An Observational Study to Assess Malnutrition Risk

Recruiting

• Conditions: Malnutrition

• Registration Number: NCT06709001
• Lead Sponsor: Abbott Nutrition

Brief Summary

This is a prospective, observational study for assessing malnutrition risk and its characteristics among children aged 1 to 5 living in under-resourced communities in Colombia. There is also a qualitative component that seeks to gain caregiver, community health worker (CHW), public health professional (PHP), and non-for-profit organization (NGO) insights related to malnutrition risk.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Study First Posted: 2024-11-29
• Study Start: 2024-12-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-13
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Children aged 1-5 years
• Children's legal guardian agrees to participate in the study
• Full term pregnancy
• Residence in study area attending Children International (NGO) centers

Quantitative

Exclusion Criteria

• 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; 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 already enrolled in a nutrition program/intervention that includes a supplement

Qualitative Inclusion Criteria:

• NGO staff taking part in nutrition screenings
• Caregivers taking part in nutrition screenings as part of this study
• Community health workers (CHW) working with pediatric malnutrition risk
• Public health professionals (PHP) working with pediatric malnutrition risk
• Agrees to participate in focus group/survey

Qualitative Exclusion Criteria:

• Not involved in the implementation of the study
• Not involved in working with pediatric malnutrition risk
• Declines participation in focus group/survey

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anthropometrics - Height/Length	Baseline, 3 Months and 6 Months	Measured in cm
Anthropometrics - Mid-Upper Arm Circumference (MUAC)	Baseline, 3 Months and 6 Months	Measured in mm

Secondary Outcome Measures

Name	Time	Method
Anthropometrics - Weight	Baseline, 3 Months and 6 Months	Measured in kg
Anthropometrics - Head Circumference	Baseline, 3 Months and 6 Months	Measured in cm
Nutrient Intake	Baseline and 6 Months	Caregiver completed 24-hour dietary recall
Pediatric Quality of Life Inventory	Baseline and 6 Months	A 23-item questionnaire rated 0 to 4 where higher scores indicate better health-related quality of life
World Health Organization Quality of Life Brief Version	Baseline and 6 Months	a 26-item caregiver completed questionnaire scored 0 to 100 where higher scores indicate higher quality of life
Healthcare Resource Utilization	Baseline and 6 Months	Caregiver completed questionnaire to obtain illness frequency, severity and related missed school/work days. Higher frequency, severity and missed days associated with greater healthcare utilization.

Trial Locations

Locations (1)

Children International; 🇺🇸 Kansas City, Missouri, United States