Why is the research being done?

Research indicates there is an unmet need, to test an individualised nutrition and physical activity program for people with obesity-associated asthma that addresses nutritional and physical activity inadequacies, while also considering patient preferences, behaviours, and comorbidities. The purpose of this study is to address this unmet need, by testing the first individualised obesity management approach for adults with asthma. The study will seek to achieve this through the provision of medical nutrition therapy and personalised physical activity prescription, and by assessing the efficacy, mechanisms, acceptability, and cost of this intervention.

Who can participate in the research study/trial?

Research indicates there is an unmet need, to test an individualised nutrition and physical activity program for people with obesity-associated asthma that addresses nutritional and physical activity inadequacies, while also considering patient preferences, behaviours, and comorbidities. The purpose of this study is to address this unmet need, by testing the first individualised obesity management approach for adults with asthma. The study will seek to achieve this through the provision of medical nutrition therapy and personalised physical activity prescription, and by assessing the efficacy, mechanisms, acceptability, and cost of this intervention.

Who can participate in the research study/trial?

This study may be suitable for you if you are aged 18 years or older with a doctor’s diagnosis of asthma, are usually using your asthma therapy two (2) times per week or more, have current asthma symptoms, and have a body mass index (BMI) equal to or greater than 30kg/m².

This study is not suitable for you if you:

• Are a current smoker;
• Are pregnant or breastfeeding;
• Have a serious medical condition (e.g., unstable angina, stroke, renal (kidney) failure, hepatic (liver) failure, heart failure, human immunodeficiency virus (HIV), or terminal illness;
• Have had unstable weight (±5% last three months);
• Currently have severe orthopaedic problems or a medical issue that would compromise ability to undertake physical activity. 
• Are taking insulin (oral diabetes medications are ok).

What will participants be asked to do?

Telephone Screening

Before we admit you into the study, we will need to check that the study is suitable for you and to do this we will ask you some screening questions about your medications and medical history.

Screening Visit

If you agree to participate in this study, you will be asked to attend a screening visit at the Clinical Trial Centre on Level 4 of the Hunter Medical Research Institute, prior to being admitted into the study. At this initial visit you will be asked to sign the Participant Consent Form. During this appointment, we will measure your height, weight and blood pressure, complete some questionnaires, collect a blood sample, and do some breathing tests (see below for more information). We may look at your medical record to find information about your asthma and other health conditions. If this study is suitable, we will organise a mutually convenient time for you to begin the study. For all participants in this study, we would like to access and record the visits and lung function results in your medical records. This will involve our staff accessing your medical record and recording the results of your visit in your patient notes.

If our screening assessments indicate that the study is suitable for you, we will send a letter to your GP with information explaining the study, your blood test results and a clearance form which must be signed off by the GP, clearing you to participate in the program. If this study is not suitable for you, with your permission we will advise your GP of your test results and will forward the information to your GP for follow-up.

Assessment (Visit 1)

If you are eligible and choose to participate, after completion of baseline data collection (Assessment Visit 1) you will be randomly allocated (like a coin toss) to one of two groups:

1. Group 1 – The ‘IDEAL’ Program: 16 weeks of personalised dietary counselling with a dietitian, as well as an individualised physical activity prescription with a physiotherapist or exercise physiologist. Assessment visits at baseline, 4 months, and 12 months.
2. Group 2 – The Control Group: Usual diet and physical activity for 12 months. Assessment visits at baseline, 4 months, and 12 months. Following the 12-month visit, this group will receive a 90-minute dietary and physical activity counselling session.

Download the Participant Information and Consent Form for the full program schedule for both groups

Contact details

For further information about the study or to participant please contact:

Dr Hayley Scott, Chief Investigator, (02) 40420113 or email hayley.scott@newcastle.edu.au

Catherine Delahunty, Study Coordinator, (02) 4042 0135, or email catherine.delahunty@newcastle.edu.au

Tamara Blickisdorf. PHD Candidate, (02) 40550983, or email Tamara.Blickisdorf@uon.edu.au