Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Weight Change (Percent of Initial Body Weight) From Baseline to Month 12, Main Effect of Time
研究概览
简要总结
When delivered online, behavioral obesity treatments have the potential to reach large numbers of individuals with overweight/obesity and produce significant improvements in health and wellbeing. In order to maximize the public health benefit of disseminating these treatments online, this study will use the Multiphase Optimization Strategy (MOST) framework to most quickly and efficiently determine which, if any, of 5 innovative intervention components, alone or in combination, increases the proportion of patients achieving a ≥5% weight loss, and mean weight loss, after a 12-month online behavioral obesity treatment.
详细描述
Decades of research have demonstrated that behavioral obesity treatments can produce clinically significant weight losses that improve health and disease risk/severity. However, these treatments have not been disseminated widely due to high costs and lack of qualified providers. The investigators therefore aim to develop and test a fully automated online obesity treatment that would produce clinically significant weight losses (i.e., ≥ 5 % of initial body weight) when delivered online. In order to maximize the public health impact of online obesity treatment, and advance the science of online behavioral intervention in general, it is imperative to evaluate innovative behavioral intervention components with the potential to optimize weight loss outcomes. Because digital health technology evolves rapidly, this research will use the Multiphase Optimization Strategy (MOST) framework to most quickly and efficiently determine which, if any, of 5 innovative intervention components, alone or in combination, increases the proportion of patients achieving a ≥5% weight loss, and mean weight loss, of the online Rx Weight loss (RxWL) program at 12- months. The 5 intervention components to be tested are: (a) Web-based virtual reality intervention for training in basic behavioral weight loss skills; tailored interactive intervention targeting (b) structured physical activity and (c) dysregulated eating; (d) a platform for social interaction including opportunities for friendly competition, and (e) interactive video feedback with content tailored to the unique needs of each participant and a focus on dietary skills. A sample of 384 individuals with BMI ≥ 25 will be randomized to receive RxWL and 0-5 of the experimental intervention components in a full factorial experiment. This design will allow the investigators to determine which intervention components maximize weight loss and whether there are favorable combinations of components. In addition, by evaluating the effects of each component on proximal outcomes (i.e., mediators) it will be possible learn not only which components are (or are not) effective but also why or how they exert their effects. This project advances the science of behavioral obesity treatment, and will directly impact the care of patients receiving RxWL.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English language fluent and literate at the 6th grade level
- •Body mass index (BMI) between 25 and 50 kg/m-squared
- •Able to walk 2 city blocks without stopping
- •Not currently participating in another weight loss program
- •Not currently taking weight loss medication
- •Has not lost ≥5% of body weight in the 6 months prior to enrolling
- •Has not been pregnant within the 6 months prior to enrolling
- •Does not plan to become pregnant within 12 months of enrolling
- •Denies having a heart condition, chest pain during periods of activity or rest, or loss of consciousness in the 12 months prior to enrolling
- •Denies any medical condition that would affect the safety of participating in unsupervised physical activity
- •Denies any condition that would result in inability to follow the study protocol, including terminal illness, substance abuse, eating disorder (not including Binge Eating Disorder) and untreated major psychiatric illness
排除标准
- 未提供
研究组 & 干预措施
Exercise, VR
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Social Support, Dysregulated Eating, Exercise, Feedback, VR
干预措施: Skills Training for Dysregulated Eating (Behavioral)
Core Program Only
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Social Support, Exercise
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Dysregulated Eating
