Dortmund Nutritional and Anthropometric Longitudinally Designed Study
Organizational Data
- DRKS-ID:
- DRKS00029092
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2022-06-09
- Last update in DRKS:
- 2024-02-16
- Registration type:
- Retrospective
Acronym/abbreviation of the study
DONALD Study
URL of the study
Brief summary in lay language
The DONALD study is a longitudinal study in which 30-40 infants from the Dortmund area have been recruited every year since 1985 and followed into adulthood. At the examination in the study center, which are usually conducted annually, the subjects are anthropometrically measured, medically examined and fill out questionnaires. Subsequently, a 3-day weighed dietary record is conducted at home and a 24-hour urine is collected from the age of 3-4 years.
Brief summary in scientific language
The DONALD study is an open cohort study in which 30-40 infants from the Dortmund area have been recruited each year since 1985 and followed into adulthood. Recruitment is non-systematic. The examinations are quarterly in the 1st year of life, semi-annually in the 2nd year, and annually thereafter. Since 2004, adult participants have also been invited to an examination every 5 years. At the examination appointments at the study center, subjects are anthropometrically measured (e.g., height, weight, skin folds), medically examined, and complete questionnaires (e.g., chronotype, physical activity). Subsequently, a 3-day weighed dietary record protocol is conducted at home (validated against nitrogen excretion in urine) and a 24h urine is collected from the age of 3-4 years. Blood is also drawn from the participants at the adult examinations. To date (as of the end of 2021), a total of 1.800 subjects have participated in the study, of which 24,000 anthropometric measurements, 18,000 dietary records, 10.000 24h urine samples and 1,200 blood samples are available. Since recruitment is continuous and there is no end date for the study, there is no planned number of study participants or measurements.
Health condition or problem studied
- Free text:
- Adiposity, body composition, growth, cardiometabolic risk markers in adulthood, carotid intima media thickness, thyroid volume, metabolic and excretory parameters in 24-h urine, description of modern infant, child, and adolescent dietary habits
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Surveys: Anthropometry, dietary record at each examination, 24h urine from age 3-4 years, questionnaires (e.g. chronotype, physical activity, etc.) according to age, ultrasound of thyroid and carotid intima media from age 12 years, blood pressure from age 6 years, parental data (anthropometry, blood pressure, questionnaires e.g. on socioeconomic status) every 4 years.
Endpoints
- Primary outcome:
- Longitudinal, observational study during growth, therefore no primary endpoints.
- Secondary outcome:
- - not applicable -
Study Design
- Purpose:
- Prevention
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- Epidemiological study
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Other Universität Bonn/Studienzentrum Dortmund Dortmund
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 1985-05-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- No Entry
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 3 Months
- Maximum Age:
- 9 Months
- Additional Inclusion Criteria:
- Healthy infants from the Dortmund region from families with sufficient knowledge of the German language
Exclusion Criteria
Children with diagnosed diseases that are likely to alter growth, nutrition or metabolism, places of residence outside the Dortmund region, insufficient knowledge of the German language on the part of the parents
Addresses
Primary Sponsor
- Address:
- Rheinische Friedrich-Wilhelms-Universität Bonn Institut für Ernährungs- und Lebensmittelwissenschaften (IEL) Lehrstuhl für ErnährungsepidemiologieProf. Dr. Ute NöthlingsFriedrich-Hirzebruch-Allee 753115 BonnGermany
- Telephone:
- 0228 73 60490
- Fax:
- 0228 73 60492
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.ernaehrungsepidemiologie.uni-bonn.de/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universität Bonn, IEL, Lehrstuhl ErnährungsepidemiologieProf. Dr. Ute NöthlingsFriedrich-Hirzebruch-Allee 753115 BonnGermany
- Telephone:
- 02287360490
- Fax:
- 02287360492
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.ernaehrungsepidemiologie.uni-bonn.de/
Contact for Public Queries
- Address:
- Universität Bonn, IEL, DONALD-StudiePD Dr. Ute AlexyHeinstück 1144225 DortmundGermany
- Telephone:
- 023179221027
- Fax:
- 023179221033
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.donald-studie.de
Principal Investigator
- Address:
- Universität Bonn, IEL, Lehrstuhl ErnährungsepidemiologieProf. Dr. Ute NöthlingsFriedrich-Hirzebruch-Allee 753115 BonnGermany
- Telephone:
- 02287360490
- Fax:
- 02287360492
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.ernaehrungsepidemiologie.uni-bonn.de/
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Ministerium für Kultur und Wissenschaft, NRWVölkinger Straße 4940221 DüsseldorfGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.mkw.nrw/
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission Medizinische Fakultät BonnVenusberg Campus 1, Geb. 0253105 BonnGermany
- Telephone:
- +49-228-28751282
- Fax:
- +49-228-28751932
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2005-04-27
- Ethics committee number:
- 002/05
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2005-05-12
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- In accordance with the consent form for the participants, the pseudonymized study data are not permitted to be made publicly available. However, the DONALD data may be made available to external researchers upon request for cooperation or data use. In this case, a cooperation or data use agreement must be concluded in advance . The use of the DONALD data by external scientists is therefore only possible with detailed prior justification (scientific purpose) and after agreement of the study head.
Study protocol and other study documents
- Study protocols:
- Kroke A, Manz F, Kersting M, Remer T, Sichert-Hellert W, Alexy U, Lentze MJ. The DONALD Study. History, current status and future perspectives. Eur J Nutr. 2004 Feb;43(1):45-54. doi: 10.1007/s00394-004-0445-7. Epub 2004 Jan 6. PMID: 14991269.
- Buyken AE, Alexy U, Kersting M, Remer T. Die DONALD Kohorte. Ein aktueller Überblick zu 25 Jahren Forschung im Rahmen der Dortmund Nutritional and Anthropometric Longitudinally Designed Study [The DONALD cohort. An updated overview on 25 years of research based on the Dortmund Nutritional and Anthropometric Longitudinally Designed study]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2012 Jun;55(6-7):875-84. German. doi: 10.1007/s00103-012-1503-6. PMID: 22736170.
- Study abstract:
- No Entry
- Other study documents:
- Perrar I, Alexy U, Nöthlings U. Cohort profile update-overview of over 35 years of research in the Dortmund Nutritional and Anthropometric Longitudinally Designed (DONALD) study. Eur J Nutr. 2023 Dec 27. doi: 10.1007/s00394-023-03290-x. Epub ahead of print. PMID: 38151532.
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Jancovic et al.: Changes in chronotype and social jetlag during adolescence and their association with concurrent changes in BMI-SDS and body composition, in the DONALD Study. Eur J Clin Nutr 2022; 76: 765-771
- Montejano Vallejo et al. Associations of Adherence to a Dietary Index Based on the EAT-Lancet Reference Diet with Nutritional, Anthropometric, and Ecological Sustainability Parameters: Results from the German DONALD Cohort Study. J Nutr 2022; 152: 1763-1772
- Oluwagbemigun et al.: Long-term dietary intake from infancy to late adolescence is associated with gut microbiota composition in young adulthood. AJCN 2021; 113: 647-656
- Brachem et al. Associations of BMI and Body Fat with Urine Metabolome in Adolescents Are Sex-Specific: A Cross-Sectional Study. Metabolites 2020; 10(8): 330
- Date of first publication of study results:
- 1998-01-15
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry