Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001260314
Ethics application status
Approved
Date submitted
25/08/2017
Date registered
30/08/2017
Date last updated
23/11/2018
Date data sharing statement initially provided
23/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
LIFE Study: Liver transplant recipient Initiative: Feasibility study to Enhance cardio-metabolic health
Scientific title
Randomised controlled trial to assess the feasibility of implementing a telehealth model of care for delivering nutrition and exercise advice to enhance cardio-metabolic health in liver transplant recipients
Secondary ID [1] 292739 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
LIFE study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver Transplant Recipients 304508 0
Cardiometabolic health 304547 0
Condition category
Condition code
Diet and Nutrition 303847 303847 0 0
Obesity
Cardiovascular 303848 303848 0 0
Other cardiovascular diseases
Physical Medicine / Rehabilitation 303849 303849 0 0
Other physical medicine / rehabilitation
Oral and Gastrointestinal 303868 303868 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 303869 303869 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will assess the feasibility of implementing a telehealth model of care for delivering nutrition and exercise advice for the prevention and treatment of obesity and metabolic dysfunction after liver transplantation. There will be two groups; intervention group and a wait list control group randomised in a 2:1 ratio.
Intervention:
- Participants will undergo education for increasing physical activity in line with Australian National Guidelines (30minutes daily, up to 150minutes per week of aerobic and resistance activity) and aligning dietary patterns with Mediterranean Eating style. The Mediterranean diet education will focus on increasing use of extra virgin olive oil, increasing vegetables, fruits and legumes and nuts, increasing fish and seafood and decreasing dairy products and red meat. The dietary intervention will not include recommendations to include red wine as alcohol abstinence is expected to be maintained in this target group. Education is focused on food choice and dietary pattern with no specific education around weight reduction even though weight loss may occur as a result of dietary change.
The exercise intervention will consist of x1 per week for 12 weeks supervised (via QHealth Portal) exercising involving a 10minute warm up, 20 minutes of a variety of aerobic and resistance exercises, followed by stretches 10min. The physical activity performed during these face to face sessions will vary across the course of the study to educate the participants on a variety of different exercises that they can choose to undertake to reach their daily 30min or weekly 150mins physical activity. Participants can freely choose what exercise to undertake outside of the supervised sessions, and can use the sessions to ask questions, discuss goal setting and receive any individualised modifications to exercises to suit their needs.
Workbooks, cookbooks and exercise equipment including stepper, mat and thera-bands will be provided and used in the education sessions so that the participants can freely choose recipes and exercises that match with their personal preferences.
A Dietitian will provide the education and support for Mediterranean Eating with fortnightly group appointments. An Exercise Physiologist will provide education and support for weekly exercise training sessions. Both health professionals will assist in goal setting and tracking of activities. Fidelity of the service delivery will be assessed by regular supervision of the intervention appointments by principal investigators and professional support and case discussions at weekly team meetings.
The intervention will be delivered via the Queensland Health Portal whereby participants will log in online from their home device (computer/laptop/ipad) with the health professional located centrally at the Princess Alexandra Hospital and multiple participants logging in to each appointment for a group session. The first session will be one-on-one for the health professional to determine any individual specific needs, but all remaining appointments will be group based.
The intervention will continue for 12 weeks with x5 1 hr sessions with the Dietitian and x12 1hr sessions with Exercise Physiologist.
Adherence and compliance with the model of care will be assessed at each session by the health professional. Log books to record exercise sessions and diet tracking checklists will assist in recording adherence to recommendations for diet and exercise. Heart rate monitors will be used to monitor intensity of exercise reached.
Intervention code [1] 298983 0
Lifestyle
Comparator / control treatment
The control group is a waitlist control group who will receive usual care which is currently no treatment. After repeat testing of outcomes at 12 weeks, those in the control group will undertake the intervention in the same way as the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 303208 0
Feasibility (assessed by recruitment rate, percentage of appointments completed, adverse events, attrition). Adverse events such as musculoskeletal injury from exercise or gastrointestinal upset from dietary changes will be assessed at each appointment and recorded in the database and any deviation from protocol to accommodate individual needs documented.
Timepoint [1] 303208 0
0, 12, 24 weeks
Primary outcome [2] 303223 0
Adherence to diet and exercise prescription (assessed by Mediterranean Diet Score and IPAC survey)
Timepoint [2] 303223 0
0, 12, 24 weeks
Secondary outcome [1] 338244 0
Presence of the Metabolic Syndrome: Determined by the combined results of a clinical and biochemical assessment involving Waist circumference measured in cm, fasting serum Triglyceride levels (mmol/L), fasting serum HDL Cholesterol (mmol/L), and clinically measured systolic and diastolic blood pressure (mmHg).
Timepoint [1] 338244 0
0, 12, 24 weeks
Secondary outcome [2] 338245 0
Quality of Life: SF12v2 Quality of life questionnaire
Timepoint [2] 338245 0
0, 12, 24 weeks
Secondary outcome [3] 338280 0
Patient and staff acceptance (by qualitative interviews/focus groups. Both participants and clinic staff will be asked about their experience with the telehealth model of service delivery and their perceptions of sustainability for cardiometabolic health).
Timepoint [3] 338280 0
24 weeks
Secondary outcome [4] 338282 0
Cost of implementation (assessed by calculating direct cost to health service for service delivery and cost per patient)
Timepoint [4] 338282 0
Week 24
Secondary outcome [5] 338284 0
Confidence in food and exercise activity: Assessed using likert scales of confidence in choosing foods aligning with mediterranean eating and performing activity in line with guidelines. These have been developed specifically for this study and is not a validated tool.
Timepoint [5] 338284 0
12, 24 weeks
Secondary outcome [6] 338285 0
Cost to patient (assessed by determining estimated cost of food purchasing habits before and after intervention based on dietary recall data collection)
Timepoint [6] 338285 0
Week 24

