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| Name | Class |
|---|---|
| Consorcio Centro de Investigación Biomédica en Red (CIBER) | OTHER_GOV |
| Hospital Clinico Universitario San Cecilio | OTHER |
| Instituto Mixto Universitario Deporte y Salud | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | 2 Usual Physical Education sessions/week | |
| Intervention Group | Experimental | A 5-months physical exercise-based program (3-5 Physical Education after school sessions/week + 2 Usual Physical Education sessions/week) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A 5-months physical exercise-based program | Behavioral | 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. |
| 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). |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26924671 | Background | Cadenas-Sanchez C, Mora-Gonzalez J, Migueles JH, Martin-Matillas M, Gomez-Vida J, Escolano-Margarit MV, Maldonado J, Enriquez GM, Pastor-Villaescusa B, de Teresa C, Navarrete S, Lozano RM, de Dios Beas-Jimenez J, Estevez-Lopez F, Mena-Molina A, Heras MJ, Chillon P, Campoy C, Munoz-Hernandez V, Martinez-Avila WD, Merchan ME, Perales JC, Gil A, Verdejo-Garcia A, Aguilera CM, Ruiz JR, Labayen I, Catena A, Ortega FB. An exercise-based randomized controlled trial on brain, cognition, physical health and mental health in overweight/obese children (ActiveBrains project): Rationale, design and methods. Contemp Clin Trials. 2016 Mar;47:315-24. doi: 10.1016/j.cct.2016.02.007. Epub 2016 Feb 23. | |
| 28789992 |
| Label | URL |
|---|---|
| Pubmed link Methodological | View source |
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There is not a plan to make IPD available.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 19, 2021 | Jun 21, 2021 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Research Center for Mind, Brain and Behavior, Spain |
| OTHER |
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| 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). |
| Result |
| Esteban-Cornejo I, Cadenas-Sanchez C, Contreras-Rodriguez O, Verdejo-Roman J, Mora-Gonzalez J, Migueles JH, Henriksson P, Davis CL, Verdejo-Garcia A, Catena A, Ortega FB. A whole brain volumetric approach in overweight/obese children: Examining the association with different physical fitness components and academic performance. The ActiveBrains project. Neuroimage. 2017 Oct 1;159:346-354. doi: 10.1016/j.neuroimage.2017.08.011. Epub 2017 Aug 5. |
| 29031643 | Result | Rodriguez-Ayllon M, Cadenas-Sanchez C, Esteban-Cornejo I, Migueles JH, Mora-Gonzalez J, Henriksson P, Martin-Matillas M, Mena-Molina A, Molina-Garcia P, Estevez-Lopez F, Enriquez GM, Perales JC, Ruiz JR, Catena A, Ortega FB. Physical fitness and psychological health in overweight/obese children: A cross-sectional study from the ActiveBrains project. J Sci Med Sport. 2018 Feb;21(2):179-184. doi: 10.1016/j.jsams.2017.09.019. Epub 2017 Oct 4. |
| 30809168 | Result | Esteban-Cornejo I, Rodriguez-Ayllon M, Verdejo-Roman J, Cadenas-Sanchez C, Mora-Gonzalez J, Chaddock-Heyman L, Raine LB, Stillman CM, Kramer AF, Erickson KI, Catena A, Ortega FB, Hillman CH. Physical Fitness, White Matter Volume and Academic Performance in Children: Findings From the ActiveBrains and FITKids2 Projects. Front Psychol. 2019 Feb 12;10:208. doi: 10.3389/fpsyg.2019.00208. eCollection 2019. |
| 31133870 | Result | Plaza-Florido A, Migueles JH, Mora-Gonzalez J, Molina-Garcia P, Rodriguez-Ayllon M, Cadenas-Sanchez C, Esteban-Cornejo I, Solis-Urra P, de Teresa C, Gutierrez A, Michels N, Sacha J, Ortega FB. Heart Rate Is a Better Predictor of Cardiorespiratory Fitness Than Heart Rate Variability in Overweight/Obese Children: The ActiveBrains Project. Front Physiol. 2019 May 7;10:510. doi: 10.3389/fphys.2019.00510. eCollection 2019. |
