An Observational Study to Assess Malnutrition Risk

NCT06709001 | Completed

• 1 other identifier: HA70
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (2)

• Anthropometrics - Height/Length

  Measured in cm

  Baseline, 3 Months and 6 Months

• Anthropometrics - Mid-Upper Arm Circumference (MUAC)

  Measured in mm

  Baseline, 3 Months and 6 Months

Secondary Outcomes (6)

• Anthropometrics - Weight

  Baseline, 3 Months and 6 Months

• Anthropometrics - Head Circumference

  Baseline, 3 Months and 6 Months

• Nutrient Intake

  Baseline and 6 Months

• Pediatric Quality of Life Inventory

  Baseline and 6 Months

• World Health Organization Quality of Life Brief Version

  Baseline and 6 Months

Other Outcomes (3)

• Focus Groups with NGOs, Caregivers, CHWs, PHPs

  Baseline, 3 Months and 6 Months

• Staff Insights Questionnaire

  6 Months

• Process Outcomes

  Baseline, 3 Months and 6 Months

Study Arms (2)

Quantitative - Children assessed for Malnutrition Risk

Children living in under-resourced communities

Qualitative - NGOs, Caregivers, CHWs, and PHPs

Involved in the study as a staff or caregiver or have experience with pediatric malnutrition

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Between 2-4 under-resourced communities within Colombia

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Abbott Nutrition: lead
• Children International: collaborator

Study Sites (1)

Children International

Kansas City, Missouri, 64121, United States

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Amy Sharn, MS, RDN, LD

  Abbott

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: December 9, 2024
• Primary Completion: July 25, 2025
• Study Completion: July 25, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)