Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2012-01-31
2012-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lifestyle intervention
Lifestyle intervention.
Physical activity, dietary counseling, coaching
Physical activity, dietary counseling, coaching
Interventions
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Physical activity, dietary counseling, coaching
Physical activity, dietary counseling, coaching
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Medical intake
7 Years
10 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Inge Holm
Administrator
Principal Investigators
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Nina Marie Birk Eriksen, MD
Role: PRINCIPAL_INVESTIGATOR
Centre of Inflammation and Metabolism
Locations
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Centre of Inflammation and Metabolism, Rigshospitalet
Copenhagen, , Denmark
Countries
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References
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Harder-Lauridsen NM, Birk NM, Ried-Larsen M, Juul A, Andersen LB, Pedersen BK, Krogh-Madsen R. A randomized controlled trial on a multicomponent intervention for overweight school-aged children - Copenhagen, Denmark. BMC Pediatr. 2014 Oct 21;14:273. doi: 10.1186/1471-2431-14-273.
Other Identifiers
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H-2-2011-132
Identifier Type: -
Identifier Source: org_study_id