Multifactorial intervention for children with asthma and overweight (Mikado): study design of a randomised controlled
Maartje Willeboordse1, Kim D G van de Kant, Maroeska N de Laat
1Department of Paediatric Respiratory Medicine, School for Public Health and Primary Care (CAPHRI), Maastricht University Medical Centre (MUMC), P, Debyelaan 25, P,O, Box 5800, Maastricht, AZ, 6202, The Netherlands. m.willeboordse@mumc.nl
Insights
This study investigates a weight reduction program for children with asthma and obesity. The intervention aims to improve lung function and asthma control, offering new treatment strategies for this growing health concern.
Area of Science:
- Pediatric Pulmonology
- Pediatric Endocrinology
- Clinical Trial Research
Background:
- High prevalence of childhood obesity and asthma.
- Obesity in asthmatic children is linked to poorer asthma control and increased medication needs.
- Limited research on weight reduction interventions for pediatric asthma-obesity phenotype.
Purpose of the Study:
- To evaluate the effectiveness of a long-term, multifactorial weight reduction intervention on asthma characteristics in children with asthma and high body weight.
- To explore potential underlying mechanisms linking asthma and obesity in children.
- To inform optimal management programs and clinical guidelines.
Main Methods:
- Two-armed randomized controlled trial (RCT) involving 104 children aged 6-16 years.
- Intervention group receives an 18-month multifactorial program (sports, parental involvement, counseling, lifestyle/dietary advice, CBT).
- Control group receives usual care; primary outcomes include FEV1 and BMI-SDS.
Main Results:
- This section is not applicable as the abstract describes a study in progress and does not contain results.
Conclusions:
- The study will assess the potential of a multifactorial weight reduction intervention for improving asthma outcomes in overweight/obese children.
- Findings will elucidate mechanisms in the asthma-obesity relationship in pediatric populations.
- Results are expected to guide clinical management and guidelines for this patient group.
Background:
In children, the prevalence's of both obesity and asthma are disconcertingly high. Asthmatic children with obesity are characterised by less asthma control and a high need for asthma medication. As the obese asthmatic child is becoming more common in the clinical setting and the disease burden of the asthma-obesity phenotype is high, there is an increasing need for effective treatment in these children. In adults, weight reduction resulted in improved lung function, better asthma control and less need for asthma medication. In children this is hardly studied. The Mikado study aims to evaluate the effectiveness of a long term multifactorial weight reduction intervention, on asthma characteristics in children with asthma and a high body weight.
Methods/Design:
The Mikado study is a two-armed, randomised controlled trial. In total, 104 participants will be recruited via online questionnaires, pulmonary paediatricians, the youth department of the Municipal Health Services and cohorts of existing studies. All participants will be aged 6-16 years, will have current asthma, a Body Mass Index in the overweight or obesity range, and no serious comorbidities (such as diabetes, heart diseases). Participants in the intervention arm will receive a multifactorial intervention of 18 months consisting of sessions concerning sports, parental involvement, individual counselling and lifestyle advices including dietary advices and cognitive behavioural therapy. The control group will receive usual care. The primary outcome variables will include Forced Expiratory Volume in one second and Body Mass Index - Standard Deviation Score. Secondary outcomes will include other lung function parameters (including dynamic and static lung function parameters), asthma control, asthma-specific quality of life, use of asthma medication and markers of systemic inflammation and airway inflammation.
Discussion:
In this randomised controlled trial we will study the potential of a multifactorial weight reduction intervention to improve asthma-related outcome measures in asthmatic children with overweight. Moreover, it will provide information about the underlying mechanisms in the relationship between asthma and a high body weight in children. These findings can contribute to optimal management programs and better clinical guidelines for children with asthma and overweight.
Trial Registration:
Clinicaltrial.gov NCT00998413.
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