Get Social: Randomized Trial of a Social Network Delivered Lifestyle Intervention

NCT ID: NCT02646618

Last Updated: 2023-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 329 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2020-02-26

Brief Summary

The present study is a non-inferiority trial comparing the efficacy of a lifestyle intervention delivered entirely via an online social network to a traditional lifestyle intervention delivered via group meetings.

Detailed Description

Lifestyle interventions have had established efficacy for over a decade but are still not widely disseminated, largely due to high cost and patient and provider burden. Online social networks are an alternative way to deliver lifestyle counseling and delivery via this modality may virtually eliminate patient visits, the main source of cost and burden in traditional modalities. Interactions in online social networks are frequent, brief, and asynchronous because users login to their online communities during downtime during work and leisure time, or when they simply feel a need for social connection. As such, social media becomes embedded into people's daily lives. This provides an opportunity to embed health behavior change programming into people's daily lives. Thus far in the literature, existing online social networks have been used as component of web- or mobile app-based lifestyle interventions but not as the primary modality for intervention delivery. The purpose of this work is to conduct a non-inferiority trial to compare a lifestyle intervention delivered entirely via private groups on the online social network Twitter to a traditional in-person group-based lifestyle intervention. Using a randomized trial (N=328), investigators will test whether a lifestyle intervention delivered via an online social network (Get Social condition) will result in a mean percent weight loss at 12 months that is not appreciably worse than the gold-standard in-person group-based lifestyle intervention (Traditional condition), i.e., the social network arm will not lose on average 2% less than the in-person arm. Secondary non-inferiority outcomes include weight loss at 12 months, and dietary intake and physical activity at 12-months. Investigators hypothesize that the Get Social condition will be less expensive than the Traditional condition. To understand for whom an online social network modality is most suited, investigators will test predictors of weight loss in the Get Social condition including engagement, age, sociability, neuroticism, openness, and smartphone and social network use. Investigators hypothesize that people who are younger, more sociable, engage more on the social network, higher in neuroticism/openness, and heavier overall smartphone and social network users will lose more weight in the Get Social condition. Findings from this study may support an intervention delivery modality that is more conducive to settings like worksites, health plans, and clinics that serve large populations but have limited space, staffing, and resources for traditional in person interventions.

Conditions

Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Get Social

Get Social participants will receive a weight loss intervention in a "protected" Twitter group. The intervention content will be structured to deliver in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet.

Group Type: ACTIVE_COMPARATOR

Get Social

Intervention Type: BEHAVIORAL

Online-delivered weight loss intervention

Smartphone

Intervention Type: DEVICE

A smartphone is needed to use MyFitnessPal for all participants and to access Twitter for the Get Social participants

Traditional

Participants will attend weight loss groups weekly for 8 weeks, then biweekly for 16 weeks, then monthly between months 6 and 12. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet.

Group Type: ACTIVE_COMPARATOR

Traditional

Intervention Type: BEHAVIORAL

Group-delivered weight loss intervention

Smartphone

Intervention Type: DEVICE

A smartphone is needed to use MyFitnessPal for all participants and to access Twitter for the Get Social participants

Interventions

Get Social

Online-delivered weight loss intervention

Intervention Type: BEHAVIORAL

Traditional

Group-delivered weight loss intervention

Intervention Type: BEHAVIORAL

Smartphone

A smartphone is needed to use MyFitnessPal for all participants and to access Twitter for the Get Social participants

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Smartphone users

2. Ages 18-65

3. Body Mass Index (BMI) 27-45

4. Must currently log into a social media platform on a daily basis basis and engage (like, reply, post) at least 4 days per week.

Participants will be excluded if they:

1. Do not have a smartphone;

2. Are unable to get medical clearance from their Primary Care Physician (PCP);

3. Have plans to move during study;

4. Are not interested in losing weight;

5. Have Type 1 or uncontrolled 2 Diabetes (as determined by PCP);

6. Have medical conditions that would prevent increasing physical activity or making dietary changes;

7. Are pregnant/lactating or plans to become pregnant during study;

8. Are currently taking medication affecting weight;

9. Currently participating in a weight loss program or using an online social network to assist them with weight loss (e.g. Weight Watchers, Sparkpeople, etc);

10. Unable to walk at least ¼ mile unaided without stopping;

11. Experienced a weight loss of 5% or more in past 3 month;

12. A history of/or plans on having bariatric surgery;

13. Did not complete the baseline measures;

14. Not willing to use Twitter, or if a current Twitter user, not willing to create a new account specifically for study purposes;

15. Participated in another weight loss study under the direction of the PI of this study;

16. Current smoker (smokes 3 or more cigarettes per day);

17. Unavailable to attend weekly group meetings;

18. Prefers one condition over another;

19. Score of 30 or higher on the Beck Depression Inventory (BDI) or endorsement of 2 or 3 on BDI #9 indicating suicidal thoughts;

20. Presence of binge eating disorder

21. Did not complete the orientation webinar;

22. Are unable to provide consent due to mental illness or a cognitive impairment;

23. Does not speak English; or

24. Are a prisoner.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Worcester Polytechnic Institute

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Connecticut

OTHER

Sponsor Role: lead

Responsible Party

Sherry Pagoto

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sherry Pagoto

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Locations

University of Connecticut

Storrs, Connecticut, United States

Countries

United States

References

Pagoto SL, Goetz JM, Xu R, Wang ML, Palmer L, Lemon SC. Randomized non-inferiority trial comparing an asynchronous remotely-delivered versus clinic-delivered lifestyle intervention. Int J Obes (Lond). 2025 Jan;49(1):76-83. doi: 10.1038/s41366-024-01617-0. Epub 2024 Aug 27.

Reference Type: DERIVED

PMID: 39191926 (View on PubMed)

Jake-Schoffman DE, Brown SD, Baiocchi M, Bibeau JL, Daubenmier J, Ferrara A, Galarce MN, Hartogensis W, Hecht FM, Hedderson MM, Moran PJ, Pagoto SL, Tsai AL, Waring ME, Kiernan M. Methods-Motivational Interviewing Approach for Enhanced Retention and Attendance. Am J Prev Med. 2021 Oct;61(4):606-617. doi: 10.1016/j.amepre.2021.04.005.

Reference Type: DERIVED

PMID: 34544560 (View on PubMed)

Wang ML, Waring ME, Jake-Schoffman DE, Oleski JL, Michaels Z, Goetz JM, Lemon SC, Ma Y, Pagoto SL. Clinic Versus Online Social Network-Delivered Lifestyle Interventions: Protocol for the Get Social Noninferiority Randomized Controlled Trial. JMIR Res Protoc. 2017 Dec 11;6(12):e243. doi: 10.2196/resprot.8068.

Reference Type: DERIVED

PMID: 29229591 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01DK103944-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H17-210

Identifier Type: -

Identifier Source: org_study_id