Becoming United in Lifestyle Decisions

Overweight and Obesity Clinical Trial

— BUILD  

Official title:

Optimizing a Couples-Based mHealth Intervention for Weight Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05796141
• Other study ID #: HR22-0023
• Secondary ID: 1R01DK132386-01
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2024
• Est. completion date: November 2026

Study information

• Verified date: April 2024
• Source: University of Connecticut
• Contact: Zeely Denmat, BS
• Phone: 860-455-3842
• Email: zeely.denmat[@]uconn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 736
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Core Behavioral Weight Loss (BWL) intervention
Behavioral weight loss core (lessons, self weighing, self-monitoring, individual action planning, feedback and progress check ins)
• Dyadic Action Planning
Participants will develop dyadic action plans together.
• Joint Feedback
Participants will see data on their partner's progress, in addition to their own weight and behavioral data.
• Autonomy Support Training
Participants will receive training in how to create an autonomy supportive environment within their marriage/partnership.
• Home Environment Modifications
Participants will be trained in how to structure their home environment to support health behavior.

Locations

Country	Name	City	State
United States	UConn's Weight Management Research Group	Hartford	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
University of Connecticut	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight (kg)	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	Goal Coordination (Wingrove Goal Coordination Scale)	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
Secondary	Transactive Density	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
Secondary	Shared Goal Representation	The Important Others Questionnaire will be used to capture shared goal representation at baseline, 3, and 6 months.	Baseline, 3 months, 6 months
Secondary	Home Food Environment (Household Food Inventory)	The home food environment will be measured with the Household Food Inventory, administered at baseline, 3, and 6 months.	Baseline, 3 months, 6 months
Secondary	Home Exercise Environment (Exercise Environment Questionnaire)	The home exercise environment will be measured with the Exercise Environment Questionnaire, administered at baseline, 3, and 6 months.	Baseline, 3 months, 6 months
Secondary	Dietary Intake	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
Secondary	Physical Activity (Paffenbarger Physical Activity Questionnaire)	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