Motivational Interviewing in the Management of Non Alcoholic Fatty Liver Disease

NCT06348628 | Completed DMC

• 1 other identifier: P/38/04/2021
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

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).

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Motivational Interview; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (5)

• Change in weight after 1 year compared to baseline

  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

  Lower AST and ALT levels have a better outcome

  Baseline and 12 months

• Change in platelet count after 1 year compared to baseline

  Lower platelet count has a poor outcome

  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.

  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.

  Baseline and 12 months

Secondary Outcomes (3)

• 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

Study Arms (2)

Motivational Interview with Placebo

EXPERIMENTAL

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; Behavioral: Placebo

Placebo

PLACEBO COMPARATOR

Participants receive dietary, exercise and lifestyle advices at the recruitment, 1, 3 and 6 months

Behavioral: Placebo

Interventions

Motivational Interview BEHAVIORAL

4 Motivational interviews within first 6 months

Motivational Interview with Placebo

Placebo BEHAVIORAL

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

Motivational Interview with Placebo; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Madunil Anuk Niriella: lead

Study Sites (1)

Faculty of Medicine, University of Kelaniya

Ragama, Western Province, 11010, Sri Lanka

Location

Related Publications (14)

• Younossi ZM, Stepanova M, Afendy M, Fang Y, Younossi Y, Mir H, Srishord M. Changes in the prevalence of the most common causes of chronic liver diseases in the United States from 1988 to 2008. Clin Gastroenterol Hepatol. 2011 Jun;9(6):524-530.e1; quiz e60. doi: 10.1016/j.cgh.2011.03.020. Epub 2011 Mar 25.

  PMID: 21440669 BACKGROUND

• Niriella MA, Pathmeswaran A, De Silva ST, Kasturiratna A, Perera R, Subasinghe CE, Kodisinghe K, Piyaratna C, Rishikesawan V, Dassanayaka AS, De Silva AP, Wickramasinghe R, Takeuchi F, Kato N, de Silva HJ. Incidence and risk factors for non-alcoholic fatty liver disease: A 7-year follow-up study among urban, adult Sri Lankans. Liver Int. 2017 Nov;37(11):1715-1722. doi: 10.1111/liv.13478. Epub 2017 Jun 10.

  PMID: 28544258 BACKGROUND

• Hu XY, Li Y, Li LQ, Zheng Y, Lv JH, Huang SC, Zhang W, Liu L, Zhao L, Liu Z, Zhao XJ. Risk factors and biomarkers of non-alcoholic fatty liver disease: an observational cross-sectional population survey. BMJ Open. 2018 Apr 5;8(4):e019974. doi: 10.1136/bmjopen-2017-019974.

  PMID: 29626047 BACKGROUND

• Hagstrom H, Nasr P, Ekstedt M, Hammar U, Stal P, Hultcrantz R, Kechagias S. Fibrosis stage but not NASH predicts mortality and time to development of severe liver disease in biopsy-proven NAFLD. J Hepatol. 2017 Dec;67(6):1265-1273. doi: 10.1016/j.jhep.2017.07.027. Epub 2017 Aug 10.

  PMID: 28803953 BACKGROUND

• Kawamura Y, Arase Y, Ikeda K, Seko Y, Imai N, Hosaka T, Kobayashi M, Saitoh S, Sezaki H, Akuta N, Suzuki F, Suzuki Y, Ohmoto Y, Amakawa K, Tsuji H, Kumada H. Large-scale long-term follow-up study of Japanese patients with non-alcoholic Fatty liver disease for the onset of hepatocellular carcinoma. Am J Gastroenterol. 2012 Feb;107(2):253-61. doi: 10.1038/ajg.2011.327. Epub 2011 Oct 18.

  PMID: 22008893 BACKGROUND

• Sarwar R, Pierce N, Koppe S. Obesity and nonalcoholic fatty liver disease: current perspectives. Diabetes Metab Syndr Obes. 2018 Sep 25;11:533-542. doi: 10.2147/DMSO.S146339. eCollection 2018.

