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

Deakin University0 sites28 target enrollmentDecember 13, 2021

Overview

No summary available.

Registry

who.int

Start Date

December 13, 2021

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

•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.

•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