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Weight LossNCT02646618

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

A study testing Get Social, Traditional and Smartphone in people with Weight Loss, run by University of Connecticut at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Weight Loss
What is being tested?
Get Social, Traditional and Smartphone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
329 participants
Where
1 siteUnited States
Study dates
Apr 2016to 26 Feb 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Smartphone users
  • Ages 18-65
  • Body Mass Index (BMI) 27-45
  • 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:
  • Do not have a smartphone;
Show all 29Show fewer
  • Are unable to get medical clearance from their Primary Care Physician (PCP);
  • Have plans to move during study;
  • Are not interested in losing weight;
  • Have Type 1 or uncontrolled 2 Diabetes (as determined by PCP);
  • Have medical conditions that would prevent increasing physical activity or making dietary changes;
  • Are pregnant/lactating or plans to become pregnant during study;
  • Are currently taking medication affecting weight;
  • 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);
  • Unable to walk at least ¼ mile unaided without stopping;
  • Experienced a weight loss of 5% or more in past 3 month;
  • A history of/or plans on having bariatric surgery;
  • Did not complete the baseline measures;
  • Not willing to use Twitter, or if a current Twitter user, not willing to create a new account specifically for study purposes;
  • Participated in another weight loss study under the direction of the PI of this study;
  • Current smoker (smokes 3 or more cigarettes per day);
  • Unavailable to attend weekly group meetings;
  • Prefers one condition over another;
  • Score of 30 or higher on the Beck Depression Inventory (BDI) or endorsement of 2 or 3 on BDI #9 indicating suicidal thoughts;
  • Presence of binge eating disorder
  • Did not complete the orientation webinar;
  • Are unable to provide consent due to mental illness or a cognitive impairment;
  • Does not speak English; or
  • Are a prisoner.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Connecticut

    Storrs, Connecticut, 06269

Other trials in United States

About this study

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.

Read the 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
Being tested
Get Social, Traditional, Smartphone
Medical subject headings
Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Get SocialBehavioural

    Online-delivered weight loss intervention

  • TraditionalBehavioural

    Group-delivered weight loss intervention

  • SmartphoneDevice

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

Study groups in NCT02646618
Study groupRoleWhat they receive
Get SocialActive comparatorGet 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.
Receives: Behavioral: Get Social; Device: Smartphone
TraditionalActive comparatorParticipants 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.
Receives: Behavioral: Traditional; Device: Smartphone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight

    A digital scale (Scaletronix, Model-5002) will be used to record weight

    Measured: Baseline

  2. Percent Weight Change

    A digital scale (Scaletronix, Model-5002) will be used to record weight

    Measured: Baseline to 6-months

  3. Percent Weight Change

    A digital scale (Scaletronix, Model-5002) will be used to record weight

    Measured: Baseline to 12-months

Secondary outcomes (46)
  1. Cost Associated With Intervention

    Total time to deliver the intervention and administrative time was tracked during the study for each condition and cost was calculated using national median salary for dietitians \& nutritionists and administrative assistants \& secretaries, and national fringe data for all civilian workers across all industries from Bureau of Labor Statistics. Hourly rate based on salary plus fringe divided by 2080 hours (40 hours/week x 52 weeks). Administrative tasks charged at administrative assistant salary rate, all other treatment delivery tasks charged at dietitian rate. Dollars per participant was calculated by dividing total cost for each condition by the number of participants in that condition.

    Measured: 12-months

  2. Time Spent During Intervention

    Administrative and intervention-delivery was measured. Amount of administrative and intervention delivery time per participant was calculated.

    Measured: 12-months

  3. Retention at Follow-up

    Retention will be calculated as the percentage of participants who complete the final weigh-in in each condition.

    Measured: 12-months

  4. Acceptability of the Intervention

    Acceptability and their satisfaction with intervention was measured by asking participants "If given the opportunity to continue participating in the program, how willing would you be to continue?" Response options were from 1 ("Definitely would") to 5 ("Definitely would not"). The outcome is the number of positive responses which include responses of 1 or 2 ("Probably would") on this measure.

