Acceptability and Feasibility of a New Approach to Engage Patients With Steatotic Liver Disease in Physical Activity

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHopital Montfort

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 volunteers

Qualifiers

>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

Design model

Single group

Treatments tested in this trial

  • Telehealth coaching for liver disease

    Behavioral

    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.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Coaching InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

attendance rate of participants

to evaluate the feasibility of the intervention

Time frame
1 year
2

number of participants who completed the intervention

to evaluate the feasibility of the intervention

Time frame
1 year
3

refusal rates

to evaluate the feasibility of the trial

Time frame
1 year
4

recruitment rates

to evaluate the feasibility of the trial

Time frame
1 year

Secondary outcomes

1

Measurement of daily PA time using a accelerometer during phases A

to evaluate the changes in daily PA before and after the coaching intervention

Time frame
18 months
2

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

Time frame
18 months
3

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

Time frame
18 months
4

Measurement of glucose levels: fasting glucose and insulin, HbA1clevels, triglycerides levels

to evaluate the changes in biological variables before and after the coaching intervention

Time frame
18 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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