{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T11:23:13Z","timestamp":1790680993030,"version":"4.1.0"},"reference-count":39,"publisher":"Georg Thieme Verlag KG","issue":"08","license":[{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"The Leona M. and Harry B. Helmsley Charitable\n                        Trust","award":["#2018PG-T1D022 and #2003-04286"],"award-info":[{"award-number":["#2018PG-T1D022 and #2003-04286"]}]},{"name":"Helmholtz Munich, German Research Center for Environmental\n                        Health, Germany"},{"DOI":"10.13039\/501100002347","name":"Bundesministerium f\u00fcr Bildung und\n                        Forschung","doi-asserted-by":"crossref","award":["FKZ: 01KX1818"],"award-info":[{"award-number":["FKZ: 01KX1818"]}],"id":[{"id":"10.13039\/501100002347","id-type":"DOI","asserted-by":"crossref"}]},{"name":"EASD-Novo Nordisk Foundation Diabetes Prize for Excellence to\n                        AGZ","award":["NNF22SA0081044"],"award-info":[{"award-number":["NNF22SA0081044"]}]},{"name":"The Leona M. and Harry B. Helmsley Charitable\n                        Trust","award":["#2018PG-T1D023 and #2007-04031"],"award-info":[{"award-number":["#2018PG-T1D023 and #2007-04031"]}]},{"name":"German Center for Diabetes Research\n                        (DZD e.V.) to Helmholtz Munich"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Horm Metab Res"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Understanding the determinants that influence parents\u2019 decisions to participate\n                    with their infants in primary prevention trials is essential for achieving\n                    representative study samples and ensuring the generalizability of outcomes. We\n                    analyzed quantitative and qualitative data collected from infants eligible for\n                    the Primary Oral Insulin Trial (N=2,750) or the Supplementation with\n                        B.\n               INfantis for Mitigation of Type 1 Diabetes Autoimmunity Trial\n                    (N=3,309). Both trials were conducted within the Global Platform for the\n                    Prevention of Autoimmune Diabetes between 07\/2017 and 04\/2024. Among all\n                    eligible infants, a longer decision time (odds ratio: 1.01, 95% confidence\n                    interval: 1.00\u20131.01, and p=0.002), having a first-degree relative with\n                    type 1 diabetes (odds ratio: 2.18, 95% confidence interval: 1.95\u20132.43, and\n                        p&lt;0.001), and a higher maternal age (odds ratio: 1.03, 95%\n                    confidence interval: 1.01\u20131.05, and p=0.003) were associated with a\n                    higher likelihood of participation, whereas infants born in fall (odds ratio:\n                    0.85, 95% confidence interval: 0.73\u20130.98, and p=0.03) and families with\n                    longer travel distances to the study center (odds ratio: 0.97, 95% confidence\n                    interval: 0.95-0.99, and p=0.01) were less likely to participate.\n                    Participation was lower in the Supplementation with B. INfantis for\n                    Mitigation of Type 1 Diabetes Autoimmunity Trial than in the Primary Oral\n                    Insulin Trial (odds ratio: 0.86, 95% confidence interval: 0.78\u20130.96, and\n                        p=0.005), and stratified analyses indicated that some factors, such\n                    as recruitment during the COVID-19 pandemic, affected participation differently\n                    between studies. Analysis of qualitative data from 638 families identified\n                    additional factors, including the parental perception of the child\u2019s risk for\n                    type 1 diabetes and the burden of participation. In conclusion, this study\n                    identifies both general and study-specific determinants and reasons of\n                    participation and non-participation in infant primary prevention trials.<\/jats:p>","DOI":"10.1055\/a-2884-2277","type":"journal-article","created":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T22:45:21Z","timestamp":1782945921000},"page":"323-333","source":"Crossref","is-referenced-by-count":1,"title":["Determinants of Infant Participation and Non-Participation in Primary\n                    Prevention Trials"],"prefix":"10.1055","volume":"58","clinical-trial-number":[{"clinical-trial-number":"nct03364868","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04769037","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Franziska","family":"W\u00f6rl","sequence":"additional","affiliation":[{"name":"Ludwig-Maximilians-Universit\u00e4t M\u00fcnchen, Germany","place":["Munich"],"department":["Institute for Medical Information