Healthy VolunteersNCT02622035
New Technology and Child Health
A study testing Provision of information, Emotion induction and visual perceptual load in people with Healthy Volunteers, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
Background: We are involved in testing new behavioral science methods and measures for future research projects. In the course of these evaluations, we will also test research questions related to parents psychological experiences and how these relate to the responses they have when they encounter different types of… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Provision of information, Emotion induction and visual perceptual load
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 415 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2016to 29 Nov 2024
- Phase
- Interventional
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants in the main trial will be healthy adult parents 18 years and older
- being the parent of a biological child who is between 4 and 7 years old with no major allergies or dietary-related health conditions;
- having some responsibility for child s dietary intake ;
- having the ability to read, write, and converse in English;
- being able to come to the NIH Clinical Center for one visit.
- Participants in the Pilot test will be healthy adult parents 18 years and older.
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- being the parent of a biological child who is between 3 and 7 years old with no major allergies or dietary-related health conditions, but only for the first 10 participants;
- having the ability to read, write, and converse in English;
- being able to come to the NIH Clinical Center for one visit.
- Participants in the secondary Buffet Serving Evaluation will be healthy adult parents 18 years and older
- being the parent of a biological child who is between 3 and 7 years old with no major allergies or dietary-related health conditions;
- having some responsibility for child s dietary intake ;
- having the ability to read, write, and converse in English;
- being able to come to the NIH Clinical Center for one visit.
- Participants in the Olfactory Awareness Test will be healthy adults between the ages of 18 and 59
- Having the ability to read, write and converse in English
- Able to come to the clinical center for on visit.
- We may also include the following inclusion criteria:
- Being the parent of a biological child who is between 3 and 7 years old with no major allergies or dietary-related health conditions
- Having some responsibility for child s dietary intake; however, if we encounter recruitment difficulties, we may instead sample nonparent participants who are of the same general age range as parents who participated in our past studies using the virtual buffet. For the pilot test, we will sample non-parents in the age range of past parent participants
Who cannot join
- having received information about the study purpose;
- being an NHGRI employee;
- being from a family wherein another household member or co-parent of a biological child has already participated or is scheduled to participate.
- Exclusion criteria related to use of the virtual reality environment include:
- having a medical susceptibility to dizziness, disorientation or nausea;
- having a seizure disorder or epilepsy;
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- having a high propensity for motion sickness;
- lacking freedom of movement;
- known pregnancy;
- low, uncorrected vision and hearing.
- having received information about the study purpose;
- being an NHGRI employee;
- low, uncorrected vision and hearing.
- being an NHGRI employee;
- being from a family wherein another household member or co-parent of a biological child has already participated or is scheduled to participate.
- EXCLUSION CRITERIA - BUFFET SERVING EVALUATION (VIRTUAL REALITY)
- Exclusion criteria related to use of the virtual reality environment include:
- having a medical susceptibility to dizziness, disorientation or nausea;
- having a seizure disorder or epilepsy;
- having a high propensity for motion sickness;
- lacking freedom of movement;
- known pregnancy;
- low, uncorrected vision and hearing.
- Being an NHGRI employee;
- Having participated in the Parents TAKE study conducted previously in this lab.
- Exclusion criteria related to use of the virtual reality environment include:
- Having a medical susceptibility to dizziness, disorientation or nausea;
- Having a seizure disorder or epilepsy;
- Having a high propensity for motion sickness;
- Lacking freedom of movement;
- Known pregnancy;
- Weak, uncorrected vision, hearing, and/or smell. No adults older than age 59 will be able to participate in this study because older adults tend to experience a decline in olfactory function
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
We are involved in testing new behavioral science methods and measures for future research projects. In the course of these evaluations, we will also test research questions related to parents psychological experiences and how these relate to the responses they have when they encounter different types of communication about child health. We are testing multiple research questions in the course of this research.
Read more
Objective:
- To learn about technologies and approaches to use in future research studies.
Eligibility:
- Parents (fathers and mothers) of children between the ages of 3-7.