| 31330300 | Result | Adelantado-Renau M, Esteban-Cornejo I, Rodriguez-Ayllon M, Cadenas-Sanchez C, Gil-Cosano JJ, Mora-Gonzalez J, Solis-Urra P, Verdejo-Roman J, Aguilera CM, Escolano-Margarit MV, Verdejo-Garcia A, Catena A, Moliner-Urdiales D, Ortega FB. Inflammatory biomarkers and brain health indicators in children with overweight and obesity: The ActiveBrains project. Brain Behav Immun. 2019 Oct;81:588-597. doi: 10.1016/j.bbi.2019.07.020. Epub 2019 Jul 19. |
| 31379602 | Result | Plaza-Florido A, Migueles JH, Mora-Gonzalez J, Molina-Garcia P, Rodriguez-Ayllon M, Cadenas-Sanchez C, Esteban-Cornejo I, Navarrete S, Maria Lozano R, Michels N, Sacha J, Ortega FB. The Role of Heart Rate on the Associations Between Body Composition and Heart Rate Variability in Children With Overweight/Obesity: The ActiveBrains Project. Front Physiol. 2019 Jul 16;10:895. doi: 10.3389/fphys.2019.00895. eCollection 2019. |
| 31465844 | Result | Solis-Urra P, Esteban-Cornejo I, Cadenas-Sanchez C, Rodriguez-Ayllon M, Mora-Gonzalez J, Migueles JH, Labayen I, Verdejo-Roman J, Kramer AF, Erickson KI, Hillman CH, Catena A, Ortega FB. Early life factors, gray matter brain volume and academic performance in overweight/obese children: The ActiveBrains project. Neuroimage. 2019 Nov 15;202:116130. doi: 10.1016/j.neuroimage.2019.116130. Epub 2019 Aug 26. |
| 31583747 | Result | Leppanen MH, Migueles JH, Cadenas-Sanchez C, Henriksson P, Mora-Gonzalez J, Henriksson H, Labayen I, Lof M, Esteban-Cornejo I, Ortega FB. Hip and wrist accelerometers showed consistent associations with fitness and fatness in children aged 8-12 years. Acta Paediatr. 2020 May;109(5):995-1003. doi: 10.1111/apa.15043. Epub 2019 Oct 20. |
| 31822016 | Result | Ubago-Guisado E, Gracia-Marco L, Medrano M, Cadenas-Sanchez C, Arenaza L, Migueles JH, Mora-Gonzalez J, Tobalina I, Escolano-Margarit MV, Oses M, Martin-Matillas M, Labayen I, Ortega FB. Differences in areal bone mineral density between metabolically healthy and unhealthy overweight/obese children: the role of physical activity and cardiorespiratory fitness. Pediatr Res. 2020 Jun;87(7):1219-1225. doi: 10.1038/s41390-019-0708-x. Epub 2019 Dec 10. |
| 31876665 | Result | Rodriguez-Ayllon M, Esteban-Cornejo I, Verdejo-Roman J, Muetzel RL, Migueles JH, Mora-Gonzalez J, Solis-Urra P, Erickson KI, Hillman CH, Catena A, Tiemeier H, Ortega FB. Physical Activity, Sedentary Behavior, and White Matter Microstructure in Children with Overweight or Obesity. Med Sci Sports Exerc. 2020 May;52(5):1218-1226. doi: 10.1249/MSS.0000000000002233. |
| 32249933 | Result | Mora-Gonzalez J, Esteban-Cornejo I, Solis-Urra P, Migueles JH, Cadenas-Sanchez C, Molina-Garcia P, Rodriguez-Ayllon M, Hillman CH, Catena A, Pontifex MB, Ortega FB. Fitness, physical activity, sedentary time, inhibitory control, and neuroelectric activity in children with overweight or obesity: The ActiveBrains project. Psychophysiology. 2020 Jun;57(6):e13579. doi: 10.1111/psyp.13579. Epub 2020 Apr 6. |
| 32290576 | Result | Zavala-Crichton JP, Esteban-Cornejo I, Solis-Urra P, Mora-Gonzalez J, Cadenas-Sanchez C, Rodriguez-Ayllon M, Migueles JH, Molina-Garcia P, Verdejo-Roman J, Kramer AF, Hillman CH, Erickson KI, Catena A, Ortega FB. Association of Sedentary Behavior with Brain Structure and Intelligence in Children with Overweight or Obesity: The ActiveBrains Project. J Clin Med. 2020 Apr 12;9(4):1101. doi: 10.3390/jcm9041101. |
