NCT04534088

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2020

Completed
Last Updated

September 24, 2020

Status Verified

September 1, 2020

Enrollment Period

1 month

First QC Date

August 27, 2020

Last Update Submit

September 22, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Intervention Satisfaction

    Participant satisfaction ratings of virtual reality scenarios on a scale where 1 = very dissatisfied to 4 = very satisfied

    4 weeks

Secondary Outcomes (1)

  • Proportion of participants retained

    4 weeks

Other Outcomes (1)

  • weight loss

    4 weeks

Study Arms (2)

Standard Behavioral Weight Loss plus Non-Weight-Related VR app

ACTIVE COMPARATOR

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 plus Weight-Related VR app

EXPERIMENTAL

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

Interventions

Standard Behavioral Weight Loss Program

Standard Behavioral Weight Loss plus Non-Weight-Related VR app

Standard Behavioral Weight Loss plus Weight-Related VR app

Standard Behavioral Weight Loss plus Weight-Related VR app

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Self-reported serious psychological problems or medical problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cal Poly

San Luis Obispo, California, 93407, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Suzanne Phelan, PhD

    Cal Poly Dept. KPH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 27, 2020

First Posted

September 1, 2020

Study Start

March 1, 2019

Primary Completion

April 1, 2019

Study Completion

November 1, 2019

Last Updated

September 24, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations