The Good Tastes Study: Young Children's Food Acceptance Patterns

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT04549233
Collaborator
The Sugar Association (Other), Purdue University (Other)
110
1
6.1
18.1

Study Details

Study Description

Brief Summary

Children begin developing food acceptance and preferences during the first years of life, especially through repeated exposure and increased familiarity. Caregivers pay attention to the amounts of food that their children consume, and they also are sensitive to when their refuses to eat what is offered. This study will examine the interactions between caregivers and their infants when bitter vegetables are introduced to infants and toddlers. The goals for this study are to:

  1. understand if masking bitterness with very low levels of sugar or salt may facilitate whether infants accept new vegetables;

  2. understand if masking bitterness impacts caregivers' perceptions of infants' acceptance of new vegetables; and

  3. understand the stress levels experienced by infants and caregivers throughout this process.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    During a single visit, four versions of a kale puree will be made with 1) no added sugar or sodium; 2) 1.2% added sugar; 3) 1.8% added sugar; and 4) 0.2% added sodium to mask bitterness. First, a familiar food will be offered to provide baseline data. Then each of the four versions of the novel kale puree will be offered to the infant by their caregiver, and the order the kale versions are presented will be randomized. The salt version will always be offered last to control for the effects of a very different taste exposure (salt vs. sweet) and to try to avoid any significant carryover effects of salt taste on sweet perception. Feeding interactions will be video recorded for behavioral coding of infant responses to each bite. Additionally, infant and caregiver heart rate and skin conductance will be monitored to assess physiological responses in each participant throughout the feeding interaction.

    Several measures will be observed in order to test predictors of infant food acceptance, caregiver perceptions of infants' responses, and physiological responses in infants and caregivers. These include:

    • Demographic measures

    • Observed caregiver height and weight

    • Observed infant length and weight

    • Child developmental stage using Ages and Stages screening tool

    • Caregiver neophobia

    • Caregiver preferences for and intake of fruits and vegetables

    • Infant feeding history and food experience

    • Eating behaviors using the Child Eating Behavior Questionnaire for Toddlers

    • Infant behavior using the Infant Behavior Questionnaire-Revised (Garstein & Rothbart 2003 Infant Behav Dev)

    • Caregiver feeding persistence

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    110 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Good Tastes Study: Young Children's Response to Vegetables and Caregiver Perceptions Regarding Their Children's Food Acceptance Patterns
    Actual Study Start Date :
    Jul 6, 2017
    Actual Primary Completion Date :
    Jan 7, 2018
    Actual Study Completion Date :
    Jan 7, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Infant rate of acceptance of kale puree [Baseline]

      Acceptance is measured using an adaptation of the Feeding Infants: Behavior and Facial Expression Coding System (FIBFECS) on a 4-point scale from 0-3 where 0 = refusal and 3 = early acceptance of food. (Hetherington et al. 2016 Food Qual Prefer)

    2. Infant responses to kale puree [Baseline]

      Responses are measured using an adaptation of the Feeding Infants: Behavior and Facial Expression Coding System (FIBFECS). Positive behaviors include leaning forward, and negative behaviors include turning head away, getting fussy, and pushing the spoon away. (Hetherington et al. 2016 Food Qual Prefer)

    Secondary Outcome Measures

    1. Caregivers' perceived ratings of infant liking of kale [Baseline]

      After feeding each vegetable version, the caregiver will be instructed to rate how much he/she thought his/her infant liked the vegetable using a 9-point scale ranging from 1 = "dislikes extremely", 5 = "neither likes nor dislikes", to 9 = "likes extremely"(19).

    2. Caregivers' intentions to offer kale again [Baseline]

      After feeding each vegetable version, the caregiver will be instructed to rate how likely he/she is to offer his/her infant kale in the future. Caregivers will be asked to respond using a 5-point scale ranging from 1 = "note at all likely" to 5 = "very likely".

    3. Infant mean heart rate reactivity to kale exposure [Baseline]

      Infant heart rate will be collected through disposable leads placed on the infant's torso. The mean heart rate for each of the four vegetable versions will be compared to the mean heart rate when given a familiar food.

    4. Infant amplitude of skin conductance in response to kale exposure [Baseline]

      Infant skin conductance will be collected by placing a lead on the infant's foot. The amplitude of voltage across a resistor is measured to calculate the amplitude of skin conductance. (Lykken and Venables 1971 Psychophysiology)

    5. Caregiver mean heart rate reactivity to infant exposure to kale [Baseline]

      Caregiver heart rate will be collected by placing disposable leads on the caregiver's torso. The mean heart rate recorded during the offering of each of the four vegetable versions will be compared to the mean heart rate during the offering of a familiar food.

    6. Caregiver amplitude of skin conductance in response to infant exposure to kale [Baseline]

      Caregiver skin conductance will be collected by placing a lead on the caregiver's finger. The amplitude of voltage across a resistor is measured to calculate the amplitude of skin conductance. (Lykken and Venables 1971 Psychophysiology)

    7. Infant respiratory sinus arrhythmia (RSA) in response to kale exposure [Baseline]

      Infant heart rate will be collected through disposable leads placed on the infant's torso. Respiratory sinus arrhythmia, the heart rate response to breathing, will be calculated using a proprietary algorithm through CardioBatch Plus (Brain-Body Center, University of North Carolina, Chapel Hill). The mean RSA observed during the offering of each vegetable version will be compared to the mean RSA observed during the offering a familiar food.

    8. Caregiver respiratory sinus arrhythmia (RSA) in response to infant exposure to kale [Baseline]

      Caregiver heart rate will be collected by placing disposable leads on the caregiver's torso. Respiratory sinus arrhythmia, the heart rate response to breathing, will be calculated using a proprietary algorithm through CardioBatch Plus (Brain-Body Center, University of North Carolina, Chapel Hill). The mean RSA observed during the offering of each vegetable version will be compared to the mean RSA observed during the offering a familiar food.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 24 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Term birth (gestational age > 37 weeks);

    • Experience with at least 1 complementary food (e.g., infant cereal);

    • Caregivers who are > 18 y and < 51 y of age;

    • Caregivers who live within 75 miles of the University of Colorado-Denver campus.

    Exclusion Criteria:
    • Has genetic disorders or developmental disabilities as these conditions often result in feeding difficulties;

    • Has a reported illness or metabolic disorder that would affect food intake (e.g., significant history of allergies);

    • Born prematurely (< 37 weeks gestation);

    • Caregivers who are younger than 18 y of age or > 51 y;

    • Caregivers who live more than 75 miles from the University of Colorado-Denver campus;

    • Caregivers who do not read and speak English.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado Denver Aurora Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver
    • The Sugar Association
    • Purdue University

    Investigators

    • Principal Investigator: Susan L Johnson, PhD, UC Denver
    • Principal Investigator: Kameron J Moding, PhD, Purdue University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT04549233
    Other Study ID Numbers:
    • 15-2437
    First Posted:
    Sep 16, 2020
    Last Update Posted:
    Sep 16, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Colorado, Denver
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 16, 2020