Treatment of Overweight and Obese Children -Using the "Holbaek-Method" in a Municipality Based Treatment Program.
Primary Purpose
Pediatric Obesity, Dyslipidemia, Hypertension
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Community-based treatment of overweight and obesity
Sponsored by
About this trial
This is an interventional health services research trial for Pediatric Obesity focused on measuring Pediatric obesity, Community-based treatment, dyslipidemia, hypertension, diabetes
Eligibility Criteria
Inclusion Criteria:
- Body mass index above 90-percentile for age and gender
Exclusion Criteria:
- None
Sites / Locations
- Pediatric department
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Community-based treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in blood pressure standard deviation score
Change in the concentration of blood lipids
change in the concentration of fasting blood-glucose, HBA1C and insulin
Change in body composition measured by Tanita BC 418
Change in quality of life assessed by PedsQL
Full Information
NCT ID
NCT02013843
First Posted
December 6, 2013
Last Updated
March 28, 2016
Sponsor
Holbaek Sygehus
Collaborators
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT02013843
Brief Title
Treatment of Overweight and Obese Children -Using the "Holbaek-Method" in a Municipality Based Treatment Program.
Official Title
Treatment of Overweight and Obese Children - the "Holbaek-Method" in a Municipality Based Treatment Program.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Holbaek Sygehus
Collaborators
University of Copenhagen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Dyslipidemia, Hypertension, Diabetes, Quality of Life
Keywords
Pediatric obesity, Community-based treatment, dyslipidemia, hypertension, diabetes
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1007 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Community-based treatment
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Community-based treatment of overweight and obesity
Intervention Description
Community based treatment of overweight and obese children using the "Holbaek-method".
Primary Outcome Measure Information:
Title
Body mass index standard deviation score
Description
primary outcome is the change in body mass index standard deviation score during 12 month treatment of overweight and obesity.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in blood pressure standard deviation score
Time Frame
1 year
Title
Change in the concentration of blood lipids
Time Frame
1 year
Title
change in the concentration of fasting blood-glucose, HBA1C and insulin
Time Frame
1 year
Title
Change in body composition measured by Tanita BC 418
Time Frame
1 year
Title
Change in quality of life assessed by PedsQL
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
cost effectiveness
Description
Assessed by the amount of hours used per child per year in each municipality
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Body mass index above 90-percentile for age and gender
Exclusion Criteria:
None
Facility Information:
Facility Name
Pediatric department
City
Holbaek
ZIP/Postal Code
4300
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
22157326
Citation
Holm JC, Gamborg M, Neland M, Ward L, Gammeltoft S, Heitmann BL, Sorensen 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.
Results Reference
background
PubMed Identifier
21529264
Citation
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.
Results Reference
background
PubMed Identifier
28213684
Citation
Mollerup PM, Nielsen TRH, Bojsoe C, Kloppenborg JT, Baker JL, Holm JC. Quality of life improves in children and adolescents during a community-based overweight and obesity treatment. Qual Life Res. 2017 Jun;26(6):1597-1608. doi: 10.1007/s11136-017-1504-x. Epub 2017 Feb 17.
Results Reference
derived
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Treatment of Overweight and Obese Children -Using the "Holbaek-Method" in a Municipality Based Treatment Program.
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