Stunting and Targeting Reduction of Impaired Growth in Kids Effectively (STRIKE)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Malnutrition (Calorie)

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Christina Becherer Children International; Phone Number: 207-592-4917; Email: cbecherer@children.org

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64121
      • Children International

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Via screening by existing community-based programming via Children International (NGO)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Household; Includes eligible Children and their Caregivers
Organization; NGO Staff

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Program Feasibility	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	Baseline to 12 months
Growth Anthropometrics	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)	Baseline to 3, 6, 9, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare Resource Utilization	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.	Baseline, 6 and 12 months
Pediatric Quality of Life Inventory	A 23-item questionnaire rated 0 to 4 where higher scores indicate better health-related quality of life	Baseline, 6, and 12 months
World Health Organization Quality of Life Brief Version	A 26-item caregiver completed questionnaire scored 0 to 100 where higher scores indicate higher quality of life	Baseline, 6, and 12 months
Nutrient Intake	Caregiver completed 24-hour dietary recall	Baseline, 3, 6, 9, and 12 months
Pediatric Nutrition Risk Status via Anthropometrics	Calculated from anthropometrics measurements as compared to established standards	Baseline, 3, 6, 9, and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutrition Behavior	Parent completed 35-item questionnaire, where higher scores indicate higher levels for that specific eating behavior	Baseline, 6, and 12 months
Staff Experience Survey	Assesses caregiver experience, satisfaction, and recommendations for improvement regarding the nutrition program using a combination of closed- and open-ended questions. Closed-ended questions will use Likert-scale responses ranging from strongly disagree to strongly agree.	12 Months
Nutrition Program Enrollment and Adherence	Enrollment and adherence to the nutrition program	12 Months
Caregiver Experience Survey	Assesses caregiver experience, satisfaction, and recommendations for improvement regarding the nutrition program using a combination of closed- and open-ended questions in addition to the Net Promoter Score (NPS). Closed-ended questions will use Likert-scale responses ranging from strongly disagree to strongly agree or very unsatisfied to very satisfied.	12 Months

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Collaborators: Children International
• Investigators: Study Chair: Amy Sharn, MS, RDN, LD, Abbott

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Nutritional and Metabolic Diseases; Malnutrition
• Other Study ID Numbers: HA65

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No