Individualised Diet and Exercise for Asthma and Lung Function (IDEAL) study

Not Applicable

• Conditions: Asthma; Obesity; Respiratory - Asthma; Diet and Nutrition - Obesity

• Registration Number: ACTRN12623000979651
• Lead Sponsor: niversity of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-08
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

1. Obese [defined as a Body Mass Index (BMI) greater than or equal to 30kg/m2] adults (aged 18 years or older).
2. Physician diagnosed asthma, as the primary respiratory diagnosis.
3. No respiratory infection, asthma exacerbation, corticosteroid burst or antibiotic use, change in asthma therapy in the 4 weeks preceding the baseline study visit, and no hospitalisation for respiratory exacerbation in the 3 months preceding the baseline study visit (visit will be postponed until stable).
4. Using asthma therapy at least 2 times per week.
5. Uncontrolled asthma [defined as an Asthma Control Questionnaire (ACQ) score greater than or equal to 1.5].
6. Post-bronchodilator forced expiratory volume in 1 second (FEV1) greater than or equal to 50% predicted and SpO2 greater than or equal to 90% on room air.
7. Physician approval to participate in study.
8. Documented variable airflow limitation at screening visit or documented within the past 10 years, confirmed by evidence of at least one of the following:
• Bronchodilator response (BDR) greater than or equal to 12% and a minimum of 200mL (post-bronchodilator FEV1 following administration of 400µg salbutamol, pMDI with spacer; after 10 minutes, or following administration of nebulised Ventolin)
• Airway hyperresponsiveness (in response to any standard challenge agent)
• Peak flow variability >12% when monitored over at least one week
• FEV1 variability >12% (between two FEV1 values measured within two months of each
other)

Exclusion Criteria

1. Respiratory condition other than asthma as the primary respiratory diagnosis.
2. Current smoker (smoked within previous 6 months).
3. Current viral infection as indicated by the common cold questionnaire (CCQ) (visit will be postponed up to a maximum of 4 weeks either side of visit due date).
4. Serious medical condition (e.g., unstable angina, unstable metabolic disease, stroke, renal failure (eGFR<30 or undergoing dialysis). eGFR>30-<60 will require physician approval to participate), hepatic failure (liver screening blood results greater than or equal to 1.5 times the normal reference range will require doctor sign off), heart failure, HIV, terminal illness.
5. Unstable weight (±5% weight change in the last three months).
6. Pregnancy or breastfeeding.
7. Orthopaedic or medical issue that would compromise ability to undertake physical activity or dietary modification, including previous bariatric surgery.
8. Insulin-dependent diabetes mellitus.
9. Severe hyperglycaemia (HbA1c > 10%).
10. Severe hypoglycaemia within preceding 3 months [defined as needing external assistance (e.g., ambulance for a hypoglycaemic event)] and/or people with hypoglycaemic unawareness.
11. Cognitive impairment, poor English language skills or untreated hearing impairment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified