Type 2 DiabetesNCT06407245
Efficacy of Exercise Snacks in Real-World Settings in Individuals Living With Type 2 Diabetes
A study testing Exercise Snacks in people with Type 2 Diabetes, run by University of British Columbia at 1 site in Canada.
Trial summary
To conduct a pilot randomized control trial to determine the feasibility of a 12-week, technology-enabled exercise snacks intervention in adults living with type 2 diabetes in a real-world setting. We will also assess preliminary efficacy based on measures of glycemic control and fitness. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Exercise Snacks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 20 Apr 2024to 19 Jul 2025
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 30-75 years.
- Have physician-diagnosed type 2 diabetes.
- Physically inactive (performing <150 min moderate-to-vigorous physical activity per week).
- Body mass index: 18.5-40 kg/m2.
- Taking ≤3 glucose-lowering medications (excluding insulin) and stable dose for > 6 months.
- Taking ≤2 commonly prescribed cardiovascular medications (e.g., statins, antihypertensive).
Show all 11Show fewer
- HbA1c ≤8.5%.
- Able to maintain current physical activity patterns during the study.
- Cleared to engage in physical activity using the Get Active Questionnaire and, if applicable, consultation with a health care provider or Qualified Exercise Professional.
- Access to a computer, tablet or smartphone for intervention delivery and tracking.
- Ability to read and write in English.
Who cannot join
- Chronic musculoskeletal condition or recent (within 2 years) cardiovascular event preventing participation in exercise.
- Lack of internet access.
- Angina upon exertion assessed by the Rose Angina Questionnaire.
- Prescribed beta-blockers that can compromise the validity of heart rate measurements. during the submaximal exercise test.
- Have uncontrolled high blood pressure (hypertension; ≥ 160/90 mmHg) or an atypical blood pressure or pulse rate at rest or during exercise as determined by a physician.
- Have a scheduled surgical procedure within the next 3-4 months that would prevent exercise participation.
Show all 15Show fewer
- Currently diagnosed with a cardiac or pulmonary disease (e.g., angina, arrythmia, exercise-induced bronchospasm) that would prevent exercise participation.
- Have a psychiatric disorder that could prevent you from completing the study procedures or visits.
- Have donated more than 0.5 L of blood within the last 4 weeks.
- Currently following an extreme diet (e.g., very low carbohydrate/calorie, ketogenic) or taking dietary/nutritional supplements that impact glucose control (e.g., exogenous ketones).
- Currently have diabetic ulcers, peripheral vascular disease, or diabetic neuropathy that will prevent participation in exercise.
- Currently participating in another clinical trial that interferes with the study procedures.
- Currently on dialysis.
- Currently pregnant or planning on becoming pregnant during the intervention (i.e., within the next 4 months).
- Have had an episode of severe hypoglycemia in the past 6 months (defined as having neurological symptoms consistent with neuroglycopenia and required assistance in treatment by a second party).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia Okanagan
Kelowna, British Columbia, V1V 3G1
Jonathan Little, PhD, 2508079876, jonathan.little@ubc.ca
2508079876, jonathan.little@ubc.ca
About this study
To conduct a pilot randomized control trial to determine the feasibility of a 12-week, technology-enabled exercise snacks intervention in adults living with type 2 diabetes in a real-world setting. We will also assess preliminary efficacy based on measures of glycemic control and fitness.
Read the detailed description
Participants will be randomized into an Exercise Snacks or a Placebo Exercise group for 12 weeks. The former will involve bodyweight exercises performed with vigorous effort and the latter will involve low-intensity exercises. Following baseline testing, individualized interventions will be delivered at home or work via customized mobile application ("app") or web platform. Participants will be instructed to perform a minimum of 4 isolated bouts of prescribed exercises per day on at least 5 days per week. Each bout will be one minute in duration. The interventions will be individualized and consider exercise preferences and physical abilities (e.g., fitness, musculoskeletal issues), and be adaptable to multiple environments (e.g., home, work). To facilitate this, participants will have a pre-intervention meeting wherein any physical limitations will be documented, and a research assistant will discuss the prescribed intervention and determine when and where the participants will plan to perform their exercises. After 12 weeks, participants will be asked to return to the lab for follow-up testing.
- Conditions
- Type 2 Diabetes
- Being tested
- Exercise Snacks, Placebo Exercise
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise SnacksOther
The "movement breaks" will be individualized to exercise preferences and physical abilities (e.g., fitness, musculoskeletal issues) and adaptable to multiple environments (e.g., home, work) delivered via mobile phone application.
Placebo ExerciseOther
The "movement breaks" will be individualized to exercise preferences and physical abilities (e.g., fitness, musculoskeletal issues) and adaptable to multiple environments (e.g., home, work) delivered via mobile phone application.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Snacks | Experimental | Vigorous-intensity bodyweight exercises performed 4 times per day on at least 5 days per week. Receives: Other: Exercise Snacks |
| Placebo Exercise | Active comparator | Low-intensity stretching exercises performed 4 times per day on at least 5 days per week. Receives: Other: Placebo Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the number of individuals living with type 2 diabetes that are eligible to participate in the trial
The number of participants approached and reasons for not joining the study.
