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NCT Number: NCT07524907

Stunting and Targeting Reduction of Impaired Growth in Kids Effectively

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.

Recruiting

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Key information

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children International

Kansas City, Missouri, 64121, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Program Feasibility

    Time frame: Baseline to 12 months

    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

  2. Growth Anthropometrics

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

    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)

Secondary outcomes

  1. Healthcare Resource Utilization

    Time frame: Baseline, 6 and 12 months

    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.

  2. Pediatric Quality of Life Inventory

    Time frame: Baseline, 6, and 12 months

    A 23-item questionnaire rated 0 to 4 where higher scores indicate better health-related quality of life

  3. World Health Organization Quality of Life Brief Version

    Time frame: Baseline, 6, and 12 months

    A 26-item caregiver completed questionnaire scored 0 to 100 where higher scores indicate higher quality of life

  4. Nutrient Intake

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

    Caregiver completed 24-hour dietary recall

  5. Pediatric Nutrition Risk Status via Anthropometrics

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

    Calculated from anthropometrics measurements as compared to established standards

Other outcomes

  1. Nutrition Behavior

    Time frame: Baseline, 6, and 12 months

    Parent completed 35-item questionnaire, where higher scores indicate higher levels for that specific eating behavior

  2. Staff Experience Survey

    Time frame: 12 Months

    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.

  3. Nutrition Program Enrollment and Adherence

    Time frame: 12 Months

    Enrollment and adherence to the nutrition program

  4. Caregiver Experience Survey

    Time frame: 12 Months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Becherer Children International

CONTACT

[email protected]

207-592-4917

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Collaborators

  • Children International

Registry information

Official study title

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

Acronym: STRIKE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 13, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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