The Physical Activity and Nutrition in Children (PANIC) Study

Not Applicable

• Conditions: Overweight; Blood Pressure; Atherosclerosis; Glucose Metabolism Disorders; Lipid Metabolism Disorders
• Interventions: Behavioral: lifestyle counseling

• Registration Number: NCT01803776
• Lead Sponsor: University of Eastern Finland

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2013-02-21
• Study First Submitted QC: 2013-03-01
• Study First Posted: 2013-03-04
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-24
• Last Update Posted: 2020-07-28
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 504

Inclusion Criteria

• boys and girls, 6-9 years of age at baseline, from the city of Kuopio, Finland

Exclusion Criteria

• physical disabilities that could hamper participation in the intervention
• no time or motivation to attend the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lifestyle counseling	lifestyle counseling	Physical activity and dietary counseling

Primary Outcome Measures

Name	Time	Method
Change in insulin resistance	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	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	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

Secondary Outcome Measures

Name	Time	Method
Change in cognitive function	From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)	General mental ability assessed by Raven's Coloured Progressive Matrices
Change in sedentary time	From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)	Sedentary time assessed objectively by heart rate and body movement monitoring
Change in lipid metabolism	From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)	Biomarkers of lipid metabolism (fasting triglycerides, HDL cholesterol and LDL cholesterol)
Change in diet	From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)	Food consumption and nutrient intake assessed by 4-day dietary recording
Change in physical activity	From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)	Physical activity assessed objectively by heart rate and body movement monitoring
Change in cardiorespiratory fitness	From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)	Maximal workload and peak oxygen consumption assessed by a maximal exercise test on a bicycle ergometer
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 bone mineral density assessed by dual-energy X-ray absorptiometry
Change in liver adiposity	From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)	Biomarkers of liver adiposity (alanine aminotransferase and gamma glutamyltransferase)
Change in blood pressure	From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)	Systolic and diastolic blood pressure at rest
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)	Costs associated with the use of healthcare services received from national and local health registries
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)	Use of healthcare services received from national and local health registries

Trial Locations

Locations (1)

University of Eastern Finland; 🇫🇮 Kuopio, Finland