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Dysregulated Eating
干预措施: Skills Training for Dysregulated Eating (Behavioral)
Social Support, Dysregulated Eating
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Exercise
干预措施: Tailored Intervention for Structured Physical Activity (Behavioral)
Social Support, Dysregulated Eating
干预措施: Skills Training for Dysregulated Eating (Behavioral)
Social Support, Dysregulated Eating
干预措施: Platform for Social Support & Friendly Competition (Behavioral)
Exercise
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Social Support, Exercise
干预措施: Tailored Intervention for Structured Physical Activity (Behavioral)
Social Support, Exercise
干预措施: Platform for Social Support & Friendly Competition (Behavioral)
Dysregulated Eating, Exercise
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Dysregulated Eating, Exercise
干预措施: Tailored Intervention for Structured Physical Activity (Behavioral)
Dysregulated Eating, Exercise
干预措施: Skills Training for Dysregulated Eating (Behavioral)
Social Support, Dysregulated Eating, Exercise
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Social Support, Dysregulated Eating, Exercise
干预措施: Tailored Intervention for Structured Physical Activity (Behavioral)
Social Support, Dysregulated Eating, Exercise
干预措施: Skills Training for Dysregulated Eating (Behavioral)
Social Support, Dysregulated Eating, Exercise
干预措施: Platform for Social Support & Friendly Competition (Behavioral)
Feedback
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Feedback
干预措施: Tailored Interactive Video Feedback (Behavioral)
Social Support, Feedback
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Social Support, Feedback
干预措施: Tailored Interactive Video Feedback (Behavioral)
Social Support, Feedback
干预措施: Platform for Social Support & Friendly Competition (Behavioral)
Dysregulated Eating, Feedback
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Dysregulated Eating, Feedback
干预措施: Tailored Interactive Video Feedback (Behavioral)
Dysregulated Eating, Feedback
干预措施: Skills Training for Dysregulated Eating (Behavioral)
Social Support, Dysregulated Eating, Feedback
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Social Support, Dysregulated Eating, Feedback
干预措施: Tailored Interactive Video Feedback (Behavioral)
Social Support, Dysregulated Eating, Feedback
干预措施: Skills Training for Dysregulated Eating (Behavioral)
Social Support, Dysregulated Eating, Feedback
干预措施: Platform for Social Support & Friendly Competition (Behavioral)
Exercise, Feedback
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Exercise, Feedback
干预措施: Tailored Interactive Video Feedback (Behavioral)
Social Support, Exercise, Feedback
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Social Support, Exercise, Feedback
干预措施: Tailored Interactive Video Feedback (Behavioral)
Social Support, Exercise, Feedback
干预措施: Tailored Intervention for Structured Physical Activity (Behavioral)
Social Support, Exercise, Feedback
干预措施: Platform for Social Support & Friendly Competition (Behavioral)
Dysregulated Eating, Exercise, Feedback
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Dysregulated Eating, Exercise, Feedback
干预措施: Tailored Interactive Video Feedback (Behavioral)
Dysregulated Eating, Exercise, Feedback
干预措施: Tailored Intervention for Structured Physical Activity (Behavioral)
Dysregulated Eating, Exercise, Feedback
干预措施: Skills Training for Dysregulated Eating (Behavioral)
Social Support, Dysregulated Eating, Exercise, Feedback
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Social Support, Dysregulated Eating, Exercise, Feedback
干预措施: Tailored Interactive Video Feedback (Behavioral)
Social Support, Dysregulated Eating, Exercise, Feedback
干预措施: Tailored Intervention for Structured Physical Activity (Behavioral)
Social Support, Dysregulated Eating, Exercise, Feedback
干预措施: Skills Training for Dysregulated Eating (Behavioral)
Social Support, Dysregulated Eating, Exercise, Feedback
干预措施: Platform for Social Support & Friendly Competition (Behavioral)
VR
干预措施: Online Behavioral Weight Loss Program (Behavioral)
VR
干预措施: Virtual Reality for Behavioral Weight Loss Skills Training (Behavioral)
Social Support, VR
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Social Support, VR
干预措施: Virtual Reality for Behavioral Weight Loss Skills Training (Behavioral)
Social Support, VR
干预措施: Platform for Social Support & Friendly Competition (Behavioral)
