NCT00998413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

October 1, 2013

Status Verified

September 1, 2013

Enrollment Period

3.2 years

First QC Date

October 19, 2009

Last Update Submit

September 30, 2013

Conditions

AsthmaOverweightObesity

Keywords

asthmaoverweightobesitychildren

Outcome Measures

Primary Outcomes (1)

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

    2 years

Secondary Outcomes (6)

  • Airway inflammation

    2 years

  • Symptom-free days, exacerbations

    2 years

  • Need for beta-2 agonists/anti-inflammatory medication

    2 years

  • Weight, height, body mass index (BMI)

    2 years

  • Levels of serum adipokines

    2 years

  • +1 more secondary outcomes

Study Arms (2)

Multifaceted intervention

EXPERIMENTAL

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

Behavioral: Multifaceted intervention

Control

NO INTERVENTION

standard usual care

Interventions

Multifaceted interventionBEHAVIORAL

multifaceted family-based, physical exercise, nutrition, and behavioural intervention study for 18 month, in children aged 6-16 years with asthma and overweight/obesity.

Also known as: MIKADO
Multifaceted intervention

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 6-16 years
  • BMI in the overweight/obesity range according to data of Cole et al.
  • Asthma diagnosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maastricht University Medical Centre

Maastricht, Limburg, 6202 AZ, Netherlands

Location

Maastricht University Medical Centre

Maastricht, Limburg, 6202AZ, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 27294869DERIVED

  • 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.

    PMID: 23692648DERIVED

MeSH Terms

Conditions

AsthmaOverweightObesity

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Edward Dompeling, PhD, MD

    Maastricht University Medical Centre

    PRINCIPAL INVESTIGATOR

  • Kim van de Kant, MSc

    Maastricht University Medical Centre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2009

First Posted

October 20, 2009

Study Start

January 1, 2010

Primary Completion

April 1, 2013

Study Completion

September 1, 2013

Last Updated

October 1, 2013

Record last verified: 2013-09

Locations

NL(2)