Protocol for a randomized clinical trial investigating the clinical effectiveness and cost benefit of a lifestyle intervention targeting Type 2 Diabetes Mellitus.

INTERVENTION: The intervention will consist of participants enrolled in the intervention arm of the study participating in a lifestyle intervention known as the Complete Health Improvement Program (CHIP) for 12 weeks. Thereafter, participants will be contacted for the purpose of providing motivation and support on a monthly basis for an additional 9 months. This opportunity will be used to provide ongoing encouragement and support for lifestyle change, to answer questions, and to provide additional information as required or requested by the participants. Participants will also be invited to attend Club CHIP events, if and when available in their local area. Club CHIP is an optional support and continuing education group usually established and run by CHIP graduates. Club CHIP is not a requirement and therefore it is not available in all locations. There is one Club CHIP in operation which is geographically accessible to participants who may enroll in the study. The CHIP intervention consists of 18 education sessions, each of 90 minutes duration. The 18 sessions are run over a 12 week period according to group availability The following pattern is mostly adopted. 3 sessions per week for the first 2 weeks, then 2 sessions a week for the next 2 weeks and then 1 session a week for another 8 weeks. Approximately half of each session is devoted to viewing pre‐recorded visual material while interactive group discussions and activities, including food preparation and exercise demonstrations, make up the remaining time. An outline of the topics covered over the 18 sessions can be viewed below. 1 The rise of chronic disease 2 Lifestyle as medicine 3 The common denominator of chronic disease 4 The optimal lifestyle 5 Eat more, weigh less 6 Fibre, your new best friend 7 Disarming Diabetes 8 The heart of the matter – heart healthy 9 Controlling blood pressure and discovering protein 10 Bone health essentials 11 Cancer prevention 12 Understanding your results and taking action 13 Become what you believe. Your DNA is not your destiny 14 Practicing forgiveness 15 Re‐engineering your environment 16 Stress relieving strategies 17 Fix how you feel 18 From surviving to thriving Each participant receives a CHIP kit containing a textbook, workbook, recipe book, water bottle and pedometer. The intervention is run by voluntary facilitators who have been specifically trained to run the intervention. The intervention was designed, written and recorded by a team of health professionals and is under license from Sanitarium Health and Well Being. The intervention will be run in community halls on the central coast of NSW. The additional follow up will be conducted by the researcher who is a trained facilitator via telephone. A record of participants attendance will be kept. The workbook contains a page where participants may keep records of their own goals and adherence. These pages will not be assessed as part of the research. participants will complete the Active Q survey and questions relating to their eating pattern on commencement, at 12 weeks and again at 12 months as described in the outcomes section CONDITION: Type 2 Diabetes Mellitus ; INCLUSION CRITERIA: A current diagnosis of Type 2 Diabetes Mellitus Over the age of 18 years Sessions 1 to 11 provides information on the aetiology, risk factors and pathological mechanism responsible for lifestyle related chronic disease. Emphasis is placed on the links between obesity, diabetes, hypertension, hyperlipidaemia and cardiovascular disease. Participants are provided with information relating to how lifestyle changes, particularly in diet and levels of physical activity, can positively alter the risk factors for as well as the course of chronic diseases. Specifically, the adoption of a plant‐based, restricted sugar and salt diet is encouraged as well as daily physical activity involving a combination of aerobic and strengthening exercise most days of the week. Sessions 12 to 18 provide information related to other important lifestyle behaviors like substance use, rest, and sleep and stress management. Participants are provided with strategies that will assist them in assuming a position of control of their health, to overcome barriers, to manage and maintain behavior change and to cope with environmental pressures and stressors. PRIMARY OUTCOME: Change in glycaemic control. This will be measured through fasting blood sugar level, and Hb A1C measurements (serum assay) as well as changes in medication requirements, This is a composite primary outcome. medication change will be assessed from the patient survey ; To determine the cost benefit of the intervention. This will be obtained through a cost analysis which will include the cost of the intervention and assessment tools e.g. SF‐36 Quality of life questionnaire, as well as cost relating to medical appointments, interventions, hospitalizations as well as monitoring and treatment costs. SECONDARY OUTCOME: Change in HDL cholesterol levels. This will be measured through a change in lipid modulating medication requirements. The information will be obtained from the participant survey. Change in HDL cholesterol levels. This will be measured through serum assay. Change in LDL Cholesterol levels. This will be measured through a change in lipid modulating medication requirements. This information will be obtained from the participant survey Change in LDL Cholesterol levels. This will be measured through serum assay. Change in blood pressure levels. Blood pressure will be measured by a trained health professional, using a calibrated sphygmomanometer and stethoscope. Change in blood pressure measurement. Data will be obtained regarding a change in requirements for antihypertensive medication. Change in body mass index (BMI). This will be measured using calibrated weight and height scales and the formula BMI =weight (in kilograms)/height x height (in metres) Change in levels of physical activity. ; This will be assessed using the Revised Active‐Q physical activity questionnaire obtained from Stephanie Bonn from Karlinska Instutet, Sweden. This questionnaire has been validated in its web based form. It has not been validated in its paper format, however the questions are identical. Change in levels of total cholesterol. This will be measured through a change in lipid modulating medication requirements. This information will be obtained from the patient survey. Change in levels of total cholesterol. This will be measured through serum assay. ; Change in lifestyle measured over a 12 month period. This will be assessed using dietary questions designed specifically for this study and included in the demographic and medical history assessment form. Change in quality of life. This will be measured using the RAND 36 Health Survey. Change in tryiglyceride levels. This will be measured through a change in lipid modulating medication requirements. The information will be obtained from the participant survey Change in tryiglyceride levels. This will be measured through serum assay. Change in waist to height ratio. This will be measured using a calibrated height measure and tape measure according to the WHO STEPS protocol and using the formula waist circumference (cm) /height (cm) Change in waist to hip ratio. This will be measured using a calibrated tape measure according to the WHO STEPS protocol and using the formula waist circumference (cm)/hip circumference (cm)