    Measured: 6-months

  5. Burden of Intervention

    Burden was measured through the question "Participating in the program was time consuming." Response options were 1 ("Strongly agree") to 5 ("Strongly disagree"). We are reporting number of participants who agreed with the statement by responding with a 1 ("Strongly agree") or 2 ("Agree")

    Measured: 6-months

  6. Dietary Intake

    National Cancer Institute's (NCI) automated self-administered 24-hour dietary recall (ASA24™) was used to measure caloric intake.

    Measured: Baseline

  7. Change in Dietary Intake

    National Cancer Institute's (NCI) automated self-administered 24-hour dietary recall (ASA24™) measured caloric intake. Difference in caloric intake during baseline and 6 month evaluations was calculated.

    Measured: Baseline to 6-months

  8. Change in Dietary Intake

    National Cancer Institute's (NCI) automated self-administered 24-hour dietary recall (ASA24™) will record dietary intake. Change in caloric intake between baseline and 12 months was calculated.

    Measured: Baseline to 12-months

  9. Physical Activity

    Arizona Physical Activity Questionnaire will be used to provide estimates of total energy expenditure to calculate number of participants reaching the guideline of 150 minutes per week of moderate to vigorous physical activity.

    Measured: Baseline

  10. Physical Activity

    Arizona Physical Activity Questionnaire will be used to provide estimates of total energy expenditure to calculate number of participants reaching the guideline of 150 minutes per week of moderate to vigorous physical activity.

    Measured: Baseline to 6-months

  11. Physical Activity

    Arizona Physical Activity Questionnaire will be used to provide estimates of total energy expenditure to calculate number of participants reaching the guideline of 150 minutes per week of moderate to vigorous physical activity.

    Measured: Baseline to 12-months

  12. Intervention Engagement

    Engagement will be measured by tracking group attendance and quantifying communication in the online group throughout the intervention in terms of percent of intervention modules participated in.

    Measured: 6-months

  13. Intervention Engagement

    Engagement will be measured by tracking group attendance and quantifying communication in the online group throughout the intervention in terms of percent of intervention modules participated in.

    Measured: 12-months

  14. Social Support for Weight Loss

    Weight Management Support Inventory to assess social support for weight management. The directions ask respondents to rate on a 5-point scale how frequently they experienced a certain interaction with other people in the past 4 weeks, ranging from 1 (never) to 5 (daily). The items also ask how helpful that event was when it occurred, rated on a 5-point scale ranging from 1 (not helpful) to 5 (extremely helpful). Higher scores indicate more frequent or more helpful social support events. We asked this about four potential social groups: family, friends, friends on Twitter, and friends on Facebook.

    Measured: Baseline

  15. Social Support for Weight Loss

    Weight Management Support Inventory to assess social support for weight management. The directions ask respondents to rate on a 5-point scale how frequently they experienced a certain interaction with other people in the past 4 weeks, ranging from 1 (never) to 5 (daily). The items also ask how helpful that event was when it occurred, rated on a 5-point scale ranging from 1 (not helpful) to 5 (extremely helpful). Higher scores indicate more frequent or more helpful social support events. We asked this about four potential social groups: family, friends, friends on Twitter, and friends on Facebook.

    Measured: 6-months

  16. Social Support for Weight Loss

    Weight Management Support Inventory to assess social support for weight management. The directions ask respondents to rate on a 5-point scale how frequently they experienced a certain interaction with other people in the past 4 weeks, ranging from 1 (never) to 5 (daily). The items also ask how helpful that event was when it occurred, rated on a 5-point scale ranging from 1 (not helpful) to 5 (extremely helpful). Higher scores indicate more frequent or more helpful social support events. We asked this about four potential social groups: family, friends, friends on Twitter, and friends on Facebook.

    Measured: 12-months

  17. Neuroticism/Emotional Stability and Openness to Experience

    Openness to Experience and Neuroticism/Emotional Stability were measured using the Ten-Item Personality Inventory. The Ten-Item Personality Inventory consists of 10 items that measure the five dimensions of the Five Factor model of personality. Participants are asked to respond to a series of words with personality descriptions with the prompt "I see myself as" with response options of 1 ("Disagree Strongly") to 7 ("Agree Strongly"). Opposite items are reverse coded. Items for Emotional Stability/Neuroticism are "anxious, easily upset" and "calm, emotionally stable". Items for Openness to experience are "open to new experiences, complex" or "conventional, uncreative." The average of the scores represents each dimension with higher scores indicating higher levels of Openness or Emotional Stability (and lower levels of Neuroticism).

