Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001706864
Ethics application status
Approved
Date submitted
28/10/2021
Date registered
13/12/2021
Date last updated
18/01/2023
Date data sharing statement initially provided
13/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of using telehealth to deliver an exercise and nutrition intervention to people with non-alcoholic fatty liver disease
Scientific title
Feasibility of a 12-Week Telehealth Exercise and High Protein Nutritional Intervention to Optimise Body Composition in People with Non-alcoholic Fatty Liver Disease: A Pilot Randomised Controlled Trial
Secondary ID [1] 305607 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non alcoholic fatty liver disease 324040 0
Condition category
Condition code
Musculoskeletal 321542 321542 0 0
Other muscular and skeletal disorders
Metabolic and Endocrine 321543 321543 0 0
Other metabolic disorders
Diet and Nutrition 321544 321544 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 12-week pilot randomized controlled trial designed to investigate the feasibility of using telehealth as an approach to remotely deliver an exercise and dietary program for middle-aged and older adults (aged 45 years and over) with diagnosed non-alcoholic fatty liver disease (NAFLD). Specifically, the program will focus on lifestyle strategies aimed to promote regular muscle strengthening training, increased dietary protein intake (predominantly from plant-based sources) and promote healthy eating behaviours to optimise body composition, muscle strength and function.

Following baseline assessments, participants will be randomised (1:1 ratio) to receive either usual care or the telehealth lifestyle intervention. Those participants allocated to the telehealth intervention will be prescribed a 12-week muscle strengthening program by a qualified accredited exercise physiologists (EP) using a commercially available (and free) web-based exercise prescription platform and app (TeleHab) accessible via a smart device (phone or tablet). TeleHab is a digital platform specifically designed for health professionals to prescribe exercise programs to participants remotely that can also track and monitor progress, provide regular feedback and assess particpant adherence via app analytics. Selecting from a library of >5,000 exercises, the EP will design an individualised program for each participant including the training dose (frequency, sets, repetitions) for each exercise. The participant can set reminders for exercise times, record exercise completion (sets, repetitions) and rate their perceived exertion and any pain for each exercise. Exercise prescription will be personalised based on the participant’s baseline assessment, medical and physical activity history, and the EP’s clinical judgement. Participants will be prescribed a 25 minute muscle strengthening program consisting of 6-8 exercises utilising major muscle groups (2 sets of 10-12 repetitions) at a moderate intensity to be completed thrice weekly (on non-consecutive days). Some examples of the exercises to be prescribed include squats, lunges, hip abduction/adduction, bench stepping, bent over row, press ups, triceps dips, calf raises, lying back extension and core postural exercises (eg. plank). At week 6, the EP will prescribe (via Telehab) a new set of exercises for the remaining 6 weeks of the intervention. In addition, participants will be instructed to engage in regular aerobic activity (e.g., brisk walking) for at least 30 minutes at least twice per week, which they will record in a calendar. Prior to commencing the study, participants will receive education on the TeleHab app and safety by the EP and prescription of their individualised exercise program via video (zoom) consultation. In weeks 2 and 6 participants will attend small group (~5 participant, ~30-60 min sessions) video consultations with the EP. These sessions will be used to respond to any questions, modify the exercise program if required and promote motivation and a sense of community for participants.

Participants will also receive a healthy eating plan devised by a dietitian/nutritionist. It is hypothesized that it will emphasize a protein intake of 1.2-1.5 g/kg/day from predominately plant-based (legumes, tofu, nuts, peanuts, nut paste, peas, beans), as well as white meat and fish sources. Participants will follow the healthy eating plan during the 12-week intervention. Participants will receive dietary information via a video (zoom) consultation by the dietitian/nutritionist at baseline to outline the healthy eating plan, focusing on a high protein intake and more broadly how different protein sources (e.g., plant-based) can be incorporated into the diet. These recommendations will be based on a heart healthy, modified Mediterranean style dietary pattern informed by current clinical guidelines for NAFLD which incorporate increasing intakes of mono and polyunsaturated fats, vegetables, legumes, fruit, wholegrains, nuts and seeds and reducing intakes of processed sugars, red and processed meats. Additionally, participants will attend small group (~5 participants) video (zoom) consultations with the dietitian/nutritionist conducted in weeks 2 and 6 to provide information and tips on increasing protein intake, provide feedback on protein checklists, and promote motivation for participants and in week 12 to conduct semi-qualitative interviews to assess participants perceptions of the program. Changes in macro and micronutrient intakes and food groups will be assessed via three separate 24-hour records conducted at baseline, 6 and 12 weeks collected via a web-based dietary app. Nutrition information will be analysed using Foodworks nutrient analysis software (Xyris, Brisbane, Queensland, Australia). Additionally, online protein checklists will be completed at weeks 0, 2, 6, 9 and 12 weeks to further assess adherence to the higher protein intake from predominantly plant-based sources.