Eligibility
Key inclusion criteria
Participants will be considered eligible when they meet the following inclusion criteria:
a) Adults under the care of Queensland Liver Transplant Service (QLTS), >6mths post-transplant, expected survival >1year.
b) Have current access to a mobile phone or computer hardware with internet access and capabilities for webcam attachment; and
c) Provide written informed consent.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
This study will exclude participants that do not satisfy the above inclusion criteria, or:
Have a food allergy or dietary restriction that results in MedDiet being deemed inappropriate
Have a physical disability that whereby an increase in physical activity would be deemed inappropriate
Are deemed unsafe to participate by their Hepatologist or Transplant Surgeon
Are non-English speaking; and/or unable to read and write in English

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised 2:1 in the first phase to either a Cardio-protective intervention (n=33) for 12 weeks or usual care (wait list control group) (n=17). The wait list control group will be offered the intervention program after completion of 12 week wait control so all participants (n=50) will have the opportunity to participate in the initiative, provide feedback on feasibility while supporting the need for RCT design. Randomisation will be implemented by the trial coordinator using the REDCap research management system which will incorporate computer-generated random numbers. The investigator will use sealed envelopes to distribute group allocation and inform the consenting participant of their assigned intervention at their baseline appointment, after the baseline assessments have been provided.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using freeware at randomisation.com
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is a feasibility pilot study that will be used to inform the design of a larger effectiveness trial. The statistical analysis of the feasibility variables will be largely descriptive. Some of the clinical variables will use pre-post analysis such as paired t-tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/09/2017
Actual
6/09/2017
Date of last participant enrolment
Anticipated
2/03/2018
Actual
1/02/2018
Date of last data collection
Anticipated
8/06/2018
Actual
31/07/2018
Sample size
Target
50
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8889 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 17139 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 297375 0
Charities/Societies/Foundations
Name [1] 297375 0
Princess Alexandra Hospital Research Foundation
Country [1] 297375 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
Ipswich Rd
Woolloongabba Qld 4102
Country
Australia
Secondary sponsor category [1] 296353 0
None
Name [1] 296353 0
None
Address [1] 296353 0
None
Country [1] 296353 0
Other collaborator category [1] 279686 0
University
Name [1] 279686 0
University of Queensland
Address [1] 279686 0
School of Human Movement and Nutrition Sciences
Level 5, Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country [1] 279686 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298479 0
MetroSouth Health and Hospital Services Human Research Ethics Committee
Ethics committee address [1] 298479 0
Ethics committee country [1] 298479 0
Australia
Date submitted for ethics approval [1] 298479 0
04/04/2017
Approval date [1] 298479 0
16/05/2017
Ethics approval number [1] 298479 0
HREC/17/QPAH/208

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

Contacts
Principal investigator
Name 77214 0
Dr Ingrid Hickman
Address 77214 0
Dept Nutrition and Dietetics
Ground Floor, Building 15
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba Qld 4102
Country 77214 0
Australia
Phone 77214 0
+61 7 3176 5588
Fax 77214 0
+61 7 3176 5619
Email 77214 0
[email protected]
Contact person for public queries
Name 77215 0
Ingrid Hickman
Address 77215 0
Dept Nutrition and Dietetics
Ground Floor, Building 15
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba Qld 4102
Country 77215 0
Australia
Phone 77215 0
+61 7 3176 5588
Fax 77215 0
+61 7 3176 5619
Email 77215 0
[email protected]
Contact person for scientific queries
Name 77216 0
Ingrid Hickman
Address 77216 0
Dept Nutrition and Dietetics
Ground Floor, Building 15
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba Qld 4102
Country 77216 0
Australia
Phone 77216 0
+61 7 3176 5588
Fax 77216 0
Email 77216 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
Data is stored anonymously and no individual data is used


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.