    Measured: Baseline

  18. Social Media Use

    Twitter use was measured by asking participants which social networks they had an account on

    Measured: Baseline

  19. Social Media Use

    Participants were asked which social networks they had an account on and number with a Twitter account was reported.

    Measured: 6-months

  20. Social Media Use

    Participants were asked which social networks they had an account on and number with a Twitter account was reported.

    Measured: 12-months

  21. Blood Pressure

    The average of two blood pressure readings was used as the measure of blood pressure. If participants only had one blood pressure reading that was used as the measure of blood pressure.

    Measured: Baseline

  22. Blood Pressure

    The average of two blood pressure readings was used as the measure of blood pressure. If participants only had one blood pressure reading that was used as the measure of blood pressure.

    Measured: 6-months

  23. Blood Pressure

    The average of two blood pressure readings was used as the measure of blood pressure. If participants only had one blood pressure reading that was used as the measure of blood pressure.

    Measured: 12-months

  24. STOP (Snoring, Tired, Observed Apnea, Pressure) Questionnaire

    Participants completed the four item STOP sleep apnea questionnaire. Participants who answered yes to 0-1 items were classified as low risk for sleep apnea. Participants who answered yes to 2-4 items were classified as high risk for sleep apnea.

    Measured: Baseline

  25. STOP (Snoring, Tired, Observed Apnea, Pressure) Questionnaire

    Participants completed the four item STOP sleep apnea questionnaire. Participants who answered yes to 0-1 items were classified as low risk for sleep apnea. Participants who answered yes to 2-4 items were classified as high risk for sleep apnea.

    Measured: 6-month

  26. STOP (Snoring, Tired, Observed Apnea, Pressure) Questionnaire

    Participants completed the four item STOP sleep apnea questionnaire. Participants who answered yes to 0-1 items were classified as low risk for sleep apnea. Participants who answered yes to 2-4 items were classified as high risk for sleep apnea.

    Measured: 12-month

  27. Insomnia Severity Index

    To measure sleep quality, participants completed the Insomnia Severity Index. Higher scores (maximum 28) represent increased levels of insomnia, from 0-7 ("Absence of insomnia"), through 8-14 ("Sub-threshold insomnia"), 15-21 ("Moderate insomnia"), and 22-28 ("Severe insomnia").

    Measured: Baseline

  28. Insomnia Severity Index

    To measure sleep quality, participants completed the Insomnia Severity Index. Higher scores (maximum 28) represent increased levels of insomnia, from 0-7 ("Absence of insomnia"), through 8-14 ("Sub-threshold insomnia"), 15-21 ("Moderate insomnia"), and 22-28 ("Severe insomnia").

    Measured: 6-months

  29. Insomnia Severity Index

    To measure sleep quality, participants completed the Insomnia Severity Index. Higher scores (maximum 28) represent increased levels of insomnia, from 0-7 ("Absence of insomnia"), through 8-14 ("Sub-threshold insomnia"), 15-21 ("Moderate insomnia"), and 22-28 ("Severe insomnia").

    Measured: 12-months

  30. Sleep Duration

    To measure sleep quality we used select questions from the Pittsburgh Sleep Quality Index which allowed the calculation of sleep duration.

    Measured: Baseline

  31. Sleep Duration

    To measure sleep quality we used select questions from the Pittsburgh Sleep Quality Index which allowed the calculation of sleep duration.

    Measured: 6-months

  32. Sleep Duration

    To measure sleep quality we used select questions from the Pittsburgh Sleep Quality Index which allowed the calculation of sleep duration.

    Measured: 12-months

  33. History of Sleep Apnea

    Participants were asked whether they had ever been diagnosed with sleep apnea with response options Yes or No.

    Measured: Baseline

  34. Previous or Current Treatment for Sleep Apnea

    Participants were asked 1. Are you being treated for sleep apnea presently? (Yes/No) and 2. Have you ever received treatment for sleep apnea?

