Actively Recruiting

Phase Not Applicable
Age: 13Years - 16Years
All Genders
Healthy Volunteers
ID06615791

FIT FIRST Teen Effectiveness and School Implementation Study - a Cluster Randomised Mixed Methods Trial

Led by University of Southern Denmark · Updated on 2024-09-27

912

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Southern Denmark

Lead Sponsor

T

The Novo Nordic Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research evaluates the effects of the FIT FIRST Teen program on adolescents aged 13 to 16 years, focusing on physical fitness, motivation, well-being, and how the program can be implemented in schools. The study aims to answer if the program improves cardiorespiratory fitness, body composition, muscle strength, well-being, motivation towards physical activity, and body image. It also explores challenges teachers and schools face during program implementation. The study compares the FIT FIRST Teen program, which involves high-intensity sports drills and games, to usual physical education curricula. Teachers in participating schools receive a one-day training and use a manual to deliver three 45-minute lessons per week over a full school year. The control group continues regular physical education. Schools keep logbooks to report weekly activities. Participants will undergo various assessments including the Yo-Yo intermittent recovery test for cardiometabolic fitness, body composition measurements, muscular fitness and motor control tests, and questionnaires assessing well-being, body image, motivation, and self-perception. The study uses a mixed-method approach including interviews and questionnaires to evaluate implementation. The total study duration is a full school year with outcomes measured from baseline to 40 weeks.

CONDITIONS

Brief Title

FIT FIRST Teen - School Intervention Study

Who Can Participate

Age: 13Years - 16Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Being part of the enrolled classes
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 40 weeks

Participants receive the FIT FIRST Teen program consisting of three 45-minute physical education lessons per week focusing on high-intensity sports drills and games throughout the school year.

Weekly visits for 40 weeks

Follow-up

Duration - Up to 40 weeks after baseline

Participants are assessed for changes in physical fitness, motivation, and well-being following the intervention period.

1 or more assessment visits

Trial Site Locations

Total: 1 location

1

Rosengårdskolen

Odense, Denmark, 5230

Actively Recruiting

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Research Team

P

Peter Krustrup, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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