Stunting and Targeting Reduction of Impaired Growth in Kids Effectively
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
- Malnutrition (Calorie)
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
| Arm | Description | Assigned Intervention |
|---|---|---|
| Household | Includes eligible Children and their Caregivers | |
| Organization | NGO Staff |
Recruiting Locations
Kansas City, Missouri 64121
More Details
- Status
- Recruiting
- Sponsor
- Abbott Nutrition