NCT03804151

Brief Summary

This study evaluates the long-term effects of the FitSpirit extra-curricular, girl-only intervention on numerous health outcomes of adolescent girls.

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
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 7, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

January 24, 2019

Status Verified

January 1, 2019

Enrollment Period

3.5 years

First QC Date

January 7, 2019

Last Update Submit

January 22, 2019

Conditions

Keywords

Exercise

Outcome Measures

Primary Outcomes (5)

  • 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).

    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.

    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).

    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.

    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.

    Markers re evaluated at the beginning and the end of each school years (approximately 7 months appart)

Study Arms (1)

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.

Behavioral: FitSpirit intervention

Interventions

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.

FitSpirit Intervention

Eligibility Criteria

Age12 Years - 17 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants who self-identify as female adolescents are eligible to the intervention.
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Attend high-school registered to FitSpirit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Montréal

Montreal, Quebec, H3T 1P1, Canada

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Marie-Eve Mathieu, PhD

    Université de Montréal

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Eve Mathieu, PhD

CONTACT

Jo-Anne Gilbert, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 15, 2019

Study Start

January 1, 2018

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

January 24, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

The database, excluding individual information, will be shared with the co-investigators of the study.

Locations