Clinical trial NCT04544332: The GAIN Study: Understanding What Helps Children Learn to Like and Eat New Foods
Official title: The GAIN Study: Understanding What Helps Children Learn to Like and Eat New Foods
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Preferences
Parenting
Keywords: Infant Feeding
Toddler Feeding
Food Acceptance
Food Parenting
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Temple University
name: Global Alliance for Improved Nutrition
name: Purdue University
First posted: 2020-09-10
Enrollment: 58
Sex: ALL
Minimum age (years): 7
Maximum age (years): 24
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants and toddlers and their caregivers will be recruited for this study via:

* printed advertisements placed in a number of community and healthcare venues and posted on online websites.
* emails sent through the university
* referrals from other participating caregivers

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.

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)

Eligibility criteria: Inclusion Criteria:

* Term birth (at least 37 weeks gestation)
* Experience with complementary foods
* Previous exposure to nuts (butters, powders, or other nut ingredients)
* Caregiver at least 18 years of age and \< 51 years of age
* Caregiver lives within 75 miles of the University of Colorado Anschutz Medical Campus
* Caregiver must feed the infant or toddler at least 50% of the time

Exclusion Criteria:

* Has a genetic disorder or developmental disability, as these conditions often result in feeding difficulties
* Has a reported illness or metabolic disorder (e.g., food allergy) that could affect food intake
* Was born prematurely (\< 37 weeks gestation)
* Caregiver is less than 18 years of age
* Caregiver lives more than 75 miles from the University of Colorado Anschutz Medical Campus
* Caregiver does not read and speak English
* Caregiver has a food allergy

Primary outcomes:
measure: Change in rate of infant acceptance of sweetened and unsweetened nutritional supplement
timeFrame: Baseline, Week 2
measure: Change in infant consumption of sweetened and unsweetened nutritional supplement
timeFrame: Baseline up to Week 2
Secondary outcomes:
measure: Baseline caregivers' perceived ratings of infant liking of sweetened and unsweetened supplements
timeFrame: Baseline
measure: Follow up caregivers' perceived ratings of infant liking of sweetened and unsweetened supplements
timeFrame: Visit two: change from baseline caregivers' perceived ratings at two weeks
measure: Baseline caregivers' perceived acceptability of the sweetened and unsweetened supplements
timeFrame: Baseline
measure: Follow up caregivers' perceived acceptability of the sweetened and unsweetened supplements
timeFrame: Visit two: change from baseline caregivers' acceptability ratings at two weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Susan L Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Matthew Greenhawt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Temple University
name: Jennifer O Fisher, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Purdue University
name: Kameron J Moding, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thompson AL, Mendez MA, Borja JB, Adair LS, Zimmer CR, Bentley ME. Development and validation of the Infant Feeding Style Questionnaire. Appetite. 2009 Oct;53(2):210-21. doi: 10.1016/j.appet.2009.06.010. Epub 2009 Jul 1.
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: Johnson SL, Shapiro ALB, Moding KJ, Flesher A, Davis K, Fisher JO. Infant and Toddler Consumption of Sweetened and Unsweetened Lipid Nutrient Supplements After 2-Week Home Repeated Exposures. J Nutr. 2021 Sep 4;151(9):2825-2834. doi: 10.1093/jn/nxab148.