Motivational Interviewing in the Management of Non Alcoholic Fatty Liver Disease
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Interventions
- Behavioral: Motivational InterviewBehavioral: Placebo
- Registration Number
- NCT06348628
- Lead Sponsor
- Madunil Anuk Niriella
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 231
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Motivational Interview with Placebo Motivational Interview Each participant receives a motivational interview session at the recruitment, 1, 3, 6 months. Simultaneously, They receive dietary, exercise and lifestyle advices. Placebo Placebo Participants receive dietary, exercise and lifestyle advices at the recruitment, 1, 3 and 6 months Motivational Interview with Placebo Placebo Each participant receives a motivational interview session at the recruitment, 1, 3, 6 months. Simultaneously, They receive dietary, exercise and lifestyle advices.
- Primary Outcome Measures
Name Time Method Change in weight after 1 year compared to baseline Baseline, 3 months, 6 months, 12 months Weight is measured using a digital scale
Change in platelet count after 1 year compared to baseline Baseline and 12 months Lower platelet count has a poor outcome
Change in Aspartate aminotransferase (AST) level and Alanine aminotransferase (ALT) level after 1 year compared to baseline Baseline and 12 months Lower AST and ALT levels have a better outcome
Change in total fat percentage and visceral fat percentage after 1 year compared to baseline Baseline and 12 months Both are measured by impedance method.
Change in waist circumference and hip circumference after 1 year compared to baseline Baseline and 12 months The waist circumference is measured at the narrowest part of the waist. The hip circumference is measured at the widest part of the hips. Both are measured by using a measuring tape.
- Secondary Outcome Measures
Name Time Method Change in motivation for weight loss after 1 year compared to baseline Baseline, 12 months It is assessed using the validated self-report University of Rhode Island Change Assessment (URICA) scale. The minimum value is -2 and the maximum value is +14. a higher score means a better outcome while a lower score means a poor outcome.
Change in depression, anxiety and stress after 1 year compared to baseline Baseline, 12 months It is assessed using the Depression, Anxiety and Stress Scale-21 (DASS-21). The minimum value for depression is 0 while maximum value is 28. A score more than 21 means severe depression. A minimum value for anxiety is 0 while maximum value is 20. A score more than 15 means severe anxiety. A minimum value for stress is 0 while maximum value is 34. A score more than 26 means severe stress.
Change in quality of life after 1 year compared to baseline Baseline, 12 months It is assessed using the World Health Organization Quality of Life Brief (WHOQOL-BREF) version. The minimum value is 0 and the maximum value is 100. A lower score indicates poor quality of life while a higher score indicates a good quality of life.
Trial Locations
- Locations (1)
Faculty of Medicine, University of Kelaniya
🇱🇰Ragama, Western Province, Sri Lanka