Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
- Behavioral: Online Behavioral Weight Loss Program
- Behavioral: Platform for Social Support & Friendly Competition
- Behavioral: Skills Training for Dysregulated Eating
- Behavioral: Tailored Intervention for Structured Physical Activity
- Behavioral: Tailored Interactive Video Feedback
- Behavioral: Virtual Reality for Behavioral Weight Loss Skills Training
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Miriam Hospital Weight Control and Diabetes Resarch Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
- English language fluent and literate at the 6th grade level
- Body mass index (BMI) between 25 and 50 kg/m-squared
- Able to walk 2 city blocks without stopping
- Not currently participating in another weight loss program
- Not currently taking weight loss medication
- Has not lost ≥5% of body weight in the 6 months prior to enrolling
- Has not been pregnant within the 6 months prior to enrolling
- Does not plan to become pregnant within 12 months of enrolling
- Denies having a heart condition, chest pain during periods of activity or rest, or loss of consciousness in the 12 months prior to enrolling
- Denies any medical condition that would affect the safety of participating in unsupervised physical activity
- Denies any condition that would result in inability to follow the study protocol, including terminal illness, substance abuse, eating disorder (not including Binge Eating Disorder) and untreated major psychiatric illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Exercise
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
Periodic self-assessment is used to guide selection of a physical activity goal.
Home-based instructional videos are provided to help meet the selected goal.
|
|
Experimental: Feedback
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
Video-recorded messages are used to provide periodic feedback on progress with weight loss, dietary change, and physical activity.
Additional videos provide dietary skills training.
|
|
Experimental: Social Support
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
An online platform is provided for participants to connect with each other, support each other, and compete on achievement of behavioral and weight loss milestones.
|
|
Experimental: Core Program Only
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
|
|
Experimental: Dysregulated Eating
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
|
|
Experimental: Social Support, Dysregulated Eating
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
An online platform is provided for participants to connect with each other, support each other, and compete on achievement of behavioral and weight loss milestones.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
|
|
Experimental: Social Support, Exercise
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
An online platform is provided for participants to connect with each other, support each other, and compete on achievement of behavioral and weight loss milestones.
Periodic self-assessment is used to guide selection of a physical activity goal.
Home-based instructional videos are provided to help meet the selected goal.
|
|
Experimental: Dysregulated Eating, Exercise
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
Periodic self-assessment is used to guide selection of a physical activity goal.
Home-based instructional videos are provided to help meet the selected goal.
|
|
Experimental: Social Support, Dysregulated Eating, Exercise
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
An online platform is provided for participants to connect with each other, support each other, and compete on achievement of behavioral and weight loss milestones.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
Periodic self-assessment is used to guide selection of a physical activity goal.
Home-based instructional videos are provided to help meet the selected goal.
|
|
Experimental: Social Support, Feedback
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
An online platform is provided for participants to connect with each other, support each other, and compete on achievement of behavioral and weight loss milestones.
Video-recorded messages are used to provide periodic feedback on progress with weight loss, dietary change, and physical activity.
Additional videos provide dietary skills training.
|
|
Experimental: Dysregulated Eating, Feedback
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
Video-recorded messages are used to provide periodic feedback on progress with weight loss, dietary change, and physical activity.
Additional videos provide dietary skills training.
|
|
Experimental: Social Support, Dysregulated Eating, Feedback
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
An online platform is provided for participants to connect with each other, support each other, and compete on achievement of behavioral and weight loss milestones.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
Video-recorded messages are used to provide periodic feedback on progress with weight loss, dietary change, and physical activity.
Additional videos provide dietary skills training.
|
|
Experimental: Exercise, Feedback
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
Video-recorded messages are used to provide periodic feedback on progress with weight loss, dietary change, and physical activity.
Additional videos provide dietary skills training.
|
|
Experimental: Social Support, Exercise, Feedback
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
An online platform is provided for participants to connect with each other, support each other, and compete on achievement of behavioral and weight loss milestones.
Periodic self-assessment is used to guide selection of a physical activity goal.
Home-based instructional videos are provided to help meet the selected goal.
Video-recorded messages are used to provide periodic feedback on progress with weight loss, dietary change, and physical activity.
Additional videos provide dietary skills training.
|
|
Experimental: Dysregulated Eating, Exercise, Feedback
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
Periodic self-assessment is used to guide selection of a physical activity goal.
