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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date September 2020
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Colorado Denver Aurora Colorado

Sponsors (3)

Lead Sponsor Collaborator
University of Colorado, Denver Purdue University, The Sugar Association

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

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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