Clinical trial NCT02295072: Effects of an Exercise Program on Cognition and Brain in Overweight/Obese Preadolescent Children
Official title: ActiveBrains: Effects of an Exercise-based Randomized Controlled Trial on Cognition, Brain Structure and Brain Function in Overweight/Obese Preadolescent Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function 1, Social
Mental Health Wellness 1
Obesity
Overweight
Keywords: Exercise-based Randomized Controlled Trial
Brain structure
Brain function
Cognitive function
Physical fitness
Body Mass Index
Cardiovascular disease risk factors
Mental health
Stress
Neurology
Obesity
brain
risk factors
bone
bones
body composition
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Centro de Investigación Biomédica
name: Hospital Clinico Universitario San Cecilio
name: Instituto Mixto Universitario Deporte y Salud
name: Centro de Investigación Mente, Cerebro y Comportamiento
First posted: 2014-11-20
Enrollment: 110
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The ActiveBrains project aims to examine whether a 5-months physical exercise program has benefits on cognition and brain, as well as on selected physical and mental health outcomes in preadolescent overweight/obese children.

Detailed description: New advances in neuroelectric and neuroimaging technologies in the last years provide a golden opportunity to further explore and understand how cognition and brain function can be stimulated by environmental factors, such as exercise, and particularly to study whether physical activity influences brain development in early ages. The present study, namely the ActiveBrains project, aims to examine the effects of a 5-months physical exercise program on cognition and brain, as well as on selected physical and mental health outcomes in preadolescents overweight/obese children.

A total of 100 overweight/obese preadolescent children aged 9 to 10 years will be randomized into an exercise group (N=50) and a control group (N=50). For practical and feasibility reasons, the study will be conducted in 2 waves, a 1st wave with a sample of 30 and a 2nd wave with a sample of 75. In this regard, 15 children will be intervened within one academic year (5-month intervention) and 35 children will be intervened within the following academic year. The control group will receive the usual physical education sessions (2 per week). In order to study the extent to which the effect of the intervention remains or disappears once the formal intervention is finished, we will do a 3rd evaluation in a subsample (50 participants from the 1st wave) 9 months after the intervention has finished. Waitlist control group strategy will be used, through which the control group will also receive an after-school exercise program but later, after all the assessments of the effectiveness of the program have been completed.

Based on existing literature, we believe that a 5-months physical exercise program is potentially beneficial for the cognition and brain, and for the physical and mental health of the overweight/obese children participating.

Eligibility criteria: Inclusion Criteria:

* Preadolescent children of Tanner stage of I, II or III.
* Children of 8 to 11 years-old,
* Overweight or obese defined based on the sex-and-age specific body mass index standards of Cole (2002).
* Girls must not have menstruation.

Exclusion Criteria:

* Children with Attention-Deficit Hyperactivity Disorder or any other psychiatric disorder.
* Left-handed children.
* Children with medical problem that prevent to practice physical activity.

Primary outcomes:
measure: Changes in Brain function and structure using magnetic resonance imaging (MRI)
timeFrame: 20 days during baselines and Post-evaluations (after intervention).
measure: Brain and cognitive functioning assessment by electroencephalogram (EEG)
timeFrame: 20 days during baselines and Post-evaluations (after intervention).
measure: Cognitive performance (DKEFS test battery)
timeFrame: 20 days during baselines and Post-evaluations (after intervention).
measure: Academic achievement
timeFrame: 20 days during baselines and Post-evaluations (after intervention).
Secondary outcomes:
measure: Physical Fitness
timeFrame: 20 days during baselines and Post-evaluations (after intervention).
measure: Mental Health
timeFrame: 20 days during baselines and Post-evaluations (after intervention).
measure: Body fatness and bone mass
timeFrame: 20 days during baselines and Post-evaluations (after intervention).
measure: Cardio-metabolic risk factors
timeFrame: 20 days during baselines and Post-evaluations (after intervention).
Other outcomes:
Locations:
Study officials:
References:
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