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.
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
- Type of treatment
- Medical device, Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Get Social | Active comparator | 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. Receives: Behavioral: Get Social; Device: Smartphone |
| Traditional | Active comparator | 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. Receives: Behavioral: Traditional; Device: Smartphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
A digital scale (Scaletronix, Model-5002) will be used to record weight
Measured: Baseline
Percent Weight Change
A digital scale (Scaletronix, Model-5002) will be used to record weight
Measured: Baseline to 6-months
Percent Weight Change
A digital scale (Scaletronix, Model-5002) will be used to record weight
Measured: Baseline to 12-months
Secondary outcomes (46)
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
Time Spent During Intervention
Administrative and intervention-delivery was measured. Amount of administrative and intervention delivery time per participant was calculated.
Measured: 12-months
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
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
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
Dietary Intake
National Cancer Institute's (NCI) automated self-administered 24-hour dietary recall (ASA24™) was used to measure caloric intake.
Measured: Baseline
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
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
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
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
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
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
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
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
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
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
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
Social Media Use
Twitter use was measured by asking participants which social networks they had an account on
Measured: Baseline
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
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
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
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
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
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
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
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
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
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
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
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
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
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
History of Sleep Apnea
Participants were asked whether they had ever been diagnosed with sleep apnea with response options Yes or No.
Measured: Baseline
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted5 Jan 2016 (estimated)
- Study startApr 2016
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- Worcester Polytechnic Institute, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Sherry Pagoto, University of Connecticut
- Investigators
- Sherry Pagoto, Principal investigator, University of Connecticut
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 39191926Jake-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 34544560Wang 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Get Social: Randomized Trial of a Social Network Delivered Lifestyle Intervention
- ClinicalTrials.gov ID
- NCT02646618
- Acronym / sponsor ID
- H17-210
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- Worcester Polytechnic Institute, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Apr 2016 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 5 Jan 2016 (estimated)
- Results
- Posted 5 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Get Social | Active comparator | Behavioral: Get Social, Device: SmartphoneGet 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. |
| Traditional | Active comparator | Behavioral: Traditional, Device: SmartphoneParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- 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.
- Do not have a smartphone;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Get SocialOnline-delivered weight loss intervention | Behavioural | Get Social |
| TraditionalGroup-delivered weight loss intervention | Behavioural | Traditional |
| SmartphoneA smartphone is needed to use MyFitnessPal for all participants and to access Twitter for the Get Social participants | Device | Get Social, Traditional |
Primary outcome
Weight
Time frame: Baseline
A digital scale (Scaletronix, Model-5002) will be used to record weight
Percent Weight Change
Time frame: Baseline to 6-months
A digital scale (Scaletronix, Model-5002) will be used to record weight
Percent Weight Change
Time frame: Baseline to 12-months
A digital scale (Scaletronix, Model-5002) will be used to record weight
46 secondary outcomes
Cost Associated With Intervention
Time frame: 12-months
Time Spent During Intervention
Time frame: 12-months
Retention at Follow-up
Time frame: 12-months
Acceptability of the Intervention
Time frame: 6-months
Burden of Intervention
Time frame: 6-months
Dietary Intake
Time frame: Baseline
Change in Dietary Intake
Time frame: Baseline to 6-months
Change in Dietary Intake
Time frame: Baseline to 12-months
Physical Activity
Time frame: Baseline
Physical Activity
Time frame: Baseline to 6-months
Physical Activity
Time frame: Baseline to 12-months
Intervention Engagement
Time frame: 6-months
Intervention Engagement
Time frame: 12-months
Social Support for Weight Loss
Time frame: Baseline
Social Support for Weight Loss
Time frame: 6-months
Social Support for Weight Loss
Time frame: 12-months
Neuroticism/Emotional Stability and Openness to Experience
Time frame: Baseline
Social Media Use
Time frame: Baseline
Social Media Use
Time frame: 6-months
Social Media Use
Time frame: 12-months
Blood Pressure
Time frame: Baseline
Blood Pressure
Time frame: 6-months
Blood Pressure
Time frame: 12-months
STOP (Snoring, Tired, Observed Apnea, Pressure) Questionnaire
Time frame: Baseline
STOP (Snoring, Tired, Observed Apnea, Pressure) Questionnaire
Time frame: 6-month
STOP (Snoring, Tired, Observed Apnea, Pressure) Questionnaire
Time frame: 12-month
Insomnia Severity Index
Time frame: Baseline
Insomnia Severity Index
Time frame: 6-months
Insomnia Severity Index
Time frame: 12-months
Sleep Duration
Time frame: Baseline
Sleep Duration
Time frame: 6-months
Sleep Duration
Time frame: 12-months
History of Sleep Apnea
Time frame: Baseline
Previous or Current Treatment for Sleep Apnea
Time frame: Baseline
Diagnosis or Current Treatment for Sleep Apnea
Time frame: 6-months
Diagnosis or Current Treatment for Sleep Apnea
Time frame: 12-months
Beck Depression Inventory
Time frame: Baseline
Beck Depression Inventory
Time frame: 6-months
Beck Depression Inventory
Time frame: 12-months
Weight-Loss Related Social Media Use
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39191926Pagoto 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.
- Derived from this study: PubMed 34544560Jake-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.
- Derived from this study: PubMed 29229591Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherry Pagoto principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
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.