Combination of Oral Nutritional Supplements and Dietary Counseling Is More Effective than Dietary Counseling Alone in Improving Growth Indicators among Undernourished United States Children: A Randomized Controlled Clinical Trial.
- 1Abbott Laboratories, Nutrition Division, Nutrition Science, Columbus, OH, United States.
- 2MARS Group Inc., Bloomington, IL, United States.
Abstract
Approximately 14% of United States children show ≥1 indicator of undernutrition, highlighting an opportunity to deepen research evaluating oral nutrition supplements (ONSs) on growth in United States children. The purpose of this 2-arm, individually randomized, parallel controlled trial was to evaluate the impact of ONS plus dietary counseling (ONS+DC) compared with DC alone on growth in undernourished United States children (36-107 mo) over 120 d. Over the 120-d intervention, participants [mid-upper arm circumference (MUAC) or body mass index (BMI)-for-age z-score between -3 and -1) attended 2 DC sessions, and ONS+DC group ingested 2 servings of ONS (480 kcal) daily. Growth measurements occurred at baseline, days 30, 60, and 120. Parents/caregivers completed a 24-h dietary recall and questionnaires at all timepoints. A total of 279 children participated (ONS+DC: n = 174 enrolled, n = 89 protocol evaluable; DC: n = 105 enrolled, n = 82 protocol evaluable). The primary outcome was change in weight-for-age z-score at 120 d. ONS+DC had a significantly higher change in weight-for-age z-score than DC at 120 d (group difference: 0.255 ± 0.058, P < 0.001). Average and change from baseline in weight, weight-for-age, weight-for-height, and BMI-for-age z-scores and percentiles were larger in ONS+DC than DC at all timepoints (P < 0.05). Change in MUAC-for-age z-score was higher in ONS+DC than DC at 30 and 120 d (P < 0.05). Change in height-for-age percentile was higher in ONS+DC than DC at 120 d (P < 0.05). Change in muscle area was larger in ONS+DC than DC over 120 d (P < 0.05), with no differences in arm fat area or index (P > 0.05). In undernourished United States children, 2 servings of ONS over 120 d improved growth measures more than DC alone.This trial was registered at clinicaltrials.gov as NCT05161000 (https://clinicaltrials.gov/study/NCT05161000?intr=NCT05161000&rank=1; registered 3 December 2021).
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BibTeX
@article{niemiro2026combination,
title = {{Combination of Oral Nutritional Supplements and Dietary Counseling Is More Effective than Dietary Counseling Alone in Improving Growth Indicators among Undernourished United States Children: A Randomized Controlled Clinical Trial.}},
author = {Grace M Niemiro and Tricia L Hart and Jennifer A Williams and Menaka Yalawar and Geraldine E Baggs and Penni D Hicks},
journal = {Current developments in nutrition},
year = {2026},
month = oct,
doi = {10.1016/j.cdnut.2026.109552},
url = {https://europepmc.org/article/MED/42999576},
note = {CC BY},
}
RIS
TY - JOUR
TI - Combination of Oral Nutritional Supplements and Dietary Counseling Is More Effective than Dietary Counseling Alone in Improving Growth Indicators among Undernourished United States Children: A Randomized Controlled Clinical Trial.
AU - Grace M Niemiro
AU - Tricia L Hart
AU - Jennifer A Williams
AU - Menaka Yalawar
AU - Geraldine E Baggs
AU - Penni D Hicks
PY - 2026
DA - 2026/10/09
JO - Current developments in nutrition
DO - 10.1016/j.cdnut.2026.109552
UR - https://europepmc.org/article/MED/42999576
AB - Approximately 14% of United States children show ≥1 indicator of undernutrition, highlighting an opportunity to deepen research evaluating oral nutrition supplements (ONSs) on growth in United States children. The purpose of this 2-arm, individually randomized, parallel controlled trial was to evaluate the impact of ONS plus dietary counseling (ONS+DC) compared with DC alone on growth in undernourished United States children (36-107 mo) over 120 d. Over the 120-d intervention, participants [mid-upper arm circumference (MUAC) or body mass index (BMI)-for-age z-score between -3 and -1) attended 2 DC sessions, and ONS+DC group ingested 2 servings of ONS (480 kcal) daily. Growth measurements occurred at baseline, days 30, 60, and 120. Parents/caregivers completed a 24-h dietary recall and questionnaires at all timepoints. A total of 279 children participated (ONS+DC: n = 174 enrolled, n = 89 protocol evaluable; DC: n = 105 enrolled, n = 82 protocol evaluable). The primary outcome was change in weight-for-age z-score at 120 d. ONS+DC had a significantly higher change in weight-for-age z-score than DC at 120 d (group difference: 0.255 ± 0.058, P < 0.001). Average and change from baseline in weight, weight-for-age, weight-for-height, and BMI-for-age z-scores and percentiles were larger in ONS+DC than DC at all timepoints (P < 0.05). Change in MUAC-for-age z-score was higher in ONS+DC than DC at 30 and 120 d (P < 0.05). Change in height-for-age percentile was higher in ONS+DC than DC at 120 d (P < 0.05). Change in muscle area was larger in ONS+DC than DC over 120 d (P < 0.05), with no differences in arm fat area or index (P > 0.05). In undernourished United States children, 2 servings of ONS over 120 d improved growth measures more than DC alone.This trial was registered at clinicaltrials.gov as NCT05161000 (https://clinicaltrials.gov/study/NCT05161000?intr=NCT05161000&rank=1; registered 3 December 2021).
SN - 2475-2991
ER -