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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK135949-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
The investigators will evaluate whether the ROBUST intervention not only addresses individual-level behaviors (i.e., healthy eating, increased physical activity) but also:
Participants in the control arm will receive the same number of lifestyle sessions as those randomized to the social network intervention.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Social Network Intervention | Experimental | Participants will complete 3 communication skills sessions with their social network members during weeks 3, 5, and 15. |
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| Individual Lifestyle Intervention | Placebo Comparator | Participants will complete standard diabetes prevention program (DPP) based health coaching sessions during weeks 3, 5, and 15. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Index Participant:
Social Network Member:
Exclusion Criteria:
Index Participant:
Social Network Member:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rosio Ramos, BS | Contact | 646-962-5037 | ror2023@med.cornell.edu | |
| Anika Lewis, MS | Contact | ale4008@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Erica G Phillips, MD, MS | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | Recruiting | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40239159 | Derived | 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. |
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Individual participant data that underlie the results reported in any publication will be shared after deidentification (text, tables, figures, and appendices).
Data will become available beginning 6 months following publication and ending 5 years following publication.
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.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D003142 | Communication |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. |
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| 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. |
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| Baseline, End of Study (24 weeks) |
| 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) |
| Change in median Fitbit wear time in minutes | Total minutes spent in very active intensity during activity | Weekly up to 24 weeks |
| 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 |
| Change in median number of days that the Fitbit is worn | Weekly up to 24 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |