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Trial record 1 of 1 for:    1R01DK103944-01A1
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Get Social: Randomized Trial of a Social Network Delivered Lifestyle Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02646618
Recruitment Status : Active, not recruiting
First Posted : January 5, 2016
Last Update Posted : November 5, 2019
Sponsor:
Collaborators:
Worcester Polytechnic Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Sherry Pagoto, University of Connecticut

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.

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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

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02646618


Locations
Layout table for location information
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
Layout table for investigator information
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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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    Key Record Dates
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:
Layout table for MeSH terms
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms