Social Ties Program for Obesity

(ROBUST Trial)

Recruiting at 4 trial locations

Overseen By Erica Phillips, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Must not be taking: Weight-loss medications

Disqualifiers: Advanced illness, Dementia, Pregnancy, others

Compensation: Varies

Number of Visits: 15

Duration: 24 weeks

264 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to aid weight loss by involving friends, family, or co-workers in the process. It compares the weight loss results of those with social support to those without it. Participants will attend communication skills sessions with their social network members as part of the Social Network Intervention, while another group receives standard health coaching. Ideal participants are Black or Hispanic individuals with a BMI over 30 (indicating obesity), who can use a smartphone app and have at least one supportive adult willing to join the study. As an unphased trial, this study offers a unique opportunity to contribute to innovative weight loss strategies that leverage social support.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be actively using weight-loss medications.

What prior data suggests that this social network intervention is safe for participants?

Research has shown that using social networks for weight loss is generally safe. Studies on social media programs for weight loss have found they can aid in weight loss and improve health measures like BMI, which compares weight to height. Importantly, these studies did not identify any major safety issues.

Additionally, participants in group weight loss programs often find support from others helpful, with no significant negative effects reported. These findings suggest that incorporating social connections in weight loss efforts is well-tolerated.

Overall, using social networks is considered safe for those trying to lose weight. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Social Network Intervention for obesity because it taps into the power of social connections to drive behavior change, a method quite distinct from traditional treatments like individual lifestyle and dietary changes or medication. This intervention involves participants engaging in communication skills sessions with their social network members, promoting a supportive environment that could enhance motivation and accountability. Unlike standard approaches that often focus on the individual, this method leverages the influence of social interactions, which could potentially lead to more sustainable lifestyle changes and weight management.

What evidence suggests that the Social Network Intervention is effective for weight loss?

Research shows that support from friends or family can aid in weight loss. Studies have found that this support leads to significant weight loss and smaller waist sizes. In one study, 97% of participants maintained their weight loss 16 months after receiving help. Even support through social media can enhance weight loss results. This trial will compare a Social Network Intervention, where participants engage in communication skills sessions with their social network, to an Individual Lifestyle Intervention, which involves standard health coaching sessions. These findings suggest that a supportive social network is important for managing weight. ^{1 6 7 8 9}

Who Is on the Research Team?

Erica G Phillips, MD, MS

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for individuals struggling with obesity. Participants should be willing to involve up to two friends, family members, or co-workers in the study. The exact criteria for who can join are not provided here.

Inclusion Criteria

Social Network Member: Access to the internet or a smartphone

Index Participant: Black race or Hispanic ethnicity

Index Participant: Calculated BMI > 30kg/m2 from objectively measured height and weight by study staff

Exclusion Criteria

I am actively trying to lose weight through a program, medication, or planning surgery.

I have a condition that prevents me from regular physical activity.

Index Participant: Contraindications to exercise based on the Physical Activity Readiness Questionnaire or lack of clearance from a health care provider

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 15 coaching sessions over 24 weeks, including communication skills sessions with social network members

24 weeks

15 sessions (in-person or virtual)

Follow-up

Participants are monitored for changes in weight-related social norms and communication skills

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Social Network Intervention

Trial Overview

The study is testing a weight loss program that includes the participant's social network. It compares results from those whose social ties are involved versus those without such involvement.

How Is the Trial Designed?

Group I: Social Network Member Experimental Treatment 1 Intervention

Social Network Members will complete 3 communication skills sessions with the social network intervention participant during weeks 3, 5, and 15.

Group II: Social Network Intervention Experimental Treatment 1 Intervention

Participants will complete 3 communication skills sessions with their social network members during weeks 3, 5, and 15.

Group III: Individual Lifestyle Intervention Placebo Group 1 Intervention

Participants will complete standard diabetes prevention program (DPP) based health coaching sessions during weeks 3, 5, and 15.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A 16-week trial involving 36 participants showed that adding technology to a standard weight-loss program did not significantly improve weight loss outcomes compared to the standard treatment alone, with both groups losing around 5% of their body weight.

