A Three-year Behavioral Treatment of Obese Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-01-31

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Childhood Obesity

Keywords

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Childhood obesity Age-dependent Long-term treatment BMI SDS Dropouts

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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6-9 years

Age at start of treatment

Group Type ACTIVE_COMPARATOR

Individually and in groups

Intervention Type BEHAVIORAL

During three year in a clinical setting.

10-13 years

Age at start of treatment

Group Type ACTIVE_COMPARATOR

Individually and in groups

Intervention Type BEHAVIORAL

During three year in a clinical setting.

14-16 years

Age at start of treatment

Group Type ACTIVE_COMPARATOR

Individually and in groups

Intervention Type BEHAVIORAL

During three year in a clinical setting.

Control 6-9 years

Untreated control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Individually and in groups

During three year in a clinical setting.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Karolinska Institutet

Principal Investigators

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Claude Marcus, Professor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Karolinska University Hospital, Karolinska Institutet, Dept. of Clinical Science, Intervention and Technology (CLINTEC), Division of Pediatrics

Stockholm, Huddinge, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED

PMID: 22433615 (View on PubMed)

Other Identifiers

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BORIS

Identifier Type: -

Identifier Source: org_study_id

A Three-year Behavioral Treatment of Obese Children

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

6-9 years

Individually and in groups

10-13 years

Individually and in groups

14-16 years

Individually and in groups

Control 6-9 years

Interventions

Individually and in groups

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Karolinska University Hospital

Responsible Party

Principal Investigators

Claude Marcus, Professor

Locations

Karolinska University Hospital, Karolinska Institutet, Dept. of Clinical Science, Intervention and Technology (CLINTEC), Division of Pediatrics

Countries

References

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.

Other Identifiers

BORIS