Design:
As part of the main study, participants will do four tasks:
Task 1: Before participants arrive for an in-person visit, they will answer questions online about themselves, their child, and their thoughts and opinions related to health.
Task 2: At the in-person visit, participants will watch a short scene from a movie and answer some questions
Task 3: At the in-person visit, participants will read information about a child health topic and answer questions
Task 4: At the in-person visit, participants will use a virtual reality-based buffet restaurant simulation to make hypothetical food choices for their child...
Read the detailed description
Background:
We are involved in testing new behavioral science methods and measures for future research projects. In the course of these evaluations, we will also test research questions related to parents psychological experiences and how these relate to the responses they have when they encounter different types of communication about child health. We are testing multiple research questions in the course of this research.
Objective:
- To learn about technologies and approaches to use in future research studies.
Eligibility:
- Parents (fathers and mothers) of children between the ages of 3-7.
Design:
As part of the main study, participants will do four tasks:
Task 1: Before participants arrive for an in-person visit, they will answer questions online about themselves, their child, and their thoughts and opinions related to health.
Task 2: At the in-person visit, participants will watch a short scene from a movie and answer some questions
Task 3: At the in-person visit, participants will read information about a child health topic and answer questions
Task 4: At the in-person visit, participants will use a virtual reality-based buffet restaurant simulation to make hypothetical food choices for their child
- Conditions
- Healthy Volunteers
- Being tested
- Provision of information, Emotion induction, visual perceptual load
- Keywords
- Child Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provision of informationBehavioural
Information about fruit and vegetable feeding for children framed in gain vs. loss manner
Emotion inductionBehavioural
Film clip designed to induce anger or fear
visual perceptual loadBehavioural
visual and interactivity-based load of virtual reality buffet environment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Gain frame; Anger Receives: Behavioral: Provision of information; Behavioral: Emotion induction |
| 1b | Experimental | high visual perceptual load high interactive Receives: Behavioral: visual perceptual load |
| 2 | Experimental | Gain frame; Fear Receives: Behavioral: Provision of information; Behavioral: Emotion induction |
| 2b | Experimental | high visual perceptual load Receives: Behavioral: visual perceptual load |
| 3 | Experimental | Loss frame; Anger Receives: Behavioral: Provision of information; Behavioral: Emotion induction |
| 3b | Experimental | low visual perceptual load Receives: Behavioral: visual perceptual load |
| 4 | Experimental | Loss frame; Fear Receives: Behavioral: Provision of information; Behavioral: Emotion induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhibited emotion, Feeding decisions, self-reported attitudes, beliefs and intentions; perceptual responses
feeding behavior and self-reported outcomes
Measured: At lab visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study start15 Jan 2016
- Primary completion29 Nov 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 415 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
- NCT02622035
- Sponsor's protocol ID
- 160026
- Other IDs
- 16-HG-0026
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2015
- Last updated
- 5 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data set is not currently deidentified and participants were not consented for data sharing.
Publications
Persky S, Ferrer RA, Klein WMP, Goldring MR, Cohen RW, Kistler WD, Yaremych HE, Bouhlal S. Effects of Fruit and Vegetable Feeding Messages on Mothers and Fathers: Interactions Between Emotional State and Health Message Framing. Ann Behav Med. 2019 Aug 16;53(9):789-800. doi: 10.1093/abm/kay088.
PubMed 30395145
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Technology and Child Health
- ClinicalTrials.gov ID
- NCT02622035
- Acronym / sponsor ID
- 160026
- Conditions
- Healthy Volunteers
- Keywords
- Child Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 4 Dec 2015 (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 involved in testing new behavioral science methods and measures for future research projects. In the course of these evaluations, we will also test research questions related to parents psychological experiences and how these relate to the responses they have when they encounter different types of communication about child health. We are testing multiple research questions in the course of this research.
Objective:
- To learn about technologies and approaches to use in future research studies.
Eligibility:
- Parents (fathers and mothers) of children between the ages of 3-7.
