FIT FIRST Teen - School Intervention Study

September 24, 2024 updated by: Peter Krustrup, University of Southern Denmark

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background. Physical activity (PA) is an important part of a healthy lifestyle for children and youth, as it improves physical fitness, motor competencies, and well-being, and reduces the risk of developing overweight and non-communicable diseases later in life. Current recommendations from the Danish Health Authorities are that young people should participate in at least 60 minutes of moderate-to-vigorous physical activity (MVPA) per day, of which at least 3 times per week should involve muscle strengthening training, however, currently only about one-quarter of the Danish 11-15-year-olds meet these recommendations.

Given that children and adolescents, irrespective of socio-economic background, spend a substantial portion of their waking hours in school, schools serve as pivotal settings for the widespread promotion of PA. However, current school-based PA interventions have shown limited effects. Often the poor results of interventions can be ascribed to implementation challenges, encompassing deficiencies in program fidelity, suboptimal attendance rates, or lack of access to intended resources, time, or space. Details about the contextual environment and how to implement interventions are typically derived from implementation evaluations. Nonetheless, such evaluations are rarely undertaken.

The FIT FIRST program was developed to address these limitations. FIT FIRST was originally an acronym for a 40-week intervention study for 8- to 9-year-olds with Frequent Intense Training through Football, Interval Running, and Circuit Strength Training. In 2018, the FIT FIRST 10 concept was developed for 6-9-yr-olds that covered 10 sports. In 2020, the FIT FIRST 20 concept for 10-12-year-olds was developed to include 20 sports. In brief, all versions of the FIT FIRST concept are built on the principles of using multiple sporting activities modified for the school setting, with a focus on high intensity, high involvement, fun, and inclusion. The use of multiple sporting activities modified for the school setting may also recess activities and leisure-time sports. Therefore, it will be investigated whether the developed abilities and motivation for FIT FIRST sporting activities can result in recruitment or re-recruitment of members to the local sports clubs.

The implementation of the FIT FIRST Teen project is based on training teachers to deliver such a program, which has been developed by experienced staff from SDU (University of Southern Denmark (SDU), The DIF (Danish Sports Confederation (DIF), and Team Denmark. These partners have developed 3-6 lessons for each of the sports, all using pair-based exercises and small-sided game drills and activities. All the lessons included in the FIT FIRST Teen program have been developed to (1) provide high-intensity strength and cardiovascular training and (2) motivate children to participate, according to the self-determination theory.

FIT FIRST Teen will run over a full school year with physical fitness, motivation, and well-being as primary outcomes, and project implementation as co-primary outcome. In this study, the research team will be testing the effects of the FIT FIRST Teen program by randomizing schools into two groups. Hence, this will be a cluster RCT with a 1:1 randomization of schools into an intervention arm, which will implement the FIT FIRST Teen program 3 times a week weekly (three 40-minute lessons a week), and a control arm, which will provide the usual physical education curricula.

Measures. To evaluate the intervention effect on adolescents' fitness levels and health profile the following measures will be employed.

Cardiometabolic fitness. The Yo-Yo intermittent recovery level 1 test for adolescents (YYIR1C test) will be conducted to evaluate cardiometabolic fitness levels. Resting heart rate and blood pressure will be measured at rest. We will conduct 3 measurements after an 8-minute resting period.

Body Composition: Tanita Height scales and InBody 270 bioimpedance measurements will be used to assess body mass, lean mass, fat mass, fat percentage, and BMI z-score.

Muscular fitness and motor control. The horizontal countermovement jump test, arrowhead agility test, the stork balance test and the handgrip strength test will be used to assess muscular fitness and motor control.

To investigate the potential impact of the FIT FIRST Teen program on students' well-being and body perceptions, a series of questionnaires will be used.

Health-Related Quality of Life will be assessed using the KIDSCREEN-27. To investigate adolescents' body image, the Body Appreciation Scale will be employed. The Functionality Appreciation Scale will be used to measure such an outcome. The Perceived Locus of Causality Scale will be used to examine adolescents' motivational regulation towards physical education. Finally, the physical self-perception will be measured using the Physical Self-Inventory.

A mixed-method approach will be used to investigate the FIT FIRST Teen implementation, fidelity, acceptability, appropriateness, and feasibility. Questionnaires, semi-structured interviews, and logbooks will be employed by the research team.

Study Type

Interventional

Enrollment (Estimated)

912

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • part of the enrolled classes

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FIT FIRST Teen

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
High intensity sports drills and games.
No Intervention: Control
School teachers will continue to offer the usual physical education curricula to students.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiometabolic Fitness
Time Frame: Change from baseline to 40 weeks
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
Time Frame: From baseline to 40 weeks
Implementation of the FIT FIRST Teen Program will be evaluated.
From baseline to 40 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-Related Quality of Life
Time Frame: Change from baseline to 40 weeks
Health-Related Quality of Life will be measured using the KIDSCREEN-27 inventory.
Change from baseline to 40 weeks
Body Image
Time Frame: Change from baseline to 40 weeks
Adolescents' body image will be measured using the Body Appreciation Scale-2.
Change from baseline to 40 weeks
Body Functionality Appreciation
Time Frame: Change from baseline to 40 weeks
Adolescents' body functionality appreciation will be measured using the Functionality Appreciation Scale.
Change from baseline to 40 weeks
Motivation towards Physical Education
Time Frame: Change from baseline to 40 weeks
Adolescents' motivational regulation towards physical education will be assessed using the Perceived Locus of Causality Scale.
Change from baseline to 40 weeks
Body Self-perception
Time Frame: Change from baseline to 40 weeks
Adolescents' physical self-perception will be measured using the Physical Self-Inventory.
Change from baseline to 40 weeks
Resting Heart Rate
Time Frame: Change from baseline to 40 weeks
Resting heart rate will be measured at rest. We will conduct 3 measurements after an 8-minute resting period
Change from baseline to 40 weeks
Blood Pressure
Time Frame: Change from baseline to 40 weeks
Blood Pressure will be measured at rest. We will conduct 3 measurements after an 8-minute resting period
Change from baseline to 40 weeks
Muscular Fitness
Time Frame: Change from baseline to 40 weeks
To investigate muscular fitness, the horizontal countermovement jump will be used to assess the lower body strength.
Change from baseline to 40 weeks
Muscular Fitness
Time Frame: Change from baseline to 40 weeks
To investigate muscular fitness, the the handgrip test will be employed to evaluate the upper body strength.
Change from baseline to 40 weeks
Muscular Fitness
Time Frame: Change from baseline to 40 weeks
To investigate muscular fitness, the Arrowhead agility test will be used.
Change from baseline to 40 weeks
Muscular Fitness
Time Frame: Change from baseline to 40 weeks
To investigate postutal balance, the stork test will be used.
Change from baseline to 40 weeks
Body Composition
Time Frame: Change from baseline to 40 weeks
InBody 270 bioimpedance will be used to measure body composition.
Change from baseline to 40 weeks
Height
Time Frame: Change from baseline to 40 weeks
Tanita Height scales will be used to measure height.
Change from baseline to 40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

The Novo Nordic Foundation
Team Denmark
The Danish Sports Confederation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

September 13, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

September 27, 2024

Last Update Submitted That Met QC Criteria

September 24, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • USouthernDenmark-FITFIRSTTeen

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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