Type 2 DiabetesFHT HIITNCT04109235
Family Health Team High-Intensity Interval Training
A study testing High-Intensity Interval Training Physical Activity (PA) Advice and Population-Based Physical Activity (PA) Advice in people with Type 2 Diabetes, run by Western University, Canada at 1 site in Canada.
Trial summary
With the rapid shift to virtual care, this pilot study aims to determine the feasibility of prescribing low-duration, interval-based training through virtual care. If successful, this study will inform a larger randomized control trial to determine if the prescription of low-duration interval-based training improves… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- High-Intensity Interval Training Physical Activity (PA) Advice and Population-Based Physical Activity (PA) Advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 13 Feb 2020to 13 Jul 2026
- 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
- adults, at least 18 years of age
- non-pregnant
- having a diagnosis of type 2 diabetes in accordance with the 2018 Diabetes Canada Clinical Practice Guidelines
- capable of consenting
- deemed capable and safe to exercise by their physician (Dr. Fernando)
- without a medical history of myocardial infarction in the past three months.
Who cannot join
- < 18 years of age
- pregnant
- not having a type 2 diabetes diagnosis
- having a medical history of myocardial infarction in the past 3 months
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
East Elgin Family Health Team
Aylmer, Ontario, N5H1K9
Michael Fernando, mfernando@eefht.ca
About this study
Official title: IS SHORT-DURATION, HIGH-INTENSITY-INTERVAL TRAINING (HIIT) SUPERIOR TO POPULATION-BASED MODERATE-INTENSITY PHYSICAL ACTIVITY GUIDELINES FOR INDIVIDUALS WITH TYPE 2 DIABETES? A PILOT STUDY
With the rapid shift to virtual care, this pilot study aims to determine the feasibility of prescribing low-duration, interval-based training through virtual care. If successful, this study will inform a larger randomized control trial to determine if the prescription of low-duration interval-based training improves chronic disease through the measurement of hemoglobin A1C (HbA1C), and weight to a greater extent than the general guideline to aim for 150 minutes of PA weekly.
Read the detailed description
Dr. Fernando will invite patients to participate in this trial during their virtual diabetes appointments at the East Elgin Family Health Team (EEFHT). Participants will be randomized 1:1 using computer-generated randomization software to receive either a population-based, standard activity intervention (control group) or a high-intensity interval training (HIIT) intervention, which they will complete on their own time, at the location of their choosing (at home, gym, outside, or elsewhere). Data will be collected at baseline (T1), and participants will be followed up after 3 months (T2) and 6 months (T3). All data acquisition is from standard of care (i.e. patients are already seen every 3 months for diabetes visits). Data collection at T1, T2 and T3 will include:
- Weight and Height (measured using the Health-O-Meter weigh scale, used to calculate BMI)
- Minutes of PA (self-reported by participants using the log books designed for this study)
- HbA1C (requisition will be provided by Dr. Fernando. Patients will be exempt from completing the baseline HbA1C if they have had a HbA1C measurement in the past 30 days \& the patient has not made significant lifestyle changes or had any blood glucose medications changed; in this case, the measurement completed in the past 30 days will be used as the baseline measure)
- Blood glucose and blood pressure medications
- Conditions
- Type 2 Diabetes
- Being tested
- High-Intensity Interval Training Physical Activity (PA) Advice, Population-Based Physical Activity (PA) Advice
- Keywords
- HbA1C, virtual care, blood glucose, physical activity, HIIT
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval Training Physical Activity (PA) AdviceOther
This PA intervention will be primarily self-directed by the patients themselves. Each participant will receive a 1-page double-sided handout detailing their PA protocol. Participants in this arm will receive a High-Intensity-Interval-Training (HIIT) handout (developed based on research from Dr. Martin Gibala) detailing their PA recommendations. Participants will be instructed to follow their PA protocol, while noting down which days they completed the PA using a log booklet provided to them by Dr. Fernando (their family physician). Participants will be provided with the phone number for a research assistant who is a lifestyle coach and co-investigator on this trial. If participants have questions about their PA protocol, the research assistant will respond to these over the phone.
