Effects of an Exercise Program on Cognition and Brain in Overweight/Obese Preadolescent Children (ActiveBrains)
Primary Purpose
Cognitive Function 1, Social, Mental Health Wellness 1, Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
A 5-months physical exercise-based program
Sponsored by

About this trial
This is an interventional treatment trial for Cognitive Function 1, Social focused on measuring Exercise-based Randomized Controlled Trial, Brain structure, Brain function, Cognitive function, Physical fitness, Body Mass Index, Cardiovascular disease risk factors, Mental health, Stress, Neurology, Obesity, brain, risk factors, bone, bones, body composition
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Intervention Group
Arm Description
2 Usual Physical Education sessions/week
A 5-months physical exercise-based program (3-5 Physical Education after school sessions/week + 2 Usual Physical Education sessions/week)
Outcomes
Primary Outcome Measures
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
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.
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
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.
Secondary Outcome Measures
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
Mental Health
Chronic Stress indicators and behaviour and personality tests.
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
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)
Full Information
NCT ID
NCT02295072
First Posted
November 14, 2014
Last Updated
June 21, 2021
Sponsor
Universidad de Granada
Collaborators
Centro de Investigación Biomédica, Hospital Clinico Universitario San Cecilio, Instituto Mixto Universitario Deporte y Salud, Centro de Investigación Mente, Cerebro y Comportamiento
1. Study Identification
Unique Protocol Identification Number
NCT02295072
Brief Title
Effects of an Exercise Program on Cognition and Brain in Overweight/Obese Preadolescent Children
Acronym
ActiveBrains
Official Title
ActiveBrains: Effects of an Exercise-based Randomized Controlled Trial on Cognition, Brain Structure and Brain Function in Overweight/Obese Preadolescent Children
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
Collaborators
Centro de Investigación Biomédica, Hospital Clinico Universitario San Cecilio, Instituto Mixto Universitario Deporte y Salud, Centro de Investigación Mente, Cerebro y Comportamiento
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Function 1, Social, Mental Health Wellness 1, Obesity, Overweight
Keywords
Exercise-based Randomized Controlled Trial, Brain structure, Brain function, Cognitive function, Physical fitness, Body Mass Index, Cardiovascular disease risk factors, Mental health, Stress, Neurology, Obesity, brain, risk factors, bone, bones, body composition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
2 Usual Physical Education sessions/week
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
A 5-months physical exercise-based program (3-5 Physical Education after school sessions/week + 2 Usual Physical Education sessions/week)
Intervention Type
Behavioral
Intervention Name(s)
A 5-months physical exercise-based program
Intervention Description
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 Outcome Measure Information:
Title
Changes in Brain function and structure using magnetic resonance imaging (MRI)
Description
10-15 mins of high resolution scanning, 10 mins of resting state and 20 mins of Diffusion Tensor Imaging
Time Frame
20 days during baselines and Post-evaluations (after intervention).
Title
Brain and cognitive functioning assessment by electroencephalogram (EEG)
Description
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.
Time Frame
20 days during baselines and Post-evaluations (after intervention).
Title
Cognitive performance (DKEFS test battery)
Description
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
Time Frame
20 days during baselines and Post-evaluations (after intervention).
Title
Academic achievement
Description
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.
Time Frame
20 days during baselines and Post-evaluations (after intervention).
Secondary Outcome Measure Information:
Title
Physical Fitness
Description
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
Time Frame
20 days during baselines and Post-evaluations (after intervention).
Title
Mental Health
Description
Chronic Stress indicators and behaviour and personality tests.
Time Frame
20 days during baselines and Post-evaluations (after intervention).
Title
Body fatness and bone mass
Description
Body fatness and bone mass assessment using dual-energy X-ray absorciometry (DXA, Discovery densitometer from Hologic), following protocols used in previous studies
Time Frame
20 days during baselines and Post-evaluations (after intervention).
Title
Cardio-metabolic risk factors
Description
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)
Time Frame
20 days during baselines and Post-evaluations (after intervention).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.
Citations:
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26924671
Citation
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Links:
URL
https://pubmed.ncbi.nlm.nih.gov/26924671/
Description
Pubmed link Methodological
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Effects of an Exercise Program on Cognition and Brain in Overweight/Obese Preadolescent Children
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