Efficacy of Exercise Snacks in Real-World Settings in Individuals Living With Type 2 Diabetes

May 6, 2024 updated by: Jonathan Little, University of British Columbia
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1V 3G1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 30-75 years.
  2. Have physician-diagnosed type 2 diabetes.
  3. Physically inactive (performing <150 min moderate-to-vigorous physical activity per week).
  4. Body mass index: 18.5-40 kg/m2.
  5. Taking ≤3 glucose-lowering medications (excluding insulin) and stable dose for > 6 months.
  6. Taking ≤2 commonly prescribed cardiovascular medications (e.g., statins, antihypertensive).
  7. HbA1c ≤8.5%.
  8. Able to maintain current physical activity patterns during the study.
  9. Cleared to engage in physical activity using the Get Active Questionnaire and, if applicable, consultation with a health care provider or Qualified Exercise Professional.
  10. Access to a computer, tablet or smartphone for intervention delivery and tracking.
  11. Ability to read and write in English.

Exclusion Criteria:

  1. Chronic musculoskeletal condition or recent (within 2 years) cardiovascular event preventing participation in exercise.
  2. Lack of internet access.
  3. Angina upon exertion assessed by the Rose Angina Questionnaire.
  4. Prescribed beta-blockers that can compromise the validity of heart rate measurements. during the submaximal exercise test.
  5. 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.
  6. Have a scheduled surgical procedure within the next 3-4 months that would prevent exercise participation.
  7. Currently diagnosed with a cardiac or pulmonary disease (e.g., angina, arrythmia, exercise-induced bronchospasm) that would prevent exercise participation.
  8. Have a psychiatric disorder that could prevent you from completing the study procedures or visits.
  9. Have donated more than 0.5 L of blood within the last 4 weeks.
  10. 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).
  11. Currently have diabetic ulcers, peripheral vascular disease, or diabetic neuropathy that will prevent participation in exercise.
  12. Currently participating in another clinical trial that interferes with the study procedures.
  13. Currently on dialysis.
  14. Currently pregnant or planning on becoming pregnant during the intervention (i.e., within the next 4 months).
  15. 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise Snacks
Vigorous-intensity bodyweight exercises performed 4 times per day on at least 5 days per week.
Other: Exercise Snacks
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.
Active Comparator: Placebo Exercise
Low-intensity stretching exercises performed 4 times per day on at least 5 days per week.
Other: Placebo Exercise
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
NA (recruitment period)
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.
NA (recruitment period)
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.
after the 12-week intervention
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.
during the 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in glycated hemoglobin measured before and after the 12-week intervention
Time Frame: 0-12 weeks
Glycated hemoglobin (A1c) at baseline and after 12 weeks.
0-12 weeks
Change in fasting glucose measured before and after the 12-week intervention
Time Frame: 0-12 weeks
Fasting glucose measured at baseline and after the 12-week intervention.
0-12 weeks
Change in fasting insulin measured before and after the 12-week intervention
Time Frame: 0-12 weeks
Fasting insulin measured at baseline and after the 12-week intervention
0-12 weeks
Change in 24h glucose concentration
Time Frame: before (week 0; before the intervention) and week 11 of the intervention
Average of 24h glucose value measured with continuous glucose monitor at week 0 and week 11 of the intervention.
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
Submaximal YMCA cycle ergometer test to estimate VO2 peak.
0-12 weeks
Change in lower body muscular endurance measured before and after the 12-week intervention
Time Frame: 0-12 weeks
The 30-second sit-to-stand pre- and post-intervention.
0-12 weeks
Change in upper body maximal strength measured before and after the 12-week intervention
Time Frame: 0-12 weeks
Grip strength test using a hand dynamometer pre- and post-intervention
0-12 weeks
Change in body composition measured before and after the 12-week intervention
Time Frame: 0-12 weeks
Waist circumference, weight and body mass index assessed pre- and post- intervention.
0-12 weeks
Change in blood pressure measured before and after the 12-week intervention
Time Frame: 0-12 weeks
Seated systolic and diastolic blood pressure measured before and after the 12-week intervention.
0-12 weeks
Change in blood lipid profile measured before and after the 12-week intervention
Time Frame: 0-12 weeks
Total cholesterol, high-density lipoprotein (HDL) cholesterol, Non-HDL cholesterol, low-density lipoprotein (LDL) cholesterol, and Triglycerides.
0-12 weeks
Change in complete blood count measured before and after the 12-week intervention
Time Frame: 0-12 weeks
Red blood cells, white blood cells, haemoglobin, haematocrit, and platelet.
0-12 weeks
Change in plasma inflammatory cytokines measured before and after the 12-week intervention
Time Frame: 0-12 weeks
TNF-α, IL-6, IL-10, CRP
0-12 weeks
Change in health-related quality of life measured before and after the 12-week intervention
Time Frame: 0-12 weeks
Euro Quality of Life 5 Dimension 5 Level (EQ-5D-5L) questionnaire pre- and post-intervention
0-12 weeks
Changes in diabetes distress measured before and after the intervention 12-week intervention
Time Frame: 0-12 weeks
Diabetes Distress Scale (DDS) questionnaire pre- and post-intervention
0-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
McMaster University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonathan Little, PhD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 19, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 19, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H24-03417

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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