Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000979651
Ethics application status
Approved
Date submitted
28/07/2023
Date registered
8/09/2023
Date last updated
8/09/2023
Date data sharing statement initially provided
8/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Individualised Diet and Exercise for Asthma and Lung Function (IDEAL) study
Scientific title
Effect of personalising the management of obesity-associated asthma using medical nutrition therapy and physical activity prescription on asthma control: The IDEAL Study
Secondary ID [1] 309538 0
Nil known
Universal Trial Number (UTN)
U1111-1291-8501
Trial acronym
IDEAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 329822 0
Obesity 329823 0
Condition category
Condition code
Respiratory 326719 326719 0 0
Asthma
Diet and Nutrition 326720 326720 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 325965 0
Lifestyle
Comparator / control treatment
The control group will be asked to continue with their usual dietary intake and physical activity levels for the 16 week control period. Following the final assessment visit, participants will receive a 90-minute counselling session with the study dietitian and physiotherapist/exercise physiologist where they will receive general information regarding the Australian dietary and physical activity guidelines.
Control group
Active

Outcomes
Primary outcome [1] 334588 0
Juniper Asthma Control Questionnaire (ACQ) score
Timepoint [1] 334588 0
Week 0 (baseline), week 16 post-baseline (primary endpoint), 12 months post-baseline (long term follow up)
Secondary outcome [1] 421304 0
Lung function as measured by spirometry [forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC)]
Timepoint [1] 421304 0
Week 0 (baseline), week 16 post-baseline, 12 months post-baseline (long term follow up)
Secondary outcome [2] 421305 0
Airway inflammation as measured by fraction exhaled nitric oxide (FeNO)
Timepoint [2] 421305 0
Week 0 (baseline), week 16 post-baseline, 12 months post-baseline (long term follow up)
Secondary outcome [3] 421306 0
Number of asthma exacerbations as measured by exacerbation history questionnaire. This questionnaire has been used and reported in previous clinical trials in an asthma population (e.g., Gibson et al. 2017)

Gibson PG, Yang IA, Upham JW, et al. Effect of azithromycin on asthma exacerbations and quality of life in adults with persistent uncontrolled asthma (AMAZES): a randomised, double-blind, placebo-controlled trial. Lancet. 2017;390(10095):659-668. doi:10.1016/S0140-6736(17)31281-3
Timepoint [3] 421306 0
Week 0 (baseline), week 16 post-baseline, 12 months post-baseline (long term follow up)
Secondary outcome [4] 421307 0
Immune susceptibility to exacerbating-viral respiratory infection as measured by peripheral blood mononuclear cell (PBMC) cytokine responses to ex vivo respiratory virus infection.
Timepoint [4] 421307 0
Week 0 (baseline), week 16 post-baseline, 12 months post-baseline (long term follow up)
Secondary outcome [5] 421308 0
Metabolic health assessed by blood pressure and biomarkers in blood samples [fasting triglycerides, cholesterol (total, LDL-c, HDL-c), apolipoprotein A1, apolipoprotein B100, glucose, insulin, and HbA1c]
Timepoint [5] 421308 0
Week 0 (baseline), week 16 post-baseline, 12 months post-baseline (long term follow up)
Secondary outcome [6] 421309 0
Body composition assessed by dual-energy x-ray absorptiometry (DXA)
Timepoint [6] 421309 0
Week 0 (baseline), week 16 post-baseline, 12 months post-baseline (long term follow up)
Secondary outcome [7] 421310 0
Dietary intake as measured by a four-day weighed food record completed using the Easy Diet Diary app
Timepoint [7] 421310 0
Week 0 (baseline), week 16 post-baseline, 12 months post-baseline (long term follow up)
Secondary outcome [8] 421311 0
Physical activity levels assessed by one week of accelerometry in conjunction with the short form of the International Physical Activity Questionnaire (IPAQ)
Timepoint [8] 421311 0
Week 0 (baseline), week 16 post-baseline, 12 months post-baseline (long term follow up)
Secondary outcome [9] 421312 0
Physical fitness assessed by a six-minute walk test (6MWT)
Timepoint [9] 421312 0
Week 0 (baseline), week 16 post-baseline, 12 months post-baseline (long term follow up)
Secondary outcome [10] 421314 0
Strength assessed by hand-grip strength (hand-grip dynamometry)
Timepoint [10] 421314 0
Week 0 (baseline), week 16 post-baseline, 12 months post-baseline (long term follow up)
Secondary outcome [11] 421315 0
Cellular metabolism (metabolomics) assessed from blood (plasma) samples
Timepoint [11] 421315 0
Week 0 (baseline), week 16 post-baseline, 12 months post-baseline (long term follow up)
Secondary outcome [12] 421316 0
Gut microbiome assessed by shotgun metagenomic sequencing of stool samples
Timepoint [12] 421316 0
Week 0 (baseline), week 16 post-baseline, 12 months post-baseline (long term follow up)
Secondary outcome [13] 424800 0
Plasma Fatty Acids
Timepoint [13] 424800 0
Week 0 (baseline), week 16 post-baseline, 12 months post-baseline (long term follow up)
Secondary outcome [14] 424801 0
Plasma Carotenoids
Timepoint [14] 424801 0
Week 0 (baseline), week 16 post-baseline, 12 months post-baseline (long term follow up)
Secondary outcome [15] 425396 0
Systemic inflammation as measured by inflammatory biomarkers in blood samples (enzyme-linked immunosorbent assay, ELISA)
Timepoint [15] 425396 0
Week 0 (baseline), week 16 post-baseline, 12 months post-baseline (long term follow up)
Secondary outcome [16] 425401 0
Number of asthma-related hospitalisations as measured by exacerbation history questionnaire. This questionnaire has been used and reported in previous clinical trials in an asthma population (e.g., Gibson et al. 2017).

