New Technology and Child Health

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 Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Behavioral: Provision of information; Behavioral: Emotion induction; Behavioral: visual perceptual load

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 Type: Interventional
• Enrollment (Estimated): 670
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan Persky, Ph.D.; Phone Number: (301) 443-0098; Email: perskys@mail.nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

7

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exhibited emotion, Feeding decisions, self-reported attitudes, beliefs and intentions; perceptual responses	feeding behavior and self-reported outcomes	At lab visit

Collaborators and Investigators

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

Publications and helpful links

General 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.

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2016
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 3, 2015
• First Submitted That Met QC Criteria: December 3, 2015
• First Posted (Estimated): December 4, 2015

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: June 27, 2023

More Information

Terms related to this study

• Keywords: Child Feeding
• Other Study ID Numbers: 160026; 16-HG-0026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: .Data set is not currently deidentified and participants were not consented for data sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No