Motivational Interviewing in the Management of Non Alcoholic Fatty Liver Disease

September 24, 2025 updated by: Madunil Anuk Niriella

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

231

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sri Lanka
    • Western Province
      • Ragama, Western Province, Sri Lanka, 11010
        • Faculty of Medicine, University of Kelaniya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Motivational Interview with Placebo

Each participant receives a motivational interview session at the recruitment, 1, 3, 6 months.

Simultaneously, They receive dietary, exercise and lifestyle advices.
Behavioral: Motivational Interview
4 Motivational interviews within first 6 months
Behavioral: Placebo
Advices on standard of care treatment of NAFLD within first 6 months
Placebo Comparator: Placebo
Participants receive dietary, exercise and lifestyle advices at the recruitment, 1, 3 and 6 months
Behavioral: Placebo
Advices on standard of care treatment of NAFLD within first 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 3 months, 6 months, 12 months
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
Baseline and 12 months
Change in platelet count after 1 year compared to baseline
Time Frame: Baseline and 12 months
Lower platelet count has a poor outcome
Baseline and 12 months
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.
Baseline and 12 months
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.
Baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 12 months
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.
Baseline, 12 months
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.
Baseline, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Madunil Anuk Niriella

Investigators

  • Study Director: Aruni Hapangama, MBBS, MDPsych, FRANZCP, The Alfred Hospital, Melbourne, Victoria, Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2022

Primary Completion (Actual)

April 22, 2025

Study Completion (Actual)

June 24, 2025

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Estimated)

September 30, 2025

Last Update Submitted That Met QC Criteria

September 24, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/38/04/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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