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
  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: Multifaceted intervention

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:


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


Enrollment: 87
Study Start Date: January 2010
Study Completion Date: September 2013
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: 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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Maastricht University Medical Center

Additional 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 3.4.09.002
Study First Received: October 19, 2009
Last Updated: September 30, 2013
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
Body Weight
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Nutrition Disorders
Overnutrition
Respiratory Hypersensitivity
Respiratory Tract Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014