Diabetes type2CDPPNCT05784220
The Canadian Diabetes Prevention Program
A study testing DPP Curriculum for Lifestyle Intervention in people with Diabetes type2, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes type2
- What is being tested?
- DPP Curriculum for Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,174 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jun 2019to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.);
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Type 2 Diabetes Using a Digital Wellness Coaching Intervention: The Canadian Diabetes Prevention Program
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.
Read the 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
- Being tested
- DPP Curriculum for Lifestyle Intervention
- Keywords
- Diabetes, Pre-diabetes, Diabetes prevention
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPP Curriculum for Lifestyle InterventionBehavioural
See arms.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: DPP Curriculum for Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight assessed by a scale
Measured: 12 months from baseline
Change in weight assessed by a scale
Measured: 18 months from baseline
BMI < 25.0 and/or weight loss ≥ 5.0%
Measured: 12 months from baseline
BMI < 25.0 and/or weight loss ≥ 5.0%
Measured: 18 months from baseline
Change in waist circumference assessed by measurement in waist circumference
Measured: 12 months from baseline
> 3% and ≥ 5% reduction in waist circumference
Measured: 12 months from baseline
> 3% and ≥ 5% reduction in waist circumference
Measured: 18 months from baseline
A1c at final visit <6.5% measured by lab test
Measured: 12 months from baseline
A1c at final visit <6.5% measured by lab test
Measured: 18 months from baseline
Fasting blood glucose at final visit < 7 mmol/L measured by lab test
Measured: 12 months from baseline
Fasting blood glucose at final visit < 7 mmol/L measured by lab test
Measured: 8 months from baseline
Secondary outcomes (20)
Number of participants in each category and sub-category (of each question) of CANRISK Questionnaire
Measured: Baseline, 6 months and 12 months
Number of participants that are diagnosed with prediabetes vs. at high risk
Measured: Baseline, 6 months and 12 months
The number of people who develop diabetes during the program
Measured: 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.
Measured: Baseline
Intervention reach assessed by postal code
Measured: Baseline
Participants knowledge about disease risk factors and lifestyle change assessed through the Knowledge Questionnaire
Measured: Baseline, 6 months and 12 months
The proportion of individuals who lower their risk of diabetes (CANRISK score)
Measured: 6 months and 12 months
The proportion of participants who had an improvement in quality of life assessed by the SF-12 Questionnaire
Measured: 6 months and 12 months
The proportion of participants who had a change in diet, based on ASA-24 Questionnaire
Measured: 6 months and 12 months
The number of participants in each category of the stages of change assessed by the Stages of Change Questionnaire
Measured: Baseline, 6 months and 12 months
Participants change in the stage of change assessed by Stages of Change Questionnaire
Measured: 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
Measured: 9 months
Participant satisfaction by Participant Satisfaction Survey and Post Program Interview
Measured: 6 months and 12 months
The proportion of participants who had a change in physical activity
Measured: 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.
Measured: 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)
Measured: 12 months
Change in HDL
Measured: 12 months
Change in triglycerides
Measured: 12 months
Proportion of subjects with improvement of triglyceride levels within normal limit for the lab
Measured: 12 months
Change in blood pressure
Both systolic and diastolic blood pressure will be measured.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start21 Jun 2019
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes type2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,174 participants (actual)
Sponsor and investigators
- Lead sponsor
- LMC Diabetes & Endocrinology Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC)
- Responsible party
- Principal investigator, Dr. Harpreet Bajaj, LMC Diabetes & Endocrinology Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784220
- Sponsor's protocol ID
- CDPP
- Acronym
- CDPP
- Status last verified
- Mar 2023
- First submitted
- 22 Oct 2021
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Type 2 Diabetes Using a Digital Wellness Coaching Intervention: The Canadian Diabetes Prevention Program
- ClinicalTrials.gov ID
- NCT05784220
- Acronym / sponsor ID
- CDPP / CDPP
- Conditions
- Diabetes type2
- Keywords
- Diabetes, Pre-diabetes, Diabetes prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,174 participants (actual)
- Lead sponsor
- LMC Diabetes & Endocrinology Ltd.University, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC)
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DPP | Other | Behavioral: DPP Curriculum for Lifestyle InterventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.);
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DPP Curriculum for Lifestyle InterventionSee arms. | Behavioural | DPP |
Primary outcome
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
20 secondary outcomes
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.
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
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.
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
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DPP Curriculum for Lifestyle Intervention in people with Diabetes type2, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight assessed by a scale (time frame: 12 months from baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.