Processing, Biometry, and Epidemiology\n                    (IBE), Chair of Public Health and Health Service Research, LMU\n                    Medizin"]},{"name":"Pettenkofer School of Public Health, Germany","place":["Munich"]},{"name":"Helmholtz Munich, German Research Center for Environmental\n                    Health, Germany","place":["Neuherberg"],"department":["Institute of Diabetes Research"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Achenbach","sequence":"additional","affiliation":[{"name":"Helmholtz Munich, German Research Center for Environmental\n                    Health, Germany","place":["Neuherberg"],"department":["Institute of Diabetes Research"]},{"name":"Technical University of Munich School of Medicine and\n                    Health, BY, Germany","place":["Munich"],"department":["Forschergruppe Diabetes, TUM University Hospital"]},{"name":"German Center for Diabetes Research (DZD\n                    e.V.), Germany","place":["Neuherberg"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ezio","family":"Bonifacio","sequence":"additional","affiliation":[{"name":"Technische Universit\u00e4t Dresden, Germany","place":["Dresden"],"department":["Center for Regenerative Therapies Dresden"]},{"name":"Technische Universit\u00e4t Dresden, SN, Germany","place":["Dresden"],"department":["Paul Langerhans Institute Dresden of Helmholtz Munich at University\n                    Hospital Carl Gustav Carus, Faculty of Medicine"]},{"name":"Helmholtz Munich, German Research\n                Center for Environmental Health, Neuherberg, Germany","department":["Institute of Diabetes and Obesity"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristina","family":"Casteels","sequence":"additional","affiliation":[{"name":"KU Leuven, Flanders, Belgium","place":["Leuven"],"department":["Department of Development and Regeneration"]},{"name":"University Hospital Gasthuisberg, Leuven, Belgium","department":["Department of Pediatrics"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gita","family":"Gemulla","sequence":"additional","affiliation":[{"name":"University Hospital Carl Gustav Carus,\n                Technische Universit\u00e4t Dresden, Germany","place":["Dresden"],"department":["Department of Pediatrics"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florian","family":"Haupt","sequence":"additional","affiliation":[{"name":"Helmholtz Munich, German Research Center for Environmental\n                    Health, Germany","place":["Neuherberg"],"department":["Institute of Diabetes Research"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophia","family":"Hawkins","sequence":"additional","affiliation":[{"name":"University of Oxford, England, United Kingdom of Great Britain and Northern Ireland","place":["Oxford"],"department":["Oxford Vaccine Group, Department of Paediatrics"]},{"name":"NIHR Oxford Biomedical Research Centre, England, United Kingdom of Great Britain and Northern Ireland","place":["Oxford"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela","family":"Hommel","sequence":"additional","affiliation":[{"name":"Technische Universit\u00e4t Dresden, Germany","place":["Dresden"],"department":["Center for Regenerative Therapies Dresden"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sharon","family":"King","sequence":"additional","affiliation":[{"name":"The Great North Children's Hospital, Royal\n                Victoria Infirmary, Newcastle upon Tyne, UK","department":["General Paediatrics"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Kordonouri","sequence":"additional","affiliation":[{"name":"AUF DER BULT, Germany","place":["Hanover"],"department":["Kinder- und Jugendkrankenhaus"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helena","family":"Elding Larsson","sequence":"additional","affiliation":[{"name":"Lund University, Sk\u00e5ne County, Sweden","place":["Lund"],"department":["Unit for Pediatric Endocrinology, Department of Clinical Sciences\n                    Malm\u00f6"]},{"name":"Skane University Hospital, Sweden","place":["Malm\u00f6\/Lund"],"department":["Department of Paediatrics"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anja","family":"Loff","sequence":"additional","affiliation":[{"name":"Technische Universit\u00e4t Dresden, Germany","place":["Dresden"],"department":["Center for Regenerative Therapies Dresden"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Markus","family":"Lundgren","sequence":"additional","affiliation":[{"name":"Lund University, Sk\u00e5ne County, Sweden","place":["Lund"],"department":["Unit for Pediatric Endocrinology, Department of Clinical Sciences\n                    Malm\u00f6"]},{"name":"Skane University Hospital, Sweden","place":["Kristianstad"],"department":["Department of