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Primary PreventionNCT06615791

FIT FIRST Teen - School Intervention Study

A study testing FIT FIRST Teen in people with Primary Prevention, run by University of Southern Denmark at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Primary Prevention
What is being tested?
FIT FIRST Teen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
912 participants
Where
1 siteDenmark
Study dates
15 Aug 2024to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • part of the enrolled classes

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country.

Peter Krustrup, PhD contact

+4565504913

pkrustrup@health.sdu.dk

Denmark1 site, 1 recruiting
  • Rosengårdskolen

    Odense, 5230

    Giampiero Tarantino, gtarantino@health.sdu.dk

    Recruiting

Other trials in Denmark

About this study

Official title: 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?

Read more

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.
Read the 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.

Being tested
FIT FIRST Teen
Keywords
physical activity, sports
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FIT FIRST TeenBehavioural

    High intensity sports drills and games.

Study groups in NCT06615791
Study groupRoleWhat they receive
FIT FIRST TeenExperimentalSchool 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.
Receives: Behavioral: FIT FIRST Teen
ControlNo interventionSchool teachers will continue to offer the usual physical education curricula to students.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from baseline to 40 weeks

  2. Implementation

    Implementation of the FIT FIRST Teen Program will be evaluated.

    Measured: From baseline to 40 weeks

Secondary outcomes (13)
  1. Health-Related Quality of Life

    Health-Related Quality of Life will be measured using the KIDSCREEN-27 inventory.

    Measured: Change from baseline to 40 weeks

  2. Body Image

    Adolescents' body image will be measured using the Body Appreciation Scale-2.

    Measured: Change from baseline to 40 weeks

  3. Body Functionality Appreciation

    Adolescents' body functionality appreciation will be measured using the Functionality Appreciation Scale.

    Measured: Change from baseline to 40 weeks

  4. Motivation towards Physical Education

    Adolescents' motivational regulation towards physical education will be assessed using the Perceived Locus of Causality Scale.

    Measured: Change from baseline to 40 weeks

  5. Body Self-perception

    Adolescents' physical self-perception will be measured using the Physical Self-Inventory.

    Measured: Change from baseline to 40 weeks

  6. Resting Heart Rate

    Resting heart rate will be measured at rest. We will conduct 3 measurements after an 8-minute resting period

    Measured: Change from baseline to 40 weeks

  7. Blood Pressure

    Blood Pressure will be measured at rest. We will conduct 3 measurements after an 8-minute resting period

    Measured: Change from baseline to 40 weeks

  8. Muscular Fitness

    To investigate muscular fitness, the horizontal countermovement jump will be used to assess the lower body strength.

    Measured: Change from baseline to 40 weeks

  9. Muscular Fitness

    To investigate muscular fitness, the the handgrip test will be employed to evaluate the upper body strength.

    Measured: Change from baseline to 40 weeks

  10. Muscular Fitness

    To investigate muscular fitness, the Arrowhead agility test will be used.

    Measured: Change from baseline to 40 weeks

  11. Muscular Fitness

    To investigate postutal balance, the stork test will be used.

    Measured: Change from baseline to 40 weeks

  12. Body Composition

    InBody 270 bioimpedance will be used to measure body composition.

    Measured: Change from baseline to 40 weeks

  13. Height

    Tanita Height scales will be used to measure height.

    Measured: Change from baseline to 40 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2024
  2. Study start15 Aug 2024
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two parallel arms
Masking
None (open label)
Enrolment
912 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06615791
Sponsor's protocol ID
USouthernDenmark-FITFIRSTTeen
Status last verified
Sep 2024
First submitted
13 Sep 2024
Last updated
27 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing FIT FIRST Teen in people with Primary Prevention, run by University of Southern Denmark at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Peter Krustrup, PhD (+4565504913, pkrustrup@health.sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiometabolic Fitness (time frame: Change from baseline to 40 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.

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