NCT02550236

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,000

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Oct 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Oct 2010Dec 2026

Study Start

First participant enrolled

October 1, 2010

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2014

Completed
9 months until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 4, 2024

Status Verified

February 1, 2024

Enrollment Period

16.2 years

First QC Date

December 15, 2014

Last Update Submit

February 29, 2024

Conditions

Keywords

ChildrenPregnancyGrowthLifestyleMetabolic and cardiovascular healthBirthDevelopmentReference Values

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

LIFE Child Health

The LIFE Child HEALTH cohort is a sample of over 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 ten years also by the child itself.

LIFE Child Obesity

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 and spirometry.

LIFE Child Health: Pregnancy/Birth

The LIFE child Pregnancy/Birth cohort is a sample of over 1,200 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.

Eligibility Criteria

Age0 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • severe diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LIFE Leipzig Research Centre for Civilization Diseases, University of Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

Related Publications (17)

  • Poulain T, Schmidt R, Kiess W, Krause S, Golz S, Meigen C. Performance on an attention test is positively related to reading but negatively related to watching TV and playing video games in children. BMC Pediatr. 2025 Oct 28;25(1):872. doi: 10.1186/s12887-025-06260-w.

  • Durgen P, Wolfle PJ, Ceglarek U, Kratzsch J, Kiess W, Vogel M. New sex hormone-binding globulin and estimated free testosterone reference intervals for children and adolescents: The effects of age, sex, BMI and oral contraceptives. Clin Chim Acta. 2026 Jan 15;579:120621. doi: 10.1016/j.cca.2025.120621. Epub 2025 Sep 25.

  • von Heimburg P, Baber R, Willenberg A, Wolfle P, Kratzsch J, Kiess W, Vogel M. Effect of sex, pubertal stage, body mass index, oral contraceptive use, and C-reactive protein on vitamin D binding protein reference values. Front Endocrinol (Lausanne). 2025 Feb 18;16:1470513. doi: 10.3389/fendo.2025.1470513. eCollection 2025.

  • Gruning Parache L, Vogel M, Meigen C, Kiess W, Poulain T. Family structure, socioeconomic status, and mental health in childhood. Eur Child Adolesc Psychiatry. 2024 Jul;33(7):2377-2386. doi: 10.1007/s00787-023-02329-y. Epub 2023 Dec 26.

  • Wex I, Geserick M, Leibert T, Igel U, Sobek C, Meigen C, Kiess W, Vogel M. Active school transport in an urban environment:prevalence and perceived barriers. BMC Public Health. 2023 Mar 23;23(1):557. doi: 10.1186/s12889-023-15464-7.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

* blood samples for mRNA and DNA analysis * serum samples * plasma samples * serum samples from oral glucose tolerance testing * urine samples * stool samples * hair samples * mother's milk samples * cord blood samples * placenta samples * dental plaque samples * milk teeth samples

Study Officials

  • Antje Körner, Prof., MD

    University of Leipzig

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antje Körner, Prof., MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Antje Körner

Study Record Dates

First Submitted

December 15, 2014

First Posted

September 15, 2015

Study Start

October 1, 2010

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 4, 2024

Record last verified: 2024-02

Locations