Implementation of the Fatty Liver Index in Primary Care

NCT06363617 | Completed

• 1 other identifier: CSAPG-58
• Study Type: interventional
• Target: 434
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Lifestyle Intervention

  Percentage of participants receiving a lifestyle intervention from the start of the study to month 6

  Month 6

Secondary Outcomes (8)

• Low-density lipoprotein cholesterol

  Month 12

• Triglycerides

  Month 12

• Gamma-glutamyl transpeptidase

  Month 12

• Medical and nursing visits

  Month 12

• Analytical checks in the first year

  Month 12

Study Arms (2)

FLI test implementation

EXPERIMENTAL

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

control

NO INTERVENTION

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

Interventions

FLI OTHER

Health professionals will use the FLI test in their clinical practice

FLI test implementation

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorci Sanitari de l'Alt Penedès i Garraf: lead

Study Sites (1)

Centro de Salud Vilanova i la Geltrú 3 Baix A Mar

Vilanova i la Geltrú, Barcelona, Spain

Location

MeSH Terms

Conditions

Fatty Liver; Overweight; Obesity

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• M Carmen Rosas, MD

  CSAPG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: May 2, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After publication of main results of the study.
• Access Criteria: IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.

Locations

ES (1)