Obesity Clinical Trial
Official title:
Effectiveness of an Intervention of Physical Activity Promotion in Schoolchildren on Preventing Obesity During the Adiposity Rebound Period: a Cross-over Randomized Cluster Trial.
Coordinated project whose objectives are: a) to assess the effectiveness of a physical activity intervention (MOVI-KIDS) on preventing obesity and improving fitness during the adiposity rebound period; and b) to examine the effectiveness of MOVI-KIDS on reducing the carotid intima-media thickness.
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 programs of recreational physical activity to control obesity and other
cardiovascular risk factors in primary school children (8-to-11 years)in Cuenca, Spain.
The first edition, called MOVI, showed moderate effect in reducing adiposity and improving
the lipid profile, but did not significantly improve overall cardiometabolic risk, mainly
because of did not reduce blood insulin levels. A second edition (MOVI-2), increased
duration and intensity of the sessions and was more focused on increased muscle strength.
Preliminary analysis also show a decrease in body fat, a reduction of global cardiometabolic
because of decreased 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 consist of two
sub-projects that 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 a cross-over randomized trial aimed to test the
effectiveness of an intervention to promote physical activity in the school environment
(MOVI-KIDS) during two-years in 22 schools (20 public and two private schools) in the
provinces of Cuenca and Ciudad Real, Spain.
This principal subproject consisted of a mixed study including both the trial cited above
and a nested qualitative study aimed to identify barriers and facilitators to physical
activity in children in the school environment (social and family factors, urban planning,
etc.), and produce knowledge about the perceptions of children, parents and teachers on how
you can improve conditions of physical and social environment to facilitate physical
activity.
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 the body fat percentage in the intervention group versus the control group in
2%.
2. Improve the several components of fitness: aerobic capacity, strength, speed and
agility.
3. Reduce the carotid intima-media thickness and
4. Reduce fat, increase fat free mass, and reduce sedentary behavior.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
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