title: An exercise-based randomized controlled trial on brain, cognition, physical health and mental health in overweight/obese children (ActiveBrains project): Rationale, design and methods.
abstract: The new and recent advances in neuroelectric and neuroimaging technologies provide a new era for further exploring and understanding how brain and cognition function can be stimulated by environmental factors, such as exercise, and particularly to study whether physical exercise influences brain development in early ages. The present study, namely the ActiveBrains project, aims to examine the effects of a physical exercise programme on brain and cognition, as well as on selected physical and mental health outcomes in overweight/obese children. A total of 100 participants aged 8 to 11 years are randomized into an exercise group (N=50) or a control group (N=50). The intervention lasts 20-weeks, with 3-5 sessions per week of 90 min each, and is mainly focused on high-intensity aerobic exercise yet also includes muscle-strengthening exercises. The extent to what the intervention effect remains 8-months after the exercise programme finishes is also studied in a subsample. Brain structure and function and cognitive performance are assessed using structural and functional magnetic resonance imaging and electroencephalographic recordings. Secondary outcomes include physical health outcomes (e.g. physical fitness, body fatness, bone mass and lipid-metabolic factors) and mental health outcomes (e.g. chronic stress indicators and overall behavioural and personality measurements such as anxiety or depression). This project will substantially contribute to the existing knowledge and will have an impact on societies, since early stimulation of brain development might have long lasting consequences on cognitive performance, academic achievement and in the prevention of behavioural problems and the promotion of psychological adjustment and mental health. Clinical trials. Gov identifier: NCT02295072.
authors.affiliation: PROFITH "PROmoting FITness and Health through physical activity" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Cadenas-Sánchez
authors.affiliation: PROFITH "PROmoting FITness and Health through physical activity" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.
authors.forename: José
authors.initials: J
authors.lastname: Mora-González
authors.affiliation: PROFITH "PROmoting FITness and Health through physical activity" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.
authors.forename: Jairo H
authors.initials: JH
authors.lastname: Migueles
authors.affiliation: PROFITH "PROmoting FITness and Health through physical activity" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.
authors.forename: Miguel
authors.initials: M
authors.lastname: Martín-Matillas
authors.affiliation: Department of Pediatrics, San Cecilio Hospital, Granada, Spain.
authors.forename: José
authors.initials: J
authors.lastname: Gómez-Vida
authors.affiliation: Department of Pediatrics, San Cecilio Hospital, Granada, Spain.
authors.forename: María Victoria
authors.initials: MV
authors.lastname: Escolano-Margarit
authors.affiliation: Department of Pediatrics, School of Medicine, University of Granada, Granada, Spain; and the Institute of Biomedicine Research (Instituto de Investigación Biosanitaria (IBS), Granada, Spain.
authors.forename: José
authors.initials: J
authors.lastname: Maldonado
authors.affiliation: PROFITH "PROmoting FITness and Health through physical activity" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.
authors.forename: Gala María
authors.initials: GM
authors.lastname: Enriquez
authors.affiliation: Department of Biochemistry and Molecular Biology II, Institute of Nutrition and Food Technology, Centre for Biomedical Research, University of Granada, Granada, Spain; and CIBER Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Madrid, Spain.
authors.forename: Belén
authors.initials: B
authors.lastname: Pastor-Villaescusa
authors.affiliation: Andalusian Centre of Sport Medicine (CAMD), Junta de Andalucía, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: de Teresa
authors.affiliation: Andalusian Centre of Sport Medicine (CAMD), Junta de Andalucía, Spain.
authors.forename: Socorro
authors.initials: S
authors.lastname: Navarrete
authors.affiliation: Andalusian Centre of Sport Medicine (CAMD), Junta de Andalucía, Spain.
authors.forename: Rosa María
authors.initials: RM
authors.lastname: Lozano
authors.affiliation: Andalusian Centre of Sport Medicine (CAMD), Junta de Andalucía, Spain.
authors.forename: Juan
authors.initials: J
authors.lastname: de Dios Beas-Jiménez
authors.affiliation: Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain; Department of Psychology, Faculty of Social and Behavioural Sciences, Utrecht University, Utrecht, The Netherlands.
