National Childhood Obesity Prevention Programme BE FIT 24
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Mean percentage change in BMI of children over the intervention period
研究概览
简要总结
The project is a national, prospective, multicenter, interventional pilot project of early detection of childhood overweight and the prevention of obesity in the Czech Republic.
The main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection of childhood overweight and the prevention of obesity and setting up and testing new methods and implementation into the system of health care.
详细描述
The project is a national, prospective, multicenter, interventional pilot project of early detection of childhood overweight and the prevention of obesity in the Czech Republic.
The aim of the project is to prepare and test innovative tools for optimization of health parameters in childhood, including the preparation of a general health prevention program for obesity as one of the main predeterminants of negative health development in the child population. The primary measurable clinical goal of the project is a 5% reduction in Body mass index (BMI) in children after completing the one-year program.
The project will engage approximately 1,000 overweight children aged 6-11 years in an innovative, gamified experience promoting a healthy lifestyle. Each child will receive a fitness bracelet to monitor their physical activity, while a fun, interactive mobile app will motivate them through challenges and games to maintain a balanced energy level. Additionally, the whole family will benefit from educational resources on a web portal, encouraging a playful and supportive approach to adopting healthier habits together.
The project is supported by the European Social Fund (Operational Program Employment plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0003842.
Study is conducted at approximately 100 sites across Czechia. For a complete list of study sites, please contact the overall study coordinator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 6-11 years
- •BMI: Between the 90th and 97th percentile
- •Signed consent to participate in the project and GDPR
排除标准
- •Children with a BMI between the 90th and 97th percentile with an associated chronic disease requiring continuous pharmacological treatment
结局指标
主要结局
Mean percentage change in BMI of children over the intervention period
时间窗: Up to 1 year from enrollment
次要结局
- Changes in BMI by subgroups of children (by gender, age, region, with/without playmate)(Up to 1 year from enrollment)
- Evaluation of energy expenditure (kilojoules) measured using a fitness bracelet during the competition weeks.(Up to 1 year from enrollment)
- Proportion of children who completed the full process (one-year participation in the program)(Up to 1 year from enrollment)