Reducing Obesity Using Social Ties Program

Not Applicable

Recruiting

• Conditions: Obesity
• Interventions: Behavioral: Individual Lifestyle Intervention; Behavioral: Social Network Intervention; Other: Social Network Member

• Registration Number: NCT06335810
• Lead Sponsor: Weill Medical College of Cornell University

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.

Study Timeline

• Study First Submitted: 2024-03-22
• Study First Submitted QC: 2024-03-22
• Study First Posted: 2024-03-28
• Study Start: 2024-04-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-06
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 264

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individual Lifestyle Intervention	Individual Lifestyle Intervention	Participants will complete standard diabetes prevention program (DPP) based health coaching sessions during weeks 3, 5, and 15.
Social Network Intervention	Social Network Intervention	Participants will complete 3 communication skills sessions with their social network members during weeks 3, 5, and 15.
Social Network Member	Social Network Member	Social Network Members will complete 3 communication skills sessions with the social network intervention participant during weeks 3, 5, and 15.

Primary Outcome Measures

Name	Time	Method
Number of intervention participants who have at least one social network member engage in the study	End of Study (24 weeks)
Number of participants who have attended at least 75 percent of the behavioral coaching sessions	End of study (24 weeks)
Number of participants and social network members combined who complete the final study assessment	End of Study (24 Weeks)

Secondary Outcome Measures

Name	Time	Method
Change in median Fitbit wear time in minutes	Weekly up to 24 weeks	Total minutes spent in very active intensity during activity
Change in positive communication and problem solving as measured by the McMaster Family Assessment Device (FAD) Questionnaire	Baseline, End of Study (24 weeks)	The lowest score on the McMaster Family Assessment Device (FAD) Questionnaire a participant can receive is 60 and the highest score on the McMaster Family Assessment Device (FAD) Questionnaire a participant can receive is 240. Higher scores mean positive family communication and problem solving.
Change in weight related social norms	Baseline, End of Study (24 weeks)	A 5 point Likert scale that measures unhealthy weight norms. The lowest score is 7 and the highest score is 35. Higher scores mean healthy eating and physical activity weight norms.
Change in median number of days that the Fitbit is worn	Weekly up to 24 weeks
Change in total caloric amounts on three-day food record	Weekly up to 24 weeks	Participants complete food records at minimum 3 days a week

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States