{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T05:31:34Z","timestamp":1783056694386,"version":"3.54.6"},"reference-count":34,"publisher":"BMJ","issue":"10","license":[{"start":{"date-parts":[[2025,10,15]],"date-time":"2025-10-15T00:00:00Z","timestamp":1760486400000},"content-version":"unspecified","delay-in-days":14,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"the Department of Health Research, Ministry of Health and Family Welfare, Govt of India","award":["R.11014\/30\/2023-GIA\/HR"],"award-info":[{"award-number":["R.11014\/30\/2023-GIA\/HR"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,9,1]]},"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Dietary modification, particularly low-carbohydrate diet, and diabetes self-management education (DSME) have shown promise in improving glycaemic control among persons with type 2 diabetes mellitus (T2DM). However, real-world evidence from India is limited. This protocol describes the methods of a cluster randomised trial to determine the effectiveness and feasibility of adopting a low-carbohydrate diet among persons with T2DM.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>Our cluster-randomised trial with a mixed-method process evaluation will use computer-generated block randomisation sequence to randomise Urban Primary Health Centres (UPHCs) (n=16) to either continue delivering the usual guideline-based care under the National Programme for Prevention and Control of Non-Communicable Diseases (NPNCD) or our study intervention. The study intervention will comprise a personalised nutrition counselling focusing on (i) low-carbohydrate diet (&lt;130\u2009g\/day) (ii) diabetes self-management principles. A primary care nurse will deliver the intervention at baseline, 3, 6, 9 and 12 months.<\/jats:p>\n                    <jats:p>We will include persons with T2DM, over the age of 30 years and above, irrespective of comorbidities, registered in the selected UPHC under care for diabetes for at least a month and with an glycated haemoglobin (HbA1c) level \u22656.5% during the screening test. We will collect data electronically using semistructured questionnaires and measure HbA1c, blood pressure, lipid profile, serum creatinine and body weight at baseline, 3, 6, 9 and 12 months after enrolment. We will use a difference in difference analysis, adjusted for clustering, to compare the change in HbA1c at the follow-up visits compared with baseline across the two study arms. We will conduct both intention-to-treat and per-protocol analysis, exploring reasons for differences in effect size.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study protocol was reviewed and approved by the Scientific Advisory Committee\/Institutional Human Ethics Committee of the research institution (NIE\/IHEC\/202302-03). The findings of this study will be disseminated through publication in peer-reviewed journals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>Clinical Trials Registry-India (CTRI\/2024\/02\/062202).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-100310","type":"journal-article","created":{"date-parts":[[2025,10,15]],"date-time":"2025-10-15T09:18:56Z","timestamp":1760519936000},"page":"e100310","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Effectiveness of primary care-led low-carbohydrate diet and self-management advice on glycaemic control in individuals with type 2 diabetes mellitus: protocol of a cluster randomised controlled trial"],"prefix":"10.1136","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8636-0634","authenticated-orcid":false,"given":"Joshua","family":"Chadwick","sequence":"first","affiliation":[{"name":"ICMR-National Institute of Epidemiology (ICMR-NIE), Chennai, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7466-7965","authenticated-orcid":false,"given":"Parasuraman","family":"Ganeshkumar","sequence":"additional","affiliation":[{"name":"National Institute of Epidemiology, Chennai, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6459-3659","authenticated-orcid":false,"given":"Kathiresan","family":"Jeyashree","sequence":"additional","affiliation":[{"name":"National Institute of Epidemiology, Chennai, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hemant Deepak","family":"Shewade","sequence":"additional","affiliation":[{"name":"Health System Research, ICMR - National Institute of Epidemiology, Chennai, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Madhanraj","family":"Kalyanasundaram","sequence":"additional","affiliation":[{"name":"ICMR-National Institute of Epidemiology (ICMR-NIE), Chennai, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Devika","family":"Shanmugasundaram","sequence":"additional","affiliation":[{"name":"National Institute of Epidemiology, Chennai, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4348-1572","authenticated-orcid":false,"given":"Lokesh","family":"Shanmugam","sequence":"additional","affiliation":[{"name":"ICMR-National Institute of Epidemiology (ICMR-NIE), Chennai, India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,10,15]]},"reference":[{"key":"2025120415071660000_15.10.e100310.1","doi-asserted-by":"crossref","first-page":"203","DOI":"10.1016\/S0140-6736(23)01301-6","article-title":"Global, regional, and national burden of diabetes from 1990 to 2021, with projections of prevalence to 2050: a systematic analysis for the Global Burden of Disease Study 2021","volume":"402","author":"Ong","year":"2023","journal-title":"The Lancet"},{"key":"2025120415071660000_15.10.e100310.2","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0246712","article-title":"National noncommunicable disease monitoring survey (NNMS) in India: Estimating risk factor prevalence in adult population","volume":"16","author":"Mathur","year":"2021","journal-title":"PLoS One"},{"key":"2025120415071660000_15.10.e100310.3","doi-asserted-by":"crossref","first-page":"474","DOI":"10.1016\/S2213-8587(23)00119-5","article-title":"Metabolic non-communicable disease health report of India: the ICMR-INDIAB national cross-sectional study (ICMR-INDIAB-17)","volume":"11","author":"Anjana","year":"2023","journal-title":"Lancet Diabetes Endocrinol"},{"key":"2025120415071660000_15.10.e100310.4","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0298340","article-title":"Prevalence of Noncommunicable Disease (NCDs) risk factors in Tamil Nadu: Tamil Nadu STEPS Survey (TN STEPS), 2020","volume":"19","author":"Selvavinayagam","year":"2024","journal-title":"PLoS ONE"},{"key":"2025120415071660000_15.10.e100310.5","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.n262","article-title":"Low and very low carbohydrate diets for diabetes remission","volume":"373","author":"Goldenberg","year":"2021","journal-title":"BMJ"},{"key":"2025120415071660000_15.10.e100310.6","doi-asserted-by":"publisher","DOI":"10.1093\/ajcn\/nqy096"},{"key":"2025120415071660000_15.10.e100310.7","doi-asserted-by":"publisher","DOI":"10.1093\/nutrit\/nuy049"},{"key":"2025120415071660000_15.10.e100310.8","doi-asserted-by":"publisher","DOI":"10.2337\/dc25-S005"},{"key":"2025120415071660000_15.10.e100310.9","doi-asserted-by":"publisher","DOI":"10.4103\/IJMR.IJMR_1698_18"},{"key":"2025120415071660000_15.10.e100310.10","doi-asserted-by":"crossref","unstructured":"Anjana RM , Srinivasan S , Sudha V , et al . 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