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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK103944-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Worcester Polytechnic Institute | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Get Social | Behavioral | Online-delivered weight loss intervention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | A digital scale (Scaletronix, Model-5002) will be used to record weight | Baseline |
| Percent Weight Change | A digital scale (Scaletronix, Model-5002) will be used to record weight | Baseline to 6-months |
| Percent Weight Change | A digital scale (Scaletronix, Model-5002) will be used to record weight | Baseline to 12-months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion:
Participants will be excluded if they:
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| Name | Affiliation | Role |
|---|---|---|
| Sherry Pagoto | University of Connecticut | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut | Storrs | Connecticut | 06269 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39191926 | Derived | 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. | |
| 34544560 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Get Social: Online-delivered weight loss intervention Smartphone: A smartphone is needed to use MyFitnessPal for all participants and to access Twitter for the Get Social participants |
| FG001 | 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. Traditional: Group-delivered weight loss intervention Smartphone: A smartphone is needed to use MyFitnessPal for all participants and to access Twitter for the Get Social participants |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Get Social: Online-delivered weight loss intervention Smartphone: A smartphone is needed to use MyFitnessPal for all participants and to access Twitter for the Get Social participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight | A digital scale (Scaletronix, Model-5002) will be used to record weight | Randomized participants | Posted | Mean | Standard Deviation | lbs | Baseline |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Get Social: Online-delivered weight loss intervention Smartphone: A smartphone is needed to use MyFitnessPal for all participants and to access Twitter for the Get Social participants |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal Pain or Injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sherry Pagoto | University of Connecticut | 8604868979 | Sherry.Pagoto@uconn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 24, 2018 | Feb 26, 2021 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 26, 2021 | Feb 26, 2021 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 3, 2018 | Apr 1, 2021 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Traditional |
| Behavioral |
Group-delivered weight loss intervention |
|
| Smartphone | Device | A smartphone is needed to use MyFitnessPal for all participants and to access Twitter for the Get Social participants |
|
| 12-months |
| Time Spent During Intervention | Administrative and intervention-delivery was measured. Amount of administrative and intervention delivery time per participant was calculated. | 12-months |
| Retention at Follow-up | Retention will be calculated as the percentage of participants who complete the final weigh-in in each condition. | 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. | 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") | 6-months |
| Dietary Intake | National Cancer Institute's (NCI) automated self-administered 24-hour dietary recall (ASA24™) was used to measure caloric intake. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | Baseline |
| Social Media Use | Twitter use was measured by asking participants which social networks they had an account on | Baseline |
| Social Media Use | Participants were asked which social networks they had an account on and number with a Twitter account was reported. | 6-months |
| Social Media Use | Participants were asked which social networks they had an account on and number with a Twitter account was reported. | 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. | 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. | 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. | 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. | 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. | 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. | 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"). | 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"). | 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"). | 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. | Baseline |
| Sleep Duration | To measure sleep quality we used select questions from the Pittsburgh Sleep Quality Index which allowed the calculation of sleep duration. | 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. | 12-months |
| History of Sleep Apnea | Participants were asked whether they had ever been diagnosed with sleep apnea with response options Yes or No. | 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? | 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. | 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. | 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"). | 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"). | 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"). | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 12-months |
| 29229591 | Derived | 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. |
| BG001 | 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. Traditional: Group-delivered weight loss intervention |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | 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. Traditional: Group-delivered weight loss intervention |
|
|
| Primary | Percent Weight Change | A digital scale (Scaletronix, Model-5002) will be used to record weight | Randomized participants | Posted | Mean | Standard Error | Percent change in weight | Baseline to 6-months |
|
|
|
|
| Primary | Percent Weight Change | A digital scale (Scaletronix, Model-5002) will be used to record weight | Randomized participants | Posted | Mean | Standard Error | Percent change in weight | Baseline to 12-months |
|
|
|
|
| Secondary | 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. | Randomized participants | Posted | Number | dollars per participant | 12-months |
|
|
|
| Secondary | Time Spent During Intervention | Administrative and intervention-delivery was measured. Amount of administrative and intervention delivery time per participant was calculated. | Randomized participants | Posted | Mean | Standard Deviation | Hours per participant | 12-months |
|
|
|
|
| Secondary | Retention at Follow-up | Retention will be calculated as the percentage of participants who complete the final weigh-in in each condition. | Randomized participants | Posted | Count of Participants | Participants | 12-months |
|
|
|
| Secondary | 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. | Randomized participants who completed the acceptability question | Posted | Count of Participants | Participants | 6-months |
|
|
|
| Secondary | 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") | Randomized participants who completed the burden question | Posted | Count of Participants | Participants | 6-months |
|
|
|
| Secondary | Dietary Intake | National Cancer Institute's (NCI) automated self-administered 24-hour dietary recall (ASA24™) was used to measure caloric intake. | Randomized participants with valid recall data | Posted | Mean | Standard Deviation | kcal | Baseline |
