COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted/resubmitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619001606178
Ethics application status
Approved
Date submitted
24/10/2019
Date registered
21/11/2019
Date last updated
21/11/2019
Date data sharing statement initially provided
21/11/2019
Date results information initially provided
21/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prevention of Unintentional Weight Gain Post Lung Transplant
Scientific title
Prevention of Unintentional Weight Gain Post Lung Transplant
Secondary ID [1] 299580 0
Alfred Research Trusts Small Project Grant: T11721
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung transplant 314854 0
Overweight and obesity 314855 0
Diabetes 314856 0
Hyperlipidaemia 314857 0
Condition category
Condition code
Diet and Nutrition 313194 313194 0 0
Obesity
Respiratory 313195 313195 0 0
Other respiratory disorders / diseases
Metabolic and Endocrine 313517 313517 0 0
Other metabolic disorders
Metabolic and Endocrine 313518 313518 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
15 patients recruited into control group within the first two weeks of their transplant whilst still an inpatient. Once those 15 patients had finished their 3 month rehabilitation, the next 15 participants were recruited into the intervention group in the same fashion.

Intervention group
The intervention group will receive usual nutrition care and as part of the study (see Control group), will attend four 30 minute group education sessions within the first 3 months of transplant. Sessions include a powerpoint presentation, provision of resources and educational activities. The following topics will be covered at the (additional) intervention group education sessions by the Lung Transplant Dietitian:
Session 1: General healthy eating based on the Australian Dietary Guidelines (NHMRC 2013b).
• Discuss the different food groups, what one serve equivalent is, and how many serves are needed each day
• Activities: guessing which food group a food belongs too; developing a day’s meal plan
• Resource: Australian Guide to Healthy Eating booklet, blank meal plan template

Session 2: Portion control and energy density.
• Discuss energy content of fat, alcohol, carbohydrate and protein; discuss opting for less refined/processed carbohdyrates; discuss how to label read; discuss concept of energy in vs energy out through exercise
• Activities: guessing which meal a) would take longer to prepare b) which is cheaper c) which provides more nutrition; guessing how long it takes to walk to burn the equivalent energy in different foods
• Resource: ‘How to understand food labels’ from Australian Government website www.eatforhealth.gov.au

Session 3: Exercise (by Respiratory Physiotherapist).
• Discuss reasons why exercise is important after lung transplant, benefits of physical activity and recommended targets.

Session 4: Mindfulness
• Discuss how to calculate body mass index and healthy range, discuss waist circumference and healthy measurements, discuss benefits of being in healthy weight range, discuss SMART goals (specific, measureable, achieveable, relevant, timed), discuss monitoring of hunger, food intake and anthropometric measures, discuss rewards, discuss mindful eating
• Activities: calculating their own body mass index; mindfulness activity (eating raisin)
• Resources: Australian Government Department of Health “My Goals”, “My Physical Activity Planner”, “My Meal Planner”

This group will then receive follow up with the Lung Transplant Dietitian via phone coaching at 4, 5, 6 and 9 months (approx. 30min each), with a face-to-face consultation at 12 months (approx. 60min). If participants within the intervention group require more intensive nutrition input (as per clinical judgement of lung transplant dietitian), they can also be seen on an individual basis in the lung transplant clinic, as per usual nutrition care.
Intervention code [1] 315835 0
Prevention
Comparator / control treatment
Control group
The control group will receive usual nutrition care post lung transplant. This includes one group education at the hospital after transplant which briefly discusses the possibility of weight gain as well as the concept of healthy eating. Additionally, this may include individualised nutrition counselling with a dietitian in the lung transplant clinic. Follow up duration and frequency is per the clinical judgement of the lung transplant dietitian. These participants may be discharged from nutrition care within 12 months of transplant if deemed nutritionally stable.
Control group
Active

Outcomes
Primary outcome [1] 321705 0
Difference between control and intervention groups in mean change in body weight (kg) using Bioelectrical Impedance Analysis scales (SECA mBCA 514, Seca, Germany, distributed by Ecomed Australia, Seven Hills, NSW).
Timepoint [1] 321705 0
Between enrolment and 12 months post-transplant.
Secondary outcome [1] 375970 0
Differences between control and intervention groups in mean change in fat mass (kg) using body composition analysis device SECA mBCA 514, Seca, Germany, distributed by Ecomed Australia, Seven Hills, NSW
Timepoint [1] 375970 0
Between enrolment and 12 months post-transplant
Secondary outcome [2] 375971 0
Differences between control and intervention groups in mean change in fat-free mass (kg) using body composition analysis device SECA mBCA 514, Seca, Germany, distributed by Ecomed Australia, Seven Hills, NSW
Timepoint [2] 375971 0
Between enrolment and 12 months post-transplant
Secondary outcome [3] 375972 0
Differences between control and intervention groups in nutrition knowledge score using the General Nutrition Knowledge Questionnaire (Parmenter, 1999)
Timepoint [3] 375972 0
At 12 months post-transplant
Secondary outcome [4] 375973 0
Differences between control and intervention groups in diet quality using 24h dietary recall in comparison to Australian Dietary Guidelines (NHMRC 2013b)
Timepoint [4] 375973 0
At 12 months post-transplant
Secondary outcome [5] 375974 0
Differences between control and intervention groups in physical activity level using the Victorian Population Health Survey for Physical Activity (DHHS Vic, 1998)
Timepoint [5] 375974 0
At 12 months post-transplant

