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Weight-reduction Intervention in Asthmatic Children With Overweight/Obesity

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ClinicalTrials.gov Identifier: NCT00998413
Recruitment Status : Completed
First Posted : October 20, 2009
Last Update Posted : October 1, 2013
The Netherlands Asthma Foundation
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief 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.

Condition or disease Intervention/treatment
Asthma Overweight Obesity Behavioral: Multifaceted intervention

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Secondary Prevention of Asthma in Overweight/Obese Children by a Combined Dietary-behavioural-physical Activity Intervention
Study Start Date : January 2010
Primary Completion Date : April 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Multifaceted intervention
Multifaceted intervention:physical exercise, nutrition, and behavioural intervention.
Behavioral: Multifaceted intervention
multifaceted family-based, physical exercise, nutrition, and behavioural intervention study for 18 month, in children aged 6-16 years with asthma and overweight/obesity.
Other Name: MIKADO
No Intervention: Control
standard usual care

Primary Outcome Measures :
  1. Forced Expiratory Volume in the first second (FEV1 %) predicted value [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Airway inflammation [ Time Frame: 2 years ]
  2. Symptom-free days, exacerbations [ Time Frame: 2 years ]
  3. Need for beta-2 agonists/anti-inflammatory medication [ Time Frame: 2 years ]
  4. Weight, height, body mass index (BMI) [ Time Frame: 2 years ]
  5. Levels of serum adipokines [ Time Frame: 2 years ]
  6. aerobic capacity [ Time Frame: 2 years ]
    VO2max measured with an maximal ergometry test

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children aged 6-16 years
  • BMI in the overweight/obesity range according to data of Cole et al.
  • Asthma diagnosis

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00998413

Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6202 AZ
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6202AZ
Sponsors and Collaborators
Maastricht University Medical Center
The Netherlands Asthma Foundation
Principal Investigator: Edward Dompeling, PhD, MD Maastricht University Medical Centre
Study Chair: Kim van de Kant, MSc Maastricht University Medical Centre

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00998413     History of Changes
Other Study ID Numbers: MEC 09-2-088
NAF ( Other Grant/Funding Number: Dutch Asthma Foundation )
First Posted: October 20, 2009    Key Record Dates
Last Update Posted: October 1, 2013
Last Verified: September 2013

Keywords provided by Maastricht University Medical Center:

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases