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Stunting and Targeting Reduction of Impaired Growth in Kids Effectively

STRIKE: Stunting and Targeting Reduction of Impaired Growth in Kids Effectively: A Community Engaged Comprehensive, Multi-Faceted Nutrition Quality Improvement Program

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07524907
Acronym
STRIKE
Enrollment
158
Registered
2026-04-13
Start date
2026-05-11
Completion date
2028-01-01
Last updated
2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition (Calorie)

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

Abbott Nutrition
Lead SponsorINDUSTRY
Children International
CollaboratorUNKNOWN

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Program FeasibilityBaseline to 12 monthsCaregiver 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 AnthropometricsBaseline to 3, 6, 9, and 12 monthsChange 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

MeasureTime frameDescription
Healthcare Resource UtilizationBaseline, 6 and 12 monthsCaregiver 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 InventoryBaseline, 6, and 12 monthsA 23-item questionnaire rated 0 to 4 where higher scores indicate better health-related quality of life
World Health Organization Quality of Life Brief VersionBaseline, 6, and 12 monthsA 26-item caregiver completed questionnaire scored 0 to 100 where higher scores indicate higher quality of life
Nutrient IntakeBaseline, 3, 6, 9, and 12 monthsCaregiver completed 24-hour dietary recall
Pediatric Nutrition Risk Status via AnthropometricsBaseline, 3, 6, 9, and 12 monthsCalculated from anthropometrics measurements as compared to established standards

Countries

United States

Contacts

CONTACTChristina Becherer Children International
cbecherer@children.org207-592-4917
STUDY_CHAIRAmy Sharn, MS, RDN, LD

Abbott

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026