The Online Mood Booster Challenge to Support Physical and Mental Health

• Sponsor: McGill University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05772650
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 4.7
• Patients Per Site Per Month: 105.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Mental Health Wellness 1	Behavioral: e-Health Program

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Healthier Together Mood Booster Challenge
• Actual Study Start Date: Feb 6, 2023
• Anticipated Primary Completion Date: Apr 16, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Outcome Measures

Primary Outcome Measures

1. Improvement in Physical Activity Levels [Feb 20 - April 16, 2023]

   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)

2. Adherence to Program [Feb 20 - April 16, 2023]

   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

3. Improvement in Stress [Feb 20 - April 16, 2023]

   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)

4. Improvement in Sleep [Feb 20 - April 16, 2023]

   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

5. Improvement in Mood [Feb 20 - April 16, 2023]

   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

6. Improvement in Burnout [Feb 20 - April 16, 2023]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Affiliated with McGill University or family member

Exclusion Criteria: None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McGill University	Montreal	Quebec	Canada	h3a 0g4

Sponsors and Collaborators

• McGill University

Investigators

• Principal Investigator: Dr. Steven Grover, MD, McGill University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Steven Grover, MD, Professor of Medicine, McGill University, McGill University
• ClinicalTrials.gov Identifier: NCT05772650
• Other Study ID Numbers: CLIN1903
• First Posted: Mar 16, 2023
• Last Update Posted: Mar 16, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Steven Grover, MD, Professor of Medicine, McGill University, McGill University: web based health promotion

Study Results

No Results Posted as of Mar 16, 2023