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

U

University of Granada (UGR)

Status

Completed

Conditions

Overweight
Mental Health Wellness 1
Obesity
Cognitive Function 1, Social

Treatments

Behavioral: A 5-months physical exercise-based program

Study type

Interventional

Funder types

Other

Identifiers

NCT02295072
DEP2013-47540-R

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 patients

Sex

All

Ages

8 to 11 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

110 participants in 2 patient groups

Control group
No Intervention group
Description:
2 Usual Physical Education sessions/week
Intervention Group
Experimental group
Description:
A 5-months physical exercise-based program (3-5 Physical Education after school sessions/week + 2 Usual Physical Education sessions/week)
Treatment:
Behavioral: A 5-months physical exercise-based program

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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