Clinical trial NCT01841372: A Virtual Reality Intervention to Improve Weight Maintenance
Official title: A Virtual Reality Intervention (Second Life) to Improve Weight Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Keywords: Obesity
Overweight
Weight Maintenance
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2013-04-26
Enrollment: 202
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.).

Primary outcomes:
measure: Difference in Weight Change
timeFrame: Change from month 0 (after 6 mo weight loss) to Month 12
Secondary outcomes:
measure: Total Attendance at Meetings
timeFrame: Month 0 to12 Months
measure: Assessment of Self-Efficacy for Weight Loss
timeFrame: Change from Month 0 to 12 Months
measure: Assessment of Self-Efficacy for Physical Activity (PA)
timeFrame: Change from Month 0 to 12 Months
measure: Assessment of Self-Efficacy for Problem Solving Skills
timeFrame: Change from Month 0 to 12 Months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Joseph Donnelly, Ed.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kansas Medical Center
name: Debra Sullivan, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sullivan DK, Goetz JR, Gibson CA, Mayo MS, Washburn RA, Lee Y, Ptomey LT, Donnelly JE. A virtual reality intervention (Second Life) to improve weight maintenance: Rationale and design for an 18-month randomized trial. Contemp Clin Trials. 2016 Jan;46:77-84. doi: 10.1016/j.cct.2015.11.019. Epub 2015 Nov 23.