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Weight-reduction Intervention in Asthmatic Children With Overweight/Obesity

NCT ID: NCT00998413

Last Updated: 2013-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-09-30

Brief Summary

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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

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Conditions

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Asthma Overweight Obesity

Keywords

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asthma overweight obesity children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Multifaceted intervention

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

Group Type EXPERIMENTAL

Multifaceted intervention

Intervention Type BEHAVIORAL

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

Control

standard usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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MIKADO

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Netherlands Asthma Foundation

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edward Dompeling, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Centre

Kim van de Kant, MSc

Role: STUDY_CHAIR

Maastricht University Medical Centre

Locations

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Maastricht University Medical Centre

Maastricht, Limburg, Netherlands

Site Status

Maastricht University Medical Centre

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 27294869 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23692648 (View on PubMed)

Other Identifiers

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NAF 3.4.09.002

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MEC 09-2-088

Identifier Type: -

Identifier Source: org_study_id