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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02646618
Enrollment
329
Registered
2016-01-05
Start date
2016-04-30
Completion date
2020-02-26
Last updated
2023-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight Loss

Brief summary

The present study is a non-inferiority trial comparing the efficacy of a lifestyle intervention delivered entirely via an online social network to a traditional lifestyle intervention delivered via group meetings.

Detailed description

Lifestyle interventions have had established efficacy for over a decade but are still not widely disseminated, largely due to high cost and patient and provider burden. Online social networks are an alternative way to deliver lifestyle counseling and delivery via this modality may virtually eliminate patient visits, the main source of cost and burden in traditional modalities. Interactions in online social networks are frequent, brief, and asynchronous because users login to their online communities during downtime during work and leisure time, or when they simply feel a need for social connection. As such, social media becomes embedded into people's daily lives. This provides an opportunity to embed health behavior change programming into people's daily lives. Thus far in the literature, existing online social networks have been used as component of web- or mobile app-based lifestyle interventions but not as the primary modality for intervention delivery. The purpose of this work is to conduct a non-inferiority trial to compare a lifestyle intervention delivered entirely via private groups on the online social network Twitter to a traditional in-person group-based lifestyle intervention. Using a randomized trial (N=328), investigators will test whether a lifestyle intervention delivered via an online social network (Get Social condition) will result in a mean percent weight loss at 12 months that is not appreciably worse than the gold-standard in-person group-based lifestyle intervention (Traditional condition), i.e., the social network arm will not lose on average 2% less than the in-person arm. Secondary non-inferiority outcomes include weight loss at 12 months, and dietary intake and physical activity at 12-months. Investigators hypothesize that the Get Social condition will be less expensive than the Traditional condition. To understand for whom an online social network modality is most suited, investigators will test predictors of weight loss in the Get Social condition including engagement, age, sociability, neuroticism, openness, and smartphone and social network use. Investigators hypothesize that people who are younger, more sociable, engage more on the social network, higher in neuroticism/openness, and heavier overall smartphone and social network users will lose more weight in the Get Social condition. Findings from this study may support an intervention delivery modality that is more conducive to settings like worksites, health plans, and clinics that serve large populations but have limited space, staffing, and resources for traditional in person interventions.

Interventions

BEHAVIORALGet Social

Online-delivered weight loss intervention

BEHAVIORALTraditional

Group-delivered weight loss intervention

DEVICESmartphone

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

Sponsors

Worcester Polytechnic Institute
CollaboratorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Connecticut
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Inclusion: 1. Smartphone users 2. Ages 18-65 3. Body Mass Index (BMI) 27-45 4. Must currently log into a social media platform on a daily basis basis and engage (like, reply, post) at least 4 days per week. Participants will be excluded if they: 1. Do not have a smartphone; 2. Are unable to get medical clearance from their Primary Care Physician (PCP); 3. Have plans to move during study; 4. Are not interested in losing weight; 5. Have Type 1 or uncontrolled 2 Diabetes (as determined by PCP); 6. Have medical conditions that would prevent increasing physical activity or making dietary changes; 7. Are pregnant/lactating or plans to become pregnant during study; 8. Are currently taking medication affecting weight; 9. Currently participating in a weight loss program or using an online social network to assist them with weight loss (e.g. Weight Watchers, Sparkpeople, etc); 10. Unable to walk at least ¼ mile unaided without stopping; 11. Experienced a weight loss of 5% or more in past 3 month; 12. A history of/or plans on having bariatric surgery; 13. Did not complete the baseline measures; 14. Not willing to use Twitter, or if a current Twitter user, not willing to create a new account specifically for study purposes; 15. Participated in another weight loss study under the direction of the PI of this study; 16. Current smoker (smokes 3 or more cigarettes per day); 17. Unavailable to attend weekly group meetings; 18. Prefers one condition over another; 19. Score of 30 or higher on the Beck Depression Inventory (BDI) or endorsement of 2 or 3 on BDI #9 indicating suicidal thoughts; 20. Presence of binge eating disorder 21. Did not complete the orientation webinar; 22. Are unable to provide consent due to mental illness or a cognitive impairment; 23. Does not speak English; or 24. Are a prisoner.

