CompletedNot Applicable

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

110 participantsStarted 2014-12

Plain-language 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.

Who can participate

Age range

8 Years – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in Brain function and structure using magnetic resonance imaging (MRI)

Timeframe: 20 days during baselines and Post-evaluations (after intervention).

Brain and cognitive functioning assessment by electroencephalogram (EEG)

Timeframe: 20 days during baselines and Post-evaluations (after intervention).

Cognitive performance (DKEFS test battery)

Timeframe: 20 days during baselines and Post-evaluations (after intervention).

Academic achievement

Timeframe: 20 days during baselines and Post-evaluations (after intervention).

Trial details

NCT IDNCT02295072

SponsorUniversidad de Granada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-03

View on ClinicalTrials.gov More Cognitive Function 1, Social trials

Who can participate

Age range

8 Years – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Changes in Brain function and structure using magnetic resonance imaging (MRI)

Timeframe: 20 days during baselines and Post-evaluations (after intervention).

Brain and cognitive functioning assessment by electroencephalogram (EEG)

Timeframe: 20 days during baselines and Post-evaluations (after intervention).

Cognitive performance (DKEFS test battery)

Timeframe: 20 days during baselines and Post-evaluations (after intervention).

Academic achievement

Timeframe: 20 days during baselines and Post-evaluations (after intervention).