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Completed

NCT Number: NCT04549233

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

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.

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Key information

Conditions

Food Neophobia Avoidant Restrictive Food Intake Disorder Feeding and Eating Disorders Mental Disorders Parenting

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Infant rate of acceptance of kale puree

    Time frame: 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

    Time frame: 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 outcomes

  1. Caregivers' perceived ratings of infant liking of kale

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Purdue University
  • The Sugar Association

Registry information

Official study title

The Good Tastes Study: Young Children's Response to Vegetables and Caregiver Perceptions Regarding Their Children's Food Acceptance Patterns

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 16, 2020
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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