Viewing Study NCT06590103


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Ignite Modification Date: 2026-02-24 @ 2:29 PM
Study NCT ID: NCT06590103
Status: RECRUITING
Last Update Posted: 2024-09-19
First Post: 2024-09-06
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Effectiveness of Integrating Physically Active Learning Through Co-teaching in Extremadura: ACTIVA-MENTE Project
Sponsor: University of Extremadura
Organization:

Study Overview

Official Title: Effectiveness of Integrating Physically Active Learning Through Co-teaching in Extremadura: ACTIVA-MENTE Project
Status: RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ACTIVA-MENTE
Brief Summary: Study based on a school-based physically active learning intervention during the school day on physical activity, fitness, health and education outcomes in adolescents.
Detailed Description: Activamente is a quasi-experimental study coordinated by fully qualified researchers in physical activity and sport sciences from the University of Extremadura (UEX), Spain. This study is aimed at students from 1st to 4th year of Secondary Education (11-16 years old), belonging to 10 schools in the Autonomous Community of Extremadura. Each school will have five experimental groups and five control groups. Thus, there will be 50 experimental groups (n=1100) and 50 control groups (n=1100). The intervention will last 8 months, and will consist of one component, which is the inclusion of one physically active class per week.

Before and after the intervention, physical activity and sedentary time will be assessed by activity bracelets, health-related fitness levels by field tests, body composition parameters by anthropometry, academic performance by school grades, positive health (quality of life and self-perception of health) by questionnaire, and cognitive parameters (executive functions) by specific cognition tests. In addition, two intermediate measures of physical activity levels and sedentary time will be measured.

At the end of the intervention the investigators will determine changes in the main outcome variables. Also, the main hypotheses raised will be:

1. Students belonging to the experimental group will improve physical activity and decrease sedentary time during the school day when compared to students belonging to the control group.
2. The students belonging to the experimental group will improve in the markers of physical and psychological health when compared to the students belonging to the control group.
3. Students in the experimental group will improve their academic and cognitive indicators when compared to students in the control group.
4. Students belonging to the experimental group will improve school climate and motivational variables in academic classes when compared to students belonging to the control group.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: