RecruitingNCT07524907STRIKEUpdated Jul 24, 2026

Stunting and Targeting Reduction of Impaired Growth in Kids Effectively

An observational study in Malnutrition (Calorie), sponsored by Abbott Nutrition. Recruiting at 1 site in United States. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by Abbott Nutrition · Observational

Study type: Observational
Model: Ecologic or community
Time perspective: Prospective
Enrollment: 158
Ages: 1 Year to 5 Years
Sex: All

Study 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 studied

Malnutrition (Calorie)

Browse trials for

Malnutrition 1,585

Who can participate

Ages eligible: 1 Year to 5 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

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

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

Study design

Observational model: Ecologic or community
Time perspective: Prospective
Enrollment: 158 participants (estimated)
Patient registry: No

Groups and cohorts

Household
Includes eligible Children and their Caregivers
Organization
NGO Staff

What researchers measure

Primary outcomes

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
Time frame: 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)
Time frame: Baseline to 3, 6, 9, and 12 months

Secondary outcomes

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.
Time frame: 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
Time frame: 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
Time frame: Baseline, 6, and 12 months
Nutrient Intake
Caregiver completed 24-hour dietary recall
Time frame: Baseline, 3, 6, 9, and 12 months
Pediatric Nutrition Risk Status via Anthropometrics
Calculated from anthropometrics measurements as compared to established standards
Time frame: Baseline, 3, 6, 9, and 12 months

Other outcomes

Nutrition Behavior
Parent completed 35-item questionnaire, where higher scores indicate higher levels for that specific eating behavior
Time frame: 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.
Time frame: 12 Months
Nutrition Program Enrollment and Adherence
Enrollment and adherence to the nutrition program
Time frame: 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.
Time frame: 12 Months

Study locations

1 of 1 sites recruiting

Children International
Kansas City, Missouri 64121, United States
Recruiting

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT07524907
Lead sponsor: Abbott Nutrition
Collaborators: Children International
Responsible party: Sponsor
First posted: Apr 13, 2026
Start date: May 11, 2026
Primary completion: Jan 2028 (estimated)
Completion: Jan 2028 (estimated)
Last update: Jul 24, 2026

Study contacts

Christina Becherer Children International

Contact

cbecherer@children.org

207-592-4917

Amy Sharn, MS, RDN, LD

study chair · Abbott

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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