Design outcomes

Primary

MeasureTime frameDescription
WeightBaselineA digital scale (Scaletronix, Model-5002) will be used to record weight
Percent Weight ChangeBaseline to 6-monthsA digital scale (Scaletronix, Model-5002) will be used to record weight

Secondary

MeasureTime frameDescription
Time Spent During Intervention12-monthsAdministrative and intervention-delivery was measured. Amount of administrative and intervention delivery time per participant was calculated.
Retention at Follow-up12-monthsRetention will be calculated as the percentage of participants who complete the final weigh-in in each condition.
Acceptability of the Intervention6-monthsAcceptability 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.
Burden of Intervention6-monthsBurden 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)
Dietary IntakeBaselineNational Cancer Institute's (NCI) automated self-administered 24-hour dietary recall (ASA24™) was used to measure caloric intake.
Change in Dietary IntakeBaseline to 6-monthsNational 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.
Physical ActivityBaselineArizona 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.
Social Support for Weight LossBaselineWeight 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.
Neuroticism/Emotional Stability and Openness to ExperienceBaselineOpenness 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).
Social Media UseBaselineTwitter use was measured by asking participants which social networks they had an account on
Intervention Engagement6-monthsEngagement 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.
STOP (Snoring, Tired, Observed Apnea, Pressure) QuestionnaireBaselineParticipants 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.
Insomnia Severity IndexBaselineTo 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).
Sleep DurationBaselineTo measure sleep quality we used select questions from the Pittsburgh Sleep Quality Index which allowed the calculation of sleep duration.
History of Sleep ApneaBaselineParticipants were asked whether they had ever been diagnosed with sleep apnea with response options Yes or No.
Previous or Current Treatment for Sleep ApneaBaselineParticipants were asked 1. Are you being treated for sleep apnea presently? (Yes/No) and 2. Have you ever received treatment for sleep apnea?
Diagnosis or Current Treatment for Sleep Apnea6-monthsParticipants 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.
Beck Depression InventoryBaselineTo 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).
Weight-Loss Related Social Media UseBaselineParticipants 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.
Treatment Fidelity6-monthsThe 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.
Habitual Sleep EfficiencyBaselineTo 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).
Blood PressureBaselineThe 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.
Cost Associated With Intervention12-monthsTotal 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
167
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
162
Total329

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up1014

Baseline characteristics

CharacteristicGet SocialTraditionalTotal
Age, Continuous45.3 years
STANDARD_DEVIATION 11.2
45.5 years
STANDARD_DEVIATION 11.6
45.4 years
STANDARD_DEVIATION 11.4
Body Mass Index34.9 kg/m^2
STANDARD_DEVIATION 4.8
35.1 kg/m^2
STANDARD_DEVIATION 4.4
35.0 kg/m^2
STANDARD_DEVIATION 4.6
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants8 Participants16 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
158 Participants154 Participants312 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
4 Participants1 Participants5 Participants
Race (NIH/OMB)
Black or African American
4 Participants3 Participants7 Participants
Race (NIH/OMB)
More than one race
3 Participants5 Participants8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants2 Participants5 Participants
Race (NIH/OMB)
White
152 Participants150 Participants302 Participants
Region of Enrollment
United States
167 participants162 participants329 participants
Sex: Female, Male
Female
136 Participants132 Participants268 Participants
Sex: Female, Male
Male
31 Participants30 Participants61 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1670 / 162
other
Total, other adverse events
52 / 16749 / 162
serious
Total, serious adverse events
0 / 1670 / 162

Outcome results

Primary

Percent Weight Change

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

Time frame: Baseline to 6-months

Population: Randomized participants

ArmMeasureValue (MEAN)Dispersion
Get SocialPercent Weight Change-2.6 Percent change in weightStandard Error 0.5
TraditionalPercent Weight Change-4.5 Percent change in weightStandard Error 0.5
p-value: 0.003895% CI: [0.6, 3.3]Mixed Models Analysis
Primary

Percent Weight Change

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

Time frame: Baseline to 12-months

Population: Randomized participants

ArmMeasureValue (MEAN)Dispersion
Get SocialPercent Weight Change-2.6 Percent change in weightStandard Error 0.6
TraditionalPercent Weight Change-3.7 Percent change in weightStandard Error 0.6
p-value: 0.148595% CI: [-0.4, 2.8]Mixed Models Analysis
Primary

Weight

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

Time frame: Baseline

Population: Randomized participants

ArmMeasureValue (MEAN)Dispersion
Get SocialWeight214.7 lbsStandard Deviation 36.9
TraditionalWeight215.4 lbsStandard Deviation 35.8
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.

