Effects of an Exercise Program on Cognition and Brain in Overweight/Obese Preadolescent Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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ActiveBrains: Effects of an Exercise-based Randomized Controlled Trial on Cognition, Brain Structure and Brain Function in Overweight/Obese Preadolescent Children

Conditions
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Obesity, Cognitive Function 1, Social, Mental Health Wellness 1, Overweight

Intervention / Treatment
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* Behavioral: A 5-months physical exercise-based program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>2 Usual Physical Education sessions/week | |
| Experimental: Intervention Group<br>A 5-months physical exercise-based program (3-5 Physical Education after school sessions/week + 2 Usual Physical Education sessions/week) | Behavioral: A 5-months physical exercise-based program<br>* The physical exercise program consists of 3-5 after-school sessions/week of 90 min plus exercise homework in the weekends, and will focus on high-intensity aerobic exercise mainly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Brain function and structure using magnetic resonance imaging (MRI) | 10-15 mins of high resolution scanning, 10 mins of resting state and 20 mins of Diffusion Tensor Imaging | 20 days during baselines and Post-evaluations (after intervention). | 
| Brain and cognitive functioning assessment by electroencephalogram (EEG) | Assessment of the processing information and speed trought event-related brain potentials, cognitive function using a EEG and doing two cognitive tasks of attention and working memory. | 20 days during baselines and Post-evaluations (after intervention). | 
| Cognitive performance (DKEFS test battery) | Executive function assessment with a set of tests of the DKEFS test battery that provide an assessment of verbal and non-verbal intelligence, one's initiation of problem-solving behavior, fluency in generating visual patterns, creativity in drawing new designs, simultaneous processing in drawing the designs while observing the rules and restrictions of the task, and inhibiting previously drawn responses, spatial planning, rule learning, inhibition of impulsive and perseverative responding, cognitive inhibition, flexibility of thinking on a visual-motor sequencing task and relational memory | 20 days during baselines and Post-evaluations (after intervention). | 
| Academic achievement | Academic achievement is assessed using final school recorded scores and the III Woodcock-Muñoz Battery which includes 5 reading tests, 4 oral tests, 4 mathematics tests, 4 written language tests and 4 tests of academic language. | 20 days during baselines and Post-evaluations (after intervention). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Fitness | Aerobic fitness, muscular strength and speed-agility, following the ALPHA fitness test battery. In addition aerobic fitness will be additionally assessed using a gas analyzer (General Electric Corporation) while performing and maximal incremental treadmill test modified for poorly fit children | 20 days during baselines and Post-evaluations (after intervention). | 
| Mental Health | Chronic Stress indicators and behaviour and personality tests. | 20 days during baselines and Post-evaluations (after intervention). | 
| Body fatness and bone mass | Body fatness and bone mass assessment using dual-energy X-ray absorciometry (DXA, Discovery densitometer from Hologic), following protocols used in previous studies | 20 days during baselines and Post-evaluations (after intervention). | 
| Cardio-metabolic risk factors | Here we will include a complete set of risk factors as markers of lipid profile (triglycerides and total-, HDL and LDL-cholesterol), blood pressure (following standard procedures), and insulin resistance (glucose and insulin, homeostasis model assessment, HOMA) | 20 days during baselines and Post-evaluations (after intervention). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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