Sedentary BehaviorNCT03804151
Long-term Evaluation of the FitSpirit Intervention
A study testing FitSpirit intervention in people with Sedentary Behavior, run by Université de Montréal at 1 site in Canada.
Trial summary
This study evaluates the long-term effects of the FitSpirit extra-curricular, girl-only intervention on numerous health outcomes of adolescent girls. Read more about this study
- Who is it for?
- Ages 12 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior
- What is being tested?
- FitSpirit intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2018to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Attend high-school registered to FitSpirit
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Université de Montréal
Montreal, Quebec, H3T 1P1
Marie-Eve Mathieu, PhD, +1-514-343-6737, me.mathieu@umontreal.ca
Jo-Anne Gilbert, PhD, +1-343-6111 ext. 42143, j.gilbert@umontreal.ca
About this study
Official title: 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.
- Conditions
- Sedentary Behavior
- Being tested
- FitSpirit intervention
- Keywords
- Exercise
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitSpirit interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| FitSpirit Intervention | Experimental | 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. Receives: Behavioral: FitSpirit intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity participation
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).
Measured: Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
Eating habits
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.
Measured: Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
Sleep habits
An online questionnaire assesses sleep habits. They are evaluated based on the usual number of hours of sleep (hours per night).
Measured: Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
Physical self-efficacy
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.
Measured: Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
Physical self-perception
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.
Measured: Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start1 Jan 2018
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- FitSpirit, Public Health Agency of Canada (PHAC)
- Responsible party
- Principal investigator, Marie-Ève Mathieu, Université de Montréal
- Investigators
- Marie-Eve Mathieu, PhD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804151
- Sponsor's protocol ID
- FitSpirit Evaluation LAPS
- Status last verified
- Jan 2019
- First submitted
- 7 Jan 2019
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The database, excluding individual information, will be shared with the co-investigators of the study.
Publications
Leduc G, Gilbert JA, Ayotte A, Moreau N, Drapeau V, Lemoyne J, Monthuy-Blanc J, Tremblay J, Mathieu ME. The FitSpirit approach for increasing physical activity in canadian teenage girls: protocol of a longitudinal, quasi-experimental study. BMC Public Health. 2021 Jan 28;21(1):229. doi: 10.1186/s12889-021-10200-5.
PubMed 33509155
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03804151
- Acronym / sponsor ID
- FitSpirit Evaluation LAPS
- Conditions
- Sedentary Behavior
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- FitSpirit, Public Health Agency of Canada (PHAC)
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the long-term effects of the FitSpirit extra-curricular, girl-only intervention on numerous health outcomes of adolescent girls.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FitSpirit Intervention | Experimental | Behavioral: FitSpirit interventionFitSpirit 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Attend high-school registered to FitSpirit
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FitSpirit interventionThe 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. | Behavioural | FitSpirit Intervention |
Primary outcome
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).
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.
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).
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Derived from this study: PubMed 33509155Leduc G, Gilbert JA, Ayotte A, Moreau N, Drapeau V, Lemoyne J, Monthuy-Blanc J, Tremblay J, Mathieu ME. The FitSpirit approach for increasing physical activity in canadian teenage girls: protocol of a longitudinal, quasi-experimental study. BMC Public Health. 2021 Jan 28;21(1):229. doi: 10.1186/s12889-021-10200-5.
- Individual participant dataSharing planned: No. The database, excluding individual information, will be shared with the co-investigators of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Eve Mathieu, PhD principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FitSpirit intervention in people with Sedentary Behavior, run by Université de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Eve Mathieu, PhD (+1-514-343-6737, me.mathieu@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity participation (time frame: Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03804151, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2019.