Implementation of the Fatty Liver Index in Primary Care

NCT ID: NCT06363617

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 434 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-02
• Study Completion Date: 2025-02-01

Brief Summary

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.

Conditions

Hepatic Steatosis; Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

FLI test implementation

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.

Group Type: EXPERIMENTAL

FLI

Intervention Type: OTHER

Health professionals will use the FLI test in their clinical practice

control

This group of healthcare professionals will continue with their usual clinical practice.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

FLI

Health professionals will use the FLI test in their clinical practice

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Men and women aged 14 years and older.
• Attended at the Basic Care Units (BCU) participating in the Primary Care Center Baix a Mar study.
• Intention to undergo medical follow-up at the study center.
• Body mass index ≥ 25.

Exclusion Criteria

• Pregnant women
• Alcohol consumption habit (Standard Drink Unit (SDU); one SDU equals 10 grams of alcohol. Risky consumption is considered from 4 SDUs in men and 2 SDUs in women).
• Displaced patients not assigned to the study center.
• Patients classified as Advanced Chronic Care Model or Complex Chronic Patient.
• Participants diagnosed with any of the following pathologies: Chronic liver diseases, including hepatic steatosis; Dementia; Active oncological diseases
• Cognitive or affective pathology that limits the ability to collaborate with lifestyle interventions carried out at the center.
• Patients under the care of endocrinology specialists.
• Participation in another clinical trial involving an experimental intervention during the period of this trial.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consorci Sanitari de l'Alt Penedès i Garraf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

M Carmen Rosas, MD

Role: PRINCIPAL_INVESTIGATOR

CSAPG

Locations

Centro de Salud Vilanova i la Geltrú 3 Baix A Mar

Vilanova i la Geltrú, Barcelona, Spain

Countries

Spain

Other Identifiers

CSAPG-58

Identifier Type: -

Identifier Source: org_study_id