Pediatric ObesityNCT02013843
Treatment of Overweight and Obese Children -Using the "Holbaek-Method" in a Municipality Based Treatment Program.
A study testing Community-based treatment of overweight and obesity in people with Pediatric Obesity and Dyslipidemia, run by Holbaek Sygehus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Pediatric Obesity, Dyslipidemia, Hypertension
- What is being tested?
- Community-based treatment of overweight and obesity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,007 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2013to Mar 2015
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Body mass index above 90-percentile for age and gender
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Overweight and Obese Children - the "Holbaek-Method" in a Municipality Based Treatment Program.
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.
Read the 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.
- Conditions
- Pediatric Obesity, Dyslipidemia, Hypertension, Diabetes, Quality of Life
- Being tested
- Community-based treatment of overweight and obesity
- Keywords
- Pediatric obesity, Community-based treatment, dyslipidemia, hypertension, diabetes
- Medical subject headings
- Pediatric Obesity, Dyslipidemias, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based treatment of overweight and obesityBehavioural
Community based treatment of overweight and obese children using the "Holbaek-method".
| Study group | Role | What they receive |
|---|---|---|
| Community-based treatment | Other | 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. Receives: Behavioral: Community-based treatment of overweight and obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
Change in blood pressure standard deviation score
Measured: 1 year
Change in the concentration of blood lipids
Measured: 1 year
change in the concentration of fasting blood-glucose, HBA1C and insulin
Measured: 1 year
Change in body composition measured by Tanita BC 418
Measured: 1 year
Change in quality of life assessed by PedsQL
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,007 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holbaek Sygehus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Pernille Maria Mollerup, Holbaek Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013843
- Sponsor's protocol ID
- TCOCmunicipalities
- Other IDs
- Region Sjaelland 2012
- Status last verified
- Mar 2016
- First submitted
- 6 Dec 2013
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22157326Holm 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.
PubMed 21529264Mollerup 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.
PubMed 28213684
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Overweight and Obese Children - the "Holbaek-Method" in a Municipality Based Treatment Program.
- ClinicalTrials.gov ID
- NCT02013843
- Acronym / sponsor ID
- TCOCmunicipalities
- Conditions
- Pediatric Obesity, Dyslipidemia, Hypertension, Diabetes, Quality of Life
- Keywords
- Pediatric obesity, Community-based treatment, dyslipidemia, hypertension, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,007 participants (actual)
- Lead sponsor
- Holbaek SygehusUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 Dec 2013 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community-based treatment | Other | Behavioral: Community-based treatment of overweight and obesityOverweight 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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Body mass index above 90-percentile for age and gender
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Community-based treatment of overweight and obesityCommunity based treatment of overweight and obese children using the "Holbaek-method". | Behavioural | Community-based treatment |
Primary outcome
Body mass index standard deviation score
Time frame: 1 year
primary outcome is the change in body mass index standard deviation score during 12 month treatment of overweight and obesity.
5 secondary outcomes
Change in blood pressure standard deviation score
Time frame: 1 year
Change in the concentration of blood lipids
Time frame: 1 year
change in the concentration of fasting blood-glucose, HBA1C and insulin
Time frame: 1 year
Change in body composition measured by Tanita BC 418
Time frame: 1 year
Change in quality of life assessed by PedsQL
Time frame: 1 year
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 29 Mar 2016.
- Background: PubMed 22157326Holm 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.
- Background: PubMed 21529264Holm 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.
- Derived from this study: PubMed 28213684Mollerup 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based treatment of overweight and obesity in people with Pediatric Obesity and Dyslipidemia, run by Holbaek Sygehus at 1 site in Denmark.
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 1 inclusion and 1 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 29 Mar 2016. 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 Denmark. 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?
Body mass index standard deviation score (time frame: 1 year). 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 NCT02013843, which also lists 3 linked publications.
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 29 Mar 2016.