Lifestyle Intervention for early diabetes: A randomised controlled trial

INTERVENTION: Standard care (i.e, standard diabetes management by a healthcare provider) plus a 1‐week intensive residential lifestyle program with booster sessions held over 14 weeks. The multimodal lifestyle intervention will be held at The Gawler Foundation. This intervention will be delivered by a team of multidisciplinary health professionals and will consist of daily group sessions educating participants about diabetes pathophysiology, risks, stress management, and lifestyle factors (diet and exercise) and behaviour likely to better control T2DM. The minimum dietary change advocated to participants will be in line with recommendations of the American Diabetes Association. During the residential program a plant‐based high‐fibre wholefood diet will be available to participants and healthy eating behaviour will be encouraged. This will encompass the use of mindfulness when eating, awareness of hunger and satiety signals, and enjoyment of food through paced food consumption. Participants in the lifestyle group will also receive counselling and group interaction designed to improve their compliance with lifestyle change. The intervention will draw upon the ESSENCE framework for health. This is a model of wellbeing suitable for the layperson and is taught to medical graduates of Monash University. It is based on the tenet that there are seven factors that are essential to well being: Education, Stress management, Spirituality, Exercise, Nutrition, Connectedness, and Environment. The duration of standard care will be variable for each patient. It will be determined by their usual general practitioner or endocrinologist as would normally occur in the context of usual care. CONDITION: Cardiovascular disease risk Psychological distress Type 2 Diabetes health service utilisation PRIMARY OUTCOME: For all patients the primary outcome will be glycaemic control operationalised as HbA1c level. The percentage of patients achieving normal glycaemic control as assessed using fasting BSL (using WHO definition) and HbA1c (defined as a haemoglobin A1c <8%). SECONDARY OUTCOME: Cholesterol (Fasting LDL//HDL, total cholesterol) Diabetes symptoms (Type 2 diabetes Symptom Checklist) Health service utilisation measured by (1) self report (and valdated by medical records data) for the number of general practitioner visits and (2) self‐report for the number of unplanned hospital attendances. Lifestyle indicators: ; Diet, Exercise, Smoking, Alcohol intake, ; Meditation, (via researcher designed survey) Lipids: Fasting Serum triglyceride levels Number and dose of hypoglycaemic drugs being taken for glycaemic control. Number of co‐morbidities measured by patient self‐report using a researcher devised survey Number type and dose of other medications measured by patient self report and verified by medical records data. Plasma Vitamin D (25‐hydroxyvitamin D) Psychological Distress (Kessler Psychological Distress Scale (k‐10)) blood pressure measured using a digital sphygmomanometer. The average of three measurements will be used. body mass index : Calculated from Height, weight pulse measured using a digital pulse oximeter. waist girth measured in centimetres by tape measure at the level of the naval while in the standing position. INCLUSION CRITERIA: Aged 18 years or more With newly identified (within 24 months at the time of intervention) T2DM Able to attend a 1‐week residential program in and 4 X 3 hour booster sessions held over the subsequent 14 week period. Willing to undertake significant lifestyle change