German Infant Study on the Influence of Nutrition Intervention plus Air pollution and Genetics on Allergy Development

Id of the project(*) : nfdi4health-30016

Resource classification(*)

Type of the resource : Study

Title(s)/name(s) of the Project

Title/name : German Infant Study on the Influence of Nutrition Intervention plus Air pollution and Genetics on Allergy Development
Language of the title/name : English

Acronym(s) of the Project

Acronym : GINIplus
Language of the acronym : English

Description(s) of the Project

Description : The German Infant Study on the Influence of Nutrition Intervention plus Air pollution and Genetics on Allergy Development (GINIplus) is a multicentre, population-based prospective birth cohort study. The study consists of two arms: an interventional and an observational arm. Both arms together represent a population-based birth cohort. Newborns with family history of allergy were recruited for the interventional arm (GINI = German Infant Nutritional Intervention program, see https://csh.nfdi4health.de/mdr/studyhub_resources/184). Newborns with a negative family history or positive family history but refusing participation in the trial were included in the observational study arm. In total (both arms) the study enrolled 5991 healthy full-term newborns in two German regions, Munich (n = 2949) representing an urban area and Wesel (n = 3042) representing a rural area. Enrollment started in September 1995 and ended in June 1998. Participants were followed-up since birth at 1, 2, 3, 4, 6, 10, 15, 20 and now 25 years of age, as well as during the COVID-19 pandemic.
Language of the description : English

Keyword(s) describing the Project

Keyword(*) : Infant health, Child, Adolescent, Allergy and Immonology, Health, Environmental Exposure, Lifestyle, Genetics, Traffic-Related Pollution, Atopy (finding), Diet, Food, Nutrition, Body Weight, Physical activity (observable entity)

Language(s) of the project : German

Web page of the project : https://www.helmholtz-munich.de/en/epi/cohort/giniplus

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Research group
Funding identifier(s) : Federal Ministry for Education,Science,Research and Technology,institutional funding (Helmholtz Zentrum Munich,Research Institute at Marien-Hospital Wesel,LMU Munich,TU Munich,IUF - Leibniz Research-Institute for Environmental Medicine at the University of Düsseldorf,Federal Ministry for Environment,Commission of the European Communities (7th Framework Program: MeDALL project),Mead Johnson and Nestlé.
Name of the organisation/institution/group(*) : Allergic Disease Epidemiolgy & Lung Epidemiology
Details about the contributing person(s)
Contributor type(*) : Not specified
Given name(*) : Not specified
Family name(s)(*) : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : marie.standl@helmholtz-munich.de
Phone number : +49 89 3187 2952
Organisation(s) associated with the contributor
Name(*) : Helmholtz Zentrum München, Institute of Epidemiology
Address : Ingolstädter Landstraße 1, 85764 Neuherberg
Web page : https://www.helmholtz-munich.de/en
Digital identifier(s)
Identifier(*) : 00cfam450
Scheme(*) : ROR

Alternative identifiers

Type of the registry(*) : Not specified
Identifier(*) : Not specified

Characteristics of the Project

Is it an interventional or non-interventional Project? : Non-interventional
Specification of the type of the Project
Interventional Project type : []
Non-interventional Project type : Birth cohort
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Allergic disorder (disorder), Atopic dermatitis (disorder), Asthma (disorder), Allergic rhinitis (disorder), Obesity (disorder), Mental disorder (disorder), General diet (disorder), Physical activity (observable entity, Air pollution (event), Local environment and neighborhood details (observable entity)
Terminology/classification(*) : SNOMED CT
Code of the health condition or disease : 781474001, 24079001, 195967001, 61582004, 414916001, 74732009, 41449007, 102413006, 224153006
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Other
On which diseases or conditions were the data collected? : []
Collects mortality data? : No
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Ongoing (III): Recruitment completed, but data collection ongoing
Participants enrolled by invitation? : Not specified
Start date : 9 January 1995
End date : Not specified
Mono- or multicentric? : Multicentric
Number of centers : 2
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : Not specified
Unit of age(*) : Not specified
Eligibility criteria: Maximum age
Maximum eligible age(*) : Not specified
Unit of age(*) : Not specified
Eligible gender : []
Inclusion criteria : Healthy and mature newborns with a birth weight of more than 2,500 g
Exclusion criteria : Newborns whose mothers suffered from an immunologically relevant chronic disease, like diabetes, HIV, or autoimmune disease, or who were drug or alcohol addicted, were excluded.Children whose parents were not sufficiently capable of the German languagewere also not included in the study.
Population of the Project(*)
Coverage : National
Country(ies) : Germany
Region(s) and/or city(ies) : Not specified
Interventions of the Project
Name of the intervention(*) : Not specified
Type of the intervention : Not specified
Additional information about the intervention : Not specified
Name(s) of the arm(s) associated with the given intervention : Not specified
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : risk factors
Description of the outcome measure : Not specified
Type of the outcome measure : Primary
Time point(s) of assessment : 1, 2, 3, 4, 6, 10, 15, 20, 23, 25 years of age
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : No, there is no plan to make data available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : false
Non-interventional aspects of the Project
Temporal design : Prospective
Target follow-up duration of the Project
Target follow-up duration(*) : 1
Unit of time(*) : Years
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : Samples with DNA
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Not specified
Masking of intervention(s) assignment
Masking implemented? : Not specified
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Not specified
Off-label use of a drug product : Not specified

German Infant Study on the Influence of Nutrition Intervention plus Air pollution and Genetics on Allergy Development

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