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

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ClinicalTrials.gov Identifier: NCT01803776
Recruitment Status : Active, not recruiting
First Posted : March 4, 2013
Last Update Posted : June 21, 2018
Sponsor:
Collaborators:
Kuopio University Hospital
University of Turku
University of Cambridge
Early Growth Genetics (EGG) Consortium
Ministry of Education and Culture, Finland
Ministry of Social Affairs and Health of Finland
Sitra, the Finnish Innovation Fund
Social Insurance Institution, Finland
Finnish Cultural Foundation
Foundation for Paediatric Research, Finland
Juho Vainio Foundation
Paavo Nurmi Foundation
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 June 21, 2018
Study Start Date  ICMJE October 2007
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2015)
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) ]
Cardiometabolic risk score and its components (waist circumference, fasting serum insulin, fasting plasma glucose, triglycerides and HDL cholesterol, systolic and diastolic blood pressure)
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 Complete list of historical versions of study NCT01803776 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2015)
  • Change in body size and composition [ Time Frame: From baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood) ]
    Body height and weight, body mass index, body mass index standard deviation score, waist circumference, body fat percentage, lean body mass
  • Change in cardiometabolic risk factors [ Time Frame: From baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood) ]
    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)
  • 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 and oxygen consumption 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
  • 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) ]
    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) ]
    Food record, nutrient intake, food consumption and eating frequency calculated from food records by Micro Nutrica® programme; eating behaviour questionnaire
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 Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Physical Activity and Nutrition in Children Study
Official Title  ICMJE Physical Activity and Diet Intervention Study to Improve Health and Wellbeing of Children
Brief Summary The Physical Activity and Nutrition in Children (PANIC) Study is a single-centre physical activity and diet intervention study that provides novel scientific information on physical activity, nutrition, overweight, obesity, physical fitness, cognition, oral health, sleep, pain and other aspects of quality of life as well as health care costs in a population sample of children and adolescents. The main hypothesis of the study is that regular physical activity and dietary changes improve health and quality of life among children and adolescents.
Detailed Description

The study population is a population sample of 512 children from the city of Kuopio, Finland. The children will be recruited at the age of 6-8 years and allocated into the intervention group and the control group. The intervention group will undergo intensive, individualized and family-based physical activity and diet intervention that also includes exercise and cooking clubs. All children will be examined after the 2-year follow-up. The intervention group will continues with a less intensive exercise and diet intervention until adulthood. All children will be re-examined in adolescence and in early adulthood.

The results of the PANIC Study will help in improving children's health by increased physical activity and improved nutrition, in identifying high-risk children who would benefit most from exercise and diet intervention, and in targeting the high-risk children for more careful health examinations, exercise and diet intervention and health follow-up and in preventing chronic diseases and their societal consequences in adulthood.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Overweight
  • Glucose Metabolism Disorders
  • Lipid Metabolism Disorders
  • Blood Pressure
Intervention  ICMJE Behavioral: lifestyle counseling
Lifestyle intervention is based on Finnish exercise and nutrition recommendations. The children and their parents in the intervention group undergo intensive individual family-based exercise and diet intervention. They meet an exercise specialist and an authorized nutritionist, who give detailed and individualized instructions on health promoting physical activity and nutrition at months 0, 1.5, 3, 6, 12, 18, and 24 with a specific topic at each visit. After the 2-year intensive intervention period the intervention continues with yearly physical activity and dietary counseling sessions. Group-based exercise and cooking clubs are part of intervention.
Study Arms Experimental: lifestyle counseling
Intervention: Behavioral: lifestyle counseling
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: March 1, 2013)
512
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date November 2022
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • boys and girls, 6-8 years of age at baseline, from the city of Kuopio, Finland

Exclusion Criteria:

  • children with severe physical disabilities
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 8 Years   (Child)
Accepts Healthy Volunteers 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 Not Provided
Responsible Party Timo Lakka, University of Eastern Finland
Study Sponsor  ICMJE University of Eastern Finland
Collaborators  ICMJE
  • Kuopio University Hospital
  • University of Turku
  • University of Cambridge
  • Early Growth Genetics (EGG) Consortium
  • Ministry of Education and Culture, Finland
  • Ministry of Social Affairs and Health of Finland
  • Sitra, the Finnish Innovation Fund
  • Social Insurance Institution, Finland
  • Finnish Cultural Foundation
  • Foundation for Paediatric Research, Finland
  • Juho Vainio Foundation
  • Paavo Nurmi Foundation
Investigators  ICMJE
Principal Investigator: Timo A Lakka, MD University of Eastern Finland, Kuopio campus
PRS Account University of Eastern Finland
Verification Date June 2018

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