Clinical trial NCT01803776: The Physical Activity and Nutrition in Children (PANIC) Study
Official title: The Physical Activity and Nutrition in Children (PANIC) Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight
Glucose Metabolism Disorders
Lipid Metabolism Disorders
Blood Pressure
Atherosclerosis
Keywords: 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
medication
cost-effectiveness
Lead sponsor: University of Eastern Finland
Sponsor class: OTHER
Collaborators: name: Kuopio University Hospital
name: University of Jyvaskyla
name: Kuopio Research Institute of Exercise Medicine
name: University of Turku
name: Tampere University
name: Folkhälsan Researech Center
name: University of Cambridge
name: University of Exeter
name: University of Copenhagen
name: Norwegian School of Sport Sciences
name: University of Tromso
name: University of Iceland
name: Early Growth Genetics (EGG) Consortium
name: LongITools Consortium
First posted: 2013-03-04
Enrollment: 504
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Change in insulin resistance
timeFrame: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
measure: Change in fasting plasma glucose
timeFrame: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
measure: Change in body composition
timeFrame: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Secondary outcomes:
measure: Change in physical activity
timeFrame: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
measure: Change in sedentary time
timeFrame: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
measure: Change in diet
timeFrame: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
measure: Change in cardiorespiratory fitness
timeFrame: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
measure: Change in lipid metabolism
timeFrame: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
measure: Change in liver adiposity
timeFrame: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
measure: Change in blood pressure
timeFrame: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
measure: Change in cognitive function
timeFrame: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
measure: Change in bone mineral density
timeFrame: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
measure: Change in the use of healthcare services
timeFrame: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
measure: Change in costs associated with the use of healthcare services
timeFrame: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: University of Eastern Finland
Study officials:
affiliation: University of Eastern Finland, Kuopio campus
name: Timo A Lakka, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.