Stunting and Targeting Reduction of Impaired Growth in Kids Effectively

NCT07524907 | Not Yet Recruiting

• 1 other identifier: HA65
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition (Calorie)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Healthcare Resource Utilization

  Baseline, 6 and 12 months

• Pediatric Quality of Life Inventory

  Baseline, 6, and 12 months

• World Health Organization Quality of Life Brief Version

  Baseline, 6, and 12 months

• Nutrient Intake

  Baseline, 3, 6, 9, and 12 months

• Pediatric Nutrition Risk Status via Anthropometrics

  Baseline, 3, 6, 9, and 12 months

Other Outcomes (4)

• Nutrition Behavior

  Baseline, 6, and 12 months

• Staff Experience Survey

  12 Months

• Nutrition Program Enrollment and Adherence

  12 Months

Study Arms (2)

Household

Includes eligible Children and their Caregivers

Organization

NGO Staff

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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
• NGO staff taking part in nutrition screenings
• Agrees to participate in survey
• Not involved in the implementation of the study
• Not involved in working with pediatric stunting or its risk

Sponsors & Collaborators

• Abbott Nutrition: lead
• Children International: collaborator

Study Sites (1)

Children International

Kansas City, Missouri, 64121, United States

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Amy Sharn, MS, RDN, LD

  Abbott

  STUDY CHAIR

Central Study Contacts

Christina Becherer Children International

CONTACT

207-592-4917; cbecherer@children.org

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 13, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)