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

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
      • Chia, Colombia
        • University of La Sabana

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:

  • Ferritin
  • Hemoglobin
  • Mean corpuscular volume
  • Zinc
  • Vitamin A
  • Vitamin B12
  • Folate
  • Vitamin D

Serum fatty acids

Inflammatory biomarkers:

  • C-reactive protein

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
Reported age at first menstrual period
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.

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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