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

• ClinicalTrials.gov Identifier: NCT02646618
• Recruitment Status: Active, not recruiting
• First Posted: January 5, 2016
• Last Update Posted: November 5, 2019
• Sponsor: University of Connecticut
• Collaborators: Worcester Polytechnic Institute; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): Sherry Pagoto, University of Connecticut

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Weight Loss	Behavioral: Get Social; Behavioral: Traditional; Device: Smartphone	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 328 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Get Social: Randomized Trial of a Social Network Delivered Lifestyle Intervention
• Study Start Date: April 2016
• Estimated Primary Completion Date: August 2020
• Estimated Study Completion Date: August 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Behavioral: Get Social; Online-delivered weight loss intervention; Device: Smartphone; A smartphone is needed to use MyFitnessPal for all participants and to access Twitter for the Get Social participants
Active Comparator: 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.	Behavioral: Traditional; Group-delivered weight loss intervention; Device: Smartphone; A smartphone is needed to use MyFitnessPal for all participants and to access Twitter for the Get Social participants

Outcome Measures

Primary Outcome Measures :

1. A digital scale (Scaletronix, Model-5002) will be used to record weight [ Time Frame: Baseline ]
   Weight
2. A digital scale (Scaletronix, Model-5002) will be used to record weight [ Time Frame: 6-months ]
   Weight
3. A digital scale (Scaletronix, Model-5002) will be used to record weight [ Time Frame: 12-months ]
   Weight

Secondary Outcome Measures :

