 months, 6 months
|
Dietary intake will be assessed at baseline and 3 months as a hypothesized behavioral mediator and at 6 months as a secondary outcome measure.
|
Baseline, 3 months, 6 months
|
|
Physical Activity (Paffenbarger Physical Activity Questionnaire)
Time Frame: Baseline, 3 months, 6 months
|
Physical activity will be assessed using the Paffenbarger Physical Activity Questionnaire at baseline and 3 months as a hypothesized behavioral mediator and at 6 months as a secondary outcome measure.
|
Baseline, 3 months, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 13, 2024
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Study Registration Dates
First Submitted
February 22, 2023
First Submitted That Met QC Criteria
March 21, 2023
First Posted (Actual)
April 3, 2023
Study Record Updates
Last Update Posted (Actual)
June 9, 2026
Last Update Submitted That Met QC Criteria
June 5, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HR22-0023
- 1R01DK132386-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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