Time frame: 6-months

Population: Randomized participants who completed the acceptability question

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Get SocialAcceptability of the Intervention100 Participants
TraditionalAcceptability of the Intervention104 Participants
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).

Time frame: Baseline

Population: Randomized participants

ArmMeasureValue (MEAN)Dispersion
Get SocialBeck Depression Inventory6.1 score on a scaleStandard Deviation 5.3
TraditionalBeck Depression Inventory7.7 score on a scaleStandard Deviation 7.3
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).

Time frame: 6-months

Population: Randomized participants who completed the BDI

ArmMeasureValue (MEAN)Dispersion
Get SocialBeck Depression Inventory5.6 score on a scaleStandard Deviation 5.8
TraditionalBeck Depression Inventory6.3 score on a scaleStandard Deviation 7.5
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).

Time frame: 12-months

Population: Randomized participants who completed the BDI

ArmMeasureValue (MEAN)Dispersion
Get SocialBeck Depression Inventory4.8 score on a scaleStandard Deviation 5.3
TraditionalBeck Depression Inventory5.7 score on a scaleStandard Deviation 5.9
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.

Time frame: Baseline

Population: Randomized participants

ArmMeasureGroupValue (MEAN)Dispersion
Get SocialBlood PressureSystolic blood pressure134.4 mmHgStandard Deviation 13
Get SocialBlood PressureDiastolic blood pressure82.4 mmHgStandard Deviation 8.3
TraditionalBlood PressureDiastolic blood pressure82.3 mmHgStandard Deviation 10.3
TraditionalBlood PressureSystolic blood pressure133.1 mmHgStandard Deviation 12.9
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.

Time frame: 6-months

Population: Randomized participants who were able to complete blood pressure measurement

ArmMeasureGroupValue (MEAN)Dispersion
Get SocialBlood PressureSystolic blood pressure130.6 mmHgStandard Deviation 12.7
Get SocialBlood PressureDiastolic blood pressure80.1 mmHgStandard Deviation 8.8
TraditionalBlood PressureDiastolic blood pressure81.1 mmHgStandard Deviation 9.2
TraditionalBlood PressureSystolic blood pressure130.2 mmHgStandard Deviation 13.6
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.

Time frame: 12-months

Population: Randomized participants who were able to have their blood pressure measured

ArmMeasureGroupValue (MEAN)Dispersion
Get SocialBlood PressureSystolic blood pressure130.6 mmHgStandard Deviation 14
Get SocialBlood PressureDiastolic blood pressure80.3 mmHgStandard Deviation 9.3
TraditionalBlood PressureSystolic blood pressure129.7 mmHgStandard Deviation 13.7
TraditionalBlood PressureDiastolic blood pressure81.1 mmHgStandard Deviation 9.6
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)

Time frame: 6-months

Population: Randomized participants who completed the burden question

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Get SocialBurden of Intervention37 Participants
TraditionalBurden of Intervention62 Participants
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.

Time frame: Baseline to 12-months

Population: Randomized participants with valid recall data

ArmMeasureValue (MEAN)Dispersion
Get SocialChange in Dietary Intake-396 kcalStandard Error 55
TraditionalChange in Dietary Intake-321 kcalStandard Error 54
p-value: 0.332395% CI: [-226, 77]Mixed Models Analysis
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.

Time frame: Baseline to 6-months

Population: Randomized participants with valid recall data

ArmMeasureValue (MEAN)Dispersion
Get SocialChange in Dietary Intake-316 kcalStandard Error 52
TraditionalChange in Dietary Intake-410 kcalStandard Error 51
p-value: 0.202595% CI: [-50, 237]Mixed Models Analysis
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.

Time frame: 12-months

Population: Randomized participants

ArmMeasureValue (NUMBER)
Get SocialCost Associated With Intervention114 dollars per participant
TraditionalCost Associated With Intervention165 dollars per participant
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.

