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Introduction
Noncommunicable disorders rank as the foremost reasons for premature death globally. Both hereditary factors and environmental exposure influence the risk of these diseases. While biobanks have enhanced comprehension of genetic indicators related to these conditions, the role of environmental factors is anticipated to exert a more substantial effect on disease progression. Individuals also construct their own environments and lifestyles predicated on genetically influenced preferences, leading to gene-environment interactions that require extensive datasets for investigation. Biobanks may be deficient in adequate lifestyle and environmental information, thus hindering their application. We propose a methodology for a biobank-recall study (BioRecall) aimed at gathering data concerning lifestyle and environmental exposure, merging these insights with genotypes, biological samples, and clinical results.
Methods and analysis
All previously genotyped contributors from the Central Finland Biobank diagnosed with type 2 diabetes who agree to recalls will be invited to the initial study. The initial feasibility evaluation indicates there are 1,386 eligible candidates. Participants will complete an electronic survey on a secure online platform. The survey contains validated inquiries about lifestyles, anthropometric measurements, history of weight loss, health status, symptoms, work characteristics, emotional well-being, and residential surroundings. Information on postcodes will assist in adding spatial environmental data. Genotype and relevant clinical data will be included in the study in accordance with the Finnish Biobank Act and integrated with survey data.
Ethics and open data
The Human Sciences Ethics Committee at the University of Jyvaskyla has given a positive endorsement concerning the study protocol (1671/13.00.04.00/2023). The Central Finland Biobank has approved the research proposal (no: BB24-0333-A01). The data collected will be returned to the Central Finland Biobank for research purposes with the consent of the participants. Authorization for data utilization can subsequently be sought through standard procedures of the Fingenious service (www.fingenious.fi). If successful, the study will expand to involve other contributors and Finnish biobanks.
The authors have disclosed no competing interests.
This initiative is backed by the JYU.Well strategic funding from the University of Jyvaskyla (to ES) and the research infrastructure funding provided by the Research Council of Finland (grant number: 358894 to ES) as part of the BBMRI.fi consortium. ES is also supported by the Research Council of Finland (grant numbers: 341750, 346509, and 361981), the Juho Vainio Foundation, and the Paivikki and Sakari Sohlberg Foundation. SR and TF benefit from support by the Juho Vainio Foundation. MR is funded by the Research Council of Finland (grant number: 330185). KA is partially funded by the European Regional Development Fund through the Regional Council of Northern Savo (No. A80407) for the enhancement of FOODNUTRI infrastructure and by the Joint Action on Cardiovascular Diseases and Diabetes (JACARDI), financed by the EU4Health Programme (Grant Agreement No. 101126953).
I affirm that all relevant ethical protocols have been adhered to, and all required IRB and/or ethics committee approvals have been secured.
Yes
The specifics of the IRB/oversight entity that rendered approval or exemption for the research described are provided below:
The Human Sciences Ethics Committee of the University of Jyvaskyla has issued a positive statement on the study protocol (1671/13.00.04.00/2023). The Central Finland Biobank has authorized the research plan (no: BB24-0333-A01).
I confirm that all requisite patient/participant consent has been obtained and the necessary institutional documents have been filed, ensuring that any patient/participant/sample identifiers included were not accessible to anyone (e.g., hospital personnel, patients, or participants themselves) outside the research group, thus preventing the identification of individuals.
Yes
I recognize that all clinical trials and any additional prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I affirm that any such investigation reported in this manuscript has been registered and the trial registration ID is provided (note: if submitting a prospective study registered retrospectively, please include a statement in the trial ID field explaining why the study was not pre-registered).
Yes
I have adhered to all pertinent research reporting guidelines, including any relevant EQUATOR Network research reporting checklist(s) and other applicable materials, if necessary.
Yes
The Finnish biobank data can be accessed via the Fingenious services (managed by Finnish biobank cooperative). New physical activity questions developed during the project and their REDCap implementation can be obtained from the corresponding authors upon reasonable request. The HDI questionnaire is available and administered by the Finnish Institute for Health and Welfare (THL). Feedback based on the HDI can be requested reasonably from the FOODNUTRI project (KA).
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