"Fit For Kids"-Copenhagen (FFK)

Rigshospitalet

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Physical activity, dietary counseling, coaching

Study type: Interventional

Funder types: Other

Identifiers

NCT01660789

H-2-2011-132

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 7 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Obese children

Exclusion criteria

• Other chronic medical conditions
• Medical intake

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Lifestyle intervention

Other group

Description:

Lifestyle intervention.

Treatment:

Behavioral: Physical activity, dietary counseling, coaching