About this trial
Steatosis is the building of fat in the liver. Steatotic liver disease (SLD) regroups MASLD (metabolic dysfunction-associated steatotic liver disease) and MASH (metabolic dysfunction-associated steatohepatitis) i.e. MASLD with inflammation. An estimated 30% of the population worldwide has MASLD and 5% of Canadians have MASH. MASH is a leading cause of liver transplantation in Canada. There is no cure for SLD, and the treatment relies on diet, weight loss, and physical activity (PA).
Is a counselling intervention to help patients progressively engage in more PA a feasible and acceptable approach? Objectives. This proposal has three primary objectives: 1) To assess the feasibility of our PA counselling intervention (to be delivered online) with SLD patients; 2) To evaluate the acceptability of our intervention; 3) To evaluate the feasibility of the study methods/procedures.
Methodology. This study is an open-label, mono-centred, single-case experimental design with multiple base levels. The study will comprise 3 phases, alternating periods of observation (A) and 1 period of counselling (B) with an A1-B-A2 design.
PA will be assessed continuously using an accelerometer for 7 to 14 days per (A) phase. During phase (B), participants will receive the intervention, i.e. 6 x 45-minute, real-time, face-to-face, virtual sessions with a PA counsellor.
Based on past studies, our sample size will be 12 participants. They will be recruited through the hepatology clinic at Hôpital Montfort.
The primary outcomes of the project are to evaluate the feasibility and acceptability of the trial and intervention. The secondary outcomes are Daily PA time and biological/imaging data evolution
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>18 years of age,
confirmed MASLD or MASH without cirrhosis
access to a computer with an internet connection
Disqualifiers
liver disease from another cause,
the existence of cirrhosis on imaging or clinically,
weekly alcohol consumption over 50g,
having a contraindication to PA without medical clearance (the Get Active questionnaire from the Canadian Society for Exercise Physiology is used to determine if medical clearance is needed),
Trial design
Single group
Treatments tested in this trial
Telehealth coaching for liver disease
BehavioralThis study is an open-label, mono-centred, single-case experimental design with multiple base levels. The study will comprise 3 phases, alternating periods of observation (A) and 1 period of counselling (B) with an A1-B-A2 design. PA will be assessed continuously using an accelerometer for 7 to 14 days per (A) phase. During phase (B), participants will receive the intervention, i.e. 6 x 45-minute, real-time, face-to-face, virtual sessions with a PA counsellor.
Treatment groups
Trial outcomes
Primary outcomes
attendance rate of participants
to evaluate the feasibility of the intervention
number of participants who completed the intervention
to evaluate the feasibility of the intervention
refusal rates
to evaluate the feasibility of the trial
recruitment rates
to evaluate the feasibility of the trial
Secondary outcomes
Measurement of daily PA time using a accelerometer during phases A
to evaluate the changes in daily PA before and after the coaching intervention
Measurement of liver function tests (ALT, AST, Gamma Glutamyl Transferase, Alkaline Phosphatase, bilirubin, albumin)
to evaluate the changes in biological variables before and after the coaching intervention
Measurement of lipids : fasting free fatty acids, total/High Density Lipoprotein/Low Density Lipoprotein cholesterol levels, triglycerides levels
to evaluate the changes in biological variables before and after the coaching intervention
Measurement of glucose levels: fasting glucose and insulin, HbA1clevels, triglycerides levels
to evaluate the changes in biological variables before and after the coaching intervention
Locations
Sponsors and contacts
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