Study Results
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Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-08-30
2026-12-31
Brief Summary
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Detailed Description
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The main objective of presented project is to compare the progression of NAFLD/NASH in patients with metabolic syndrome randomly assigned to a standard care or a professional lifestyle modification counselling during a 1-yr follow-up. The investigators hypothesize that professionally tailored life-style counselling in patient with metabolic syndrome and NAFLD will improve liver fat content and other non-invasive parameters of liver disease, and factors (including gut microbiota) affecting progression/regression of NAFLD will be identified.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Professional lifestyle modification counselling (behavioral therapy)
Lifestyle intervention will be based on CBT (cognitive behavioral therapy) and mindfulness, especially mindful eating by professional organisation STOB.
Cognitive behavioral therapy
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.
standard care
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.
No interventions assigned to this group
Interventions
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Cognitive behavioral therapy
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Presence of malignant disease.
* Uncontrolled cardiovascular disease
* Pregnancy.
18 Years
ALL
No
Sponsors
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General University Hospital, Prague
OTHER
Responsible Party
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Radan Bruha
Head of 4th Internal clinic
Principal Investigators
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Radan Bruha, Prof.
Role: PRINCIPAL_INVESTIGATOR
General University Hospital, Prague
Locations
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General University Hospital
Prague, , Czechia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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NU23-01-00288
Identifier Type: -
Identifier Source: org_study_id
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