Population-Based Physical Activity (PA) AdviceOther
This PA intervention will be primarily self-directed by the patients themselves. Each participant will receive a 1-page double-sided handout detailing their PA protocol. Participants in this arm will receive a CSEP handout (page 4\&5 from: http://csep.ca/CMFiles/Guidelines/CSEP_PAGuidelines_0-65plus_en.pdf) detailing their PA recommendations.Participants will be instructed to follow their PA protocol, while noting down which days they completed the PA using a log booklet provided to them by Dr. Fernando (their family physician). Participants will be provided with the phone number for a research assistant who is a lifestyle coach and co-investigator on this trial. If participants have questions about their PA protocol, the research assistant will respond to these over the phone.
| Study group | Role | What they receive |
|---|---|---|
| Population-Based Physical Activity (PA) Advice | Active comparator | This PA intervention will be primarily self-directed by the patients themselves. Each participant will receive a 1-page double-sided handout detailing their PA protocol. Participants in this arm will receive a CSEP handout (page 4\&5 from: http://csep.ca/CMFiles/Guidelines/CSEP_PAGuidelines_0-65plus_en.pdf) detailing their PA recommendations.Participants will be instructed to follow their PA protocol, while noting down which days they completed the PA using a log booklet provided to them by Dr. Fernando (their family physician). Participants will be provided with the phone number for a research assistant who is a lifestyle coach and co-investigator on this trial. If participants have questions about their PA protocol, the research assistant will respond to these over the phone. Receives: Other: Population-Based Physical Activity (PA) Advice |
| High-Intensity Interval Training Physical Activity (PA) Advice | Experimental | This PA intervention will be primarily self-directed by the patients themselves. Each participant will receive a 1-page double-sided handout detailing their PA protocol. Participants in this arm will receive a High-Intensity-Interval-Training (HIIT) handout (developed based on research from Dr. Martin Gibala) detailing their PA recommendations. Participants will be instructed to follow their PA protocol, while noting down which days they completed the PA using a log booklet provided to them by Dr. Fernando (their family physician). Participants will be provided with the phone number for a research assistant who is a lifestyle coach and co-investigator on this trial. If participants have questions about their PA protocol, the research assistant will respond to these over the phone. Receives: Other: High-Intensity Interval Training Physical Activity (PA) Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1C
Glycosylated Hemoglobin measured at lab
Measured: 3-month and 6-month follow-up
Secondary outcomes (2)
Weight
self-reported by participants using home scale
Measured: 3-month and 6-month follow-up
Physical Activity (minutes per week)
self-reported by participants using the log books designed for this study
Measured: 3-month and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start13 Feb 2020
- Primary completion13 Jul 2026 (estimated)
- Study completion13 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- East Elgin Family Health Team
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109235
- Sponsor's protocol ID
- 111930
- Acronym
- FHT HIIT
- Status last verified
- Mar 2024
- First submitted
- 12 Sep 2019
- Last updated
- 12 Mar 2024
- 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IS SHORT-DURATION, HIGH-INTENSITY-INTERVAL TRAINING (HIIT) SUPERIOR TO POPULATION-BASED MODERATE-INTENSITY PHYSICAL ACTIVITY GUIDELINES FOR INDIVIDUALS WITH TYPE 2 DIABETES? A PILOT STUDY
- ClinicalTrials.gov ID
- NCT04109235
- Acronym / sponsor ID
- FHT HIIT / 111930
- Conditions
- Type 2 Diabetes
- Keywords
- HbA1C, virtual care, blood glucose, physical activity, HIIT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- East Elgin Family Health Team
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 13 Jul 2026 (estimated)
- Study completion
- 13 Jul 2026 (estimated)
- First posted
- 30 Sep 2019 (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.
With the rapid shift to virtual care, this pilot study aims to determine the feasibility of prescribing low-duration, interval-based training through virtual care. If successful, this study will inform a larger randomized control trial to determine if the prescription of low-duration interval-based training improves chronic disease through the measurement of hemoglobin A1C (HbA1C), and weight to a greater extent than the general guideline to aim for 150 minutes of PA weekly.
