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Weight-reduction Intervention in Asthmatic Children With Overweight/Obesity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00998413
First Posted: October 20, 2009
Last Update Posted: October 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Netherlands Asthma Foundation
Information provided by (Responsible Party):
Maastricht University Medical Center
October 19, 2009
October 20, 2009
October 1, 2013
January 2010
April 2013   (Final data collection date for primary outcome measure)
Forced Expiratory Volume in the first second (FEV1 %) predicted value [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT00998413 on ClinicalTrials.gov Archive Site
  • 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 ]
    VO2max measured with an maximal ergometry test
  • 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 ]
Not Provided
Not Provided
 
Weight-reduction Intervention in Asthmatic Children With Overweight/Obesity
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Asthma
  • Overweight
  • Obesity
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
  • Experimental: Multifaceted intervention
    Multifaceted intervention:physical exercise, nutrition, and behavioural intervention.
    Intervention: Behavioral: Multifaceted intervention
  • No Intervention: Control
    standard usual care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
September 2013
April 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Years to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00998413
MEC 09-2-088
NAF 3.4.09.002 ( Other Grant/Funding Number: Dutch Asthma Foundation )
No
Not Provided
Not Provided
Maastricht University Medical Center
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
Maastricht University Medical Center
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP