Clinical trial NCT02646618: Get Social: Randomized Trial of a Social Network Delivered Lifestyle Intervention
Official title: Get Social: Randomized Trial of a Social Network Delivered Lifestyle Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: Worcester Polytechnic Institute
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-01-05
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion:

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.

Primary outcomes:
measure: Weight
timeFrame: Baseline
measure: Percent Weight Change
timeFrame: Baseline to 6-months
measure: Percent Weight Change
timeFrame: Baseline to 12-months
Secondary outcomes:
measure: Cost Associated With Intervention
timeFrame: 12-months
measure: Time Spent During Intervention
timeFrame: 12-months
measure: Retention at Follow-up
timeFrame: 12-months
measure: Acceptability of the Intervention
timeFrame: 6-months
measure: Burden of Intervention
timeFrame: 6-months
measure: Dietary Intake
timeFrame: Baseline
measure: Change in Dietary Intake
timeFrame: Baseline to 6-months
measure: Change in Dietary Intake
timeFrame: Baseline to 12-months
measure: Physical Activity
timeFrame: Baseline
measure: Physical Activity
timeFrame: Baseline to 6-months
measure: Physical Activity
timeFrame: Baseline to 12-months
measure: Intervention Engagement
timeFrame: 6-months
measure: Intervention Engagement
timeFrame: 12-months
measure: Social Support for Weight Loss
timeFrame: Baseline
measure: Social Support for Weight Loss
timeFrame: 6-months
measure: Social Support for Weight Loss
timeFrame: 12-months
measure: Neuroticism/Emotional Stability and Openness to Experience
timeFrame: Baseline
measure: Social Media Use
timeFrame: Baseline
measure: Social Media Use
timeFrame: 6-months
measure: Social Media Use
timeFrame: 12-months
measure: Blood Pressure
timeFrame: Baseline
measure: Blood Pressure
timeFrame: 6-months
measure: Blood Pressure
timeFrame: 12-months
measure: STOP (Snoring, Tired, Observed Apnea, Pressure) Questionnaire
timeFrame: Baseline
measure: STOP (Snoring, Tired, Observed Apnea, Pressure) Questionnaire
timeFrame: 6-month
measure: STOP (Snoring, Tired, Observed Apnea, Pressure) Questionnaire
timeFrame: 12-month
measure: Insomnia Severity Index
timeFrame: Baseline
measure: Insomnia Severity Index
timeFrame: 6-months
measure: Insomnia Severity Index
timeFrame: 12-months
measure: Sleep Duration
timeFrame: Baseline
measure: Sleep Duration
timeFrame: 6-months
measure: Sleep Duration
timeFrame: 12-months
measure: History of Sleep Apnea
timeFrame: Baseline
measure: Previous or Current Treatment for Sleep Apnea
timeFrame: Baseline
measure: Diagnosis or Current Treatment for Sleep Apnea
timeFrame: 6-months
measure: Diagnosis or Current Treatment for Sleep Apnea
timeFrame: 12-months
measure: Beck Depression Inventory
timeFrame: Baseline
measure: Beck Depression Inventory
timeFrame: 6-months
measure: Beck Depression Inventory
timeFrame: 12-months
measure: Weight-Loss Related Social Media Use
timeFrame: Baseline
measure: Weight-Loss Related Social Media Use
timeFrame: 6-months
measure: Weight-Loss Related Social Media Use
timeFrame: 12-months
measure: Treatment Fidelity
timeFrame: 6-months
measure: Habitual Sleep Efficiency
timeFrame: Baseline
measure: Habitual Sleep Efficiency
timeFrame: 6-months
measure: Habitual Sleep Efficiency
timeFrame: 12-months
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Sherry Pagoto
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.