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The effect of weight loss through a low calory diet on exercise induced asthma in children with asthma and moderate overweight.


- candidate number8708
- NTR NumberNTR2631
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-nov-2010
- Secondary IDsNL 34595.044.10 / P10-42 ; CCMO / METC
- Public TitleThe effect of weight loss through a low calory diet on exercise induced asthma in children with asthma and moderate overweight.
- Scientific TitleThe effect of weight loss through a low calory diet on exercise induced bronchoconstriction in children with asthma and moderate overweight.
- ACRONYMEIB in overweight children
- hypothesisPrevious studies in asthmatic obese children show a relation between obesity and bronchial hyperresponsiveness, a characteristic feature of asthma. Several underlying mechanisms have been suggested to explain the interaction between obesity and asthma. The effect of weight loss on BHR to an indirect stimulus has not yet been studied in adults or children. The aim of our study is to investigate the effect of weight loss through a low calory diet on EIB in children with asthma and moderate overweight. We expect losing weight will improve pulmonary function, decrease symptom scores and diminishes ∆FEV1 after exercise.
To analyze the relation between reduction in BMI and reduction in the exercise induced fall of FEV1 after a diet-period of 6 weeks. Secondary we analyze the relation between reduction in BMI and the recovery of the lungfunction to baseline (measured as total Area Under the Curve), the increase in baseline FEV1, the reduction in FeNO (measured with the miniNIOX®), quality of life (measured with the Pediatric Asthma Quality of Life Questionnaire) and the asthma control (measured with the Asthma Control Questionnaire).
- Healt Condition(s) or Problem(s) studiedOverweight, Children, Exercise induced Asthma
- Inclusion criteria1. Age between 8-18 years;
2. Doctors diagnosis of mild to moderate asthma;
3. Exercise induced asthma defined by a >10% exercise induced fall in FEV1;
4. BMI score above or at the cut off points for overweight, based on international data and linked to the widely accepted adult cut off points of a body mass index of 25 kg/m2;
5. Clinically stable period at least 3 weeks before the study period;
6. Maximal FEV1 >70% of predicted value.
- Exclusion criteria1. Other pulmonary or cardiovascular illnesses;
2. Genetic disorders;
3. Maximal FEV1 <70% of predicted value;
4. Use of long acting bronchodilators 24 hours before testing;
5. Use of short acting bronchodilators 8 hours before testing.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 13-dec-2010
- planned closingdate1-mrt-2011
- Target number of participants29
- InterventionsAll children will follow a low calory diet for 6 weeks in order to lose weight. After that period we measure the change in BMI.
- Primary outcomeAnalyze the relation between the reduction in BMI and the reduction in exercise induced fall in FEV1, after a diet-period of 6 weeks.
We measure the exercise induced fall in FEV1 with an exercise provocation test before and after the diet.
- Secondary outcomeSecondary we analyze the relation between reduction in BMI and the recovery of the lungfunction to baseline, the increase in baseline FEV1, the reduction in FeNO, quality of life and the asthma control.
- TimepointsThe measurements will be done before and after the diet period of 6 weeks. Weight, height and bio-electric impedance will also be measured after 2 and 4 weeks.
To measure pulmonary volumes and flow-volume loops we use a MicroLoop spirometer in combination with Spida5 software.
The FENO we measure with the miniNOX.
The quality of life with the pediactric asthma quality of life questionnaire.
The asthma control with the asthma control questionnaire.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Mira Hoogstrate
- CONTACT for SCIENTIFIC QUERIESDr. B.J. Thio
- Sponsor/Initiator Medisch Spectrum Twente, Afdeling Kindergeneeskunde
- Funding
(Source(s) of Monetary or Material Support)
Medisch Spectrum Twente
- PublicationsN/A
- Brief summaryPrevious studies in asthmatic obese children show a relation between obesity and bronchial hyperresponsiveness, a characteristic feature of asthma. Several underlying mechanisms have been suggested to explain the interaction between obesity and asthma. The effect of weight loss on BHR to an indirect stimulus has not yet been studied in adults or children. The aim of our study is to investigate the effect of weight loss through a low calory diet on EIB in children with asthma and moderate overweight. We expect losing weight will improve pulmonary function, decrease symptom scores and diminishes ∆FEV1 after exercise.
- Main changes (audit trail)
- RECORD29-nov-2010 - 15-dec-2010


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