According to Diabetes Canada ("DC"), in 2015, the estimated prevalence of prediabetes in Canada (\>20 years of age) is 5.7 million people (22.1%). This rate is estimated to increase to 6.4 million people (23.2%) by 2025. Risk factors contributing to prediabetes and consequently Type 2 Diabetes include rising obesity rates, lack of physical activity, an aging population, and the cultural diversity of Canada . There is convincing evidence that modifiable risk factors, such as diet and physical activity reduce the development of Type 2 Diabetes with the benefits extending beyond the active intervention stage. The underlying theory that supports this intervention relates to the imperative need to focus on weight loss and physical activity, with this population that is at risk of developing diabetes, due to its relationship with insulin resistance. DC outlines the importance of intensive and structured lifestyle modification to promote weight loss in order to reduce the progression of prediabetes to diabetes.
INTRODUCTION: LMC Healthcare, in collaboration with Diabetes Canada and INTERVENT International, is inviting participants to be part of a new program called the Canadian Diabetes Prevention Program ("CDPP") aimed at reducing the risk of developing Type 2 Diabetes. Participants can join the CDPP if participants have been diagnosed with prediabetes or participants score 33 or above on the CANRISK Questionnaire (a validated tool used to assess diabetes risk). Information collected from the CDPP will be used for research purposes. BACKGROUND / RATIONALE: According to Diabetes Canada ("DC"), in 2015, the estimated number of people with prediabetes in Canada (\>20 years of age) was 5.7 million people (22.1%). Prediabetes can be defined as people with a blood sugar level that is higher than normal but not high enough to be diagnosed with diabetes; these people are at high risk for developing diabetes. This rate is estimated to increase to 6.4 million people (23.2%) by 2025. Risk factors contributing to prediabetes and consequently type 2 diabetes include rising obesity rates, lack of physical activity, an aging population, and the cultural diversity of Canada. There is convincing evidence that modifiable risk factors, such as diet and physical activity reduce the development of Type 2 Diabetes with the benefits extending beyond the active intervention stage. The underlying theory that supports this intervention relates to the imperative need to focus on weight loss and physical activity, with this population that is at risk of developing diabetes, due to its relationship with insulin resistance. DC outlines the importance of intensive and structured lifestyle modification to promote weight loss in order to reduce the progression of prediabetes to diabetes. The proposed intervention would target participants who are identified as "at risk" using the Canadian Diabetes Risk Assessment Questionnaire (CANRISK) or those participants who have been diagnosed with prediabetes based on blood work. PURPOSE/OBJECTIVE: To reduce the risk of developing Type 2 Diabetes Mellitus by taking part in a 12-month lifestyle intervention program. A select group of participants, 452 participants, will have a follow up at 18 months to assess a post-study progression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
2,174
See arms.
LMC Diabetes Ltd
Toronto, Ontario, Canada
Change in weight assessed by a scale
Time frame: 12 months from baseline
Change in weight assessed by a scale
Time frame: 18 months from baseline
BMI < 25.0 and/or weight loss ≥ 5.0%
Time frame: 12 months from baseline
BMI < 25.0 and/or weight loss ≥ 5.0%
Time frame: 18 months from baseline
Change in waist circumference assessed by measurement in waist circumference
Time frame: 12 months from baseline
> 3% and ≥ 5% reduction in waist circumference
Time frame: 12 months from baseline
> 3% and ≥ 5% reduction in waist circumference
Time frame: 18 months from baseline
A1c at final visit <6.5% measured by lab test
Time frame: 12 months from baseline
A1c at final visit <6.5% measured by lab test
Time frame: 18 months from baseline
Fasting blood glucose at final visit < 7 mmol/L measured by lab test
Time frame: 12 months from baseline
Fasting blood glucose at final visit < 7 mmol/L measured by lab test
Time frame: 8 months from baseline
Number of participants in each category and sub-category (of each question) of CANRISK Questionnaire
Time frame: Baseline, 6 months and 12 months
Number of participants that are diagnosed with prediabetes vs. at high risk
Time frame: Baseline, 6 months and 12 months
The number of people who develop diabetes during the program
Time frame: 6 months and 12 months
Effectiveness of recruitment channels.
The following choices will be given to participants to fill out and the participant will be able to choose all that apply: doctor or health care provider, social media (facebook, instagram, twitter) google/internet search, employer, recommendation from family/friend, and/or other.
Time frame: Baseline
Intervention reach assessed by postal code
Time frame: Baseline
Participants knowledge about disease risk factors and lifestyle change assessed through the Knowledge Questionnaire
Time frame: Baseline, 6 months and 12 months
The proportion of individuals who lower their risk of diabetes (CANRISK score)
Time frame: 6 months and 12 months
The proportion of participants who had an improvement in quality of life assessed by the SF-12 Questionnaire
Time frame: 6 months and 12 months
The proportion of participants who had a change in diet, based on ASA-24 Questionnaire
Time frame: 6 months and 12 months
The number of participants in each category of the stages of change assessed by the Stages of Change Questionnaire
Time frame: Baseline, 6 months and 12 months
Participants change in the stage of change assessed by Stages of Change Questionnaire
Time frame: 6 months and 12 months
The number of participants who completed the program
A completed participant is defined as someone who attended 56% of their sessions in the first 6 months of intervention, and at least 50% of their sessions in the last 6 months of their intervention, and has been in the program for a minimum of 9 months in total
Time frame: 9 months
Participant satisfaction by Participant Satisfaction Survey and Post Program Interview
Time frame: 6 months and 12 months
The proportion of participants who had a change in physical activity
Time frame: 6 months and 12 months
The proportion of participants who report a minimum of 150 minutes of moderate- to vigorous-intensity of physical activity spread across the week.
The INTERVENT platform has the ability to measure participants' steps if they have a step-counter; therefore, the amount of time will be identified as self-reported or through a step counter.
Time frame: Baseline, 6 months and 12 months
Change in LDL-c and non-HDL (subgroup analyses for people on cholesterol lowering medications vs. no cholesterol lowering medications during the project)
Time frame: 12 months
Change in HDL
Time frame: 12 months
Change in triglycerides
Time frame: 12 months
Proportion of subjects with improvement of triglyceride levels within normal limit for the lab
Time frame: 12 months
Change in blood pressure
Both systolic and diastolic blood pressure will be measured.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.