Health TrialsbyHealthPanel

Lifestyle Modification in the Treatment of NAFLD.

ConditionNAFLD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeneral University Hospital, Prague

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals with NAFLD and metabolic syndrome

Disqualifiers

Etiology of liver disease other than NAFLD.

Presence of malignant disease.

Uncontrolled cardiovascular disease

Pregnancy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Professional lifestyle modification counselling (behavioral therapy)Experimental treatment 1 intervention
Group B: standard careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The effect of CBT on liver fat content

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

Time frame
12 months
2

The effect of CBT on inflammatory parameters

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

Time frame
12 months
3

The effect of CBT on liver fibrosis

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

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

General University Hospital, Prague

Lead sponsor

Source ClinicalTrials.gov
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