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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Kuopio University Hospital
University of Turku
University of Cambridge
Early Growth Genetics (EGG) Consortium
Ministry of Education and Culture of 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
Kuopio University Hospital EVO funding
Information provided by (Responsible Party):
Timo Lakka, University of Eastern Finland
ClinicalTrials.gov Identifier:
NCT01803776
First received: February 21, 2013
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Overweight
Glucose Metabolism Disorders
Lipid Metabolism Disorders
Blood Pressure
Fitness
Behavioral: lifestyle counseling

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Physical Activity and Diet Intervention Study to Improve Health and Wellbeing of Children

Resource links provided by NLM:


Further study details as provided by University of Eastern Finland:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    bone mineral density

    bone metabolism (osteocalcin, Afos, Ca).

    vitamin D metabolism (Vitamin D-25-OH)



Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    4-day food record, nutrient intake, food consumption and eating frequency calculated from food records by Micro Nutrica® programme; eating behaviour questionnaire


Enrollment: 512
Study Start Date: October 2007
Estimated Study Completion Date: November 2022
Estimated Primary Completion Date: November 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lifestyle counseling 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.

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.

  Eligibility

Ages Eligible for Study:   6 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803776

Locations
Finland
University of Eastern Finland
Kuopio, Finland, 70211
Sponsors and Collaborators
University of Eastern Finland
Kuopio University Hospital
University of Turku
University of Cambridge
Early Growth Genetics (EGG) Consortium
Ministry of Education and Culture of 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
Kuopio University Hospital EVO funding
Investigators
Principal Investigator: Timo A Lakka, MD University of Eastern Finland, Kuopio campus
  More Information

Additional Information:
No publications provided by University of Eastern Finland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Timo Lakka, Professor of Medical Physiology, University of Eastern Finland
ClinicalTrials.gov Identifier: NCT01803776     History of Changes
Other Study ID Numbers: PANIC
Study First Received: February 21, 2013
Last Updated: March 19, 2014
Health Authority: Finland: Research Ethics Committee of the Hospital District of Northern Savo

Keywords provided by University of Eastern Finland:
child
physical activity
sedentary activity
nutrition
diet
body composition
overweight
obesity
glucose metabolism disorders
lipid metabolism disorders
physical fitness
cardiovascular system
musculoskeletal system
bone mineral density
oral health
quality of life
wellbeing
gene-lifestyle interaction
health economics

Additional relevant MeSH terms:
Metabolic Diseases
Lipid Metabolism Disorders
Sphingolipidoses
Overweight
Glucose Metabolism Disorders
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014