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Completed

NCT Number: NCT06363617

Implementation of the Fatty Liver Index in Primary 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.

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Key information

Conditions

Hepatic Steatosis Body Weight Digestive System Diseases Fatty Liver Liver Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Salud Vilanova i la Geltrú 3 Baix A Mar

Vilanova i la Geltrú, Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FLI

Other

Health professionals will use the FLI test in their clinical practice

Primary outcomes

  1. Lifestyle Intervention

    Time frame: Month 6

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

Secondary outcomes

  1. Low-density lipoprotein cholesterol

    Time frame: Month 12

    Value of low-density lipoprotein cholesterol (LDL cholesterol) in analyses performed between 6 months and one year post-intervention

  2. Triglycerides

    Time frame: Month 12

    Value of triglycerides in analyses performed between 6 months and one year post-intervention

  3. Gamma-glutamyl transpeptidase

    Time frame: Month 12

    Value of gamma-glutamyl transpeptidase in analyses performed between 6 months and one year post-intervention

  4. Medical and nursing visits

    Time frame: Month 12

    Number of medical and nursing visits in the year following the intervention.

  5. Analytical checks in the first year

    Time frame: Month 12

    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.

  6. Lipid-lowering drugs

    Time frame: Month 12

    Number of prescriptions for lipid-lowering drugs.

  7. Healthcare spending

    Time frame: Month 12

    Analysis of healthcare spending associated with each intervention, using billing data from the center associated with the use of resources by the insured party.

  8. FLI administration

    Time frame: Month 12

    Percentage of patients with body mass index equal or more than 25 who have been administered the FLI

Sponsors and collaborators

Lead sponsor

Consorci Sanitari de l'Alt Penedès i Garraf

Other

Registry information

Official study title

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

Acronym: FLI-AP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 12, 2024
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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