Time frame: 6-months

Population: Randomized participants who completed questions relating to sleep apnea at 6 months

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Get SocialDiagnosis or Current Treatment for Sleep ApneaDiagnosis of sleep apneaNo103 Participants
Get SocialDiagnosis or Current Treatment for Sleep ApneaCurrent treatment for sleep apneaNo9 Participants
Get SocialDiagnosis or Current Treatment for Sleep ApneaCurrent treatment for sleep apneaYes16 Participants
Get SocialDiagnosis or Current Treatment for Sleep ApneaDiagnosis of sleep apneaYes25 Participants
TraditionalDiagnosis or Current Treatment for Sleep ApneaCurrent treatment for sleep apneaYes9 Participants
TraditionalDiagnosis or Current Treatment for Sleep ApneaDiagnosis of sleep apneaNo124 Participants
TraditionalDiagnosis or Current Treatment for Sleep ApneaDiagnosis of sleep apneaYes17 Participants
TraditionalDiagnosis or Current Treatment for Sleep ApneaCurrent treatment for sleep apneaNo8 Participants
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.

Time frame: 12-months

Population: Randomized participants who completed the questions about sleep apnea

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Get SocialDiagnosis or Current Treatment for Sleep ApneaDiagnosis of sleep apneaNo94 Participants
Get SocialDiagnosis or Current Treatment for Sleep ApneaDiagnosis of sleep apneaYes23 Participants
Get SocialDiagnosis or Current Treatment for Sleep ApneaCurrent treatment of sleep apneaNo8 Participants
Get SocialDiagnosis or Current Treatment for Sleep ApneaCurrent treatment of sleep apneaYes15 Participants
TraditionalDiagnosis or Current Treatment for Sleep ApneaCurrent treatment of sleep apneaYes9 Participants
TraditionalDiagnosis or Current Treatment for Sleep ApneaDiagnosis of sleep apneaNo114 Participants
TraditionalDiagnosis or Current Treatment for Sleep ApneaCurrent treatment of sleep apneaNo6 Participants
TraditionalDiagnosis or Current Treatment for Sleep ApneaDiagnosis of sleep apneaYes15 Participants
Secondary

Dietary Intake

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

Time frame: Baseline

Population: Randomized participants with valid recall data

ArmMeasureValue (MEAN)Dispersion
Get SocialDietary Intake2168 kcalStandard Deviation 642
TraditionalDietary Intake2042 kcalStandard Deviation 548
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).

Time frame: Baseline

Population: Randomized participants who completed the PSQI items

ArmMeasureValue (MEDIAN)
Get SocialHabitual Sleep Efficiency87.5 Percentage of time spent in bed sleeping
TraditionalHabitual Sleep Efficiency87.5 Percentage of time spent in bed sleeping
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).

Time frame: 6-months

Population: Randomized participants who completed the PSQI items

ArmMeasureValue (MEDIAN)
Get SocialHabitual Sleep Efficiency86.7 Percentage of time spent in bed sleeping
TraditionalHabitual Sleep Efficiency85.7 Percentage of time spent in bed sleeping
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).

Time frame: 12-months

Population: Randomized participants who completed the PSQI items

ArmMeasureValue (MEDIAN)
Get SocialHabitual Sleep Efficiency87.5 Percentage of time spent in bed sleeping
TraditionalHabitual Sleep Efficiency85.7 Percentage of time spent in bed sleeping
Secondary

History of Sleep Apnea

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

Time frame: Baseline

Population: Randomized participants

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Get SocialHistory of Sleep ApneaNo143 Participants
Get SocialHistory of Sleep ApneaYes24 Participants
TraditionalHistory of Sleep ApneaNo144 Participants
TraditionalHistory of Sleep ApneaYes18 Participants
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).

Time frame: Baseline

Population: Randomized participants

ArmMeasureValue (MEDIAN)
Get SocialInsomnia Severity Index5 score on a scale
TraditionalInsomnia Severity Index6 score on a scale
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).

Time frame: 6-months

Population: Randomized participants who completed the ISI at 6 months.

ArmMeasureValue (MEDIAN)
Get SocialInsomnia Severity Index5 score on a scale
TraditionalInsomnia Severity Index6 score on a scale
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).

Time frame: 12-months

Population: Randomized participants who completed the ISI at 12 months

ArmMeasureValue (MEDIAN)
Get SocialInsomnia Severity Index5 score on a scale
TraditionalInsomnia Severity Index5 score on a scale
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.

Time frame: 12-months

Population: Randomized participants

ArmMeasureValue (MEDIAN)
Get SocialIntervention Engagement81.8 Percentage of modules participated in
TraditionalIntervention Engagement63.6 Percentage of modules participated in
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.

