A Virtual Reality Intervention to Improve Weight Maintenance

NCT ID: NCT01841372

Last Updated: 2020-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2020-03-15

Brief Summary

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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

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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.

Conditions

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Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Group Phone Conference Call

Intervention Type BEHAVIORAL

Second Life (2L)

2L group meeting will be conducted weekly during the first 9 months and twice/month during the final 9 months

Group Type EXPERIMENTAL

Second Life

Intervention Type OTHER

Second Life is an online virtual reality environment.

Interventions

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Second Life

Second Life is an online virtual reality environment.

Intervention Type OTHER

Group Phone Conference Call

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.).
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Joseph Donnelly

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph Donnelly, Ed.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Debra Sullivan, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26616535 (View on PubMed)

Other Identifiers

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13610

Identifier Type: -

Identifier Source: org_study_id

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