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CompletedNCT06709001Updated Sep 10, 2025

An Observational Study to Assess Malnutrition Risk

An observational study in Malnutrition, sponsored by Abbott Nutrition. Completed at 1 site in United States. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2025-09-10.

Sponsored by Abbott Nutrition · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
206
Ages
1 Year to 5 Years
Sex
All
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Study 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.

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Conditions studied

  • Malnutrition

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In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 206 is close to the median of 203 across 388 observational studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Abbott Nutrition is the lead sponsor of 153 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Between 2-4 under-resourced communities within Colombia

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
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Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
206 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. Anthropometrics - Height/Length

    Measured in cm

    Time frame: Baseline, 3 Months and 6 Months

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

    Measured in mm

    Time frame: Baseline, 3 Months and 6 Months

Secondary outcomes

  1. Anthropometrics - Weight

    Measured in kg

    Time frame: Baseline, 3 Months and 6 Months

  2. Anthropometrics - Head Circumference

    Measured in cm

    Time frame: Baseline, 3 Months and 6 Months

  3. Nutrient Intake

    Caregiver completed 24-hour dietary recall

    Time frame: Baseline and 6 Months

  4. Pediatric Quality of Life Inventory

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

    Time frame: Baseline and 6 Months

  5. World Health Organization Quality of Life Brief Version

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

    Time frame: Baseline and 6 Months

  6. Healthcare Resource Utilization

    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.

    Time frame: Baseline and 6 Months

Other outcomes

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

    Nutrition program feasibility discussion related to nutrition screening and program participation

    Time frame: Baseline, 3 Months and 6 Months

  2. Staff Insights Questionnaire

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

    Time frame: 6 Months

  3. Process Outcomes

    Enrollment and adherence to nutrition program

    Time frame: Baseline, 3 Months and 6 Months

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Study locations

1 site
  • Children International
    Kansas City, Missouri 64121, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06709001
Lead sponsor
Abbott Nutrition
Collaborators
Children International
Responsible party
Sponsor
First posted
Nov 29, 2024
Start date
Dec 9, 2024
Primary completion
Jul 25, 2025
Completion
Jul 25, 2025
Last update
Sep 10, 2025

Study contacts

Amy Sharn, MS, RDN, LD
study chair · Abbott

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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