Family Health Team High-Intensity Interval Training

NCT04109235 | Recruiting

• 1 other identifier: 111930
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Type 2 Diabetes

Keywords

HbA1C; virtual care; blood glucose; physical activity; HIIT

Outcome Measures

Primary Outcomes (1)

• Change in HbA1C

  Glycosylated Hemoglobin measured at lab

  3-month and 6-month follow-up

Secondary Outcomes (2)

• Weight

  3-month and 6-month follow-up

• Physical Activity (minutes per week)

  3-month and 6-month follow-up

Study Arms (2)

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.

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.

Other: High-Intensity Interval Training Physical Activity (PA) Advice

Interventions

High-Intensity Interval Training Physical Activity (PA) Advice OTHER

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.

High-Intensity Interval Training Physical Activity (PA) Advice

Population-Based Physical Activity (PA) Advice OTHER

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.

Population-Based Physical Activity (PA) Advice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \< 18 years of age
• pregnant
• not having a type 2 diabetes diagnosis
• having a medical history of myocardial infarction in the past 3 months

Sponsors & Collaborators

• Western University, Canada: lead
• East Elgin Family Health Team: collaborator

Study Sites (1)

East Elgin Family Health Team

Aylmer, Ontario, N5H1K9, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Interventions

Counseling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Michael Fernando, MD

CONTACT

519-773-3715; mfernando@eefht.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: One of the investigators, Justine Horne, will be blinded to group allocations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 30, 2019
• Study Start: February 13, 2020
• Primary Completion (Estimated): July 13, 2026
• Study Completion (Estimated): July 13, 2026
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

CA (1)