Impact of NAFLD vs MAFLD Stigma on Quality of Life in Egyptian Patients

NCT06503068 | Recruiting

• 1 other identifier: 36264PR627/4/24
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Non-alcoholic fatty liver disease (NAFLD) has become the leading cause of liver disease worldwide. The global burden of NAFLD is about 30% of the population, With a higher prevalence in Egypt about 47.5 %. The prevalence increases significantly with the presence of type 2 diabetes and obesity. NAFLD is commonly associated with metabolic dysfunction and the development of cardiovascular disease. However, the NAFLD definition excludes other causes. It is not correlated with metabolic dysfunction and cardiovascular risk, so in 2020, the term metabolic-dysfunction-associated fatty liver disease (MAFLD) was suggested to replace the term NAFLD. The nomenclature change was partly related to the stigma associated with the term NAFLD. As the words "alcoholic" and "fatty" were considered stigmatizing. A recent global survey showed that 26% of patients (57% in the USA and 7% in MENA) felt stigmatized relating to overweight/obesity and 8% of patients (22 % in the USA and 3% in MENA) felt stigmatized by the term NAFLD. While 34% and 38% of physicians considered the words "non-alcoholic" and "fatty" stigmatizing, respectively. There is a discrepancy between the different regions of the world and between patients and providers regarding the perception of NAFLD/ MAFLD stigma. This study aims to assess the perception and stigmatization of various diagnostic terms (fatty liver, NAFLD \& MAFLD) among Egyptian patients and physicians. Also, to assess the impact of stigma on the quality of life and the motivations and barriers for lifestyle modification which is the cornerstone of NAFLD/MAFLD management.

Conditions

NAFLD

Keywords

Metabolic- associated fatty liver disease (MAFLD); Non-alcoholic fatty liver disease (NAFLD); stigma; Metabolic dysfunction-associated steatotic liver disease (MASLD)

Outcome Measures

Primary Outcomes (2)

• Awareness of NAFLD/MAFLD stigma in Egypt

  Using a questionnaire to assess awareness of stigma related to various diagnostic terms such as "fatty liver", "NAFLD", "MAFLD", and Metabolic dysfunction-associated steatotic liver disease "MASLD" in patients and in NAFLD/NASH treating physicians in Egypt.

  till August 2024

• Perception of NAFLD/MAFLD stigma in Egypt

  Using a questionnaire to assess perception of stigma related to various diagnostic terms such as "fatty liver", "NAFLD", "MAFLD", and "MASLD" in patients and in NAFLD/NASH treating physicians in Egypt.

  till August 2024

Secondary Outcomes (3)

• impact on quality of life

  till August 2024

• Motivations to lifestyle changes

  till August 2024

• Barriers to lifestyle changes

  till August 2024

Study Arms (2)

NAFLD/NASH patients

Patients ≥ 18 years old diagnosed with NAFLD/ NASH and willing to complete the survey.

Other: Questionnaire

Physicians

Physicians treating patients with NAFLD/NASH (hepatologists, gastroenterologists, endocrinologists, and internal medicine physicians).

Other: Questionnaire

Interventions

Questionnaire OTHER

A questionnaire in both digital and written forms in both Arabic and English versions.

NAFLD/NASH patients; Physicians

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The questionnaire will target a convenience sample of NAFLD/NASH patients presenting to the Tropical Medicine Department clinics. physicians treating NAFLD/NASH patients in Egypt

You may qualify if:

• Patients ≥ 18 years old diagnosed with NAFLD/ NASH and willing to complete the survey.
• Physicians treating patients with NAFLD/NASH (hepatologists, gastroenterologists, endocrinologists, and internal medicine physicians).

You may not qualify if:

• Unwilling to participate

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tropical medicine department, Tanta University Hospitals

Tanta, Gharbyea, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Social Stigma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Rania M Elkafoury, MD

CONTACT

00201004672358; rania.elkafoury@med.tanta.edu.eg

Shimaa M Ebrahim, MD

CONTACT

00201020018360; shimaaebrahim@med.tanta.edu.eg

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 16, 2024
• Study Start: May 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 15, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

EG (1)