Gibson PG, Yang IA, Upham JW, et al. Effect of azithromycin on asthma exacerbations and quality of life in adults with persistent uncontrolled asthma (AMAZES): a randomised, double-blind, placebo-controlled trial. Lancet. 2017;390(10095):659-668. doi:10.1016/S0140-6736(17)31281-3
Timepoint [16] 425401 0
Week 0 (baseline), week 16 post-baseline, 12 months post-baseline (long term follow up)
Secondary outcome [17] 426219 0
Airway inflammation as measured by sputum cell counts
Timepoint [17] 426219 0
Week 0 (baseline), week 16 post-baseline, 12 months post-baseline (long term follow up)
Secondary outcome [18] 426220 0
Airway inflammation as measured by sputum inflammatory biomarkers (enzyme-linked immunosorbent assay, ELISA)
Timepoint [18] 426220 0
Week 0 (baseline), week 16 post-baseline, 12 months post-baseline (long term follow up)
Secondary outcome [19] 426221 0
Strength assessed by 30-second Sit-to-Stand (STS) test
Timepoint [19] 426221 0
Week 0 (baseline), week 16 post-baseline, 12 months post-baseline (long term follow up)

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting an independent person who holds the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Our previous weight loss study observed a clinically significant improvement in ACQ (change=0.5, SD=0.7). To have 90% power to detect a 0.5±0.7 unit difference in ACQ, using a=0.05, we need 42 participants per group. Allowing for a 20% loss-to-follow-up, we require a total of n=102.

Participant data will be recorded in a RedCap database. Data will be exported for analysis in SAS 9.4 (SAS Institute, Cary, NC) and/or Stata 15 (StataCorp, College Station, TX).

The primary outcome is group mean difference in ACQ at 16 weeks, which will be analysed by ANCOVA, adjusted for baseline ACQ and strata variables sex and asthma severity. Group differences in secondary outcomes at each timepoint will also be estimated via ANCOVA, adjusted for baseline values and strata variables. A linear mixed model of ACQ at two follow-up timepoints (16 weeks, 12 months) with a fixed effect for group x time and a random effect for participant will be used to estimate an overall group effect, adjusted for baseline ACQ and strata variables. A second model that also adjusts for participant BMI and number of years since asthma onset will be fitted. Sensitivity analyses will include: 1) an analysis of the primary outcome using multiple imputation to impute missing data, 2) an analysis of the primary outcome restricted to participants with high compliance (defined as attendance at greater than or equal to 80% of scheduled sessions and greater than or equal to 80% compliance with physical activity prescription, tracked using an activity monitor). Number of exacerbations (rescue oral corticosteroid use, unscheduled doctor visits and hospitalisations for asthma) will be reported and compared by group using negative binomial regression. Subgroup analyses will be performed by estimating the primary outcome within subgroups defined by sex (males, females) and asthma severity (severe, non-severe). Tests of interaction (subgroup x group) will also be used. Trial reporting will adhere to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/09/2023
Actual
Date of last participant enrolment
Anticipated
1/06/2025
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24613 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 40219 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 313730 0
Government body
Name [1] 313730 0
Australian Government Department of Health and Aged Care (Medical Research Future Fund, MRFF)
Country [1] 313730 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Australia
Country
Australia
Secondary sponsor category [1] 315544 0
Hospital
Name [1] 315544 0
John Hunter Hospital
Address [1] 315544 0
Lookout Rd
New Lambton Heights NSW 2305
Australia
Country [1] 315544 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312900 0
Hunter New England Human Research Ethics Committee (HNEHREC)
Ethics committee address [1] 312900 0
Ethics committee country [1] 312900 0
Australia
Date submitted for ethics approval [1] 312900 0
11/05/2023
Approval date [1] 312900 0
19/07/2023
Ethics approval number [1] 312900 0
2023/ETH00833

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126274 0
Dr Hayley Scott
Address 126274 0
Immune Health Research Program, The University of NewcastleLevel 2 West, Hunter Medical Research Institute,Lot 1 Kookaburra CircuitNEW LAMBTON HEIGHTS NSW 2305
Country 126274 0
Australia
Phone 126274 0
+61 02 4042 0113
Fax 126274 0
+61 02 4042 0046
Email 126274 0
[email protected]
Contact person for public queries
Name 126275 0
Tamara Blickisdorf
Address 126275 0
Immune Health Research Program, The University of NewcastleLevel 2 West, Hunter Medical Research Institute,Lot 1 Kookaburra CircuitNEW LAMBTON HEIGHTS NSW 2305
Country 126275 0
Australia
Phone 126275 0
+61 02 4055 0983
Fax 126275 0
+61 02 4042 0046
Email 126275 0
[email protected]
Contact person for scientific queries
Name 126276 0
Hayley Scott
Address 126276 0
Immune Health Research Program, The University of NewcastleLevel 2 West, Hunter Medical Research Institute,Lot 1 Kookaburra CircuitNEW LAMBTON HEIGHTS NSW 2305
Country 126276 0
Australia
Phone 126276 0
+61 02 4042 0113
Fax 126276 0
+61 02 4042 0046
Email 126276 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidentiality


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19984Informed consent form https://hmri.org.au/sites/default/files/ideal_study_info_consent_v2_100723_clean.pdf_002.pdf



Results publications and other study-related documents

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