Obesity Clinical Trial
Official title:
"Fit For Kids" Copenhagen - an Interventions Study on Obesity and Physical Inactivity in Children.
This study aims to evaluate the effect of a 40- week multifactorial intervention against
overweight, obesity and physical inactivity in Danish children.
The investigators wish to examine 40 children before and after the "Fit for Kids"
intervention with basic anthropometric measures such as body mass indexi (BMI), waist/hip
ratio, systolic- and diastolic blood pressure, level of physical fitness and Total Body fat
mass.
Furthermore the investigators wish to examine the more specific inflammatory, metabolic and
hormonal effect of the intervention with a more extensive examination programme.
The tests include a DXA-scan, cardio-respiratory fitness, accelerometer monitoring,
pedometer monitoring, cognitive testing, Continuous Glucose Monitoring System, different
metabolic and inflammatory markers and an oral glucose tolerance test. The study will take
place at Centre of Inflammation and Metabolism, Rigshospitalet, Copenhagen.
The study is a randomised controlled trial with a gradual rollout. The 40 children will be
randomised. Twenty children will start the intervention at baseline and 20 children will
start after the first 20 weeks of intervention, thus providing a control group.
The investigators expect to find a significant reduction in BMI, total body fat mass and
systolic blood pressure after the intervention. As for the more extensive tests, the data
approach is explorative, as the investigators look at more statistical dependent variables.
The contribution of this project is a further description on the effect of intervention
against overweight and physical inactivity on the metabolic and inflammatory response.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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