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

NCT06446908 | Not Yet Recruiting

• 1 other identifier: 2024-A06PHYSACTIV
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Liver Steatosis; MASH; MASLD

Keywords

Physical activity; coaching; telehealth; liver

Outcome Measures

Primary Outcomes (7)

• attendance rate of participants

  to evaluate the feasibility of the intervention

  1 year

• number of participants who completed the intervention

  to evaluate the feasibility of the intervention

  1 year

• refusal rates

  to evaluate the feasibility of the trial

  1 year

• recruitment rates

  to evaluate the feasibility of the trial

  1 year

• attrition rates

  to evaluate the feasibility of the trial

  1 year

• semi-structured interviews at the end of participation

  to evaluate the acceptability of the intervention

  18 months

• 7-item questionnaire developed for the TELE-BariACTIV study with statements in the future tense for before phase B or past tense for after phase B

  to assess retrospective and prospective acceptability

  18 months

Secondary Outcomes (8)

• Measurement of daily PA time using a accelerometer during phases A

  18 months

• Measurement of liver function tests (ALT, AST, Gamma Glutamyl Transferase, Alkaline Phosphatase, bilirubin, albumin)

  18 months

• Measurement of lipids : fasting free fatty acids, total/High Density Lipoprotein/Low Density Lipoprotein cholesterol levels, triglycerides levels

  18 months

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

  18 months

• Measurement of weight

  18 months

Study Arms (1)

Coaching Intervention

EXPERIMENTAL

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.

Behavioral: Telehealth coaching for liver disease

Interventions

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.

Coaching Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years of age,
• confirmed MASLD or MASH without cirrhosis
• access to a computer with an internet connection

You may not qualify if:

• 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),
• being already enrolled in a supervised exercise intervention or PA behaviour change intervention or currently meeting PA guidelines of 150 mins/week
• the need for a wheelchair, cane, walker, or other support(s) to move

Sponsors & Collaborators

• Hopital Montfort: lead

MeSH Terms

Conditions

Fatty Liver; Motor Activity

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Behavior

Study Officials

• Celine Fresne, MD

  H[opital Montfort

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Celine Fresne, MD

CONTACT

6137464621; celinefresne@montfort.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 6, 2024
• Study Start: August 1, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share