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

April 30, 2025 updated by: Francisco B. Ortega Porcel, Universidad de Granada

ActiveBrains: Effects of an Exercise-based Randomized Controlled Trial on Cognition, Brain Structure and Brain Function 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 11 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
2 Usual Physical Education sessions/week
Experimental: Intervention Group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
20 days during baselines and Post-evaluations (after intervention).
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.
20 days during baselines and Post-evaluations (after intervention).
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
20 days during baselines and Post-evaluations (after intervention).
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.
20 days during baselines and Post-evaluations (after intervention).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
20 days during baselines and Post-evaluations (after intervention).
Mental Health
Time Frame: 20 days during baselines and Post-evaluations (after intervention).
Chronic Stress indicators and behaviour and personality tests.
20 days during baselines and Post-evaluations (after intervention).
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
20 days during baselines and Post-evaluations (after intervention).
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)
20 days during baselines and Post-evaluations (after intervention).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Granada

Collaborators

Hospital Clinico Universitario San Cecilio
Centro de Investigación Biomédica
Instituto Mixto Universitario Deporte y Salud
Centro de Investigación Mente, Cerebro y Comportamiento

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

November 14, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimated)

November 20, 2014

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEP2013-47540-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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