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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02295072
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : October 26, 2017
Centro de Investigación Biomédica
Hospital Clinico Universitario San Cecilio
Instituto Mixto Universitario Deporte y Salud
Centro de Investigación Mente, Cerebro y Comportamiento
Information provided by (Responsible Party):
Francisco B. Ortega Porcel, Universidad de Granada

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.

Condition or disease Intervention/treatment Phase
Cognitive Function 1, Social Mental Health Wellness 1 Obesity Overweight Behavioral: A 5-months physical exercise-based program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ActiveBrains: Effects of an Exercise-based Randomized Controlled Trial on Cognition, Brain Structure and Brain Function in Overweight/Obese Preadolescent Children
Study Start Date : December 2014
Actual Primary Completion Date : March 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Control group
2 Usual Physical Education sessions/week
Experimental: Intervention Group
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
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.

Primary Outcome Measures :
  1. Changes in Brain function and structure using magnetic resonance imaging (MRI) [ Time Frame: 20 days during baselines and Post-evaluations (after intervention). ]
    10-15 mins of high resolution scanning, 10 mins of resting state and 20 mins of Diffusion Tensor Imaging

  2. Brain and cognitive functioning assessment by electroencephalogram (EEG) [ Time Frame: 20 days during baselines and Post-evaluations (after intervention). ]
    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.

  3. Cognitive performance (DKEFS test battery) [ Time Frame: 20 days during baselines and Post-evaluations (after intervention). ]
    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

  4. Academic achievement [ Time Frame: 20 days during baselines and Post-evaluations (after intervention). ]
    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.

Secondary Outcome Measures :
  1. Physical Fitness [ Time Frame: 20 days during baselines and Post-evaluations (after intervention). ]
    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

  2. Mental Health [ Time Frame: 20 days during baselines and Post-evaluations (after intervention). ]
    Chronic Stress indicators and behaviour and personality tests.

  3. Body fatness and bone mass [ Time Frame: 20 days during baselines and Post-evaluations (after intervention). ]
    Body fatness and bone mass assessment using dual-energy X-ray absorciometry (DXA, Discovery densitometer from Hologic), following protocols used in previous studies

  4. Cardio-metabolic risk factors [ Time Frame: 20 days during baselines and Post-evaluations (after intervention). ]
    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)

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Francisco B. Ortega Porcel, Ramón & Cajal Researcher Fellow. Doctor in Exercise Physiology from University of Granada and Doctor in Medical Science from Karolinska Institutet of Stockholm., Universidad de Granada Identifier: NCT02295072    
Other Study ID Numbers: DEP2013-47540-R
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Keywords provided by Francisco B. Ortega Porcel, Universidad de Granada:
Exercise-based Randomized Controlled Trial
Brain structure
Brain function
Cognitive function
Physical fitness
Body Mass Index
Cardiovascular disease risk factors
Mental health
risk factors
body composition
Additional relevant MeSH terms:
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Body Weight
Signs and Symptoms