Reducing Obesity Using Social Ties Program

NCT06335810 | Recruiting DMC

• 2 other identifiers: 23-10026599R01DK135949-01
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Weight Loss; Undermining; Communication

Outcome Measures

Primary Outcomes (3)

• Number of participants who have attended at least 75 percent of the behavioral coaching sessions

  End of study (24 weeks)

• Number of intervention participants who have at least one social network member engage in the study

  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 Outcomes (5)

• Change in positive communication and problem solving as measured by the McMaster Family Assessment Device (FAD) Questionnaire

  Baseline, End of Study (24 weeks)

• Change in weight related social norms

  Baseline, End of Study (24 weeks)

• Change in median Fitbit wear time in minutes

  Weekly up to 24 weeks

• Change in total caloric amounts on three-day food record

  Weekly up to 24 weeks

• Change in median number of days that the Fitbit is worn

  Weekly up to 24 weeks

Study Arms (3)

Social Network Intervention

EXPERIMENTAL

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

Behavioral: Social Network Intervention

Individual Lifestyle Intervention

PLACEBO COMPARATOR

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

Behavioral: Individual Lifestyle Intervention

Social Network Member

OTHER

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

Other: Social Network Member

Interventions

Social Network Intervention 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.

Social Network Intervention

Individual Lifestyle Intervention 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.

Individual Lifestyle Intervention

Social Network Member 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.

Social Network Member

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss; Communication

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Study Officials

• Erica G Phillips, MD, MS

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosio Ramos, BS

CONTACT

646-962-5037; ror2023@med.cornell.edu

Anika Lewis, MS

CONTACT

ale4008@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 28, 2024
• Study Start: April 5, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will become available beginning 6 months following publication and ending 5 years following publication.
• Access Criteria: Anyone who wishes to access the data can request access for any purpose. Data will be made available and stored indefinitely in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository.

Locations

US (1)