A Virtual Reality Intervention to Improve Weight Maintenance
Primary Purpose
Weight Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Second Life
Group Phone Conference Call
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss focused on measuring Obesity, Overweight, 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.).
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group Phone Conference Call
Second Life (2L)
Arm Description
Group phone clinic will be conducted weekly during the first 9 months and twice/month during the final 9 months (3 to 12 months).
2L group meeting will be conducted weekly during the first 9 months and twice/month during the final 9 months
Outcomes
Primary Outcome Measures
Difference in Weight Change
Weight change measured during Month 0 (after 6 mo weight loss) to Month 12.
Secondary Outcome Measures
Total Attendance at Meetings
Number of times each individual attended group meeting during the course of the weight maintenance phase.
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.
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.
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.
Full Information
NCT ID
NCT01841372
First Posted
April 23, 2013
Last Updated
March 23, 2020
Sponsor
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01841372
Brief Title
A Virtual Reality Intervention to Improve Weight Maintenance
Official Title
A Virtual Reality Intervention (Second Life) to Improve Weight Maintenance
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
Keywords
Obesity, Overweight, Weight Maintenance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group Phone Conference Call
Arm Type
Active Comparator
Arm Description
Group phone clinic will be conducted weekly during the first 9 months and twice/month during the final 9 months (3 to 12 months).
Arm Title
Second Life (2L)
Arm Type
Experimental
Arm Description
2L group meeting will be conducted weekly during the first 9 months and twice/month during the final 9 months
Intervention Type
Other
Intervention Name(s)
Second Life
Intervention Description
Second Life is an online virtual reality environment.
Intervention Type
Behavioral
Intervention Name(s)
Group Phone Conference Call
Primary Outcome Measure Information:
Title
Difference in Weight Change
Description
Weight change measured during Month 0 (after 6 mo weight loss) to Month 12.
Time Frame
Change from month 0 (after 6 mo weight loss) to Month 12
Secondary Outcome Measure Information:
Title
Total Attendance at Meetings
Description
Number of times each individual attended group meeting during the course of the weight maintenance phase.
Time Frame
Month 0 to12 Months
Title
Assessment of Self-Efficacy for Weight Loss
Description
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.
Time Frame
Change from Month 0 to 12 Months
Title
Assessment of Self-Efficacy for Physical Activity (PA)
Description
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.
Time Frame
Change from Month 0 to 12 Months
Title
Assessment of Self-Efficacy for Problem Solving Skills
Description
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.
Time Frame
Change from Month 0 to 12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Donnelly, Ed.D.
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Debra Sullivan, PhD, RD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26616535
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.
Results Reference
derived
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A Virtual Reality Intervention to Improve Weight Maintenance
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