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

NCT ID: NCT02295072

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-07-31

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.

Conditions

Cognitive Function 1, Social; Mental Health Wellness 1; Obesity; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

2 Usual Physical Education sessions/week

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group

A 5-months physical exercise-based program (3-5 Physical Education after school sessions/week + 2 Usual Physical Education sessions/week)

Group Type: EXPERIMENTAL

A 5-months physical exercise-based program

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro de Investigación Biomédica

UNKNOWN

Sponsor Role: collaborator

Hospital Clinico Universitario San Cecilio

OTHER

Sponsor Role: collaborator

Instituto Mixto Universitario Deporte y Salud

UNKNOWN

Sponsor Role: collaborator

Centro de Investigación Mente, Cerebro y Comportamiento

UNKNOWN

Sponsor Role: collaborator

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

Francisco B. Ortega Porcel

Ramón & Cajal Researcher Fellow. Doctor in Exercise Physiology from University of Granada and Doctor in Medical Science from Karolinska Institutet of Stockholm.

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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Related Links

https://pubmed.ncbi.nlm.nih.gov/26924671/

Pubmed link Methodological

Other Identifiers

DEP2013-47540-R

Identifier Type: -

Identifier Source: org_study_id