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Recruiting Observational

Stunting and Targeting Reduction of Impaired Growth in Kids Effectively

NCT07524907 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2026-05-11
Last updated
2026-07-24

Condition(s) studied

Malnutrition (Calorie)

Study summary

The objective of this prospective, real-world evidence/pragmatic study with a quality improvement program approach is to evaluate the feasibility and effectiveness of a community-engaged nutrition-focused program utilizing nutrition screening, education, supplementation and continuous follow up for children and their families.

Eligibility

Sex
ALL
Min age
1 Year
Max age
5 Years
Healthy volunteers
No
Household Component Inclusion * Children aged 1-5 years experiencing stunting or its risk (defined as HAZ ≤ -1 SD at baseline) * Children's legal guardian agrees to participate in the study * Full term pregnancy (defined as ≥ 37 weeks gestation and ≥ 2500g birth weight) * Residence in study area attending Children International (NGO) centers Exclusion • Children who have current medical conditions requiring hospitalization: gastrointestinal tract infections or inflammatory bowel disease; active tuberculosis; acute hepatitis B or C; human immunodeficiency virus OR malignancy; cystic fibrosis; immunodeficiency syndromes, congenital abnormalities of the respiratory tract, such as lung and respiratory cilia; an unsuspected foreign body in the respiratory tract; asthma; heart abnormalities; abdominal hernias; and known metabolic disorders, renal impairment, or rheumatic diseases and diabetes * Congenital condition * Children with disabilities such as cerebral palsy, autism spectrum disorder, neurodegenerative disorders * Children with chronic or acute infections e.g. HIV, malaria * Children who are taking medications or other agents that could potentially affect body weight, including diuretics, appetite stimulants, steroids, and growth hormones * Children who have genetic conditions impacting weight status such as but not limited to: Bardet-Biedl Syndrome, Prader-Willi Syndrome * Children already enrolled in a nutrition program that includes a supplement * Participant has an allergy or intolerance to any ingredient in the study supplement, as reported by the parent. * Children with sleep disorders such as but not limited to: obstructive sleep apnea, insomnia, parasomnias (sleepwalking, night terrors, bedwetting), delayed sleep phase syndrome, behavioral sleep disorders, circadian rhythm disorders * Mental health disorders such as but not limited to: anxiety, depression Organization Component Inclusion * NGO staff taking part in nutrition screenings * Agrees to participate in survey Exclusion * Not involved in the implementation of the study * Not involved in working with pediatric stunting or its risk * Declines participation in survey

Primary outcome measure(s)

  • Program Feasibility — Baseline to 12 months
    Caregiver and NGO staff program experience assessed via survey via Net Promoter Score (NPS) scored from 0 to 10 where higher score is more favorable
  • Growth Anthropometrics — Baseline to 3, 6, 9, and 12 months
    Change in Height (cm), Head Circumference (cm), Weight (kg) and Mid-Upper Arm Circumference (MUAC) (mm) as compared to pediatric growth standards (i.e. percentiles and z-scores)

Trial sites (1)

FacilityCityRegionStatus
Children International Kansas City Missouri Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07524907 on ClinicalTrials.gov ↗ ← All trials in the USA