| 32719329 | Result | Rodriguez-Ayllon M, Esteban-Cornejo I, Verdejo-Roman J, Muetzel RL, Mora-Gonzalez J, Cadenas-Sanchez C, Plaza-Florido A, Molina-Garcia P, Kramer AF, Catena A, Ortega FB. Physical fitness and white matter microstructure in children with overweight or obesity: the ActiveBrains project. Sci Rep. 2020 Jul 27;10(1):12469. doi: 10.1038/s41598-020-67996-2. |
| 33037758 | Result | Mora-Gonzalez J, Esteban-Cornejo I, Migueles JH, Rodriguez-Ayllon M, Molina-Garcia P, Cadenas-Sanchez C, Solis-Urra P, Plaza-Florido A, Kramer AF, Erickson KI, Hillman CH, Catena A, Ortega FB. Physical fitness and brain source localization during a working memory task in children with overweight/obesity: The ActiveBrains project. Dev Sci. 2021 May;24(3):e13048. doi: 10.1111/desc.13048. Epub 2020 Oct 25. |
| 33049365 | Result | Esteban-Cornejo I, Stillman CM, Rodriguez-Ayllon M, Kramer AF, Hillman CH, Catena A, Erickson KI, Ortega FB. Physical fitness, hippocampal functional connectivity and academic performance in children with overweight/obesity: The ActiveBrains project. Brain Behav Immun. 2021 Jan;91:284-295. doi: 10.1016/j.bbi.2020.10.006. Epub 2020 Oct 10. |
| 33230195 | Result | Plaza-Florido A, Altmae S, Esteban FJ, Cadenas-Sanchez C, Aguilera CM, Einarsdottir E, Katayama S, Krjutskov K, Kere J, Zaldivar F, Radom-Aizik S, Ortega FB. Distinct whole-blood transcriptome profile of children with metabolic healthy overweight/obesity compared to metabolic unhealthy overweight/obesity. Pediatr Res. 2021 May;89(7):1687-1694. doi: 10.1038/s41390-020-01276-7. Epub 2020 Nov 23. |
| 37891146 | Derived | Gil-Cosano JJ, Ubago-Guisado E, Migueles JH, Cadenas-Sanchez C, Torres-Lopez LV, Martin-Matillas M, Labayen I, Ortega FB, Gracia-Marco L. A 20-week exercise program improved total body and legs bone mineral density in children with overweight or obesity: The ActiveBrains randomized controlled trial. J Sci Med Sport. 2024 Jan;27(1):3-9. doi: 10.1016/j.jsams.2023.10.005. Epub 2023 Oct 12. |
| 37498603 | Derived | Migueles JH, Cadenas-Sanchez C, Lubans DR, Henriksson P, Torres-Lopez LV, Rodriguez-Ayllon M, Plaza-Florido A, Gil-Cosano JJ, Henriksson H, Escolano-Margarit MV, Gomez-Vida J, Maldonado J, Lof M, Ruiz JR, Labayen I, Ortega FB. Effects of an Exercise Program on Cardiometabolic and Mental Health in Children With Overweight or Obesity: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2324839. doi: 10.1001/jamanetworkopen.2023.24839. |
| 36040742 | Derived | Ortega FB, Mora-Gonzalez J, Cadenas-Sanchez C, Esteban-Cornejo I, Migueles JH, Solis-Urra P, Verdejo-Roman J, Rodriguez-Ayllon M, Molina-Garcia P, Ruiz JR, Martinez-Vizcaino V, Hillman CH, Erickson KI, Kramer AF, Labayen I, Catena A. Effects of an Exercise Program on Brain Health Outcomes for Children With Overweight or Obesity: The ActiveBrains Randomized Clinical Trial. JAMA Netw Open. 2022 Aug 1;5(8):e2227893. doi: 10.1001/jamanetworkopen.2022.27893. |
| 32343251 | Derived | Migueles JH, Cadenas-Sanchez C, Aguiar EJ, Molina-Garcia P, Solis-Urra P, Mora-Gonzalez J, Garcia-Marmol E, Shiroma EJ, Labayen I, Chillon P, Lof M, Tudor-Locke C, Ortega FB. Step-Based Metrics and Overall Physical Activity in Children With Overweight or Obesity: Cross-Sectional Study. JMIR Mhealth Uhealth. 2020 Apr 28;8(4):e14841. doi: 10.2196/14841. |
| 28939688 | Derived | Nystrom CD, Henriksson P, Martinez-Vizcaino V, Medrano M, Cadenas-Sanchez C, Arias-Palencia NM, Lof M, Ruiz JR, Labayen I, Sanchez-Lopez M, Ortega FB. Does Cardiorespiratory Fitness Attenuate the Adverse Effects of Severe/Morbid Obesity on Cardiometabolic Risk and Insulin Resistance in Children? A Pooled Analysis. Diabetes Care. 2017 Nov;40(11):1580-1587. doi: 10.2337/dc17-1334. Epub 2017 Sep 22. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |