An Observational Study to Assess Malnutrition Risk

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

206 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-09

Study Completion Date

2025-07-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Malnutrition

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Quantitative - Children assessed for Malnutrition Risk

Children living in under-resourced communities

No interventions assigned to this group

Qualitative - NGOs, Caregivers, CHWs, and PHPs

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

No interventions assigned to this group

Eligibility Criteria

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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

* 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

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

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

Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No