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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
231
4 Motivational interviews within first 6 months
Advices on standard of care treatment of NAFLD within first 6 months
Faculty of Medicine, University of Kelaniya
Ragama, Western Province, Sri Lanka
Change in weight after 1 year compared to baseline
Weight is measured using a digital scale
Time frame: Baseline, 3 months, 6 months, 12 months
Change in Aspartate aminotransferase (AST) level and Alanine aminotransferase (ALT) level after 1 year compared to baseline
Lower AST and ALT levels have a better outcome
Time frame: Baseline and 12 months
Change in platelet count after 1 year compared to baseline
Lower platelet count has a poor outcome
Time frame: Baseline and 12 months
Change in waist circumference and hip circumference after 1 year compared to baseline
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.
Time frame: Baseline and 12 months
Change in total fat percentage and visceral fat percentage after 1 year compared to baseline
Both are measured by impedance method.
Time frame: Baseline and 12 months
Change in motivation for weight loss after 1 year compared to baseline
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.
Time frame: Baseline, 12 months
Change in depression, anxiety and stress after 1 year compared to baseline
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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.
Time frame: Baseline, 12 months
Change in quality of life after 1 year compared to baseline
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.
Time frame: Baseline, 12 months