eDIAMOND PoC Study V1
Research type
Research Study
Full title
The effectiveness of a low-carbohydrate, low-energy diet with remote support for patients with type 2 diabetes in primary care on weight loss: a proof of concept (PoC) trial
IRAS ID
323582
Contact name
Nicola Guess
Contact email
Sponsor organisation
University of Oxford
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 0 days
Research summary
Type 2 diabetes (T2D) can be put into remission (achieving normal or near-normal blood glucose levels without medications) if treated with intensive weight loss support. Currently available evidence is that a very low-energy diet (about 800-900kcal per day) delivered using meal replacement products is the most effective way of achieving remission. However, about 75% of people offered a meal replacement programme turn it down, and low-carbohydrate low-energy diets could be an attractive alternative for many. Researchers at the University of Oxford developed a face-to-face low-carbohydrate, low-energy diet (the DIAMOND programme) which achieved on average almost 10kg weight loss and normalisation of blood glucose in a 12-week feasibility study.
The patients and healthcare professionals who took part in the DIAMOND study wanted to know whether the same results could be achieved using this dietary approach but provided through digital tools and remote support as an alternative to face-to-face appointments with a practice nurse. This has the potential for more frequent support without increasing the demand on the primary care workforce. Remotely-delivered interventions also offer more flexibility for the patient, without the need to attend a GP practice or physical location at a particular time. Encouraging data from other weight loss programmes show that a remote version can work just as well as a face-to-face version. Nevertheless, we want to test whether a remote intervention of DIAMOND can achieve similar weight loss results as seen in the face-to-face version before rolling it out at scale.
Therefore, this proof of concept study aims to assess whether a remotely delivered behavioural support programme helps people follow a low-carbohydrate, low-energy diet (eDIAMOND) achieves clinically significant weight loss compared with no support or dietary advice.
Patients in eDIAMOND will be randomised with an equal chance to either the eDIAMOND programme, or NHS standard care for type 2 diabetes patients.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
23/EE/0278
Date of REC Opinion
26 Jan 2024
REC opinion
Further Information Favourable Opinion