This trial is active, not recruiting.

Condition weight loss
Treatments second life, group phone conference call
Sponsor University of Kansas Medical Center
Start date September 2013
End date August 2016
Trial size 202 participants
Trial identifier NCT01841372, 13610


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Group phone clinic will be conducted weekly during the first 9 months and twice/month during the final 9 months (3 to 12 months).
group phone conference call
2L group meeting will be conducted weekly during the first 9 months and twice/month during the final 9 months
second life
Second Life is an online virtual reality environment.

Primary Outcomes

Difference in Weight Change
time frame: Change from month 0 (after 6 mo weight loss) to Month 12

Secondary Outcomes

Total Attendance at Meetings
time frame: Month 0 to12 Months
Assessment of Self-Efficacy for Weight Loss
time frame: Change from Month 0 to 12 Months
Assessment of Self-Efficacy for Physical Activity (PA)
time frame: Change from Month 0 to 12 Months
Assessment of Self-Efficacy for Problem Solving Skills
time frame: Change from Month 0 to 12 Months

Eligibility Criteria

Male or female participants from 21 years up to 65 years old.

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.).

Additional Information

Official title A Virtual Reality Intervention (Second Life) to Improve Weight Maintenance
Principal investigator Joseph Donnelly, Ed.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of Kansas Medical Center.