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Trial registered on ANZCTR


Registration number
ACTRN12621000897864p
Ethics application status
Submitted, not yet approved
Date submitted
28/05/2021
Date registered
9/07/2021
Date last updated
9/07/2021
Date data sharing statement initially provided
9/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of a web based hypocaloric Mediterranean diet intervention compared to standard care in individuals with non-alcoholic fatty liver disease (NAFLD).
Scientific title
Feasibility of a web based hypocaloric Mediterranean diet intervention compared to standard care in individuals with non-alcoholic fatty liver disease (NAFLD).
Secondary ID [1] 304341 0
Nil
Universal Trial Number (UTN)
Trial acronym
HypoMed
Linked study record

Health condition
Health condition(s) or problem(s) studied:
non alcoholic fatty liver disease 322103 0
Condition category
Condition code
Metabolic and Endocrine 319818 319818 0 0
Other metabolic disorders
Oral and Gastrointestinal 320358 320358 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a 12 week hypocaloric MedDiet using traditional MedDiet principles with the total energy targets altered to achieve a deficit of ~750kJ per day. The diet will be prescribed by research dietitian(s). The diet will be rich in plant-based foods including vegetables, whole grains and fruit with the main added fat being extra virgin olive oil. Emphasising increased legumes, raw unsalted nut intake and oily fish, with moderate fermented dairy and poultry and small amounts of red meat. Macronutrient distribution of 44% fat, 36% carbohydrate, 20% protein and up to 5% alcohol. The diet will be designed to be easy to follow and sustainable. The dietitian will tailor the diet to nutritionally appropriate, cultural and personal preferences. Dietary adherence will be monitored using a food diary and adherence questionnaires such as the MEDAS to monitor adherence to the Mediterranean Diet.
Participants will access dietary resources using a web based platform. We will encourage to access this as regularly as they need and will collect data on frequency of access using website analytics.
Intervention code [1] 320696 0
Lifestyle
Comparator / control treatment
Participants will undergo standard care as per clinic processes. Dietitian recommendations currently include low fat diet in line with the Australian Guide to Healthy Eating.
Control group
Active

Outcomes
Primary outcome [1] 327683 0
Feasibility of a hypocaloric MedDiet assessed by changes and adherence to the diet at baseline and 12 weeks (3-day food diaries), and the PREDIMED Checklist; participants recruited (% of participant eligible) and retained (completion of study based on attrition rates); interaction with web-based intervention (website analytics) and safety (adverse events such as gastrointestinal discomfort). The systems usability scale (SUS) will also be administered to assess the MedDiet web-based intervention platform.
Timepoint [1] 327683 0
baseline and 12 weeks (end intervention)
Secondary outcome [1] 396215 0
Weight (kg) with a digital scale
Timepoint [1] 396215 0
Baseline and 12 weeks (end intervention)
Secondary outcome [2] 397190 0
Height using a stadiometer
Timepoint [2] 397190 0
Baseline and 12 weeks (end intervention)
Secondary outcome [3] 397191 0
Waist circumference using a measuring tape
Timepoint [3] 397191 0
Baseline and 12 weeks (end intervention)
Secondary outcome [4] 397192 0
Blood pressure using a digital machine
Timepoint [4] 397192 0
Baseline and 12 weeks (end intervention)
Secondary outcome [5] 397193 0
Body composition (lean tissue mass) will be assessed using Seca© bio electrical impedance analysis scales.
Timepoint [5] 397193 0
Baseline and 12 weeks (end intervention)
Secondary outcome [6] 397194 0
The Active Australia questionnaire will monitor changes in physical activity.
Timepoint [6] 397194 0
Baseline and 12 weeks (end intervention)
Secondary outcome [7] 397196 0
Biomarkers (Fasting glucose) using standard venepuncture and analysis
Timepoint [7] 397196 0
baseline and 12 weeks (end intervention)
Secondary outcome [8] 397197 0
Barriers and enablers to MedDiet adherence in a mixed methods survey will be assessed. These questions will be designed specifically for this study.
Timepoint [8] 397197 0
12 weeks (end intervention)
Secondary outcome [9] 398029 0
Biomarkers (insulin ) using standard venepuncture and analysis
Timepoint [9] 398029 0
baseline and 12 weeks
Secondary outcome [10] 398031 0
Biomarkers (liver function) using standard venepuncture and analysis
Timepoint [10] 398031 0
baseline and 12 weeks
Secondary outcome [11] 398033 0
Biomarkers (lipids) using standard venepuncture and analysis
Timepoint [11] 398033 0
baseline and 12 weeks

Eligibility
Key inclusion criteria
>/=18 years; BMI 25-39.9 kg/m2; diagnosis of NAFLD determined by routine ultrasound or biopsy, eligibility for Medicare as per hospital policy.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-English speaking; consume on average >140 g/week of alcohol; medications: immunosuppressants, amiodarone and/or perhexiline; a diagnosis of insulin dependent diabetes mellitus or taking gliclazides; pregnancy.

