{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,19]],"date-time":"2025-10-19T00:38:20Z","timestamp":1760834300137,"version":"build-2065373602"},"reference-count":48,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2025,2,17]],"date-time":"2025-02-17T00:00:00Z","timestamp":1739750400000},"content-version":"unspecified","delay-in-days":16,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Internal funding SDCC"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,1,31]]},"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Gestational diabetes mellitus (GDM) poses health risks due to hyperglycaemia, which can lead to clinical complications for mother and child. While dietary therapy serves as first-line treatment, approximately one-third of women with GDM require insulin to obtain glycaemic control. However, insulin therapy amplifies hospital care expenses and personal burdens. Intensive nutrition education, training and support may improve dietary intake leading to glycaemic control and reducing the need for insulin therapy. This study investigates the effectiveness of intensified dietary therapy versus standard dietary therapy in reducing the need for insulin and consequently lowering hospital care costs among women with GDM at high risk of requiring insulin therapy. Responses to the dietary interventions will also be examined within ethnic subgroups.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>This study is a randomised controlled parallel-group trial involving women with GDM randomised in a 1:1 ratio to receive either intensive dietary therapy (intensive group) or standard dietary therapy with only one educational consultation (control group). The educational content of the first consultation is according to routine care and similar in both groups. The intensive group receives two additional dietitian consultations and two additional consultations on request to facilitate training and support in addition to education. Assessments are conducted at baseline and 2\u20133 weeks before planned delivery, with additional data gathered from medical records. The primary outcome is the difference in the proportion of women requiring insulin therapy. Maternal outcomes, neonatal outcomes, patient-reported outcomes, health behaviour and cost-saving aspects of hospital care will also be assessed. Recruitment began in January 2024 and ends in December 2025, with a target enrolment of 214\u2009women.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>The study received approval from the Ethics Committee of the Capital Region of Denmark (H-23055674). Results will be disseminated through peer-reviewed journals, and detailed presentations to key stakeholders.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06127823\">NCT06127823<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-089231","type":"journal-article","created":{"date-parts":[[2025,2,17]],"date-time":"2025-02-17T17:55:55Z","timestamp":1739814955000},"page":"e089231","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Effect of intensive nutrition training, education and support versus standard therapy in reducing the need for insulin therapy in gestational diabetes (INTENSE-GDM): a protocol for a randomised controlled single-centre trial in Denmark"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct06127823","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9425-1764","authenticated-orcid":false,"given":"Bettina","family":"Ewers","sequence":"first","affiliation":[{"name":"Department of Diabetes Care, Steno Diabetes Center Copenhagen, Herlev, Capital Region of Denmark, Denmark"},{"name":"Department of Clinical and Translational Research, Copenhagen University Hospital - Steno Diabetes Center Copenhagen, Herlev, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin B","family":"Blond","sequence":"additional","affiliation":[{"name":"Department of Clinical and Translational Research, Copenhagen University Hospital - Steno Diabetes Center Copenhagen, Herlev, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Louise","family":"Kelstrup","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, Herlev-Gentofte University Hospital, Herlev, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Signe","family":"Foghsgaard","sequence":"additional","affiliation":[{"name":"Department of Clinical and Translational Research, Copenhagen University Hospital - Steno Diabetes Center Copenhagen, Herlev, Denmark"},{"name":"Department of Obstetrics and Gynaecology, Herlev-Gentofte University Hospital, Herlev, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Bergholt","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, Herlev-Gentofte University Hospital, Herlev, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marianne J","family":"Hansen","sequence":"additional","affiliation":[{"name":"Department of Diabetes Care, Steno Diabetes Center Copenhagen, Herlev, Capital Region of Denmark, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Heidi","family":"Storgaard","sequence":"additional","affiliation":[{"name":"Department of Diabetes Care, Steno Diabetes Center Copenhagen, Herlev, Capital Region of Denmark, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pernille","family":"Holmager","sequence":"additional","affiliation":[{"name":"Department of Diabetes Care, Steno Diabetes Center Copenhagen, Herlev, Capital Region of Denmark, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elisabeth R","family":"Mathiesen","sequence":"additional","affiliation":[{"name":"Department of Clinical and Translational Research, Copenhagen University Hospital - Steno Diabetes Center Copenhagen, Herlev, Denmark"},{"name":"Center for Pregnant Women with Diabetes, Department of Endocrinology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark"},{"name":"Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2025,2,17]]},"reference":[{"key":"2025101812241703000_15.2.e089231.1","doi-asserted-by":"crossref","first-page":"379","DOI":"10.1007\/s00592-022-02013-8","article-title":"Regional divergence and time trends in the prevalence of gestational diabetes mellitus: a national Danish cohort study","volume":"60","author":"Scheuer","year":"2023","journal-title":"Acta Diabetol"},{"key":"2025101812241703000_15.2.e089231.2","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2021.109050"},{"key":"2025101812241703000_15.2.e089231.3","doi-asserted-by":"crossref","DOI":"10.1210\/clinem\/dgaa024","article-title":"Gestational Diabetes Risk in Migrants. 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