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Weight-reduction Intervention in Asthmatic Children With Overweight/Obesity

This study has been completed.
Sponsor:
Collaborator:
The Netherlands Asthma Foundation
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00998413
First received: October 19, 2009
Last updated: September 30, 2013
Last verified: September 2013

October 19, 2009
September 30, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00998413 on ClinicalTrials.gov Archive Site
  • Airway inflammation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Symptom-free days, exacerbations [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Need for beta-2 agonists/anti-inflammatory medication [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Weight, height, body mass index (BMI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Levels of serum adipokines [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • aerobic capacity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    VO2max measured with an maximal ergometry test
  • Airway inflammation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Symptom-free days, exacerbations [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Need for beta-2 agonists/anti-inflammatory medication [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Weight, height, body mass index (BMI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Levels of serum adipokines [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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: 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
Willeboordse 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.

*   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
Both
6 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00998413
MEC 09-2-088, NAF 3.4.09.002
No
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