Non-Alcoholic Fatty Liver Disease
Conditions
Keywords
Motivational Interview, Randomized Controlled Trial
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.
Interventions
BEHAVIORALMotivational Interview
4 Motivational interviews within first 6 months
BEHAVIORALPlacebo
Advices on standard of care treatment of NAFLD within first 6 months
Sponsors
Madunil Anuk Niriella
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 platelet count after 1 year compared to baseline | Baseline and 12 months | Lower platelet count has a poor outcome |
| 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. |
| Change in weight after 1 year compared to baseline | Baseline, 3 months, 6 months, 12 months | Weight is measured using a digital scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Sri Lanka
Outcome results
None listed