Pharmacoeconomic Evaluation of the Cost/effectiveness Ratio of Physical Exercise on Non-alcoholic Fatty Liver Disease

NCT06026293 | Completed

• 1 other identifier: CER_study
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Physical inactivity and poor dietary habits are associated with an increased risk of obesity and chronic disease (World Health Organization, 2019; Glanz and Bishop, 2010). Conversely, higher levels of total physical activity result in a reduced risk of cardiovascular disease, breast and colon cancer, and diabetes (Kyu et al., 2016). Similarly, consumption of the minimum recommended level (600 g per day) of fruit and vegetables is associated with a lower risk of cardiovascular disease and cancer (Ezzati et al., 2004). However, despite these recognized benefits, unhealthy diet and physical inactivity are still major contributors to poor health and rising health care costs. Worldwide, physical inactivity accounted for 13.4 million disability-adjusted life years (DALYs) in 2013 and cost $53.8 billion to health systems and an additional $13.7 billion in productivity due to deaths attributable to physical inactivity (Ding et al., 2016). Pharmacoeconomics, or the economic evaluation of treatments aimed at maintaining the health of the population, is a set of evaluation models used to identify the value (convenience) and the overall economic impact of a possible treatment. The results of economic evaluations help decision makers inform their choice. Their advantage is that the result is obtained by applying known and validated models, and everyone can know the basis of the decision (evidence-based decision making). The clinical-economic value and the overall financial impact must be compared with the willingness to pay the related costs. Economic evaluations are a tool for defining the value of a medicine in terms of cost-opportunity, from the point of view of the patient, the NHS and society as a whole. The definition of "value" is very broad, multidimensional and includes concepts from many disciplines, beyond economics. Specifically, economic evaluations that take into consideration new medicines, innovative or not, the value is given by the marginal utility that the patient, the NHS and/or society can obtain from its acquisition. In this regard, the measurement of years of life gained in full quality of life (QALY - quality-adjusted life years) is widely applied to medicines in various regulatory contexts, albeit with the awareness that it is not able to capture all the elements that contribute to value (Carletto, A et al.; Drummond, M. F)

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Non-alcoholic fatty liver desease; Cost/effectivness; Physical activity

Outcome Measures

Primary Outcomes (1)

• Cost/effectiveness Ratio

  to define the economic value in terms of CER (Cost/Effectiveness Ratio) and ICER (Incremental Cost/Effectivness Ratio) of physical exercise in the treatment of NAFLD in patients who already have comorbidities for metabolic/cardiometabolic diseases.

  3 years

Secondary Outcomes (1)

• long term foresight of an healthy policy

  3 years

Study Arms (1)

subjects that participates to a previous clinical trial

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population was affected by NAFLD in the observation period (2018-2020), participating in health promotion activities by performing physical exercise under the supervision of the institution's kinesiologists

You may qualify if:

• Being affected by NAFLD in the observation period (2018-2020)
• Participating in health promotion activities by performing physical exercise under the supervision of the institution's kinesiologists

You may not qualify if:

• Patient deceased
• Patient who does not agree to participate in the study

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead
• Antonella Bianco: collaborator
• Pietro Trisolini: collaborator
• Giuseppe Dalfino: collaborator

Study Sites (1)

Irccs Saverio de Bellis

Castellana Grotte, Bari, 70013, Italy

Location

Related Publications (1)

• Polignano M, Bianco A, Guido D, Trisolini P, Franco I, Bonfiglio C, Giannelli G. Economic value and clinical association of a supervised lifestyle-improving program for MASLD. Front Pharmacol. 2026 Jan 16;16:1708451. doi: 10.3389/fphar.2025.1708451. eCollection 2025.

  PMID: 41625336 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Motor Activity

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Behavior

Study Officials

• Maurizio Gaetano Polignano

  IRCCS "Saverio de Bellis"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 7, 2023
• Study Start: July 20, 2023
• Primary Completion: September 30, 2023
• Study Completion: October 2, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

IT (1)