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Completed

NCT Number: NCT01660789

"Fit For Kids"-Copenhagen

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.

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Key information

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre of Inflammation and Metabolism, Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obese children

Exclusion criteria

  • Other chronic medical conditions
  • Medical intake

Treatment and study plan

Physical activity, dietary counseling, coaching

Behavioral

Physical activity, dietary counseling, coaching

Primary outcomes

  1. BMI

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Acronym: FFK

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 9, 2012
Registry last updated
Aug 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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