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The Physical Activity and Nutrition in Children (PANIC) Study (PANIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01803776
Recruitment Status : Active, not recruiting
First Posted : March 4, 2013
Last Update Posted : July 28, 2020
Sponsor:
Collaborators:
Kuopio University Hospital
University of Jyvaskyla
Kuopio Research Institute of Exercise Medicine
University of Turku
Tampere University
Folkhälsan Researech Center
University of Cambridge
University of Exeter
University of Copenhagen
Norwegian School of Sport Sciences
University of Tromso
University of Iceland
Early Growth Genetics (EGG) Consortium
LongITools Consortium
Information provided by (Responsible Party):
Timo Lakka, 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.


Condition or disease Intervention/treatment Phase
Overweight Glucose Metabolism Disorders Lipid Metabolism Disorders Blood Pressure Atherosclerosis Behavioral: lifestyle counseling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 group
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Physical Activity and Nutrition in Children (PANIC) Study
Study Start Date : October 2007
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change in insulin resistance [ Time Frame: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood) ]
    Fasting serum insulin

  2. Change in fasting plasma glucose [ Time Frame: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood) ]
    Fasting plasma glucose

  3. Change in body composition [ Time Frame: 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 :
  1. Change in physical activity [ Time Frame: 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

  2. Change in sedentary time [ Time Frame: 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

  3. Change in diet [ Time Frame: 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

  4. Change in cardiorespiratory fitness [ Time Frame: 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

  5. Change in lipid metabolism [ Time Frame: 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)

  6. Change in liver adiposity [ Time Frame: 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)

  7. Change in blood pressure [ Time Frame: 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

  8. Change in cognitive function [ Time Frame: 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

  9. Change in bone mineral density [ Time Frame: 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

  10. Change in the use of healthcare services [ Time Frame: 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

  11. Change in costs associated with the use of healthcare services [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803776


Locations
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Finland
University of Eastern Finland
Kuopio, Finland, 70211
Sponsors and Collaborators
University of Eastern Finland
Kuopio University Hospital
University of Jyvaskyla
Kuopio Research Institute of Exercise Medicine
University of Turku
Tampere University
Folkhälsan Researech Center
University of Cambridge
University of Exeter
University of Copenhagen
Norwegian School of Sport Sciences
University of Tromso
University of Iceland
Early Growth Genetics (EGG) Consortium
LongITools Consortium
Investigators
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Principal Investigator: Timo A Lakka, MD University of Eastern Finland, Kuopio campus
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Timo Lakka, Professor of Medical Physiology, University of Eastern Finland
ClinicalTrials.gov Identifier: NCT01803776    
Other Study ID Numbers: PANIC
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Keywords provided by Timo Lakka, University of Eastern Finland:
children
adolescents
physical activity
sedentary time
nutrition
diet
body composition
overweight
obesity
insulin
glucose
lipids
adipokines
myokines
metabolomics
fitness
arterial elasticity
atherosclerosis
blood pressure
bone mineral density
genetics
gene-lifestyle interaction
oral health
oral bacteriomics
wellbeing
depression
sleep
pain
health economics
healthcare services
Additional relevant MeSH terms:
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Atherosclerosis
Metabolic Diseases
Glucose Metabolism Disorders
Lipid Metabolism Disorders
Disease
Overweight
Pathologic Processes
Body Weight
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases