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Clinical Trials/NCT02013843
NCT02013843
Completed
N/A

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

Holbaek Sygehus1 site in 1 country1,007 target enrollmentMarch 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pediatric Obesity
Sponsor
Holbaek Sygehus
Enrollment
1007
Locations
1
Primary Endpoint
Body mass index standard deviation score
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
March 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Holbaek Sygehus
Responsible Party
Principal Investigator
Principal Investigator

Pernille Maria Mollerup

MD

Holbaek Sygehus

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Body mass index standard deviation score

Time Frame: 1 year

primary outcome is the change in body mass index standard deviation score during 12 month treatment of overweight and obesity.

Secondary Outcomes

  • 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)

Study Sites (1)

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