NCT06615791

Brief Summary

The goal of this cluster randomised controlled trial is to investigate the effects of the FIT FIRST Teen program on adolescents' physical fitness, motivation, and well-being, as well as the implementation of such a program within schools. The main questions it aims to answer are: Research Question 1: Does the FIT FIRST Teen program improve cardiorespiratory fitness, body composition, and muscle strength among adolescents? Research Question 2: Does the FIT FIRST Teen program improve well-being, motivation towards physical activity, and body image among adolescents? Research Question 3: What are the challenges that teachers and schools will face regarding the implementation of the FIT FIRST Teen program? The research team will compare the FIT FIRST Teen program to a control (usual physical education curricula) to see if such a program improves adolescents' physical fitness, motivation, and well-being. Participating schools will:

  • Participate in a training course, where the core principles of the FIT FIRST Teen program will be delivered.
  • Implement the FIT FIRST Teen program for a full school year (three 45-minute lessons a week).
  • Keep a logbook where the weekly practised activities will be reported.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
912

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2024

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

11 months

First QC Date

September 13, 2024

Last Update Submit

September 24, 2024

Conditions

Primary Prevention

Keywords

physical activitysports

Outcome Measures

Primary Outcomes (2)

  • Cardiometabolic Fitness

    The cardiometabolic fitness profile will be evaluated by using the Yo-Yo test measured as the total distance in meters as an indicator for the participants\' ability to perform intermittent exercise and their cardiometabolic fitness. The longer the distance, the better the cardiometabolic fitness of the participants.

    Change from baseline to 40 weeks

  • Implementation

    Implementation of the FIT FIRST Teen Program will be evaluated.

    From baseline to 40 weeks

Secondary Outcomes (13)

  • Health-Related Quality of Life

    Change from baseline to 40 weeks

  • Body Image

    Change from baseline to 40 weeks

  • Body Functionality Appreciation

    Change from baseline to 40 weeks

  • Motivation towards Physical Education

    Change from baseline to 40 weeks

  • Body Self-perception

    Change from baseline to 40 weeks

  • +8 more secondary outcomes

Study Arms (2)

FIT FIRST Teen

EXPERIMENTAL

School teachers will attend a one-day training course and will be given the FIT FIRST Teen manual, which will contain all the activities to be provided during physical education. Three 45-minute lessons per week for an entire school year will be administered to students by their teachers.

Behavioral: FIT FIRST Teen

Control

NO INTERVENTION

School teachers will continue to offer the usual physical education curricula to students.

Interventions

FIT FIRST TeenBEHAVIORAL

High intensity sports drills and games.

FIT FIRST Teen

Eligibility Criteria

Age13 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • part of the enrolled classes

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rosengårdskolen

Odense, 5230, Denmark

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Peter Krustrup, PhD

CONTACT

+4565504913pkrustrup@health.sdu.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two parallel arms
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 13, 2024

First Posted

September 27, 2024

Study Start

August 15, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

September 27, 2024

Record last verified: 2024-09

Locations

DK(1)