  PMID: 30288073 BACKGROUND

• Schubel R, Nonnenmacher T, Sookthai D, Gonzalez Maldonado S, Sowah SA, von Stackelberg O, Schlett CL, Grafetstatter M, Nabers D, Johnson T, Kirsten R, Ulrich CM, Kaaks R, Kauczor HU, Kuhn T, Nattenmuller J. Similar Weight Loss Induces Greater Improvements in Insulin Sensitivity and Liver Function among Individuals with NAFLD Compared to Individuals without NAFLD. Nutrients. 2019 Mar 4;11(3):544. doi: 10.3390/nu11030544.

  PMID: 30836637 BACKGROUND

• Vilar-Gomez E, Martinez-Perez Y, Calzadilla-Bertot L, Torres-Gonzalez A, Gra-Oramas B, Gonzalez-Fabian L, Friedman SL, Diago M, Romero-Gomez M. Weight Loss Through Lifestyle Modification Significantly Reduces Features of Nonalcoholic Steatohepatitis. Gastroenterology. 2015 Aug;149(2):367-78.e5; quiz e14-5. doi: 10.1053/j.gastro.2015.04.005. Epub 2015 Apr 10.

  PMID: 25865049 BACKGROUND

• Centis E, Moscatiello S, Bugianesi E, Bellentani S, Fracanzani AL, Calugi S, Petta S, Dalle Grave R, Marchesini G. Stage of change and motivation to healthier lifestyle in non-alcoholic fatty liver disease. J Hepatol. 2013 Apr;58(4):771-7. doi: 10.1016/j.jhep.2012.11.031. Epub 2012 Nov 29.

  PMID: 23201248 BACKGROUND

• Stewart KE, Haller DL, Sargeant C, Levenson JL, Puri P, Sanyal AJ. Readiness for behaviour change in non-alcoholic fatty liver disease: implications for multidisciplinary care models. Liver Int. 2015 Mar;35(3):936-43. doi: 10.1111/liv.12483. Epub 2014 Mar 10.

  PMID: 24521540 BACKGROUND

• Ceccarini M, Borrello M, Pietrabissa G, Manzoni GM, Castelnuovo G. Assessing motivation and readiness to change for weight management and control: an in-depth evaluation of three sets of instruments. Front Psychol. 2015 May 11;6:511. doi: 10.3389/fpsyg.2015.00511. eCollection 2015.

  PMID: 26029126 BACKGROUND

• Rodriguez-Cristobal JJ, Alonso-Villaverde C, Panisello JM, Trave-Mercade P, Rodriguez-Cortes F, Marsal JR, Pena E. Effectiveness of a motivational intervention on overweight/obese patients in the primary healthcare: a cluster randomized trial. BMC Fam Pract. 2017 Jun 20;18(1):74. doi: 10.1186/s12875-017-0644-y.

  PMID: 28633627 BACKGROUND

• Gelli C, Tarocchi M, Abenavoli L, Di Renzo L, Galli A, De Lorenzo A. Effect of a counseling-supported treatment with the Mediterranean diet and physical activity on the severity of the non-alcoholic fatty liver disease. World J Gastroenterol. 2017 May 7;23(17):3150-3162. doi: 10.3748/wjg.v23.i17.3150.

  PMID: 28533672 BACKGROUND

• Mazzotti A, Caletti MT, Brodosi L, Di Domizio S, Forchielli ML, Petta S, Bugianesi E, Bianchi G, Marchesini G. An internet-based approach for lifestyle changes in patients with NAFLD: Two-year effects on weight loss and surrogate markers. J Hepatol. 2018 Nov;69(5):1155-1163. doi: 10.1016/j.jhep.2018.07.013. Epub 2018 Oct 2.

  PMID: 30290973 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Aruni Hapangama, MBBS, MDPsych, FRANZCP

  The Alfred Hospital, Melbourne, Victoria, Australia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor in Gastroenterology

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 5, 2024
• Study Start: May 31, 2022
• Primary Completion: April 22, 2025
• Study Completion: June 24, 2025
• Last Updated: September 30, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SR (1)