Impact of Two Lifestyle Strategies for Improving Diabetes Related Health Outcomes in a Specialty Care Setting: A Randomized Controlled Trial

This is a single-center, prospective, unblinded, randomized, controlled, clinical trial of 200 subjects randomized to either a Supervised Training Program (STP), Incentivized Weight Loss (IWL) or Standard of Care (SoC).

Subjects randomized to the SoC group will be asked to return for regular 3-monthly clinic visits and for diet and exercise recommendations.The STP group will be offered once-weekly one hour supervised training sessions at no charge for a period of six months in the bcdiabetes.ca fitness center (located in the Vancouver General Hospital Employee Centre gym).

The IWL group will receive a financial reward for achieving monthly weight loss targets. Those who fail to meet their monthly goals will receive no financial reward. Such financial incentives have been considered in previous research. Due to the nature of the intervention, none of the investigative staff, trainers or subjects will be blinded to randomized assignment.

The primary objective of this study is to investigate whether a behavioral modification intervention in the form of either a 6-month supervised training program or a 6-month financial incentive program, results in overall superior clinical outcomes in comparison to standard of care. Specifically, improvement in glucose control, measured by A1c, will be considered. Given the objective nature of the Primary Outcome, there is little possibility of assessment bias of the primary or clinical outcomes.The secondary objective is to investigate the impact of a supervised training program and an incentivized weight loss program on weight-loss, LDL (apoB), blood pressure, waist-hip circumference, and diabetes-specific quality of life measures including behavioral and emotional impact (refer to Secondary Outcomes section).

Patients attending BCDiabetes ( Diabetes Clinic at Diamond Center )will be approached by one of their diabetes caregivers who will describe the study and determine whether they have interest in participating. If the patient expresses an interest, they will be provided additional information and a study consent form and be free to ask questions about the study. They may choose to provide consent at the time or to leave with the consent form and return at a later time to ask further questions. A research nurse, coordinator and/or co/principal investigator will be available to answer any questions the patient may have. When consent is provided, confirmation of the eligibility criteria will be completed and the subject will receive their randomized group assignment.