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NCT Number: NCT02295072

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

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.

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Key information

Conditions

Cognitive Function 1, Social Behavior Body Weight Mental Health Wellness 1 Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Signs and Symptoms

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Changes in Brain function and structure using magnetic resonance imaging (MRI)

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

    10-15 mins of high resolution scanning, 10 mins of resting state and 20 mins of Diffusion Tensor Imaging

  2. Brain and cognitive functioning assessment by electroencephalogram (EEG)

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

    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.

  3. Cognitive performance (DKEFS test battery)

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

    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

  4. Academic achievement

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

    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.

Secondary outcomes

  1. Physical Fitness

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

    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

  2. Mental Health

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

    Chronic Stress indicators and behaviour and personality tests.

  3. Body fatness and bone mass

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

    Body fatness and bone mass assessment using dual-energy X-ray absorciometry (DXA, Discovery densitometer from Hologic), following protocols used in previous studies

  4. Cardio-metabolic risk factors

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

    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)

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Collaborators

  • Consorcio Centro de Investigación Biomédica en Red (CIBER)
  • Hospital Clinico Universitario San Cecilio
  • Instituto Mixto Universitario Deporte y Salud
  • Research Center for Mind, Brain and Behavior, Spain

Registry information

Official study title

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

Acronym: ActiveBrains

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 20, 2014
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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