A Virtual Reality Intervention (Second Life) to Improve Weight Maintenance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Difference in Weight Change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.).
研究组 & 干预措施
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).
干预措施: Group Phone Conference Call (Behavioral)
Second Life (2L)
2L group meeting will be conducted weekly during the first 9 months and twice/month during the final 9 months
干预措施: Second Life (Other)
结局指标
主要结局
Difference in Weight Change
时间窗: 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.
次要结局
- Assessment of Self-Efficacy for Weight Loss(Change from Month 0 to 12 Months)
- Total Attendance at Meetings(Month 0 to12 Months)
- Assessment of Self-Efficacy for Physical Activity (PA)(Change from Month 0 to 12 Months)
- Assessment of Self-Efficacy for Problem Solving Skills(Change from Month 0 to 12 Months)
研究者
Joseph Donnelly
Professor
University of Kansas Medical Center