NCT04520256

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 384 (actual)
• Sponsor: The Miriam Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Online Behavioral Weight Loss Program	A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
BEHAVIORAL	Virtual Reality for Behavioral Weight Loss Skills Training	This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
BEHAVIORAL	Tailored Interactive Video Feedback	Video-recorded messages are used to provide periodic feedback on progress with weight loss, dietary change, and physical activity. Additional videos provide dietary skills training.
BEHAVIORAL	Tailored Intervention for Structured Physical Activity	Periodic self-assessment is used to guide selection of a physical activity goal. Home-based instructional videos are provided to help meet the selected goal.
BEHAVIORAL	Skills Training for Dysregulated Eating	Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
BEHAVIORAL	Platform for Social Support & Friendly Competition	An online platform is provided for participants to connect with each other, support each other, and compete on achievement of behavioral and weight loss milestones.

Timeline

• Start date: 2020-09-22
• Primary completion: 2023-05-18
• Completion: 2023-05-18
• First posted: 2020-08-20
• Last updated: 2025-01-15
• Results posted: 2025-01-15

Locations

1 site across 1 country: United States