NCT01803776

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
504

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 4, 2013

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

16.2 years

First QC Date

February 21, 2013

Last Update Submit

July 24, 2020

Conditions

Keywords

childrenadolescentsphysical activitysedentary timenutritiondietbody compositionoverweightobesityinsulinglucoselipidsadipokinesmyokinesmetabolomicsfitnessarterial elasticityatherosclerosisblood pressurebone mineral densitygeneticsgene-lifestyle interactionoral healthoral bacteriomicswellbeingdepressionsleeppainhealth economicshealthcare servicesmedicationcost-effectiveness

Outcome Measures

Primary Outcomes (3)

  • Change in insulin resistance

    Fasting serum insulin

    From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)

  • Change in fasting plasma glucose

    Fasting plasma glucose

    From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)

  • Change in body composition

    Body fat percentage and lean body mass assessed by dual-energy X-ray absorptiometry

    From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)

Secondary Outcomes (11)

  • Change in physical activity

    From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)

  • Change in sedentary time

    From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)

  • Change in diet

    From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)

  • Change in cardiorespiratory fitness

    From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)

  • Change in lipid metabolism

    From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)

  • +6 more secondary outcomes

Study Arms (2)

lifestyle counseling

EXPERIMENTAL

Physical activity and dietary counseling

Behavioral: lifestyle counseling

Control

NO INTERVENTION

No active intervention

Interventions

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.

lifestyle counseling

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • boys and girls, 6-9 years of age at baseline, from the city of Kuopio, Finland

You may not qualify if:

  • physical disabilities that could hamper participation in the intervention
  • no time or motivation to attend the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Eastern Finland

Kuopio, 70211, Finland

Location

Related Publications (25)

  • Viisanen M, Raittio E, Ikavalko T, Peltomaki T, Suominen AL, Tolonen V, Soininen S, Karvinen H, Lakka TA. Orthodontic Visits According to Socioeconomic Status Among Children Living in the City of Kuopio, Finland: The PANIC Study. Clin Exp Dent Res. 2026 Feb;12(1):e70280. doi: 10.1002/cre2.70280.

  • Liimatta J, Huotari J, du Toit T, Fluck CE, Jaaskelainen J, Hackney AC, Hakkinen MR, Lehtonen M, Auriola S, Lakka TA, Voutilainen R. Serum and hair steroid profiles and their associations with body composition in adolescence. Eur J Endocrinol. 2025 Nov 26;193(6):640-650. doi: 10.1093/ejendo/lvaf235.

  • Macro LE, Vlachopoulos D, Haapala EA, Wadey CA, Lakka TA, Barker AR. Effect of Scaling Peak Oxygen Uptake for Body Size and Composition to Assess Cardiometabolic Risk in Children. Med Sci Sports Exerc. 2025 Dec 1;57(12):2795-2806. doi: 10.1249/MSS.0000000000003828. Epub 2025 Jul 25.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

OverweightGlucose Metabolism DisordersLipid Metabolism DisordersAtherosclerosisMotor ActivitySedentary BehaviorObesityInsulin ResistanceDepressionPain

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMetabolic DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesBehaviorHyperinsulinismBehavioral SymptomsNeurologic Manifestations

Study Officials

  • Timo A Lakka, MD

    University of Eastern Finland, Kuopio campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A single-centre controlled trial in which the participants are allocated to a combined physical activity and dietary intervention group and a control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medical Physiology

Study Record Dates

First Submitted

February 21, 2013

First Posted

March 4, 2013

Study Start

October 1, 2007

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

July 28, 2020

Record last verified: 2020-07

Locations