ArticleBMJ open2025
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.
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionDietary 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. METHODS AND ANALYSIS: 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 (<130 g/day) (ii) diabetes self-management principles. A primary care nurse will deliver the intervention at baseline, 3, 6, 9 and 12 months.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 ≥6.5% 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: Clinical Trials Registry-India (CTRI/2024/02/062202).
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.