Overweight Clinical Trial
— PANICOfficial title:
The Physical Activity and Nutrition in Children (PANIC) Study
Verified date | July 2020 |
Source | University of Eastern Finland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Finland | University of Eastern Finland | Kuopio |
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 |
Finland,
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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