Body WeightNCT01888913
Patient Perspectives and Doctor Visits
An observational study of Body Weight, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
Background: We are studying people s psychological experiences and how these relate to the way people respond have when they see information communicated in different ways. We are testing multiple research questions in this research. Objectives: To learn about how to design future research studies. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Body Weight
- How many people
- 1,464 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2013to 10 Feb 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: All participants will be adult women. Inclusion for Study 1 are: (1) being part of a Knowledge Networks Panel; (2) having a self-reported body mass index of greater than or equal to 25. Inclusion criteria for Study 2 are: (1) being between 18 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.
Who may be able to join
- being between 18 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 or training to become a physician;
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Patient Perspectives and Simulated Clinical Interactions
Background:
- We are studying people s psychological experiences and how these relate to the way people respond have when they see information communicated in different ways. We are testing multiple research questions in this research.
Read more
Objectives:
- To learn about how to design future research studies. Also to learn about how to best give people information about health topics.
Eligibility:
- Women with a Body Mass Index of 25 or higher.
Design:
- Before the study visit, participants will answer some questions online about themselves, their experiences, and their thoughts about their weight.
- During the study visit, participants will watch a short scene from a movie, and then answer questions about it.
- Participants will have a simulated doctor visit with a computerized, virtual reality doctor. They will answer more questions about themselves, their experiences, and their thoughts about their weight. Then they will answer questions with researchers.
Read the detailed description
The primary goal of this research project is to continue building an evidence base on the benefits or pitfalls of introducing genomic information into weight-related primary care encounters. We are particularly interested in how this information will impact patients health-related attitudes, beliefs and behavior, and patient perceptions of stigmatization. Furthermore, this project aims to determine whether a patient s emotional state during a clinical interaction will moderate the consequences of genomic information provision.
Genetic and genomic information are expected to be integrated into personalized prevention and treatment regimens of the future. Such information may influence patient beliefs, attitudes, and behaviors related to weight and obesity. Previous research has shown that provision of genomic information can lead to positive effects, negative effects and often no effect with respect to patient motivation for health-promoting behaviors. The literature describing the influence of emotion on judgment and decision-making suggests that patients emotional state may, in part, account for this discrepancy. By better understanding the influence of emotional state on patients reactions to general, weight-related genomic information, we may be better able to shape clinical communications of the future to increase the likelihood that genomic information will lead to positive, health-promoting behavior. Indeed, there is a need for exploration of strategies through which providers can counsel patients about weight such that patients feel motivated by the counseling, and that it does not make them feel stigmatized.
The current protocol describes two studies; both are randomized, controlled experiments. The first will be conducted through an internet panel via the Time-Sharing Experiments in the Social Sciences program. The current proposal was already reviewed and was successfully approved and funded for fielding through this program. The second study is a lab-based study that will take place in the Immersive Virtual Environment Testing Area in the NIH Clinical Center. In both studies, overweight, adult women will undergo a task designed to elicit mild-to-moderate emotional states. In Study 1 the elicited emotions will include anger, fear and neutral; Study 2 will include only anger and fear. Participants will then participate in a weight counseling encounter with a simulated doctor who will provide weight management information that includes discussions of either behavioral or genomic etiology. Participants in Study 1 will engage with the doctor via video clips over the internet, participants in Study 2 will engage with the doctor in an immersive virtual environment. Primary outcome measures pertain to participants health-related attitudes, behavioral intentions, and perceptions of stigmatization related to weight. Participants will include women who have a BMI of greater than or equal to 25. The final data set in Study 1 will include approximately 600 participants who are already part of an existing, nationally representative internet panel (ceiling n=700). The final data set in Study 2 will include approximately 250 participants recruited from the local area (ceiling n=500).
- Conditions
- Body Weight
- Keywords
- Body Weight, Virtual Environment, 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 |
|---|---|---|
| Adult Women | Adult Women aged 18-50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
A
The primary goal of this research project is to continue building an evidence base on the benefits or pitfalls of introducing genomic information into weight-related primary care encounters.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study start5 Jul 2013
- Primary completion10 Feb 2016
- Study completion10 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Body WeightStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,464 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
- NCT01888913
- Sponsor's protocol ID
- 130158
- Other IDs
- 13-HG-0158
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2013
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tetlock PE, Kristel OV, Elson SB, Green MC, Lerner JS. The psychology of the unthinkable: taboo trade-offs, forbidden base rates, and heretical counterfactuals. J Pers Soc Psychol. 2000 May;78(5):853-70. doi: 10.1037//0022-3514.78.5.853.
PubMed 10821194Agurs-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 19037221Kushner 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, Ferrer RA, Klein WM. Nonverbal and paraverbal behavior in (simulated) medical visits related to genomics and weight: a role for emotion and race. J Behav Med. 2016 Oct;39(5):804-14. doi: 10.1007/s10865-016-9747-5. Epub 2016 May 4.
PubMed 27146511Persky S, Ferrer RA, Klein WM. Genomic Information may Inhibit Weight-Related Behavior Change Inclinations Among Individuals in a Fear State. Ann Behav Med. 2016 Jun;50(3):452-9. doi: 10.1007/s12160-016-9771-2.