authors.forename: Fernando
authors.initials: F
authors.lastname: Estévez-López
authors.affiliation: PROFITH "PROmoting FITness and Health through physical activity" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.
authors.forename: Alejandra
authors.initials: A
authors.lastname: Mena-Molina
authors.affiliation: Materno Infantil Hospital, Granada, Spain.
authors.forename: María José
authors.initials: MJ
authors.lastname: Heras
authors.affiliation: PROFITH "PROmoting FITness and Health through physical activity" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.
authors.forename: Palma
authors.initials: P
authors.lastname: Chillón
authors.affiliation: EURISTIKOS Excellence Centre for Paediatric Research, University of Granada, Granada, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Campoy
authors.affiliation: PROFITH "PROmoting FITness and Health through physical activity" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.
authors.forename: Victoria
authors.initials: V
authors.lastname: Muñoz-Hernández
authors.affiliation: PROFITH "PROmoting FITness and Health through physical activity" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.
authors.forename: Wendy Daniela
authors.initials: WD
authors.lastname: Martínez-Ávila
authors.affiliation: PROFITH "PROmoting FITness and Health through physical activity" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.
authors.forename: María Elisa
authors.initials: ME
authors.lastname: Merchan
authors.affiliation: Mind, Brain, and Behaviour Research Centre-CIMCYC, University of Granada, Granada, Spain; Department of Experimental Psychology, University of Granada, Granada, Spain.
authors.forename: José C
authors.initials: JC
authors.lastname: Perales
authors.affiliation: Department of Biochemistry and Molecular Biology II, Institute of Nutrition and Food Technology, Centre for Biomedical Research, University of Granada, Granada, Spain; and CIBER Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Madrid, Spain.
authors.forename: Ángel
authors.initials: Á
authors.lastname: Gil
authors.affiliation: Department of Experimental Psychology, University of Granada, Granada, Spain; Institute of Neuroscience F. Olóriz, University of Granada, Spain; School of Psychological Sciences & Monash Institute of Cognitive and Clinical Neurosciences, Monash University, Melbourne, Australia.
authors.forename: Antonio
authors.initials: A
authors.lastname: Verdejo-García
authors.affiliation: Department of Biochemistry and Molecular Biology II, Institute of Nutrition and Food Technology, Centre for Biomedical Research, University of Granada, Granada, Spain; and CIBER Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Madrid, Spain.
authors.forename: Concepción M
authors.initials: CM
authors.lastname: Aguilera
authors.affiliation: PROFITH "PROmoting FITness and Health through physical activity" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain; Department of Biosciences and Nutrition, Karolinska Institutet, Huddinge, Sweden.
authors.forename: Jonatan R
authors.initials: JR
authors.lastname: Ruiz
authors.affiliation: Department of Nutrition and Food Science, University of the Basque Country, UPV-EHU, Vitoria-Gasteiz, Spain.
authors.forename: Idoia
authors.initials: I
authors.lastname: Labayen
authors.affiliation: Mind, Brain, and Behaviour Research Centre-CIMCYC, University of Granada, Granada, Spain.
authors.forename: Andrés
authors.initials: A
authors.lastname: Catena
authors.affiliation: PROFITH "PROmoting FITness and Health through physical activity" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain; Department of Biosciences and Nutrition, Karolinska Institutet, Huddinge, Sweden. Electronic address: ortegaf@ugr.es.
authors.forename: Francisco B
authors.initials: FB
authors.lastname: Ortega
mesh_terms: D000124:Achievement; D001921:Brain / Q000000981:diagnostic imaging / Q000502:physiology*; D002648:Child; D002985:Clinical Protocols; D003071:Cognition; D004569:Electroencephalography; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008603:Mental Health; D063766:Pediatric Obesity / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D010809:Physical Fitness; D012107:Research Design; D016896:Treatment Outcome
keywords: Academic performance; Behaviour; Magnetic imaging resonance; Personality; Physical activity; Preadolescents