NCT03297970

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,202

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2006

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2017

Completed
Last Updated

September 29, 2017

Status Verified

September 1, 2017

Enrollment Period

9.5 years

First QC Date

September 26, 2017

Last Update Submit

September 28, 2017

Conditions

NutritionChild HealthChild GrowthNeurocognitive DevelopmentSexual MaturationInfectious MorbidityBehavior Problem

Outcome Measures

Primary Outcomes (2)

  • Externalizing behavior problems

    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

    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 Outcomes (1)

  • Behavior problem subscale scores (aggressive behavior, rule breaking behavior, anxious/depressed, withdrawn/depressed, somatic complaints, attention problems, social problems, and thought problems)

    Assessed at one point in time when the children were 11-18 years old.

Other Outcomes (5)

  • Body mass index change

    Median 6.5 years from recruitment

  • Linear growth

    Median 6.5 years from recruitment

  • Age at menarche

    Median 6.5 years from recruitment

  • +2 more other outcomes

Study Arms (1)

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

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children were selected from primary public schools in Bogota, Colombia.

You may qualify if:

  • Primary public school enrollment in February 2006

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

FINUSAD - Foundation for Research in Nutrition and Health

Bogotá, Colombia

Location

University of La Sabana

Chía, Colombia

Location

Related Publications (1)

  • Robinson SL, Marin C, Oliveros H, Mora-Plazas M, Richards BJ, Lozoff B, Villamor E. Iron Deficiency, Anemia, and Low Vitamin B-12 Serostatus in Middle Childhood Are Associated with Behavior Problems in Adolescent Boys: Results from the Bogota School Children Cohort. J Nutr. 2018 May 1;148(5):760-770. doi: 10.1093/jn/nxy029.

    PMID: 29897579DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, serum, and DNA

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Eduardo Villamor, MD MPH DrPH

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 26, 2017

First Posted

September 29, 2017

Study Start

February 1, 2006

Primary Completion

August 11, 2015

Study Completion

August 11, 2015

Last Updated

September 29, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

CO(2)