- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01443910
Weight Management Interactions in a Virtual Clinical Environment
This study is part of an effort to learn about interactions between doctors and patients. We aim to understand how women feel about techniques that doctors use to talk with patients about their weight. We are studying women s reactions to these techniques using a virtual reality version of a doctor s office to create as realistic a model of a doctor s visit as possible. This can help us better understand what happens during real doctor s visits.
Women between the ages of 20 and 50 who are currently overweight may be eligible for this study. Participants will be recruited from the Washington D.C. area. This is not a weight treatment study.
Participants undergo the following procedures:
- Complete an online questionnaire about themselves, their experiences, and their thoughts about their weight
- Participate in activities in a virtual reality environment in which they interact with a virtual doctor in a virtual clinical scenario. For this experiment, participants wear a head-mounted display that allows them to see the virtual world images.
- Fill out a questionnaire after completing the virtual reality activities. This questionnaire includes information on the participants' virtual reality experience, the information provided in the experience, and additional questions about themselves and their thoughts.
Study Overview
Status
Conditions
Detailed Description
The primary goal of this research project is to build an evidence base related to primary care encounters that include discussions about a patient s body weight. We are particularly interested in how encounters impact patients health-related and weight-related attitudes and beliefs. Furthermore, this project aims to determine how a physician s approach to the health care encounter impacts its outcome.
The current study is a controlled experiment in which participants will be participate in a weight counseling encounter with a virtual reality-based doctor. The virtual doctor will present weight etiology information. Participants will fill out a self-report questionnaire online, prior to this encounter. They will then come in to the Immersive Virtual Environment Testing Area in the NIH Clinical Center for a visit. During this visit, they will engage in the interaction with the virtual doctor and then fill out a post-test questionnaire. Participants in the main trial will include approximately 222 healthy adult females between 20-50 years of age who have a BMI of greater than or equal to 25 and are dissatisfied with their current weight.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
INCLUSION CRITERIA:
- being between 20 and 50 years old
- having a self-reported body mass index of greater than or equal to 25
- having the ability to read, write, and converse in English
- being able to come to the NIH Clinical Center for one visit
EXCLUSION CRITERIA:
- having a vestibular or seizure disorder
- having a high propensity for motion sickness
- known pregnancy
- uncorrected low vision or hearing
- inability to complete tasks in the virtual environment
- being an NHGRI employee
- being or training to become a health care provider
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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behavior, supportive
receiving information about behavior with supportive provider communication
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behaviors, directive
receiving information about behavior with directive provider communication
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genetics, directive
receiving information about genetics with directive provider communication
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genetics, supportive
receiving information about genetics with supportive provider communication
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
attitudes, beliefs, and behavior
Time Frame: cross-sectional
|
self-report outcomes
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cross-sectional
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Collaborators and Investigators
Investigators
- Principal Investigator: Susan Persky, Ph.D., National Human Genome Research Institute (NHGRI)
Publications and helpful links
General Publications
- Agurs-Collins T, Khoury MJ, Simon-Morton D, Olster DH, Harris JR, Milner JA. Public health genomics: translating obesity genomics research into population health benefits. Obesity (Silver Spring). 2008 Dec;16 Suppl 3(Suppl 3):S85-94. doi: 10.1038/oby.2008.517.
- Kumanyika SK, Van Horn L, Bowen D, Perri MG, Rolls BJ, Czajkowski SM, Schron E. Maintenance of dietary behavior change. Health Psychol. 2000 Jan;19(1S):42-56. doi: 10.1037/0278-6133.19.suppl1.42.
- Kushner RF. Understanding obesity by asking the right questions. Perspect Biol Med. 2010 Winter;53(1):148-51. doi: 10.1353/pbm.0.0139.
- Persky S, Street RL Jr. Evaluating Approaches for Communication About Genomic Influences on Body Weight. Ann Behav Med. 2015 Oct;49(5):675-84. doi: 10.1007/s12160-015-9701-8.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 110238
- 11-HG-0238
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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