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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
Denmark1 site, 1 recruiting
- Recruiting
Rosengårdskolen
Odense, 5230
Giampiero Tarantino, gtarantino@health.sdu.dk
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.
- Conditions
- Primary Prevention
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: FIT FIRST Teen |
| Control | No intervention | School 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.
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
Implementation
Implementation of the FIT FIRST Teen Program will be evaluated.
Measured: From baseline to 40 weeks
Secondary outcomes (13)
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
Body Image
Adolescents' body image will be measured using the Body Appreciation Scale-2.
Measured: Change from baseline to 40 weeks
Body Functionality Appreciation
Adolescents' body functionality appreciation will be measured using the Functionality Appreciation Scale.
Measured: Change from baseline to 40 weeks
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
Body Self-perception
Adolescents' physical self-perception will be measured using the Physical Self-Inventory.
Measured: Change from baseline to 40 weeks
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
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
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
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
Muscular Fitness
To investigate muscular fitness, the Arrowhead agility test will be used.
Measured: Change from baseline to 40 weeks
Muscular Fitness
To investigate postutal balance, the stork test will be used.
Measured: Change from baseline to 40 weeks
Body Composition
InBody 270 bioimpedance will be used to measure body composition.
Measured: Change from baseline to 40 weeks
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.
- First posted27 Sep 2024
- Study start15 Aug 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- The Novo Nordic Foundation, Team Denmark, The Danish Sports Confederation
- Responsible party
- Principal investigator, Peter Krustrup, University of Southern Denmark
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIT FIRST Teen Effectiveness and School Implementation Study - a Cluster Randomised Mixed Methods Trial.
- ClinicalTrials.gov ID
- NCT06615791
- Acronym / sponsor ID
- USouthernDenmark-FITFIRSTTeen
- Conditions
- Primary Prevention
- Keywords
- physical activity, sports
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 912 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- The Novo Nordic Foundation, Team Denmark, The Danish Sports Confederation
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel arms
| Arm | Type | Receives |
|---|---|---|
| FIT FIRST Teen | Experimental | Behavioral: FIT FIRST TeenSchool 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. |
| Control | No intervention | –School teachers will continue to offer the usual physical education curricula to students. |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- part of the enrolled classes
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FIT FIRST TeenHigh intensity sports drills and games. | Behavioural | FIT FIRST Teen |
Primary outcome
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.
Implementation
Time frame: From baseline to 40 weeks
Implementation of the FIT FIRST Teen Program will be evaluated.
13 secondary outcomes
Health-Related Quality of Life
Time frame: Change from baseline to 40 weeks
Body Image
Time frame: Change from baseline to 40 weeks
Body Functionality Appreciation
Time frame: Change from baseline to 40 weeks
Motivation towards Physical Education
Time frame: Change from baseline to 40 weeks
Body Self-perception
Time frame: Change from baseline to 40 weeks
Resting Heart Rate
Time frame: Change from baseline to 40 weeks
Blood Pressure
Time frame: Change from baseline to 40 weeks
Muscular Fitness
Time frame: Change from baseline to 40 weeks
Muscular Fitness
Time frame: Change from baseline to 40 weeks
Muscular Fitness
Time frame: Change from baseline to 40 weeks
Muscular Fitness
Time frame: Change from baseline to 40 weeks
Body Composition
Time frame: Change from baseline to 40 weeks
Height
Time frame: Change from baseline to 40 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Primary Prevention
RecruitingPhase 2
Prevention of ProliFerative Vitreoretinopathy With Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial
Proliferative Vitreoretinopathy, Rhegmatogenous Retinal Detachment
Active, not recruitingObservational study
Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
Migraine
RecruitingObservational study
Physical Function and Fall Risk in Older Adults in the Lalín Frailty Prevention Program
Frailty, Fall Risk, Fall Prevention
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.