Overview

This trial is active, not recruiting.

Conditions overweight, glucose metabolism disorders, lipid metabolism disorders, blood pressure
Treatment lifestyle counseling
Sponsor University of Eastern Finland
Collaborator Kuopio University Hospital
Start date October 2007
End date November 2022
Trial size 512 participants
Trial identifier NCT01803776, PANIC

Summary

The Physical Activity and Nutrition in Children (PANIC) Study is a single-centre physical activity and diet intervention study that provides novel scientific information on physical activity, nutrition, overweight, obesity, physical fitness, cognition, oral health, sleep, pain and other aspects of quality of life as well as health care costs in a population sample of children and adolescents. The main hypothesis of the study is that regular physical activity and dietary changes improve health and quality of life among children and adolescents.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
lifestyle counseling
Lifestyle intervention is based on Finnish exercise and nutrition recommendations. The children and their parents in the intervention group undergo intensive individual family-based exercise and diet intervention. They meet an exercise specialist and an authorized nutritionist, who give detailed and individualized instructions on health promoting physical activity and nutrition at months 0, 1.5, 3, 6, 12, 18, and 24 with a specific topic at each visit. After the 2-year intensive intervention period the intervention continues with yearly physical activity and dietary counseling sessions. Group-based exercise and cooking clubs are part of intervention.

Primary Outcomes

Measure
Change in composite measure of metabolic syndrome
time frame: From baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood)

Secondary Outcomes

Measure
Change in body size and composition
time frame: From baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood)
Change in cardiometabolic risk factors
time frame: From baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood)
Change in cardiorespiratory fitness and function
time frame: From baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood)
Change in musculoskeletal fitness and function
time frame: From baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood)
Change in heart rate, blood pressure and autonomic nervous system regulation
time frame: From baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood)
Change in endothelial function, systemic and skeletal muscle blood flow
time frame: From baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood)
Change in cognitive function
time frame: From baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood)
Change in medical health status
time frame: From baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood)
Change in oral health status
time frame: From baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood)
Change in wellbeing
time frame: From baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood)
Change in health care costs
time frame: From baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood)
Change in bone mineral density
time frame: From baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood)
Change in physical activity
time frame: From baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood)
Change in diet and eating behavior
time frame: From baseline to 2-year follow-up and 8-year follow-up (adolescence) and 13-year follow-up (early adulthood)

Eligibility Criteria

Male or female participants from 6 years up to 8 years old.

Inclusion Criteria: - boys and girls, 6-8 years of age at baseline, from the city of Kuopio, Finland Exclusion Criteria: - children with severe physical disabilities

Additional Information

Official title Physical Activity and Diet Intervention Study to Improve Health and Wellbeing of Children
Principal investigator Timo A Lakka, MD
Description The study population is a population sample of 512 children from the city of Kuopio, Finland. The children will be recruited at the age of 6-8 years and allocated into the intervention group and the control group. The intervention group will undergo intensive, individualized and family-based physical activity and diet intervention that also includes exercise and cooking clubs. All children will be examined after the 2-year follow-up. The intervention group will continues with a less intensive exercise and diet intervention until adulthood. All children will be re-examined in adolescence and in early adulthood. The results of the PANIC Study will help in improving children's health by increased physical activity and improved nutrition, in identifying high-risk children who would benefit most from exercise and diet intervention, and in targeting the high-risk children for more careful health examinations, exercise and diet intervention and health follow-up and in preventing chronic diseases and their societal consequences in adulthood.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Eastern Finland.