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 involved contacting the holder of the allocation schedule who was "off-site" or at central administration site
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
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
The sample size for this feasibility study is based on consensus in the literature and will include 12 valid sets of data per arm. Allowing for attrition of 20% based on our previous experience with this cohort, this feasibility study will recruit 28 participants, (two groups of 14) in 4 months based patients seen annually at relevant clinics and a participation rate of 30%.
For feasibility outcomes (i.e. acceptability, retention, safety), data will be presented as frequencies and relative frequencies and chi square tests will be used to compare between arms. For continuous outcomes (i.e. dietary adherence and change, weight loss and BMI change, waist circumference and body composition parameter changes) as well as blood pressure and laboratory measures, data will be presented as mean (SD) or median and IQR. For between group comparisons non-paired t tests or non-parametric equivalent tests will be used.

Recruitment
Recruitment status
Not yet 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] 19591 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 34198 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 308713 0
University
Name [1] 308713 0
Deakin University, Institute for Physical Activity and Nutrition Seed Funding
Address [1] 308713 0
221 Burwood Hwy Burwood 3125 VIC
Country [1] 308713 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Hwy Burwood 3125 VIC
Country
Australia
Secondary sponsor category [1] 309605 0
Hospital
Name [1] 309605 0
Alfred health
Address [1] 309605 0
55 Commercial Road Melbourne 3004 VIC
Country [1] 309605 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308638 0
Alfred Health Human Resarch Ethics Committee
Ethics committee address [1] 308638 0
55 Commercial Road Melbourne 3004, VIC
Ethics committee country [1] 308638 0
Australia
Date submitted for ethics approval [1] 308638 0
19/04/2021
Approval date [1] 308638 0
Ethics approval number [1] 308638 0

Summary
Brief summary
Non-alcoholic liver disease (NAFLD) affects 20-30% of the population and significantly increases the risk of liver related all-cause mortality, transplant, cardiovascular disease and liver cancer. There are no proven safe or effective pharmacotherapies and current management targets weight loss. In the absence of optimal diet and exercise prescription effective management strategies for NAFLD require urgent attention. There are currently no established recommendations for diet or exercise prescription to achieve weight loss. Establishing an effective management strategy for NAFLD, in light of the high (~5.5 million Australians in 2021) and increasing prevalence of the condition, is a public health priority.

Weight loss is the current recommendation for NAFLD and known to improve liver and cardiovascular outcomes. The Mediterranean Diet (MedDiet) is a promising intervention, improving body composition and metabolic risk factors in the absence of weight loss. These benefits are attributable to the MedDiet’s anti-inflammatory and antioxidant composition. Thus, developing a better understanding of the combined benefits of weight loss and MedDiet on body composition will facilitate the development of evidence-based interventions that can be translated into practice to improve outcomes for people with NAFLD.

Rationale/Justification:
The proposed research is significant as this innovative research will be the first worldwide to assess the feasibility of a web based hypocaloric MedDiet in NAFLD, in a non-Mediterranean cohort. A concept that would translate to an intervention that is novel yet simple, as well as cost effective, and can be integrated into practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111390 0
Dr Elena George
Address 111390 0
Deakin University,
221 Burwood Hwy Burwood 3125 VIC
Country 111390 0
Australia
Phone 111390 0
+61 3 924 68622
Fax 111390 0
Email 111390 0
elena.george@deakin.edu.au
Contact person for public queries
Name 111391 0
Dr Elena George
Address 111391 0
Deakin University
221 Burwood Hwy Burwood 3125 VIC
Country 111391 0
Australia
Phone 111391 0
+61 3 924 68622
Fax 111391 0
Email 111391 0
elena.george@deakin.edu.au
Contact person for scientific queries
Name 111392 0
Dr Elena George
Address 111392 0
Deakin Univeristy
221 Burwood Hwy Burwood 3125 VIC
Country 111392 0
Australia
Phone 111392 0
+61 3 924 68622
Fax 111392 0
Email 111392 0
elena.george@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants will not be identifiable and thus individual data will not be made available to protect confidentiality
What supporting documents are/will be available?
No other documents available
Summary results
No Results