Frequent intense training in schools for teenagers
| ISRCTN | ISRCTN76457599 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76457599 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil Known |
| Protocol serial number | Nil known |
| Sponsor | University of Southern Denmark |
| Funders | Ole Kirk's Fond, Novo Nordisk Fonden |
- Submission date
- 04/06/2024
- Registration date
- 04/07/2024
- Last edited
- 10/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study plans to evaluate the effects of a 10-week FIT FIRST Teen (FFT) intervention on blood pressure, physical fitness and body composition of Danish adolescents aged 12-15 years old. The 10-week FFT training is expected to have beneficial effects on resting heart rate for Danish 12-15-year-olds, calling for further development and long-term evaluation of the program.
Who can participate?
Danish pupils aged 12 to 17 years old in 6th to 9th grade from 15 municipal schools
What does the study involve?
Participants will be randomly allocated to an intervention group or a usual practice control group. The FFT group will complete three weekly 40-minute FFT sessions with modified, motivating, involving, high-intensity sports-based activities. Before and after the 10-week intervention, resting heart rate and blood pressure, body composition (InBody270), postural balance, standing long jump and performance on the Yo-Yo intermittent recovery level 1 children’s test (YYIR1C) will be measured.
What are the possible benefits and risks of participating?
The possible benefits are a better health profile and there are no risks of participating.
Where is the study run from?
University of Southern Denmark
When is the study starting and how long is it expected to run for?
August 2021 to December 2022
Who is funding the study?
1. Ole Kirk's Foundation
2. Novo Nordisk Foundation
Who is the main contact?
Dr Malte Larsen, mnlarsen@health.sdu.dk
Contact information
Public, Scientific, Principal investigator
University of Southern Denmark, Campusvej 55
Odense
5231
Denmark
| Phone | +45 40304689 |
|---|---|
| mnlarsen@health.sdu.dk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomized controlled trial |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | The physical health effects of frequent intense training in schools for teenagers |
| Study acronym | FIT FIRST TEEN |
| Study objectives | Frequent intense training in schools for teenagers will improve their physical health status |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | 17/08/2021: The Scientific Ethics Committee 2 for Region Southern Denmark confirmed that the project is not subject to notification to the committee system, as the project does not fall within the definition of a health science research project; ref: 21/43086 |
| Health condition(s) or problem(s) studied | Prevention of lifestyle diseases |
| Intervention | Randomization will be performed on a school level by picking notes with school names from a bowl. Pupils will be randomly allocated to either the intervention group or a usual practice control group. The intervention uses a specific sports training concept (FIT FIRST), which the teachers in the school deliver 3 x 40 minutes per week for 10 weeks. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Cardiorespiratory fitness measured using the Yoyo test at baseline and after 10 weeks |
| Key secondary outcome measure(s) |
The following secondary outcome measures will be assessed at baseline and after 10 weeks: |
| Completion date | 30/12/2022 |
Eligibility
| Participant type(s) | Learner/student |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 17 Years |
| Sex | All |
| Target sample size at registration | 1200 |
| Total final enrolment | 1355 |
| Key inclusion criteria | Pupils at the recruited schools in 6th to 9th grade |
| Key exclusion criteria | Not meeting the participant inclusion criteria |
| Date of first enrolment | 01/08/2022 |
| Date of final enrolment | 20/12/2022 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Odense
5231
Denmark
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/09/2024: Sponsor contact was updated.
05/06/2024: Study's existence confirmed by the Scientific Ethics Committee 2 for Region Southern Denmark.
