Lifestyle Intervention for early diabetes: A randomised controlled trial

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By 2010 T2DM is expected to affect in excess of 1.1 million Australians. This is clearly an epidemic that threatens to overwhelm the resources of our health system. Evidence-based strategies that engage patients to make lifestyle choices that result in better glucose control are urgently needed. Better glucose control has the potential to significantly decrease complications and health care costs, and halt or reverse disease progression. The proposed research offers an opportunity to manage chronic illness through sustained lifestyle change facilitated by delivery in a residential setting. The research aims to determine the feasibility and efficacy of a residential lifestyle intervention plus standard care compared to standard care alone in patients with newly established type 2 diabetes in (1) stabilising average blood glucose (as assessed using HbA1c); and (2) achieving normal glucose control assessed by fasting blood sugar level. A randomised controlled trial will be conducted for adult patients with newly diagnosed diabetes. Patients will be allocated to receive either standard care only (i.e, standard diabetes management by a healthcare provider) or standard care 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. Patients will be followed up at 12 months. Outcome measures will include glycaemic control as measured using glycated haemoglobin A1c (HbA1c; primary outcome) and fasting capillary blood sugar. Secondary outcome measure will include lipid status (low density and high density lipoprotein, triglyceride levels), Vitamin D, bodyweight, body mass index, waist girth, waist-to-hip ratio, blood pressure, pulse, number of co-morbidities, diabetes symptoms and diabetes specific health-related quality of life, and compliance with lifestyle change. An economic analysis will be undertaken at the conclusion of the study to determine the cost-benefit of the program. Among other endpoints this will consider costs associated with medication use and health service utilisation.This research will add to the literature regarding strategies for controlling the diabetes epidemic by assessing whether intensive lifestyle interventions prevent the progression to diabetes in patients with pre-diabetes, or improved glycemic control in patients with diabetes. This may ultimately revolutionise treatment approaches to pre-diabetes and diabetes and decrease the costs borne by individuals and the health system. This research investigates an inexpensive approach with the capacity for widespread adoption that is likely to be highly cost-effective and sustainable.

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