The Physical Activity and Nutrition in Children (PANIC) Study

Overweight Clinical Trial

— PANIC  

Official title:

The Physical Activity and Nutrition in Children (PANIC) Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01803776
• Other study ID #: PANIC
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2007
• Est. completion date: December 2023

Study information

• Verified date: July 2020
• Source: University of Eastern Finland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 504
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Blood Pressure
• Disease
• Glucose Metabolism Disorders
• Lipid Metabolism Disorders
• Metabolic Diseases
• Overweight

Intervention

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.

Locations

Country	Name	City	State
Finland	University of Eastern Finland	Kuopio

Sponsors (15)

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

Country where clinical trial is conducted

Finland, 

Outcome

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

External Links

•   Detailed information about the PANIC study from the webpages of University of Eastern Finland