Home-based instructional videos are provided to help meet the selected goal.
Video-recorded messages are used to provide periodic feedback on progress with weight loss, dietary change, and physical activity.
Additional videos provide dietary skills training.
|
|
Experimental: Social Support, Dysregulated Eating, Exercise, Feedback
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
An online platform is provided for participants to connect with each other, support each other, and compete on achievement of behavioral and weight loss milestones.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
Periodic self-assessment is used to guide selection of a physical activity goal.
Home-based instructional videos are provided to help meet the selected goal.
Video-recorded messages are used to provide periodic feedback on progress with weight loss, dietary change, and physical activity.
Additional videos provide dietary skills training.
|
|
Experimental: VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Social Support, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
An online platform is provided for participants to connect with each other, support each other, and compete on achievement of behavioral and weight loss milestones.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Dysregulated Eating, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Social Support, Dysregulated Eating, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
An online platform is provided for participants to connect with each other, support each other, and compete on achievement of behavioral and weight loss milestones.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Exercise, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
Periodic self-assessment is used to guide selection of a physical activity goal.
Home-based instructional videos are provided to help meet the selected goal.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Social Support, Exercise, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
An online platform is provided for participants to connect with each other, support each other, and compete on achievement of behavioral and weight loss milestones.
Periodic self-assessment is used to guide selection of a physical activity goal.
Home-based instructional videos are provided to help meet the selected goal.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Dysregulated Eating, Exercise, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
Periodic self-assessment is used to guide selection of a physical activity goal.
Home-based instructional videos are provided to help meet the selected goal.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Social Support, Dysregulated Eating, Exercise, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
An online platform is provided for participants to connect with each other, support each other, and compete on achievement of behavioral and weight loss milestones.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
Periodic self-assessment is used to guide selection of a physical activity goal.
Home-based instructional videos are provided to help meet the selected goal.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Feedback, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
Video-recorded messages are used to provide periodic feedback on progress with weight loss, dietary change, and physical activity.
Additional videos provide dietary skills training.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Social Support, Feedback, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
An online platform is provided for participants to connect with each other, support each other, and compete on achievement of behavioral and weight loss milestones.
Video-recorded messages are used to provide periodic feedback on progress with weight loss, dietary change, and physical activity.
Additional videos provide dietary skills training.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Dysregulated Eating, Feedback, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
Video-recorded messages are used to provide periodic feedback on progress with weight loss, dietary change, and physical activity.
Additional videos provide dietary skills training.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Social Support, Dysregulated Eating, Feedback, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
An online platform is provided for participants to connect with each other, support each other, and compete on achievement of behavioral and weight loss milestones.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
Video-recorded messages are used to provide periodic feedback on progress with weight loss, dietary change, and physical activity.
Additional videos provide dietary skills training.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Exercise, Feedback, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
Periodic self-assessment is used to guide selection of a physical activity goal.
Home-based instructional videos are provided to help meet the selected goal.
Video-recorded messages are used to provide periodic feedback on progress with weight loss, dietary change, and physical activity.
Additional videos provide dietary skills training.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Social Support, Exercise, Feedback, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
An online platform is provided for participants to connect with each other, support each other, and compete on achievement of behavioral and weight loss milestones.
Periodic self-assessment is used to guide selection of a physical activity goal.
Home-based instructional videos are provided to help meet the selected goal.
Video-recorded messages are used to provide periodic feedback on progress with weight loss, dietary change, and physical activity.
Additional videos provide dietary skills training.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Dysregulated Eating, Exercise, Feedback, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
Periodic self-assessment is used to guide selection of a physical activity goal.
Home-based instructional videos are provided to help meet the selected goal.
Video-recorded messages are used to provide periodic feedback on progress with weight loss, dietary change, and physical activity.
Additional videos provide dietary skills training.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
|
Experimental: Social Support, Dysregulated Eating, Exercise, Feedback, VR
|
A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
An online platform is provided for participants to connect with each other, support each other, and compete on achievement of behavioral and weight loss milestones.
Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
Periodic self-assessment is used to guide selection of a physical activity goal.
Home-based instructional videos are provided to help meet the selected goal.
Video-recorded messages are used to provide periodic feedback on progress with weight loss, dietary change, and physical activity.
Additional videos provide dietary skills training.
