- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01803776
The Physical Activity and Nutrition in Children (PANIC) Study (PANIC)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kuopio, Finland, 70211
- University of Eastern Finland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control
No active intervention
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Experimental: lifestyle counseling
Physical activity and dietary counseling
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Fasting serum insulin
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From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
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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)
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Fasting plasma glucose
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From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
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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)
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Body fat percentage and lean body mass assessed by dual-energy X-ray absorptiometry
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From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Physical activity assessed objectively by heart rate and body movement monitoring
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From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
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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)
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Sedentary time assessed objectively by heart rate and body movement monitoring
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From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
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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)
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Food consumption and nutrient intake assessed by 4-day dietary recording
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From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
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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)
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Maximal workload and peak oxygen consumption assessed by a maximal exercise test on a bicycle ergometer
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From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
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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)
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Biomarkers of lipid metabolism (fasting triglycerides, HDL cholesterol and LDL cholesterol)
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From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
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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)
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Biomarkers of liver adiposity (alanine aminotransferase and gamma glutamyltransferase)
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From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
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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)
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Systolic and diastolic blood pressure at rest
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From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
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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)
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General mental ability assessed by Raven's Coloured Progressive Matrices
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From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
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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)
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Change in bone mineral density assessed by dual-energy X-ray absorptiometry
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From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
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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)
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Use of healthcare services received from national and local health registries
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From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
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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)
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Costs associated with the use of healthcare services received from national and local health registries
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From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Timo A Lakka, MD, University of Eastern Finland, Kuopio campus
Publications and helpful links
General Publications
- Soininen S, Eloranta AM, Schwab U, Lakka TA. Sources of vitamin D and determinants of serum 25-hydroxyvitamin D in Finnish adolescents. Eur J Nutr. 2023 Mar;62(2):1011-1025. doi: 10.1007/s00394-022-03039-y. Epub 2022 Nov 9.
- Constable AM, Vlachopoulos D, Barker AR, Moore SA, Soininen S, Haapala EA, Vaisto J, Jaaskelainen J, Voutilainen R, Auriola S, Hakkinen MR, Laitinen T, Lakka TA. The Mediating Role of Endocrine Factors in the Positive Relationship Between Fat Mass and Bone Mineral Content in Children Aged 9-11 Years: The Physical Activity and Nutrition in Children Study. Front Endocrinol (Lausanne). 2022 Mar 24;13:850448. doi: 10.3389/fendo.2022.850448. eCollection 2022.
- Kuvaja-Kollner V, Lintu N, Lindi V, Rissanen E, Eloranta AM, Kiiskinen S, Martikainen J, Kankaanpaa E, Valtonen H, Lakka TA. Cost-effectiveness of physical activity intervention in children - results based on the Physical Activity and Nutrition in Children (PANIC) study. Int J Behav Nutr Phys Act. 2021 Sep 6;18(1):116. doi: 10.1186/s12966-021-01181-0.
- Constable AM, Vlachopoulos D, Barker AR, Moore SA, Soininen S, Haapala EA, Vaisto J, Westgate K, Brage S, Mahonen A, Lakka TA. The independent and interactive associations of physical activity intensity and vitamin D status with bone mineral density in prepubertal children: the PANIC Study. Osteoporos Int. 2021 Aug;32(8):1609-1620. doi: 10.1007/s00198-021-05872-z. Epub 2021 Feb 5.
- Lakka TA, Lintu N, Vaisto J, Viitasalo A, Sallinen T, Haapala EA, Tompuri TT, Soininen S, Karjalainen P, Schnurr TM, Mikkonen S, Atalay M, Kilpelainen TO, Laitinen T, Laaksonen DE, Savonen K, Brage S, Schwab U, Jaaskelainen J, Lindi V, Eloranta AM. A 2 year physical activity and dietary intervention attenuates the increase in insulin resistance in a general population of children: the PANIC study. Diabetologia. 2020 Nov;63(11):2270-2281. doi: 10.1007/s00125-020-05250-0. Epub 2020 Aug 20.
- Eloranta AM, Sallinen T, Viitasalo A, Lintu N, Vaisto J, Jalkanen H, Tompuri TT, Soininen S, Haapala EA, Kiiskinen S, Schnurr TM, Kilpelainen TO, Mikkonen S, Savonen K, Atalay M, Brage S, Laaksonen DE, Lindi V, Agren J, Schwab U, Jaaskelainen J, Lakka TA. The effects of a 2-year physical activity and dietary intervention on plasma lipid concentrations in children: the PANIC Study. Eur J Nutr. 2021 Feb;60(1):425-434. doi: 10.1007/s00394-020-02260-x. Epub 2020 May 4.
- Mantyselka A, Lindi V, Viitasalo A, Eloranta AM, Agren J, Vaisanen S, Voutilainen R, Laitinen T, Lakka TA, Jaaskelainen J. Associations of Dehydroepiandrosterone Sulfate With Cardiometabolic Risk Factors in Prepubertal Children. J Clin Endocrinol Metab. 2018 Jul 1;103(7):2592-2600. doi: 10.1210/jc.2018-00184.
