Study of the level of physical activity, inactivity, and sleep patterns in children and adolescents in the Autonomous Community of the Basque Country (6–17 years old)
| ISRCTN | ISRCTN65573865 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65573865 |
| Secondary identifying numbers | PI2020011 |
- Submission date
- 15/03/2021
- Registration date
- 09/06/2021
- Last edited
- 20/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Physical inactivity and increased sedentary behavior are increasingly common problems and can lead to overweight, obesity, diabetes, heart disease, and decreased motor and cognitive capacity among children and adolescents. Establishing some healthy habits in childhood is essential for proper physical, motor, and cognitive development. The aim of this study is to describe the level of physical activity, sedentary behavior and sleep of children and adolescents in the Autonomous Community of the Basque Country.
Who can participate?
All children aged 6-17 enrolled in a school in the Basque Autonomous Community
What does the study involve?
Participants will be selected randomly based on gender, age, school, school location and socioeconomic status. They will have to wear an accelerometer for 7 full days and fill in a health habits diary.
What are the possible benefits and risks of participating?
The main benefit is to find out whether children and adolescents are sufficiently physically active on a daily basis, and assess their sedentary behavior and the relationship between these behaviors and sleep. This study has no risks as the participants will only have to wear an accelerometer and fill in a diary.
Where is the study run from?
The study is conducted from the Basque Autonomous Community and is carried out by the Basque Government, the University of Deusto and Mondragon Unibertzitatea, Mugikon and Athlon (Spain)
When is the study starting and how long is it expected to run for?
September 2020 to April 2022
Who is funding the study?
The Basque Government (Spain)
Who is the main contact?
Dr Aitor Coca Nuñez
aitor.coca@euneiz.com
Contact information
Scientific
Unibertsitate Etorb., 24
Bibao
48007
Spain
| Phone | +34 (0)688749145 |
|---|---|
| aitor.coca@euneiz.com |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | School |
| Study type | Quality of life |
| Participant information sheet | ISRCTN65573865_PIS.pdf |
| Scientific title | Study protocol on the level of physical activity, sedentary behavior, and sleep in the child and adolescent population in the Autonomous Community of the Basque Country (6–17 years old) |
| Study acronym | MUGIKERTU |
| Study objectives | To describe the level of physical activity, sedentary behavior, or sleep of the child and adolescent population from 6 to 17 years old in the Basque Autonomous Country. |
| Ethics approval(s) | Approved 14/10/2020, Euskadi Drug Research Ethics Committee (Basque Government Department of Health, CEIm-Departamento de Salud del Gobierno Vasco, C/ Donostia-San Sebastián, nº 1. Vitoria-Gasteiz 01010, Spain; +34 (0)945 01 92 96; +34 (0)945 01 56 34 ; +34 (0)945 01 64 59; ceic.eeaa@euskadi.eus), ref: PI2020011 |
| Health condition(s) or problem(s) studied | Physical activity, sedentary behavior, sleep |
| Intervention | This study aims to recruit 1,111 representative random samples of children and adolescents from 6 to 17 years old from the Basque Autonomous Country. Participants must wear the ActiGraph WGT3X-BT accelerometer for a full 7 days and fill out a habit log of physical activity, sedentary behavior, and sleep routine. Participants will be randomly selected. |
| Intervention type | Behavioural |
| Primary outcome measure | The level of physical activity, sedentary behavior, and sleep routine measured by ActiGraph WGT3X-BT accelerometers for 7 days. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/09/2020 |
| Completion date | 15/04/2022 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 1111 |
| Total final enrolment | 1150 |
| Key inclusion criteria | 1. Belong to the student body of a participating school or institute 2. Have authorization to participate through a signed informed consent by the parents or legal guardians of the child or adolescent |
| Key exclusion criteria | Non-consent or refusal by the child or adolescent to complete the physical activity diary or to use the accelerometer, even with a signed informed consent by their parents or legal guardians |
| Date of first enrolment | 01/11/2020 |
| Date of final enrolment | 30/10/2021 |
Locations
Countries of recruitment
- Spain
Study participating centres
Bilbao
48007
Spain
Mondragón
20500
Spain
Sponsor information
Government
Donostia-San Sebastián kalea, 1
Vitoria-Gasteiz
01010
Spain
| Phone | +34 (0)945018000 |
|---|---|
| comisionjuridica@euskadi.eus | |
| Website | https://www.euskadi.net |
"ROR" |
https://ror.org/00pz2fp31 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Gobierno Vasco, Basque Government
- Location
- Spain
Results and Publications
| Intention to publish date | 01/10/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | 1. Planned publication of the protocol 2. Planned publication of the results in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets are stored in a private server that only researchers approved by the ethics committee have access to. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 09/06/2021 | No | Yes | ||
| Protocol article | Protocol | 11/03/2022 | 17/03/2023 | Yes | No |
| Results article | outcome results | 15/03/2023 | 17/03/2023 | Yes | No |
| Results article | results with and without sports | 06/01/2023 | 17/03/2023 | Yes | No |
Additional files
- ISRCTN65573865_PIS.pdf
- uploaded 09/06/2021
Editorial Notes
20/03/2023: 2. The overall trial end date has been changed from 28/02/2022 to 15/04/2022 and the plain English summary updated accordingly:
17/03/2023: The following changes have been made:
1. Three publication references added.
2. Total final enrolment added.
22/09/2022: The scientific contact's details have changed and the plain English summary has been updated accordingly.
09/06/2021: The participant information sheet was uploaded as an additional file.
22/03/2021: Trial's existence confirmed by the Euskadi Drug Research Ethics Committee.
