Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-30 @ 1:12 AM
Study NCT ID:
NCT05772650
Status:
UNKNOWN
Last Update Posted:
2023-03-16
First Post:
2023-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Online Mood Booster Challenge to Support Physical and Mental Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-14', 'studyFirstSubmitDate': '2023-02-13', 'studyFirstSubmitQcDate': '2023-03-14', 'lastUpdatePostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in Physical Activity Levels', 'timeFrame': 'Feb 20 - April 16, 2023', 'description': '8 week program to create healthy habits of incorporating increased physical activity in daily life.\n\nSelf-reported physical activity levels using the International Physical Activity Questionnaire (IPAQ) (weekly metabolic equivalents (METs); using an estimate of 4 METs/ min moderate exercise and 8 METs/ min vigorous exercise)'}, {'measure': 'Adherence to Program', 'timeFrame': 'Feb 20 - April 16, 2023', 'description': '8 Week program to help change behaviour for healthy habit creation. Adherence will be measured as the number of days tracking physical activity levels and answering the behaviour change questions.\n\nLess than 7 days = very poor adherence 7-21 days = poor adherence 22-42 days = moderate adherence 43-49 days = good adherence Greater than 49 days = excellent adherence'}, {'measure': 'Improvement in Stress', 'timeFrame': 'Feb 20 - April 16, 2023', 'description': 'The following methodology will be used to measure the above metric:\n\n\\- Stress score - Perceived Stress Scale. 10 questions; Total score from 0 to 40; ≥18 high stress (1 standard deviation above the mean)'}, {'measure': 'Improvement in Sleep', 'timeFrame': 'Feb 20 - April 16, 2023', 'description': 'The following methodology will be used to measure the above metric:\n\n\\- Sleep score - Insomnia Severity Index. 7 questions; Total score from 0 to 28; ≥ 8 subthreshold insomnia'}, {'measure': 'Improvement in Mood', 'timeFrame': 'Feb 20 - April 16, 2023', 'description': 'The following methodology will be used to measure the above metric:\n\n\\- Depression score - Centre for Epidemiological Studies - Depression questionnaire 20 questions; Total score 0-40; ≥16 subthreshold depressive symptoms'}, {'measure': 'Improvement in Burnout', 'timeFrame': 'Feb 20 - April 16, 2023', 'description': 'The following methodology will be used to measure the above metric:\n\n\\- Burnout - Oldenburg burnout assessment. \\<2.89 no or little sign of burnout; 2.89 to 3.51 may be at risk of burnout; \\>3.51 at very high risk of burnout'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['web based health promotion'], 'conditions': ['Mental Health Wellness 1']}, 'descriptionModule': {'briefSummary': 'Healthier Together Mood Booster Challenge - To improve mental and physical fitness, while providing participants with online education, tracking, social connectivity, and feedback.', 'detailedDescription': 'An 8-week web-based health promotion program to learn strategies and use digital tools that will give participants a physical, mental, and emotional boost, with exercise remaining a key component of the mission.\n\nEach week participants will learn and practice evidence-based strategies that they will master to improve their physical and mental health.\n\nTechniques will be focused on: spending time exercising outdoors, practicing daily gratitude, practicing good posture, building social connection, deep breathing, listening to music, limiting time on social media and focusing on better sleep.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'McGill University faculty, staff, students and invited family members', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Affiliated with McGill University or family member\n\nExclusion Criteria: None'}, 'identificationModule': {'nctId': 'NCT05772650', 'briefTitle': 'The Online Mood Booster Challenge to Support Physical and Mental Health', 'organization': {'class': 'OTHER', 'fullName': 'McGill University'}, 'officialTitle': 'Healthier Together Mood Booster Challenge', 'orgStudyIdInfo': {'id': 'CLIN1903'}}, 'armsInterventionsModule': {'interventions': [{'name': 'e-Health Program', 'type': 'BEHAVIORAL', 'description': 'Lifestyle modification for health and disease management using digital solutions'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'h3a 0g4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Dr. Steven Grover, MD', 'role': 'CONTACT', 'email': 'steven.grover@mcGill.ca', 'phone': '514-791-5688'}, {'name': 'Violette Berberian, B.S.C., MBA', 'role': 'CONTACT', 'email': 'violette.berberian@affiliate.mcgill.ca', 'phone': '514-715-2827'}, {'name': 'Dr. Steven Grover, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'McGill University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Dr. Steven Grover, MD', 'role': 'CONTACT', 'email': 'steven.grover@mcgill.ca', 'phone': '514-846-7973', 'phoneExt': '223'}, {'name': 'Violette Berberian, B.Sc.., MBA', 'role': 'CONTACT', 'email': 'violette.berberian@affiliate.mcgill.ca', 'phone': '514-715-2827'}], 'overallOfficials': [{'name': 'Dr. Steven Grover, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Aggregate data analysis'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, McGill University', 'investigatorFullName': 'Steven Grover, MD', 'investigatorAffiliation': 'McGill University'}}}}