Weight-reduction Intervention in Asthmatic Children With Overweight/Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00998413
• Other study ID #: MEC 09-2-088
• Secondary ID: NAF 3.4.09.002
• Status: Completed
• Phase: N/A
• First received: October 19, 2009
• Last updated: September 30, 2013
• Start date: January 2010
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: September 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Asthma
• Obesity
• Overweight

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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht	Limburg
Netherlands	Maastricht University Medical Centre	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	The Netherlands Asthma Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Expiratory Volume in the first second (FEV1 %) predicted value		2 years	No
Secondary	Airway inflammation		2 years	No
Secondary	Symptom-free days, exacerbations		2 years	No
Secondary	Need for beta-2 agonists/anti-inflammatory medication		2 years	No
Secondary	Weight, height, body mass index (BMI)		2 years	No
Secondary	Levels of serum adipokines		2 years	No
Secondary	aerobic capacity	VO2max measured with an maximal ergometry test	2 years	No