Non-alcoholic Fatty Liver Disease
Conditions
Interventions
This is a randomized, controlled, non-blinded clinical trial in patients diagnosed with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). Patients will be randomly allocated into 2 gro
Sponsors
Faculdade de Medicina da Universidade Federal de Minas Gerais
Faculdade de Medicina da Universidade Federal de Minas Gerais
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients diagnosed with Metabolic Dysfunction-Associated Steatotic Liver Disease - MASLD by imaging method or liver biopsy; age between 18 and 65 years; agreement to participate in the study and signing of the Informed Consent Form; both sexes
Exclusion criteria
Exclusion criteria: Age over 65 years of both sexes; illiterate individuals; diagnosis of decompensated liver cirrhosis or Child-Pugh B or C; patients with liver cancer; individuals who do not have digital skills; individuals who have practiced mindfulness, meditation or yoga in the last 6 months (with regular practice of at least 3 times a week); individuals who are in an acute phase of depression and/or have a high score on the Depression Anxiety Stress Scale - 21 items (DASS-21); individuals diagnosed with schizophrenia and at suicide risk; pregnant women; individuals with untreated hypothyroidism and/or hyperthyroidism, Cushing's syndrome and individuals who have undergone bariatric surgery (less than 5 years ago); patients who have not participated in the leveling session to start the groups; patients who have been using orlistat, bupropion hydrochloride and Glucagon-Like Peptide - 1 (GLP-1) analogues for less than 6 months or whose dose has been modified in the last 6 months; patients using tamoxifen, methotrexate, corticosteroids, amiodarone and sodium valproate; women with alcohol consumption greater than 20g/day (140g/week) and men with consumption greater than 30g/day (210g/week); patients who have obtained a score below stage 3 (preparation) in the readiness for change questionnaire; patients who have had weight loss greater than 5% in the last 6 months; individuals who have undergone cancer treatment less than 5 years ago, except for basal cell and squamous cell skin cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that there will be an improvement in eating behavior, verified through binge eating variable, based on the finding of a significant reduction in the Binge Eating Scale score. Data will be collected before, at the end of the interventions and 6 months after their completion | — |
Secondary
| Measure | Time frame |
|---|---|
| Food consumption: It is expected to find an improvement in food intake after the intervention and six months after its completion, verified through the Quest-Nova web platform, based on the finding of an increase in the consumption of natural and minimally processed foods and a reduction in the consumption of processed and ultra-processed foods;Perceived stress: A reduction in perceived stress is expected after the intervention and six months after its completion, as verified by means of a scale that measures the degree to which individuals perceive situations as stressful (Perceived Stress Scale - PSS). A reduction in the scale score is expected;Eating behavior: It is expected to find improvements in the three dimensions of eating behavior, emotional eating, eating due to external factors and restrictive eating, after the intervention and six months after its completion, through a reduction in the score on the Dutch Eating Behavior Questionnaire (DEBQ) scale;Anthropometric parameters: To evaluate the effects of the intervention on nutritional status, determined through anthropometric parameters [body mass index - BMI (weight/height²), waist circumference - WC and calf circumference - CP] after the intervention and six months after its completion;Body composition and muscle strength: To assess changes in body composition, verified through bioelectrical impedance [BIA - Quantum X (RJL Systems, Inc., Clinton Township, Michigan, USA)], and to assess changes in muscle strength, through dynamometry analysis, using a hydraulic dynamometer [JAMAR ® (Preston, Jackson, MI, USA)]. Analyses will be performed before, at the end of the interventions and 6 months after their completion;Liver and metabolic function markers : Assess metabolic markers, determined through biochemical tests (glutamic-oxaloacetic transaminase, glutamic-pyruvic transaminase, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, blood glucose, glycohemoglobin, albumin and platelet count), b | — |
Countries
BR
Contacts
Public ContactLuciana Faria
Universidade Federal de Minas Gerais
Outcome results
None listed