Couples Weight Loss Program for Obesity

(BUILD Trial)

Overseen By Amy Gorin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Connecticut

Disqualifiers: Pregnancy, Bariatric surgery, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

736 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to enhance an online weight loss program for couples. The study tests strategies such as planning together, receiving feedback, and making home changes to support weight loss. It aims to identify the best combination for effective weight loss in couples. Eligible couples should have a BMI between 25-55, live together, and be comfortable using a smartphone with internet access. As an unphased trial, this study offers couples the chance to contribute to innovative weight loss solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It would be best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that behavioral weight loss (BWL) programs are generally safe and easy for participants to follow. One study on a telehealth BWL program found it practical and well-received, with participants losing a significant amount of weight without major side effects. Another review confirms that BWL treatments effectively help people manage their weight over time, with no major safety concerns reported.

The Core BWL intervention in this trial uses similar methods, aiming to help couples support each other in losing weight. Since this study does not test a new drug or device, the safety risks are minimal. Overall, participants can expect this program to be a safe way to manage weight with their partners. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring a multi-faceted approach to weight loss by involving couples in the process. Unlike traditional weight loss programs that often focus solely on the individual, this trial incorporates elements like Dyadic Action Planning and Autonomy Support Training, which encourage partners to work together and support one another. Additionally, the trial looks at modifying the home environment to make it more conducive to healthy habits. By integrating these unique components, the trial aims to uncover whether a collaborative, supportive approach can lead to more effective and sustainable weight loss outcomes.

What evidence suggests that this trial's treatments could be effective for obesity?

Research shows that behavioral weight loss (BWL) programs effectively manage obesity. In this trial, participants will receive the Core BWL Intervention, a key component across all treatment arms. Studies have found that these programs greatly improve eating habits in people who are overweight or obese, helping participants gain better control over unhealthy eating patterns. Many BWL programs include digital tools to track weight, diet, and exercise, supporting long-term weight management. Overall, BWL is a recommended method for effective weight management. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for married or cohabitating couples where both partners are overweight (BMI between 25-55), speak and read English, have a smartphone with internet access, an active email address, and are willing to videoconference. Both must meet the criteria to participate.

Inclusion Criteria

English speaking/reading

I am willing to participate in video calls.

BMI between 25-55kg/m2

Exclusion Criteria

Pregnant or plan to become pregnant during the study period

I have a health condition that makes weight loss programs unsafe for me.

Report chest pain or loss of consciousness on the Physical Activity Readiness Questionnaire

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an online-only couples weight loss program using various strategies such as dyadic action planning, joint feedback, autonomy support training, and home environment modifications

6 months

Online interactions

Follow-up

Participants are monitored for weight change and other secondary outcomes such as physical activity and dietary intake

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Autonomy Support Training
• Core Behavioral Weight Loss (BWL) intervention
• Dyadic Action Planning
• Home Environment Modifications
• Joint Feedback

Trial Overview The study tests four strategies to boost weight loss in couples using an online program: dyadic action planning, joint feedback on goals, training to support each other's autonomy, and changes in the home environment. These will be added to a core behavioral weight loss intervention.

How Is the Trial Designed?

Group I: Condition 9 Experimental Treatment 2 Interventions

1\) Core BWL Intervention; 2) Dyadic Action Planning

Group II: Condition 8 Experimental Treatment 4 Interventions

1\) Core BWL Intervention; 2) Joint Feedback; 3) Autonomy Support Training; 4) Home Environment Modifications

Group III: Condition 7 Experimental Treatment 3 Interventions

1\) Core BWL Intervention; 2) Joint Feedback; 3) Autonomy Support Training

Group IV: Condition 6 Experimental Treatment 3 Interventions

1\) Core BWL Intervention; 2) Joint Feedback; 3) Home Environment Modifications

Group V: Condition 5 Experimental Treatment 2 Interventions

1\) Core BWL Intervention; 2) Joint Feedback

Group VI: Condition 4 Experimental Treatment 3 Interventions

1\) Core BWL Intervention; 2) Autonomy Support Training; 3) Home Environment Modifications

