New Technology and Child Health

Healthy Volunteers Clinical Trial

Official title:

New Technology and Child Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02622035
• Other study ID #: 160026
• Secondary ID: 16-HG-0026
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2016
• Est. completion date: December 31, 2025

Study information

• Verified date: May 3, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Susan Persky, Ph.D.
• Phone: (301) 443-0098
• Email: perskys[@]mail.nih.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 670
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

• INCLUSION CRITERIA - MAIN TRIAL

• All participants in the main trial will be healthy adult parents 18 years and older

• Inclusion criteria include:

1. being the parent of a biological child who is between 4 and 7 years old with no major allergies or dietary-related health conditions;

2. having some responsibility for child s dietary intake ;

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 - MAIN TRIAL

• Exclusion criteria include:

1. having received information about the study purpose;

2. being an NHGRI employee;

3. 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:

1. having a medical susceptibility to dizziness, disorientation or nausea;

2. having a seizure disorder or epilepsy;

3. having a high propensity for motion sickness;

4. lacking freedom of movement;

5. known pregnancy;

6. 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:

1. 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;

2. having the ability to read, write, and converse in English;

3. being able to come to the NIH Clinical Center for one visit.

EXCLUSION CRITERIA - PILOT

1. having received information about the study purpose;

2. being an NHGRI employee;

3. 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:

1. being the parent of a biological child who is between 3 and 7 years old with no major allergies or dietary-related health conditions;

2. having some responsibility for child s dietary intake ;

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 - BUFFET SERVING EVALUATION (MAIN)

1. being an NHGRI employee;

2. 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:

1. having a medical susceptibility to dizziness, disorientation or nausea;

2. having a seizure disorder or epilepsy;

3. having a high propensity for motion sickness;

4. lacking freedom of movement;

5. known pregnancy;

6. 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:

1. Having the ability to read, write and converse in English

2. Able to come to the clinical center for on visit.

We may also include the following inclusion criteria:

1. Being the parent of a biological child who is between 3 and 7 years old with no major allergies or dietary-related health conditions

2. 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:

1. Being an NHGRI employee;

2. Having participated in the Parents TAKE study conducted previously in this lab.

Exclusion criteria related to use of the virtual reality environment include:

1. Having a medical susceptibility to dizziness, disorientation or nausea;

2. Having a seizure disorder or epilepsy;

3. Having a high propensity for motion sickness;

4. Lacking freedom of movement;

5. Known pregnancy;

6. 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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Behavioral:
• Provision of information
Information about fruit and vegetable feeding for children framed in gain vs. loss manner
• Emotion induction
Film clip designed to induce anger or fear
• visual perceptual load
visual and interactivity-based load of virtual reality buffet environment

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Human Genome Research Institute (NHGRI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exhibited emotion, Feeding decisions, self-reported attitudes, beliefs and intentions; perceptual responses	feeding behavior and self-reported outcomes	At lab visit

External Links

•   NIH Clinical Center Detailed Web Page