Clinical trial NCT06709001: An Observational Study to Assess Malnutrition Risk
Official title: CROSS: Colombia's Potential Realized: an Observational Study for Stunting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malnutrition
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
Collaborators: name: Children International
First posted: 2024-11-29
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Between 2-4 under-resourced communities within Colombia

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.


Eligibility 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

Primary outcomes:
measure: Anthropometrics - Height/Length
timeFrame: Baseline, 3 Months and 6 Months
measure: Anthropometrics - Mid-Upper Arm Circumference (MUAC)
timeFrame: Baseline, 3 Months and 6 Months
Secondary outcomes:
measure: Anthropometrics - Weight
timeFrame: Baseline, 3 Months and 6 Months
measure: Anthropometrics - Head Circumference
timeFrame: Baseline, 3 Months and 6 Months
measure: Nutrient Intake
timeFrame: Baseline and 6 Months
measure: Pediatric Quality of Life Inventory
timeFrame: Baseline and 6 Months
measure: World Health Organization Quality of Life Brief Version
timeFrame: Baseline and 6 Months
measure: Healthcare Resource Utilization
timeFrame: Baseline and 6 Months
Other outcomes:
measure: Focus Groups with NGOs, Caregivers, CHWs, PHPs
timeFrame: Baseline, 3 Months and 6 Months
measure: Staff Insights Questionnaire
timeFrame: 6 Months
measure: Process Outcomes
timeFrame: Baseline, 3 Months and 6 Months
Locations:
city: Kansas City
country: United States
facility: Children International
state: Missouri
Study officials:
affiliation: Abbott
name: Amy Sharn, MS, RDN, LD
role: STUDY_CHAIR
References: