Stunting and Targeting Reduction of Impaired Growth in Kids Effectively
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Malnutrition (Calorie). Basic parameters: 1 year — 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
STRIKE: Stunting and Targeting Reduction of Impaired Growth in Kids Effectively: A Community Engaged Comprehensive, Multi-Faceted Nutrition Quality Improvement Program
Overview
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.
Primary outcome measures
- Program Feasibility [Time frame: Baseline to 12 months]
- Growth Anthropometrics [Time frame: Baseline to 3, 6, 9, and 12 months]
Secondary outcome measures (5)
- Healthcare Resource Utilization [Time frame: Baseline, 6 and 12 months]
- Pediatric Quality of Life Inventory [Time frame: Baseline, 6, and 12 months]
- World Health Organization Quality of Life Brief Version [Time frame: Baseline, 6, and 12 months]
- Nutrient Intake [Time frame: Baseline, 3, 6, 9, and 12 months]
- Pediatric Nutrition Risk Status via Anthropometrics [Time frame: Baseline, 3, 6, 9, and 12 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Ecologic or community
Study locations
United States · 1 center
- Children International — Kansas City
Identifiers
NCT: NCT07524907 · HA65