Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy

Phase 2

Completed

Conditions: Overweight and Obesity

Interventions: Behavioral: Online Behavioral Weight Loss Program
Behavioral: Skills Training for Dysregulated Eating
Behavioral: Tailored Intervention for Structured Physical Activity
Behavioral: Tailored Interactive Video Feedback
Behavioral: Virtual Reality for Behavioral Weight Loss Skills Training
Behavioral: Platform for Social Support & Friendly Competition

Registration Number: NCT04520256

Lead Sponsor: The Miriam Hospital

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 384

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Core Program Only	Online Behavioral Weight Loss Program	-
Social Support, Dysregulated Eating	Skills Training for Dysregulated Eating	-
Exercise	Online Behavioral Weight Loss Program	-
Dysregulated Eating, Exercise	Tailored Intervention for Structured Physical Activity	-
Social Support, Dysregulated Eating	Online Behavioral Weight Loss Program	-
Social Support, Dysregulated Eating	Platform for Social Support & Friendly Competition	-
Social Support	Online Behavioral Weight Loss Program	-
Social Support	Platform for Social Support & Friendly Competition	-
Dysregulated Eating	Online Behavioral Weight Loss Program	-
Dysregulated Eating, Exercise	Online Behavioral Weight Loss Program	-
Exercise, Feedback	Online Behavioral Weight Loss Program	-
Exercise	Tailored Intervention for Structured Physical Activity	-
Social Support, Exercise	Online Behavioral Weight Loss Program	-
Dysregulated Eating	Skills Training for Dysregulated Eating	-
Social Support, Dysregulated Eating, Exercise	Online Behavioral Weight Loss Program	-
Social Support, Dysregulated Eating, Feedback	Platform for Social Support & Friendly Competition	-
Social Support, Exercise	Tailored Intervention for Structured Physical Activity	-
Social Support, Exercise	Platform for Social Support & Friendly Competition	-
Social Support, Dysregulated Eating, Exercise	Tailored Intervention for Structured Physical Activity	-
Feedback	Tailored Interactive Video Feedback	-
Dysregulated Eating, Feedback	Tailored Interactive Video Feedback	-
Social Support, Exercise, Feedback	Platform for Social Support & Friendly Competition	-
Dysregulated Eating, Exercise, Feedback	Tailored Interactive Video Feedback	-
Social Support, Dysregulated Eating, Exercise, Feedback	Tailored Interactive Video Feedback	-
Exercise, Feedback, VR	Online Behavioral Weight Loss Program	-
Dysregulated Eating, Exercise	Skills Training for Dysregulated Eating	-
Social Support, Dysregulated Eating, Feedback	Tailored Interactive Video Feedback	-
Dysregulated Eating, Exercise, Feedback	Tailored Intervention for Structured Physical Activity	-
Social Support, Dysregulated Eating, Exercise, Feedback	Skills Training for Dysregulated Eating	-
Social Support, VR	Online Behavioral Weight Loss Program	-
Social Support, VR	Platform for Social Support & Friendly Competition	-
Social Support, Dysregulated Eating, Exercise	Skills Training for Dysregulated Eating	-
Feedback	Online Behavioral Weight Loss Program	-
Social Support, Feedback	Platform for Social Support & Friendly Competition	-
Social Support, Dysregulated Eating, Feedback	Skills Training for Dysregulated Eating	-
Social Support, Exercise, Feedback	Online Behavioral Weight Loss Program	-
Dysregulated Eating, Exercise, Feedback	Online Behavioral Weight Loss Program	-
Dysregulated Eating, Exercise, Feedback	Skills Training for Dysregulated Eating	-
Social Support, Dysregulated Eating, Exercise, Feedback	Tailored Intervention for Structured Physical Activity	-
VR	Online Behavioral Weight Loss Program	-
Social Support, Dysregulated Eating, VR	Online Behavioral Weight Loss Program	-
Social Support, Dysregulated Eating, VR	Virtual Reality for Behavioral Weight Loss Skills Training	-
Exercise, VR	Online Behavioral Weight Loss Program	-
Exercise, VR	Virtual Reality for Behavioral Weight Loss Skills Training	-
Social Support, Dysregulated Eating, Exercise	Platform for Social Support & Friendly Competition	-
Social Support, Feedback	Online Behavioral Weight Loss Program	-
Social Support, Feedback	Tailored Interactive Video Feedback	-
Dysregulated Eating, Feedback	Online Behavioral Weight Loss Program	-
Dysregulated Eating, Feedback	Skills Training for Dysregulated Eating	-
Social Support, Dysregulated Eating, Feedback	Online Behavioral Weight Loss Program	-
Social Support, Dysregulated Eating, Exercise, Feedback	Online Behavioral Weight Loss Program	-
Social Support, Dysregulated Eating, Exercise, Feedback	Platform for Social Support & Friendly Competition	-
VR	Virtual Reality for Behavioral Weight Loss Skills Training	-
Exercise, Feedback	Tailored Interactive Video Feedback	-
Social Support, Exercise, Feedback	Tailored Interactive Video Feedback	-
Social Support, Exercise, Feedback	Tailored Intervention for Structured Physical Activity	-
Social Support, VR	Virtual Reality for Behavioral Weight Loss Skills Training	-
