Clinical trial NCT04549233: The Good Tastes Study: Young Children's Food Acceptance Patterns
Official title: The Good Tastes Study: Young Children's Response to Vegetables and Caregiver Perceptions Regarding Their Children's Food Acceptance Patterns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Neophobia
Parenting
Keywords: Infant Feeding
Toddler Feeding
Complementary Feeding
Food Acceptance
Parenting
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: The Sugar Association
name: Purdue University
First posted: 2020-09-16
Enrollment: 110
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Infant rate of acceptance of kale puree
timeFrame: Baseline
measure: Infant responses to kale puree
timeFrame: Baseline
Secondary outcomes:
measure: Caregivers' perceived ratings of infant liking of kale
timeFrame: Baseline
measure: Caregivers' intentions to offer kale again
timeFrame: Baseline
measure: Infant mean heart rate reactivity to kale exposure
timeFrame: Baseline
measure: Infant amplitude of skin conductance in response to kale exposure
timeFrame: Baseline
measure: Caregiver mean heart rate reactivity to infant exposure to kale
timeFrame: Baseline
measure: Caregiver amplitude of skin conductance in response to infant exposure to kale
timeFrame: Baseline
measure: Infant respiratory sinus arrhythmia (RSA) in response to kale exposure
timeFrame: Baseline
measure: Caregiver respiratory sinus arrhythmia (RSA) in response to infant exposure to kale
timeFrame: Baseline
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: UC Denver
name: Susan L Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Purdue University
name: Kameron J Moding, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1111/1469-7610.00792.
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. doi: 10.1093/jpepsy/22.3.313.
citation: 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.
citation: 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.