ActiveBrains: Effects of an Exercise-based Randomized Controlled Trial on Cognition, Brain Structure and Brain Function in Overweight/Obese Preadolescent Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 主要终点
- Changes in Brain function and structure using magnetic resonance imaging (MRI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Children with Attention-Deficit Hyperactivity Disorder or any other psychiatric disorder.
- •Left-handed children.
- •Children with medical problem that prevent to practice physical activity.
研究组 & 干预措施
Control group
2 Usual Physical Education sessions/week
Intervention Group
A 5-months physical exercise-based program (3-5 Physical Education after school sessions/week + 2 Usual Physical Education sessions/week)
干预措施: A 5-months physical exercise-based program (Behavioral)
结局指标
主要结局
Changes in Brain function and structure using magnetic resonance imaging (MRI)
时间窗: 20 days during baselines and Post-evaluations (after intervention).
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)
时间窗: 20 days during baselines and Post-evaluations (after intervention).
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)
时间窗: 20 days during baselines and Post-evaluations (after intervention).
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
时间窗: 20 days during baselines and Post-evaluations (after intervention).
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.
次要结局
- Physical Fitness(20 days during baselines and Post-evaluations (after intervention).)
- Mental Health(20 days during baselines and Post-evaluations (after intervention).)
- Body fatness and bone mass(20 days during baselines and Post-evaluations (after intervention).)
- Cardio-metabolic risk factors(20 days during baselines and Post-evaluations (after intervention).)
研究者
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.
Universidad de Granada