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Implementation of the Fatty Liver Index in Primary Care

Implementation of the Fatty Liver Index in Primary Care for Patients at Risk of Hepatic Steatosis to Optimize Clinical Control: Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06363617
Acronym
FLI-AP
Enrollment
434
Registered
2024-04-12
Start date
2024-05-02
Completion date
2025-02-01
Last updated
2025-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Steatosis, Overweight and Obesity

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.

Interventions

OTHERFLI

Health professionals will use the FLI test in their clinical practice

Sponsors

Consorci Sanitari de l'Alt Penedès i Garraf
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Lifestyle InterventionMonth 6Percentage of participants receiving a lifestyle intervention from the start of the study to month 6

Secondary

MeasureTime frameDescription
TriglyceridesMonth 12Value of triglycerides in analyses performed between 6 months and one year post-intervention
Gamma-glutamyl transpeptidaseMonth 12Value of gamma-glutamyl transpeptidase in analyses performed between 6 months and one year post-intervention
Medical and nursing visitsMonth 12Number of medical and nursing visits in the year following the intervention.
Low-density lipoprotein cholesterolMonth 12Value of low-density lipoprotein cholesterol (LDL cholesterol) in analyses performed between 6 months and one year post-intervention
Lipid-lowering drugsMonth 12Number of prescriptions for lipid-lowering drugs.
Healthcare spendingMonth 12Analysis of healthcare spending associated with each intervention, using billing data from the center associated with the use of resources by the insured party.
FLI administrationMonth 12Percentage of patients with body mass index equal or more than 25 who have been administered the FLI
Analytical checks in the first yearMonth 12Percentage 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026