AsthmaNCT00998413
Weight-reduction Intervention in Asthmatic Children With Overweight/Obesity
A study testing Multifaceted intervention in people with Asthma and Overweight, run by Maastricht University Medical Center at 2 sites in Netherlands.
Trial summary
The purpose of this study is to determine the efficacy of a multifactorial intervention with weight reduction, behavioural therapy, and physical exercise on the severity and control of asthma in obese children. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Asthma, Overweight, Obesity
- What is being tested?
- Multifaceted intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jan 2010to Sep 2013
- 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
- Children aged 6-16 years
- BMI in the overweight/obesity range according to data of Cole et al.
- Asthma diagnosis
Who cannot join
- Children with a normal weight according to data of Cole et al.
- Children without any provable asthmatic complaints
- Congenital malformations of the airways or other chronic lung diseases like cystic fibrosis (CF)
- Mental retardation or syndromes
- Heart disease
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Maastricht University Medical Centre
Maastricht, Limburg, 6202 AZ
Maastricht University Medical Centre
Maastricht, Limburg, 6202AZ
About this study
Official title: Secondary Prevention of Asthma in Overweight/Obese Children by a Combined Dietary-behavioural-physical Activity Intervention
The purpose of this study is to determine the efficacy of a multifactorial intervention with weight reduction, behavioural therapy, and physical exercise on the severity and control of asthma in obese children.
- Conditions
- Asthma, Overweight, Obesity
- Being tested
- Multifaceted intervention
- Keywords
- asthma, overweight, obesity, children
- Medical subject headings
- Asthma, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifaceted interventionBehavioural
Also called MIKADO
multifaceted family-based, physical exercise, nutrition, and behavioural intervention study for 18 month, in children aged 6-16 years with asthma and overweight/obesity.
| Study group | Role | What they receive |
|---|---|---|
| Multifaceted intervention | Experimental | Multifaceted intervention:physical exercise, nutrition, and behavioural intervention. Receives: Behavioral: Multifaceted intervention |
| Control | No intervention | standard usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in the first second (FEV1 %) predicted value
Measured: 2 years
Secondary outcomes (6)
Airway inflammation
Measured: 2 years
Symptom-free days, exacerbations
Measured: 2 years
Need for beta-2 agonists/anti-inflammatory medication
Measured: 2 years
Weight, height, body mass index (BMI)
Measured: 2 years
Levels of serum adipokines
Measured: 2 years
aerobic capacity
VO2max measured with an maximal ergometry test
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startJan 2010
- Primary completionApr 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Netherlands Asthma Foundation
- Responsible party
- Sponsor
- Investigators
- Edward Dompeling, PhD, MD, Principal investigator, Maastricht University Medical CentreKim van de Kant, MSc, Study chair, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998413
- Sponsor's protocol ID
- MEC 09-2-088
- Other IDs
- NAF 3.4.09.002
- Status last verified
- Sep 2013
- First submitted
- 19 Oct 2009
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Willeboordse M, van de Kant KDG, Tan FE, Mulkens S, Schellings J, Crijns Y, Ploeg Lv, van Schayck CP, Dompeling E. A Multifactorial Weight Reduction Programme for Children with Overweight and Asthma: A Randomized Controlled Trial. PLoS One. 2016 Jun 13;11(6):e0157158. doi: 10.1371/journal.pone.0157158. eCollection 2016.
PubMed 27294869Willeboordse M, van de Kant KD, de Laat MN, van Schayck OC, Mulkens S, Dompeling E. Multifactorial intervention for children with asthma and overweight (Mikado): study design of a randomised controlled trial. BMC Public Health. 2013 May 21;13:494. doi: 10.1186/1471-2458-13-494.
PubMed 23692648
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Prevention of Asthma in Overweight/Obese Children by a Combined Dietary-behavioural-physical Activity Intervention
- ClinicalTrials.gov ID
- NCT00998413
- Acronym / sponsor ID
- MEC 09-2-088
- Conditions
- Asthma, Overweight, Obesity
- Keywords
- asthma, overweight, obesity, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- The Netherlands Asthma Foundation
- Study start
- Jan 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Oct 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 purpose of this study is to determine the efficacy of a multifactorial intervention with weight reduction, behavioural therapy, and physical exercise on the severity and control of asthma in obese children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifaceted intervention | Experimental | Behavioral: Multifaceted interventionMultifaceted intervention:physical exercise, nutrition, and behavioural intervention. |
| Control | No intervention | –standard usual care |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 6-16 years
- BMI in the overweight/obesity range according to data of Cole et al.
- Asthma diagnosis
Key exclusion criteria (5 listed)
- Children with a normal weight according to data of Cole et al.
- Children without any provable asthmatic complaints
- Congenital malformations of the airways or other chronic lung diseases like cystic fibrosis (CF)
- Mental retardation or syndromes
- Heart disease
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 |
|---|---|---|
| Multifaceted interventionAlso: MIKADOmultifaceted family-based, physical exercise, nutrition, and behavioural intervention study for 18 month, in children aged 6-16 years with asthma and overweight/obesity. | Behavioural | Multifaceted intervention |
Primary outcome
Forced Expiratory Volume in the first second (FEV1 %) predicted value
Time frame: 2 years
6 secondary outcomes
Airway inflammation
Time frame: 2 years
Symptom-free days, exacerbations
Time frame: 2 years
Need for beta-2 agonists/anti-inflammatory medication
Time frame: 2 years
Weight, height, body mass index (BMI)
Time frame: 2 years
Levels of serum adipokines
Time frame: 2 years
aerobic capacity
Time frame: 2 years
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 1 Oct 2013.
- Derived from this study: PubMed 27294869Willeboordse M, van de Kant KDG, Tan FE, Mulkens S, Schellings J, Crijns Y, Ploeg Lv, van Schayck CP, Dompeling E. A Multifactorial Weight Reduction Programme for Children with Overweight and Asthma: A Randomized Controlled Trial. PLoS One. 2016 Jun 13;11(6):e0157158. doi: 10.1371/journal.pone.0157158. eCollection 2016.
- Derived from this study: PubMed 23692648Willeboordse M, van de Kant KD, de Laat MN, van Schayck OC, Mulkens S, Dompeling E. Multifactorial intervention for children with asthma and overweight (Mikado): study design of a randomised controlled trial. BMC Public Health. 2013 May 21;13:494. doi: 10.1186/1471-2458-13-494.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Edward Dompeling, PhD, MD principal investigator
Maastricht University Medical Centre
Kim van de Kant, MSc study chair
Maastricht University Medical Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifaceted intervention in people with Asthma and Overweight, run by Maastricht University Medical Center at 2 sites in Netherlands.
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 3 inclusion and 5 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 1 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
Forced Expiratory Volume in the first second (FEV1 %) predicted value (time frame: 2 years). 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 NCT00998413, which also lists 2 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 1 Oct 2013.