- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02550236
LIFE Child (LIFE Leipzig Research Centre for Civilization Diseases) (LIFE-Child)
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
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Antje Körner, Prof., MD
- Email: antje.koerner@medizin.uni-leipzig.de
Study Contact Backup
- Name: LIFE Child
- Email: lifechild@medizin.uni-leipzig.de
Study Locations
-
-
Saxony
-
Leipzig, Saxony, Germany, 04103
- Recruiting
- LIFE Leipzig Research Centre for Civilization Diseases, University of Leipzig
-
Contact:
- LIFE Child
- Email: lifechild@medizin.uni-leipzig.de
-
Contact:
- Antje Körner, Prof. MD
- Email: antje.koerner@medizin.uni-leipzig.de
-
Principal Investigator:
- Antje Körner, Prof.,MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- children with their families and pregnant women of the area of Leipzig
Exclusion Criteria:
- severe diseases
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Civilization diseases and their risk factors
Time Frame: 20 years
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Antje Körner, Prof., MD, University of Leipzig
Publications and helpful links
General Publications
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- LIFE Child Leipzig
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Child Development
-
Yale UniversityRobinhood Foundation; Adelphi University; Docs for TotsCompletedSocial Skills | Child Behavior | Child Development | Infant DevelopmentUnited States
-
University of Southern CaliforniaSafe Water and AIDS Project (SWAP); Early Childhood Development Network for...RecruitingChild Behavior | Child Development | Language, ChildKenya
-
Windward Islands Research and Education FoundationGrand Challenges Canada; St. George's University; GRENCASECompletedDevelopment, Child | Behavior, Child | Neurocognition, ChildGrenada
-
London School of Hygiene and Tropical MedicineInternational Centre for Diarrhoeal Disease Research, Bangladesh; University... and other collaboratorsActive, not recruitingChild Development | Child Development DisorderBangladesh, Tanzania, Nepal
-
Children's Hospital of PhiladelphiaNational Institute on Minority Health and Health Disparities (NIMHD)Active, not recruitingDevelopment Delay | Development, ChildUnited States
-
The Hospital for Sick ChildrenAga Khan University; March of DimesCompletedChild Development | Child Mortality | Child Morbidity | Child BehaviourPakistan
-
University Hospital, RouenRecruitingChild Development | Child Mental Disorder | Adolescent Behavior | Child Behavior Disorders | Behavior, Child | Adolescent Development | Adolescent - Emotional Problem | Child Development DisorderFrance
-
O-KidiaRecruitingChild Development | Child Development DisorderFrance
-
International Centre for Diarrhoeal Disease Research...UnknownChild Behavior | Child DevelopmentBangladesh
-
Boston Medical CenterCenter for the Study of Social PolicyCompletedChild Abuse | Parenting | Child Development | Child Rearing | Child NeglectUnited States