An interventional study of FLI in Hepatic Steatosis and Overweight and Obesity, sponsored by Consorci Sanitari de l'Alt Penedès i Garraf. Completed at 1 site in Spain. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2025-06-29.
Sponsored by Consorci Sanitari de l'Alt Penedès i Garraf · Not applicable, Interventional, and Supportive care
This trial aims to evaluate the impact on cardiovascular risk control in individuals in risk of being affected by hepatic steatosis through the implementation of a screening test (Fatty Liver Index) in Primary Care. Medical teams in a primary care center will be divided into 2 groups, with one group using the screening test in their clinical practice. The number of interventions on cardiovascular risk occurring in patients attended by each group of medical teams will be evaluated and compared.
1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.
This study's enrollment of 434 is above the median of 60 across 1,003 interventional studies indexed under Fatty Liver.
Browse Fatty Liver studies →Consorci Sanitari de l'Alt Penedès i Garraf is the lead sponsor of 36 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A training session will be conducted for healthcare professionals on the risks of hepatic steatosis in patients with a body mass index (BMI) equal to or greater than 25. Additionally, professionals will be instructed in the use of the Fatty Liver Index (FLI) tool, validated for assessing the risk of steatosis. This tool will be implemented in the center's computer system, making it accessible via a link for the professionals receiving the intervention.
Other: FLI
This group of healthcare professionals will continue with their usual clinical practice.
Health professionals will use the FLI test in their clinical practice
Lifestyle Intervention
Percentage of participants receiving a lifestyle intervention from the start of the study to month 6
Time frame: Month 6
Low-density lipoprotein cholesterol
Value of low-density lipoprotein cholesterol (LDL cholesterol) in analyses performed between 6 months and one year post-intervention
Time frame: Month 12
Triglycerides
Value of triglycerides in analyses performed between 6 months and one year post-intervention
Time frame: Month 12
Gamma-glutamyl transpeptidase
Value of gamma-glutamyl transpeptidase in analyses performed between 6 months and one year post-intervention
Time frame: Month 12
Medical and nursing visits
Number of medical and nursing visits in the year following the intervention.
Time frame: Month 12
Analytical checks in the first year
Percentage of patients who had not undergone previous analytical checks according to protocol and who undergo analysis in the first year after the start of the study.
Time frame: Month 12
Lipid-lowering drugs
Number of prescriptions for lipid-lowering drugs.
Time frame: Month 12
Healthcare spending
Analysis of healthcare spending associated with each intervention, using billing data from the center associated with the use of resources by the insured party.
Time frame: Month 12
FLI administration
Percentage of patients with body mass index equal or more than 25 who have been administered the FLI
Time frame: Month 12
Plan to share: Yes — IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
Supporting information: Study protocol, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Consorci Sanitari de l'Alt Penedès i Garraf