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Completed

NCT Number: NCT00998413

Weight-reduction Intervention in Asthmatic Children With Overweight/Obesity

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.

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Key information

Conditions

Asthma Body Weight Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Centre, Maastricht, Limburg, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multifaceted intervention

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.

Other names: MIKADO

Primary outcomes

  1. Forced Expiratory Volume in the first second (FEV1 %) predicted value

    Time frame: 2 years

Secondary outcomes

  1. Airway inflammation

    Time frame: 2 years

  2. Symptom-free days, exacerbations

    Time frame: 2 years

  3. Need for beta-2 agonists/anti-inflammatory medication

    Time frame: 2 years

  4. Weight, height, body mass index (BMI)

    Time frame: 2 years

  5. Levels of serum adipokines

    Time frame: 2 years

  6. aerobic capacity

    Time frame: 2 years

    VO2max measured with an maximal ergometry test

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • The Netherlands Asthma Foundation

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 20, 2009
Registry last updated
Oct 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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