Group VII: Condition 3 Experimental Treatment 2 Interventions

1\) Core BWL Intervention; 2) Autonomy Support Training

Group VIII: Condition 2 Experimental Treatment 2 Interventions

1\) Core BWL Intervention; 2) Home Environment Modifications

Group IX: Condition 16 Experimental Treatment 5 Interventions

1\) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Autonomy Support Training; 5) Home Environment Modifications

Group X: Condition 15 Experimental Treatment 4 Interventions

1\) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Autonomy Support Training

Group XI: Condition 14 Experimental Treatment 4 Interventions

1\) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Home Environment Modifications

Group XII: Condition 13 Experimental Treatment 3 Interventions

1\) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback

Group XIII: Condition 12 Experimental Treatment 4 Interventions

1\) Core BWL Intervention; 2) Dyadic Action Planning; 3) Autonomy Support Training 4) Home Environment Modifications

Group XIV: Condition 11 Experimental Treatment 3 Interventions

1\) Core BWL Intervention; 2) Dyadic Action Planning; 3) Autonomy Support Training

Group XV: Condition 10 Experimental Treatment 3 Interventions

1\) Core BWL Intervention; 2) Dyadic Action Planning; 3) Home Environment Modifications

Group XVI: Condition 1 Experimental Treatment 1 Intervention

1\) Core BWL Intervention

Who Is Running the Clinical Trial?

University of Connecticut

Lead Sponsor

Trials

194

Recruited

162,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a 40-week behavioral weight loss program with 139 participants, increased meal planning frequency was linked to greater weight loss, suggesting that consistent meal planning is crucial for effective weight management.

While exercise planning frequency increased over time, it did not correlate with weight loss; in fact, higher exercise planning was associated with unexpected increases in BMI, indicating it may not be a reliable strategy for weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Greater Average Meal Planning Frequency Predicts Greater Weight Loss Outcomes in a Worksite-Based Behavioral Weight Loss Program. Hayes, JF., Balantekin, KN., Fitzsimmons-Craft, EE., et al.[2022]

This study aims to enhance online behavioral lifestyle interventions (BLI) for obesity by testing five innovative components, including virtual reality training and tailored physical activity promotion, with 384 adults over a 12-month period.

The research will use a systematic approach to identify the most effective combination of these components, potentially leading to improved weight loss outcomes and a better understanding of how these interventions work for different individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of intervention components to maximize outcomes of behavioral obesity treatment delivered online: A factorial experiment following the multiphase optimization strategy framework. Thomas, JG., Goldstein, CM., Bond, DS., et al.[2022]

A core outcome set for behavioral weight management programs (BWMPs) is being developed to standardize how outcomes are reported, allowing for better comparison of different interventions for adults with overweight and obesity.

The study will utilize a Delphi process involving 40 experts to reach consensus on which outcomes to measure and the definitions or instruments to use, ensuring that the findings are relevant and applicable in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a core outcome set for behavioural weight management programmes for adults with overweight and obesity: protocol for obtaining expert consensus using Delphi methodology. Mackenzie, RM., Ells, LJ., Simpson, SA., et al.[2023]

The study will involve adults aged 18 to 70 with overweight or obesity, using digital tools for self-monitoring in a 24-month behavioral weight loss program aimed at achieving and maintaining a 10% weight loss.

It will explore the effectiveness of different data sharing partnerships (with coaches, group members, and friends/family) on long-term weight loss, potentially revealing how these interactions can enhance weight loss outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sharing digital self-monitoring data with others to enhance long-term weight loss: A randomized controlled trial. Miller, NA., Ehmann, MM., Hagerman, CJ., et al.[2023]

In a study involving 141 overweight and obese adults over 48 weeks, participants in the Weight Watchers (WW) program achieved greater weight loss compared to those in a combined treatment (CT) approach that included brief behavioral weight loss (BWL) strategies.

The results indicated that 36.7% of WW participants lost at least 10% of their baseline weight, significantly more than those in the BWL (13.0%) or CT (15.2%) groups, suggesting that the WW program alone is effective for weight loss without the need for additional BWL components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining behavioral weight loss treatment and a commercial program: a randomized clinical trial. Pinto, AM., Fava, JL., Hoffmann, DA., et al.[2022]

A comprehensive weight-loss program that included changes to the home environment led to better weight loss results at 6 months compared to a standard behavioral weight-loss program, particularly benefiting women.

