Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT04549233
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
Study:
NCT04549233
Study Brief:
Protocol Section:
NCT04549233