NCT00998413CompletedNot Applicable
Secondary Prevention of Asthma in Overweight/Obese Children by a Combined Dietary-behavioural-physical Activity Intervention
Maastricht University Medical Center2 sites in 1 country87 target enrollmentStarted: January 1, 2010Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 87
- Locations
- 2
- Primary Endpoint
- Forced Expiratory Volume in the first second (FEV1 %) predicted value
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Multifaceted intervention
Experimental
Multifaceted intervention:physical exercise, nutrition, and behavioural intervention.
Intervention: Multifaceted intervention (Behavioral)
Control
No Intervention
standard usual care
Outcomes
Primary Outcomes
Forced Expiratory Volume in the first second (FEV1 %) predicted value
Time Frame: 2 years
Secondary Outcomes
- 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)
- aerobic capacity(2 years)
Investigators
Study Sites (2)
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