None listed
Conditions
Brief summary
Purpose: Research indicates there is an unmet need, to test an individualised obesity management approach for people with 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. Hypothesis: Obesity-associated asthma is driven by excess adiposity, poor diet quality, physical inactivity, and poor metabolic health. An individualised obesity management intervention, utilising medical nutrition therapy and a personalised physical activity prescription, will improve diet quality, physical activity levels and metabolic health in obese adults with asthma, resulting in better asthma control and lung function.
Interventions
The intervention group will attend once monthly visits over 16 weeks (i.e., weeks 0, 4, 8, 12, and 16) with a dietitian as well as a physiotherapist/exercise physiologist. Each session will consist of one-on-one consultation with both the dietitian and physiotherapist/exercise physiologist. Sessions will be delivered face-to-face with an estimated total duration of 90 minutes. The dietitian intervention involves Medical Nutrition Therapy, according to the Nutrition Care Process Model, with the goal of modifying the intake of foods and nutrients known to be associated with asthma outcomes, metabolic health, and the gut microbiome (e.g., fruits and vegetables, whole grain foods, fish, legumes, low-fat dairy, soluble fibre, phytochemicals, monounsaturated fatty acids and omega-3 fatty acids). The dietitian will guide participants to follow a reduced energy diet (2000-4000kJ/day energy deficit), which will lead to a modest weight loss (approximately 5-10% body weight over 16 weeks). The first session will commence with a nutrition assessment and determination of a nutrition diagnosis(es). A nutrition diagnosis is the identification of an existing nutrition problem(s) that the dietitian will be responsible for treating (e.g., high saturated fat intake), which differs from a medical diagnosis (e.g., diabetes). The nutrition diagnosis(es) will inform individualised nutrition intervention goals, in collaboration with the participant. Person-centred nutrition counselling will then commence, which will target the nutrition intervention goals and will focus on the participants needs (preferences, eating styles, comorbidities, etc.). Counselling will focus on nutrition education, behaviour modification, and motivational strategies. At each subsequent medical nutrition therapy session, the dietitian will conduct a nutrition re assessment and review the nutrition diagnosis(es), ensuring each counselling session is individualised. To promote mindful eating, participants will keep a food diary using the Easy Diet Diary app, to be sent to the dietitian fortnightly for adherence monitoring. The dietitian will periodically email participants to offer feedback and motivation. The Physiotherapist or Exercise Physiologist will prescribe an individualised physical activity programme, with the goal of meeting the Australian physical activity guidelines (150 minutes of moderate-vigorous aerobic physical activity and two muscle strengthening activity sessions per week). Aerobic exercise is also referred to as cardiovascular exercise and the aim of this type of exercise can be to improve fitness and endurance. Examples of aerobic exercise can include activities like walking, swimming, or cycling. Resistance exercise is also known as strengthening exercise. This type of exercise is aiming to increase muscle strength. Examples of resistance exercise can include lifting hand held weights, using resistance bands or tubing, or doing movements using body weight as the resistance like wall push ups. The physical activity intervention will commence with a physical activity screening assessment which will determine risk and safety to exercise, assessed via the adult pre-exercise screening system (APSS), and exercise preferences, barriers, and goals, assessed via the personalized exercise questionnaire (PEQ). Each participant will receive a physical activity starter pack (physical activity tracker, selection of resistance bands and/or free weights). They will also receive education and resources throughout the program to suit their individual needs. The physical activity monitor will assist in guiding their exercise intensity, by allowing the participant to monitor their heart rate during exercise and work towards a target range. The activity monitor will also provide an element of motivation and assist the physiotherapist in monitoring adherence. The physiotherapist/exercise physiologist will periodically email participants to offer feedback and motivation.
Sponsors
Study design
Eligibility
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.