|
|
|
| Secondary | 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. | Randomized participants with valid recall data | Posted | Mean | Standard Error | kcal | Baseline to 6-months |
|
|
|
|
| Secondary | 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. | Randomized participants with valid recall data | Posted | Mean | Standard Error | kcal | Baseline to 12-months |
|
|
|
|
| Secondary | 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. | Randomized participants | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | 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. | Randomized participants | Posted | Count of Participants | Participants | Baseline to 6-months |
|
|
|
|
| Secondary | 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. | Randomized participants | Posted | Count of Participants | Participants | Baseline to 12-months |
|
|
|
|
| Secondary | 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. | Randomized participants | Posted | Median | Inter-Quartile Range | Percentage of modules participated in | 6-months |
|
|
|
| Secondary | 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. | Randomized participants | Posted | Median | Inter-Quartile Range | Percentage of modules participated in | 12-months |
|
|
|
| Secondary | 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. | Randomized participants who completed each of the WMSI subscales. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline |
|
|
|
| Secondary | 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. | Randomized participants who completed the relevant WMSI scales | Posted | Median | Inter-Quartile Range | score on a scale | 6-months |
|
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| Secondary | 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. | Randomized participants who complete the relevant module of the WMSI | Posted | Median | Inter-Quartile Range | units on a scale | 12-months |
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| Secondary | 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). | Randomized participants | Posted | Median | Inter-Quartile Range | score on a scale | Baseline |
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| Secondary | Social Media Use | Twitter use was measured by asking participants which social networks they had an account on | Randomized participants | Posted | Count of Participants | Participants | Baseline |
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| Secondary | Social Media Use | Participants were asked which social networks they had an account on and number with a Twitter account was reported. | Randomized participants who completed questions about social media use | Posted | Count of Participants | Participants | 6-months |
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| Secondary | Social Media Use | Participants were asked which social networks they had an account on and number with a Twitter account was reported. | Randomized participants who completed questions regarding social media use | Posted | Count of Participants | Participants | 12-months |
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| Secondary | 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. | Randomized participants | Posted | Mean | Standard Deviation | mmHg | Baseline |
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| Secondary | 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. | Randomized participants who were able to complete blood pressure measurement | Posted | Mean | Standard Deviation | mmHg | 6-months |
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| Secondary | 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. | Randomized participants who were able to have their blood pressure measured | Posted | Mean | Standard Deviation | mmHg | 12-months |
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| Secondary | 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. | Randomized participants | Posted | Count of Participants | Participants | Baseline |
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| Secondary | 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. | Randomized participants who completed the STOP questionnaire | Posted | Count of Participants | Participants | 6-month |
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| Secondary | 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. | Randomized participants who completed the STOP questionnaire | Posted | Count of Participants | Participants | 12-month |
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| Secondary | 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"). | Randomized participants | Posted | Median | Inter-Quartile Range | score on a scale | Baseline |
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| Secondary | 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"). | Randomized participants who completed the ISI at 6 months. | Posted | Median | Inter-Quartile Range | score on a scale | 6-months |
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| Secondary | 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"). | Randomized participants who completed the ISI at 12 months | Posted | Median | Inter-Quartile Range | score on a scale | 12-months |
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| Secondary | Sleep Duration | To measure sleep quality we used select questions from the Pittsburgh Sleep Quality Index which allowed the calculation of sleep duration. | Randomized participants who completed the PSQI items | Posted | Median | Inter-Quartile Range | hours | Baseline |
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| Secondary | Sleep Duration | To measure sleep quality we used select questions from the Pittsburgh Sleep Quality Index which allowed the calculation of sleep duration. | Randomized participants who completed the PSQI items | Posted | Median | Inter-Quartile Range | hours | 6-months |
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| Secondary | Sleep Duration | To measure sleep quality we used select questions from the Pittsburgh Sleep Quality Index which allowed the calculation of sleep duration. | Randomized participants who completed the PSQI items | Posted | Median | Inter-Quartile Range | hours | 12-months |
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| Secondary | History of Sleep Apnea | Participants were asked whether they had ever been diagnosed with sleep apnea with response options Yes or No. | Randomized participants | Posted | Count of Participants | Participants | Baseline |
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| Secondary | 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? | Randomized participants (For current treatment, only randomized participants who reported previous sleep apnea diagnosis) | Posted | Count of Participants | Participants | Baseline |
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| Secondary | 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. | Randomized participants who completed questions relating to sleep apnea at 6 months | Posted | Count of Participants | Participants | 6-months |
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| Secondary | 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. | Randomized participants who completed the questions about sleep apnea | Posted | Count of Participants | Participants | 12-months |
