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

NCT06407245 | Recruiting

• 1 other identifier: H24-03417
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  during the 12 weeks

Secondary Outcomes (14)

• Change in glycated hemoglobin measured before and after the 12-week intervention

  0-12 weeks

• Change in fasting glucose measured before and after the 12-week intervention

  0-12 weeks

• Change in fasting insulin measured before and after the 12-week intervention

  0-12 weeks

• Change in 24h glucose concentration

  before (week 0; before the intervention) and week 11 of the intervention

• Change in cardiorespiratory fitness measured before and after the 12-week intervention

  0-12 weeks

Study Arms (2)

Exercise Snacks

EXPERIMENTAL

Vigorous-intensity bodyweight exercises performed 4 times per day on at least 5 days per week.

Other: Exercise Snacks

Placebo Exercise

ACTIVE COMPARATOR

Low-intensity stretching exercises performed 4 times per day on at least 5 days per week.

Other: Placebo Exercise

Interventions

Exercise Snacks OTHER

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.

Exercise Snacks

Placebo Exercise OTHER

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 Exercise

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• University of British Columbia: lead
• McMaster University: collaborator

Study Sites (1)

University of British Columbia Okanagan

Kelowna, British Columbia, V1V 3G1, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jonathan Little, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan P Little, PhD

CONTACT

250.807.9876; jonathan.little@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: May 9, 2024
• Study Start: April 20, 2024
• Primary Completion: July 19, 2025
• Study Completion: July 19, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)