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Completed

NCT Number: NCT06348628

Motivational Interviewing in the Management of Non Alcoholic Fatty Liver Disease

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).

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, University of Kelaniya

Ragama, Western Province, 11010, Sri Lanka

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational interview

Behavioral

4 Motivational interviews within first 6 months

Placebo

Behavioral

Advices on standard of care treatment of NAFLD within first 6 months

Primary outcomes

  1. 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

  2. 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

  3. Change in platelet count after 1 year compared to baseline

    Time frame: Baseline and 12 months

    Lower platelet count has a poor outcome

  4. 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.

  5. 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.

Secondary outcomes

  1. Change in motivation for weight loss after 1 year compared to baseline

    Time frame: 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.

  2. Change in depression, anxiety and stress after 1 year compared to baseline

    Time frame: 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.

  3. Change in quality of life after 1 year compared to baseline

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Madunil Anuk Niriella

Other

Registry information

Official study title

Motivational Interviewing for Weight Loss in the Management of Non Alcoholic Fatty Liver Disease - A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 5, 2024
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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