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Weight-reduction Intervention in Asthmatic Children With Overweight/Obesity

This study is ongoing, but not recruiting participants.
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: January 16, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention
Asthma
Overweight
Obesity
 Behavioral: Multifactoral Intervention for Children with asthma and overweight

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Secondary Prevention of Asthma in Overweight/Obese Children by a Combined Dietary-behavioural-physical Activity Intervention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Forced Expiratory Volume in the first second (FEV1 %) predicted value [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 150
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multifaceted intervention
Multifaceted intervention:physical exercise, nutrition, and behavioural intervention.
 Behavioral: Multifactoral Intervention for Children with asthma and overweight
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

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998413

Locations
Netherlands
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
Investigators
Principal Investigator: Edward Dompeling, PhD, MD Maastricht University Medical Centre
Study Chair: Kim van de Kant, MSc Maastricht University Medical Centre
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00998413     History of Changes
Other Study ID Numbers: MEC 09-2-088, NAF 3.4.09.002
Study First Received: October 19, 2009
Last Updated: January 16, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
asthma
overweight
obesity
children

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

ClinicalTrials.gov processed this record on May 16, 2013