An Observational Study to Assess Malnutrition Risk

Abbott

Status: Completed

Conditions: Malnutrition

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06709001

HA70

Details and patient eligibility

About

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.

Enrollment: 206 patients

Sex: All

Ages: 1 to 5 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Quantitative 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

Trial design

206 participants in 2 patient groups

Quantitative - Children assessed for Malnutrition Risk

Description:

Children living in under-resourced communities

Qualitative - NGOs, Caregivers, CHWs, and PHPs

Description:

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