Parenting Clinical Trial
Official title:
The Good Tastes Study: Young Children's Response to Vegetables and Caregiver Perceptions Regarding Their Children's Food Acceptance Patterns
NCT number | NCT04549233 |
Other study ID # | 15-2437 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 6, 2017 |
Est. completion date | January 7, 2018 |
Verified date | September 2020 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | January 7, 2018 |
Est. primary completion date | January 7, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 24 Months |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Denver | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | Purdue University, The Sugar Association |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Baseline | |
Primary | 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) | Baseline | |
Secondary | 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). | Baseline | |
Secondary | 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". | Baseline | |
Secondary | 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. | Baseline | |
Secondary | 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) | Baseline | |
Secondary | 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. | Baseline | |
Secondary | 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) |
Baseline | |
Secondary | 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. | Baseline | |
Secondary | 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. | Baseline |
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