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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
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

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

8 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

    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
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    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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    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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