Lifestyle Modification in the Treatment of NAFLD.

NCT05816915 | Recruiting

• 1 other identifier: NU23-01-00288
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The project will study the impact of individually tailored lifestyle counselling compared to standard care on the parameters of NAFLD/NASH in patients with metabolic syndrome. The factors affecting the outcome (including clinical and laboratory parameters and microbiome profiling) will be evaluated.

Conditions

NAFLD

Keywords

NAFLD; Cognitive behavioral therapy

Outcome Measures

Primary Outcomes (3)

• The effect of CBT on liver fat content

  The effect of CBT on liver fat content measured by MRS (percentual change from baseline).

  12 months

• The effect of CBT on inflammatory parameters

  The effect of CBT on inflammatory biochemical parameters (percentual change from baseline).

  12 months

• The effect of CBT on liver fibrosis

  The effect of CBT on liver fibrosis measured by elastography (percentual change from baseline).

  12 months

Study Arms (2)

Professional lifestyle modification counselling (behavioral therapy)

EXPERIMENTAL

Lifestyle intervention will be based on CBT (cognitive behavioral therapy) and mindfulness, especially mindful eating by professional organisation STOB.

Behavioral: Cognitive behavioral therapy

standard care

NO INTERVENTION

Patients will have standard care with regular visits at an outpatient Department of Hepatology. Standard recommendations of lifestyle change and weight reduction will be given by hepatologists.

Interventions

Cognitive behavioral therapy BEHAVIORAL

Subjects will receive professional lifestyle intervention conducted by STOB organization. Using CBT and the so-called third wave of CBT, especially mindfulness, the patients will be guided by certified experts to increase motivation and to change eating and exercise habits, which will be mapped before and after the intervention.

Professional lifestyle modification counselling (behavioral therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with NAFLD and metabolic syndrome

You may not qualify if:

• Etiology of liver disease other than NAFLD.
• Presence of malignant disease.
• Uncontrolled cardiovascular disease
• Pregnancy.

Sponsors & Collaborators

• General University Hospital, Prague: lead

Study Sites (1)

General University Hospital

Prague, 12808, Czechia

RECRUITING

Related Publications (3)

• Zelber-Sagi S, Ratziu V, Oren R. Nutrition and physical activity in NAFLD: an overview of the epidemiological evidence. World J Gastroenterol. 2011 Aug 7;17(29):3377-89. doi: 10.3748/wjg.v17.i29.3377.

  PMID: 21876630 BACKGROUND

• Smid V, Dvorak K, Sedivy P, Kosek V, Lenicek M, Dezortova M, Hajslova J, Hajek M, Vitek L, Bechynska K, Bruha R. Effect of Omega-3 Polyunsaturated Fatty Acids on Lipid Metabolism in Patients With Metabolic Syndrome and NAFLD. Hepatol Commun. 2022 Jun;6(6):1336-1349. doi: 10.1002/hep4.1906. Epub 2022 Feb 11.

  PMID: 35147302 BACKGROUND

• Fernandez T, Vinuela M, Vidal C, Barrera F. Lifestyle changes in patients with non-alcoholic fatty liver disease: A systematic review and meta-analysis. PLoS One. 2022 Feb 17;17(2):e0263931. doi: 10.1371/journal.pone.0263931. eCollection 2022.

  PMID: 35176096 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Radan Bruha, Prof.

  General University Hospital, Prague

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radan Bruha, Prof.

CONTACT

+420224962506; bruha@cesnet.cz

Vaclav Smid, MD

CONTACT

+420224962506; vaclav.smid@vfn.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of 4th Internal clinic

Model Details: Patients with NAFLD and metabolic syndrome will be randomly assigned to a standard care or a professional lifestyle modification counselling during a 1-yr follow-up.

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 18, 2023
• Study Start: August 30, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

CZ (1)