Introduction Some clinicians have observed that low-carbohydrate, low-energy diets can improve blood glucose control, with reports of remission from type 2 diabetes in some patients. In clinical trials, support for low-carbohydrate, low-energy diets has been provided by specialist staff and these programmes are unsuitable for widespread deployment in routine primary care. The aim of this trial is to test whether a newly developed behavioural support programme can effectively deliver a low-energy, low-carbohydrate diet in a primary care setting.
Methods and analysis This is a feasibility randomised controlled trial (RCT) with embedded qualitative study. Thirty adult patients with type 2 diabetes and body mass index ≥30 kg/m2 in 2–4 general practices will be randomised 2:1 intervention or control and followed up over 12 weeks. The intervention diet comprises 8 weeks of a low-carbohydrate food-based diet providing around 800 kcal/day, followed by 4 weeks of weight maintenance. This programme will be delivered by practice nurses, who will also support patients through goal-setting, motivation and self-monitoring across four appointments, and provide a self-help booklet with recipes, shopping lists and other behavioural support. Primary outcome measures of feasibility will be met if CIs do not cross the following proportions: that 60% of intervention group participants attempt the dietary intervention, healthcare professionals conduct the intervention delivery session with at least 60% of essential elements present and 60% of participants attend the final follow-up session. Secondary outcome measures will assess process and qualitative measures, as well as exploratory outcomes including change in haemoglobin A1c and change in weight.
Ethics and dissemination This study has been granted ethical approval by the National Research Ethics Service, South Central Oxford B Research Ethics Committee (ref: 18/SC/0071). The study results will inform whether to progress to a full-scale RCT to test the efficacy of offering this programme for patients with type 2 diabetes in primary care.
Trial registration number ISRCTN62452621; Pre-results.
- weight loss
- primary care
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Contributors EM, PA and SAJ developed the concept for the study and wrote the first draft of the protocol. EM, PA, SAJ and PD prepared the study documents and coordinated the HRA and ethics application. EM drafted the manuscript for publication, with input from PA and SAJ. PD, MN, CB, RF, KH and GT were involved in the detailed design of the study, and approved the final protocol and manuscript.
Funding PA and SAJ are NIHR Senior Investigators and funded by NIHR CLAHRC Oxford. PA, SAJ, GDT, PD and MN are supported by the NIHR Oxford BRC. This work was supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC) and the School for Primary Care Research (SPCR) (grant reference number 404).
Disclaimer This report is independent research by the National Institute for Health Research. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the University of Oxford, the NIHR or the Department of Health.
Competing interests PA and SAJ have received research grant funding but no personal renumeration from commercial weight loss companies, but none of these companies have interests in the programme described here. CB is the author of “The 8-week blood sugar diet recipe book”, published in 2016. PAD is a member of the PHE/SACNE/DUK committee reviewing evidence on the effects of low carbohydrate diets in people with type 2 diabetes.
Patient consent Not required.
Ethics approval The study protocol (V2.0 1.3.18) was reviewed and approved by the South Central Oxford B REC Committee (Ref: 18/SC/0071).
Provenance and peer review Not commissioned; externally peer reviewed.
Author note This trial is sponsored by the University of Oxford, Clinical Trials and Research Governance, Joint Research Office, Block 60, Churchill Hospital, Old Road, Headington, Oxford, OX3 7LE, UK.
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