Recruiting
Observational
Stunting and Targeting Reduction of Impaired Growth in Kids Effectively
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
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)
| Facility | City | Region | Status |
| Children International |
Kansas City |
Missouri |
Recruiting |
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