Healthy VolunteersNCT01443910
Weight Management Interactions in a Virtual Clinical Environment
An observational study of Healthy Volunteers and Body Weight, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Healthy Volunteers, Body Weight
- How many people
- 318 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Feb 2012to 6 Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Overweight, adult women will participate in a weight counseling encounter with a virtual reality-based doctor
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Healthy Volunteers, Body Weight
- Keywords
- Body Weight, Healthy Volunteer, Natural History
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
attitudes, beliefs, and behavior
self-report outcomes
Measured: cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study start29 Feb 2012
- Primary completion6 Apr 2016
- Study completion6 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Susan Persky, Ph.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443910
- Sponsor's protocol ID
- 110238
- Other IDs
- 11-HG-0238
- Status last verified
- Dec 2023
- First submitted
- 10 Sep 2011
- Last updated
- 14 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 19037221Kumanyika 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.
PubMed 10709947Kushner RF. Understanding obesity by asking the right questions. Perspect Biol Med. 2010 Winter;53(1):148-51. doi: 10.1353/pbm.0.0139.
PubMed 20201162Persky 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.
PubMed 25894275
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Management Interactions in a Virtual Clinical Environment
- ClinicalTrials.gov ID
- NCT01443910
- Acronym / sponsor ID
- 110238
- Conditions
- Healthy Volunteers, Body Weight
- Keywords
- Body Weight, Healthy Volunteer, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 29 Feb 2012 (actual)
- Primary completion
- 6 Apr 2016 (actual)
- Study completion
- 6 Apr 2016 (actual)
- First posted
- 30 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Overweight, adult women will participate in a weight counseling encounter with a virtual reality-based doctor
Key inclusion criteria (4 listed)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
attitudes, beliefs, and behavior
Time frame: cross-sectional
self-report outcomes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Background: PubMed 19037221Agurs-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.
- Background: PubMed 10709947Kumanyika 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.
- Background: PubMed 20201162Kushner RF. Understanding obesity by asking the right questions. Perspect Biol Med. 2010 Winter;53(1):148-51. doi: 10.1353/pbm.0.0139.
- Derived from this study: PubMed 25894275Persky 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Persky, Ph.D. principal investigator
National Human Genome Research Institute (NHGRI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers and Body Weight, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
attitudes, beliefs, and behavior (time frame: cross-sectional). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01443910, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.