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

NCT ID: NCT04520256

Last Updated: 2025-01-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

384 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-22

Study Completion Date

2023-05-18

Brief Summary

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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

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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

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Core Program Only

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type BEHAVIORAL

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

Social Support

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type BEHAVIORAL

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

Platform for Social Support & Friendly Competition

Intervention Type 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.

Dysregulated Eating

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type BEHAVIORAL

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

Skills Training for Dysregulated Eating

Intervention Type 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).

Social Support, Dysregulated Eating

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type BEHAVIORAL

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

Skills Training for Dysregulated Eating

Intervention Type 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

Intervention Type 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.

Exercise

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type BEHAVIORAL

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

Tailored Intervention for Structured Physical Activity

Intervention Type 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.

Social Support, Exercise

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type BEHAVIORAL

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

Tailored Intervention for Structured Physical Activity

Intervention Type 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.

Platform for Social Support & Friendly Competition

Intervention Type 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.

Dysregulated Eating, Exercise

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type BEHAVIORAL

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

Tailored Intervention for Structured Physical Activity

Intervention Type 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

Intervention Type 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).

Social Support, Dysregulated Eating, Exercise

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type BEHAVIORAL

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

Tailored Intervention for Structured Physical Activity

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Feedback

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type BEHAVIORAL

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

Tailored Interactive Video Feedback

Intervention Type 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.

Social Support, Feedback

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type BEHAVIORAL

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

Tailored Interactive Video Feedback

Intervention Type 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.

Platform for Social Support & Friendly Competition

Intervention Type 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.

Dysregulated Eating, Feedback

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type BEHAVIORAL

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

Tailored Interactive Video Feedback

Intervention Type 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.

Skills Training for Dysregulated Eating

Intervention Type 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).

Social Support, Dysregulated Eating, Feedback

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type BEHAVIORAL

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

Tailored Interactive Video Feedback

Intervention Type 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.

Skills Training for Dysregulated Eating

Intervention Type 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

Intervention Type 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.

Exercise, Feedback

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type BEHAVIORAL

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

Tailored Interactive Video Feedback

Intervention Type 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.

Social Support, Exercise, Feedback

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type BEHAVIORAL

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

Tailored Interactive Video Feedback

Intervention Type 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

Intervention Type 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.

Platform for Social Support & Friendly Competition

Intervention Type 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.

Dysregulated Eating, Exercise, Feedback

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type BEHAVIORAL

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

Tailored Interactive Video Feedback

Intervention Type 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

Intervention Type 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

Intervention Type 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).

Social Support, Dysregulated Eating, Exercise, Feedback

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type BEHAVIORAL

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

Tailored Interactive Video Feedback

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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.

VR

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type 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

Intervention Type BEHAVIORAL

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

Social Support, VR

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type 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

Intervention Type BEHAVIORAL

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

Platform for Social Support & Friendly Competition

Intervention Type 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.

Dysregulated Eating, VR

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type 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

Intervention Type BEHAVIORAL

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

Skills Training for Dysregulated Eating

Intervention Type 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).

Social Support, Dysregulated Eating, VR

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type 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

Intervention Type BEHAVIORAL

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

Skills Training for Dysregulated Eating

Intervention Type 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

Intervention Type 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.

Exercise, VR

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type 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

Intervention Type BEHAVIORAL

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

Tailored Intervention for Structured Physical Activity

Intervention Type 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.

Social Support, Exercise, VR

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type 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

Intervention Type BEHAVIORAL

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

Tailored Intervention for Structured Physical Activity

Intervention Type 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.

Platform for Social Support & Friendly Competition

Intervention Type 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.

Dysregulated Eating, Exercise, VR

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type 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

Intervention Type BEHAVIORAL

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

Tailored Intervention for Structured Physical Activity

Intervention Type 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

Intervention Type 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).

Social Support, Dysregulated Eating, Exercise, VR

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type 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

Intervention Type BEHAVIORAL

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

Tailored Intervention for Structured Physical Activity

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Feedback, VR

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Social Support, Feedback, VR

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Platform for Social Support & Friendly Competition

Intervention Type 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.

Dysregulated Eating, Feedback, VR

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Skills Training for Dysregulated Eating

Intervention Type 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).

Social Support, Dysregulated Eating, Feedback, VR

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Skills Training for Dysregulated Eating

Intervention Type 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

Intervention Type 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.

Exercise, Feedback, VR

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Social Support, Exercise, Feedback, VR

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Platform for Social Support & Friendly Competition

Intervention Type 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.

Dysregulated Eating, Exercise, Feedback, VR

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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).

Social Support, Dysregulated Eating, Exercise, Feedback, VR

Group Type EXPERIMENTAL

Online Behavioral Weight Loss Program

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Interventions

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Online Behavioral Weight Loss Program

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

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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).

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Miriam Hospital Weight Control and Diabetes Resarch Center

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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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 Sep 18. doi: 10.1002/oby.70039. Online ahead of print.

Reference Type DERIVED
PMID: 40968617 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01DK117857

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01DK117857

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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