ObesityROBUSTNCT06335810
Reducing Obesity Using Social Ties Program
A study testing Social Network Intervention, Individual Lifestyle Intervention and Social Network Member in people with Obesity, run by Weill Medical College of Cornell University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Social Network Intervention, Individual Lifestyle Intervention and Social Network Member
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Social Network Member:
- Male or Female 18 years of age or older
- Access to the internet or a smartphone
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anika Lewis, MS contact
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Anika Lewis, MS, 646-962-9209, ale4008@med.cornell.edu
Erica Phillips, MD, MS, 646-962-5013
About this study
Official title: Reducing Obesity Using Social Ties (ROBUST): Randomized Control Trial
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.
Read the 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:
- 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
- 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:
- 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.
- Receive 15 coaching sessions over 24 weeks.
- 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.
- Complete a 3-day weekly food log and wear a provided Fitbit for at least 9 hours daily.
- 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.
- Conditions
- Obesity
- Being tested
- Social Network Intervention, Individual Lifestyle Intervention, Social Network Member
- Keywords
- Weight Loss, Undermining, Communication
- Medical subject headings
- Obesity, Weight Loss, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Network InterventionBehavioural
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 InterventionBehavioural
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.
Social Network MemberOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Social Network Intervention | Experimental | Participants will complete 3 communication skills sessions with their social network members during weeks 3, 5, and 15. Receives: 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. Receives: 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. Receives: Other: Social Network Member |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who have attended at least 75 percent of the behavioral coaching sessions
Measured: End of study (24 weeks)
Number of intervention participants who have at least one social network member engage in the study
Measured: End of Study (24 weeks)
Number of participants and social network members combined who complete the final study assessment
Measured: 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
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.
Measured: 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.
Measured: Baseline, End of Study (24 weeks)
Change in median Fitbit wear time in minutes
Total minutes spent in very active intensity during activity
Measured: 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
Measured: Weekly up to 24 weeks
Change in median number of days that the Fitbit is worn
Measured: Weekly up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start5 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erica G Phillips, MD, MS, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335810
- Sponsor's protocol ID
- 23-10026599
- Other IDs
- R01DK135949-01
- Acronym
- ROBUST
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in any publication will be shared after deidentification (text, tables, figures, and appendices).
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.
PubMed 40239159
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Obesity Using Social Ties (ROBUST): Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06335810
- Acronym / sponsor ID
- ROBUST / 23-10026599
- Conditions
- Obesity
- Keywords
- Weight Loss, Undermining, Communication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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:
- 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.
- Receive 15 coaching sessions over 24 weeks.
- 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.
- Complete a 3-day weekly food log and wear a provided Fitbit for at least 9 hours daily.
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Social Network Intervention | Experimental | Behavioral: Social Network InterventionParticipants will complete 3 communication skills sessions with their social network members during weeks 3, 5, and 15. |
| Individual Lifestyle Intervention | Placebo comparator | Behavioral: Individual Lifestyle InterventionParticipants will complete standard diabetes prevention program (DPP) based health coaching sessions during weeks 3, 5, and 15. |
| Social Network Member | Other | Other: Social Network MemberSocial Network Members will complete 3 communication skills sessions with the social network intervention participant during weeks 3, 5, and 15. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Index Participant:
- Social Network Member:
Key exclusion criteria (8 listed)
- Index Participant:
- Social Network Member:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Network InterventionSocial 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. | Behavioural | Social Network Intervention |
| Individual Lifestyle InterventionThe 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. | Behavioural | Individual Lifestyle Intervention |
| Social Network MemberThe 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. | Other | Social Network Member |
Primary outcome
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)
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Derived from this study: PubMed 40239159Phillips 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in any publication will be shared after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anika Lewis, MS contact
Erica G Phillips, MD, MS principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Network Intervention, Individual Lifestyle Intervention and Social Network Member in people with Obesity, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosio Ramos, BS (646-962-5037, ror2023@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who have attended at least 75 percent of the behavioral coaching sessions (time frame: End of study (24 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06335810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.