Overweight and Obesity
Conditions
Keywords
Diet, Physical activity, Online
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.
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.
Interventions
BEHAVIORALOnline Behavioral Weight Loss Program
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
BEHAVIORALVirtual 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.
BEHAVIORALTailored 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.
BEHAVIORALTailored 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.
BEHAVIORALSkills 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).
BEHAVIORALPlatform 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.
Sponsors
The Miriam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change (Percent of Initial Body Weight) From Baseline to Month 12, Main Effect of Time | 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). |
| Weight Change (Percent of Initial Body Weight) From Baseline to Month 12, Time by Intervention Component Interaction | 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). |
| Proportion of Participants With Weight Loss ≥ 5% at Month 12, Main Effect of Time | 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). |
| Proportion of Participants With Weight Loss ≥ 5% at Month 12, Time by Intervention Component Interaction | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Core Program Only Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity. | 12 |
| Social Support Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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. | 12 |
| Dysregulated Eating Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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). | 12 |
| Social Support, Dysregulated Eating Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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).
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. | 12 |
| Exercise Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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. | 12 |
| Social Support, Exercise Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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. | 12 |
| Dysregulated Eating, Exercise Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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). | 12 |
| Social Support, Dysregulated Eating, Exercise Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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).
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. | 12 |
| Feedback Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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. | 12 |
| Social Support, Feedback Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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. | 12 |
| Dysregulated Eating, Feedback Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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). | 12 |
| Social Support, Dysregulated Eating, Feedback Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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).
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. | 12 |
| Exercise, Feedback Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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. | 12 |
| Social Support, Exercise, Feedback Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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.
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. | 12 |
| Dysregulated Eating, Exercise, Feedback Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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.
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). | 12 |
| Social Support, Dysregulated Eating, Exercise, Feedback Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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.
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).
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. | 12 |
| Virtual Reality Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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. | 12 |
| Social Support, VR Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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. | 12 |
| Dysregulated Eating, VR Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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). | 12 |
| Social Support, Dysregulated Eating, VR Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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).
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. | 12 |
| Exercise, VR Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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. | 12 |
| Social Support, Exercise, VR Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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.
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. | 12 |
| Dysregulated Eating, Exercise, VR Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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.
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). | 12 |
| Social Support, Dysregulated Eating, Exercise, VR Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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.
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).
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. | 12 |
| Feedback, VR Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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. | 12 |
| Social Support, Feedback, VR Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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.
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. | 12 |
| Dysregulated Eating, Feedback, VR Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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.
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). | 12 |
| Social Support, Dysregulated Eating, Feedback, VR Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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.
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).
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. | 12 |
| Exercise, Feedback, VR Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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.
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. | 12 |
| Social Support, Exercise, Feedback, VR Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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.
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.
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. | 12 |
| Dysregulated Eating, Exercise, Feedback, VR Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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.
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.
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). | 12 |
| Social Support, Dysregulated Eating, Exercise, Feedback, VR Online Behavioral Weight Loss Program: A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
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.
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.
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.
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).
