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

Obesity Clinical Trial

— ActiveBrains  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295072
• Other study ID #: DEP2013-47540-R
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: July 2017

Study information

• Verified date: June 2021
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Universidad de Granada	Centro de Investigación Biomédica, Centro de Investigación Mente, Cerebro y Comportamiento, Hospital Clinico Universitario San Cecilio, Instituto Mixto Universitario Deporte y Salud

References & Publications (17)

Adelantado-Renau M, Esteban-Cornejo I, Rodriguez-Ayllon M, Cadenas-Sanchez C, Gil-Cosano JJ, Mora-Gonzalez J, Solis-Urra P, Verdejo-Román J, Aguilera CM, Escolano-Margarit MV, Verdejo-Garcia A, Catena A, Moliner-Urdiales D, Ortega FB. Inflammatory biomark — View Citation

Cadenas-Sánchez C, Mora-González J, Migueles JH, Martín-Matillas M, Gómez-Vida J, Escolano-Margarit MV, Maldonado J, Enriquez GM, Pastor-Villaescusa B, de Teresa C, Navarrete S, Lozano RM, de Dios Beas-Jiménez J, Estévez-López F, Mena-Molina A, Heras MJ, Chillón P, Campoy C, Muñoz-Hernández V, Martínez-Ávila WD, Merchan ME, Perales JC, Gil Á, Verdejo-García 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. — View Citation

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 associ — View Citation

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 i — View Citation

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. Brai — View Citation

Leppänen MH, Migueles JH, Cadenas-Sanchez C, Henriksson P, Mora-Gonzalez J, Henriksson H, Labayen I, Löf M, Esteban-Cornejo I, Ortega FB. Hip and wrist accelerometers showed consistent associations with fitness and fatness in children aged 8-12 years. Act — View Citation

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 workin — View Citation

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 — View Citation

Plaza-Florido A, Altmäe S, Esteban FJ, Cadenas-Sanchez C, Aguilera CM, Einarsdottir E, Katayama S, Krjutškov K, Kere J, Zaldivar F, Radom-Aizik S, Ortega FB. Distinct whole-blood transcriptome profile of children with metabolic healthy overweight/obesity — View Citation

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 H — View Citation

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, Gutiérrez Á, Michels N, Sacha J, Ortega FB. Heart Rate Is a Better Predictor of Cardiorespiratory Fitness — View Citation

Rodriguez-Ayllon M, Cadenas-Sanchez C, Esteban-Cornejo I, Migueles JH, Mora-Gonzalez J, Henriksson P, Martín-Matillas M, Mena-Molina A, Molina-García P, Estévez-López F, Enriquez GM, Perales JC, Ruiz JR, Catena A, Ortega FB. Physical fitness and psycholog — View Citation

Rodriguez-Ayllon M, Esteban-Cornejo I, Verdejo-RomÁn 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 wi — View Citation

Rodriguez-Ayllon M, Esteban-Cornejo I, Verdejo-Román 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 obesi — View Citation

Solis-Urra P, Esteban-Cornejo I, Cadenas-Sanchez C, Rodriguez-Ayllon M, Mora-Gonzalez J, Migueles JH, Labayen I, Verdejo-Román J, Kramer AF, Erickson KI, Hillman CH, Catena A, Ortega FB. Early life factors, gray matter brain volume and academic performanc — View Citation

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, Martín-Matillas M, Labayen I, Ortega FB. Differences in areal bone mineral density between metabolically heal — View Citation

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 Bra — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Primary	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	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).
Secondary	Mental Health	Chronic Stress indicators and behaviour and personality tests.	20 days during baselines and Post-evaluations (after intervention).
Secondary	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).
Secondary	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).

External Links

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