Measured: NA (recruitment period)
Determine the number of eligible individuals who would be willing to take part in this trial
The number of patients who enrol.
Measured: NA (recruitment period)
Determine the number and percentage of participants retained after the 12-week intervention
Number and percentage of patients who drop-out and reasons.
Measured: after the 12-week intervention
Determine the number of one-minute exercise bouts performed during the 12-week intervention
Number of exercise bouts performed each week of the intervention.
Measured: during the 12 weeks
Secondary outcomes (14)
Change in glycated hemoglobin measured before and after the 12-week intervention
Glycated hemoglobin (A1c) at baseline and after 12 weeks.
Measured: 0-12 weeks
Change in fasting glucose measured before and after the 12-week intervention
Fasting glucose measured at baseline and after the 12-week intervention.
Measured: 0-12 weeks
Change in fasting insulin measured before and after the 12-week intervention
Fasting insulin measured at baseline and after the 12-week intervention
Measured: 0-12 weeks
Change in 24h glucose concentration
Average of 24h glucose value measured with continuous glucose monitor at week 0 and week 11 of the intervention.
Measured: before (week 0; before the intervention) and week 11 of the intervention
Change in cardiorespiratory fitness measured before and after the 12-week intervention
Submaximal YMCA cycle ergometer test to estimate VO2 peak.
Measured: 0-12 weeks
Change in lower body muscular endurance measured before and after the 12-week intervention
The 30-second sit-to-stand pre- and post-intervention.
Measured: 0-12 weeks
Change in upper body maximal strength measured before and after the 12-week intervention
Grip strength test using a hand dynamometer pre- and post-intervention
Measured: 0-12 weeks
Change in body composition measured before and after the 12-week intervention
Waist circumference, weight and body mass index assessed pre- and post- intervention.
Measured: 0-12 weeks
Change in blood pressure measured before and after the 12-week intervention
Seated systolic and diastolic blood pressure measured before and after the 12-week intervention.
Measured: 0-12 weeks
Change in blood lipid profile measured before and after the 12-week intervention
Total cholesterol, high-density lipoprotein (HDL) cholesterol, Non-HDL cholesterol, low-density lipoprotein (LDL) cholesterol, and Triglycerides.
Measured: 0-12 weeks
Change in complete blood count measured before and after the 12-week intervention
Red blood cells, white blood cells, haemoglobin, haematocrit, and platelet.
Measured: 0-12 weeks
Change in plasma inflammatory cytokines measured before and after the 12-week intervention
TNF-α, IL-6, IL-10, CRP
Measured: 0-12 weeks
Change in health-related quality of life measured before and after the 12-week intervention
Euro Quality of Life 5 Dimension 5 Level (EQ-5D-5L) questionnaire pre- and post-intervention
Measured: 0-12 weeks
Changes in diabetes distress measured before and after the intervention 12-week intervention
Diabetes Distress Scale (DDS) questionnaire pre- and post-intervention
Measured: 0-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start20 Apr 2024
- Primary completion19 Jul 2025 (estimated)
- Study completion19 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Principal investigator, Jonathan Little, University of British Columbia
- Investigators
- Jonathan Little, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407245
- Sponsor's protocol ID
- H24-03417
- Status last verified
- May 2024
- First submitted
- 19 Apr 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Babir FJ, Marcotte-Chenard A, Sandilands RE, Falkenhain K, Mulkewich N, Islam H, McCarthy SF, Richards DL, Madden K, Singer J, Riddell MC, Jung ME, Gibala MJ, Little JP. Exercise Snacks Are Feasible to Perform in the Real World and Improve Physical Capacity for Adults Living With Non-Insulin Treated Type 2 Diabetes: A Randomised Trial. Diabetes Obes Metab. 2026 Jul 25. doi: 10.1111/dom.71052. Online ahead of print.
PubMed 42502209
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Exercise Snacks in Real-World Settings in Individuals Living With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06407245
- Acronym / sponsor ID
- H24-03417
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 19 Jul 2025 (estimated)
- Study completion
- 19 Jul 2025 (estimated)
- First posted
- 9 May 2024 (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.
To conduct a pilot randomized control trial to determine the feasibility of a 12-week, technology-enabled exercise snacks intervention in adults living with type 2 diabetes in a real-world setting. We will also assess preliminary efficacy based on measures of glycemic control and fitness.
