Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy
December 23, 2024 updated by: The Miriam Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Behavioral: Online Behavioral Weight Loss Program
- Behavioral: Platform for Social Support & Friendly Competition
- 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
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.
Study Type
Interventional
Enrollment (Actual)
384
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Miriam Hospital Weight Control and Diabetes Resarch Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise
|
A self-guided, online program that helps participants reduce energy intake and gradually increase 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.
|
|
Experimental: Feedback
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
|
|
Experimental: Social Support
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
|
|
Experimental: Core Program Only
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
|
|
Experimental: Dysregulated Eating
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
|
|
Experimental: Social Support, Dysregulated Eating
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
|
|
Experimental: Social Support, Exercise
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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.
|
|
Experimental: Dysregulated Eating, Exercise
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
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.
|
|
Experimental: Social Support, Dysregulated Eating, Exercise
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
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.
|
|
Experimental: Social Support, Feedback
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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.
|
|
Experimental: Dysregulated Eating, Feedback
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
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.
|
|
Experimental: Social Support, Dysregulated Eating, Feedback
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
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.
|
|
Experimental: Exercise, Feedback
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
|
|
Experimental: Social Support, Exercise, Feedback
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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.
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.
|
|
Experimental: Dysregulated Eating, Exercise, Feedback
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
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.
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.
|
|
Experimental: Social Support, Dysregulated Eating, Exercise, Feedback
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
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.
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.
|
|
Experimental: VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Social Support, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Dysregulated Eating, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Social Support, Dysregulated Eating, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Exercise, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase 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.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Social Support, Exercise, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Dysregulated Eating, Exercise, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
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.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Social Support, Dysregulated Eating, Exercise, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
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.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Feedback, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Social Support, Feedback, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Dysregulated Eating, Feedback, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
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.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Social Support, Dysregulated Eating, Feedback, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
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.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Exercise, Feedback, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase 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.
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.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Social Support, Exercise, Feedback, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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.
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.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Dysregulated Eating, Exercise, Feedback, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
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.
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.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Social Support, Dysregulated Eating, Exercise, Feedback, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
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.
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.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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). |
From Baseline to Month 12
|
|
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). |
From Baseline to Month 12
|
|
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). |
Month 12
|
|
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). |
Month 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight loss self-efficacy
Time Frame: 12-month end of treatment
|
Measured via the Weight Efficacy Life-Style Questionnaire (WEL).
Scores range from 0 to 180; higher scores indicate a better outcome.
|
12-month end of treatment
|
|
Supportive accountability
Time Frame: 12-month end of treatment
|
Measured via the Supportive Accountability Measure (SAM).
Scores range from 17.14 to 100; higher scores indicate a better outcome.
|
12-month end of treatment
|
|
Social support for diet and exercise behaviors
Time Frame: 12-month end of treatment
|
Measured via the Scales to Measure Social Support for Diet and Exercise Behaviors.
Scores range from 10 to 75; higher scores indicate a better outcome.
|
12-month end of treatment
|
|
Internal disinhibition
Time Frame: 12-month end of treatment
|
Measured via the Eating Inventory.
Scores range from 0 to 16; lower scores indicate a better outcome.
|
12-month end of treatment
|
|
Structured physical activity
Time Frame: 12-month end of treatment
|
Daily time spent in structured moderate to vigorous intensity physical activity will be measured using the ActiGraph GT9X Link
|
12-month end of treatment
|
|
Dietary quality
Time Frame: 12-month end of treatment
|
Data collected via the National Cancer Institute Automated Self-Administered 24-hour recall system (ASA-24).
Diet quality is measured by the The Health Eating Index, 2015, score that reflects conformance to the 2015 Dietary Guidelines for Americans.
Higher scores indicate a better outcome.
|
12-month end of treatment
|
|
Dietary energy density
Time Frame: 12-month end of treatment
|
Data collected via the National Cancer Institute Automated Self-Administered 24-hour recall system (ASA-24).
Energy density of the diet is calculated as total energy intake from food ÷ total weight of the food.
Lower scores indicate a better outcome.
|
12-month end of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 22, 2020
Primary Completion (Actual)
May 18, 2023
Study Completion (Actual)
May 18, 2023
Study Registration Dates
First Submitted
August 12, 2020
First Submitted That Met QC Criteria
August 17, 2020
First Posted (Actual)
August 20, 2020
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 23, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DK117857 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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