{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T19:28:36Z","timestamp":1786649316888,"version":"build-2736575974"},"reference-count":19,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"6","license":[{"start":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T00:00:00Z","timestamp":1761955200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction:<\/jats:title>\n                    <jats:p>Gestational diabetes mellitus (GDM) affects up to 31% of pregnancies in South Asia, posing significant risks to maternal and neonatal health. Despite their potential, Indian primary health centres (PHCs) are underutilised in GDM prevention. This study aims to evaluate the effectiveness of a multipronged intervention compared to standard care in reducing GDM incidence among high-risk pregnant women and to explore barriers to adherence.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>This is a mixed-methods, two-arm, parallel-group cluster randomised controlled trial involving 12 PHCs randomised (1:1) to intervention or control arms. The intervention includes personalised dietary counselling (Medical Nutrition Therapy with millet-based, low-glycaemic index meals), structured physical activity guidance, educational booklets, WhatsApp-based reminders, and PHC staff training. Control PHCs will provide routine antenatal care. A total of 1200 participants (600 per arm) will be recruited. The primary outcome is GDM incidence, assessed via OGTT at 23\u201325 and 37 weeks using IADPSG criteria. Secondary outcomes include adherence to intervention, changes in metabolic biomarkers, and maternal and neonatal health indicators. Qualitative data from in-depth interviews and focus group discussions will undergo deductive content analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>This protocol outlines planned analyses. Both intention-to-treat and per-protocol analyses will be conducted. A conceptual framework will be developed to represent qualitative findings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>This trial implements a culturally tailored, scalable intervention integrated into India\u2019s primary healthcare system. Findings may guide national GDM prevention strategies, support early intervention, and improve maternal and neonatal outcomes in resource-constrained settings.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.4103\/ijem.ijem_645_25","type":"journal-article","created":{"date-parts":[[2025,12,19]],"date-time":"2025-12-19T14:00:20Z","timestamp":1766152820000},"page":"624-630","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":0,"title":["Effectiveness of a Multipronged Intervention to Reduce Gestational Diabetes Mellitus Incidence in High-Risk Pregnant Women in Puducherry: A Mixed Method Cluster Randomised Controlled Trial Protocol Behavioural Regulation, Individual Guidance, and Healthy Transformation for MOM"],"prefix":"10.4103","volume":"29","author":[{"given":"Mohammed K.","family":"Musthafa","sequence":"first","affiliation":[{"name":"Department of Preventive and Social Medicine, JIPMER, Puducherry, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Venkatachalam","family":"Jayaseelan","sequence":"additional","affiliation":[{"name":"Department of Preventive and Social Medicine, JIPMER, Puducherry, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Murali","family":"Subbaiah","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, JIPMER, Puducherry, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nivedita","family":"Nanda","sequence":"additional","affiliation":[{"name":"Department of Biochemistry, JIPMER, Puducherry, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anandalaksmi","family":"Varadharajalu","sequence":"additional","affiliation":[{"name":"Department of Public Health, Government of Puducherry, Puducherry, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kalaiselvy","family":"Arikrishnan","sequence":"additional","affiliation":[{"name":"Department of Preventive and Social Medicine, JIPMER, Puducherry, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahadevan","family":"Duraiswamy","sequence":"additional","affiliation":[{"name":"Department of Preventive and Social Medicine, JIPMER, Puducherry, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Premarajan K.","family":"Cheriyarath","sequence":"additional","affiliation":[{"name":"Department of Preventive and Social Medicine, JIPMER, Puducherry, India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2025,12,19]]},"reference":[{"key":"R2-20251220","doi-asserted-by":"crossref","first-page":"47","DOI":"10.1007\/s00404-020-05564-9","article-title":"Comparison of criteria of International Association of Diabetes and Pregnancy Study Groups (IADPSG) with National Institute for Health and Care Excellence (NICE) for diagnosis of gestational diabetes mellitus","volume":"302","author":"Todi","year":"2020","journal-title":"Arch Gynecol Obstet"},{"key":"R3-20251220","doi-asserted-by":"crossref","first-page":"206","DOI":"10.1016\/j.dsx.2013.10.017","article-title":"Feto-maternal outcomes in women with and without gestational diabetes mellitus according to the International Association of Diabetes and Pregnancy Study Groups (IADPSG) diagnostic criteria","volume":"7","author":"Nayak","year":"2013","journal-title":"Diabetes Metab Syndr Clin Res Rev"},{"key":"R5-20251220","first-page":"1","article-title":"Barriers to nutritional practices and dietary education