Dysregulated Eating, VR
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Dysregulated Eating, VR
干预措施: Virtual Reality for Behavioral Weight Loss Skills Training (Behavioral)
Dysregulated Eating, VR
干预措施: Skills Training for Dysregulated Eating (Behavioral)
Social Support, Dysregulated Eating, VR
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Social Support, Dysregulated Eating, VR
干预措施: Virtual Reality for Behavioral Weight Loss Skills Training (Behavioral)
Social Support, Dysregulated Eating, VR
干预措施: Skills Training for Dysregulated Eating (Behavioral)
Social Support, Dysregulated Eating, VR
干预措施: Platform for Social Support & Friendly Competition (Behavioral)
Exercise, VR
干预措施: Virtual Reality for Behavioral Weight Loss Skills Training (Behavioral)
Exercise, VR
干预措施: Tailored Intervention for Structured Physical Activity (Behavioral)
Social Support, Exercise, VR
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Social Support, Exercise, VR
干预措施: Virtual Reality for Behavioral Weight Loss Skills Training (Behavioral)
Social Support, Exercise, VR
干预措施: Tailored Intervention for Structured Physical Activity (Behavioral)
Social Support, Exercise, VR
干预措施: Platform for Social Support & Friendly Competition (Behavioral)
Dysregulated Eating, Exercise, VR
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Dysregulated Eating, Exercise, VR
干预措施: Virtual Reality for Behavioral Weight Loss Skills Training (Behavioral)
Dysregulated Eating, Exercise, VR
干预措施: Tailored Intervention for Structured Physical Activity (Behavioral)
Dysregulated Eating, Exercise, VR
干预措施: Skills Training for Dysregulated Eating (Behavioral)
Social Support, Dysregulated Eating, Exercise, VR
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Social Support, Dysregulated Eating, Exercise, VR
干预措施: Virtual Reality for Behavioral Weight Loss Skills Training (Behavioral)
Social Support, Dysregulated Eating, Exercise, VR
干预措施: Tailored Intervention for Structured Physical Activity (Behavioral)
Social Support, Dysregulated Eating, Exercise, VR
干预措施: Skills Training for Dysregulated Eating (Behavioral)
Social Support, Dysregulated Eating, Exercise, VR
干预措施: Platform for Social Support & Friendly Competition (Behavioral)
Feedback, VR
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Feedback, VR
干预措施: Virtual Reality for Behavioral Weight Loss Skills Training (Behavioral)
Feedback, VR
干预措施: Tailored Interactive Video Feedback (Behavioral)
Social Support, Feedback, VR
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Social Support, Feedback, VR
干预措施: Virtual Reality for Behavioral Weight Loss Skills Training (Behavioral)
Social Support, Feedback, VR
干预措施: Tailored Interactive Video Feedback (Behavioral)
Social Support, Feedback, VR
干预措施: Platform for Social Support & Friendly Competition (Behavioral)
Dysregulated Eating, Feedback, VR
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Dysregulated Eating, Feedback, VR
干预措施: Virtual Reality for Behavioral Weight Loss Skills Training (Behavioral)
Dysregulated Eating, Feedback, VR
干预措施: Tailored Interactive Video Feedback (Behavioral)
Dysregulated Eating, Feedback, VR
干预措施: Skills Training for Dysregulated Eating (Behavioral)
Social Support, Dysregulated Eating, Feedback, VR
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Social Support, Dysregulated Eating, Feedback, VR
干预措施: Virtual Reality for Behavioral Weight Loss Skills Training (Behavioral)
Social Support, Dysregulated Eating, Feedback, VR
干预措施: Tailored Interactive Video Feedback (Behavioral)
Social Support, Dysregulated Eating, Feedback, VR
干预措施: Skills Training for Dysregulated Eating (Behavioral)
Social Support, Dysregulated Eating, Feedback, VR
干预措施: Platform for Social Support & Friendly Competition (Behavioral)
Exercise, Feedback, VR
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Exercise, Feedback, VR
干预措施: Virtual Reality for Behavioral Weight Loss Skills Training (Behavioral)
Exercise, Feedback, VR
干预措施: Tailored Interactive Video Feedback (Behavioral)
Exercise, Feedback, VR
干预措施: Tailored Intervention for Structured Physical Activity (Behavioral)
Social Support, Exercise, Feedback, VR
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Social Support, Exercise, Feedback, VR
干预措施: Virtual Reality for Behavioral Weight Loss Skills Training (Behavioral)
Social Support, Exercise, Feedback, VR
干预措施: Tailored Interactive Video Feedback (Behavioral)
Social Support, Exercise, Feedback, VR
