A Virtual Reality Intervention to Improve Weight Maintenance

Not Applicable

Completed

• Conditions: Weight Loss
• Interventions: Behavioral: Group Phone Conference Call; Other: Second Life

• Registration Number: NCT01841372
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-26
• Study Start: 2013-09
• Status Verified: 2020-03
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-15
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Phone Conference Call	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).
Second Life (2L)	Second Life	2L group meeting will be conducted weekly during the first 9 months and twice/month during the final 9 months

Primary Outcome Measures

Name	Time	Method
Difference in Weight Change	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.

Secondary Outcome Measures

Name	Time	Method
Total Attendance at Meetings	Month 0 to12 Months	Number of times each individual attended group meeting during the course of the weight maintenance phase.
Assessment of Self-Efficacy for Physical Activity (PA)	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.
Assessment of Self-Efficacy for Weight Loss	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.
Assessment of Self-Efficacy for Problem Solving Skills	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.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States