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Weight-reduction Intervention in Asthmatic Children With Overweight/Obesity

Primary Purpose

Asthma, Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Multifaceted intervention
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring asthma, overweight, obesity, children

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maastricht University Medical Centre
  • Maastricht University Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multifaceted intervention

Control

Arm Description

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

standard usual care

Outcomes

Primary Outcome Measures

Forced Expiratory Volume in the first second (FEV1 %) predicted value

Secondary Outcome Measures

Airway inflammation
Symptom-free days, exacerbations
Need for beta-2 agonists/anti-inflammatory medication
Weight, height, body mass index (BMI)
Levels of serum adipokines
aerobic capacity
VO2max measured with an maximal ergometry test

Full Information

First Posted
October 19, 2009
Last Updated
September 30, 2013
Sponsor
Maastricht University Medical Center
Collaborators
The Netherlands Asthma Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00998413
Brief Title
Weight-reduction Intervention in Asthmatic Children With Overweight/Obesity
Official Title
Secondary Prevention of Asthma in Overweight/Obese Children by a Combined Dietary-behavioural-physical Activity Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
The Netherlands Asthma Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Overweight, Obesity
Keywords
asthma, overweight, obesity, children

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multifaceted intervention
Arm Type
Experimental
Arm Description
Multifaceted intervention:physical exercise, nutrition, and behavioural intervention.
Arm Title
Control
Arm Type
No Intervention
Arm Description
standard usual care
Intervention Type
Behavioral
Intervention Name(s)
Multifaceted intervention
Other Intervention Name(s)
MIKADO
Intervention Description
multifaceted family-based, physical exercise, nutrition, and behavioural intervention study for 18 month, in children aged 6-16 years with asthma and overweight/obesity.
Primary Outcome Measure Information:
Title
Forced Expiratory Volume in the first second (FEV1 %) predicted value
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Airway inflammation
Time Frame
2 years
Title
Symptom-free days, exacerbations
Time Frame
2 years
Title
Need for beta-2 agonists/anti-inflammatory medication
Time Frame
2 years
Title
Weight, height, body mass index (BMI)
Time Frame
2 years
Title
Levels of serum adipokines
Time Frame
2 years
Title
aerobic capacity
Description
VO2max measured with an maximal ergometry test
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Dompeling, PhD, MD
Organizational Affiliation
Maastricht University Medical Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kim van de Kant, MSc
Organizational Affiliation
Maastricht University Medical Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6202 AZ
Country
Netherlands
Facility Name
Maastricht University Medical Centre
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6202AZ
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
27294869
Citation
Willeboordse M, van de Kant KDG, Tan FE, Mulkens S, Schellings J, Crijns Y, Ploeg Lv, van Schayck CP, Dompeling E. A Multifactorial Weight Reduction Programme for Children with Overweight and Asthma: A Randomized Controlled Trial. PLoS One. 2016 Jun 13;11(6):e0157158. doi: 10.1371/journal.pone.0157158. eCollection 2016. Erratum In: PLoS One. 2017 Jul 6;12 (7):e0181130.
Results Reference
derived
PubMed Identifier
23692648
Citation
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.
Results Reference
derived

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Weight-reduction Intervention in Asthmatic Children With Overweight/Obesity

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