A Virtual-reality Based Approach to Improve Behavioral Weight Management Outcomes

Study Overview
=================
Brief Summary
-----------------
A pilot randomized trial was done to test the feasibility integrating virtual reality (VR) into standard behavioral weight loss treatment.

Detailed Description
-----------------
Participants with overweight or obesity are randomly assigned to a 4-week Standard Behavioral Weight Loss plus Non-Weight-Related VR app (i.e., Control Group) or Standard Behavioral Weight Loss plus Weight-Related VR app (i.e., Intervention Group). The Intervention's VR tool was designed to enable practice of behavioral skills taught in weekly group meetings, including managing social and home environmental cues for eating and activity.

Official Title
-----------------
A Virtual-reality Based Approach to Improve Behavioral Weight Management Outcomes

Conditions
-----------------
Weight Loss

Intervention / Treatment
-----------------
* Behavioral: Standard Behavioral Weight Loss plus Non-Weight-Related VR app
* Behavioral: Standard Behavioral Weight Loss plus Weight-Related VR app


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-pregnant Adults (age > 18 years) Overweight or obesity (BMI ≥ 25) Able to speak and read in English. Available on Thursday evenings Have an iPhone 6 or higher Exclusion Criteria: Self-reported serious psychological problems or medical problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Behavioral Weight Loss plus Non-Weight-Related VR app<br>The VR tool was an attention control and was not weight related. | Behavioral: Standard Behavioral Weight Loss plus Non-Weight-Related VR app<br>* Standard Behavioral Weight Loss Program<br>|
| Experimental: Standard Behavioral Weight Loss plus Weight-Related VR app<br>The Intervention's VR tool was designed to enable practice of behavioral skills taught in weekly group meetings, including managing social and home environmental cues for eating and activity. | Behavioral: Standard Behavioral Weight Loss plus Weight-Related VR app<br>* Standard Behavioral Weight Loss plus Weight-Related VR app<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Satisfaction | Participant satisfaction ratings of virtual reality scenarios on a scale where 1 = very dissatisfied to 4 = very satisfied | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants retained | Number of participants who complete the final assessment divided by the number of participants enrolled at baseline | 4 weeks |