In addition to the regular support from the EP and dietitian/nutritionist, participants will receive regular push notifications (4-5 messages/week, approximately 30 sec read per message) with health focused messages to support behavioural change including reminders and tips for increasing daily serves of protein (predominately plant-based) and physical activity/movement tips and motivational messages.
Intervention code [1] 322010 0
Prevention
Intervention code [2] 322011 0
Lifestyle
Intervention code [3] 322012 0
Treatment: Other
Comparator / control treatment
Participants assigned to usual care will undergo standard (usual) care as per the liver clinic processes (i.e., continue to see their liver specialist at the time points deemed necessary, as well as any other ongoing referrals ). In addition, they will receive a generic handout on the importance of healthy eating (approximate 20 minute read) adapted from the Australian Heart Foundation and being physically active.
Control group
Active

Outcomes
Primary outcome [1] 329311 0
Adherence (66% or two out of threee sessions/week) to the exercise (muscle strengthening program): assessed via Telehab App
Timepoint [1] 329311 0
At completion of the 12 week intervention
Primary outcome [2] 329312 0
Adherence (>80% of serves to protein rich foods/week): as assessed via protein check lists
Timepoint [2] 329312 0
At completion of the 12 week intervention
Secondary outcome [1] 402102 0
Retention to the exercise and nutrition intervention as assessed via audit of study records (REDCap)
Timepoint [1] 402102 0
At completion of the 12 week intervention
Secondary outcome [2] 402104 0
Usability as assessed via the System Usability Scale questionnaire
Timepoint [2] 402104 0
At completion of the 12 week intervention
Secondary outcome [3] 402105 0
Acceptability of exercise intervention as assessed via questionnaire (Likert scale) and qualitative interview data (thematic analysis)
Timepoint [3] 402105 0
At completion of the 12 week intervention
Secondary outcome [4] 402107 0
Acceptability of nutrition intervention as assessed via questionnaire (Likert scale) and qualitative interview data (thematic analysis)
Timepoint [4] 402107 0
At completion of the 12 week intervention
Secondary outcome [5] 402313 0
Satisfaction of exercise intervention as assessed via questionnaire (Likert scale) and qualitative interview data (thematic analysis)
Timepoint [5] 402313 0
At completion of the 12 week intervention
Secondary outcome [6] 402314 0
Satisfaction of nutrtion intervention as assessed via questionnaire (Likert scale) and qualitative interview data (thematic analysis)
Timepoint [6] 402314 0
At completion of the 12 week intervention
Secondary outcome [7] 402315 0
Adverse events (eg. muscle sprain, exacerbation of existing injury) for exercise (muscle strengthening) program: collected via Telehab App and video consultations conducted with accredited exercise physiologist.
Timepoint [7] 402315 0
Collected weekly (Telehab app) and at weeks 2 and 6 after commencing intervention (video consults): reported at completion of the 12 week intervention
Secondary outcome [8] 402316 0
Perceptions of safety for exercise (muscle strengthening) program assessed via a 5-point Likert scale
Timepoint [8] 402316 0
At completion of the 12 week intervention
Secondary outcome [9] 402317 0
Lower limb muscle strength/function: assessed via sit to stand test
Timepoint [9] 402317 0
Baseline, 6 and 12 weeks after commencing the intervention
Secondary outcome [10] 402318 0
Physical activity (sedentary, light intensity and moderate-vigorous physical activity): assessed via accelerometer
Timepoint [10] 402318 0
Baseline, 6 and 12 weeks after commencing the intervention
Secondary outcome [11] 402319 0
Protein Intake (g/kg/day): as assessed via 24-hour diet record
Timepoint [11] 402319 0
Baseline, 6 and 12 weeks after commencing the intervention