Design:
As part of the main study, participants will do four tasks:
Task 1: Before participants arrive for an in-person visit, they will answer questions online about themselves, their child, and their thoughts and opinions related to health.
Task 2: At the in-person visit, participants will watch a short scene from a movie and answer some questions
Task 3: At the in-person visit, participants will read information about a child health topic and answer questions
Task 4: At the in-person visit, participants will use a virtual reality-based buffet restaurant simulation to make hypothetical food choices for their child...
Detailed description
Background:
We are involved in testing new behavioral science methods and measures for future research projects. In the course of these evaluations, we will also test research questions related to parents psychological experiences and how these relate to the responses they have when they encounter different types of communication about child health. We are testing multiple research questions in the course of this research.
Objective:
- To learn about technologies and approaches to use in future research studies.
Eligibility:
- Parents (fathers and mothers) of children between the ages of 3-7.
Design:
As part of the main study, participants will do four tasks:
Task 1: Before participants arrive for an in-person visit, they will answer questions online about themselves, their child, and their thoughts and opinions related to health.
Task 2: At the in-person visit, participants will watch a short scene from a movie and answer some questions
Task 3: At the in-person visit, participants will read information about a child health topic and answer questions
Task 4: At the in-person visit, participants will use a virtual reality-based buffet restaurant simulation to make hypothetical food choices for their child
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Provision of information, Behavioral: Emotion inductionGain frame; Anger |
| 1b | Experimental | Behavioral: visual perceptual loadhigh visual perceptual load high interactive |
| 2 | Experimental | Behavioral: Provision of information, Behavioral: Emotion inductionGain frame; Fear |
| 2b | Experimental | Behavioral: visual perceptual loadhigh visual perceptual load |
| 3 | Experimental | Behavioral: Provision of information, Behavioral: Emotion inductionLoss frame; Anger |
| 3b | Experimental | Behavioral: visual perceptual loadlow visual perceptual load |
| 4 | Experimental | Behavioral: Provision of information, Behavioral: Emotion inductionLoss frame; Fear |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- All participants in the main trial will be healthy adult parents 18 years and older
- Participants in the Pilot test will be healthy adult parents 18 years and older.
- Participants in the secondary Buffet Serving Evaluation will be healthy adult parents 18 years and older
- Participants in the Olfactory Awareness Test will be healthy adults between the ages of 18 and 59
- Having the ability to read, write and converse in English
Key exclusion criteria (32 listed)
- Exclusion criteria related to use of the virtual reality environment include:
- having received information about the study purpose;
- being an NHGRI employee;
- low, uncorrected vision and hearing.
- being an NHGRI employee;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provision of informationInformation about fruit and vegetable feeding for children framed in gain vs. loss manner | Behavioural | 1, 2, 3, 4 |
| Emotion inductionFilm clip designed to induce anger or fear | Behavioural | 1, 2, 3, 4 |
| visual perceptual loadvisual and interactivity-based load of virtual reality buffet environment | Behavioural | 1b, 2b, 3b |
Primary outcome
Exhibited emotion, Feeding decisions, self-reported attitudes, beliefs and intentions; perceptual responses
Time frame: At lab visit
feeding behavior and self-reported 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 5 Dec 2024.
- Derived from this study: PubMed 30395145Persky S, Ferrer RA, Klein WMP, Goldring MR, Cohen RW, Kistler WD, Yaremych HE, Bouhlal S. Effects of Fruit and Vegetable Feeding Messages on Mothers and Fathers: Interactions Between Emotional State and Health Message Framing. Ann Behav Med. 2019 Aug 16;53(9):789-800. doi: 10.1093/abm/kay088.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Data set is not currently deidentified and participants were not consented for data sharing.
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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?
A study testing Provision of information, Emotion induction and visual perceptual load in people with Healthy Volunteers, 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 20 inclusion and 32 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 5 Dec 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?
Exhibited emotion, Feeding decisions, self-reported attitudes, beliefs and intentions; perceptual responses (time frame: At lab visit). 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 NCT02622035, which also lists 1 linked publication.
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 5 Dec 2024.