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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
Sponsor:
Information provided by (Responsible Party):
Joseph Donnelly, University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Weight Loss Other: Second Life Behavioral: Group Phone Conference Call Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.).

Information from the National Library of Medicine

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


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Joseph Donnelly, Ed.D. University of Kansas Medical Center
Principal Investigator: Debra Sullivan, PhD, RD University of Kansas Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joseph Donnelly, Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01841372     History of Changes
Other Study ID Numbers: 13610
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Keywords provided by Joseph Donnelly, University of Kansas Medical Center:
Obesity
Overweight
Weight Maintenance
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes