Treatment of Overweight and Obese Children -Using the "Holbaek-Method" in a Municipality Based Treatment Program.

Not Applicable

Completed

• Conditions: Pediatric Obesity; Quality of Life; Hypertension; Dyslipidemia; Diabetes
• Interventions: Behavioral: Community-based treatment of overweight and obesity

• Registration Number: NCT02013843
• Lead Sponsor: Holbaek Sygehus

Brief Summary

In the present study the effect of a community-based treatment of overweight and obese children is analyzed. The treatment-method is based on the principals and the method used in the Children Obesity Clinic in the Pediatric department i Holbaek. The effect is evaluated by the change in body mass index standard deviation score, change in blood pressure standard deviation score, quality of life and concentration of fasting blood lipids and glucose during one year of treatment.

Detailed Description

In the present study the effect of a community-based treatment of overweight and obese children is analyzed. The treatment-method is based on the principals and the method used in the Children Obesity Clinic in the Pediatric department i Holbaek and the care providers in each of the eight municipalities included are thought thoroughly to use this method.

The treatment effect is evaluated after one year, and the effect is assessed by the change in body mass index standard deviation score, change in blood pressure standard deviation score, quality of life (PedsQL), body composition and concentration of fasting blood lipids and glucose.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-12-06
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-17
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-28
• Last Update Posted: 2016-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1007

Inclusion Criteria

• Body mass index above 90-percentile for age and gender

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Community-based treatment	Community-based treatment of overweight and obesity	Overweight and obese children are seen on a regular basis by health care professionals in the 8 communities included in the project. The care providers are all trained thoroughly in using the "Holbaek-method" for treatment of pediatric obesity.

Primary Outcome Measures

Name	Time	Method
Body mass index standard deviation score	1 year	primary outcome is the change in body mass index standard deviation score during 12 month treatment of overweight and obesity.

Secondary Outcome Measures

Name	Time	Method
Change in blood pressure standard deviation score	1 year
Change in the concentration of blood lipids	1 year
change in the concentration of fasting blood-glucose, HBA1C and insulin	1 year
Change in body composition measured by Tanita BC 418	1 year
Change in quality of life assessed by PedsQL	1 year

Trial Locations

Locations (1)

Pediatric department; 🇩🇰 Holbaek, Denmark