Eligibility
Key inclusion criteria
Participants must be adults aged 45 years and over with a diagnosis of NAFLD determined by routine ultrasound or biopsy; and/or at least one elevated serum ALT level (>20 U/L female, >30 U/L male) during the past 6 months. Eligible participants must have no evidence of another form of liver disease and have consent from their consulting physician. To be included in this study participants must also have access to a smart phone ipad/tablet or computer with text message functioning and be able and willing to use it during course of study to receive messages and push notifications, have a home internet connection and own or have access to (e.g., chemists, GP) electronic scales suitable for self-reported weighing.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study based on the following
1) current/prior involvement in PRT (>1/week) or moderate-intensity physical activity (>150 min/week) in last 3 months
2) experienced weight loss/gain of approximately 5kg in the last 3 months
3) medical conditions (renal disease or impairment, orthopaedic, cardiovascular, respiratory) preventing participation in the intervention or those with absolute contraindications to exercise as defined by the American College of Sports Medicine (ACSM)
4) answer ‘no’ to all six questions on the Exercise and Sports Science Australia (ESSA) pre-exercise screening tool to ensure that it is safe for them to exercise at moderate exertion. This is a validated and recommended pre-exercise screening tool endorsed by Australia’s peak exercise body (ESSA)
5) current intake of 2 or more serves protein rich (fortified) supplements per week
6) an average intake of >2 alcoholic drinks/day
7) currently seeking/undertaking any other medical or dietary interventions due to NAFLD or other medical conditions
8) unable to speak or read English
9) not currently following a vegetarian or vegan diet

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)
Individuals will be randomized (following baseline assessments) by an independent researcher not directly involved in the study to conceal allocation. Research staff conducting all assessments and the statistical analysis will be blinded to the group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation prepared by our study biostatistician, stratified by gender, with a 1:1 allocation to the telehealth and ususal care group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Participants will be randomized into either the telehealth intervention or usual care group.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
.A total of 30 participants will be recruited, allowing for a 20% attrition rate (i.e., 12 participants per group required) as per the power calculations for this study. Data analysis will include calculating retention (proportion of participants completing the intervention), adherence and completion rates for data collection measures. Qualitative data (semi-structured small group interviews) will be analysed using thematic analysis to permit in depth enquiry into participants perceptions and factors that may affect the implementation and outcome of the intervention. As this study is a feasibility study, no formal sample size calculations or significance testing will be conducted. Instead, this study will calculate observed effect sizes (Cohen d) for the physical activity and anthropometric measures to explore trends (between group differences) in the quantitative? data. Effect sizes of d = 0.20, 0,50 and 0.80 will be used to demonstrate a small, medium and large change respectively. Descriptive variables will be calculated using STATA SE software and data will be reported as mean (SD) and proportions.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/04/2022
Actual
1/09/2022
Date of last participant enrolment
Anticipated
1/09/2022
Actual
3/11/2022
Date of last data collection
Anticipated
30/01/2023
Actual
Sample size
Target
30
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309970 0
University
Name [1] 309970 0
Deakin University
Country [1] 309970 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Deakin University
Institute for Physical Activity and Nutrition
School of Exercise and Nutrition Sciences
221 Burwood Highway, Burwood
Melbourne, VIC
Australia 3125
Country
Australia
Secondary sponsor category [1] 311015 0
None
Name [1] 311015 0
Address [1] 311015 0
Country [1] 311015 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309681 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 309681 0
Ethics committee country [1] 309681 0
Australia
Date submitted for ethics approval [1] 309681 0
13/10/2021
Approval date [1] 309681 0
07/01/2022
Ethics approval number [1] 309681 0
2021-359

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

Contacts
Principal investigator
Name 115022 0
Prof Robin Daly
Address 115022 0
Deakin University
Institute for Physical Activity and Nutrition
School of Exercise and Nutrition Sciences,
221 Burwood Highway, Burwood,
Melbourne, VIC, Australia 3125
Country 115022 0
Australia
Phone 115022 0
+61 03 92446040
Fax 115022 0
Email 115022 0
[email protected]
Contact person for public queries
Name 115023 0
Christine Freer
Address 115023 0
Deakin University
Institute for Physical Activity and Nutrition
School of Exercise and Nutrition Sciences,
221 Burwood Highway, Burwood
Melbourne, VIC, Australia 3125
Country 115023 0
Australia
Phone 115023 0
+61 418637904
Fax 115023 0
Email 115023 0
[email protected]
Contact person for scientific queries
Name 115024 0
Robin Daly
Address 115024 0
Deakin University
Institute for Physical Activity and Nutrition
School of Exercise and Nutrition Sciences,
221 Burwood Highway, Burwood,
Melbourne, VIC, Australia 3125
Country 115024 0
Australia
Phone 115024 0
+61 03 92446040
Fax 115024 0
Email 115024 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial.
When will data be available (start and end dates)?
Data will be available after the main findings from the study are published, no end date detemined.
Available to whom?
Researchers requesting data only
Available for what types of analyses?
To address secondary related (or unrelated) research questions associated with the approval aims/study design.
How or where can data be obtained?
By emailing the Principal Investigator Prof Robin Daly ([email protected])


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.