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Feasibility of using telehealth to deliver an exercise and nutrition intervention to people with non-alcoholic fatty liver disease

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001706864
Enrollment
28
Registered
2021-12-13
Start date
2022-09-01
Completion date
2022-11-03
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Low muscle mass (sarcopenia) is emerging as a significant risk factor for non-alcoholic fatty liver disease (NAFLD) and there is evidence to suggest this risk may be even higher in those with obesity. While weight loss, through hypocaloric diets and aerobic exercise is currently the mainstay of NAFLD prevention and management a concurrent loss of muscle (lean) mass often occurs with this approach. Studies conducted in non-NAFLD participants have indicated weight loss in conjunction with a higher protein intake and/or progressive resistance training (PRT) may improve or attenuate the associated loss of muscle (lean) mass during weight loss interventions. Yet, no study to date has assessed the feasibility of a higher protein intake from predominately plant-based sources in conjunction with exercise incorporating AT plus PRT in a NAFLD cohort. Uptake and adherence to community and clinic-based exercise programs is typically poor. Telehealth has emerged as an encouraging intervention delivery method to expand participant reach and accessibility by shifting treatment from clinics and hospitals to patients’ homes for people with chronic disease such as NAFLD and T2D. For example, telehealth facilitates contact to and overcomes several barriers to traditional exercise and nutrition interventions, including access to evidence-based programs anytime and anywhere, cost, transport and issues related to geographical location. Furthermore, telehealth allows regular follow-ups with healthcare professionals and can be individualised according to each patient’s needs. However, few lifestyle focused telehealth programs have been conducted in NAFLD cohorts, and before they can be widely implemented further research is required required to assess the feasibility, adherence, and effectiveness of telehealth as a model of healthcare delivery for people with NAFLD . Therefore the aim of this 12-week randomsied controlled trial is to evaluate whether a telehealth intervention focused on increasing daily protein intake (predominately from plant-based sources) combined with a smart device exercise app to promote regular muscle strengthening exercise is safe and feasible for middle aged and older adults with NAFLD. Secondly, whether the above mentioned telehealth lifestyle intervention can improve lifestyle behaviours related to overall physical activity and diet quality and functional muscle strength.

Interventions

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 he

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.

Sponsors

Deakin University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026