The Physical Activity and Nutrition in Children (PANIC) Study

The Physical Activity and Nutrition in Children (PANIC) Study

Sponsors

Lead Sponsor: University of Eastern Finland

Collaborator: 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

Source University of Eastern Finland
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.

Overall Status Active, not recruiting
Start Date 2007-10-01
Completion Date 2023-12-01
Primary Completion Date 2023-12-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in insulin resistance 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 From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Change in body composition From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Secondary Outcome
Measure Time Frame
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)
Change in liver adiposity From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Change in blood pressure From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Change in cognitive function 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 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 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 From baseline to 2-year follow-up (childhood), 8-year follow-up (adolescence), and 14-year follow-up (early adulthood)
Enrollment 504
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: lifestyle counseling

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.

Arm Group Label: lifestyle counseling

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

Gender:

All

Minimum Age:

6 Years

Maximum Age:

9 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Timo A Lakka, MD Principal Investigator University of Eastern Finland, Kuopio campus
Location
Facility: University of Eastern Finland
Location Countries

Finland

Verification Date

2020-07-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Eastern Finland

Investigator Full Name: Timo Lakka

Investigator Title: Professor of Medical Physiology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: lifestyle counseling

Type: Experimental

Description: Physical activity and dietary counseling

Label: Control

Type: No Intervention

Description: No active intervention

Acronym PANIC
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

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

Masking: None (Open Label)

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