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

March 28, 2016 updated by: Pernille Maria Mollerup, Holbaek Sygehus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

1007

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Holbaek, Denmark, 4300
        • Pediatric department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Community-based treatment
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.
Behavioral: Community-based treatment of overweight and obesity
Community based treatment of overweight and obese children using the "Holbaek-method".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
cost effectiveness
Time Frame: 1 year
Assessed by the amount of hours used per child per year in each municipality
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Holbaek Sygehus

Collaborators

University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

December 6, 2013

First Submitted That Met QC Criteria

December 16, 2013

First Posted (Estimate)

December 17, 2013

Study Record Updates

Last Update Posted (Estimate)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 28, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCOCmunicipalities
  • Region Sjaelland 2012 (Other Grant/Funding Number: Region Sjaelland)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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