PubMed 26850762
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Perspectives and Simulated Clinical Interactions
- ClinicalTrials.gov ID
- NCT01888913
- Acronym / sponsor ID
- 130158
- Conditions
- Body Weight
- Keywords
- Body Weight, Virtual Environment, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,464 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 5 Jul 2013 (actual)
- Primary completion
- 10 Feb 2016 (actual)
- Study completion
- 10 Feb 2016 (actual)
- First posted
- 28 Jun 2013 (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.
Background:
- We are studying people s psychological experiences and how these relate to the way people respond have when they see information communicated in different ways. We are testing multiple research questions in this research.
Objectives:
- To learn about how to design future research studies. Also to learn about how to best give people information about health topics.
Eligibility:
- Women with a Body Mass Index of 25 or higher.
Design:
- Before the study visit, participants will answer some questions online about themselves, their experiences, and their thoughts about their weight.
- During the study visit, participants will watch a short scene from a movie, and then answer questions about it.
- Participants will have a simulated doctor visit with a computerized, virtual reality doctor. They will answer more questions about themselves, their experiences, and their thoughts about their weight. Then they will answer questions with researchers.
Detailed description
The primary goal of this research project is to continue building an evidence base on the benefits or pitfalls of introducing genomic information into weight-related primary care encounters. We are particularly interested in how this information will impact patients health-related attitudes, beliefs and behavior, and patient perceptions of stigmatization. Furthermore, this project aims to determine whether a patient s emotional state during a clinical interaction will moderate the consequences of genomic information provision.
Genetic and genomic information are expected to be integrated into personalized prevention and treatment regimens of the future. Such information may influence patient beliefs, attitudes, and behaviors related to weight and obesity. Previous research has shown that provision of genomic information can lead to positive effects, negative effects and often no effect with respect to patient motivation for health-promoting behaviors. The literature describing the influence of emotion on judgment and decision-making suggests that patients emotional state may, in part, account for this discrepancy. By better understanding the influence of emotional state on patients reactions to general, weight-related genomic information, we may be better able to shape clinical communications of the future to increase the likelihood that genomic information will lead to positive, health-promoting behavior. Indeed, there is a need for exploration of strategies through which providers can counsel patients about weight such that patients feel motivated by the counseling, and that it does not make them feel stigmatized.
The current protocol describes two studies; both are randomized, controlled experiments. The first will be conducted through an internet panel via the Time-Sharing Experiments in the Social Sciences program. The current proposal was already reviewed and was successfully approved and funded for fielding through this program. The second study is a lab-based study that will take place in the Immersive Virtual Environment Testing Area in the NIH Clinical Center. In both studies, overweight, adult women will undergo a task designed to elicit mild-to-moderate emotional states. In Study 1 the elicited emotions will include anger, fear and neutral; Study 2 will include only anger and fear. Participants will then participate in a weight counseling encounter with a simulated doctor who will provide weight management information that includes discussions of either behavioral or genomic etiology. Participants in Study 1 will engage with the doctor via video clips over the internet, participants in Study 2 will engage with the doctor in an immersive virtual environment. Primary outcome measures pertain to participants health-related attitudes, behavioral intentions, and perceptions of stigmatization related to weight. Participants will include women who have a BMI of greater than or equal to 25. The final data set in Study 1 will include approximately 600 participants who are already part of an existing, nationally representative internet panel (ceiling n=700). The final data set in Study 2 will include approximately 250 participants recruited from the local area (ceiling n=500).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Women | – | –Adult Women aged 18-50 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All participants will be adult women. Inclusion for Study 1 are: (1) being part of a Knowledge Networks Panel; (2) having a self-reported body mass index of greater than or equal to 25. Inclusion criteria for Study 2 are: (1) being between 18 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.
Key inclusion criteria (4 listed)
- being between 18 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.
Key exclusion criteria (6 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
A
Time frame: ongoing
The primary goal of this research project is to continue building an evidence base on the benefits or pitfalls of introducing genomic information into weight-related primary care encounters.
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 20 Jun 2024.
- Background: PubMed 10821194Tetlock PE, Kristel OV, Elson SB, Green MC, Lerner JS. The psychology of the unthinkable: taboo trade-offs, forbidden base rates, and heretical counterfactuals. J Pers Soc Psychol. 2000 May;78(5):853-70. doi: 10.1037//0022-3514.78.5.853.
- 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 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 27146511Persky S, Ferrer RA, Klein WM. Nonverbal and paraverbal behavior in (simulated) medical visits related to genomics and weight: a role for emotion and race. J Behav Med. 2016 Oct;39(5):804-14. doi: 10.1007/s10865-016-9747-5. Epub 2016 May 4.
- Derived from this study: PubMed 26850762Persky S, Ferrer RA, Klein WM. Genomic Information may Inhibit Weight-Related Behavior Change Inclinations Among Individuals in a Fear State. Ann Behav Med. 2016 Jun;50(3):452-9. doi: 10.1007/s12160-016-9771-2.
- 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 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 6 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 20 Jun 2024. 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?
A (time frame: ongoing). 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 NCT01888913, which also lists 5 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 20 Jun 2024.