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The Physical Activity and Nutrition in Children (PANIC) Study (PANIC)

Primary Purpose

Overweight, Glucose Metabolism Disorders, Lipid Metabolism Disorders

Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
lifestyle counseling
Sponsored by
University of Eastern Finland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring 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

Eligibility Criteria

6 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Eastern Finland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

lifestyle counseling

Control

Arm Description

Physical activity and dietary counseling

No active intervention

Outcomes

Primary Outcome Measures

Change in insulin resistance
Fasting serum insulin
Change in fasting plasma glucose
Fasting plasma glucose
Change in body composition
Body fat percentage and lean body mass assessed by dual-energy X-ray absorptiometry

Secondary Outcome Measures

Change in physical activity
Physical activity assessed objectively by heart rate and body movement monitoring
Change in sedentary time
Sedentary time assessed objectively by heart rate and body movement monitoring
Change in diet
Food consumption and nutrient intake assessed by 4-day dietary recording
Change in cardiorespiratory fitness
Maximal workload and peak oxygen consumption assessed by a maximal exercise test on a bicycle ergometer
Change in lipid metabolism
Biomarkers of lipid metabolism (fasting triglycerides, HDL cholesterol and LDL cholesterol)
Change in liver adiposity
Biomarkers of liver adiposity (alanine aminotransferase and gamma glutamyltransferase)
Change in blood pressure
Systolic and diastolic blood pressure at rest
Change in cognitive function
General mental ability assessed by Raven's Coloured Progressive Matrices
Change in bone mineral density
Change in bone mineral density assessed by dual-energy X-ray absorptiometry
Change in the use of healthcare services
Use of healthcare services received from national and local health registries
Change in costs associated with the use of healthcare services
Costs associated with the use of healthcare services received from national and local health registries

Full Information

First Posted
February 21, 2013
Last Updated
July 24, 2020
Sponsor
University of Eastern Finland
Collaborators
Kuopio University Hospital, University of Jyvaskyla, Kuopio Research Institute of Exercise Medicine, University of Turku, Tampere University, Folkhälsan Researech Center, University of Cambridge, University of Exeter, University of Copenhagen, Norwegian School of Sport Sciences, University of Tromso, University of Iceland, Early Growth Genetics (EGG) Consortium, LongITools Consortium
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1. Study Identification

Unique Protocol Identification Number
NCT01803776
Brief Title
The Physical Activity and Nutrition in Children (PANIC) Study
Acronym
PANIC
Official Title
The Physical Activity and Nutrition in Children (PANIC) Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Eastern Finland
Collaborators
Kuopio University Hospital, University of Jyvaskyla, Kuopio Research Institute of Exercise Medicine, University of Turku, Tampere University, Folkhälsan Researech Center, University of Cambridge, University of Exeter, University of Copenhagen, Norwegian School of Sport Sciences, University of Tromso, University of Iceland, Early Growth Genetics (EGG) Consortium, LongITools Consortium

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
504 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lifestyle counseling
Arm Type
Experimental
Arm Description
Physical activity and dietary counseling
Arm Title
Control
Arm Type
No Intervention
Arm Description
No active intervention
Intervention Type
Behavioral
Intervention Name(s)
lifestyle counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in insulin resistance
Description
Fasting serum insulin
Time Frame
From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Title
Change in fasting plasma glucose
Description
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)
Title
Change in body composition
Description
Body fat percentage and lean body mass assessed by dual-energy X-ray absorptiometry
Time Frame
From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Secondary Outcome Measure Information:
Title
Change in physical activity
Description
Physical activity assessed objectively by heart rate and body movement monitoring
Time Frame
From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Title
Change in sedentary time
Description
Sedentary time assessed objectively by heart rate and body movement monitoring
Time Frame
From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Title
Change in diet
Description
Food consumption and nutrient intake assessed by 4-day dietary recording
Time Frame
From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Title
Change in cardiorespiratory fitness
Description
Maximal workload and peak oxygen consumption assessed by a maximal exercise test on a bicycle ergometer
Time Frame
From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Title
Change in lipid metabolism
Description
Biomarkers of lipid metabolism (fasting triglycerides, HDL cholesterol and LDL cholesterol)
Time Frame
From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Title
Change in liver adiposity
Description
Biomarkers of liver adiposity (alanine aminotransferase and gamma glutamyltransferase)
Time Frame
From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Title
Change in blood pressure
Description
Systolic and diastolic blood pressure at rest
Time Frame
From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Title
Change in cognitive function
Description
General mental ability assessed by Raven's Coloured Progressive Matrices
Time Frame
From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Title
Change in bone mineral density
Description
Change in bone mineral density assessed by dual-energy X-ray absorptiometry
Time Frame
From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Title
Change in the use of healthcare services
Description
Use of healthcare services received from national and local health registries
Time Frame
From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Title
Change in costs associated with the use of healthcare services
Description
Costs associated with the use of healthcare services received from national and local health registries
Time Frame
From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timo A Lakka, MD
Organizational Affiliation
University of Eastern Finland, Kuopio campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Eastern Finland
City
Kuopio
ZIP/Postal Code
70211
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
36350359
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.
Results Reference
derived
PubMed Identifier
35399927
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.
Results Reference
derived
PubMed Identifier
34488794
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.
Results Reference
derived
PubMed Identifier
33547487
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.
Results Reference
derived
PubMed Identifier
32816094
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.
Results Reference
derived
PubMed Identifier
32367254
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.
Results Reference
derived
PubMed Identifier
29757399
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.
Results Reference
derived
PubMed Identifier
29750416
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.
Results Reference
derived
PubMed Identifier
29112780
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.
Results Reference
derived
PubMed Identifier
27334557
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.
Results Reference
derived
PubMed Identifier
27612875
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.
Results Reference
derived
PubMed Identifier
27581473
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.
Results Reference
derived
PubMed Identifier
27558140
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.
Results Reference
derived
PubMed Identifier
26915641
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.
Results Reference
derived
PubMed Identifier
26030086
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.
Results Reference
derived
PubMed Identifier
25207813
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.
Results Reference
derived
PubMed Identifier
24766669
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.
Results Reference
derived
Links:
URL
http://www.panicstudy.fi/en/etusivu
Description
Detailed information about the PANIC study from the webpages of University of Eastern Finland

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The Physical Activity and Nutrition in Children (PANIC) Study

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