The Canadian Diabetes Prevention Program

NCT05784220 | Unknown

• 1 other identifier: CDPP
• Study Type: interventional
• Target: 2,174
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes type2

Keywords

Diabetes; Pre-diabetes; Diabetes prevention

Outcome Measures

Primary Outcomes (11)

• Change in weight assessed by a scale

  12 months from baseline

• Change in weight assessed by a scale

  18 months from baseline

• BMI < 25.0 and/or weight loss ≥ 5.0%

  12 months from baseline

• BMI < 25.0 and/or weight loss ≥ 5.0%

  18 months from baseline

• Change in waist circumference assessed by measurement in waist circumference

  12 months from baseline

• > 3% and ≥ 5% reduction in waist circumference

  12 months from baseline

• > 3% and ≥ 5% reduction in waist circumference

  18 months from baseline

• A1c at final visit <6.5% measured by lab test

  12 months from baseline

• A1c at final visit <6.5% measured by lab test

  18 months from baseline

• Fasting blood glucose at final visit < 7 mmol/L measured by lab test

  12 months from baseline

• Fasting blood glucose at final visit < 7 mmol/L measured by lab test

  8 months from baseline

Secondary Outcomes (20)

• Number of participants in each category and sub-category (of each question) of CANRISK Questionnaire

  Baseline, 6 months and 12 months

• Number of participants that are diagnosed with prediabetes vs. at high risk

  Baseline, 6 months and 12 months

• The number of people who develop diabetes during the program

  6 months and 12 months

• Effectiveness of recruitment channels.

  Baseline

• Intervention reach assessed by postal code

  Baseline

Other Outcomes (5)

• The number of reported technical issues related to software

  12 months

• Level of participant engagement

  6 months and 12 months

• Issues with delivery by service providers

  12 months from baseline

Study Arms (1)

DPP

OTHER

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.

Behavioral: DPP Curriculum for Lifestyle Intervention

Interventions

DPP Curriculum for Lifestyle Intervention BEHAVIORAL

See arms.

DPP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.);

You may not qualify if:

• 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

Sponsors & Collaborators

• LMC Diabetes & Endocrinology Ltd.: lead
• Public Health Agency of Canada (PHAC): collaborator

Study Sites (1)

LMC Diabetes Ltd

Toronto, Ontario, M4G 3E8, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Intolerance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrinologist and Director of Late-Phase Research, LMC Healthcare

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: March 24, 2023
• Study Start: June 21, 2019
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

CA (1)