Motivational Interviewing for Weight Loss in the Management of Non Alcoholic Fatty Liver Disease - A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Sponsor
- Madunil Anuk Niriella
- Enrollment
- 231
- Locations
- 1
- Primary Endpoint
- Change in weight after 1 year compared to baseline
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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.
Investigators
Madunil Anuk Niriella
Professor in Gastroenterology
University of Kelaniya
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
Outcomes
Primary Outcomes
Change in weight after 1 year compared to baseline
Time Frame: Baseline, 3 months, 6 months, 12 months
Weight is measured using a digital scale
Change in platelet count after 1 year compared to baseline
Time Frame: 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
Time Frame: 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
Time Frame: Baseline and 12 months
Both are measured by impedance method.
Change in waist circumference and hip circumference after 1 year compared to baseline
Time Frame: 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 Outcomes
- Change in motivation for weight loss after 1 year compared to baseline(Baseline, 12 months)
- Change in depression, anxiety and stress after 1 year compared to baseline(Baseline, 12 months)
- Change in quality of life after 1 year compared to baseline(Baseline, 12 months)