Malnutrition (Calorie)
Conditions
Brief 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.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare Resource Utilization | Baseline, 6 and 12 months | Caregiver completed open ended questions to obtain the frequency of healthcare resource utilization including illness frequency, severity and related missed school/work days, where more utilization means worse outcomes. |
| Pediatric Quality of Life Inventory | Baseline, 6, and 12 months | A 23-item questionnaire rated 0 to 4 where higher scores indicate better health-related quality of life |
| World Health Organization Quality of Life Brief Version | Baseline, 6, and 12 months | A 26-item caregiver completed questionnaire scored 0 to 100 where higher scores indicate higher quality of life |
| Nutrient Intake | Baseline, 3, 6, 9, and 12 months | Caregiver completed 24-hour dietary recall |
| Pediatric Nutrition Risk Status via Anthropometrics | Baseline, 3, 6, 9, and 12 months | Calculated from anthropometrics measurements as compared to established standards |
Countries
United States
Contacts
Abbott