Clinical trial NCT02550236: LIFE Child (LIFE Leipzig Research Centre for Civilization Diseases)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Child Development
Keywords: Children
Pregnancy
Growth
Lifestyle
Metabolic and cardiovascular health
Birth
Development
Reference Values
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: European Social Fund
name: European Regional Development Fund
name: Free State of Saxony
name: Helmholtz Center for Environmental Research Leipzig
name: Leipzig Research Center for Early Child Development
name: Robert Koch Institute Berlin
First posted: 2015-09-15
Enrollment: 7000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The LIFE Child study is a prospective longitudinal population-based cohort study. All children with their families and pregnant women of the area of Leipzig are eligible to participate in the LIFE Child study. This sample is supposed to represent the population of the city.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* severe diseases

Primary outcomes:
measure: Civilization diseases and their risk factors
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: LIFE Leipzig Research Centre for Civilization Diseases, University of Leipzig
state: Saxony
Study officials:
affiliation: University of Leipzig
name: Antje Körner, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schild CE, Meigen C, Kappelt J, Kiess W, Poulain T. Associations between sociodemographic and behavioural parameters and child development depending on age and sex: a cross-sectional analysis. BMJ Open. 2022 Nov 2;12(11):e065936. doi: 10.1136/bmjopen-2022-065936.
citation: Kiess A, Green J, Willenberg A, Ceglarek U, Dahnert I, Jurkutat A, Korner A, Hiemisch A, Kiess W, Vogel M. Age-Dependent Reference Values for hs-Troponin T and NT-proBNP and Determining Factors in a Cohort of Healthy Children (The LIFE Child Study). Pediatr Cardiol. 2022 Jun;43(5):1071-1083. doi: 10.1007/s00246-022-02827-x. Epub 2022 Mar 12.
citation: Hovestadt I, Kiess W, Lewien C, Willenberg A, Poulain T, Meigen C, Korner A, Vogel M. HbA1c percentiles and the association between BMI, age, gender, puberty, and HbA1c levels in healthy German children and adolescents. Pediatr Diabetes. 2022 Mar;23(2):194-202. doi: 10.1111/pedi.13297. Epub 2021 Dec 20.
citation: Menzel P, Vogel M, Austin S, Sprenger N, Grafe N, Hilbert C, Jurkutat A, Kiess W, Binia A. Concentrations of oligosaccharides in human milk and child growth. BMC Pediatr. 2021 Oct 30;21(1):481. doi: 10.1186/s12887-021-02953-0.
citation: Ziegelasch N, Vogel M, Korner A, Koch E, Jurkutat A, Ceglarek U, Dittrich K, Kiess W. Cystatin C relates to metabolism in healthy, pubertal adolescents. Pediatr Nephrol. 2022 Feb;37(2):423-432. doi: 10.1007/s00467-021-05209-2. Epub 2021 Aug 25.
citation: Surup H, Vogel M, Koerner A, Hiemisch A, Oelkers L, Willenberg A, Kiess W, Kratzsch J. Pediatric Reference Intervals for Thyrotropin, Free Triiodothyronine, and Free Thyroxine and the Relevance of Body Mass Index and Puberty in Measurement Interpretation. Thyroid. 2021 Aug;31(8):1192-1202. doi: 10.1089/thy.2020.0780. Epub 2021 Jun 21.
citation: Michel L, Shevlyakova M, Ni Cleirigh E, Eckhardt E, Holvoet S, Nutten S, Sprenger N, Korner A, Vogel M, Nembrini C, Kiess W, Blanchard C. Novel approach to visualize the inter-dependencies between maternal sensitization, breast milk immune components and human milk oligosaccharides in the LIFE Child cohort. PLoS One. 2020 Apr 21;15(4):e0230472. doi: 10.1371/journal.pone.0230472. eCollection 2020.
citation: Dathan-Stumpf A, Vogel M, Jank A, Thiery J, Kiess W, Stepan H. Reference intervals of serum lipids in the second and third trimesters of pregnancy in a Caucasian cohort: the LIFE Child study. Arch Gynecol Obstet. 2019 Dec;300(6):1531-1539. doi: 10.1007/s00404-019-05342-2. Epub 2019 Oct 30.
citation: Haas M, Hiemisch A, Vogel M, Wagner O, Kiess W, Poulain T. Sensation seeking in 3- to 6-year-old children: associations with socio-demographic parameters and behavioural difficulties. BMC Pediatr. 2019 Mar 11;19(1):77. doi: 10.1186/s12887-019-1450-6.
citation: Ziegelasch N, Vogel M, Muller E, Tremel N, Jurkutat A, Loffler M, Terliesner N, Thiery J, Willenberg A, Kiess W, Dittrich K. Cystatin C serum levels in healthy children are related to age, gender, and pubertal stage. Pediatr Nephrol. 2019 Mar;34(3):449-457. doi: 10.1007/s00467-018-4087-z. Epub 2018 Nov 20.
citation: Poulain T, Peschel T, Vogel M, Jurkutat A, Kiess W. Cross-sectional and longitudinal associations of screen time and physical activity with school performance at different types of secondary school. BMC Public Health. 2018 Apr 27;18(1):563. doi: 10.1186/s12889-018-5489-3.
citation: Rieger K, Vogel M, Engel C, Ceglarek U, Harms K, Wurst U, Lengfeld H, Richter M, Kiess W. Does physiological distribution of blood parameters in children depend on socioeconomic status? Results of a German cross-sectional study. BMJ Open. 2018 Mar 1;8(3):e019143. doi: 10.1136/bmjopen-2017-019143.