Clinical trial NCT06348628: Motivational Interviewing in the Management of Non Alcoholic Fatty Liver Disease
Official title: Motivational Interviewing for Weight Loss in the Management of Non Alcoholic Fatty Liver Disease - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: Motivational Interview
Randomized Controlled Trial
Lead sponsor: University of Kelaniya
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in weight after 1 year compared to baseline
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in Aspartate aminotransferase (AST) level and Alanine aminotransferase (ALT) level after 1 year compared to baseline
timeFrame: Baseline and 12 months
measure: Change in platelet count after 1 year compared to baseline
timeFrame: Baseline and 12 months
measure: Change in waist circumference and hip circumference after 1 year compared to baseline
timeFrame: Baseline and 12 months
measure: Change in total fat percentage and visceral fat percentage after 1 year compared to baseline
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change in motivation for weight loss after 1 year compared to baseline
timeFrame: Baseline, 12 months
measure: Change in depression, anxiety and stress after 1 year compared to baseline
timeFrame: Baseline, 12 months
measure: Change in quality of life after 1 year compared to baseline
timeFrame: Baseline, 12 months
Other outcomes:
Locations:
city: Ragama
country: Sri Lanka
facility: Faculty of Medicine, University of Kelaniya
state: Western Province
Study officials:
affiliation: The Alfred Hospital, Melbourne, Victoria, Australia
name: Aruni Hapangama, MBBS, MDPsych, FRANZCP
role: STUDY_DIRECTOR
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