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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01803776
Other study ID # PANIC
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
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