<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03804151</url>
  </required_header>
  <id_info>
    <org_study_id>FitSpirit Evaluation LAPS</org_study_id>
    <nct_id>NCT03804151</nct_id>
  </id_info>
  <brief_title>Long-term Evaluation of the FitSpirit Intervention</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université de Montréal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>FitSpirit</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Public Health Agency of Canada (PHAC)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Université de Montréal</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the long-term effects of the FitSpirit extra-curricular, girl-only&#xD;
      intervention on numerous health outcomes of adolescent girls.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physical activity participation</measure>
    <time_frame>Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Eating habits</measure>
    <time_frame>Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep habits</measure>
    <time_frame>Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)</time_frame>
    <description>An online questionnaire assesses sleep habits. They are evaluated based on the usual number of hours of sleep (hours per night).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical self-efficacy</measure>
    <time_frame>Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical self-perception</measure>
    <time_frame>Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>Sedentary Behavior</condition>
  <arm_group>
    <arm_group_label>FitSpirit Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>FitSpirit intervention</intervention_name>
    <description>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.</description>
    <arm_group_label>FitSpirit Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Attend high-school registered to FitSpirit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Participants who self-identify as female adolescents are eligible to the intervention.</gender_description>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie-Eve Mathieu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Université de Montréal</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marie-Eve Mathieu, PhD</last_name>
    <phone>+1-514-343-6737</phone>
    <email>me.mathieu@umontreal.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jo-Anne Gilbert, PhD</last_name>
    <phone>+1-514-343-6111</phone>
    <phone_ext>42143</phone_ext>
    <email>j.gilbert@umontreal.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Université de Montréal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3T 1P1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie-Eve Mathieu, PhD</last_name>
      <phone>+1-514-343-6737</phone>
      <email>me.mathieu@umontreal.ca</email>
    </contact>
    <contact_backup>
      <last_name>Jo-Anne Gilbert, PhD</last_name>
      <phone>+1-343-6111</phone>
      <phone_ext>42143</phone_ext>
      <email>j.gilbert@umontreal.ca</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Université de Montréal</investigator_affiliation>
    <investigator_full_name>Marie-Ève Mathieu</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>Exercise</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The database, excluding individual information, will be shared with the co-investigators of the study.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03804151
org study id: FitSpirit Evaluation LAPS
nct id: NCT03804151
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the long-term effects of the FitSpirit extra-curricular, girl-only
      intervention on numerous health outcomes of adolescent girls.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Physical activity participation
time frame: Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
description: 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).
measure: Eating habits
time frame: Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
description: 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.
measure: Sleep habits
time frame: Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
description: An online questionnaire assesses sleep habits. They are evaluated based on the usual number of hours of sleep (hours per night).
measure: Physical self-efficacy
time frame: Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
description: 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.
measure: Physical self-perception
time frame: Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)
description: 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.
arm group label: FitSpirit Intervention
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: FitSpirit intervention
description: 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.
arm group label: FitSpirit Intervention
criteria: 
gender: Female
gender based: Yes
gender description: Participants who self-identify as female adolescents are eligible to the intervention.
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marie-Eve Mathieu, PhD
role: Principal Investigator
affiliation: Université de Montréal
last name: Marie-Eve Mathieu, PhD
phone: +1-514-343-6737
email: me.mathieu@umontreal.ca
last name: Jo-Anne Gilbert, PhD
phone: +1-514-343-6111
phone ext: 42143
email: j.gilbert@umontreal.ca
facility: 
status: Recruiting
contact: 
contact backup: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Université de Montréal
investigator full name: Marie-Ève Mathieu
investigator title: Associate professor
sharing ipd: No
ipd description: The database, excluding individual information, will be shared with the co-investigators of the study.