However, by 18 months, both groups showed similar weight regain, indicating that while initial environmental changes can enhance weight loss, they may not lead to long-term maintenance of weight loss, highlighting the need for further research on sustained strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a comprehensive home environment-focused weight-loss program for adults. Gorin, AA., Raynor, HA., Fava, J., et al.[2022]

Participants in a 12-week internet-delivered behavioral weight loss program who received extra support after poor initial weight loss (less than 2.3% at Week 4) lost twice as much weight compared to those who did not receive additional support.

The study suggests that providing targeted interventions to early non-responders can enhance program adherence and improve overall weight loss outcomes, indicating that personalized support may be beneficial in weight management programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary investigation into whether early intervention can improve weight loss among those initially non-responsive to an internet-based behavioral program. Unick, JL., Dorfman, L., Leahey, TM., et al.[2022]

In a study of 180 participants, young adults using an internet-based weight loss program with financial incentives lost an average of 5.4% of their weight, compared to 2.8% without incentives, indicating that financial rewards can enhance weight loss outcomes for this age group.

The results showed that 42% of young adults in the incentive group achieved a 10% weight loss, significantly higher than the 6% in the non-incentive group, suggesting that financial incentives can effectively motivate young adults to engage in weight loss efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Secondary Data Analysis Examining Young Adults' Performance in an Internet Weight Loss Program with Financial Incentives. LaRose, JG., Leahey, TM., Lanoye, A., et al.[2020]

In an 18-month study involving 132 heterosexual couples, the weight loss of partners was influenced by the dietary changes of the primary participant, particularly in the TOGETHER treatment group where both attended the program.

While direct treatment was most effective for participants, untreated partners experienced greater weight loss when their spouses reduced calorie and fat intake, indicating that positive dietary changes can have a ripple effect in couples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining a ripple effect: do spouses' behavior changes predict each other's weight loss? Schierberl Scherr, AE., McClure Brenchley, KJ., Gorin, AA.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7050499/

Core outcome set for behavioural weight management ... We have developed a core outcome set for behavioural weight management intervention programmes for adults with overweight and obesity.

2. sciencedirect.com sciencedirect.com/science/article/pii/S258953702400628X

The impact of weight loss interventions on disordered ... In people living with overweight/obesity, behavioural weight loss interventions were associated with significant improvements in disordered eating scores.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5477769/

Identifying the mechanisms through which behavioral ... Behavioral weight loss (BWL) programs are the recommended treatment for obesity, yet it is unknown whether these programs change one's ability to use ...

4. mhealth.jmir.org mhealth.jmir.org/2023/1/e45057

Patterns and Predictors of Engagement With Digital Self ... This study explored patterns of digital SM of weight, diet, and exercise during WLM (aim 1) and examined timing, patterns, and rates of disengagement and ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/osp4.70051

Testing a Personalized Behavioral Weight Loss Approach ... The primary aim of this study was to test the feasibility and preliminary efficacy of using the PBWL approach in individuals with overweight or ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8559298/

Behavioral weight loss in emerging adults - PubMed Central Formative data revealed that existing BWL programs do not meet their unique needs and identified motivation as a fundamental barrier for weight management. The ...

7. tandfonline.com tandfonline.com/doi/full/10.1080/15374416.2023.2251164

Evidence Base Update on Behavioral Treatments for ... This review provides an update to a previous Evidence Base Update addressing behavioral treatments for overweight and obesity in children and adolescents.

8. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2022.813822/full

Predictors of Weight Loss and Weight Loss Maintenance in ... Predictors of body weight loss (BWL) and body weight loss maintenance (BWLM) after behavioral weight loss intervention are well-investigated in adults.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11662970/

The Group‐basEd Telehealth behavioral WEight Loss ... This telehealth group BWL program was feasible and acceptable for breast cancer survivors, yielding a clinically significant weight loss.