A Three-year Behavioral Treatment of Obese Children
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Individually and in groups
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Obesity focused on measuring Childhood obesity, Age-dependent, Long-term treatment, BMI SDS, Dropouts
Eligibility Criteria
Inclusion Criteria:
- All children treated with behavioral treatment at the National childhood obesity center Stockholm between january 1998 - december 2004.
- Classified as obese by using the Tim Cole standard.
Exclusion Criteria:
- Children with obesity together with other diagnosis
- Children with other treatment like pharmacological, low calorie diets and surgery
Sites / Locations
- Karolinska University Hospital, Karolinska Institutet, Dept. of Clinical Science, Intervention and Technology (CLINTEC), Division of Pediatrics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
No Intervention
Arm Label
6-9 years
10-13 years
14-16 years
Control 6-9 years
Arm Description
Age at start of treatment
Age at start of treatment
Age at start of treatment
Untreated control group
Outcomes
Primary Outcome Measures
Measured as change in BMI SDS.
Secondary Outcome Measures
Full Information
NCT ID
NCT01029964
First Posted
December 9, 2009
Last Updated
December 9, 2009
Sponsor
Karolinska University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01029964
Brief Title
A Three-year Behavioral Treatment of Obese Children
Official Title
A Three-year Behavioral Treatment of Obese Children: the Effect of Age on Change in BMI SDS and Dropout Rate
Study Type
Interventional
2. Study Status
Record Verification Date
January 1997
Overall Recruitment Status
Completed
Study Start Date
January 1997 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Karolinska University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The prevalence of overweight and obesity among children and adolescents has reached epidemic proportions worldwide. Among Swedish 10-year old children 15-20% are overweight and 3-5% are obese. The probability that an obese child becomes an obese adult is very high. This chronic disease requires lifetime treatment. The standard treatment of childhood obesity involves behavioural interventions focused on eating habits and physical activity. Studies often include small study samples, the absence of control groups and short treatments times. Several long-term follow-up studies of shorter interventions are available. The results from these studies are disappointing since the number of children who are "cured" i.e., have become non-obese is low. Thus, effective treatments are currently lacking.The National Childhood Obesity Center treats children in a University hospital setting. The children are enrolled from the catchment areas of the hospital as well as the rest of Sweden. Treatment alternatives include behavioural treatment (individual and group), low and very low calorie diet, pharmacological and surgical treatment. Patients treated with surgical and pharmacological methods safety is ensured using these treatments exclusively in controlled studies. The clinic was the first in Sweden with this wide range of treatment options.
BORIS is a national health care quality register for childhood obesity, supervised by the Swedish Association of Local Authority and Regions.
Detailed Description
The primary aim of this study was to compare treatment effects (changes in BMI SDS) during the first three years of behavioral treatment in relation to age at start of treatment. The secondary aim was to evaluate specific factors of importance (gender, heredity, parental weight status, socioeconomic factors and age at obesity onset) for treatment effects. The third aim was to investigate factors correlated to drop out.
This is a longitudinal study of all patients referred to National Childhood Obesity Center between January 1997 and December 2004. Only patients with behavioral treatment were included. Patients with other treatments (VLCD/LCD, drugs and surgery) and other diagnoses (syndromes, craniopharyngioma, Mb Down, myelomeningocele, various types of mental and psychological disorders) and children <6 and >17 year at inclusion were excluded. The remaining children were divided into three age groups of obese children depending of age at onset of obesity treatment (6-9, 10-13 and 14-16year). All patient data were registered in the BORIS nationwide childhood obesity database.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Childhood obesity, Age-dependent, Long-term treatment, BMI SDS, Dropouts
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
6-9 years
Arm Type
Active Comparator
Arm Description
Age at start of treatment
Arm Title
10-13 years
Arm Type
Active Comparator
Arm Description
Age at start of treatment
Arm Title
14-16 years
Arm Type
Active Comparator
Arm Description
Age at start of treatment
Arm Title
Control 6-9 years
Arm Type
No Intervention
Arm Description
Untreated control group
Intervention Type
Behavioral
Intervention Name(s)
Individually and in groups
Intervention Description
During three year in a clinical setting.
Primary Outcome Measure Information:
Title
Measured as change in BMI SDS.
Time Frame
Three years behavioral treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All children treated with behavioral treatment at the National childhood obesity center Stockholm between january 1998 - december 2004.
Classified as obese by using the Tim Cole standard.
Exclusion Criteria:
Children with obesity together with other diagnosis
Children with other treatment like pharmacological, low calorie diets and surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude Marcus, Professor
Organizational Affiliation
1National Childhood Obesity Center, Children´s Hospital, Karolinska University Hospital, Karolinska Institutet, Dept. of Clinical Science, Intervention and Technology (CLINTEC), Division of Pediatrics, Stockholm, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital, Karolinska Institutet, Dept. of Clinical Science, Intervention and Technology (CLINTEC), Division of Pediatrics
City
Stockholm
State/Province
Huddinge
ZIP/Postal Code
141 86
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
22433615
Citation
Danielsson P, Svensson V, Kowalski J, Nyberg G, Ekblom O, Marcus C. Importance of age for 3-year continuous behavioral obesity treatment success and dropout rate. Obes Facts. 2012;5(1):34-44. doi: 10.1159/000336060. Epub 2012 Mar 2.
Results Reference
derived
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A Three-year Behavioral Treatment of Obese Children
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