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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05772650
Other study ID # CLIN1903
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 6, 2023
Est. completion date June 30, 2023

Study information

Verified date March 2023
Source McGill University
Contact Dr. Steven Grover, MD
Phone 514-846-7973
Email steven.grover@mcgill.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Healthier Together Mood Booster Challenge - To improve mental and physical fitness, while providing participants with online education, tracking, social connectivity, and feedback.


Description:

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. Each week participants will learn and practice evidence-based strategies that they will master to improve their physical and mental health. Techniques 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date June 30, 2023
Est. primary completion date April 16, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Affiliated with McGill University or family member Exclusion Criteria: None

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
e-Health Program
Lifestyle modification for health and disease management using digital solutions

Locations

Country Name City State
Canada McGill University Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement in Physical Activity Levels 8 week program to create healthy habits of incorporating increased physical activity in daily life.
Self-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)
Feb 20 - April 16, 2023
Primary Adherence to Program 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.
Less 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
Feb 20 - April 16, 2023
Primary Improvement in Stress The following methodology will be used to measure the above metric:
- Stress score - Perceived Stress Scale. 10 questions; Total score from 0 to 40; =18 high stress (1 standard deviation above the mean)
Feb 20 - April 16, 2023
Primary Improvement in Sleep The following methodology will be used to measure the above metric:
- Sleep score - Insomnia Severity Index. 7 questions; Total score from 0 to 28; = 8 subthreshold insomnia
Feb 20 - April 16, 2023
Primary Improvement in Mood The following methodology will be used to measure the above metric:
- Depression score - Centre for Epidemiological Studies - Depression questionnaire 20 questions; Total score 0-40; =16 subthreshold depressive symptoms
Feb 20 - April 16, 2023
Primary Improvement in Burnout The following methodology will be used to measure the above metric:
- 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
Feb 20 - April 16, 2023
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