Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy
1 other identifier
interventional
384
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2020
CompletedFirst Posted
Study publicly available on registry
August 20, 2020
CompletedStudy Start
First participant enrolled
September 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2023
CompletedResults Posted
Study results publicly available
January 15, 2025
CompletedJanuary 15, 2025
March 1, 2024
2.7 years
August 12, 2020
November 25, 2024
December 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Weight Change (Percent of Initial Body Weight) From Baseline to Month 12, Main Effect of Time
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: \[(baseline weight - month 12 weight) Ă· baseline weight\] Ă— 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
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: \[(baseline weight - month 12 weight) Ă· baseline weight\] Ă— 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
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: \[(baseline weight - month 12 weight) Ă· baseline weight\] Ă— 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
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: \[(baseline weight - month 12 weight) Ă· baseline weight\] Ă— 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
Study Arms (32)
Core Program Only
EXPERIMENTALSocial Support
EXPERIMENTALDysregulated Eating
EXPERIMENTALSocial Support, Dysregulated Eating
EXPERIMENTALExercise
EXPERIMENTALSocial Support, Exercise
EXPERIMENTALDysregulated Eating, Exercise
EXPERIMENTALSocial Support, Dysregulated Eating, Exercise
EXPERIMENTALFeedback
EXPERIMENTALSocial Support, Feedback
EXPERIMENTALDysregulated Eating, Feedback
EXPERIMENTALSocial Support, Dysregulated Eating, Feedback
EXPERIMENTALExercise, Feedback
EXPERIMENTALSocial Support, Exercise, Feedback
EXPERIMENTALDysregulated Eating, Exercise, Feedback
EXPERIMENTALSocial Support, Dysregulated Eating, Exercise, Feedback
EXPERIMENTALVR
EXPERIMENTALSocial Support, VR
EXPERIMENTALDysregulated Eating, VR
EXPERIMENTALSocial Support, Dysregulated Eating, VR
EXPERIMENTALExercise, VR
EXPERIMENTALSocial Support, Exercise, VR
EXPERIMENTALDysregulated Eating, Exercise, VR
EXPERIMENTALSocial Support, Dysregulated Eating, Exercise, VR
EXPERIMENTALFeedback, VR
EXPERIMENTALSocial Support, Feedback, VR
EXPERIMENTALDysregulated Eating, Feedback, VR
EXPERIMENTALSocial Support, Dysregulated Eating, Feedback, VR
EXPERIMENTALExercise, Feedback, VR
EXPERIMENTALSocial Support, Exercise, Feedback, VR
EXPERIMENTALDysregulated Eating, Exercise, Feedback, VR
EXPERIMENTALSocial Support, Dysregulated Eating, Exercise, Feedback, VR
EXPERIMENTALInterventions
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.
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.
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.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
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.
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (1)
Miriam Hospital Weight Control and Diabetes Resarch Center
Providence, Rhode Island, 02903, United States
Related Publications (1)
Thomas JG, Goldstein CM, Bond DS, Lillis J, Hekler E, Goldstein SP, Butryn ML, Cao Z, Wing RR. Evaluation of Five Novel Intervention Components in Online Obesity Treatment: Outcomes of a Randomized Factorial Experiment. Obesity (Silver Spring). 2025 Nov;33(11):2128-2138. doi: 10.1002/oby.70039. Epub 2025 Sep 18.
PMID: 40968617DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. J. Graham Thomas
- Organization
- The Miriam Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2020
First Posted
August 20, 2020
Study Start
September 22, 2020
Primary Completion
May 18, 2023
Study Completion
May 18, 2023
Last Updated
January 15, 2025
Results First Posted
January 15, 2025
Record last verified: 2024-03