Frequent intense training in schools for teenagers
| ISRCTN | ISRCTN76457599 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76457599 |
| EudraCT/CTIS number | Nil Known |
- 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
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
| Study design | Cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The physical health effects of frequent intense training in schools for teenagers |
| Study acronym | FIT FIRST TEEN |
| Study hypothesis | 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 |
| Condition | 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 | Cardiorespiratory fitness measured using the Yoyo test at baseline and after 10 weeks |
| Secondary outcome measures | The following secondary outcome measures will be assessed at baseline and after 10 weeks: 1. Body composition measured using bioimpedance (InBody 270) 2. Resting heart rate and blood pressure measured using the Oscillometric method 3. Balance measured using the stork balance test 4. Muscle strength measured using the standing long jump test |
| Overall study start date | 01/08/2021 |
| Overall study end date | 30/12/2022 |
Eligibility
| Participant type(s) | Learner/student |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 1200 |
| Total final enrolment | 1355 |
| Participant inclusion criteria | Pupils at the recruited schools in 6th to 9th grade |
| Participant exclusion criteria | Not meeting the participant inclusion criteria |
| Recruitment start date | 01/08/2022 |
| Recruitment end date | 20/12/2022 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Odense
5231
Denmark
Sponsor information
University/education
Campusvej 55
Odense
5231
Denmark
| Phone | +45 65001000 |
|---|---|
| contracts@sdu.dk | |
| Website | https://www.sdu.dk/en |
"ROR" |
https://ror.org/03yrrjy16 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Ole Kirks Fond, Ole Kirk's Foundation
- Location
- Denmark
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Novo Nordisk Foundation, Novo Nordic Foundation, NNF
- Location
- Denmark
Results and Publications
| Intention to publish date | 01/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
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.
