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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03297970
Other study ID # HUM00043252
Secondary ID
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
Health authority
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
Accepts healthy volunteers
Gender All
Age group 5 Years to 12 Years
Eligibility Inclusion Criteria:

- Primary public school enrollment in February 2006

Exclusion Criteria:

Study Design


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.
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