Bogota School Children Cohort

Nutrition Clinical Trial

— BoSCCo  

Official title:

Bogota School Children Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03297970
• Other study ID #: HUM00043252
• Status: Completed
• Phase: N/A
• First received: September 26, 2017
• Last updated: September 28, 2017
• Start date: February 1, 2006
• Est. completion date: August 11, 2015

Study information

• Verified date: September 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3202
• Est. completion date: August 11, 2015
• Est. primary completion date: August 11, 2015
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• Primary public school enrollment in February 2006

Exclusion Criteria:

Related Conditions & MeSH terms

• Behavior Problem
• Child Growth
• Child Health
• Infectious Morbidity
• Neurocognitive Development
• Nutrition
• Problem Behavior
• Sexual Maturation

Locations

Country	Name	City	State
Colombia	FINUSAD - Foundation for Research in Nutrition and Health	Bogota
Colombia	University of La Sabana	Chia

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	Foundation for Research in Nutrition and Health (FINUSAD), Universidad de la Sabana

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body mass index change	Change in body mass index for age Z-score from baseline to the last follow-up visit	Median 6.5 years from recruitment
Other	Linear growth	Change in height for age Z-score from baseline to the last follow-up visit	Median 6.5 years from recruitment
Other	Age at menarche	Reported age at first menstrual period	Median 6.5 years from recruitment
Other	Grade repetition	Outcome of school grades between 2006-2011	5 years
Other	Blood pressure		Median 6.5 years from recruitment
Primary	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.
Primary	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	Behavior problem subscale scores (aggressive behavior, rule breaking behavior, anxious/depressed, withdrawn/depressed, somatic complaints, attention problems, social problems, and thought problems)	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.