Reducing Obesity Using Social Ties Program

NCT ID: NCT06335810

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-05
• Study Completion Date: 2026-03-01

Brief Summary

This trial aims to test the feasibility and acceptability of addressing interpersonal barriers to weight-related behavior change. Specifically, the study will test if, by including up to two friends, family members, or co-workers in a lifestyle intervention for weight loss, the person enrolled in the study loses more weight than someone whose friends, family members, or co-workers were not invited to participate.

Detailed Description

The investigators will evaluate whether the ROBUST intervention not only addresses individual-level behaviors (i.e., healthy eating, increased physical activity) but also:

1. reduces social undermining as well as changes perceived health norms by activating communal coping - a behavioral process that involves thinking, communicating, and acting as if a health risk (i.e., Type 2 diabetes) is shared; and

2. dampens the harmful effects of increased interpersonal conflict on weight by teaching participants how to induce a positive affect and self-affirming mindset

Participants in the control arm will receive the same number of lifestyle sessions as those randomized to the social network intervention.

Participants will:

1. Be randomly assigned to either the study group, which is asked to invite up to two friends or family members to join them at three coaching sessions, or the group that does not invite anyone.

2. Receive 15 coaching sessions over 24 weeks.

3. Complete an online questionnaire about eating and physical activity habits, confidence in developing healthier habits, mood, and health habits of twelve of their closest friends and family members.

4. Complete a 3-day weekly food log and wear a provided Fitbit for at least 9 hours daily.

5. The invited friends and family members will also be asked to complete a brief questionnaire about their eating and physical activity habits when they start and end the study.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Social Network Intervention

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

Group Type: EXPERIMENTAL

Social Network Intervention

Intervention Type: BEHAVIORAL

Social Network interventions are an intentional effort to modify or use the characteristics of social networks to improve, generate, and maintain healthy behaviors among individuals and populations. This study will focus on implementing a behavioral social-network intervention to promote changes in weight loss behaviors.

Individual Lifestyle Intervention

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

Group Type: PLACEBO_COMPARATOR

Individual Lifestyle Intervention

Intervention Type: BEHAVIORAL

The individual lifestyle intervention will serve as the control group and will implement the use of DPP based health coaching sessions to promote individual level changes in weight loss behaviors.

Social Network Member

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

Group Type: OTHER

Social Network Member

Intervention Type: OTHER

The social network member will serve as the friend, family member, or co-worker nominated to participate in the social network intervention by the social network intervention participant.

Interventions

Social Network Intervention

Social Network interventions are an intentional effort to modify or use the characteristics of social networks to improve, generate, and maintain healthy behaviors among individuals and populations. This study will focus on implementing a behavioral social-network intervention to promote changes in weight loss behaviors.

Intervention Type: BEHAVIORAL

Individual Lifestyle Intervention

The individual lifestyle intervention will serve as the control group and will implement the use of DPP based health coaching sessions to promote individual level changes in weight loss behaviors.

Intervention Type: BEHAVIORAL

Social Network Member

The social network member will serve as the friend, family member, or co-worker nominated to participate in the social network intervention by the social network intervention participant.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Index Participant:

1. Black race or Hispanic ethnicity

2. Male or Female 18 years of age or older

3. Calculated BMI > 30kg/m2 from objectively measured height and weight by study staff

4. Access & willingness to use program food intake app via home computer or a smartphone

5. Ability to identify at least one adult social network member who will participate in the study

• Social Network Member:

1. Male or Female 18 years of age or older

2. Access to the internet or a smartphone

Exclusion Criteria

• Index Participant:

1. Active enrollment in a weight-loss program, use of weight-loss medications, or planning weight-loss surgery

2. Advanced medical illness, dementia, hospitalization, injury, or pregnancy that inhibits regular physical activity

3. Contraindications to exercise based on the Physical Activity Readiness Questionnaire or lack of clearance from a health care provider

4. Unresolved Food insecurity

5. Speaks a language other than English or Spanish

• Social Network Member:

1. Speaks a language other than English or Spanish

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erica G Phillips, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rosio Ramos, BS

Role: CONTACT

ror2023@med.cornell.edu

646-962-5037

Anika Lewis, MS

Role: CONTACT

ale4008@med.cornell.edu

Facility Contacts

Anika Lewis, MS

Role: primary

ale4008@med.cornell.edu

646-962-9209

Erica Phillips, MD, MS

Role: backup

646-962-5013

References

Phillips E, Potter C, Poole J, Lewis A, Nahid M, Christos P, Hootman K, Winston G, de la Haye K. Reducing Obesity Using Social Ties (ROBUST): Protocol for a randomized control trial of a social network lifestyle intervention. PLoS One. 2025 Apr 16;20(4):e0318990. doi: 10.1371/journal.pone.0318990. eCollection 2025.

Reference Type: DERIVED

PMID: 40239159 (View on PubMed)

Other Identifiers

R01DK135949-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-10026599

Identifier Type: -

Identifier Source: org_study_id