Paediatrics"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannah","family":"Nenonen","sequence":"additional","affiliation":[{"name":"Lund University, Sk\u00e5ne County, Sweden","place":["Lund"],"department":["Unit for Pediatric Endocrinology, Department of Clinical Sciences\n                    Malm\u00f6"]},{"name":"Skane University Hospital, Sweden","place":["Malm\u00f6\/Lund"],"department":["Department of Paediatrics"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariusz","family":"O\u0142tarzewski","sequence":"additional","affiliation":[{"name":"Institute of Mother and Child, Poland","place":["Warsaw"],"department":["Department of Screening and Metabolic Diagnostics"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Owen","sequence":"additional","affiliation":[{"name":"The Great North Children's Hospital, Royal\n                Victoria Infirmary, Newcastle upon Tyne, UK","department":["General Paediatrics"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jasmin","family":"Paulus","sequence":"additional","affiliation":[{"name":"University Hospital\n                Gasthuisberg, Belgium","place":["Leuven"],"department":["Research & Development Endocrinology"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Robson","sequence":"additional","affiliation":[{"name":"The Great North Children's Hospital, Royal\n                Victoria Infirmary, Newcastle upon Tyne, UK","department":["General Paediatrics"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank","family":"Roloff","sequence":"additional","affiliation":[{"name":"AUF DER BULT, Germany","place":["Hanover"],"department":["Kinder- und Jugendkrankenhaus"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew","family":"Snape","sequence":"additional","affiliation":[{"name":"Oxford Vaccine Group, University of Oxford Department of Paediatrics,\n                    and NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford,\n                , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Agnieszka","family":"Szypowska","sequence":"additional","affiliation":[{"name":"Institute of Mother and Child, Poland","place":["Warsaw"],"department":["Department of Screening and Metabolic Diagnostics"]},{"name":"Department of Paediatric Diabetology and Paediatrics, The\n                    Children's Clinical Hospital J\u00f3zef Polikarp Brudzi\u0144ski, University Clinical\n                    Centre of the Medical University of Warsaw, Warsaw, Poland"},{"name":"Department of Paediatric Diabetology and Paediatrics, Medical University\n                    of Warsaw, Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manu","family":"Vatish","sequence":"additional","affiliation":[{"name":"Nuffield Department of Women\u2019s & Reproductive Health, University of\n                    Oxford, John Radcliffe Hospital, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Wei\u00df","sequence":"additional","affiliation":[{"name":"Helmholtz Munich, German Research Center for Environmental\n                    Health, Germany","place":["Neuherberg"],"department":["Institute of Diabetes Research"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christiane","family":"Winkler","sequence":"additional","affiliation":[{"name":"Helmholtz Munich, German Research Center for Environmental\n                    Health, Germany","place":["Neuherberg"],"department":["Institute of Diabetes Research"]},{"name":"German Center for Diabetes Research (DZD\n                    e.V.), Germany","place":["Neuherberg"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Zych","sequence":"additional","affiliation":[{"name":"Department of Paediatric 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Germany","place":["Neuherberg"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6554-5974","authenticated-orcid":false,"given":"Sandra","family":"Hummel","sequence":"additional","affiliation":[{"name":"Helmholtz Munich, German Research Center for Environmental\n                    Health, Germany","place":["Neuherberg"],"department":["Institute of Diabetes Research"]},{"name":"Technical University of Munich School of Medicine and\n                    Health, BY, Germany","place":["Munich"],"department":["Forschergruppe Diabetes, TUM University Hospital"]},{"name":"German Center for Diabetes Research (DZD\n                    e.V.), Germany","place":["Neuherberg"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"194","published-online":{"date-parts":[[2026,7,1]]},"reference":[{"issue":"9977","key":"ref1","doi-asserted-by":"crossref","first-page":"1502","DOI":"10.1016\/S0140-6736(15)60742-5","article-title":"The history and 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Shaikh","year":"2024","journal-title":"JAMA Netw Open"},{"issue":"08","key":"ref5","doi-asserted-by":"crossref","first-page":"14","DOI":"10.7748\/paed.19.8.14.s18","article-title":"Children\u2019s