Reducing Obesity Using Social Ties Program

Obesity Clinical Trial

— ROBUST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06335810
• Other study ID #: 23-10026599
• Secondary ID: R01DK135949-01
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2024
• Est. completion date: March 2026

Study information

• Verified date: April 2024
• Source: Weill Medical College of Cornell University
• Contact: Jesabely Solano, BS
• Phone: 646-962-9209
• Email: jes4037[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Weill Cornell Urology	Brooklyn	New York
United States	Weill Cornell Internal Medicine Associates	New York	New York
United States	Weill Cornell Primary Care at Lower Manhattan	New York	New York
United States	Weill Cornell Urology	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who have attended at least 75 percent of the behavioral coaching sessions		End of study (24 weeks)
Primary	Number of intervention participants who have at least one social network member engage in the study		End of Study (24 weeks)
Primary	Number of participants and social network members combined who complete the final study assessment		End of Study (24 Weeks)
Secondary	Change in positive communication and problem solving as measured by the McMaster Family Assessment Device (FAD) Questionnaire	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.	Baseline, End of Study (24 weeks)
Secondary	Change in weight related social norms	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.	Baseline, End of Study (24 weeks)
Secondary	Change in median Fitbit wear time in minutes	Total minutes spent in very active intensity during activity	Weekly up to 24 weeks
Secondary	Change in total caloric amounts on three-day food record	Participants complete food records at minimum 3 days a week	Weekly up to 24 weeks
Secondary	Change in median number of days that the Fitbit is worn		Weekly up to 24 weeks