Purpose

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.

Condition

Eligibility

Eligible Ages
Between 1 Year and 5 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Ecologic or Community
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Household Includes eligible Children and their Caregivers
Organization NGO Staff

Recruiting Locations

Children International
Kansas City, Missouri 64121

More Details

Status
Recruiting
Sponsor
Abbott Nutrition

Study Contact

Christina Becherer Children International
207-592-4917
cbecherer@children.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.