- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03297970
Bogota School Children Cohort (BoSCCo)
September 28, 2017 updated by: Eduardo Villamor, University of Michigan
This observational study investigates the associations of nutritional indicators, biomarkers, sociodemographic conditions, and infections with child health, as well as physical, behavioral, and cognitive development.
Investigators recruited a random sample of 3202 children from primary public schools in Bogota, Colombia in February 2006 and followed them for a median of 6.5 years.
Investigators hypothesized that poor nutritional status at the time of recruitment in middle childhood would be related to adverse health outcomes through adolescence.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
3202
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bogota, Colombia
- FINUSAD - Foundation for Research in Nutrition and Health
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Chia, Colombia
- University of La Sabana
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 12 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Children were selected from primary public schools in Bogota, Colombia.
Description
Inclusion Criteria:
- Primary public school enrollment in February 2006
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Bogota School Children Cohort
Children are classified according to exposure levels of: Micronutrient biomarker indicators:
Serum fatty acids Inflammatory biomarkers:
Diet Socioeconomic status indicators Anthropometric indicators Incidence of infectious morbidity symptoms DNA biomarkers |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Externalizing behavior problems
Time Frame: Assessed at one point in time when the children were 11-18 years old.
|
Adolescent behavior problems were ascertained with the Youth Self Report (YSR) questionnaire.
The YSR is a self-administered questionnaire consisting of 112 statements addressing behaviors or feelings that adolescents rate as false, sometimes true, or very/often true.
From responses to these questions, an Assessment Data Manager (ADM) software calculates continuous scores for aggressive behavior and rule breaking behavior.
The sum of the aggressive and rule breaking behavior subscale scores constitute the total externalizing problems score.
|
Assessed at one point in time when the children were 11-18 years old.
|
Internalizing behavior problems
Time Frame: Assessed at one point in time when the children were 11-18 years old.
|
Adolescent behavior problems were ascertained with the Youth Self Report (YSR) questionnaire.
The sum of the anxious/depressed, withdrawn/depressed, and somatic complaint subscale scores constitute the total internalizing problems score.
|
Assessed at one point in time when the children were 11-18 years old.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavior problem subscale scores (aggressive behavior, rule breaking behavior, anxious/depressed, withdrawn/depressed, somatic complaints, attention problems, social problems, and thought problems)
Time Frame: Assessed at one point in time when the children were 11-18 years old.
|
Adolescent behavior problems were ascertained with the Youth Self Report (YSR) questionnaire.
|
Assessed at one point in time when the children were 11-18 years old.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body mass index change
Time Frame: Median 6.5 years from recruitment
|
Change in body mass index for age Z-score from baseline to the last follow-up visit
|
Median 6.5 years from recruitment
|
Linear growth
Time Frame: Median 6.5 years from recruitment
|
Change in height for age Z-score from baseline to the last follow-up visit
|
Median 6.5 years from recruitment
|
Age at menarche
Time Frame: Median 6.5 years from recruitment
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Reported age at first menstrual period
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Median 6.5 years from recruitment
|
Grade repetition
Time Frame: 5 years
|
Outcome of school grades between 2006-2011
|
5 years
|
Blood pressure
Time Frame: Median 6.5 years from recruitment
|
Median 6.5 years from recruitment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eduardo Villamor, MD MPH DrPH, University of Michigan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2006
Primary Completion (Actual)
August 11, 2015
Study Completion (Actual)
August 11, 2015
Study Registration Dates
First Submitted
September 26, 2017
First Submitted That Met QC Criteria
September 28, 2017
First Posted (Actual)
September 29, 2017
Study Record Updates
Last Update Posted (Actual)
September 29, 2017
Last Update Submitted That Met QC Criteria
September 28, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00043252
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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