in patients with type 1 diabetes mellitus in India","volume":"2","author":"Joseph","year":"2017","journal-title":"J Glob Diabetes Clin Metab"},{"key":"R6-20251220","doi-asserted-by":"crossref","first-page":"e067946","DOI":"10.1136\/bmj-2021-067946","article-title":"Gestational diabetes mellitus and adverse pregnancy outcomes:Systematic review and meta-analysis","volume":"377","author":"Ye","year":"2022","journal-title":"BMJ"},{"key":"R7-20251220","doi-asserted-by":"crossref","first-page":"24","DOI":"10.2337\/dc15-0511","article-title":"Gestational diabetes mellitus can be prevented by lifestyle intervention:The Finnish gestational diabetes prevention study (RADIEL):A randomized controlled trial","volume":"39","author":"Koivusalo","year":"2016","journal-title":"Diabetes Care"},{"key":"R8-20251220","doi-asserted-by":"crossref","first-page":"387","DOI":"10.4103\/ijem.ijem_147_23","article-title":"Gestational diabetes mellitus \u2013The modern Indian perspective","volume":"27","author":"Rohini","year":"2023","journal-title":"Indian J Endocrinol Metab"},{"key":"R9-20251220","first-page":"1","article-title":"Lifestyle interventions to prevent adverse pregnancy outcomes in women at high risk for gestational diabetes mellitus:A randomized controlled trial","volume":"14","author":"Xu","year":"2023","journal-title":"Front Immunol"},{"key":"R10-20251220","doi-asserted-by":"crossref","first-page":"1","DOI":"10.3390\/life14060755","article-title":"Physical activity during pregnancy and risk of gestational diabetes mellitus:A meta-review","volume":"14","author":"Rute-Larrieta","year":"2024","journal-title":"Life"},{"key":"R11-20251220","first-page":"e71907","article-title":"Telemedicine and gestational diabetes mellitus:Systematic review and meta-analysis","volume":"16","author":"El Seifi","year":"2024","journal-title":"Cureus"},{"key":"R12-20251220","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1136\/bmj.e7586","article-title":"SPIRIT 2013 explanation and elaboration:Guidance for protocols of clinical trials","volume":"346","author":"Chan","year":"2013","journal-title":"BMJ"},{"key":"R13-20251220","doi-asserted-by":"crossref","first-page":"824","DOI":"10.4103\/2230-8210.167550","article-title":"Comparison of different criteria for diagnosis of gestational diabetes mellitus","volume":"19","author":"Sagili","year":"2015","journal-title":"Indian J Endocrinol Metab"},{"key":"R14-20251220","year":"2018","journal-title":"Ministry of Health and Family Welfare, Government of India"},{"key":"R15-20251220","doi-asserted-by":"crossref","first-page":"4","DOI":"10.1136\/bmj.f3438","article-title":"Statistics notes:Missing outcomes in randomised trials","volume":"346","author":"Vickers","year":"2013","journal-title":"BMJ"},{"key":"R16-20251220"},{"key":"R17-20251220","doi-asserted-by":"crossref","first-page":"483","DOI":"10.1186\/s13063-024-08328-x","article-title":"Statistical analysis plan for cluster randomised trial to evaluate a community-level complementary food safety and hygiene and nutrition intervention in Mali:The MaaCiwara study","volume":"25","author":"Quinn","year":"2024","journal-title":"Trials"},{"key":"R18-20251220","doi-asserted-by":"crossref","first-page":"1","DOI":"10.3389\/fphar.2021.745749","article-title":"Investigation of barriers and facilitators to medication adherence in patients with type 2 diabetes across different health literacy levels:An explanatory sequential mixed methods study","volume":"12","author":"Huang","year":"2021","journal-title":"Front Pharmacol"},{"key":"R19-20251220","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.eclinm.2022.101650","article-title":"The effectiveness of lifestyle interventions on type 2 diabetes and gestational diabetes incidence and cardiometabolic outcomes:A systematic review and meta-analysis of evidence from low- and middle-income countries","volume":"53","author":"Sagastume","year":"2022","journal-title":"eClinicalMedicine"},{"key":"R20-20251220","doi-asserted-by":"crossref","first-page":"654","DOI":"10.1016\/j.sapharm.2019.08.003","article-title":"Mixed-methods approach to determine adherence, knowledge and behavioral determinants associated with medication wastage","volume":"16","author":"West","year":"2020","journal-title":"Res Soc Adm Pharm"},{"key":"R21-20251220","doi-asserted-by":"crossref","first-page":"207","DOI":"10.1007\/s11606-017-4197-5","article-title":"Advantages to using social-behavioral models of medication adherence in research and practice","volume":"33","author":"Amico","year":"2018","journal-title":"J Gen Intern Med"}],"container-title":["Indian Journal of Endocrinology and Metabolism"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ovid.com\/10.4103\/ijem.ijem_645_25","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T18:52:23Z","timestamp":1786647143000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ovid.com\/10.4103\/ijem.ijem_645_25"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11]]},"references-count":19,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2025]]}},"URL":"https:\/\/doi.org\/10.4103\/ijem.ijem_645_25","relation":{},"ISSN":["2230-8210","2230-9500"],"issn-type":[{"value":"2230-8210","type":"print"},{"value":"2230-9500","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,11]]},"assertion":[{"value":"2025-07-16","name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-10","name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}}]}}