Participants in the enhanced group self-weighed more frequently and reported high satisfaction with the program, but both groups experienced a decline in perceived social support for diet and exercise by the one-year follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and efficacy of a novel technology-based approach to harness social networks for weight loss: the NETworks pilot randomized controlled trial. Monroe, CM., Geraci, M., Larsen, CA., et al.[2023]

Social support is crucial for maintaining weight loss, as it directly correlates with successful weight management outcomes.

Current weight management programs often focus on enhancing group support, but the effectiveness of this approach has not been thoroughly evaluated, highlighting a need for more research on the types of support that work best.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing social support in weight loss management groups. Parham, ES.[2019]

In a study of 241 children with overweight/obesity, increased social network support for healthy eating was linked to improved vegetable intake, highlighting the importance of family involvement in dietary changes during weight-loss interventions.

Conversely, greater support for unhealthy eating was associated with poorer diet quality, and increased support for sedentary activities correlated with less physical activity and more screen time, suggesting that social influences can significantly impact children's health behaviors during family-based treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relation of social network support to child health behaviors among children in treatment for overweight/obesity. Fowler, LA., Litt, MD., Rotman, SA., et al.[2023]

In a study of 387 participants in a 16-week online behavioral weight loss program, individuals with smaller social networks experienced greater weight loss, suggesting that the size of one's social network may not be as important as previously thought.

The quality of relationships, particularly affectionate and positive support, was found to enhance weight loss outcomes, indicating that fostering strong, supportive connections may be more beneficial than simply increasing the number of social contacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of social connectedness on weight loss outcomes in an online program. Gilder, CM., Gorin, AA., Huedo-Medina, T., et al.[2023]

The study highlights the potential of using social networks as a novel approach to address obesity-related behaviors, emphasizing that social ties can significantly influence both weight gain and weight loss.

By analyzing 24 studies, the research identifies key factors such as network processes and individual contexts that interact to affect obesity behaviors, suggesting that health interventions should consider these complex relationships to be more effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social network influences and the adoption of obesity-related behaviours in adults: a critical interpretative synthesis review. Serrano Fuentes, N., Rogers, A., Portillo, MC.[2021]

The study tested a 12-month app- and web-based intervention called HelpMeDoIt! for adults with obesity, which successfully promoted social support from participants' existing networks to aid in weight loss, showing feasibility and acceptability among users.

While the study was exploratory and underpowered to detect significant effects, there were indications of potential benefits in physical activity, particularly in daily step counts and reduced sedentary time, suggesting the intervention could positively impact weight loss outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An app-, web- and social support-based weight loss intervention for adults with obesity: the 'HelpMeDoIt!' feasibility randomised controlled trial. Simpson, SA., Matthews, L., Pugmire, J., et al.[2022]

In a study of 214 participants undergoing a behavioral weight loss trial, having overweight casual friends and strong social norms for unhealthy eating negatively impacted weight loss outcomes, with participants losing an average of 4.4% of their initial body weight.

While the weight status of close social connections like partners and best friends correlated with higher BMI at baseline, it was specifically the influence of casual friends and unhealthy eating norms that predicted poorer weight loss during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social networks and social norms are associated with obesity treatment outcomes. Leahey, TM., Doyle, CY., Xu, X., et al.[2022]

Engagement with self-monitoring tools, such as online diet and exercise diaries, and participation in social support forums are significantly associated with weight loss in a study of 3621 participants in an online weight control program.

Higher engagement levels, particularly with food diaries, were linked to achieving clinically significant weight loss (over 5%), with men showing a 3.45 times and women a 5.05 times greater likelihood of success compared to those with lower engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between weight loss and engagement with a web-based food and exercise diary in a commercial weight loss programme: a retrospective analysis. Johnson, F., Wardle, J.[2022]

Social Support (SS) therapy can lead to significant weight loss compared to conventional treatment, with differences in weight loss ranging from 2.3 kg to 8.3 kg over periods of 12 to 24 months in five out of seven studies analyzed.

The overall quality of the evidence is low due to heterogeneity in study designs, lack of proper control measures, and variability in results, indicating a need for more rigorous and longer-term research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evidence of social support as therapy for weight loss: a systematic review]. Flores-Gómez, I., Bacardí-Gascón, M., Armendáriz-Anguiano, AL., et al.[2018]

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