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

Completed

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

Observational

Enrollment (Actual)

318

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Overweight, adult women will participate in a weight counseling encounter with a virtual reality-based doctor

Description

  • INCLUSION CRITERIA:

    1. being between 20 and 50 years old
    2. having a self-reported body mass index of greater than or equal to 25
    3. having the ability to read, write, and converse in English
    4. being able to come to the NIH Clinical Center for one visit

EXCLUSION CRITERIA:

  1. having a vestibular or seizure disorder
  2. having a high propensity for motion sickness
  3. known pregnancy
  4. uncorrected low vision or hearing
  5. inability to complete tasks in the virtual environment
  6. being an NHGRI employee
  7. being or training to become a health care provider

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
behavior, supportive
receiving information about behavior with supportive provider communication
behaviors, directive
receiving information about behavior with directive provider communication
genetics, directive
receiving information about genetics with directive provider communication
genetics, supportive
receiving information about genetics with supportive provider communication

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
cross-sectional

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Susan Persky, Ph.D., National Human Genome Research Institute (NHGRI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 29, 2012

Primary Completion (Actual)

April 6, 2016

Study Completion (Actual)

April 6, 2016

Study Registration Dates

First Submitted

September 10, 2011

First Submitted That Met QC Criteria

September 29, 2011

First Posted (Estimated)

September 30, 2011

Study Record Updates

Last Update Posted (Estimated)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

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

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Body Weight

3
Subscribe