- Soininen S, Eloranta AM, Viitasalo A, Dion G, Erkkila A, Sidoroff V, Lindi V, Mahonen A, Lakka TA. Serum 25-Hydroxyvitamin D, Plasma Lipids, and Associated Gene Variants in Prepubertal Children. J Clin Endocrinol Metab. 2018 Jul 1;103(7):2670-2679. doi: 10.1210/jc.2018-00335.
- Mantyselka A, Jaaskelainen J, Eloranta AM, Vaisto J, Voutilainen R, Ong K, Brage S, Lakka TA, Lindi V. Associations of lifestyle factors with serum dehydroepiandrosterone sulphate and insulin-like growth factor-1 concentration in prepubertal children. Clin Endocrinol (Oxf). 2018 Feb;88(2):234-242. doi: 10.1111/cen.13511. Epub 2017 Nov 29.
- Lintu N, Savonen K, Viitasalo A, Tompuri T, Paananen J, Tarvainen MP, Lakka T. Determinants of Cardiorespiratory Fitness in a Population Sample of Girls and Boys Aged 6 to 8 Years. J Phys Act Health. 2016 Nov;13(11):1149-1155. doi: 10.1123/jpah.2015-0644. Epub 2016 Aug 24.
- Haapala EA, Eloranta AM, Venalainen T, Jalkanen H, Poikkeus AM, Ahonen T, Lindi V, Lakka TA. Diet quality and academic achievement: a prospective study among primary school children. Eur J Nutr. 2017 Oct;56(7):2299-2308. doi: 10.1007/s00394-016-1270-5. Epub 2016 Sep 9.
- Venalainen TM, Viitasalo AM, Schwab US, Eloranta AM, Haapala EA, Jalkanen HP, de Mello VD, Laaksonen DE, Lindi VI, Agren JJ, Lakka TA. Effect of a 2-y dietary and physical activity intervention on plasma fatty acid composition and estimated desaturase and elongase activities in children: the Physical Activity and Nutrition in Children Study. Am J Clin Nutr. 2016 Oct;104(4):964-972. doi: 10.3945/ajcn.116.136580. Epub 2016 Aug 31.
- Collings PJ, Westgate K, Vaisto J, Wijndaele K, Atkin AJ, Haapala EA, Lintu N, Laitinen T, Ekelund U, Brage S, Lakka TA. Cross-Sectional Associations of Objectively-Measured Physical Activity and Sedentary Time with Body Composition and Cardiorespiratory Fitness in Mid-Childhood: The PANIC Study. Sports Med. 2017 Apr;47(4):769-780. doi: 10.1007/s40279-016-0606-x.
- Viitasalo A, Eloranta AM, Lintu N, Vaisto J, Venalainen T, Kiiskinen S, Karjalainen P, Peltola J, Lampinen EK, Haapala EA, Paananen J, Schwab U, Lindi V, Lakka TA. The effects of a 2-year individualized and family-based lifestyle intervention on physical activity, sedentary behavior and diet in children. Prev Med. 2016 Jun;87:81-88. doi: 10.1016/j.ypmed.2016.02.027. Epub 2016 Feb 23.
- Haapala EA, Lintu N, Vaisto J, Robinson LE, Viitasalo A, Lindi V, Lakka TA. Associations of Physical Performance and Adiposity with Cognition in Children. Med Sci Sports Exerc. 2015 Oct;47(10):2166-74. doi: 10.1249/MSS.0000000000000652.
- Haapala EA, Poikkeus AM, Kukkonen-Harjula K, Tompuri T, Lintu N, Vaisto J, Leppanen PH, Laaksonen DE, Lindi V, Lakka TA. Associations of physical activity and sedentary behavior with academic skills--a follow-up study among primary school children. PLoS One. 2014 Sep 10;9(9):e107031. doi: 10.1371/journal.pone.0107031. eCollection 2014.
- Vaisto J, Eloranta AM, Viitasalo A, Tompuri T, Lintu N, Karjalainen P, Lampinen EK, Agren J, Laaksonen DE, Lakka HM, Lindi V, Lakka TA. Physical activity and sedentary behaviour in relation to cardiometabolic risk in children: cross-sectional findings from the Physical Activity and Nutrition in Children (PANIC) Study. Int J Behav Nutr Phys Act. 2014 Apr 26;11:55. doi: 10.1186/1479-5868-11-55.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- physical activity
- genetics
- pain
- sleep
- depression
- obesity
- overweight
- medication
- nutrition
- children
- atherosclerosis
- blood pressure
- adolescents
- insulin
- body composition
- diet
- cost-effectiveness
- lipids
- sedentary time
- oral health
- fitness
- bone mineral density
- glucose
- metabolomics
- wellbeing
- health economics
- myokines
- adipokines
- healthcare services
- arterial elasticity
- gene-lifestyle interaction
- oral bacteriomics
Additional Relevant MeSH Terms
Other Study ID Numbers
- PANIC
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