Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    1R01DK103944-01A1
Previous Study | Return to List | Next Study

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 : Completed
First Posted : January 5, 2016
Last Update Posted : November 4, 2020
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

Tracking Information
First Submitted Date  ICMJE January 4, 2016
First Posted Date  ICMJE January 5, 2016
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE April 2016
Actual Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
  • A digital scale (Scaletronix, Model-5002) will be used to record weight [ Time Frame: Baseline ]
    Weight
  • A digital scale (Scaletronix, Model-5002) will be used to record weight [ Time Frame: 6-months ]
    Weight
  • A digital scale (Scaletronix, Model-5002) will be used to record weight [ Time Frame: 12-months ]
    Weight
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • Burden of intervention [ Time Frame: 6-months ]
    Burdensome (on 0-10 scales) each intervention feature will be measured.
  • Medical History [ Time Frame: Baseline ]
    Medical history questions are included to assess exclusionary medical conditions
  • National Cancer Institute's (NCI) automated self-administered 24-hour dietary recall (ASA24™) will record dietary intake [ Time Frame: Baseline ]
    Dietary Intake
  • National Cancer Institute's (NCI) automated self-administered 24-hour dietary recall (ASA24™) will record dietary intake [ Time Frame: 6-months ]
    Dietary Intake
  • National Cancer Institute's (NCI) automated self-administered 24-hour dietary recall (ASA24™) will record dietary intake [ Time Frame: 12-months ]
    Dietary Intake
  • Arizona Physical Activity Questionnaire will be used to provide estimates of total energy expenditure [ Time Frame: Baseline ]
    Physical Activity
  • Arizona Physical Activity Questionnaire will be used to provide estimates of total energy expenditure [ Time Frame: 6-months ]
    Physical Activity
  • Arizona Physical Activity Questionnaire will be used to provide estimates of total energy expenditure [ Time Frame: 12-months ]
    Physical Activity
  • Intervention Engagement [ Time Frame: 6-months ]
    Engagement will be measured by tracking group attendance and quantifying communication in the online group throughout the intervention.
  • Intervention Engagement [ Time Frame: 12-months ]
    Engagement will be measured by tracking group attendance and quantifying communication in the online group throughout the intervention.
  • Weight Management Support Inventory to assess social support for weight management from family and friends [ Time Frame: Baseline ]
    Social support for weight loss
  • Weight Management Support Inventory to assess social support for weight management from family and friends [ Time Frame: 6-months ]
    Social support for weight loss
  • Weight Management Support Inventory to assess social support for weight management from family and friends [ Time Frame: 12-months ]
    Social support for weight loss
  • The Ten-Item Personality Inventory will measure personality factors including neuroticism and openness [ Time Frame: Baseline ]
    Neuroticism and openness
  • Social Media Use will assess social network use [ Time Frame: Baseline ]
    Social network use
  • Social Media Use will assess social network use [ Time Frame: 6-months ]
    Social network use
  • Social Media Use will assess social network use [ Time Frame: 12-months ]
    Social network use
  • Brief Medication Questionnaire [ Time Frame: Baseline ]
    Medication Use
  • Brief Medication Questionnaire [ Time Frame: 6-months ]
    Medication Use
  • Brief Medication Questionnaire [ Time Frame: 12-months ]
    Medication Use
  • Blood pressure [ Time Frame: Baseline ]
    Blood pressure
  • Blood pressure [ Time Frame: 6-months ]
    Blood pressure
  • Blood pressure [ Time Frame: 12-months ]
    Blood pressure
  • STOP Questionnaire [ Time Frame: Baseline ]
    To measure sleep quality
  • STOP Questionnaire [ Time Frame: 6-month ]
    To measure sleep quality
  • STOP Questionnaire [ Time Frame: 12-month ]
    To measure sleep quality
  • Insomnia Severity Index [ Time Frame: Baseline ]
    To measure sleep quality
  • Insomnia Severity Index [ Time Frame: 6-months ]
    To measure sleep quality
  • Insomnia Severity Index [ Time Frame: 12-months ]
    To measure sleep quality
  • Pittsburgh Sleep Quality Index [ Time Frame: Baseline ]
    To measure sleep quality
  • Pittsburgh Sleep Quality Index [ Time Frame: 6-months ]
    To measure sleep quality
  • Pittsburgh Sleep Quality Index [ Time Frame: 12-months ]
    To measure sleep quality
  • History of Sleep Apnea [ Time Frame: Baseline ]
    To measure sleep quality
  • History of Sleep Apnea [ Time Frame: 6-months ]
    To measure sleep quality
  • History of Sleep Apnea [ Time Frame: 12-months ]
    To measure sleep quality
  • Previous or Current Treatment for Sleep Apnea [ Time Frame: Baseline ]
    To measure sleep quality
  • Previous or Current Treatment for Sleep Apnea [ Time Frame: 6-months ]
    To measure sleep quality
  • Previous or Current Treatment for Sleep Apnea [ Time Frame: 12-months ]
    To measure sleep quality
  • Beck Depression Inventory [ Time Frame: Baseline ]
    To measure depression
  • Beck Depression Inventory [ Time Frame: 6-months ]
    To measure depression
  • Beck Depression Inventory [ Time Frame: 12-months ]
    To measure depression
  • EQ-5D-3L [ Time Frame: Baseline ]
    To measure quality of life
  • EQ-5D-3L [ Time Frame: 6-months ]
    To measure quality of life
  • EQ-5D-3L [ Time Frame: 12-months ]
    To measure quality of life
  • Brief Pain Inventory [ Time Frame: Baseline ]
    To measure chronic pain
  • Brief Pain Inventory [ Time Frame: 6-months ]
    To measure chronic pain
  • Brief Pain Inventory [ Time Frame: 12-months ]
    To measure chronic pain
  • Weight-Loss Related Social Media Use [ Time Frame: Baseline ]
    To measure use of social media for weight loss
  • Weight-Loss Related Social Media Use [ Time Frame: 6-months ]
    To measure use of social media for weight loss
  • Weight-Loss Related Social Media Use [ Time Frame: 12-months ]
    To measure use of social media for weight loss
  • Treatment Receipt [ Time Frame: 6-months ]
    Weekly questions related to the intervention to measure treatment receipt
  • Treatment Fidelity [ Time Frame: 6-months ]
    Treatment fidelity will be monitored throughout the intervention using weekly checklists.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
  • Cost associated with intervention [ Time Frame: 12-months ]
    Cost associated with intervention We will systematically track all costs associated with delivery of both intervention conditions. We will create an accounting system that captures administrative, intervention and participant costs. We will approximate total costs by combining intervention costs and participant time costs.
