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

September 22, 2020 updated by: Suzanne Phelan, California Polytechnic State University-San Luis Obispo
A pilot randomized trial was done to test the feasibility integrating virtual reality (VR) into standard behavioral weight loss treatment.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Luis Obispo, California, United States, 93407
        • Cal Poly

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard Behavioral Weight Loss plus Non-Weight-Related VR app
The VR tool was an attention control and was not weight related.
Behavioral: Standard Behavioral Weight Loss plus Non-Weight-Related VR app
Standard Behavioral Weight Loss Program
EXPERIMENTAL: Standard Behavioral Weight Loss plus Weight-Related VR app
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
Standard Behavioral Weight Loss plus Weight-Related VR app

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Satisfaction
Time Frame: 4 weeks
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
Time Frame: 4 weeks
Number of participants who complete the final assessment divided by the number of participants enrolled at baseline
4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight loss
Time Frame: 4 weeks
weight loss from baseline
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Polytechnic State University-San Luis Obispo

Investigators

  • Principal Investigator: Suzanne Phelan, PhD, Cal Poly Dept. KPH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2019

Primary Completion (ACTUAL)

April 1, 2019

Study Completion (ACTUAL)

November 1, 2019

Study Registration Dates

First Submitted

August 27, 2020

First Submitted That Met QC Criteria

August 31, 2020

First Posted (ACTUAL)

September 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2020

Last Update Submitted That Met QC Criteria

September 22, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VH-CP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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