Recruiting

Nutrition Program

Sponsor:

Abbott Nutrition

Code:

NCT07524907

Conditions

Malnutrition (Calorie)

Eligibility Criteria

Sex: All

Age: 1 - 5

Healthy Volunteers: Not accepted

Study Details

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)

Study ID

NCT07524907

Start date

May 11, 2026

Status verified date

Jul, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 5

Healthy Volunteers: Not accepted

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

Enrollment

158 participants

Anticipated

Interventions and Outcome Measures

Arms

Household

Includes eligible Children and their Caregivers

Organization

NGO Staff

Primary outcome measure

  • Program Feasibility [ Time Frame: Baseline to 12 months ]
  • Growth Anthropometrics [ Time Frame: Baseline to 3, 6, 9, and 12 months ]

Central Contacts and Locations

Central contacts

Christina Becherer Children International

207-592-4917cbecherer@children.org

Locations

Children International

Recruiting

Kansas City, Missouri, United States, 64121

More Information

Sponsor

Abbott Nutrition

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Abbott Nutrition on 2026-07-24.