MalnutritionNCT06709001
An Observational Study to Assess Malnutrition Risk
An observational study of Malnutrition, run by Abbott Nutrition at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Malnutrition
- How many people
- 206 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2024to 25 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Between 2-4 under-resourced communities within Colombia
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 locations and contacts
1 site in 1 country.
About this study
Official title: CROSS: Colombia's Potential Realized: an Observational Study for Stunting
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.
- Conditions
- Malnutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometrics - Height/Length
Measured in cm
Measured: Baseline, 3 Months and 6 Months
Anthropometrics - Mid-Upper Arm Circumference (MUAC)
Measured in mm
Measured: Baseline, 3 Months and 6 Months
Secondary outcomes (6)
Anthropometrics - Weight
Measured in kg
Measured: Baseline, 3 Months and 6 Months
Anthropometrics - Head Circumference
Measured in cm
Measured: Baseline, 3 Months and 6 Months
Nutrient Intake
Caregiver completed 24-hour dietary recall
Measured: Baseline and 6 Months
Pediatric Quality of Life Inventory
A 23-item questionnaire rated 0 to 4 where higher scores indicate better health-related quality of life
Measured: Baseline and 6 Months
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
Measured: Baseline and 6 Months
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.
Measured: Baseline and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start9 Dec 2024
- Primary completion25 Jul 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children International
- Responsible party
- Sponsor
- Investigators
- Amy Sharn, MS, RDN, LD, Study chair, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709001
- Sponsor's protocol ID
- HA70
- Status last verified
- Sep 2025
- First submitted
- 26 Nov 2024
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CROSS: Colombia's Potential Realized: an Observational Study for Stunting
- ClinicalTrials.gov ID
- NCT06709001
- Acronym / sponsor ID
- HA70
- Conditions
- Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Collaborators
- Children International
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Between 2-4 under-resourced communities within Colombia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anthropometrics - Height/Length
Time frame: Baseline, 3 Months and 6 Months
Measured in cm
Anthropometrics - Mid-Upper Arm Circumference (MUAC)
Time frame: Baseline, 3 Months and 6 Months
Measured in mm
6 secondary outcomes
Anthropometrics - Weight
Time frame: Baseline, 3 Months and 6 Months
Anthropometrics - Head Circumference
Time frame: Baseline, 3 Months and 6 Months
Nutrient Intake
Time frame: Baseline and 6 Months
Pediatric Quality of Life Inventory
Time frame: Baseline and 6 Months
World Health Organization Quality of Life Brief Version
Time frame: Baseline and 6 Months
Healthcare Resource Utilization
Time frame: Baseline and 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Sharn, MS, RDN, LD study chair
Abbott
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by Abbott Nutrition at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometrics - Height/Length (time frame: Baseline, 3 Months and 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.