Back to resultsA Virtual-reality Based Approach to Improve Behavioral Weight Management Outcomes
Primary Purpose
Weight Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Behavioral Weight Loss plus Non-Weight-Related VR app
Standard Behavioral Weight Loss plus Weight-Related VR app
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss
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
Sites / Locations
- Cal Poly
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Behavioral Weight Loss plus Non-Weight-Related VR app
Standard Behavioral Weight Loss plus Weight-Related VR app
Arm Description
The VR tool was an attention control and was not weight related.
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.
Outcomes
Primary Outcome Measures
Intervention Satisfaction
Participant satisfaction ratings of virtual reality scenarios on a scale where 1 = very dissatisfied to 4 = very satisfied
Secondary Outcome Measures
Proportion of participants retained
Number of participants who complete the final assessment divided by the number of participants enrolled at baseline
Full Information
NCT ID
NCT04534088
First Posted
August 27, 2020
Last Updated
September 22, 2020
Sponsor
California Polytechnic State University-San Luis Obispo
1. Study Identification
Unique Protocol Identification Number
NCT04534088
Brief Title
A Virtual-reality Based Approach to Improve Behavioral Weight Management Outcomes
Official Title
A Virtual-reality Based Approach to Improve Behavioral Weight Management Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California Polytechnic State University-San Luis Obispo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Behavioral Weight Loss plus Non-Weight-Related VR app
Arm Type
Active Comparator
Arm Description
The VR tool was an attention control and was not weight related.
Arm Title
Standard Behavioral Weight Loss plus Weight-Related VR app
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Behavioral Weight Loss plus Non-Weight-Related VR app
Intervention Description
Standard Behavioral Weight Loss Program
Intervention Type
Behavioral
Intervention Name(s)
Standard Behavioral Weight Loss plus Weight-Related VR app
Intervention Description
Standard Behavioral Weight Loss plus Weight-Related VR app
Primary Outcome Measure Information:
Title
Intervention Satisfaction
Description
Participant satisfaction ratings of virtual reality scenarios on a scale where 1 = very dissatisfied to 4 = very satisfied
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Proportion of participants retained
Description
Number of participants who complete the final assessment divided by the number of participants enrolled at baseline
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
weight loss
Description
weight loss from baseline
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Phelan, PhD
Organizational Affiliation
Cal Poly Dept. KPH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cal Poly
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93407
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34158129
Citation
Phelan S, Peruvemba S, Levinson D, Stulberg N, Lacy A, Legato M, Werner JP. Feasibility of a virtual reality-based approach to improve behavioral weight management outcomes. Pilot Feasibility Stud. 2021 Jun 22;7(1):129. doi: 10.1186/s40814-021-00865-5.
Results Reference
derived
Learn more about this trial
A Virtual-reality Based Approach to Improve Behavioral Weight Management Outcomes
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