A Virtual Reality Intervention to Improve Weight Maintenance

Weight Loss Clinical Trial

Official title:

A Virtual Reality Intervention (Second Life) to Improve Weight Maintenance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01841372
• Other study ID #: 13610
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: March 15, 2020

Study information

• Verified date: March 2020
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: March 15, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

Other:
• Second Life
Second Life is an online virtual reality environment.

Behavioral:
• Group Phone Conference Call

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Weight Change	Weight change measured during Month 0 (after 6 mo weight loss) to Month 12.	Change from month 0 (after 6 mo weight loss) to Month 12
Secondary	Total Attendance at Meetings	Number of times each individual attended group meeting during the course of the weight maintenance phase.	Month 0 to12 Months
Secondary	Assessment of Self-Efficacy for Weight Loss	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.	Change from Month 0 to 12 Months
Secondary	Assessment of Self-Efficacy for Physical Activity (PA)	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.	Change from Month 0 to 12 Months
Secondary	Assessment of Self-Efficacy for Problem Solving Skills	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.	Change from Month 0 to 12 Months