Detailed description
Dr. Fernando will invite patients to participate in this trial during their virtual diabetes appointments at the East Elgin Family Health Team (EEFHT). Participants will be randomized 1:1 using computer-generated randomization software to receive either a population-based, standard activity intervention (control group) or a high-intensity interval training (HIIT) intervention, which they will complete on their own time, at the location of their choosing (at home, gym, outside, or elsewhere). Data will be collected at baseline (T1), and participants will be followed up after 3 months (T2) and 6 months (T3). All data acquisition is from standard of care (i.e. patients are already seen every 3 months for diabetes visits). Data collection at T1, T2 and T3 will include:
- Weight and Height (measured using the Health-O-Meter weigh scale, used to calculate BMI)
- Minutes of PA (self-reported by participants using the log books designed for this study)
- HbA1C (requisition will be provided by Dr. Fernando. Patients will be exempt from completing the baseline HbA1C if they have had a HbA1C measurement in the past 30 days \& the patient has not made significant lifestyle changes or had any blood glucose medications changed; in this case, the measurement completed in the past 30 days will be used as the baseline measure)
- Blood glucose and blood pressure medications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Population-Based Physical Activity (PA) Advice | Active comparator | Other: Population-Based Physical Activity (PA) AdviceThis PA intervention will be primarily self-directed by the patients themselves. Each participant will receive a 1-page double-sided handout detailing their PA protocol. Participants in this arm will receive a CSEP handout (page 4\&5 from: http://csep.ca/CMFiles/Guidelines/CSEP_PAGuidelines_0-65plus_en.pdf) detailing their PA recommendations.Participants will be instructed to follow their PA protocol, while noting down which days they completed the PA using a log booklet provided to them by Dr. Fernando (their family physician). Participants will be provided with the phone number for a research assistant who is a lifestyle coach and co-investigator on this trial. If participants have questions about their PA protocol, the research assistant will respond to these over the phone. |
| High-Intensity Interval Training Physical Activity (PA) Advice | Experimental | Other: High-Intensity Interval Training Physical Activity (PA) AdviceThis PA intervention will be primarily self-directed by the patients themselves. Each participant will receive a 1-page double-sided handout detailing their PA protocol. Participants in this arm will receive a High-Intensity-Interval-Training (HIIT) handout (developed based on research from Dr. Martin Gibala) detailing their PA recommendations. Participants will be instructed to follow their PA protocol, while noting down which days they completed the PA using a log booklet provided to them by Dr. Fernando (their family physician). Participants will be provided with the phone number for a research assistant who is a lifestyle coach and co-investigator on this trial. If participants have questions about their PA protocol, the research assistant will respond to these over the phone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adults, at least 18 years of age
- non-pregnant
- having a diagnosis of type 2 diabetes in accordance with the 2018 Diabetes Canada Clinical Practice Guidelines
- capable of consenting
- deemed capable and safe to exercise by their physician (Dr. Fernando)
Key exclusion criteria (4 listed)
- < 18 years of age
- pregnant
- not having a type 2 diabetes diagnosis
- having a medical history of myocardial infarction in the past 3 months
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 |
|---|---|---|
| High-Intensity Interval Training Physical Activity (PA) AdviceThis PA intervention will be primarily self-directed by the patients themselves. Each participant will receive a 1-page double-sided handout detailing their PA protocol. Participants in this arm will receive a High-Intensity-Interval-Training (HIIT) handout (developed based on research from Dr. Martin Gibala) detailing their PA recommendations. Participants will be instructed to follow their PA protocol, while noting down which days they completed the PA using a log booklet provided to them by Dr. Fernando (their family physician). Participants will be provided with the phone number for a research assistant who is a lifestyle coach and co-investigator on this trial. If participants have questions about their PA protocol, the research assistant will respond to these over the phone. | Other | High-Intensity Interval Training Physical Activity (PA) Advice |
| Population-Based Physical Activity (PA) AdviceThis PA intervention will be primarily self-directed by the patients themselves. Each participant will receive a 1-page double-sided handout detailing their PA protocol. Participants in this arm will receive a CSEP handout (page 4\&5 from: http://csep.ca/CMFiles/Guidelines/CSEP_PAGuidelines_0-65plus_en.pdf) detailing their PA recommendations.Participants will be instructed to follow their PA protocol, while noting down which days they completed the PA using a log booklet provided to them by Dr. Fernando (their family physician). Participants will be provided with the phone number for a research assistant who is a lifestyle coach and co-investigator on this trial. If participants have questions about their PA protocol, the research assistant will respond to these over the phone. | Other | Population-Based Physical Activity (PA) Advice |
Primary outcome
Change in HbA1C
Time frame: 3-month and 6-month follow-up
Glycosylated Hemoglobin measured at lab
2 secondary outcomes
Weight
Time frame: 3-month and 6-month follow-up
Physical Activity (minutes per week)
Time frame: 3-month and 6-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval Training Physical Activity (PA) Advice and Population-Based Physical Activity (PA) Advice in people with Type 2 Diabetes, run by Western University, Canada 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 6 inclusion and 4 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 12 Mar 2024. 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?
Contact Michael Fernando, MD (519-773-3715 ext. 111, mfernando@eefht.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1C (time frame: 3-month and 6-month follow-up). 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 12 Mar 2024.