LIFE Leipzig Research Centre for Civilization Diseases

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Child Development

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children with their families and pregnant women of the area of Leipzig Exclusion Criteria: severe diseases

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LIFE Child Health<br>The LIFE Child HEALTH cohort is a sample of 5.000 children and adolescents. A basic program that will be carried out annually at each study centre visit. This program includes clinical history (perinatal and past medical history, medications, allergies, immunizations, developmental history and family history) clinical examination, collection of blood, hair, stool and urine samples, anthropometry and different age-dependent questionnaires. Questionnaires are completed by the parents and starting at the age of nine years also by the child itself. | |
| LIFE Child Obesity<br>The LIFE Child OBESITY cohort is a sample of 500 obese children and adolescents that will be assessed and compared to a lean control group (N=500) with equally detailed phenotyping including metabolic and cardiovascular evaluation. The LIFE Child OBESITY cohort (including the control group) performs the basic program of the LIFE Child HEALTH cohort plus additional parameters such as electrical bioimpedance, assessment of basal metabolic rate, oral glucose tolerance test, liver elastography, spirometry and actigraphy. | |
| LIFE Child Health: Pregnancy/Birth<br>The LIFE child Pregnancy/Birth cohort is a sample of 1,000 pregnant women and their offspring. Prenatal examinations are conducted during the 24th to 26th and 34th to 36th week of gestation. During the first year of life, data is collected from children at 3, 6 and 12 month of age. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Pregnancy, Growth, Lifestyle, Metabolic and cardiovascular health, Birth, Development, Reference Values