NCT05772650

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

February 13, 2023

Last Update Submit

March 14, 2023

Conditions

Keywords

web based health promotion

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Interventions

Lifestyle modification for health and disease management using digital solutions

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

McGill University faculty, staff, students and invited family members

You may qualify if:

  • Affiliated with McGill University or family member

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University

Montreal, Quebec, h3a 0g4, Canada

RECRUITING

Study Officials

  • Dr. Steven Grover, MD

    McGill University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Steven Grover, MD

CONTACT

Violette Berberian, B.Sc.., MBA

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, McGill University

Study Record Dates

First Submitted

February 13, 2023

First Posted

March 16, 2023

Study Start

February 6, 2023

Primary Completion

April 16, 2023

Study Completion

June 30, 2023

Last Updated

March 16, 2023

Record last verified: 2023-03

Locations