OverweightPANICNCT01803776
The Physical Activity and Nutrition in Children (PANIC) Study
A study testing lifestyle counseling in people with Overweight and Glucose Metabolism Disorders, run by University of Eastern Finland at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Glucose Metabolism Disorders, Lipid Metabolism Disorders
- What is being tested?
- lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2007to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- boys and girls, 6-9 years of age at baseline, from the city of Kuopio, Finland
Who cannot join
- physical disabilities that could hamper participation in the intervention
- no time or motivation to attend the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Overweight, Glucose Metabolism Disorders, Lipid Metabolism Disorders, Blood Pressure, Atherosclerosis
- Being tested
- lifestyle counseling
- 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
- Medical subject headings
- Overweight, Glucose Metabolism Disorders, Lipid Metabolism Disorders, Atherosclerosis, Motor Activity, Sedentary Behavior, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle counselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| lifestyle counseling | Experimental | Physical activity and dietary counseling Receives: Behavioral: lifestyle counseling |
| Control | No intervention | No active intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin resistance
Fasting serum insulin
Measured: 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
Measured: 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
Measured: 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
Physical activity assessed objectively by heart rate and body movement monitoring
Measured: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Change in sedentary time
Sedentary time assessed objectively by heart rate and body movement monitoring
Measured: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Change in diet
Food consumption and nutrient intake assessed by 4-day dietary recording
Measured: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Change in cardiorespiratory fitness
Maximal workload and peak oxygen consumption assessed by a maximal exercise test on a bicycle ergometer
Measured: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Change in lipid metabolism
Biomarkers of lipid metabolism (fasting triglycerides, HDL cholesterol and LDL cholesterol)
Measured: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Change in liver adiposity
Biomarkers of liver adiposity (alanine aminotransferase and gamma glutamyltransferase)
Measured: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Change in blood pressure
Systolic and diastolic blood pressure at rest
Measured: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Change in cognitive function
General mental ability assessed by Raven's Coloured Progressive Matrices
Measured: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Change in bone mineral density
Change in bone mineral density assessed by dual-energy X-ray absorptiometry
Measured: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Change in the use of healthcare services
Use of healthcare services received from national and local health registries
Measured: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
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
Measured: From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startOct 2007
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Timo Lakka, University of Eastern Finland
- Investigators
- Timo A Lakka, MD, Principal investigator, University of Eastern Finland, Kuopio campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803776
- Sponsor's protocol ID
- PANIC
- Acronym
- PANIC
- Status last verified
- Jul 2020
- First submitted
- 21 Feb 2013
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
de Ruyter H, Aitokari L, Iqbal A, Eloranta AM, Viitasalo A, Soininen S, Haapala EA, Huhtala H, Jaaskelainen J, Heinonen S, Lakka T, Kurppa K. Perinatal and Lifestyle Factors Associated with Childhood Alanine Aminotransferase Levels as an Early Indicator of Metabolic Dysfunction-Associated Steatotic Liver Disease: A Population-Based Study. J Pediatr. 2026 Aug;295:115146. doi: 10.1016/j.jpeds.2026.115146. Epub 2026 May 12.
PubMed 42128085Viisanen 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.
PubMed 41510745Liimatta 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.
PubMed 41259303Macro 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.
PubMed 40708126Kraav 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.
PubMed 39508145Toivonen E, Lee E, Leppanen MH, Laitinen T, Kahonen M, Lakka TA, Haapala EA. The associations of depressive symptoms and perceived stress with arterial health in adolescents. Physiol Rep. 2024 Mar;12(6):e15986. doi: 10.14814/phy2.15986.
PubMed 38519264Aitokari 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.
PubMed 38314943Skinner 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.
PubMed 38238707Laamanen 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.
PubMed 38127151Liimatta 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.
PubMed 37329220Soininen 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.
PubMed 36350359Constable 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.
PubMed 35399927Kuvaja-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.
PubMed 34488794Constable 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.
PubMed 33547487Lakka 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.
PubMed 32816094
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Physical Activity and Nutrition in Children (PANIC) Study
- ClinicalTrials.gov ID
- NCT01803776
- Acronym / sponsor ID
- PANIC / PANIC
- Conditions
- Overweight, Glucose Metabolism Disorders, Lipid Metabolism Disorders, Blood Pressure, Atherosclerosis
- Keywords
- children, adolescents, physical activity, sedentary time, nutrition, diet, body composition, overweight
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 504 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- 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
- Study start
- Oct 2007
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 4 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| lifestyle counseling | Experimental | Behavioral: lifestyle counselingPhysical activity and dietary counseling |
| Control | No intervention | –No active intervention |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- boys and girls, 6-9 years of age at baseline, from the city of Kuopio, Finland
Key exclusion criteria (2 listed)
- physical disabilities that could hamper participation in the intervention
- no time or motivation to attend the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lifestyle counselingThe 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. | Behavioural | lifestyle counseling |
Primary outcome
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)
Fasting serum insulin
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)
Fasting plasma glucose
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)
Body fat percentage and lean body mass assessed by dual-energy X-ray absorptiometry
11 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Derived from this study: PubMed 42128085de Ruyter H, Aitokari L, Iqbal A, Eloranta AM, Viitasalo A, Soininen S, Haapala EA, Huhtala H, Jaaskelainen J, Heinonen S, Lakka T, Kurppa K. Perinatal and Lifestyle Factors Associated with Childhood Alanine Aminotransferase Levels as an Early Indicator of Metabolic Dysfunction-Associated Steatotic Liver Disease: A Population-Based Study. J Pediatr. 2026 Aug;295:115146. doi: 10.1016/j.jpeds.2026.115146. Epub 2026 May 12.
- Derived from this study: PubMed 41510745Viisanen 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.
- Derived from this study: PubMed 41259303Liimatta 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.
- Derived from this study: PubMed 40708126Macro 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.
- Derived from this study: PubMed 39508145Kraav 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.
- Derived from this study: PubMed 38519264Toivonen E, Lee E, Leppanen MH, Laitinen T, Kahonen M, Lakka TA, Haapala EA. The associations of depressive symptoms and perceived stress with arterial health in adolescents. Physiol Rep. 2024 Mar;12(6):e15986. doi: 10.14814/phy2.15986.
- Derived from this study: PubMed 38314943Aitokari 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.
- Derived from this study: PubMed 38238707Skinner 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.
- Derived from this study: PubMed 38127151Laamanen 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.
- Derived from this study: PubMed 37329220Liimatta 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.
- Derived from this study: PubMed 36350359Soininen 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.
- Derived from this study: PubMed 35399927Constable 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.
- Detailed information about the PANIC study from the webpages of University of Eastern FinlandLink provided by the sponsor.
Related trials for Overweight
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timo A Lakka, MD principal investigator
University of Eastern Finland, Kuopio campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle counseling in people with Overweight and Glucose Metabolism Disorders, run by University of Eastern Finland at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01803776, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.