Detailed description
Participants will be randomized into an Exercise Snacks or a Placebo Exercise group for 12 weeks. The former will involve bodyweight exercises performed with vigorous effort and the latter will involve low-intensity exercises. Following baseline testing, individualized interventions will be delivered at home or work via customized mobile application ("app") or web platform. Participants will be instructed to perform a minimum of 4 isolated bouts of prescribed exercises per day on at least 5 days per week. Each bout will be one minute in duration. The interventions will be individualized and consider exercise preferences and physical abilities (e.g., fitness, musculoskeletal issues), and be adaptable to multiple environments (e.g., home, work). To facilitate this, participants will have a pre-intervention meeting wherein any physical limitations will be documented, and a research assistant will discuss the prescribed intervention and determine when and where the participants will plan to perform their exercises. After 12 weeks, participants will be asked to return to the lab for follow-up testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Snacks | Experimental | Other: Exercise SnacksVigorous-intensity bodyweight exercises performed 4 times per day on at least 5 days per week. |
| Placebo Exercise | Active comparator | Other: Placebo ExerciseLow-intensity stretching exercises performed 4 times per day on at least 5 days per week. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 30-75 years.
- Have physician-diagnosed type 2 diabetes.
- Physically inactive (performing <150 min moderate-to-vigorous physical activity per week).
- Body mass index: 18.5-40 kg/m2.
- Taking ≤3 glucose-lowering medications (excluding insulin) and stable dose for > 6 months.
Key exclusion criteria (15 listed)
- Chronic musculoskeletal condition or recent (within 2 years) cardiovascular event preventing participation in exercise.
- Lack of internet access.
- Angina upon exertion assessed by the Rose Angina Questionnaire.
- Prescribed beta-blockers that can compromise the validity of heart rate measurements. during the submaximal exercise test.
- Have uncontrolled high blood pressure (hypertension; ≥ 160/90 mmHg) or an atypical blood pressure or pulse rate at rest or during exercise as determined by a physician.
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 |
|---|---|---|
| Exercise SnacksThe "movement breaks" will be individualized to exercise preferences and physical abilities (e.g., fitness, musculoskeletal issues) and adaptable to multiple environments (e.g., home, work) delivered via mobile phone application. | Other | Exercise Snacks |
| Placebo ExerciseThe "movement breaks" will be individualized to exercise preferences and physical abilities (e.g., fitness, musculoskeletal issues) and adaptable to multiple environments (e.g., home, work) delivered via mobile phone application. | Other | Placebo Exercise |
Primary outcome
Determine the number of individuals living with type 2 diabetes that are eligible to participate in the trial
Time frame: NA (recruitment period)
The number of participants approached and reasons for not joining the study.
Determine the number of eligible individuals who would be willing to take part in this trial
Time frame: NA (recruitment period)
The number of patients who enrol.
Determine the number and percentage of participants retained after the 12-week intervention
Time frame: after the 12-week intervention
Number and percentage of patients who drop-out and reasons.
Determine the number of one-minute exercise bouts performed during the 12-week intervention
Time frame: during the 12 weeks
Number of exercise bouts performed each week of the intervention.
14 secondary outcomes
Change in glycated hemoglobin measured before and after the 12-week intervention
Time frame: 0-12 weeks
Change in fasting glucose measured before and after the 12-week intervention
Time frame: 0-12 weeks
Change in fasting insulin measured before and after the 12-week intervention
Time frame: 0-12 weeks
Change in 24h glucose concentration
Time frame: before (week 0; before the intervention) and week 11 of the intervention
Change in cardiorespiratory fitness measured before and after the 12-week intervention
Time frame: 0-12 weeks
Change in lower body muscular endurance measured before and after the 12-week intervention
Time frame: 0-12 weeks
Change in upper body maximal strength measured before and after the 12-week intervention
Time frame: 0-12 weeks
Change in body composition measured before and after the 12-week intervention
Time frame: 0-12 weeks
Change in blood pressure measured before and after the 12-week intervention
Time frame: 0-12 weeks
Change in blood lipid profile measured before and after the 12-week intervention
Time frame: 0-12 weeks
Change in complete blood count measured before and after the 12-week intervention
Time frame: 0-12 weeks
Change in plasma inflammatory cytokines measured before and after the 12-week intervention
Time frame: 0-12 weeks
Change in health-related quality of life measured before and after the 12-week intervention
Time frame: 0-12 weeks
Changes in diabetes distress measured before and after the intervention 12-week intervention
Time frame: 0-12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Derived from this study: PubMed 42502209Babir FJ, Marcotte-Chenard A, Sandilands RE, Falkenhain K, Mulkewich N, Islam H, McCarthy SF, Richards DL, Madden K, Singer J, Riddell MC, Jung ME, Gibala MJ, Little JP. Exercise Snacks Are Feasible to Perform in the Real World and Improve Physical Capacity for Adults Living With Non-Insulin Treated Type 2 Diabetes: A Randomised Trial. Diabetes Obes Metab. 2026 Jul 25. doi: 10.1111/dom.71052. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Jonathan Little, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Snacks in people with Type 2 Diabetes, run by University of British Columbia 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 11 inclusion and 15 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 9 May 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 Jonathan P Little, PhD (250.807.9876, jonathan.little@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the number of individuals living with type 2 diabetes that are eligible to participate in the trial (time frame: NA (recruitment period)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06407245, which also lists 1 linked publication.
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 9 May 2024.