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. | 12 |
| Total | 384 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 | FG022 | FG023 | FG024 | FG025 | FG026 | FG027 | FG028 | FG029 | FG030 | FG031 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 4 | 2 | 3 | 6 | 6 | 4 | 6 | 1 | 3 | 3 | 2 | 5 | 3 | 3 | 6 | 6 | 4 | 3 | 3 | 7 | 3 | 3 | 8 | 5 | 4 | 3 | 4 | 3 | 4 | 4 | 4 |
Baseline characteristics
| Characteristic | Social Support, Feedback, VR | Core Program Only | Social Support | Dysregulated Eating | Social Support, Dysregulated Eating | Exercise | Social Support, Exercise | Dysregulated Eating, Exercise | Social Support, Dysregulated Eating, Exercise | Feedback | Social Support, Feedback | Dysregulated Eating, Feedback | Social Support, Dysregulated Eating, Feedback | Exercise, Feedback | Social Support, Exercise, Feedback | Dysregulated Eating, Exercise, Feedback | Social Support, Dysregulated Eating, Exercise, Feedback | Virtual Reality | Social Support, VR | Dysregulated Eating, VR | Social Support, Dysregulated Eating, VR | Exercise, VR | Social Support, Exercise, VR | Dysregulated Eating, Exercise, VR | Social Support, Dysregulated Eating, Exercise, VR | Feedback, VR | Dysregulated Eating, Feedback, VR | Social Support, Dysregulated Eating, Feedback, VR | Exercise, Feedback, VR | Social Support, Exercise, Feedback, VR | Dysregulated Eating, Exercise, Feedback, VR | Social Support, Dysregulated Eating, Exercise, Feedback, VR | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 51.9 years STANDARD_DEVIATION 9.3 | 56.5 years STANDARD_DEVIATION 10.8 | 54.3 years STANDARD_DEVIATION 11.8 | 53.6 years STANDARD_DEVIATION 11.9 | 53.6 years STANDARD_DEVIATION 8.9 | 58.3 years STANDARD_DEVIATION 8.5 | 48 years STANDARD_DEVIATION 11.3 | 56.2 years STANDARD_DEVIATION 11 | 57.7 years STANDARD_DEVIATION 9.1 | 53.3 years STANDARD_DEVIATION 12.7 | 46.7 years STANDARD_DEVIATION 13 | 56.3 years STANDARD_DEVIATION 10.2 | 52.2 years STANDARD_DEVIATION 13.5 | 52.9 years STANDARD_DEVIATION 12.6 | 58.6 years STANDARD_DEVIATION 9.9 | 56 years STANDARD_DEVIATION 12.7 | 50.8 years STANDARD_DEVIATION 11.6 | 53.3 years STANDARD_DEVIATION 12.3 | 54.9 years STANDARD_DEVIATION 7.4 | 56.8 years STANDARD_DEVIATION 13.2 | 50.0 years STANDARD_DEVIATION 13.2 | 55.4 years STANDARD_DEVIATION 10.6 | 57.1 years STANDARD_DEVIATION 12.4 | 58.2 years STANDARD_DEVIATION 11.5 | 55 years STANDARD_DEVIATION 9.1 | 51.5 years STANDARD_DEVIATION 11.7 | 52 years STANDARD_DEVIATION 13.3 | 51.2 years STANDARD_DEVIATION 14 | 49.6 years STANDARD_DEVIATION 16.7 | 49.3 years STANDARD_DEVIATION 10.1 | 53.9 years STANDARD_DEVIATION 12.3 | 44.5 years STANDARD_DEVIATION 13.4 | 53.4 years STANDARD_DEVIATION 12.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 10 Participants | 11 Participants | 10 Participants | 10 Participants | 11 Participants | 11 Participants | 12 Participants | 11 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 10 Participants | 12 Participants | 11 Participants | 11 Participants | 8 Participants | 12 Participants | 11 Participants | 12 Participants | 7 Participants | 11 Participants | 12 Participants | 12 Participants | 11 Participants | 10 Participants | 9 Participants | 10 Participants | 350 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 00 Participants | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 3 Participants | 38 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 22 Participants |
| Race (NIH/OMB) White | 7 Participants | 7 Participants | 11 Participants | 9 Participants | 11 Participants | 10 Participants | 8 Participants | 6 Participants | 11 Participants | 11 Participants | 8 Participants | 10 Participants | 12 Participants | 11 Participants | 11 Participants | 11 Participants | 8 Participants | 11 Participants | 9 Participants | 9 Participants | 10 Participants | 12 Participants | 10 Participants | 11 Participants | 7 Participants | 8 Participants | 12 Participants | 11 Participants | 9 Participants | 10 Participants | 9 Participants | 8 Participants | 308 Participants |
| Region of Enrollment United States | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 384 participants |
| Sex/Gender, Customized Female | 11 Participants | 8 Participants | 12 Participants | 10 Participants | 8 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 11 Participants | 11 Participants | 10 Participants | 8 Participants | 12 Participants | 10 Participants | 11 Participants | 10 Participants | 11 Participants | 8 Participants | 10 Participants | 11 Participants | 10 Participants | 10 Participants | 7 Participants | 12 Participants | 9 Participants | 11 Participants | 9 Participants | 10 Participants | 10 Participants | 320 Participants |
| Sex/Gender, Customized Male | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 4 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 3 Participants | 0 Participants | 3 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 50 Participants |
| Sex/Gender, Customized Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants |
| Sex/Gender, Customized Unknown or Not Reported | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk | EG026 affected / at risk | EG027 affected / at risk | EG028 affected / at risk | EG029 affected / at risk | EG030 affected / at risk | EG031 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
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: \[(baseline weight - month 12 weight) ÷ baseline weight\] × 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).
