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临床试验/NCT04549233
NCT04549233已完成不适用

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

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2017年7月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Infant rate of acceptance of kale puree

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
6 Months 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Infant rate of acceptance of kale puree

时间窗: 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)

Infant responses to kale puree

时间窗: 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)

次要结局

  • Caregivers' perceived ratings of infant liking of kale(Baseline)
  • Caregivers' intentions to offer kale again(Baseline)
  • Infant mean heart rate reactivity to kale exposure(Baseline)
  • Infant amplitude of skin conductance in response to kale exposure(Baseline)
  • Caregiver mean heart rate reactivity to infant exposure to kale(Baseline)
  • Caregiver amplitude of skin conductance in response to infant exposure to kale(Baseline)
  • Infant respiratory sinus arrhythmia (RSA) in response to kale exposure(Baseline)
  • Caregiver respiratory sinus arrhythmia (RSA) in response to infant exposure to kale(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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