The Physical Activity and Nutrition in Children (PANIC) Study
试验速览
- 阶段
- 不适用
- 入组人数
- 504
- 试验地点
- 2
- 主要终点
- Change in insulin resistance
研究概览
简要总结
The Physical Activity and Nutrition in Children (PANIC) Study is a single-centre controlled trial on the effects of a combined physical activity and dietary intervention on cardiometabolic risk factors and other health outcomes in a population sample of children from the city of Kuopio, Finland. The study provides novel scientific information for the identification of cardiometabolic diseases and other chronic diseases since fetal period and for the prevention of these chronic diseases since childhood.
The main hypothesis of the PANIC study is that individuals at increased risk of cardiometabolic diseases and other chronic diseases can be identified in childhood and that it is possible to start the prevention of these chronic diseases by a long-term physical activity and dietary intervention since childhood.
详细描述
We will investigate a population sample of 512 children from the city of Kuopio, Finland. The children will be recruited in 2007-2009 when they are 7-9 years of age and when they will start the first grade in primary schools of the city of Kuopio. The children will be allocated to the combined physical activity and dietary intervention group and the control group after baseline examinations carried out in 2007-2009. The intervention group will undergo individualized and family-based physical activity and dietary intervention, including six intervention visits, for two years. All children from the intervention and control group will be invited to 2-year follow-up examinations carried out in 2009-2011 when they are 9-11 years of age. The intervention group will continue with a less intensive physical activity and dietary intervention until 8-year follow-up examinations carried out in 2015-2017 when the participants are 15-17 years of age. The participants from the intervention and control group will continue with an open follow-up until 14-year follow-up examinations in 2021-2023 when they are 21-23 years of age. All of these study phases will include comprehensive and detailed assessments of behavioral, biological, environmental, and genetic risk factors for cardiometabolic diseases and other chronic diseases. The results of the PANIC Study will help in 1) decreasing the risk of developing cardiometabolic diseases and other chronic diseases since childhood by increasing physical activity, decreasing sedentary time, and improving diet, 2) identifying children and adolescents at increased risk of cardiometabolic diseases and other chronic diseases who would benefit most from the physical activity and dietary interventions, 3) targeting children and adolescents, particularly those at increased risk of cardiometabolic diseases and other chronic diseases, for more careful health examinations, physical activity and dietary interventions, and health follow-up, and 4) preventing cardiometabolic diseases and other chronic diseases as well as their societal consequences in adulthood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •boys and girls, 6-9 years of age at baseline, from the city of Kuopio, Finland
排除标准
- •physical disabilities that could hamper participation in the intervention
- •no time or motivation to attend the study
结局指标
主要结局
Change in insulin resistance
时间窗: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Fasting serum insulin
Change in fasting plasma glucose
时间窗: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Fasting plasma glucose
Change in body composition
时间窗: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Body fat percentage and lean body mass assessed by dual-energy X-ray absorptiometry
次要结局
- Change in cognitive function(From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood))
- Change in sedentary time(From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood))
- Change in lipid metabolism(From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood))
- Change in physical activity(From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood))
- Change in diet(From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood))
- Change in cardiorespiratory fitness(From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood))
- Change in bone mineral density(From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood))
- Change in liver adiposity(From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood))
- Change in blood pressure(From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood))
- Change in costs associated with the use of healthcare services(From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood))
- Change in the use of healthcare services(From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood))
研究者
Timo Lakka
Professor of Medical Physiology
University of Eastern Finland