A Virtual Reality Intervention to Improve Weight Maintenance

March 23, 2020 updated by: Joseph Donnelly, University of Kansas Medical Center

A Virtual Reality Intervention (Second Life) to Improve Weight Maintenance

The purpose of this study is to determine if use of a virtual reality platform, Second Life, is more effective than traditional face-to-face methods for maintaining weight loss in overweight and obese individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study has two main parts. During the first 6 months (-6 to 0 months)potential subjects will be on a diet developed by researchers at the University of Kansas Medical Center (KUMC). Subsequent to 6 months, participants who lost 5% weight will begin the weight maintenance phase of the study (0-12 months). Thus the total duration of the study is 18 months.

Approximately 68% of U.S. adults are classified as overweight or obese (BMI >25). Behaviorally based weight loss programs, typically delivered by face-to-face clinics, produce clinically significant reductions in body weight over 3-6 months. However, approximately 50% of those who lose weight regain more than 45-75% of the weight lost within 12-30 months. Face-to-face clinics present many barriers and burdens to individuals including scheduling and logistical and financial burdens.

Virtual Reality (VR) environments allow participants to create virtual representations of themselves called "avatars". An existing VR called "Second Life" will be used for participants randomized to VR. Participants avatars attend group meetings and use headsets for voice communication to interact with each other.

Those not randomized to VR will participate in traditional face-to-face group weight loss intervention. The study will examine many different factors to determine if those participants in the Second Life group experience improved weight maintenance.

Study Type

Interventional

Enrollment (Anticipated)

202

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
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

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

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women with a BMI of 25 to 39.9 kg/m2
  • Able to obtain clearance for participation from their primary care physician (PCP)
  • Have access to a computer with internet that meets Second Life system requirements

Exclusion Criteria:

  • Report participating in a research project involving weight loss or PA in the previous 6 months
  • Report a regular exercise or PA program
  • Not weight stable (+/-2.27 kg) for 3 months prior to intake
  • Unwilling to be randomized to phone or 2L clinics subsequent to weight loss
  • Report being pregnant during the previous 6 months, lactating, or planned pregnancy in the following 18 months
  • Report serious medical risk such as type 1 diabetes, cancer, recent cardiac event (i.e. heart attack, angioplasty, etc.)
  • Report eating disorders as determined by the Eating Attitudes Test using a score of 20 or greater
  • Report current treatment for psychological issues, or taking psychotropic medications
  • Report adherence to specialized diet regimes, i.e., multiple food allergies, vegetarian, macrobiotic, etc.
  • Do not have access to grocery shopping and meal preparation (i.e. Military, college cafeteria plan, etc.).

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group Phone Conference Call
Group phone clinic will be conducted weekly during the first 9 months and twice/month during the final 9 months (3 to 12 months).
Behavioral: Group Phone Conference Call
Experimental: Second Life (2L)
2L group meeting will be conducted weekly during the first 9 months and twice/month during the final 9 months
Other: Second Life
Second Life is an online virtual reality environment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Weight Change
Time Frame: Change from month 0 (after 6 mo weight loss) to Month 12
Weight change measured during Month 0 (after 6 mo weight loss) to Month 12.
Change from month 0 (after 6 mo weight loss) to Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Attendance at Meetings
Time Frame: Month 0 to12 Months
Number of times each individual attended group meeting during the course of the weight maintenance phase.
Month 0 to12 Months
Assessment of Self-Efficacy for Weight Loss
Time Frame: Change from Month 0 to 12 Months
Weight loss self-efficacy will be assessed using the Weight Efficacy Lifestyle Questionnaire. This scale assess overeating in tempting situations. Participants rate their level of confidence on a 10-point Likert-scale with higher values indicating greater confidence to resist overeating.
Change from Month 0 to 12 Months
Assessment of Self-Efficacy for Physical Activity (PA)
Time Frame: Change from Month 0 to 12 Months
Physical activity self-efficacy will be assessed using the 5-item exercise self-efficacy scale. Participants rate their confidence level (1 = not confident at all to 7 = very confident) to engage in PA in a number of different situations including making time for exercise, resisting lapse, etc.
Change from Month 0 to 12 Months
Assessment of Self-Efficacy for Problem Solving Skills
Time Frame: Change from Month 0 to 12 Months
Problem-solving abilities will be assessed using the Social Problem Solving Inventory-Revised, short form (SPSI-R:S). The SPSI-R:S is a 25-item instrument with five component scales to assess problem-solving styles and solution generation.
Change from Month 0 to 12 Months

Collaborators and Investigators

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

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Joseph Donnelly, Ed.D., University of Kansas Medical Center

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)

September 1, 2013

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 15, 2020

Study Registration Dates

First Submitted

April 23, 2013

First Submitted That Met QC Criteria

April 23, 2013

First Posted (Estimate)

April 26, 2013

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13610

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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