Protocol: investigating the effectiveness and cost benefit of a lifestyle intervention targeting type 2 diabetes in Australia

BACKGROUND: Type 2 Diabetes Mellitus (T2DM) has become an endemic disease. A number of interrelated factors increase the risk of the onset of T2DM, however much of the pathogenesis of the disease is associated with lifestyle. A number of studies have indicated that adopting positive lifestyle changes can successfully prevent or delay the onset of T2DM in a number of different population groups. The CHIP intervention is a lifestyle program that has been shown in over more than 30 published papers have indicated that the CHIP intervention leads to dramatic improvement in the indicators of T2DM these diseases of lifestyle. METHODS: A randomized control trial will be conducted involving 150 individuals with an established diagnosis of T2DM. All participants will continue to receive usual ongoing diabetes care, however, the intervention group (75 individuals) will in addition participate in a 12-week CHIP lifestyle intervention programme followed by a further 9 months of monthly follow-up appointments. Approval for funding was obtained on 30 June 2017. DISCUSSION: The outcomes of this study have the potential to inform decisions about patient treatment and potentially provide incentive for the provision of funded lifestyle-based preventive and restorative programs for patients diagnosed with T2DM. TRIAL REGISTRATION: This trial is registered as an initial version with the Australia New Zealand Clinical Trials Registry (http://www.anzctr.org.au/), registration number ACTRN12617001233314. Registered on 23/08/2017. No enrollments in the study to date.