    Measured: Baseline

  35. Diagnosis or Current Treatment for Sleep Apnea

    Participants were asked: Have you ever been diagnosed with sleep apnea? If they answered yes, they were asked if they were currently being treated for sleep apnea.

    Measured: 6-months

  36. Diagnosis or Current Treatment for Sleep Apnea

    Participants were asked: Have you ever been diagnosed with sleep apnea? If they answered yes, they were asked if they were currently being treated for sleep apnea.

    Measured: 12-months

  37. Beck Depression Inventory

    To measure depressive symptoms, participants completed the Beck Depression Inventory. Total scores can be interpreted as 1-10 ("normal ups and downs"), 11-16 ("Mild mood disturbance"), 17-20 ("Borderline clinical depression"), 21-30 ("Moderate depression"), 31-40 ("Severe depression"), 41+ ("Extreme depression").

    Measured: Baseline

  38. Beck Depression Inventory

    To measure depressive symptoms, participants completed the Beck Depression Inventory. Total scores can be interpreted as 1-10 ("normal ups and downs"), 11-16 ("Mild mood disturbance"), 17-20 ("Borderline clinical depression"), 21-30 ("Moderate depression"), 31-40 ("Severe depression"), 41+ ("Extreme depression").

    Measured: 6-months

  39. Beck Depression Inventory

    To measure depressive symptoms, participants completed the Beck Depression Inventory. Total scores can be interpreted as 1-10 ("normal ups and downs"), 11-16 ("Mild mood disturbance"), 17-20 ("Borderline clinical depression"), 21-30 ("Moderate depression"), 31-40 ("Severe depression"), 41+ ("Extreme depression").

    Measured: 12-months

  40. Weight-Loss Related Social Media Use

    Participants were asked "Have you ever posted about or had discussions about your weight loss or desire to lose weight?" Number who answered yes are reported.

    Measured: Baseline

  41. Weight-Loss Related Social Media Use

    Participants were asked "Have you ever posted about or had discussions about your weight loss or desire to lose weight?" Number who answered yes are reported.

    Measured: 6-months

  42. Weight-Loss Related Social Media Use

    Participants were asked "Have you ever posted about or had discussions about your weight loss or desire to lose weight?" Number who answered yes are reported.

    Measured: 12-months

  43. Treatment Fidelity

    The intervention was divided into different content units delivered either during a meeting (Traditional Condition) or a series of tweets (Get Social Condition). For the Get Social Condition, tweets with intervention content were produced to meet all objectives for each content unit and programmed to go out at set times for each group so 100% of the objectives for each content unit were met. For the Traditional Condition, checklists were created with objectives for each content unit and staff listened to 2 to 3 randomly selected group recordings for each study wave to determine if these objectives were met by the interventionist. Treatment Fidelity was defined as the percentage of objectives delivered by the interventionist for each wave.

    Measured: 6-months

  44. Habitual Sleep Efficiency

    To measure sleep quality we used select questions from the Pittsburgh Sleep Quality Index to calculate habitual sleep efficiency (the percentage of time in bed spent sleeping).

    Measured: Baseline

  45. Habitual Sleep Efficiency

    To measure sleep quality we used select questions from the Pittsburgh Sleep Quality Index which allowed the calculation of habitual sleep efficiency (the percentage of time in bed spent sleeping).

    Measured: 6-months

  46. Habitual Sleep Efficiency

    To measure sleep quality we used select questions from the Pittsburgh Sleep Quality Index which allowed the calculation of habitual sleep efficiency (the percentage of time in bed spent sleeping).

    Measured: 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2016 (estimated)
  2. Study startApr 2016
  3. Primary completion26 Feb 2020
  4. Study completion26 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
329 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02646618
Sponsor's protocol ID
H17-210
Other IDs
1R01DK103944-01A1
Status last verified
Nov 2023
First submitted
4 Jan 2016
Last updated
24 Nov 2023
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 39191926
  • 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.

    PubMed 34544560
  • 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.

    PubMed 29229591

Questions about this trial

What is this clinical trial studying?

A study testing Get Social, Traditional and Smartphone in people with Weight Loss, run by University of Connecticut at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02646618, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.

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