The Canadian Diabetes Prevention Program

NCT ID: NCT05784220

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-21
• Study Completion Date: 2023-09-30

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.

Conditions

Diabetes type2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

DPP

The CDC Diabetes Prevention Program (DPP) curriculum for lifestyle intervention, including 21 education topics delivered via text-based education module, and follow-up telephone health coaching call for each topic.

Group Type: OTHER

DPP Curriculum for Lifestyle Intervention

Intervention Type: BEHAVIORAL

See arms.

Interventions

DPP Curriculum for Lifestyle Intervention

See arms.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Public Health Agency of Canada (PHAC)

OTHER_GOV

Sponsor Role: collaborator

LMC Diabetes & Endocrinology Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Dr. Harpreet Bajaj

Endocrinologist and Director of Late-Phase Research, LMC Healthcare

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

LMC Diabetes Ltd

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

CDPP

Identifier Type: -

Identifier Source: org_study_id