Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05789693 |
| Other study ID # |
UZPI21/502 |
| Secondary ID |
622733-EPP-1-202 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2022 |
| Est. completion date |
May 4, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
Universidad de Zaragoza |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this study is to design, adapt and implement a strategies and a teaching
intervention programme to improve the adolescents physical activity in a little city of
Spain, in an educational context.
Students will be divided in two groups (control and intervention) and we will apply in the
intervention in one group and we will develop different strategies aimed at improve the
active lifestyles in the adolescents. Researchers will compare both groups taking in to
account: levels of physical activity, sedentary time, healthy diet, self-concept or different
psychosocial outcomes
Description:
The purpose of the project is the development of a healthy environment from educational
centers. Healthy behaviors and perceptions of healthy environments of members of the
educational community will be analyzed. The data processing process will be anonymous in all
students. The center will receive the information corresponding to the project through the
person in charge of the investigation. The center will send a letter voluntarily accepting
your participation (attached) to the principal investigator (PI) of the project. The main
objective of the research project presented is to improve physical activity levels in
adolescents who present rates of diagnosed active impairment through the design, development
and evaluation of a multilevel and multicomponent intervention program to promote healthier
lifestyles. This program will follow the principles of the Socio-ecological model, teachers
and parents perceptions and beliefs, with the aim of achieving greater adherence to the
sports practice of adolescents.
Students of 2nd year of E.S.O would be part of this intervention program of two educational
centers of a Spanish region. Through the initial measurement made to 2nd year students of
E.S.O. Overall, the investigatos would expect to have a total of about 80 male and female
students, with ages between 12 and 15 years. Indirectly, parents of students and teachers
would also participate. In this way, identified young people who do not perform physical
activity or do not reach minimum recommendable values (recommendations of World Health
Organization), will be grouped in control and experimental schools.
The study variables will be:
- Qualitative data: Collected through focus groups: personal opinions about their
educational center and the development of healthy environments. Estimated completion
time: 45 minutes.
- Quantitative data: The data that will be required for the students in the questionnaires
(students): age, gender, place of residence and data on healthy behaviors (levels of
physical activity, hours of sleep, food, hours spent on screen, substance use). and
influences for a healthy environment and self-concept). Estimated completion time: 45
minutes.
The focus groups and the questionnaires will be applied once the approval of the Ethical
Commitee of the region has been obtained for the application of the project. Once obtained,
the following day the informed consent will be provided to the families, it will be collected
in 7 days and the following week the initial questionnaires will be carried out. At the end
of the research in May 2022, the same questionnaires will be passed again to assess the
evolution of the group in the different study variables.
Students who do not participate in the study will be invited to non-curricular activities
since participation will be voluntary. When the questionnaires are completed, the center will
enable a teacher "on duty" to attend to the students during the hour that the questionnaires
last.
Statistical analysis: Comparisons will be made to verify that there are no differences in the
baseline, using the "t" test and the χ2 test. After verifying the assumptions of normality
and homoscedasticity, an analysis of covariance with three repeated measures (ANCOVA) will be
performed on the outcome variables, by intention to treat (ITT), using the last observation
carried forward (LOCF) method. Age, sex, and baseline scores will be included as covariates
to examine differences between groups, eliminating their possible influence. The effect size
will be calculated using the partial eta square value (η2). Values ≤ 0.01 correspond to a
small effect size, = 0.06 with a medium size, and ≥ 0.14 with a large size. Contrasts will be
made between the pretest and posttest measurements, using the corresponding "t" test. The
significance level adopted will be α< 0.05.
Limitations of the study: It is a study with a reduced sample that does not want to be
representative, only to see the evaluation of the variables in that context during a specific
time to help the centers make decisions about their health promoting school project.The
benefits of this project would be framed in different levels. In the first place, the main
benefit would be obtained by the direct recipients of the project, that is, the adolescents
who would see their physical activity levels increased with the positive consequences that
this entails and with the development of healthier living habits. Secondly, Physical
Education teachers could have new methodological and motivational tools to encourage more
physical activity among their students; and the parents of these, could value the importance
of physical activity and lead an active lifestyle, collaborating from the family environment
to promote the objectives of this project.