This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight Change (Percent of Initial Body Weight) From Baseline to Month 12, Main Effect of Time
Time Frame: From Baseline to Month 12
|
Weight was measured at the research center by the research team, or measured by the participant at home and sent to the research team with with documentation of the value reported (e.g., a photograph from a home scale showing the weight). A change between two time points is reported. The value of this outcome was calculated using: [(baseline weight - month 12 weight) ÷ baseline weight] × 100. Estimated mean change was obtained from a linear mixed models analysis of variance. Data from all randomized participants were included in the model (ITT analysis). |
From Baseline to Month 12
|
|
Weight Change (Percent of Initial Body Weight) From Baseline to Month 12, Time by Intervention Component Interaction
Time Frame: From Baseline to Month 12
|
Weight was measured at the research center by the research team, or measured by the participant at home and sent to the research team with with documentation of the value reported (e.g., a photograph from a home scale showing the weight). A change between two time points is reported. The value of this outcome was calculated using: [(baseline weight - month 12 weight) ÷ baseline weight] × 100. Estimated mean change was obtained from a linear mixed models analysis of variance. Data from all randomized participants were included in the model (ITT analysis). This outcome measure is reported as an additional effect beyond that of Outcome Measure 1 (each intervention component has it's own weight loss effect that is above and beyond the weight change calculated in the Outcome Measure 1 analyses). |
From Baseline to Month 12
|
|
Proportion of Participants With Weight Loss ≥ 5% at Month 12, Main Effect of Time
Time Frame: Month 12
|
Weight was measured at the research center by the research team, or measured by the participant at home and sent to the research team with with documentation of the value reported (e.g., a photograph from a home scale showing the weight). Weight loss was calculated using: [(baseline weight - month 12 weight) ÷ baseline weight] × 100. The estimated proportion of participants achieving a weight loss of ≥ 5% of their Baseline body weight was obtained from a generalized linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis). |
Month 12
|
|
Proportion of Participants With Weight Loss ≥ 5% at Month 12, Time by Intervention Component Interaction
Time Frame: Month 12
|
Weight was measured at the research center by the research team, or measured by the participant at home and sent to the research team with with documentation of the value reported (e.g., a photograph from a home scale showing the weight). Weight loss was calculated using: [(baseline weight - month 12 weight) ÷ baseline weight] × 100. Estimated proportions of participants with weight loss of ≥ 5% of initial body weight at Month 12 were obtained from a generalized linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis). |
Month 12
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight loss self-efficacy
Time Frame: 12-month end of treatment
|
Measured via the Weight Efficacy Life-Style Questionnaire (WEL).
Scores range from 0 to 180; higher scores indicate a better outcome.
|
12-month end of treatment
|
|
Supportive accountability
Time Frame: 12-month end of treatment
|
Measured via the Supportive Accountability Measure (SAM).
Scores range from 17.14 to 100; higher scores indicate a better outcome.
|
12-month end of treatment
|
|
Social support for diet and exercise behaviors
Time Frame: 12-month end of treatment
|
Measured via the Scales to Measure Social Support for Diet and Exercise Behaviors.
Scores range from 10 to 75; higher scores indicate a better outcome.
|
12-month end of treatment
|
|
Internal disinhibition
Time Frame: 12-month end of treatment
|
Measured via the Eating Inventory.
Scores range from 0 to 16; lower scores indicate a better outcome.
|
12-month end of treatment
|
|
Structured physical activity
Time Frame: 12-month end of treatment
|
Daily time spent in structured moderate to vigorous intensity physical activity will be measured using the ActiGraph GT9X Link
|
12-month end of treatment
|
|
Dietary quality
Time Frame: 12-month end of treatment
|
Data collected via the National Cancer Institute Automated Self-Administered 24-hour recall system (ASA-24).
Diet quality is measured by the The Health Eating Index, 2015, score that reflects conformance to the 2015 Dietary Guidelines for Americans.
Higher scores indicate a better outcome.
|
12-month end of treatment
|
|
Dietary energy density
Time Frame: 12-month end of treatment
|
Data collected via the National Cancer Institute Automated Self-Administered 24-hour recall system (ASA-24).
Energy density of the diet is calculated as total energy intake from food ÷ total weight of the food.
Lower scores indicate a better outcome.
|
12-month end of treatment
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- R01DK117857 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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