Time frame: 6-months

Population: Randomized participants

ArmMeasureValue (MEDIAN)
Get SocialIntervention Engagement93.8 Percentage of modules participated in
TraditionalIntervention Engagement68.8 Percentage of modules participated in
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).

Time frame: Baseline

Population: Randomized participants

ArmMeasureGroupValue (MEDIAN)
Get SocialNeuroticism/Emotional Stability and Openness to ExperienceEmotional Stability/Neuroticism5 score on a scale
Get SocialNeuroticism/Emotional Stability and Openness to ExperienceOpenness to Experience5.5 score on a scale
TraditionalNeuroticism/Emotional Stability and Openness to ExperienceEmotional Stability/Neuroticism5 score on a scale
TraditionalNeuroticism/Emotional Stability and Openness to ExperienceOpenness to Experience6 score on a scale
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.

Time frame: Baseline to 6-months

Population: Randomized participants

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Get SocialPhysical Activity88 Participants
TraditionalPhysical Activity93 Participants
Comparison: We examined the proportion of participants engaging in 150+ minutes/week of moderate/vigorous intensity physical activity (MVPA) using generalized estimating equations with a logit link function and incorporating repeated measures over time. For participants missing MVPA at either follow-up timepoint, we used a baseline observation carried forward approach to impute their activity level (150+ vs \<150 MVPA mins/week) at that timepoint.p-value: 0.3905Generalized estimating equation
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.

Time frame: Baseline

Population: Randomized participants

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Get SocialPhysical Activity81 Participants
TraditionalPhysical Activity70 Participants
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.

Time frame: Baseline to 12-months

Population: Randomized participants

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Get SocialPhysical Activity87 Participants
TraditionalPhysical Activity78 Participants
Comparison: We examined the proportion of participants engaging in 150+ minutes/week of moderate/vigorous intensity physical activity (MVPA) using generalized estimating equations with a logit link function and incorporating repeated measures over time. For participants missing MVPA at either follow-up timepoint, we used a baseline observation carried forward approach to impute their activity level (150+ vs \<150 MVPA mins/week) at that timepoint.p-value: 0.4741Generalized estimating equation
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?

Time frame: Baseline

Population: Randomized participants (For current treatment, only randomized participants who reported previous sleep apnea diagnosis)

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Get SocialPrevious or Current Treatment for Sleep ApneaCurrent Treatment of Sleep Apnea (Participants with sleep apnea diagnosis)No5 Participants
Get SocialPrevious or Current Treatment for Sleep ApneaCurrent Treatment of Sleep Apnea (Participants with sleep apnea diagnosis)Yes19 Participants
Get SocialPrevious or Current Treatment for Sleep ApneaPast Treatment of Sleep ApneaNo145 Participants
Get SocialPrevious or Current Treatment for Sleep ApneaPast Treatment of Sleep ApneaYes22 Participants
TraditionalPrevious or Current Treatment for Sleep ApneaPast Treatment of Sleep ApneaYes16 Participants
TraditionalPrevious or Current Treatment for Sleep ApneaCurrent Treatment of Sleep Apnea (Participants with sleep apnea diagnosis)No7 Participants
TraditionalPrevious or Current Treatment for Sleep ApneaPast Treatment of Sleep ApneaNo146 Participants
TraditionalPrevious or Current Treatment for Sleep ApneaCurrent Treatment of Sleep Apnea (Participants with sleep apnea diagnosis)Yes11 Participants
Secondary

Retention at Follow-up

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

Time frame: 12-months

Population: Randomized participants

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Get SocialRetention at Follow-up157 Participants
TraditionalRetention at Follow-up148 Participants
Secondary

Sleep Duration

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

Time frame: Baseline

Population: Randomized participants who completed the PSQI items

ArmMeasureValue (MEDIAN)
Get SocialSleep Duration7.0 hours
TraditionalSleep Duration7.0 hours
Secondary

Sleep Duration

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

Time frame: 6-months

Population: Randomized participants who completed the PSQI items

ArmMeasureValue (MEDIAN)
Get SocialSleep Duration6.5 hours
TraditionalSleep Duration7.0 hours
Secondary

Sleep Duration

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

Time frame: 12-months

Population: Randomized participants who completed the PSQI items

ArmMeasureValue (MEDIAN)
Get SocialSleep Duration7.0 hours
TraditionalSleep Duration7.0 hours
Secondary

Social Media Use

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

Time frame: 12-months

Population: Randomized participants who completed questions regarding social media use

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Get SocialSocial Media Use100 Participants
TraditionalSocial Media Use68 Participants
Secondary

Social Media Use

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

Time frame: Baseline

Population: Randomized participants

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Get SocialSocial Media Use102 Participants
TraditionalSocial Media Use91 Participants
Secondary

Social Media Use

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

Time frame: 6-months

Population: Randomized participants who completed questions about social media use

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Get SocialSocial Media Use117 Participants
TraditionalSocial Media Use75 Participants
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.