干预措施: Tailored Intervention for Structured Physical Activity (Behavioral)
Social Support, Exercise, Feedback, VR
干预措施: Platform for Social Support & Friendly Competition (Behavioral)
Dysregulated Eating, Exercise, Feedback, VR
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Dysregulated Eating, Exercise, Feedback, VR
干预措施: Virtual Reality for Behavioral Weight Loss Skills Training (Behavioral)
Dysregulated Eating, Exercise, Feedback, VR
干预措施: Tailored Interactive Video Feedback (Behavioral)
Dysregulated Eating, Exercise, Feedback, VR
干预措施: Tailored Intervention for Structured Physical Activity (Behavioral)
Dysregulated Eating, Exercise, Feedback, VR
干预措施: Skills Training for Dysregulated Eating (Behavioral)
Social Support, Dysregulated Eating, Exercise, Feedback, VR
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Social Support, Dysregulated Eating, Exercise, Feedback, VR
干预措施: Virtual Reality for Behavioral Weight Loss Skills Training (Behavioral)
Social Support, Dysregulated Eating, Exercise, Feedback, VR
干预措施: Tailored Interactive Video Feedback (Behavioral)
Social Support, Dysregulated Eating, Exercise, Feedback, VR
干预措施: Tailored Intervention for Structured Physical Activity (Behavioral)
Social Support, Dysregulated Eating, Exercise, Feedback, VR
干预措施: Platform for Social Support & Friendly Competition (Behavioral)
Social Support
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Social Support
干预措施: Platform for Social Support & Friendly Competition (Behavioral)
结局指标
主要结局
Weight Change (Percent of Initial Body Weight) From Baseline to Month 12, Main Effect of Time
时间窗: From Baseline to Month 12
Weight was measured at the research center by the research team, or measured by the participant at home and sent to the research team with with documentation of the value reported (e.g., a photograph from a home scale showing the weight). A change between two time points is reported. The value of this outcome was calculated using: \[(baseline weight - month 12 weight) ÷ baseline weight\] × 100. Estimated mean change was obtained from a linear mixed models analysis of variance. Data from all randomized participants were included in the model (ITT analysis).
Weight Change (Percent of Initial Body Weight) From Baseline to Month 12, Time by Intervention Component Interaction
时间窗: From Baseline to Month 12
Weight was measured at the research center by the research team, or measured by the participant at home and sent to the research team with with documentation of the value reported (e.g., a photograph from a home scale showing the weight). A change between two time points is reported. The value of this outcome was calculated using: \[(baseline weight - month 12 weight) ÷ baseline weight\] × 100. Estimated mean change was obtained from a linear mixed models analysis of variance. Data from all randomized participants were included in the model (ITT analysis). This outcome measure is reported as an additional effect beyond that of Outcome Measure 1 (each intervention component has it's own weight loss effect that is above and beyond the weight change calculated in the Outcome Measure 1 analyses).
Proportion of Participants With Weight Loss ≥ 5% at Month 12, Main Effect of Time
时间窗: Month 12
Weight was measured at the research center by the research team, or measured by the participant at home and sent to the research team with with documentation of the value reported (e.g., a photograph from a home scale showing the weight). Weight loss was calculated using: \[(baseline weight - month 12 weight) ÷ baseline weight\] × 100. The estimated proportion of participants achieving a weight loss of ≥ 5% of their Baseline body weight was obtained from a generalized linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis).
Proportion of Participants With Weight Loss ≥ 5% at Month 12, Time by Intervention Component Interaction
时间窗: Month 12
Weight was measured at the research center by the research team, or measured by the participant at home and sent to the research team with with documentation of the value reported (e.g., a photograph from a home scale showing the weight). Weight loss was calculated using: \[(baseline weight - month 12 weight) ÷ baseline weight\] × 100. Estimated proportions of participants with weight loss of ≥ 5% of initial body weight at Month 12 were obtained from a generalized linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis).
次要结局
未报告次要终点