A Three-year Behavioral Treatment of Obese Children

This study has been completed.
Sponsor:
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01029964
First received: December 9, 2009
Last updated: NA
Last verified: January 1997
History: No changes posted
  Purpose

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.


Condition Intervention
Childhood Obesity
Behavioral: Individually and in groups

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Three-year Behavioral Treatment of Obese Children: the Effect of Age on Change in BMI SDS and Dropout Rate

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Measured as change in BMI SDS. [ Time Frame: Three years behavioral treatment ] [ Designated as safety issue: No ]

Enrollment: 1000
Study Start Date: January 1997
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 6-9 years
Age at start of treatment
Behavioral: Individually and in groups
During three year in a clinical setting.
Active Comparator: 10-13 years
Age at start of treatment
Behavioral: Individually and in groups
During three year in a clinical setting.
Active Comparator: 14-16 years
Age at start of treatment
Behavioral: Individually and in groups
During three year in a clinical setting.
No Intervention: Control 6-9 years
Untreated control group

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.

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029964

Locations
Sweden
Karolinska University Hospital, Karolinska Institutet, Dept. of Clinical Science, Intervention and Technology (CLINTEC), Division of Pediatrics
Stockholm, Huddinge, Sweden, 141 86
Sponsors and Collaborators
Karolinska University Hospital
Investigators
Principal Investigator: Claude Marcus, Professor 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
  More Information

No publications provided by Karolinska University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Claude Marcus Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01029964     History of Changes
Other Study ID Numbers: BORIS
Study First Received: December 9, 2009
Last Updated: December 9, 2009
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska University Hospital:
Childhood obesity
Age-dependent
Long-term treatment
BMI SDS
Dropouts

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 23, 2014