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Clinical Trials/NCT01660789
NCT01660789
Completed
Not Applicable

"Fit For Kids" Copenhagen - an Interventions Study on Obesity and Physical Inactivity in Children.

Rigshospitalet, Denmark1 site in 1 country37 target enrollmentJanuary 2012
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Rigshospitalet, Denmark
Enrollment
37
Locations
1
Primary Endpoint
BMI
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
August 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Inge Holm

Administrator

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

  • Obese children

Exclusion Criteria

  • Other chronic medical conditions
  • Medical intake

Outcomes

Primary Outcomes

BMI

Time Frame: One year

Study Sites (1)

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