Sun Fenghua, Wang Li-Juan, Wang Lin
Department of Health and Physical Education, The Hong Kong Institute of Education, Hong Kong, China.
School of Sport Leisure, Recreation and Arts, Shanghai University of Sport, Shanghai, China.
Trials. 2015 Apr 10;16:143. doi: 10.1186/s13063-015-0673-6.
Childhood obesity is one of the most critical public health problems in the world. It is associated with low neuromuscular function and postural deformities. Whether weight loss can improve postural stability and neuromuscular control, benefit daily activities, or prevent injury is unknown. Therefore, this study attempts to investigate the effect of a 6 month weight management program on postural stability and neuromuscular control among obese children.
METHODS/DESIGN: We will conduct a prospective, single-blind, randomized controlled trial with 120 prepubescent obese children. Participants will be randomly assigned to a weight management group or a control group. The weight management group will participate in a dietary and exercise program. The control group will receive health education. After the intervention, participants will be followed for 6 months with no active intervention. The primary and secondary outcomes will be assessed at the baseline, and after 6 months and 12 months. Primary outcome measures will include body weight, body height, body mass index, waist circumference, hip circumference, and body fat percentage. Secondary outcome measures will include three-dimensional functional biomechanics in different tasks, proprioception tests of the knee and ankle, neuromuscular response of the leg muscles, and muscle strength tests of the knee and ankle. Furthermore, adverse events will be recorded and analyzed. An intention-to-treat analysis will be performed if any participants withdraw from the trial.
The important features of this trial include the randomization procedures and large sample size. This study attempts to estimate the effect of weight loss intervention on outcomes, including daily life function, postural stability, and neuromuscular control in prepubescent obese children. Therefore, our results can be useful for obese children, medical staff, and healthcare decision makers.
Chinese Clinical Trial Registry ChiCTR-IOB-15005874.
儿童肥胖是全球最关键的公共卫生问题之一。它与神经肌肉功能低下和姿势畸形有关。体重减轻是否能改善姿势稳定性和神经肌肉控制、有益于日常活动或预防损伤尚不清楚。因此，本研究试图调查一项为期6个月的体重管理计划对肥胖儿童姿势稳定性和神经肌肉控制的影响。
方法/设计：我们将对120名青春期前肥胖儿童进行一项前瞻性、单盲、随机对照试验。参与者将被随机分配到体重管理组或对照组。体重管理组将参加饮食和运动计划。对照组将接受健康教育。干预后，对参与者进行6个月的随访，期间无积极干预措施。主要和次要结局将在基线、6个月和12个月后进行评估。主要结局指标将包括体重、身高、体重指数、腰围、臀围和体脂百分比。次要结局指标将包括不同任务中的三维功能生物力学、膝关节和踝关节的本体感觉测试、腿部肌肉的神经肌肉反应以及膝关节和踝关节的肌肉力量测试。此外，将记录和分析不良事件。如果有任何参与者退出试验，将进行意向性分析。
本试验的重要特点包括随机化程序和大样本量。本研究试图评估体重减轻干预对青春期前肥胖儿童的结局，包括日常生活功能、姿势稳定性和神经肌肉控制的影响。因此，我们的结果对肥胖儿童、医务人员和医疗保健决策者可能有用。
中国临床试验注册中心ChiCTR-IOB-15005874。