Time frame: 12-months

Population: Randomized participants who complete the relevant module of the WMSI

ArmMeasureGroupValue (MEDIAN)
Get SocialSocial Support for Weight LossFamily - Frequency1.4 units on a scale
Get SocialSocial Support for Weight LossFamily - Helpfulness3.0 units on a scale
Get SocialSocial Support for Weight LossFriends - Frequency1.2 units on a scale
Get SocialSocial Support for Weight LossFriends - Helpfulness3.1 units on a scale
Get SocialSocial Support for Weight LossTwitter Friends - Frequency1.0 units on a scale
Get SocialSocial Support for Weight LossTwitter Friends - Helpfulness2.8 units on a scale
Get SocialSocial Support for Weight LossFacebook Friends - Frequency1.0 units on a scale
Get SocialSocial Support for Weight LossFacebook Friends - Helpfulness3.0 units on a scale
TraditionalSocial Support for Weight LossFacebook Friends - Helpfulness3.0 units on a scale
TraditionalSocial Support for Weight LossFamily - Frequency1.3 units on a scale
TraditionalSocial Support for Weight LossTwitter Friends - Frequency1.0 units on a scale
TraditionalSocial Support for Weight LossFamily - Helpfulness3.0 units on a scale
TraditionalSocial Support for Weight LossFacebook Friends - Frequency1.0 units on a scale
TraditionalSocial Support for Weight LossFriends - Frequency1.2 units on a scale
TraditionalSocial Support for Weight LossTwitter Friends - Helpfulness1.0 units on a scale
TraditionalSocial Support for Weight LossFriends - Helpfulness3.0 units on a scale
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.

Time frame: Baseline

Population: Randomized participants who completed each of the WMSI subscales.

ArmMeasureGroupValue (MEDIAN)
Get SocialSocial Support for Weight LossFriends - Helpfulness1.9 score on a scale
Get SocialSocial Support for Weight LossFamily - Helpfulness2.1 score on a scale
Get SocialSocial Support for Weight LossTwitter Friends - Helpfulness1.0 score on a scale
Get SocialSocial Support for Weight LossFamily - Frequency1.5 score on a scale
Get SocialSocial Support for Weight LossFacebook Friends - Frequency1.0 score on a scale
Get SocialSocial Support for Weight LossFriends - Frequency1.3 score on a scale
Get SocialSocial Support for Weight LossFacebook Friends - Helpfulness1.2 score on a scale
Get SocialSocial Support for Weight LossTwitter Friends - Frequency1.0 score on a scale
TraditionalSocial Support for Weight LossFacebook Friends - Helpfulness1.3 score on a scale
TraditionalSocial Support for Weight LossFamily - Frequency1.4 score on a scale
TraditionalSocial Support for Weight LossFamily - Helpfulness2.0 score on a scale
TraditionalSocial Support for Weight LossFriends - Frequency1.2 score on a scale
TraditionalSocial Support for Weight LossTwitter Friends - Frequency1.0 score on a scale
TraditionalSocial Support for Weight LossTwitter Friends - Helpfulness1.0 score on a scale
TraditionalSocial Support for Weight LossFacebook Friends - Frequency1.0 score on a scale
TraditionalSocial Support for Weight LossFriends - Helpfulness2.0 score on a scale
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.

