FIT FIRST 20: a special school-based physical education program targeted to fourth- and fifth-grade students
| ISRCTN | ISRCTN14624515 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14624515 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Fund application number: 0077612 |
| Sponsor | University of Southern Denmark |
| Funder | Novo Nordisk Fonden |
- Submission date
- 23/10/2023
- Registration date
- 30/10/2023
- Last edited
- 25/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
In Denmark, less than one-third of 11- to 15-year-old children are sufficiently physically active. Physically inactive children are more likely to gain excessive weight, be inactive later in life, and develop chronic diseases. Therefore, this study aims to improve the physical fitness and well-being of children with an evidence-based physical education program.
Who can participate?
10-12-year-old children enrolled in a school in Denmark
What does the study involve?
Student participants will receive a special physical education program based on FIT FIRST principles if their schools are randomly assigned to receive the program. In the remaining schools, student participants will attend physical education classes, as previously established by the school. All students will respond to a questionnaire and carry out physical tests during a school day at school start, at the end of the school year, and 1 year after the project.
What are the possible benefits and risks of participating?
The potential benefits are improved physical fitness and well-being after the FIT FIRST program is implemented. No side effects are expected.
Where is the study run from?
University of Southern Denmark (Denmark)
When is the study starting and how long is it expected to run for? (what are the overall start and end dates?)
January 2019 to July 2026
Who is funding the study?
Novo Nordisk Foundation (Denmark)
Who is the main contact?
Peter Krustrup, pkrustrup@health.sdu.dk
Contact information
Public, Scientific
Campusvej 55
Odense
5230
Denmark
| Phone | +45 (0)65509311 |
|---|---|
| ccimenti@health.sdu.dk |
Principal investigator
Campusvej 55
Odense
5230
Denmark
 ORCID ID |
0000-0002-1461-9838 |
|---|---|
| Phone | +45 (0)21161530 |
| pkrustrup@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 effects of FIT FIRST 20 on physical fitness, well-being, and sports-club participation in 10-13-year-olds |
| Study acronym | FIT FIRST |
| Study objectives | A school-based physical activity intervention will improve psychosocial well-being and physical fitness and increase sports club participation among school-aged children and youth (4th to 5th grade, 10-12 years). |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | Conforming to current legislation, the project was submitted to The Regional Scientific Ethical Committees for Southern Denmark. The committee decided that the project was exempt from the obligation to notify. Notification of this decision was forwarded via email on 01/05/2023. |
| Health condition(s) or problem(s) studied | Well-being and physical fitness |
| Intervention | Participating schools are randomly assigned to the intervention group, the intervention and booster group, or the control group. The method of randomisation is stratified. The first and second strata include the schools recruited in the first and second recruitment rounds, respectively. As recruitment continues until summer 2024, new strata will be formed at a later stage. The intervention and intervention-and-booster schools will implement three weekly 40-minute FIT FIRST lessons during one school year. Intervention-and-booster schools will also receive an 8-week FIT FIRST 20 booster program half-school year after the FIT FIRST program is implemented. A booster is a strategy that is implemented after the end of an intervention to amplify its effects in the long term. It often applies the same principles of the original intervention within a shorter period, but more intensively. The control group will be offered the opportunity to implement the intervention 1 year later. Baseline measurements are conducted at the beginning of a school year, followed by post-intervention assessments at the end of the school year as well as 1 year after the end of the intervention for all participating schools. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
All outcomes are measured at baseline as well as 1 year and 2 years after intervention start: |
| Key secondary outcome measure(s) |
Sports club participation. Data are collected through a questionnaire. Questions include "which sports do you practice in your spare time?" and "how many times a week do you practice sports in your spare time?". Measured at baseline as well as 1 year and 2 years after intervention start. |
| Completion date | 01/07/2026 |
Eligibility
| Participant type(s) | Learner/student |
|---|---|
| Age group | Child |
| Lower age limit | 10 Years |
| Upper age limit | 12 Years |
| Sex | All |
| Target sample size at registration | 1085 |
| Key inclusion criteria | 1. Student enrolled in a school in Denmark 2. Student attending 4th, 5th or 6th grade during the research project period |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 01/04/2023 |
| Date of final enrolment | 31/08/2024 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Campusvej 55
Odense
5230
Denmark
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be available by requesting them from Peter Krustrup, Professor of Sport and Health Sciences at the University of Southern Denmark (e-mail: pkrustrup@health.sdu.dk). All data will be available after the end of the research project and indefinitely. Data is anonymized and there will be no restrictions in analyses or access criteria. |
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
25/10/2023: Study's existence confirmed by the Novo Nordisk Foundation.