1. Cost associated with intervention [ Time Frame: 12-months ]
   Costs associated with delivery and receipt of both intervention conditions will be systematically tracked. Administrative, intervention-delivery, and participant costs will be captured. Total costs by combining intervention costs and participant time costs will be approximated.
2. Time spent during intervention [ Time Frame: 12-months ]
   Time associated with delivery and receipt of both intervention conditions will be systematically tracked. Administrative, intervention-delivery, and participant time will be captured. Clinician time delivering and participant time receiving the intervention in both conditions will be tracked weekly.
3. Retention at follow-up [ Time Frame: 12-months ]
   Retention will be calculated as the proportion of participants who complete the final assessment in each condition.
4. Acceptability of the intervention [ Time Frame: 6-months ]
   Acceptability and their satisfaction with intervention components will be measured. Participants will answer questions about each aspect of the intervention components.
5. Burden of intervention [ Time Frame: 6-months ]
   Burdensome (on 0-10 scales) each intervention feature will be measured.
6. Medical History [ Time Frame: Baseline ]
   Medical history questions are included to assess exclusionary medical conditions
7. National Cancer Institute's (NCI) automated self-administered 24-hour dietary recall (ASA24™) will record dietary intake [ Time Frame: Baseline ]
   Dietary Intake
8. National Cancer Institute's (NCI) automated self-administered 24-hour dietary recall (ASA24™) will record dietary intake [ Time Frame: 6-months ]
   Dietary Intake
9. National Cancer Institute's (NCI) automated self-administered 24-hour dietary recall (ASA24™) will record dietary intake [ Time Frame: 12-months ]
   Dietary Intake
10. Arizona Physical Activity Questionnaire will be used to provide estimates of total energy expenditure [ Time Frame: Baseline ]
    Physical Activity
11. Arizona Physical Activity Questionnaire will be used to provide estimates of total energy expenditure [ Time Frame: 6-months ]
    Physical Activity
12. Arizona Physical Activity Questionnaire will be used to provide estimates of total energy expenditure [ Time Frame: 12-months ]
    Physical Activity
13. Intervention Engagement [ Time Frame: 6-months ]
    Engagement will be measured by tracking group attendance and quantifying communication in the online group throughout the intervention.
14. Intervention Engagement [ Time Frame: 12-months ]
    Engagement will be measured by tracking group attendance and quantifying communication in the online group throughout the intervention.
15. Weight Management Support Inventory to assess social support for weight management from family and friends [ Time Frame: Baseline ]
    Social support for weight loss
16. Weight Management Support Inventory to assess social support for weight management from family and friends [ Time Frame: 6-months ]
    Social support for weight loss
17. Weight Management Support Inventory to assess social support for weight management from family and friends [ Time Frame: 12-months ]
    Social support for weight loss
18. The Ten-Item Personality Inventory will measure personality factors including neuroticism and openness [ Time Frame: Baseline ]
    Neuroticism and openness
19. Social Media Use will assess social network use [ Time Frame: Baseline ]
    Social network use
20. Social Media Use will assess social network use [ Time Frame: 6-months ]
    Social network use
21. Social Media Use will assess social network use [ Time Frame: 12-months ]
    Social network use
22. Brief Medication Questionnaire [ Time Frame: Baseline ]
    Medication Use
23. Brief Medication Questionnaire [ Time Frame: 6-months ]
    Medication Use
24. Brief Medication Questionnaire [ Time Frame: 12-months ]
    Medication Use
25. Blood pressure [ Time Frame: Baseline ]
    Blood pressure
26. Blood pressure [ Time Frame: 6-months ]
    Blood pressure
27. Blood pressure [ Time Frame: 12-months ]
    Blood pressure
28. STOP Questionnaire [ Time Frame: Baseline ]
    To measure sleep quality
29. STOP Questionnaire [ Time Frame: 6-month ]
    To measure sleep quality
30. STOP Questionnaire [ Time Frame: 12-month ]
    To measure sleep quality
31. Insomnia Severity Index [ Time Frame: Baseline ]
    To measure sleep quality
32. Insomnia Severity Index [ Time Frame: 6-months ]
    To measure sleep quality
33. Insomnia Severity Index [ Time Frame: 12-months ]
    To measure sleep quality
34. Pittsburgh Sleep Quality Index [ Time Frame: Baseline ]
    To measure sleep quality
35. Pittsburgh Sleep Quality Index [ Time Frame: 6-months ]
    To measure sleep quality
36. Pittsburgh Sleep Quality Index [ Time Frame: 12-months ]
    To measure sleep quality
37. History of Sleep Apnea [ Time Frame: Baseline ]
    To measure sleep quality
38. History of Sleep Apnea [ Time Frame: 6-months ]
    To measure sleep quality
39. History of Sleep Apnea [ Time Frame: 12-months ]
    To measure sleep quality
40. Previous or Current Treatment for Sleep Apnea [ Time Frame: Baseline ]
    To measure sleep quality
41. Previous or Current Treatment for Sleep Apnea [ Time Frame: 6-months ]
    To measure sleep quality
42. Previous or Current Treatment for Sleep Apnea [ Time Frame: 12-months ]
    To measure sleep quality
43. Beck Depression Inventory [ Time Frame: Baseline ]
    To measure depression
44. Beck Depression Inventory [ Time Frame: 6-months ]
    To measure depression
45. Beck Depression Inventory [ Time Frame: 12-months ]
    To measure depression
46. EQ-5D-3L [ Time Frame: Baseline ]
    To measure quality of life
47. EQ-5D-3L [ Time Frame: 6-months ]
    To measure quality of life
48. EQ-5D-3L [ Time Frame: 12-months ]
    To measure quality of life
49. Brief Pain Inventory [ Time Frame: Baseline ]
    To measure chronic pain
50. Brief Pain Inventory [ Time Frame: 6-months ]
    To measure chronic pain
51. Brief Pain Inventory [ Time Frame: 12-months ]
    To measure chronic pain
52. Weight-Loss Related Social Media Use [ Time Frame: Baseline ]
    To measure use of social media for weight loss
53. Weight-Loss Related Social Media Use [ Time Frame: 6-months ]
    To measure use of social media for weight loss
54. Weight-Loss Related Social Media Use [ Time Frame: 12-months ]
    To measure use of social media for weight loss
55. Treatment Receipt [ Time Frame: 6-months ]
    Weekly questions related to the intervention to measure treatment receipt
56. Treatment Fidelity [ Time Frame: 6-months ]
    Treatment fidelity will be monitored throughout the intervention using weekly checklists.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion:

1. Smartphone users
2. Ages 18-65
3. 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 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 BDI or endorsement of 2 or 3 on BDI #9 indicating suicidal thoughts;
20. Did not complete the orientation webinar;
21. Are unable to provide consent due to mental illness or a cognitive impairment;
22. Does not speak English; or
23. Are a prisoner.

Contacts and Locations

Locations

United States, Connecticut

University of Connecticut

Storrs, Connecticut, United States, 06269

Sponsors and Collaborators

University of Connecticut

Worcester Polytechnic Institute

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

Investigators

• Principal Investigator: Sherry Pagoto; University of Connecticut

  Study Documents (Full-Text)

Documents provided by Sherry Pagoto, University of Connecticut:

Informed Consent Form  [PDF] August 3, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Sherry Pagoto, Professor, University of Connecticut
• ClinicalTrials.gov Identifier: NCT02646618
• Other Study ID Numbers: H17-210; 1R01DK103944-01A1 ( U.S. NIH Grant/Contract )
• First Posted: January 5, 2016
• Last Update Posted: November 5, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms