The GAIN Study: Understanding What Helps Children Learn to Like and Eat New Foods

NCT04544332 | Completed

• 1 other identifier: 17-2308
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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. 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. 2.an unsweetened version of the nutrition supplement differs in short- and long-term acceptance; and
3. 3.maternal liking of the supplement is associated with her persistence in offering the food to her child.

Conditions

Food Preferences; Parenting

Keywords

Infant Feeding; Toddler Feeding; Food Acceptance; Food Parenting

Outcome Measures

Primary Outcomes (2)

• Change in rate of infant acceptance of sweetened and unsweetened nutritional supplement

  Acceptance is measured at the conclusion of each offered bite 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

  Baseline, Week 2

• Change in infant consumption of sweetened and unsweetened nutritional supplement

  Consumption of each type of supplement will be measured in grams. The weight of the remainder of each supplement will be subtracted from the initial weight of the supplement prior to offering. The remainder of the supplements offered at home will be frozen and returned to the lab to be weighed.

  Baseline up to Week 2

Secondary Outcomes (4)

• Baseline caregivers' perceived ratings of infant liking of sweetened and unsweetened supplements

  Baseline

• Follow up caregivers' perceived ratings of infant liking of sweetened and unsweetened supplements

  Visit two: change from baseline caregivers' perceived ratings at two weeks

• Baseline caregivers' perceived acceptability of the sweetened and unsweetened supplements

  Baseline

• Follow up caregivers' perceived acceptability of the sweetened and unsweetened supplements

  Visit two: change from baseline caregivers' acceptability ratings at two weeks

Study Arms (2)

Unsweetened Supplement

Infants will receive 10 exposures to the unsweetened small quantity lipid nutritional supplement (SQ-LNS) at home

Sweetened Supplement

Infants will receive 10 exposures to the sweetened small quantity lipid nutritional supplement (SQ-LNS) at home

Eligibility Criteria

• Age: 7 Months - 24 Months
• Sex: all
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Temple University: collaborator
• Global Alliance for Improved Nutrition: collaborator
• Purdue University: collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (3)

• 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.

  PMID: 19576254 BACKGROUND

• 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.

  PMID: 11693591 BACKGROUND

• 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.

  PMID: 34036363 DERIVED

MeSH Terms

Conditions

Food Preferences

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Susan L Johnson, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Matthew Greenhawt, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Jennifer O Fisher, PhD

  Temple University

  PRINCIPAL INVESTIGATOR

• Kameron J Moding, PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 10, 2020
• Study Start: October 25, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: September 10, 2020

Record last verified: 2020-09

Locations

US (1)