๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Household Component
Inclusion
* Children aged 1-5 years experiencing stunting or its risk (defined as HAZ โค -1 SD at baseline)
* Children's legal guardian agrees to participate in the study
* Full term pregnancy (defined as โฅ 37 weeks gestation and โฅ 2500g birth weight)
* Residence in study area attending Children International (NGO) centers
Exclusion
โข 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