Reducing Obesity Using Social Ties Program

Official title

Reducing Obesity Using Social Ties (ROBUST): Randomized Control Trial

Overview

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.

Interventions

• Behavioral 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.
• 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.
• Other 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.

Primary outcome measures

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

Secondary outcome measures (5)

• Change in positive communication and problem solving as measured by the McMaster Family Assessment Device (FAD) Questionnaire [Time frame: Baseline, End of Study (24 weeks)]
• Change in weight related social norms [Time frame: Baseline, End of Study (24 weeks)]
• Change in median Fitbit wear time in minutes [Time frame: Weekly up to 24 weeks]
• Change in total caloric amounts on three-day food record [Time frame: Weekly up to 24 weeks]
• Change in median number of days that the Fitbit is worn [Time frame: Weekly up to 24 weeks]

Eligibility criteria

Inclusion criteria

• Index Participant:

• Black race or Hispanic ethnicity
• Male or Female 18 years of age or older
• Calculated BMI > 30kg/m2 from objectively measured height and weight by study staff
• Access \& willingness to use program food intake app via home computer or a smartphone
• Ability to identify at least one adult social network member who will participate in the study
• Social Network Member:

• Male or Female 18 years of age or older
• Access to the internet or a smartphone

Exclusion criteria

• Index Participant:

• Active enrollment in a weight-loss program, use of weight-loss medications, or planning weight-loss surgery
• Advanced medical illness, dementia, hospitalization, injury, or pregnancy that inhibits regular physical activity
• Contraindications to exercise based on the Physical Activity Readiness Questionnaire or lack of clearance from a health care provider
• Unresolved Food insecurity
• Speaks a language other than English or Spanish
• Social Network Member:

• Speaks a language other than English or Spanish

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Other

Study locations

United States · 1 center

• Weill Cornell Medicine — New York

Publications

• 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. PMID 40239159

Identifiers

NCT: NCT06335810 · 23-10026599 · R01DK135949-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