Time frame: 6-months

Population: Randomized participants who completed the relevant WMSI scales

ArmMeasureGroupValue (MEDIAN)
Get SocialSocial Support for Weight LossFamily - Frequency1.5 score on a scale
Get SocialSocial Support for Weight LossFamily - Helpfulness2.8 score on a scale
Get SocialSocial Support for Weight LossFriends - Frequency1.4 score on a scale
Get SocialSocial Support for Weight LossFriends - Helpfulness2.8 score on a scale
Get SocialSocial Support for Weight LossTwitter Friends - Frequency1.6 score on a scale
Get SocialSocial Support for Weight LossTwitter Friends - Helpfulness2.8 score on a scale
Get SocialSocial Support for Weight LossFacebook Friends - Frequency1.0 score on a scale
Get SocialSocial Support for Weight LossFacebook Friends - Helpfulness2.1 score on a scale
TraditionalSocial Support for Weight LossFacebook Friends - Helpfulness2.7 score on a scale
TraditionalSocial Support for Weight LossFamily - Frequency1.5 score on a scale
TraditionalSocial Support for Weight LossTwitter Friends - Frequency1.0 score on a scale
TraditionalSocial Support for Weight LossFamily - Helpfulness2.7 score on a scale
TraditionalSocial Support for Weight LossFacebook Friends - Frequency1.0 score on a scale
TraditionalSocial Support for Weight LossFriends - Frequency1.2 score on a scale
TraditionalSocial Support for Weight LossTwitter Friends - Helpfulness1.0 score on a scale
TraditionalSocial Support for Weight LossFriends - Helpfulness3.0 score on a scale
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.

Time frame: 12-month

Population: Randomized participants who completed the STOP questionnaire

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Get SocialSTOP (Snoring, Tired, Observed Apnea, Pressure) QuestionnaireLow risk of sleep apnea83 Participants
Get SocialSTOP (Snoring, Tired, Observed Apnea, Pressure) QuestionnaireHigh risk of sleep apnea34 Participants
TraditionalSTOP (Snoring, Tired, Observed Apnea, Pressure) QuestionnaireLow risk of sleep apnea96 Participants
TraditionalSTOP (Snoring, Tired, Observed Apnea, Pressure) QuestionnaireHigh risk of sleep apnea33 Participants
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.

Time frame: 6-month

Population: Randomized participants who completed the STOP questionnaire

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Get SocialSTOP (Snoring, Tired, Observed Apnea, Pressure) QuestionnaireLow risk of sleep apnea94 Participants
Get SocialSTOP (Snoring, Tired, Observed Apnea, Pressure) QuestionnaireHigh risk of sleep apnea34 Participants
TraditionalSTOP (Snoring, Tired, Observed Apnea, Pressure) QuestionnaireLow risk of sleep apnea101 Participants
TraditionalSTOP (Snoring, Tired, Observed Apnea, Pressure) QuestionnaireHigh risk of sleep apnea40 Participants
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.

Time frame: Baseline

Population: Randomized participants

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Get SocialSTOP (Snoring, Tired, Observed Apnea, Pressure) QuestionnaireLow risk for sleep apnea116 Participants
Get SocialSTOP (Snoring, Tired, Observed Apnea, Pressure) QuestionnaireHigh risk for sleep apnea51 Participants
TraditionalSTOP (Snoring, Tired, Observed Apnea, Pressure) QuestionnaireLow risk for sleep apnea105 Participants
TraditionalSTOP (Snoring, Tired, Observed Apnea, Pressure) QuestionnaireHigh risk for sleep apnea57 Participants
Secondary

Time Spent During Intervention

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

Time frame: 12-months

Population: Randomized participants

ArmMeasureValue (MEAN)Dispersion
Get SocialTime Spent During Intervention3.0 Hours per participantStandard Deviation 1.1
TraditionalTime Spent During Intervention3.9 Hours per participantStandard Deviation 1.8
p-value: 0.248t-test, 2 sided
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.

Time frame: 6-months

Population: Treatment groups of randomized participants in each condition.

ArmMeasureValue (MEAN)Dispersion
Get SocialTreatment Fidelity100 Percentage of unit objectives deliveredStandard Deviation 0
TraditionalTreatment Fidelity88.2 Percentage of unit objectives deliveredStandard Deviation 11
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.

Time frame: 12-months

Population: Randomized participants who answered the question about weight-loss related social media use.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Get SocialWeight-Loss Related Social Media Use48 Participants
TraditionalWeight-Loss Related Social Media Use28 Participants
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.

Time frame: 6-months

Population: Randomized participants who responded to the question about weight-loss related social media use

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Get SocialWeight-Loss Related Social Media Use78 Participants
TraditionalWeight-Loss Related Social Media Use36 Participants
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.

Time frame: Baseline

Population: Randomized participants

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Get SocialWeight-Loss Related Social Media Use58 Participants
TraditionalWeight-Loss Related Social Media Use59 Participants

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026