Get Social: Randomized Trial of a Social Network Delivered Lifestyle Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 329
- 试验地点
- 1
- 主要终点
- Percent Weight Change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Smartphone users
- •Body Mass Index (BMI) 27-45
- •Must currently log into a social media platform on a daily basis basis and engage (like, reply, post) at least 4 days per week.
- •Participants will be excluded if they:
- •Do not have a smartphone;
- •Are unable to get medical clearance from their Primary Care Physician (PCP);
- •Have plans to move during study;
- •Are not interested in losing weight;
- •Have Type 1 or uncontrolled 2 Diabetes (as determined by PCP);
- •Have medical conditions that would prevent increasing physical activity or making dietary changes;
- •Are pregnant/lactating or plans to become pregnant during study;
- •Are currently taking medication affecting weight;
- •Currently participating in a weight loss program or using an online social network to assist them with weight loss (e.g. Weight Watchers, Sparkpeople, etc);
- •Unable to walk at least ¼ mile unaided without stopping;
- •Experienced a weight loss of 5% or more in past 3 month;
- •A history of/or plans on having bariatric surgery;
- •Did not complete the baseline measures;
- •Not willing to use Twitter, or if a current Twitter user, not willing to create a new account specifically for study purposes;
- •Participated in another weight loss study under the direction of the PI of this study;
- •Current smoker (smokes 3 or more cigarettes per day);
- •Unavailable to attend weekly group meetings;
- •Prefers one condition over another;
- •Score of 30 or higher on the Beck Depression Inventory (BDI) or endorsement of 2 or 3 on BDI #9 indicating suicidal thoughts;
- •Presence of binge eating disorder
- •Did not complete the orientation webinar;
- •Are unable to provide consent due to mental illness or a cognitive impairment;
- •Does not speak English; or
- •Are a prisoner.
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Get Social (Behavioral)
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.
干预措施: Smartphone (Device)
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.
干预措施: Traditional (Behavioral)
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.
干预措施: Smartphone (Device)
结局指标
主要结局
Percent Weight Change
时间窗: Baseline to 12-months
A digital scale (Scaletronix, Model-5002) will be used to record weight
Weight
时间窗: Baseline
A digital scale (Scaletronix, Model-5002) will be used to record weight
Percent Weight Change
时间窗: Baseline to 6-months
A digital scale (Scaletronix, Model-5002) will be used to record weight
次要结局
- Habitual Sleep Efficiency(12-months)
- Burden of Intervention(6-months)
- Blood Pressure(12-months)
- Time Spent During Intervention(12-months)
- Retention at Follow-up(12-months)
- Acceptability of the Intervention(6-months)
- Dietary Intake(Baseline)
- Change in Dietary Intake(Baseline to 12-months)
- Social Support for Weight Loss(12-months)
- Beck Depression Inventory(12-months)
- Cost Associated With Intervention(12-months)
- Weight-Loss Related Social Media Use(12-months)
- Physical Activity(Baseline to 12-months)
- Intervention Engagement(12-months)
- Neuroticism/Emotional Stability and Openness to Experience(Baseline)
- Social Media Use(12-months)
- History of Sleep Apnea(Baseline)
- Previous or Current Treatment for Sleep Apnea(Baseline)
- Diagnosis or Current Treatment for Sleep Apnea(12-months)
- Treatment Fidelity(6-months)
- STOP (Snoring, Tired, Observed Apnea, Pressure) Questionnaire(12-month)
- Insomnia Severity Index(12-months)
- Sleep Duration(12-months)
- Change in Dietary Intake(Baseline to 6-months)
- Physical Activity(Baseline)
- Physical Activity(Baseline to 6-months)
- Intervention Engagement(6-months)
- Social Support for Weight Loss(Baseline)
- Social Support for Weight Loss(6-months)
- Social Media Use(Baseline)
- Social Media Use(6-months)
- Blood Pressure(Baseline)
- Blood Pressure(6-months)
- STOP (Snoring, Tired, Observed Apnea, Pressure) Questionnaire(Baseline)
- STOP (Snoring, Tired, Observed Apnea, Pressure) Questionnaire(6-month)
- Insomnia Severity Index(Baseline)
- Insomnia Severity Index(6-months)
- Sleep Duration(Baseline)
- Sleep Duration(6-months)
- Diagnosis or Current Treatment for Sleep Apnea(6-months)
- Beck Depression Inventory(Baseline)
- Beck Depression Inventory(6-months)
- Weight-Loss Related Social Media Use(Baseline)
- Weight-Loss Related Social Media Use(6-months)
- Habitual Sleep Efficiency(Baseline)
- Habitual Sleep Efficiency(6-months)
研究者
Sherry Pagoto
Professor
University of Connecticut