Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2025-12-27 @ 10:06 PM
Study NCT ID:
NCT05639361
Status:
UNKNOWN
Last Update Posted:
2023-05-10
First Post:
2022-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Starts: Repeated Exposure Pilot
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
Healthy Starts: Pacing of Children's Introduction to New Plant-Based Foods
Status:
UNKNOWN
Status Verified Date:
2023-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Decades of research have established that providing repeated exposure to new foods is the most robust strategy for promoting children's acceptance of new foods (1). However, there is little guidance on how best to translate this recommendation into everyday family life about how often to introduce children to new foods. We propose to conduct a proof-of-concept randomized trial that will evaluate three different schedules of repeated exposure to a novel vegetable, which will help to identify the optimal "pacing" of repeated exposure to promote children's acceptance (i.e., intake) of new vegetables. Here we define "pacing" as how often (every day, every few days, etc.) and across what interval of time (days, weeks, months) repeated exposure is effective for infants to learn to accept a novel food.
Detailed Description:
Child acceptance of a novel vegetable will be assessed at 4 periodic consumption tests. Participants will visit the Children's Eating Laboratory where caregivers will offer their infants the novel vegetable in the format of their choice (pureed, mashed, or cut into small pieces). These visits will occur at: 1) baseline; 2) 2 weeks to obtain an interim measure of acceptance; 3) 6 weeks to measure acceptance at the end of the exposure period, and 4) 3 months (approximately 6 weeks from the end of the exposure period) to measure longer-term acceptance. Caregivers will be asked not to feed their child less than 90 minutes before arriving for their visit, so that their child will be hungry when they are being offered food. The feeding sessions during each visit will be video recorded. Child acceptance of the novel vegetable will be measured by intake (consumption in grams) and rate of acceptance. The vegetable will be weighed before and after it is offered to calculate intake by the child. The videos will be coded by trained coders trained to reliability, who will code for the child's rate of acceptance of the novel food, which ranges from rejection of the food to eager anticipation of the bite (Hetherington et al. 2016 Food Qual Prefer; Nekitsing et al. 2016 Food Qual Prefer), and for child and caregiver behaviors (Barrett et al. 2021 Curr Dev Nutr).
Caregivers will be provided the novel vegetable to offer their child at home. They will be asked to offer a small taste (2 small bites' worth or up to 3 rejections) at the intervals specified above. During the in-home exposure period, caregivers will be asked to keep a brief log of each offer of the novel food. These logs will include the method of food preparation (pureed or mashed vs. whole or in small pieces), whether the caregiver fed the child or the child fed themselves, whether the child tasted the food, and the caregiver's perception of the child's liking of the vegetable.
Caregivers will be provided the novel vegetable to offer their child at home. They will be asked to offer a small taste (2 small bites' worth or up to 3 rejections) at the intervals specified above. During the in-home exposure period, caregivers will be asked to keep a brief log of each offer of the novel food. These logs will include the method of food preparation (pureed or mashed vs. whole or in small pieces), whether the caregiver fed the child or the child fed themselves, whether the child tasted the food, and the caregiver's perception of the child's liking of the vegetable.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: