The Physical Activity and Nutrition in Children (PANIC) Study

NCT ID: NCT01803776

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Overweight Glucose Metabolism Disorders Lipid Metabolism Disorders Blood Pressure Atherosclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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lifestyle counseling

Physical activity and dietary counseling

Group Type EXPERIMENTAL

lifestyle counseling

Intervention Type BEHAVIORAL

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.

Control

No active intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role collaborator

University of Jyvaskyla

OTHER

Sponsor Role collaborator

Kuopio Research Institute of Exercise Medicine

OTHER

Sponsor Role collaborator

University of Turku

OTHER

Sponsor Role collaborator

Tampere University

OTHER

Sponsor Role collaborator

Folkhälsan Researech Center

OTHER

Sponsor Role collaborator

University of Cambridge

OTHER

Sponsor Role collaborator

University of Exeter

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

Norwegian School of Sport Sciences

OTHER

Sponsor Role collaborator

University of Tromso

OTHER

Sponsor Role collaborator

University of Iceland

OTHER

Sponsor Role collaborator

Early Growth Genetics (EGG) Consortium

UNKNOWN

Sponsor Role collaborator

LongITools Consortium

UNKNOWN

Sponsor Role collaborator

University of Eastern Finland

OTHER

Sponsor Role lead

Responsible Party

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Timo Lakka

Professor of Medical Physiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Timo A Lakka, MD

Role: PRINCIPAL_INVESTIGATOR

University of Eastern Finland, Kuopio campus

Locations

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University of Eastern Finland

Kuopio, , Finland

Site Status

Countries

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Finland

References

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Kraav J, Zagura M, Viitasalo A, Soininen S, Veijalainen A, Kahonen M, Jurimae J, Tillmann V, Haapala E, Lakka T. Associations of Cardiovascular Health Metrics in Childhood and Adolescence With Arterial Health Indicators in Adolescence: The PANIC Study. J Am Heart Assoc. 2024 Nov 19;13(22):e035790. doi: 10.1161/JAHA.124.035790. Epub 2024 Nov 7.

Reference Type DERIVED
PMID: 39508145 (View on PubMed)

Aitokari L, Lahti S, Kivela L, Riekki H, Hiltunen P, Vuorela N, Viitasalo A, Soininen S, Huhtala H, Lakka T, Kurppa K. Alanine aminotransferase cutoffs for the pediatric fatty liver disease: Major impact of the reference population. J Pediatr Gastroenterol Nutr. 2024 Mar;78(3):488-496. doi: 10.1002/jpn3.12040. Epub 2023 Dec 10.

Reference Type DERIVED
PMID: 38314943 (View on PubMed)

Skinner AM, Barker AR, Moore SA, Soininen S, Haapala EA, Vaisto J, Westgate K, Brage S, Lakka TA, Vlachopoulos D. Cross-sectional and longitudinal associations between the 24-hour movement behaviours, including muscle and bone strengthening activity, with bone and lean mass from childhood to adolescence. BMC Public Health. 2024 Jan 19;24(1):227. doi: 10.1186/s12889-024-17711-x.

Reference Type DERIVED
PMID: 38238707 (View on PubMed)

Laamanen SE, Eloranta AM, Haapala EA, Sallinen T, Schwab U, Lakka TA. Associations of diet quality and food consumption with serum biomarkers for lipid and amino acid metabolism in Finnish children: the PANIC study. Eur J Nutr. 2024 Mar;63(2):623-637. doi: 10.1007/s00394-023-03293-8. Epub 2023 Dec 21.

Reference Type DERIVED
PMID: 38127151 (View on PubMed)

Liimatta J, Fluck CE, Mantyselka A, Hakkinen MR, Auriola S, Voutilainen R, Jaaskelainen J, Lakka TA. Effects of 2-Year Physical Activity and Dietary Intervention on Adrenarchal and Pubertal Development: The PANIC Study. J Clin Endocrinol Metab. 2023 Nov 17;108(12):e1603-e1613. doi: 10.1210/clinem/dgad367.

Reference Type DERIVED
PMID: 37329220 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36350359 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35399927 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34488794 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33547487 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32816094 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32367254 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29757399 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29750416 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29112780 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27612875 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27581473 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27558140 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27334557 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26915641 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26030086 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25207813 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24766669 (View on PubMed)

Related Links

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http://www.panicstudy.fi/en/etusivu

Detailed information about the PANIC study from the webpages of University of Eastern Finland

Other Identifiers

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PANIC

Identifier Type: -

Identifier Source: org_study_id

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