  • Clinician time spent during intervention [ Time Frame: 12-months ]
    Clinicians report the amount of time they spent each week reviewing the web-based interface and in session
  • 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
  • Acceptability of the intervention [ Time Frame: 12-months ]
    Acceptability and their satisfaction with intervention components will be measured. Participants will answer questions about each aspect of the intervention components.
  • Burden of intervention [ Time Frame: 12-months ]
    We will ask participants how burdensome (on 0-10 scales) each intervention feature was.
  • Treatment receipt [ Time Frame: 12-months ]
    A knowledge and skills measure will be developed to evaluate comprehension of intervention
  • National Cancer Institute's (NCI) automated self-administered 24-hour dietary recall (ASA24™) will record dietary intake [ Time Frame: Baseline ]
    Dietary Intake
  • National Cancer Institute's (NCI) automated self-administered 24-hour dietary recall (ASA24™) will record dietary intake [ Time Frame: 6-months ]
    Dietary Intake
  • National Cancer Institute's (NCI) automated self-administered 24-hour dietary recall (ASA24™) will record dietary intake [ Time Frame: 12-months ]
    Dietary Intake
  • Paffenbarger Activity Questionnaire will be used to provide estimates of total energy expenditure [ Time Frame: Baseline ]
    Physical Activity
  • Paffenbarger Activity Questionnaire will be used to provide estimates of total energy expenditure [ Time Frame: 6-months ]
    Physical Activity
  • Paffenbarger Activity Questionnaire will be used to provide estimates of total energy expenditure [ Time Frame: 12-months ]
    Physical Activity
  • Intervention Engagement [ Time Frame: 12-months ]
    Engagement will be measured by tracking group attendance and quantifying communication in the online group.
  • Weight Management Support Inventory to assess social support for weight management from family and friends neuroticism [ Time Frame: Baseline ]
    Social support for weight loss
  • Weight Management Support Inventory to assess social support for weight management from family and friends neuroticism [ Time Frame: 6-months ]
    Social support for weight loss
  • Weight Management Support Inventory to assess social support for weight management from family and friends neuroticism [ Time Frame: 12-months ]
    Social support for weight loss
  • The NEO Personality Inventory is a well-validated 60 item will measure personality factors including neuroticism and openness [ Time Frame: Baseline ]
    Neuroticism and openness
  • Pew Internet & American Life Project Poll19 questions will assess social network and smartphone use [ Time Frame: Baseline ]
    Social network and smartphone use
  • Pew Internet & American Life Project Poll19 questions will assess social network and smartphone use [ Time Frame: 6-months ]
    Social network and smartphone use
  • Pew Internet & American Life Project Poll19 questions will assess social network and smartphone use [ Time Frame: 12-months ]
    Social network and smartphone use
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Get Social: Randomized Trial of a Social Network Delivered Lifestyle Intervention
Official Title  ICMJE Get Social: Randomized Trial of a Social Network Delivered Lifestyle Intervention
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Weight Loss
Intervention  ICMJE
  • Behavioral: Get Social
    Online-delivered weight loss intervention
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Get Social
    • Device: Smartphone
  • 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.
    Interventions:
    • Behavioral: Traditional
    • Device: Smartphone
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2020)
329
Original Estimated Enrollment  ICMJE
 (submitted: January 4, 2016)
328
Actual Study Completion Date  ICMJE February 2020
Actual Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02646618
Other Study ID Numbers  ICMJE H17-210
1R01DK103944-01A1 ( U.S. NIH Grant/Contract )" onClick="openNewWindow('https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=1R01DK103944-01A1&Fy=all'); return false">1R01DK103944-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sherry Pagoto, University of Connecticut
Study Sponsor  ICMJE University of Connecticut
Collaborators  ICMJE
  • Worcester Polytechnic Institute
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Sherry Pagoto University of Connecticut
PRS Account University of Connecticut
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP