LIFE Child (LIFE Leipzig Research Centre for Civilization Diseases)

Child Development Clinical Trial

Official title:

Prospective Population-based Childhood Cohort Study in the Leipzig Area Investigating Genetic, Environmental, and Metabolic Factors and Their Association With the Development of Civilization Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02550236
• Other study ID #: LIFE Child Leipzig
• Status: Recruiting
• Start date: October 2010
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: University of Leipzig
• Contact: Antje Körner, Prof., MD
• Email: antje.koerner[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Leipzig Research Centre for Civilization Diseases (LIFE) Child Study is a prospective longitudinal population-based study with a life course approach to health and disease.

The LIFE Child Study focuses on two main research objectives:

• What are premises of normal growth, development and health in children?

• Which factors contribute to the development of non-communicable diseases such as childhood obesity and its co-morbidities, atopy and mental health problems?

Detailed assessments will be conducted alongside long-term storage of biological samples in 1,000 pregnant women and more than 5,000 children and their families.

Description:

• The LIFE Child study is part of LIFE, a life sciences research program of the University of Leipzig (Leipzig Research Centre for Civilization Diseases - LIFE). The measurements are performed in a well-equipped research centre located on the premises of the University Hospital of Leipzig.

• The study collects detailed information from clinical examinations, questionnaires and interviews and includes a collection of several types of biological materials at various time points (urine, stool, hair, blood for direct analyses, genomic DNA, dried blood spots, paxgenes (for RNA isolation and expression/eQTL studies). Children and adolescents from 0 to 20 years at baseline and their families are included. Participants are followed annually over a period of several years irrespective of the age at the first participation in the study until they reach the age of 20.

• Prenatal examinations are conducted in the 24th and 36th week of gestation and postnatal examinations in the 3rd, 6th and 12th month in the offspring. The birth cohort study collects detailed information from clinical examinations, questionnaires and interviews and biological materials (blood, cord blood, placental tissue, breast milk, hair, urine and stool)

• In addition, the LIFE Child study focuses in the disease cohort LIFE Child OBESITY and disease free controls in more detail. The aim of these subgroups is to examine aetiological associations and comorbidities with more in-depth methods.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7000
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years to 20 Years

Eligibility

Inclusion Criteria:

• children with their families and pregnant women of the area of Leipzig

Exclusion Criteria:

• severe diseases

Related Conditions & MeSH terms

• Child Development

Locations

Country	Name	City	State
Germany	LIFE Leipzig Research Centre for Civilization Diseases, University of Leipzig	Leipzig	Saxony

Sponsors (7)

Lead Sponsor	Collaborator
University of Leipzig	European Regional Development Fund, European Social Fund, Free State of Saxony, Helmholtz Center for Environmental Research Leipzig, Leipzig Research Center for Early Child Development, Robert Koch Institute Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Civilization diseases and their risk factors	Assess lifestyle, metabolic and genetic risk factors of civilization diseases (e.g. diabetes mellitus, obesity, allergy, cardiovascular diseases) from fetal life to adulthood.	20 years

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