Clinical trial NCT01971827: Effectiveness of a Physical Activity Intervention to Prevent Obesity and Improve Academic Performance
Official title: Effectiveness of Physical Activity Intervention to Prevent Obesity and Improve Academic Performance in Children With and Without Attention Deficit Hyperactivity Disorder (ADHD) Risk
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Activity
Obesity
Children
Academic Underachievement Disorder
Attention Deficit Hyperactivity Disorder
Keywords: Physical activity
Obesity
Adiposity rebound period
Children with ADHD
Children without ADHD
Academic performance
Motor skills
Health related-quality of life
Sleep
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
Collaborators: name: Carlos III Health Institute
First posted: 2013-10-29
Enrollment: 1600
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Coordinated project whose objectives are: a) to test the effectiveness of a promotion of physical activity intervention (MOVI-KIDS) on preventing obesity; and b) to improve the academic performance in both children with and without attention deficit hyperactivity disorder (ADHD)

Detailed description: The prevalence of overweight in Spanish children in the puberty age is among the highest in the world and increasing quickly. Our group has done so far two interventions based on after-school program of recreational physical activity to control obesity and other cardiovascular risk factors in primary school children (8-to-11 years) in Cuenca.

This intervention, in its first edition showed moderate effect in reducing adiposity and improving the lipid profile, but did not significantly improve overall cardiometabolic risk by not reduce blood insulin. In a second edition (MOVI-2), increased duration and intensity of the sessions and worked over the development of muscle strength. Preliminary analysis also show a decrease in body fat, a reduction of global cardiometabolic because of decreasing insulin levels.

Our project integrates a multidimensional intervention to promote physical activity, with a mixed design (cross-over randomized trial, and a qualitative study) and two sub-projects share the same study population, "Effectiveness of an intervention of physical activity promotion in schoolchildren on preventing obesity during the adiposity rebound period: a cross-over randomized cluster trial" and "Effectiveness of physical activity intervention to prevent obesity and improve academic performance in children with and without ADHD risk".

The two interventions are based on cross-over randomized trial to test the effectiveness of an intervention to promote physical activity in the school environment (MOVI-KIDS), two-year in 22 schools (20 public and two private schools) in the provinces of Cuenca and Ciudad Real, Spain.

This subproject (subproject-2) will assess the effectiveness of the intervention of the MOVI-KIDS Program in improving attention and cognition in students at risk for ADHD. Furthermore, this project will evaluate the effectiveness of MOVI-KIDS Program in improving motor skills and academic achievement in the overall sample, and the impact that changes in the year have on the amount of physical activity that the students in the sample performed during recess.

The hypotheses of this third edition are that a multidimensional intervention promoting physical activity in children at the adiposity rebound period (4-7 years),in the school environment (MOVI-KIDS), lasting two-years, will to:

1. Reduce body fat percentage in the intervention group versus the control group in 2% in children adiposity rebound age (4-7 years),
2. Improve academic performance and motor skills in children with and without attention deficit hyperactivity disorder (ADHD),
3. Reduce adiposity and sedentary time, improve academic performance, quality of life and the duration and quality of sleep in children with and without ADHD.

Eligibility criteria: Inclusion Criteria:

* Schools with at least one full course of 3rd of early childhood education and one of 1st primary school.
* The Boards of Governors (community participatory organ in each school) give its approval to the intervention and measurements at the beginning and end of the course.
* Children 4 to 7 years old.
* Children's parents/caregivers will give their written consent to the children's participation.
* Collaboration in the family to respond to questionnaires on family leisure habits, sleeping, eating, getting around town, etc., included in the measurement protocol of this project.

Exclusion Criteria:

* Have a malformation that prevents learning of the Spanish language (or Spanish sign language).
* Have some kind of physical or mental disorder identified by parents or teachers that prevent physical activity.
* Have a chronic illness such as heart disease, diabetes or asthma, as determined by their pediatrician/family doctor -after analysis of the activities program- prevents participation in them.

Primary outcomes:
measure: Body fat percentage
timeFrame: One year (interim analysis)
Secondary outcomes:
measure: Academic achievement
timeFrame: One year (interim analysis)
measure: Motor skills
timeFrame: One year (interim analysis)
measure: Health-related quality of life
timeFrame: One year (interim analysis)
measure: Sleep quality
timeFrame: One year (interim analysis)
measure: Attention-deficit/hyperactivity disorder risk
timeFrame: One year (interim analysis)
Other outcomes:
Locations:
city: Cuenca
country: Spain
facility: Health and Social Research Centre, University of Castilla-La Mancha
Study officials:
affiliation: Health and social Research Centre, University of Castilla-La Mancha, Cuenca, Spain
name: Mairena Sánchez-López, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sanchez-Lopez M, Pardo-Guijarro MJ, Del Campo DG, Silva P, Martinez-Andres M, Gulias-Gonzalez R, Diez-Fernandez A, Franquelo-Morales P, Martinez-Vizcaino V; Movi-Kids group. Physical activity intervention (Movi-Kids) on improving academic achievement and adiposity in preschoolers with or without attention deficit hyperactivity disorder: study protocol for a randomized controlled trial. Trials. 2015 Oct 12;16:456. doi: 10.1186/s13063-015-0992-7.