NCT02295072

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

2.2 years

First QC Date

November 14, 2014

Last Update Submit

April 30, 2025

Conditions

Cognitive Function 1, SocialMental Health Wellness 1ObesityOverweight

Keywords

Exercise-based Randomized Controlled TrialBrain structureBrain functionCognitive functionPhysical fitnessBody Mass IndexCardiovascular disease risk factorsMental healthStressNeurologyObesitybrainrisk factorsbonebonesbody composition

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Physical Fitness

    20 days during baselines and Post-evaluations (after intervention).

  • Mental Health

    20 days during baselines and Post-evaluations (after intervention).

  • Body fatness and bone mass

    20 days during baselines and Post-evaluations (after intervention).

  • Cardio-metabolic risk factors

    20 days during baselines and Post-evaluations (after intervention).

Study Arms (2)

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)

Behavioral: A 5-months physical exercise-based program

Interventions

A 5-months physical exercise-based programBEHAVIORAL

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.

Intervention Group

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Children with Attention-Deficit Hyperactivity Disorder or any other psychiatric disorder.
  • Left-handed children.
  • Children with medical problem that prevent to practice physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (22)

  • 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.

    PMID: 26924671BACKGROUND

  • 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.

    PMID: 28789992RESULT

  • 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.

    PMID: 29031643RESULT

  • 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.

    PMID: 30809168RESULT

  • 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.

    PMID: 31133870RESULT

  • 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.

    PMID: 31330300RESULT

  • 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.

    PMID: 31379602RESULT

  • 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.

    PMID: 31465844RESULT

  • 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.

    PMID: 31583747RESULT

  • 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.

    PMID: 31822016RESULT

  • 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.

    PMID: 31876665RESULT

  • 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.

    PMID: 32249933RESULT

  • 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.

    PMID: 32290576RESULT

  • 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.

    PMID: 32719329RESULT

  • 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.

    PMID: 33037758RESULT

  • 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.

    PMID: 33049365RESULT

  • 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.

    PMID: 33230195RESULT

  • 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.

    PMID: 37891146DERIVED

  • 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.

    PMID: 37498603DERIVED

  • 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.

    PMID: 36040742DERIVED

  • 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.

    PMID: 32343251DERIVED

  • 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.

    PMID: 28939688DERIVED

Related Links

MeSH Terms

Conditions

ObesityOverweightPsychological Well-Being

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPersonal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ramón & Cajal Researcher Fellow. Doctor in Exercise Physiology from University of Granada and Doctor in Medical Science from Karolinska Institutet of Stockholm.

Study Record Dates

First Submitted

November 14, 2014

First Posted

November 20, 2014

Study Start

December 1, 2014

Primary Completion

March 1, 2017

Study Completion

July 1, 2017

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.