Prevention of Type 2 Diabetes Using a Digital Wellness Coaching Intervention: The Canadian Diabetes Prevention Program
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,174
- 试验地点
- 2
- 主要终点
- Change in weight assessed by a scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
No masking
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Score of 33 or higher using the Canadian Diabetes Risk Assessment (CANRISK) Questionnaire (aged 18 to 74) or;
- •Age ≥ 45 and BMI ≥ 30 or;
- •Or diagnosed with prediabetes age 18 years or older with an A1c of 6.0-6.4% and/or fasting glucose 6.1-6.9 mmol/L and;
- •Access to phone and internet (options include: home, work, friend's home, relative's home, public library, etc.);
排除标准
- •Diagnosis of diabetes
- •Any glucose lowering medication
- •Any prescribed weight loss medication
- •Receiving oral/systemic glucocorticoid (steroid) therapy (not including inhalers or nasal sprays) within the past 3 months, or planning to initiate oral/systemic glucocorticoid (steroid) in the next 3 months
- •History of acute or chronic pancreatitis
- •History of an active or untreated malignancy or in remission from a clinically significant malignancy for less than 5 years
- •History of hemoglobinopathy, which may affect HbA1c measurement
- •Currently enrolled in a clinical trial involving an investigational drug (need to be free of study medication for 30 days after final visit)
- •Pregnancy or becoming pregnant during the study (the participant would be excluded due to weight gain and increased of waist circumference as they contradict the outcomes of the study)
- •Dementia/severe cognitive impairment (the study does not have the proper support staff to support participants with specific needs)
- •Inability to read English or French, or with personal or family support to interpret material
- •Outside the catchment area for lab services (blood and anthropometric collection)
- •Weight at baseline greater than upper limit of the scale used
结局指标
主要结局
Change in weight assessed by a scale
时间窗: 18 months from baseline
A1c at final visit <6.5% measured by lab test
时间窗: 18 months from baseline
Change in waist circumference assessed by measurement in waist circumference
时间窗: 12 months from baseline
BMI < 25.0 and/or weight loss ≥ 5.0%
时间窗: 18 months from baseline
Fasting blood glucose at final visit < 7 mmol/L measured by lab test
时间窗: 8 months from baseline
> 3% and ≥ 5% reduction in waist circumference
时间窗: 18 months from baseline
次要结局
- Change in HDL(12 months)
- Number of participants that are diagnosed with prediabetes vs. at high risk(Baseline, 6 months and 12 months)
- Intervention reach assessed by postal code(Baseline)
- The proportion of individuals who lower their risk of diabetes (CANRISK score)(6 months and 12 months)
- Number of participants in each category and sub-category (of each question) of CANRISK Questionnaire(Baseline, 6 months and 12 months)
- The number of people who develop diabetes during the program(6 months and 12 months)
- The proportion of participants who had a change in diet, based on ASA-24 Questionnaire(6 months and 12 months)
- Effectiveness of recruitment channels.(Baseline)
- Participants change in the stage of change assessed by Stages of Change Questionnaire(6 months and 12 months)
- The proportion of participants who had a change in physical activity(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.(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)(12 months)
- Change in blood pressure(12 months)
- Participants knowledge about disease risk factors and lifestyle change assessed through the Knowledge Questionnaire(Baseline, 6 months and 12 months)
- The number of participants in each category of the stages of change assessed by the Stages of Change Questionnaire(Baseline, 6 months and 12 months)
- Proportion of subjects with improvement of triglyceride levels within normal limit for the lab(12 months)
- The proportion of participants who had an improvement in quality of life assessed by the SF-12 Questionnaire(6 months and 12 months)
- The number of participants who completed the program(9 months)
- Participant satisfaction by Participant Satisfaction Survey and Post Program Interview(6 months and 12 months)
- Change in triglycerides(12 months)
研究者
Dr. Harpreet Bajaj
Endocrinologist and Director of Late-Phase Research, LMC Healthcare
LMC Diabetes & Endocrinology Ltd.