- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03804151
Long-term Evaluation of the FitSpirit Intervention
January 22, 2019 updated by: Marie-Ève Mathieu, Université de Montréal
The Impact of the FitSpirit Physical Activity Approach on Different Health Parameters of Canadian Adolescent Girls: the Protocol of a Large, Longitudinal Quasi-experimental Study
This study evaluates the long-term effects of the FitSpirit extra-curricular, girl-only intervention on numerous health outcomes of adolescent girls.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
1200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
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Montréal, Quebec, Canada, H3T 1P1
- Recruiting
- Université de Montréal
-
Contact:
- Marie-Eve Mathieu, PhD
- Phone Number: +1-514-343-6737
- Email: me.mathieu@umontreal.ca
-
Contact:
- Jo-Anne Gilbert, PhD
- Phone Number: 42143 +1-343-6111
- Email: j.gilbert@umontreal.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Attend high-school registered to FitSpirit
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: FitSpirit Intervention
FitSpirit physical activities and events are organized by participants' schools during the school year.
Girl-only activities such as physical activity sessions, speaking engagements, turnkey running program and special events can be offered.
The number, type and frequency of activities are decided by each school.
|
The study evaluates the effects of the FitSpirit intervention on divers health markers of adolescents.
Participants freely register to the intervention via their school.
Physical activities and event are organized by the schools with the help of the FitSpirit organization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity participation
Time Frame: Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
|
An online questionnaire assesses physical activity participation.
It is measured using the number of days per week the participant are active more than 60 min/day (scale 0 to 7 days/week).
|
Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
|
|
Eating habits
Time Frame: Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
|
An online questionnaire assesses eating habits.
They are measured using the number of servings consumed per week for each of the different food categories (fruits, vegetables, juice, milk products, sweetened beverages, and fast food).
No aggregation is done.
|
Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
|
|
Sleep habits
Time Frame: Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
|
An online questionnaire assesses sleep habits.
They are evaluated based on the usual number of hours of sleep (hours per night).
|
Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
|
|
Physical self-efficacy
Time Frame: Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
|
Physical self-efficacy is assessed using an online questionnaire by asking the participants their level of agreement with 12 statements, using a 5 level scale.
Points are attributed to each answer (Disagree totally: 1; Somewhat disagree: 2; Neutral: 3; Somewhat agree: 4; Agree totally: 5).
Total score is used to compare the participants and highest score represents a better outcome.
|
Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
|
|
Physical self-perception
Time Frame: Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
|
Physical self-perception is evaluated using an online questionnaire presenting 2 sets of 7 silhouettes.
Participants identify first the silhouette representing best their current body image.
They then identify the silhouette representing their desired body image (slimmest silhouette: 1 point; fattest silhouette: 7 points).
Satisfaction of body image is calculated by the difference between the 2 answers.
Smaller difference score represent better satisfaction of body image.
|
Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marie-Eve Mathieu, PhD, Université de Montréal
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2018
Primary Completion (ANTICIPATED)
June 30, 2021
Study Completion (ANTICIPATED)
June 30, 2021
Study Registration Dates
First Submitted
January 7, 2019
First Submitted That Met QC Criteria
January 9, 2019
First Posted (ACTUAL)
January 15, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 24, 2019
Last Update Submitted That Met QC Criteria
January 22, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FitSpirit Evaluation LAPS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The database, excluding individual information, will be shared with the co-investigators of the study.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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