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| Secondary | 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"). | Randomized participants | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | 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"). | Randomized participants who completed the BDI | Posted | Mean | Standard Deviation | score on a scale | 6-months |
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| Secondary | 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"). | Randomized participants who completed the BDI | Posted | Mean | Standard Deviation | score on a scale | 12-months |
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| Secondary | 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. | Randomized participants | Posted | Count of Participants | Participants | Baseline |
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| Secondary | 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. | Randomized participants who responded to the question about weight-loss related social media use | Posted | Count of Participants | Participants | 6-months |
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| Secondary | 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. | Randomized participants who answered the question about weight-loss related social media use. | Posted | Count of Participants | Participants | 12-months |
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| Secondary | 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. | Treatment groups of randomized participants in each condition. | Posted | Mean | Standard Deviation | Percentage of unit objectives delivered | 6-months | Treatment groups | Treatment groups |
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| Secondary | 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). | Randomized participants who completed the PSQI items | Posted | Median | Inter-Quartile Range | Percentage of time spent in bed sleeping | Baseline |
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| Secondary | 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). | Randomized participants who completed the PSQI items | Posted | Median | Inter-Quartile Range | Percentage of time spent in bed sleeping | 6-months |
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| Secondary | 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). | Randomized participants who completed the PSQI items | Posted | Median | Inter-Quartile Range | Percentage of time spent in bed sleeping | 12-months |
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| 0 |
| 167 |
| 0 |
| 167 |
| 52 |
| 167 |
| EG001 | 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. Traditional: Group-delivered weight loss intervention Smartphone: A smartphone is needed to use MyFitnessPal for all participants and to access Twitter for the Get Social participants | 0 | 162 | 0 | 162 | 49 | 162 |
| Communicable Disease (Cold, Flu, Pneumonia) | General disorders | Systematic Assessment |
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| Procedure/Surgery | Surgical and medical procedures | Systematic Assessment |
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| Cardiac Issue | Cardiac disorders | Systematic Assessment |
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| Gastrointestinal Issue | Gastrointestinal disorders | Systematic Assessment |
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| Diabetes or Blood Glucose Issue | Endocrine disorders | Systematic Assessment |
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| Changed Dose of Antidepressant Medication | Psychiatric disorders | Systematic Assessment |
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| Cancer | General disorders | Non-systematic Assessment |
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| Gyno/Urological Issue | Renal and urinary disorders | Non-systematic Assessment |
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| Non-musculoskeletal injury, result of accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Depression/Anxiety | Psychiatric disorders | Systematic Assessment |
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| Pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Assessed in females only |
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| Nerve Condition or Swelling in Legs | General disorders | Non-systematic Assessment |
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| Eye/Ear Infection | Infections and infestations | Non-systematic Assessment |
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| Hypothyroidism | Endocrine disorders | Non-systematic Assessment |
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| Autoimmune Disease | Immune system disorders | Non-systematic Assessment |
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| Asthma Exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Fatty Liver Disease | Hepatobiliary disorders | Non-systematic Assessment |
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| Bariatric Surgery | Surgical and medical procedures | Systematic Assessment |
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| Lyme Disease | Infections and infestations | Non-systematic Assessment |
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| Sleep Apnea | General disorders | Non-systematic Assessment |
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Not provided
Not provided
| Family - Helpfulness |
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| Friends - Frequency |
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| Friends - Helpfulness |
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| Twitter Friends - Frequency |
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| Twitter Friends - Helpfulness |
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| Facebook Friends - Frequency |
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| Facebook Friends - Helpfulness |
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| Family - Helpfulness |
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| Friends - Frequency |
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| Friends - Helpfulness |
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| Twitter Friends - Frequency |
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| Twitter Friends - Helpfulness |
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| Facebook Friends - Frequency |
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| Facebook Friends - Helpfulness |
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| Family - Helpfulness |
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| Friends - Frequency |
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| Friends - Helpfulness |
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| Twitter Friends - Frequency |
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| Twitter Friends - Helpfulness |
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| Facebook Friends - Frequency |
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| Facebook Friends - Helpfulness |
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| Yes |
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| Past Treatment of Sleep Apnea |
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| Yes |
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| Current treatment for sleep apnea |
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| Yes |
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| Current treatment of sleep apnea |
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