"Fit For Kids"-Copenhagen

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Physical activity, dietary counseling, coaching

• Registration Number: NCT01660789
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-04-02
• Status Verified: 2012-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Study First Submitted QC: 2012-08-06
• Study First Posted: 2012-08-09
• Last Update Submitted: 2012-08-30
• Last Update Posted: 2012-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Obese children

Exclusion Criteria

• Other chronic medical conditions
• Medical intake

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lifestyle intervention	Physical activity, dietary counseling, coaching	Lifestyle intervention.

Primary Outcome Measures

Name	Time	Method
BMI	One year

Trial Locations

Locations (1)

Centre of Inflammation and Metabolism, Rigshospitalet; 🇩🇰 Copenhagen, Denmark