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Behavioural Intervention

Group Physical Activity Intervention Delivery for Physical Activity

N/A

Recruiting

Research Sponsored by University of Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up t1 (0 days from baseline), t2 (42 days from baseline) t3 (72 days from baseline).

Awards & highlights

Study Summary

"This trial aims to test the effectiveness of two different physical activity interventions (one-on-one and group-based) compared to a wait-list control group in supporting the mental health of post-secondary students. The study

Who is the study for?

This trial is for post-secondary students who are experiencing mental health issues such as feeling overwhelmed, anxious, or depressed. Participants will be randomly assigned to either individual physical activity training, group-based training, or a waitlist control group.Check my eligibility

What is being tested?

The study tests the effectiveness of one-on-one versus group-based physical activity interventions on student mental health and well-being. It involves weekly sessions combining behavior change coaching with structured exercise over six weeks.See study design

What are the potential side effects?

Physical activity generally has positive effects on health; however, participants may experience typical exercise-related side effects like muscle soreness or fatigue. Any adverse reactions related to the intervention's structure will also be monitored.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ t1 (0 days from baseline), t2 (42 days from baseline) t3 (72 days from baseline).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~t1 (0 days from baseline), t2 (42 days from baseline) t3 (72 days from baseline).

This trial's timeline: 3 weeks for screening, Varies for treatment, and t1 (0 days from baseline), t2 (42 days from baseline) t3 (72 days from baseline). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Anxiety

Depression

Psychological distress

Secondary outcome measures

Coach Perceptions

Intervention Reach

Intervention Satisfaction

+4 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Group Physical Activity Intervention DeliveryExperimental Treatment1 Intervention

The group physical activity intervention will receive the physical activity intervention delivered in small groups of 3-8 students led by a trained sport and recreation coach.

Group II: 1:1 Physical Activity Intervention DeliveryExperimental Treatment1 Intervention

The physical activity intervention will be delivered using 1:1 coaching.

Group III: 10-Week Waitlist Control GroupActive Control1 Intervention

Students who are assigned to the 10-week waitlist control condition will be assessed on primary and secondary outcomes at baseline (T1), at 6-weeks (T2) and at 1-month follow-up (T3). At completion of the 1-month follow-up assessment, students in the wait-list control condition will be offered participation in the physical activity intervention; however, their behaviour will not be monitored or evaluated. Participants will have a choice of engaging in 1:1 physical activity intervention delivery or group-based physical activity intervention delivery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Physical Activity Intervention

2020

N/A

~990

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of TorontoLead Sponsor

690 Previous Clinical Trials

1,019,550 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently able to enroll in this ongoing study?

"As per clinicaltrials.gov, this investigation is presently enrolling participants. The initial posting of the trial was on January 8th, 2024 and the most recent update occurred on April 5th, 2024."

Answered by AI

What is the upper limit in terms of patient enrollment for this medical study?

"Indeed, as per clinicaltrials.gov data, this research endeavor is presently seeking suitable candidates. Originally shared on 1/8/2024 and most recently revised on 4/5/2024, the study aims to recruit a total of 93 individuals distributed across one location."

Answered by AI

What specific objectives does this medical study aim to fulfill?

"The primary focus of this investigation is the assessment of anxiety levels at three defined time points: T1 (baseline), T2 (42 days after baseline), and T3 (72 days after baseline). Additional areas under scrutiny are Social Connectedness, Physical Activity Behavior, and Therapeutic Alliance. Social Connectedness will be evaluated using an 8-item scale that gauges emotional separation from others on a Likert scale ranging from 1 to 6. Scores will be reversed for interpretation purposes with higher values reflecting increased social connectedness within a potential range of 8-48. Measurement of Physical Activity Behavior will entail utilizing the International Physical Activity Question"

Answered by AI

Recent research and studies

Annals of Internal MedicineJournal

CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials

Schulz, Kenneth F.. 2010. “CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials”. Annals of Internal Medicine. American College of Physicians. doi:10.7326/0003-4819-152-11-201006010-00232.

Journal of Biomedical InformaticsJournal

Research Electronic Data Capture (redcap)—a Metadata-driven Methodology and Workflow Process for Providing Translational Research Informatics Support

Harris, Paul A., Robert Taylor, Robert Thielke, Jonathon Payne, Nathaniel Gonzalez, and Jose G. Conde. 2009. “Research Electronic Data Capture (redcap)—a Metadata-driven Methodology and Workflow Process for Providing Translational Research Informatics Support”. Journal of Biomedical Informatics. Elsevier BV. doi:10.1016/j.jbi.2008.08.010.

BmjJournal

Process Evaluation of Complex Interventions: Medical Research Council Guidance

Moore, G. F., S. Audrey, M. Barker, L. Bond, C. Bonell, W. Hardeman, L. Moore, et al.. 2015. “Process Evaluation of Complex Interventions: Medical Research Council Guidance”. Bmj. BMJ. doi:10.1136/bmj.h1258.

clinicaltrials.govStudy