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Food NeophobiaNCT04549233

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

An observational study of Food Neophobia and Parenting, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 24 monthsHealthy volunteers can take part
Conditions the study is for
Food Neophobia, Parenting
How many people
110 participants
Where
1 siteUnited States
Study dates
6 Jul 2017to 7 Jan 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 24 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Infants and caregivers who live in the Denver area will be recruited using advertising flyers, emails sent through a university listserv and parent email distribution, and word of mouth.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado Denver

    Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: The Good Tastes Study: Young Children's Response to Vegetables and Caregiver Perceptions Regarding Their 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.
Read the 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
Keywords
Infant Feeding, Toddler Feeding, Complementary Feeding, Food Acceptance, Parenting
Medical subject headings
Avoidant Restrictive Food Intake Disorder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infant rate of acceptance of kale puree

    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)

    Measured: Baseline

  2. Infant responses to kale puree

    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)

    Measured: Baseline

Secondary outcomes (8)

  1. Caregivers' perceived ratings of infant liking of kale

    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).

    Measured: Baseline

  2. Caregivers' intentions to offer kale again

    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".

    Measured: Baseline

  3. Infant mean heart rate reactivity to kale exposure

    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.

    Measured: Baseline

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

    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)

    Measured: Baseline

  5. Caregiver mean heart rate reactivity to infant exposure to kale

    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.

    Measured: Baseline

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

    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)

    Measured: Baseline

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

    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.

    Measured: Baseline

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

    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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2020
  2. Study start6 Jul 2017
  3. Primary completion7 Jan 2018
  4. Study completion7 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04549233
Sponsor's protocol ID
15-2437
Status last verified
Sep 2020
First submitted
18 Aug 2020
Last updated
16 Sep 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data may be available upon request to the Principal Investigator

Publications

  • Wardle J, Guthrie CA, Sanderson S, Rapoport L. Development of the Children's Eating Behaviour Questionnaire. J Child Psychol Psychiatry. 2001 Oct;42(7):963-70. doi: 10.1111/1469-7610.00792.

    PubMed 11693591

  • Squires J, Bricker D, Potter L. Revision of a parent-completed development screening tool: Ages and Stages Questionnaires. J Pediatr Psychol. 1997 Jun;22(3):313-28. doi: 10.1093/jpepsy/22.3.313.

    PubMed 9212550

  • Ham J, Tronick E. Infant resilience to the stress of the still-face: infant and maternal psychophysiology are related. Ann N Y Acad Sci. 2006 Dec;1094:297-302. doi: 10.1196/annals.1376.038.

    PubMed 17347365

  • Johnson SL, Moding KJ, Grimm KJ, Flesher AE, Bakke AJ, Hayes JE. Infant and Toddler Responses to Bitter-Tasting Novel Vegetables: Findings from the Good Tastes Study. J Nutr. 2021 Oct 1;151(10):3240-3252. doi: 10.1093/jn/nxab198.

    PubMed 34191021

Questions about this trial

What is this clinical trial studying?

An observational study of Food Neophobia and Parenting, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infant rate of acceptance of kale puree (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04549233, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.

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