Exploring the Optimal Treatment Components for a Contactless Online Group-based Behavioral Weight Loss Program for the COVID 19 Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Weight loss
研究概览
简要总结
The current pilot study will explore the optimal cost-effective treatment configuration for online group-based weight control by focusing on two aspects of our existing treatment program which have significant associated cost and determine which contribute meaningfully to weight loss outcomes. Specifically, we will explore whether adding synchronous group social support (weekly group video chat sessions facilitated by a trained weight loss counselor) to on demand (asynchronous) social support provided through the program discussion board significantly increases weight losses achieved. We will also examine whether detailed feedback on dietary and physical activity self-monitoring records from a counselor enhances weight loss outcomes in comparison with basic feedback. Finally, we will examine the cost efficiency of the treatment constellations. Further, this pilot study will also explore the feasibility of recruiting participants nationally (rather than just locally) and the capture of data electronically (including body weight measurements) without any in-person contact.
详细描述
All participants will receive the same online group-based weight loss program, a lifestyle intervention which we have demonstrated to be effective in the past. The 16-session, goal-driven behavioral weight control program offers weekly interactive modules that provide evidence-based health education on caloric balance and physical activity increases, with a goal of fostering changes in diet and exercise habits and producing weight losses of 5-10%. The intervention is based on social cognitive theory and uses a self-regulation approach to learning new lifestyle habits that can produce and maintain weight loss. Participants in all study arms will be provided with the same calorie and physical activity goals, and all participants will be asked to self-monitor their dietary intake and physical activity daily using an app on their smart phone. They will also be asked to weigh themselves daily, consistent with research indicating that daily weighing is associated with greater weight loss and participants will be provided with a Bluetooth-enabled "smart scale" that will communicate weight to the password-protected study website (visible to only the participant and study staff). The study website also provides the dynamic programmatic content, real time graphic feedback from self-monitoring (for each individual participant) and a study group discussion board for asynchronous group interactions and social support. The website includes the core aspects of the behavioral program and is to be provided to all participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 27-55 kg/m2
- •free of medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component
- •must have a computer at home or work with video camera and access to the internet
- •must have a smart phone
- •only one member of a household may participate
- •must successfully complete a self-monitoring diary of food and beverages consumed for 7 consecutive days
- •must successfully set up the electronic scale (provided by the study at no cost) and transmit a body weight to study staff
- •must agree to be randomized to any of the 4 groups
- •must be willing to share access to their dietary and physical activity self-monitoring information collected via the Fitbit.com app/website and their weight data collected via linking the electronic smart scale with Fitbit.com
排除标准
- •taking insulin
- •currently on medication that might affect weight loss
- •currently pregnant or pregnant in the previous 6 months
- •currently breastfeeding
- •enrolled in another weight reduction program
- •have had a heart attack or stroke in the past 6 months
- •ever had weight loss surgery
- •have lost more than 10 pounds in the previous 6 months
- •currently taking medications for weight loss
- •required by their doctor to follow a special diet (other than a low fat diet)
- •anyone who has a schedule that would make it difficult to attend scheduled "chat" groups, should they be randomized to receive that treatment component
结局指标
主要结局
Weight loss
时间窗: Baseline, 2 and 4 months
Change in body weight from baseline calculated as kg lost
Change in body weight from baseline calculated as % of body weight lost
时间窗: 2 and 4 months
1 - \[follow-up body weight/ baseline body weight\] = % body weight change
次要结局
- Treatment Engagement: Attendance at Video Chat condition(Weeks 1 to 16)
- Treatment Engagement: daily weighing(Weeks 1 to 16)
- Treatment Engagement: weekly food journal submissions(Weeks 1 to 16)
- Treatment Engagement: completion of the 16 weekly interactive online modules(Weeks 1 to 16)
研究者
Delia Smith West
Professor, Exercise Science
University of South Carolina