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)
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.