Social Support, Dysregulated Eating, VR	Platform for Social Support & Friendly Competition	-
Dysregulated Eating, Exercise, VR	Skills Training for Dysregulated Eating	-
Social Support, Feedback, VR	Tailored Interactive Video Feedback	-
Dysregulated Eating, VR	Online Behavioral Weight Loss Program	-
Dysregulated Eating, VR	Virtual Reality for Behavioral Weight Loss Skills Training	-
Social Support, Exercise, VR	Tailored Intervention for Structured Physical Activity	-
Social Support, Exercise, VR	Platform for Social Support & Friendly Competition	-
Dysregulated Eating, Exercise, VR	Tailored Intervention for Structured Physical Activity	-
Social Support, Dysregulated Eating, Exercise, VR	Online Behavioral Weight Loss Program	-
Social Support, Dysregulated Eating, Exercise, VR	Tailored Intervention for Structured Physical Activity	-
Feedback, VR	Virtual Reality for Behavioral Weight Loss Skills Training	-
Social Support, Feedback, VR	Virtual Reality for Behavioral Weight Loss Skills Training	-
Social Support, Dysregulated Eating, Feedback, VR	Virtual Reality for Behavioral Weight Loss Skills Training	-
Social Support, Exercise, Feedback, VR	Virtual Reality for Behavioral Weight Loss Skills Training	-
Dysregulated Eating, Exercise, Feedback, VR	Tailored Interactive Video Feedback	-
Dysregulated Eating, Exercise, Feedback, VR	Skills Training for Dysregulated Eating	-
Dysregulated Eating, Exercise, VR	Online Behavioral Weight Loss Program	-
Dysregulated Eating, VR	Skills Training for Dysregulated Eating	-
Social Support, Dysregulated Eating, VR	Skills Training for Dysregulated Eating	-
Social Support, Feedback, VR	Online Behavioral Weight Loss Program	-
Social Support, Feedback, VR	Platform for Social Support & Friendly Competition	-
Social Support, Dysregulated Eating, Feedback, VR	Skills Training for Dysregulated Eating	-
Social Support, Dysregulated Eating, Feedback, VR	Platform for Social Support & Friendly Competition	-
Dysregulated Eating, Exercise, Feedback, VR	Online Behavioral Weight Loss Program	-
Dysregulated Eating, Exercise, Feedback, VR	Tailored Intervention for Structured Physical Activity	-
Social Support, Dysregulated Eating, Exercise, Feedback, VR	Tailored Interactive Video Feedback	-
Exercise, Feedback, VR	Tailored Interactive Video Feedback	-
Exercise, VR	Tailored Intervention for Structured Physical Activity	-
Feedback, VR	Online Behavioral Weight Loss Program	-
Exercise, Feedback, VR	Tailored Intervention for Structured Physical Activity	-
Social Support, Exercise, Feedback, VR	Tailored Intervention for Structured Physical Activity	-
Social Support, Dysregulated Eating, Exercise, VR	Virtual Reality for Behavioral Weight Loss Skills Training	-
Social Support, Dysregulated Eating, Exercise, Feedback, VR	Virtual Reality for Behavioral Weight Loss Skills Training	-
Social Support, Dysregulated Eating, Exercise, Feedback, VR	Skills Training for Dysregulated Eating	-
Social Support, Exercise, VR	Online Behavioral Weight Loss Program	-
Social Support, Exercise, VR	Virtual Reality for Behavioral Weight Loss Skills Training	-
Dysregulated Eating, Exercise, VR	Virtual Reality for Behavioral Weight Loss Skills Training	-
Social Support, Dysregulated Eating, Exercise, VR	Skills Training for Dysregulated Eating	-
Social Support, Dysregulated Eating, Exercise, VR	Platform for Social Support & Friendly Competition	-
Feedback, VR	Tailored Interactive Video Feedback	-
Dysregulated Eating, Feedback, VR	Online Behavioral Weight Loss Program	-
Dysregulated Eating, Feedback, VR	Virtual Reality for Behavioral Weight Loss Skills Training	-
Dysregulated Eating, Feedback, VR	Tailored Interactive Video Feedback	-
Dysregulated Eating, Feedback, VR	Skills Training for Dysregulated Eating	-
Exercise, Feedback, VR	Virtual Reality for Behavioral Weight Loss Skills Training	-
Social Support, Exercise, Feedback, VR	Online Behavioral Weight Loss Program	-
Social Support, Dysregulated Eating, Feedback, VR	Tailored Interactive Video Feedback	-
Social Support, Dysregulated Eating, Feedback, VR	Online Behavioral Weight Loss Program	-
Social Support, Exercise, Feedback, VR	Tailored Interactive Video Feedback	-
Dysregulated Eating, Exercise, Feedback, VR	Virtual Reality for Behavioral Weight Loss Skills Training	-
Social Support, Dysregulated Eating, Exercise, Feedback, VR	Tailored Intervention for Structured Physical Activity	-
Social Support, Exercise, Feedback, VR	Platform for Social Support & Friendly Competition	-
Social Support, Dysregulated Eating, Exercise, Feedback, VR	Online Behavioral Weight Loss Program	-
Social Support, Dysregulated Eating, Exercise, Feedback, VR	Platform for Social Support & Friendly Competition	-

Primary Outcome Measures

Name	Time	Method
Weight Change (Percent of Initial Body Weight) From Baseline to Month 12, Main Effect of Time	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	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	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	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).