FFK: "Fit For Kids"-Copenhagen

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Completed
• CT.gov ID: NCT01660789
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Arm: 1
• Duration (Months): 7
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Physical activity, dietary counseling, coaching	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: "Fit For Kids" Copenhagen - an Interventions Study on Obesity and Physical Inactivity in Children.
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Lifestyle intervention Lifestyle intervention.	Behavioral: Physical activity, dietary counseling, coaching; Physical activity, dietary counseling, coaching

Outcome Measures

Primary Outcome Measures

1. BMI [One year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 10 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Obese children

Exclusion Criteria:

• Other chronic medical conditions

• Medical intake

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre of Inflammation and Metabolism, Rigshospitalet	Copenhagen		Denmark	2100

Sponsors and Collaborators

• Rigshospitalet, Denmark

Investigators

• Principal Investigator: Nina Marie Birk Eriksen, MD, Centre of Inflammation and Metabolism

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Inge Holm, Administrator, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT01660789
• Other Study ID Numbers: H-2-2011-132
• First Posted: Aug 9, 2012
• Last Update Posted: Aug 31, 2012
• Last Verified: Aug 1, 2012

• Keywords provided by Inge Holm, Administrator, Rigshospitalet, Denmark: Obesity; Diabetes; Physical activity
• Additional relevant MeSH terms: Obesity

Study Results

No Results Posted as of Aug 31, 2012