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OpenTrials
Completed

NCT Number: NCT06709001

An Observational Study to Assess Malnutrition Risk

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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Key information

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children International

Kansas City, Missouri, 64121, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Anthropometrics - Height/Length

    Time frame: Baseline, 3 Months and 6 Months

    Measured in cm

  2. Anthropometrics - Mid-Upper Arm Circumference (MUAC)

    Time frame: Baseline, 3 Months and 6 Months

    Measured in mm

Secondary outcomes

  1. Anthropometrics - Weight

    Time frame: Baseline, 3 Months and 6 Months

    Measured in kg

  2. Anthropometrics - Head Circumference

    Time frame: Baseline, 3 Months and 6 Months

    Measured in cm

  3. Nutrient Intake

    Time frame: Baseline and 6 Months

    Caregiver completed 24-hour dietary recall

  4. Pediatric Quality of Life Inventory

    Time frame: Baseline and 6 Months

    A 23-item questionnaire rated 0 to 4 where higher scores indicate better health-related quality of life

  5. World Health Organization Quality of Life Brief Version

    Time frame: Baseline and 6 Months

    a 26-item caregiver completed questionnaire scored 0 to 100 where higher scores indicate higher quality of life

  6. Healthcare Resource Utilization

    Time frame: 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.

Other outcomes

  1. Focus Groups with NGOs, Caregivers, CHWs, PHPs

    Time frame: Baseline, 3 Months and 6 Months

    Nutrition program feasibility discussion related to nutrition screening and program participation

  2. Staff Insights Questionnaire

    Time frame: 6 Months

    A non-statistical 6-item questionnaire completed by the NGO Staff to obtain feedback on their experience with nutrition screening

  3. Process Outcomes

    Time frame: Baseline, 3 Months and 6 Months

    Enrollment and adherence to nutrition program

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Collaborators

  • Children International

Registry information

Official study title

CROSS: Colombia's Potential Realized: an Observational Study for Stunting

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2024
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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