Time frame: Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Proportion of Participants With Weight Loss ≥ 5% at Month 12, Main Effect of Time | 0.08 proportion of participants | Standard Error 0.15 |
p-value: 0.999Mixed Models Analysis
Primary
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: \[(baseline weight - month 12 weight) ÷ baseline weight\] × 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).
Time frame: Month 12
Population: All randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Proportion of Participants With Weight Loss ≥ 5% at Month 12, Time by Intervention Component Interaction | .12 proportion of participants | Standard Error 0.23 |
| Dysregulated Eating | Proportion of Participants With Weight Loss ≥ 5% at Month 12, Time by Intervention Component Interaction | .15 proportion of participants | Standard Error 0.27 |
| Exercise | Proportion of Participants With Weight Loss ≥ 5% at Month 12, Time by Intervention Component Interaction | .11 proportion of participants | Standard Error 0.21 |
| Feedback | Proportion of Participants With Weight Loss ≥ 5% at Month 12, Time by Intervention Component Interaction | .11 proportion of participants | Standard Error 0.2 |
| Virtual Reality | Proportion of Participants With Weight Loss ≥ 5% at Month 12, Time by Intervention Component Interaction | .10 proportion of participants | Standard Error 0.19 |
p-value: 0.99995% CI: [0, 0.56]Mixed Models Analysis
p-value: 0.99995% CI: [0, 0.68]Mixed Models Analysis
p-value: 0.99995% CI: [0, 0.52]Mixed Models Analysis
p-value: 0.99995% CI: [0, 0.5]Mixed Models Analysis
p-value: 0.99995% CI: [0, 0.47]Mixed Models Analysis
Primary
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: \[(baseline weight - month 12 weight) ÷ baseline weight\] × 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).
Time frame: From Baseline to Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Weight Change (Percent of Initial Body Weight) From Baseline to Month 12, Main Effect of Time | -5.8 percent of initial body weight | Standard Error 0.87 |
p-value: <0.001Mixed Models Analysis
Primary
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: \[(baseline weight - month 12 weight) ÷ baseline weight\] × 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).
Time frame: From Baseline to Month 12
Population: All randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Weight Change (Percent of Initial Body Weight) From Baseline to Month 12, Time by Intervention Component Interaction | -0.27 percent of initial body weight | Standard Error 0.7 |
| Dysregulated Eating | Weight Change (Percent of Initial Body Weight) From Baseline to Month 12, Time by Intervention Component Interaction | 0.09 percent of initial body weight | Standard Error 0.7 |
| Exercise | Weight Change (Percent of Initial Body Weight) From Baseline to Month 12, Time by Intervention Component Interaction | -0.03 percent of initial body weight | Standard Error 0.7 |
| Feedback | Weight Change (Percent of Initial Body Weight) From Baseline to Month 12, Time by Intervention Component Interaction | 0.44 percent of initial body weight | Standard Error 0.7 |
| Virtual Reality | Weight Change (Percent of Initial Body Weight) From Baseline to Month 12, Time by Intervention Component Interaction | 0.92 percent of initial body weight | Standard Error 0.7 |
p-value: 0.69395% CI: [-0.54, 0.01]Mixed Models Analysis
p-value: 0.995% CI: [0.01, 0.18]Mixed Models Analysis
p-value: 0.9695% CI: [-0.06, 0.01]Mixed Models Analysis
p-value: 0.11395% CI: [0.01, 0.88]Mixed Models Analysis
p-value: 0.18795% CI: [0.01, 1.84]Mixed Models Analysis