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Completed

NCT Number: NCT04520256

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

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.

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Key information

Conditions

Overweight and Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Miriam Hospital Weight Control and Diabetes Resarch Center

Providence, Rhode Island, 02903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Online Behavioral Weight Loss Program

Behavioral

A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.

Virtual Reality for Behavioral Weight Loss Skills Training

Behavioral

This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.

Tailored Interactive Video Feedback

Behavioral

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.

Tailored Intervention for Structured Physical Activity

Behavioral

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.

Skills Training for Dysregulated Eating

Behavioral

Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).

Platform for Social Support & Friendly Competition

Behavioral

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.

Primary outcomes

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

    Time frame: 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).

  2. Weight Change (Percent of Initial Body Weight) From Baseline to Month 12, Time by Intervention Component Interaction

    Time frame: 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).

  3. Proportion of Participants With Weight Loss ≥ 5% at Month 12, Main Effect of Time

    Time frame: 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).

  4. Proportion of Participants With Weight Loss ≥ 5% at Month 12, Time by Intervention Component Interaction

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 20, 2020
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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