The Physical Activity and Nutrition in Children (PANIC) Study

Sponsor

University of Eastern Finland (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01803776

Collaborator

Kuopio University Hospital (Other), University of Jyvaskyla (Other), Kuopio Research Institute of Exercise Medicine (Other), University of Turku (Other), Tampere University (Other), Folkhälsan Researech Center (Other), University of Cambridge (Other), University of Exeter (Other), University of Copenhagen (Other), Norwegian School of Sport Sciences (Other), University of Tromso (Other), University of Iceland (Other), Early Growth Genetics (EGG) Consortium (Other), LongITools Consortium (Other)

504

Enrollment

Location

Arms

194

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight Glucose Metabolism Disorders Lipid Metabolism Disorders Blood Pressure Atherosclerosis	Behavioral: lifestyle counseling	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

504 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A single-centre controlled trial in which the participants are allocated to a combined physical activity and dietary intervention group and a control groupA single-centre controlled trial in which the participants are allocated to a combined physical activity and dietary intervention group and a control group

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

The Physical Activity and Nutrition in Children (PANIC) Study

Study Start Date :

Oct 1, 2007

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: lifestyle counseling Physical activity and dietary counseling	Behavioral: lifestyle counseling The physical activity and dietary intervention is based on the Finnish physical activity and dietary recommendations. The children and their parents in the intervention group undergo individualized and family-based physical activity and dietary intervention between the baseline and 2-year follow-up examinations. The children and their parents meet a physical activity specialist and a nutritionist who give detailed and individualized instructions on health promoting physical activity and diet at months 0, 1.5, 3, 6, 12, and 18 with a specific topic at each visit. Between the 2-year follow-up and 8-year follow-up examinations, the intervention continues with yearly physical activity and dietary counseling sessions. The children in the intervention group, particularly those who do not attend organized sports or exercise, will also be encouraged to participate in after-school exercise clubs organized by trained exercise instructors of the study.
No Intervention: Control No active intervention

Arm

Intervention/Treatment

Experimental: lifestyle counseling

Physical activity and dietary counseling

Behavioral: lifestyle counseling

The physical activity and dietary intervention is based on the Finnish physical activity and dietary recommendations. The children and their parents in the intervention group undergo individualized and family-based physical activity and dietary intervention between the baseline and 2-year follow-up examinations. The children and their parents meet a physical activity specialist and a nutritionist who give detailed and individualized instructions on health promoting physical activity and diet at months 0, 1.5, 3, 6, 12, and 18 with a specific topic at each visit. Between the 2-year follow-up and 8-year follow-up examinations, the intervention continues with yearly physical activity and dietary counseling sessions. The children in the intervention group, particularly those who do not attend organized sports or exercise, will also be encouraged to participate in after-school exercise clubs organized by trained exercise instructors of the study.

No Intervention: Control

No active intervention

Outcome Measures

Primary Outcome Measures

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

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 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 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 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 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 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 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 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 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
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