Clinical trial NCT05784220: The Canadian Diabetes Prevention Program
Official title: Prevention of Type 2 Diabetes Using a Digital Wellness Coaching Intervention: The Canadian Diabetes Prevention Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes type2
Keywords: Diabetes
Pre-diabetes
Diabetes prevention
Lead sponsor: LMC Diabetes & Endocrinology Ltd.
Sponsor class: OTHER
Collaborators: name: Public Health Agency of Canada (PHAC)
First posted: 2023-03-24
Enrollment: 2174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.);

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in weight assessed by a scale
timeFrame: 12 months from baseline
measure: Change in weight assessed by a scale
timeFrame: 18 months from baseline
measure: BMI < 25.0 and/or weight loss ≥ 5.0%
timeFrame: 12 months from baseline
measure: BMI < 25.0 and/or weight loss ≥ 5.0%
timeFrame: 18 months from baseline
measure: Change in waist circumference assessed by measurement in waist circumference
timeFrame: 12 months from baseline
measure: > 3% and ≥ 5% reduction in waist circumference
timeFrame: 12 months from baseline
measure: > 3% and ≥ 5% reduction in waist circumference
timeFrame: 18 months from baseline
measure: A1c at final visit <6.5% measured by lab test
timeFrame: 12 months from baseline
measure: A1c at final visit <6.5% measured by lab test
timeFrame: 18 months from baseline
measure: Fasting blood glucose at final visit < 7 mmol/L measured by lab test
timeFrame: 12 months from baseline
measure: Fasting blood glucose at final visit < 7 mmol/L measured by lab test
timeFrame: 8 months from baseline
Secondary outcomes:
measure: Number of participants in each category and sub-category (of each question) of CANRISK Questionnaire
timeFrame: Baseline, 6 months and 12 months
measure: Number of participants that are diagnosed with prediabetes vs. at high risk
timeFrame: Baseline, 6 months and 12 months
measure: The number of people who develop diabetes during the program
timeFrame: 6 months and 12 months
measure: Effectiveness of recruitment channels.
timeFrame: Baseline
measure: Intervention reach assessed by postal code
timeFrame: Baseline
measure: Participants knowledge about disease risk factors and lifestyle change assessed through the Knowledge Questionnaire
timeFrame: Baseline, 6 months and 12 months
measure: The proportion of individuals who lower their risk of diabetes (CANRISK score)
timeFrame: 6 months and 12 months
measure: The proportion of participants who had an improvement in quality of life assessed by the SF-12 Questionnaire
timeFrame: 6 months and 12 months
measure: The proportion of participants who had a change in diet, based on ASA-24 Questionnaire
timeFrame: 6 months and 12 months
measure: The number of participants in each category of the stages of change assessed by the Stages of Change Questionnaire
timeFrame: Baseline, 6 months and 12 months
measure: Participants change in the stage of change assessed by Stages of Change Questionnaire
timeFrame: 6 months and 12 months
measure: The number of participants who completed the program
timeFrame: 9 months
measure: Participant satisfaction by Participant Satisfaction Survey and Post Program Interview
timeFrame: 6 months and 12 months
measure: The proportion of participants who had a change in physical activity
timeFrame: 6 months and 12 months
measure: The proportion of participants who report a minimum of 150 minutes of moderate- to vigorous-intensity of physical activity spread across the week.
timeFrame: Baseline, 6 months and 12 months
measure: Change in LDL-c and non-HDL (subgroup analyses for people on cholesterol lowering medications vs. no cholesterol lowering medications during the project)
timeFrame: 12 months
measure: Change in HDL
timeFrame: 12 months
measure: Change in triglycerides
timeFrame: 12 months
measure: Proportion of subjects with improvement of triglyceride levels within normal limit for the lab
timeFrame: 12 months
measure: Change in blood pressure
timeFrame: 12 months
Other outcomes:
measure: The number of reported technical issues related to software
timeFrame: 12 months
measure: Level of participant engagement
timeFrame: 6 months and 12 months
measure: Issues with delivery by service providers
timeFrame: 12 months from baseline
measure: Subjective scoring of program coach audits
timeFrame: 12 months from baseline
measure: Objective scoring of program coach audits
timeFrame: 12 months from baseline
Locations:
city: Toronto
country: Canada
facility: LMC Diabetes Ltd
state: Ontario
Study officials:
References: