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

Tracking Information

First Received Date ^ICMJE

October 19, 2009

Last Updated Date

January 16, 2012

Start Date ^ICMJE

January 2010

Estimated Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00998413 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Weight-reduction Intervention in Asthmatic Children With Overweight/Obesity

Official Title ^ICMJE

Secondary Prevention of Asthma in Overweight/Obese Children by a Combined Dietary-behavioural-physical Activity Intervention

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Asthma
Overweight
Obesity

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Multifaceted intervention
Multifaceted intervention:physical exercise, nutrition, and behavioural intervention.

Intervention: Behavioral: Multifactoral Intervention for Children with asthma and overweight
No Intervention: Control
standard usual care

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

December 2013

Estimated Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 16 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00998413

Other Study ID Numbers ^ICMJE

MEC 09-2-088, NAF 3.4.09.002

Has Data Monitoring Committee

Responsible Party

Maastricht University Medical Center

Study Sponsor ^ICMJE

Maastricht University Medical Center

Collaborators ^ICMJE

The Netherlands Asthma Foundation

Investigators ^ICMJE

Principal Investigator:	Edward Dompeling, PhD, MD	Maastricht University Medical Centre
Study Chair:	Kim van de Kant, MSc	Maastricht University Medical Centre

Information Provided By

Maastricht University Medical Center

Verification Date

January 2012

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

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