New Technology and Child Health

Sponsor

National Human Genome Research Institute (NHGRI) (NIH)

Overall Status

Recruiting

CT.gov ID

NCT02622035

Collaborator

(none)

670

Enrollment

Location

Arms

119.5

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Behavioral: Provision of information Behavioral: Emotion induction Behavioral: visual perceptual load	N/A

Detailed Description

Background:

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

Study Type:

Interventional

Anticipated Enrollment :

670 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

New Technology and Child Health

Actual Study Start Date :

Jan 15, 2016

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Gain frame; Anger	Behavioral: Provision of information Information about fruit and vegetable feeding for children framed in gain vs. loss manner Behavioral: Emotion induction Film clip designed to induce anger or fear
Experimental: 1b high visual perceptual load high interactive	Behavioral: visual perceptual load visual and interactivity-based load of virtual reality buffet environment
Experimental: 2 Gain frame; Fear	Behavioral: Provision of information Information about fruit and vegetable feeding for children framed in gain vs. loss manner Behavioral: Emotion induction Film clip designed to induce anger or fear
Experimental: 2b high visual perceptual load	Behavioral: visual perceptual load visual and interactivity-based load of virtual reality buffet environment
Experimental: 3 Loss frame; Anger	Behavioral: Provision of information Information about fruit and vegetable feeding for children framed in gain vs. loss manner Behavioral: Emotion induction Film clip designed to induce anger or fear
Experimental: 3b low visual perceptual load	Behavioral: visual perceptual load visual and interactivity-based load of virtual reality buffet environment
Experimental: 4 Loss frame; Fear	Behavioral: Provision of information Information about fruit and vegetable feeding for children framed in gain vs. loss manner Behavioral: Emotion induction Film clip designed to induce anger or fear

Outcome Measures

Primary Outcome Measures

Exhibited emotion, Feeding decisions, self-reported attitudes, beliefs and intentions; perceptual responses [At lab visit]
feeding behavior and self-reported outcomes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

INCLUSION CRITERIA - MAIN TRIAL
All participants in the main trial will be healthy adult parents 18 years and older
Inclusion criteria include:

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.

EXCLUSION CRITERIA - MAIN TRIAL

Exclusion criteria include:

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 - 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.

INCLUSION CRITERIA - PILOT

Participants in the Pilot test will be healthy adult parents 18 years and older.
Inclusion criteria include:

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.

EXCLUSION CRITERIA - PILOT

having received information about the study purpose;
being an NHGRI employee;
low, uncorrected vision and hearing.

INCLUSION CRITERIA - BUFFET SERVING EVALUATION

Participants in the secondary Buffet Serving Evaluation will be healthy adult parents 18 years and older
Inclusion criteria include:

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.

EXCLUSION CRITERIA - BUFFET SERVING EVALUATION (MAIN)

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.

INCLUSION CRITERIA- OLFACTORY AWARENESS TEST:

Participants in the Olfactory Awareness Test will be healthy adults between the ages of 18 and 59

Inclusion criteria include:

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

EXCLUSION CRITERIA-OLFACTORY AWRAENESS TEST:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland	United States	20892

Sponsors and Collaborators

National Human Genome Research Institute (NHGRI)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

NIH Clinical Center Detailed Web Page

Publications

None provided.

Responsible Party:

National Human Genome Research Institute (NHGRI)

ClinicalTrials.gov Identifier:

NCT02622035

Other Study ID Numbers:

160026
16-HG-0026

First Posted:

Dec 4, 2015

Last Update Posted:

Aug 25, 2022

Last Verified:

Aug 12, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by National Human Genome Research Institute (NHGRI)

Child Feeding

Study Results

No Results Posted as of Aug 25, 2022