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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04534088
Recruitment Status : Completed
First Posted : September 1, 2020
Last Update Posted : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
Suzanne Phelan, California Polytechnic State University-San Luis Obispo

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

Condition or disease Intervention/treatment Phase
Weight Loss Behavioral: Standard Behavioral Weight Loss plus Non-Weight-Related VR app Behavioral: Standard Behavioral Weight Loss plus Weight-Related VR app Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Virtual-reality Based Approach to Improve Behavioral Weight Management Outcomes
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Intervention Satisfaction [ Time Frame: 4 weeks ]
    Participant satisfaction ratings of virtual reality scenarios on a scale where 1 = very dissatisfied to 4 = very satisfied


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. weight loss [ Time Frame: 4 weeks ]
    weight loss from baseline


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04534088


Locations
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United States, California
Cal Poly
San Luis Obispo, California, United States, 93407
Sponsors and Collaborators
California Polytechnic State University-San Luis Obispo
Investigators
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Principal Investigator: Suzanne Phelan, PhD Cal Poly Dept. KPH
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Suzanne Phelan, Professor, California Polytechnic State University-San Luis Obispo
ClinicalTrials.gov Identifier: NCT04534088    
Other Study ID Numbers: VH-CP
First Posted: September 1, 2020    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Body Weight Changes