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.

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.

Keywords: Academic performance; Behaviour; Magnetic imaging resonance; Personality; Physical activity; Preadolescents.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Achievement
  • Brain / diagnostic imaging
  • Brain / physiology*
  • Child
  • Clinical Protocols
  • Cognition*
  • Electroencephalography
  • Exercise Therapy / methods*
  • Female
  • Follow-Up Studies
  • Humans
  • Magnetic Resonance Imaging
  • Male
  • Mental Health*
  • Pediatric Obesity / physiopathology
  • Pediatric Obesity / psychology
  • Pediatric Obesity / therapy*
  • Physical Fitness*
  • Research Design
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT02295072