Eligibility
Key inclusion criteria
• All Alfred Health lung transplant recipients
• Able and willing to provide informed consent to participate in the study
• Aged greater than or equal to 18 years old
• Resident of Victoria
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• BMI less than or equal to 20kg/m2 during admission post-transplant
• Expected to require enteral nutrition upon discharge from hospital
• Complex post-transplant admission (greater than 8 weeks from day of transplant)
• English language proficiency insufficient to participate in group education and phone coaching sessions
• Hearing impairment to a degree that would render participation in group education and phone coaching sessions impractical
• South Australian and Tasmanian residents (due to transfer home at about 12 weeks post-transplant and therefore unable to undertake 12 month data collection)

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Non-randomised, non-concurrent control group
Non-concurrent ensures that information is not disseminated between patients in the intervention and control group at gym sessions; this is a risk with a concurrent controls design (Participants attend 3 gym sessions per week for 3 months post-transplant)
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A significant challenge in performing sample size and power calculations for this study is the lack of suitable data on effect size (mean+/-SD weight change in control vs intervention) from other studies in lung or other solid organ transplantation on which to base these calculations.

This pilot study has been designed based on 15 participations per group, which is feasible to recruit and complete the study protocol within the small project grant timeframe and available funds. We performed a power calculation based on the observed mean+/-SD 1-year weight change for the entire lung transplant cohort (Jan 2015-April 2016 operations, n=68 with 1-year data, mean weight change 8.9+/-9.2kg). This wide standard deviation results from the dataset including those with major complications and long length of stay (who have higher risk of weight loss post-Tx) and those with low BMI pre-transplant (who tend to gain more weight as part of nutritional rehabilitation). Both of these groups are ineligible for our study, and thus it is reasonable to expect that in the study cohort the standard deviation of mean weight change could be lower.

A clinically meaningful difference in weight gain is estimated to 4.5kg (50% of that observed in usual care). The power calculation based on mean+/-SD weight change of 9+/-9kg in the control group) and 4.5kg+/-4.5kg in the intervention group (based on above data and in the absence of suitable research trial data with n=15 per group and alpha 0.05 results in a power of only 53%. To achieve a power of 80%, a sample size of 31 per group would be required unless the SD of weight change in the study itself is lower than seen for epidemiological (all-comers) data.

Therefore we regard this study as a pilot because 15 patients per group may not be sufficient to detect statistical significance in the primary outcome, unless SD is lower than our conservative estimate. Our study will therefore provide important baseline data to use to in defining a sample size required to detect an effect on weight gain, and also to identify clinically and statistically significant changes in other important outcomes such as change in fat mass, waist circumference or metabolic parameters. This will assist with planning a larger and longer intervention study if the pilot study results suggest a clinically meaningful effect of the intensive nutrition intervention can be achieved.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15000 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 28285 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 304064 0
Hospital
Name [1] 304064 0
Alfred Research Trusts Small Project Grant
Address [1] 304064 0
Alfred Hospital
55 Commercial Rd
Melbourne VIC 3004
Country [1] 304064 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health Research
Address
Alfred Hospital
55 Commercial Rd
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 304260 0
None
Name [1] 304260 0
Address [1] 304260 0
Country [1] 304260 0
Other collaborator category [1] 280993 0
Individual
Name [1] 280993 0
Susannah King
Address [1] 280993 0
Alfred Hospital
55 Commercial Rd
Melbourne VIC 3004
Country [1] 280993 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304555 0
The Alfred Ethics Committee
Ethics committee address [1] 304555 0
Alfred Hospital
55 Commercial Rd
Melbourne VIC 3004
Ethics committee country [1] 304555 0
Australia
Date submitted for ethics approval [1] 304555 0
Approval date [1] 304555 0
22/02/2018
Ethics approval number [1] 304555 0
Project 55/18

Summary
Brief summary
Lung transplant recipients at Alfred Hospital are experiencing significant unintentional weight gain within the 12 months after their surgery; resulting in more overweight and obese patients within this cohort. There are no studies investigating the management of weight gain among this population. The aim of this study is to explore whether 4 group education sessions based on healthy eating and physical activity, followed by 4 phone calls and 2 face-to-face consultations with a dietitian over 12 months can assist in preventing unintentional weight gain better than current usual care.

Hypothesis: Intensive group nutrition and exercise education combined with individual phone coaching over the 12 months following lung transplant will reduce unintentional weight gain in the healthy weight and overweight population, compared with usual care.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97370 0
Miss Christie Emsley
Address 97370 0
Nutrition Department
Alfred Hospital
55 Commercial Rd
Melbourne VIC 3004
Country 97370 0
Australia
Phone 97370 0
+61 404154266
Fax 97370 0
Email 97370 0
c.emsley@alfred.org.au
Contact person for public queries
Name 97371 0
Miss Christie Emsley
Address 97371 0
Nutrition Department
Alfred Hospital
55 Commercial Rd
Melbourne VIC 3004
Country 97371 0
Australia
Phone 97371 0
+61 404154266
Fax 97371 0
Email 97371 0
c.emsley@alfred.org.au
Contact person for scientific queries
Name 97372 0
Miss Christie Emsley
Address 97372 0
Nutrition Department
Alfred Hospital
55 Commercial Rd
Melbourne VIC 3004
Country 97372 0
Australia
Phone 97372 0
+61 404154266
Fax 97372 0
Email 97372 0
c.emsley@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary