NCT04544332|Completed
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Sponsor study identifier
observational
58
1 country
1
Study Start
October 25, 2018
Actual (reported)Primary Completion
April 1, 2019
Actual (reported)Study Completion
April 1, 2019
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 25, 2018
Actual (reported)April 1, 2019
Actual (reported)April 1, 2019
Actual (reported)August 28, 2020
Actual (reported)September 10, 2020
Actual (reported)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
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
Infants will receive 10 exposures to the unsweetened small quantity lipid nutritional supplement (SQ-LNS) at home
Infants will receive 10 exposures to the sweetened small quantity lipid nutritional supplement (SQ-LNS) at home
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
University of Colorado Denver
Aurora, Colorado, 80045, United States
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.
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.
Susan L Johnson, PhD
University of Colorado, Denver
Matthew Greenhawt, MD
University of Colorado, Denver
Jennifer O Fisher, PhD
Temple University
Kameron J Moding, PhD
Purdue University
58 participants (actual enrollment reported by the registry).
First Submitted
August 28, 2020
First Posted
September 10, 2020
Study Start
October 25, 2018
Actual (reported)ChiPP2: A Trauma-Informed Program for City School Parents
SMART Optimization of a Parenting Program for Active-duty Families
Contact the study team to confirm eligibility.
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.
Primary Completion
April 1, 2019
Actual (reported)Study Completion
April 1, 2019
Actual (reported)Last Updated
September 10, 2020
Record last verified: 2020-09
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Source: ClinicalTrials.gov.
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