Motivational Interviewing in the Management of Non Alcoholic Fatty Liver Disease

Madunil Anuk Niriella

Status: Completed

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Behavioral: Motivational Interview; Behavioral: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06348628

P/38/04/2021

Details and patient eligibility

About

The goal of this study is to assess if motivational counselling works to reduce the weight in participants with Non Alcoholic Fatty Liver Disease (NAFLD).

Full description

Participants with NAFLD who meet inclusion and exclusion criteria and who give informed written consent, will be randomly assigned to the intervention and control group. Randomization will be done by using a random sequence generator with concealed allocation.

Enrollment: 231 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 years to 60 years
• Body Mass Index (BMI) is 25 kg/m^2 or more
• Newly diagnosed with NAFLD based on clinical history, ultrasound scan and laboratory values

Exclusion criteria

• Any medical condition that will significantly alter the weight eg: hypothyroidism, hyperthyroidism, Cushing disease
• Having moderate/severe depressive disorders or psychotic symptoms and or substance use disorders that would reduce their capacity to give consent and engage in Motivational interview
• Who are on drugs which will affect weight or mood/affect (eg: corticosteroids)
• Pregnancy or expecting to be conceive within the study period
• Having any health conditions that would impede engagement in physical activities
• Having any health conditions that would compromise the ability to follow the recommended dietary behaviors
• Concurrent involvement in another weight loss programme

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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231 participants in 2 patient groups, including a placebo group

Motivational Interview with Placebo

Experimental group

Description:

Each participant receives a motivational interview session at the recruitment, 1, 3, 6 months. Simultaneously, They receive dietary, exercise and lifestyle advices.

Treatment:

Behavioral: Placebo

Behavioral: Motivational Interview

Placebo

Placebo Comparator group

Description:

Participants receive dietary, exercise and lifestyle advices at the recruitment, 1, 3 and 6 months

Treatment:

Behavioral: Placebo