A Virtual Reality Intervention to Improve Weight Maintenance
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|ClinicalTrials.gov Identifier: NCT01841372|
Recruitment Status : Active, not recruiting
First Posted : April 26, 2013
Last Update Posted : March 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Weight Loss||Other: Second Life Behavioral: Group Phone Conference Call||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||202 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Virtual Reality Intervention (Second Life) to Improve Weight Maintenance|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||July 31, 2020|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841372
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Joseph Donnelly, Ed.D.||University of Kansas Medical Center|
|Principal Investigator:||Debra Sullivan, PhD, RD||University of Kansas Medical Center|