Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT04109235
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2019-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Family Health Team High-Intensity Interval Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'One of the investigators, Justine Horne, will be blinded to group allocations.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-07-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-07', 'studyFirstSubmitDate': '2019-09-12', 'studyFirstSubmitQcDate': '2019-09-27', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1C', 'timeFrame': '3-month and 6-month follow-up', 'description': 'Glycosylated Hemoglobin measured at lab'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': '3-month and 6-month follow-up', 'description': 'self-reported by participants using home scale'}, {'measure': 'Physical Activity (minutes per week)', 'timeFrame': '3-month and 6-month follow-up', 'description': 'self-reported by participants using the log books designed for this study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HbA1C', 'virtual care', 'blood glucose', 'physical activity', 'HIIT'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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:\n\n* Weight and Height (measured using the Health-O-Meter weigh scale, used to calculate BMI)\n* Minutes of PA (self-reported by participants using the log books designed for this study)\n* 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)\n* Blood glucose and blood pressure medications'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults, at least 18 years of age\n* non-pregnant\n* having a diagnosis of type 2 diabetes in accordance with the 2018 Diabetes Canada Clinical Practice Guidelines\n* capable of consenting\n* deemed capable and safe to exercise by their physician (Dr. Fernando)\n* without a medical history of myocardial infarction in the past three months.\n\nExclusion Criteria:\n\n* \\< 18 years of age\n* pregnant\n* not having a type 2 diabetes diagnosis\n* having a medical history of myocardial infarction in the past 3 months'}, 'identificationModule': {'nctId': 'NCT04109235', 'acronym': 'FHT HIIT', 'briefTitle': 'Family Health Team High-Intensity Interval Training', 'organization': {'class': 'OTHER', 'fullName': 'Western University, Canada'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '111930'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Population-Based Physical Activity (PA) Advice', 'description': '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.', 'interventionNames': ['Other: Population-Based Physical Activity (PA) Advice']}, {'type': 'EXPERIMENTAL', 'label': 'High-Intensity Interval Training Physical Activity (PA) Advice', 'description': '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.', 'interventionNames': ['Other: High-Intensity Interval Training Physical Activity (PA) Advice']}], 'interventions': [{'name': 'High-Intensity Interval Training Physical Activity (PA) Advice', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['High-Intensity Interval Training Physical Activity (PA) Advice']}, {'name': 'Population-Based Physical Activity (PA) Advice', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Population-Based Physical Activity (PA) Advice']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N5H1K9', 'city': 'Aylmer', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Michael Fernando', 'role': 'CONTACT', 'email': 'mfernando@eefht.ca'}], 'facility': 'East Elgin Family Health Team', 'geoPoint': {'lat': 42.76679, 'lon': -80.98302}}], 'centralContacts': [{'name': 'Michael Fernando, MD', 'role': 'CONTACT', 'email': 'mfernando@eefht.ca', 'phone': '519-773-3715', 'phoneExt': '111'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western University, Canada', 'class': 'OTHER'}, 'collaborators': [{'name': 'East Elgin Family Health Team', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}