Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-01 @ 7:41 AM
Study NCT ID:
NCT04544332
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2020-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The GAIN Study: Understanding What Helps Children Learn to Like and Eat New Foods
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
The GAIN Study: Understanding What Helps Children Learn to Like and Eat New Foods
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
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:
Nutrition supplements have tremendous impact upon the nutritional and developmental status of malnourished children. These products have been designed to be acceptable to children (often by adding nutritive sweeteners to make them more palatable), but to date there has been little rigorous testing of their palatability for infants, toddlers and young children. The overall goal of this project is to investigate whether:
1. children's acceptance of a nutrition supplement is associated with maternal persistence in offering the food to her child over a 2-week period;
2. an unsweetened version of the nutrition supplement differs in short- and long-term acceptance; and
3. maternal liking of the supplement is associated with her persistence in offering the food to her child.
1. children's acceptance of a nutrition supplement is associated with maternal persistence in offering the food to her child over a 2-week period;
2. an unsweetened version of the nutrition supplement differs in short- and long-term acceptance; and
3. maternal liking of the supplement is associated with her persistence in offering the food to her child.
Detailed Description:
More rigorous pre-testing of nutrition supplements, with a focus on palatability (i.e., observations of behavioral and facial responses to its taste) and its relation to children's acceptance (defined here as consumption), could provide important insights into the capacity for these products to transition from being perceived as "medicine" to being accepted as "food," or part of the usual child diet. A clearer understanding of the relation between observed child indicators of palatability and acceptance, both initially and over time (i.e., repeated exposure effects), is important for predicting the longer-term impacts on children's dietary intake, growth and health. Further, a better grasp of caregiver perceptions of the acceptability of these products, both their child's and their own, is critical in paving the way for overcoming barriers and identifying facilitators associated with longer-term acceptance of these nutritional supplements.
We secondarily will also explore the effects of potential mediators on caregiver persistence and infant acceptance of a sweetened and an unsweetened small-quantity lipid nutrition supplement (SQ-LNS) such as:
* Maternal feeding self-efficacy
* Caregiver food neophobia
* Caregiver feeding styles using the Infant Feeding Style Questionnaire
* Infant feeding history and food experience
* Toddler eating behaviors using the Child Eating Behavior Questionnaire for Toddlers
* Infant behaviors using the Infant Behavior Questionnaire-Revised (Garstein \& Rothbart 2003 Inf Behav Dev)
We secondarily will also explore the effects of potential mediators on caregiver persistence and infant acceptance of a sweetened and an unsweetened small-quantity lipid nutrition supplement (SQ-LNS) such as:
* Maternal feeding self-efficacy
* Caregiver food neophobia
* Caregiver feeding styles using the Infant Feeding Style Questionnaire
* Infant feeding history and food experience
* Toddler eating behaviors using the Child Eating Behavior Questionnaire for Toddlers
* Infant behaviors using the Infant Behavior Questionnaire-Revised (Garstein \& Rothbart 2003 Inf Behav Dev)
Study Oversight
Has Oversight DMC:
None
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?: