REmote SUpport for Low-Carbohydrate Treatment of Type 2 Diabetes (RESULT)
Type 2 Diabetes Mellitus in Obese
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus in Obese focused on measuring Diet, Low-Carbohydrate, Digital Intervention
Eligibility Criteria
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 40 years or above.
- Diagnosed with current type 2 diabetes (i.e. not in remission) in the last 6 years
- BMI of ≥27kg/m2 (≥30kg/m2 if ethnicity recorded as white)
- Has a smartphone or computer with internet access (and the correct operating system requirements to use the intervention programme)
- Are able to complete the eligibility and baseline assessments online
- Would like to make changes to their diet or lifestyle to improve their diabetes control, lose weight, or improve their general health
Exclusion Criteria:
- Unable to understand the study materials and interventions
- Currently following a weight loss programme (defined as a structured, prescribed and monitored programme and not a self-directed weight loss attempt)
- Pregnant, breastfeeding, or planning to become pregnant during the course of the study
- History of bariatric surgery, including gastric banding
- Currently using insulin therapy
- Proliferative diabetic retinopathy, or maculopathy.
- Recent myocardial infarction or stroke (<3 months)
- Renal failure (chronic kidney disease stage 4 or 5)
- Current active treatment for cancer (other than skin cancer treated with curative intent by local treatment only)
- Their doctor does not feel they are appropriate to participate for another reason (e.g. active eating disorder diagnosis, significant psychological disturbance)
Sites / Locations
- University of Oxford
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Low Carbohydrate Diet
Standard NHS type 2 diabetes care
. The intervention, provided by "Second Nature", involves diet, activity and behaviour change components. It comprises a three-month remote behavioural change programme with mentoring from a registered dietitian or nutritionist (health coach), peer group support, structured education articles and activity tracking technology. These elements are accessed via a smartphone or web-based application. Each participant will also receive a hard copy of an instructional handbook and a recipe book.
Participants randomised to the control group will receive no additional intervention, and will continue to receive their usual NHS diabetes care from their general practice.