Childhood ObesityNCT01029964
A Three-year Behavioral Treatment of Obese Children
A study testing Individually and in groups in people with Childhood Obesity, run by Karolinska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Individually and in groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteSweden
- Study dates
- Jan 1997to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Children with obesity together with other diagnosis
- Children with other treatment like pharmacological, low calorie diets and surgery
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska University Hospital, Karolinska Institutet, Dept. of Clinical Science, Intervention and Technology (CLINTEC), Division of Pediatrics
Stockholm, Huddinge, 141 86
About this study
Official title: A Three-year Behavioral Treatment of Obese Children: the Effect of Age on Change in BMI SDS and Dropout Rate
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.
Read the 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.
- Conditions
- Childhood Obesity
- Being tested
- Individually and in groups
- Keywords
- Childhood obesity, Age-dependent, Long-term treatment, BMI SDS, Dropouts
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individually and in groupsBehavioural
During three year in a clinical setting.
| Study group | Role | What they receive |
|---|---|---|
| 6-9 years | Active comparator | Age at start of treatment Receives: Behavioral: Individually and in groups |
| 10-13 years | Active comparator | Age at start of treatment Receives: Behavioral: Individually and in groups |
| 14-16 years | Active comparator | Age at start of treatment Receives: Behavioral: Individually and in groups |
| Control 6-9 years | No intervention | Untreated control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured as change in BMI SDS.
Measured: Three years behavioral treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startJan 1997
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Claude Marcus, Professor, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029964
- Sponsor's protocol ID
- BORIS
- Status last verified
- Jan 1997
- First submitted
- 9 Dec 2009
- Last updated
- 10 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22433615
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-year Behavioral Treatment of Obese Children: the Effect of Age on Change in BMI SDS and Dropout Rate
- ClinicalTrials.gov ID
- NCT01029964
- Acronym / sponsor ID
- BORIS
- Conditions
- Childhood Obesity
- Keywords
- Childhood obesity, Age-dependent, Long-term treatment, BMI SDS, Dropouts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Jan 1997
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 10 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 6-9 years | Active comparator | Behavioral: Individually and in groupsAge at start of treatment |
| 10-13 years | Active comparator | Behavioral: Individually and in groupsAge at start of treatment |
| 14-16 years | Active comparator | Behavioral: Individually and in groupsAge at start of treatment |
| Control 6-9 years | No intervention | –Untreated control group |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Children with obesity together with other diagnosis
- Children with other treatment like pharmacological, low calorie diets and surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individually and in groupsDuring three year in a clinical setting. | Behavioural | 10-13 years, 14-16 years, 6-9 years |
Primary outcome
Measured as change in BMI SDS.
Time frame: Three years behavioral treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2009.
- Derived from this study: PubMed 22433615Danielsson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claude Marcus, Professor 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individually and in groups in people with Childhood Obesity, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measured as change in BMI SDS. (time frame: Three years behavioral treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01029964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2009.