participation in vaccine research: parents\u2019 views","volume":"19","author":"F Jay","year":"2007","journal-title":"Paediatr Nurs"},{"issue":"08","key":"ref6","doi-asserted-by":"crossref","first-page":"926","DOI":"10.1111\/jir.12605","article-title":"Fragile X syndrome clinical trials: Exploring parental decision-making","volume":"63","author":"C S D\u2019Amanda","year":"2019","journal-title":"J Intellect Disabil Res"},{"issue":"03","key":"ref7","doi-asserted-by":"crossref","first-page":"404","DOI":"10.1038\/s41372-023-01790-6","article-title":"Experiences and preferences for learning about neonatal research: insights from\n                    parent interviews","volume":"44","author":"E M Weiss","year":"2024","journal-title":"J Perinatol"},{"key":"ref8","doi-asserted-by":"crossref","first-page":"113923","DOI":"10.1016\/j.jpeds.2024.113923","article-title":"Motivations for and against participation in neonatal research: Insights from\n                    interviews of diverse parents approached for neonatal research in the united\n                    states","volume":"275","author":"E M Weiss","year":"2024","journal-title":"J Pediatr"},{"key":"ref9","doi-asserted-by":"crossref","first-page":"2149","DOI":"10.1016\/S0140-6736(23)00223-4","article-title":"Type 1 diabetes","volume":"401","author":"T Quattrin","year":"2023","journal-title":"Lancet"},{"issue":"04","key":"ref10","doi-asserted-by":"crossref","first-page":"e1002548","DOI":"10.1371\/journal.pmed.1002548","article-title":"Genetic scores to stratify risk of developing multiple islet autoantibodies and\n                    type 1 diabetes: A prospective study in children","volume":"15","author":"E Bonifacio","year":"2018","journal-title":"PLoS Med"},{"issue":"06","key":"ref11","doi-asserted-by":"crossref","first-page":"720","DOI":"10.1111\/pedi.12870","article-title":"Identification of infants with increased type 1 diabetes genetic risk for\n                    enrollment into Primary Prevention Trials\u2014GPPAD-02 study design and first\n                    results","volume":"20","author":"C Winkler","year":"2019","journal-title":"Pediatr Diabetes"},{"issue":"04","key":"ref12","doi-asserted-by":"crossref","first-page":"517","DOI":"10.1016\/j.cct.2011.03.009","article-title":"Enrollment experiences in a pediatric longitudinal observational study: The\n                    Environmental Determinants of Diabetes in the Young (TEDDY) study","volume":"32","author":"B Lernmark","year":"2011","journal-title":"Contemp Clin Trials"},{"issue":"06","key":"ref13","doi-asserted-by":"crossref","first-page":"e028578","DOI":"10.1136\/bmjopen-2018-028578","article-title":"Oral insulin therapy for primary prevention of type 1 diabetes in infants with\n                    high genetic risk: The GPPAD-POInT (global platform for the prevention of\n                    autoimmune diabetes primary oral insulin trial) study protocol","volume":"9","author":"A-G Ziegler","year":"2019","journal-title":"BMJ Open"},{"issue":"11","key":"ref14","doi-asserted-by":"crossref","first-page":"e052449","DOI":"10.1136\/bmjopen-2021-052449","article-title":"Supplementation with Bifidobacterium longum subspecies infantis EVC001 for\n                    mitigation of type 1 diabetes autoimmunity: the GPPAD-SINT1A randomised\n                    controlled trial protocol","volume":"11","author":"A-G Ziegler","year":"2021","journal-title":"BMJ Open"},{"issue":"04","key":"ref15","doi-asserted-by":"crossref","first-page":"529","DOI":"10.1038\/s41562-021-01079-8","article-title":"A global panel database of pandemic policies (Oxford COVID-19 Government\n                    Response Tracker)","volume":"5","author":"T 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children","volume":"113","author":"A R Tait","year":"2004","journal-title":"Pediatrics"},{"issue":"06","key":"ref29","doi-asserted-by":"crossref","first-page":"561","DOI":"10.1001\/jamapediatrics.2013.1050","article-title":"Factors that influence parental decisions to participate in clinical research:\n                    consenters vs nonconsenters","volume":"167","author":"A Hoberman","year":"2013","journal-title":"JAMA Pediatr"},{"key":"ref30","doi-asserted-by":"crossref","first-page":"865","DOI":"10.1038\/s41372-018-0119-6","article-title":"Informed consent for a neonatal clinical trial: parental experiences and\n                    perspectives","volume":"38","author":"A R Shah","year":"2018","journal-title":"J Perinatol"},{"key":"ref31","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1186\/1472-6939-14-7","article-title":"Effect of child health status on parents\u2019 allowing children to participate in\n                    pediatric research","volume":"14","author":"J 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