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NCT02013843 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02013843
Other study ID # TCOCmunicipalities
Secondary ID Region Sjaelland
Status Completed
Phase N/A
First received December 6, 2013
Last updated March 28, 2016
Start date March 2013
Est. completion date March 2015

Study information
Verified date March 2016
Source Holbaek Sygehus
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1007
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 18 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

Behavioral:
• Community-based treatment of overweight and obesity
Community based treatment of overweight and obese children using the "Holbaek-method".

Locations
Country Name City State
Denmark Pediatric department Holbaek

Sponsors (2)
Lead Sponsor Collaborator
Holbaek Sygehus University of Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Holm JC, Gamborg M, Bille DS, Gr Nb K HN, Ward LC, Faerk J. Chronic care treatment of obese children and adolescents. Int J Pediatr Obes. 2011 Aug;6(3-4):188-96. doi: 10.3109/17477166.2011.575157. Epub 2011 May 2. — View Citation

Holm JC, Gamborg M, Neland M, Ward L, Gammeltoft S, Heitmann BL, Sørensen TI, Ibsen KK. Longitudinal changes in blood pressure during weight loss and regain of weight in obese boys and girls. J Hypertens. 2012 Feb;30(2):368-74. doi: 10.1097/HJH.0b013e32834e4a87. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other cost effectiveness Assessed by the amount of hours used per child per year in each municipality 1 year No
Primary Body mass index standard deviation score primary outcome is the change in body mass index standard deviation score during 12 month treatment of overweight and obesity. 1 year No
Secondary Change in blood pressure standard deviation score 1 year No
Secondary Change in the concentration of blood lipids 1 year No
Secondary change in the concentration of fasting blood-glucose, HBA1C and insulin 1 year No
Secondary Change in body composition measured by Tanita BC 418 1 year No
Secondary Change in quality of life assessed by PedsQL 1 year No
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