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Trial record 1 of 1 for:    NCT01803776 | Finland
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The Physical Activity and Nutrition in Children (PANIC) Study (PANIC)

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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

Tracking Information
First Submitted Date  ICMJE February 21, 2013
First Posted Date  ICMJE March 4, 2013
Last Update Posted Date July 28, 2020
Study Start Date  ICMJE October 2007
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2020)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: March 1, 2013)
  • Change in composite measure of metabolic syndrome [ Time Frame: from baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood) ]
    Weight, body mass index standard deviation score, waist circumference; body fat mass, body fat percentage and abdominal fat. Biomarkers of glucose and insulin metabolism (fasting glucose and insulin, C-peptide) as well as lipid, lipoprotein, and fatty acid metabolism (total, HDL and LDL cholesterol, triglycerides, lipoprotein subfractions, fatty acids, sterols. Biomarkers of liver adiposity (ALAT, gamma-TG), hormonal status (DHEAS, estradiol, testosterone, SHBG, IGF-1, AMH, TSH), oxidative stress (ORAC, glutathione, protein oxidation), hyperuricemia (uric acid), thrombosis (PAI-1), vitamin D metabolism (Vitamin D-25-OH) and bone metabolism (osteocalcin, Afos, Ca). Biomarkers of adipose and skeletal muscle tissue metabolism (adiponectin, leptin, TNF-α, sTNFR, IL-1Ra, IL-6, IL-10, IL-15, IL-18, MCP-1, hs-CRP); m. vastus lateralis oxygen consumption and mitochondrial function before, during and after exercise test. Blood pressure at rest.
  • Change in cardiorespiratory fitness and function [ Time Frame: from baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood) ]
    Submaximal and maximal workloads; maximal oxygen uptake and other measures from respiratory gas exchange analysis; changes in heart rate, blood pressure and heart rate variability during and after maximal exercise stress test on cycle ergometer.
  • Change in musculoskeletal fitness and function [ Time Frame: from baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood) ]
    Modified Eurofit tests on selected musculoskeletal system functions (strength, flexibility, balance, motor ability, speed) for children, Box and block test.
  • Change in heart rate, blood pressure and autonomic nervous system regulation [ Time Frame: from baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood) ]
    Continuous recording of heart rate, heart rate variation, blood pressure, beat-to-beat blood pressure variation and arterial baroreceptor sensitivity by Cardiosoft®, Finapress®, and Cafts programmes during maximal exercise test on Ergoline® bicycle ergometer.
  • Change in endothelial function, systemic and skeletal muscle blood flow [ Time Frame: from baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood) ]
    Biomarkers of endothelial function (E-selectin, P-selectin, ICAM-1, VCAM-1, nitrites, ADMA); arterial pulse wave velocity; blood flow in vastus lateralis muscle by NIRS before, during, and after maximal exercise test.
  • Change in cognitive function [ Time Frame: from baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood) ]
    General mental ability by Raven's test, learning tests, biomarkers of brain function, such as neurotrophins.
  • Change in medical health status [ Time Frame: from baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood) ]
    Questionnaire, medical examination by a paediatrician
  • Change in oral health status [ Time Frame: from baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood) ]
    Oral health examination by a dentist and a questionnaire
  • Change in wellbeing [ Time Frame: from baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood) ]
    Questionnaire (physical, psychic and social wellbeing, sleep, pain).
  • Change in health care costs [ Time Frame: from baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood) ]
    Questionnaire, data linkage to national health registers.
  • Change in bone mineral density [ Time Frame: From baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood) ]
    bone mineral density bone metabolism (osteocalcin, Afos, Ca). vitamin D metabolism (Vitamin D-25-OH)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2020)
  • 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
  • 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
  • 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
  • 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
  • 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)
  • 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)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2013)
  • Change in physical activity [ Time Frame: From baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood) ]
    4-day Actiheart® exercise record (measures heart rate, body movements and energy expenditure) for 2 weekdays and 2 weekend days; habitual physical activity and sedentary activity questionnaire.
  • Change in diet and eating behavior [ Time Frame: From baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood) ]
    4-day food record, nutrient intake, food consumption and eating frequency calculated from food records by Micro Nutrica® programme; eating behaviour questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Physical Activity and Nutrition in Children (PANIC) Study
Official Title  ICMJE The Physical Activity and Nutrition in Children (PANIC) Study
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Overweight
  • Glucose Metabolism Disorders
  • Lipid Metabolism Disorders
  • Blood Pressure
  • Atherosclerosis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: lifestyle counseling
    Physical activity and dietary counseling
    Intervention: Behavioral: lifestyle counseling
  • No Intervention: Control
    No active intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 24, 2020)
504
Original Actual Enrollment  ICMJE
 (submitted: March 1, 2013)
512
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 9 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01803776
Other Study ID Numbers  ICMJE PANIC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Timo Lakka, University of Eastern Finland
Study Sponsor  ICMJE University of Eastern Finland
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Timo A Lakka, MD University of Eastern Finland, Kuopio campus
PRS Account University of Eastern Finland
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP