NAFLDNCT06503068
Impact of NAFLD vs MAFLD Stigma on Quality of Life in Egyptian Patients
An observational study of NAFLD, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- NAFLD
- What is being tested?
- Questionnaire
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 15 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- Unwilling to participate
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tropical medicine department, Tanta University Hospitals
Tanta, Gharbyea, 31527
Ferial Elkalla, MD, 00201006023289, f.elkalla@gmail.com
Shimaa M Ebrahim, MD
About this study
Official title: NAFLD Stigma vs MAFLD Stigma and Their Impact on Quality of Life in Egyptian Patients: A Survey Study
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.
Read more
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.
Read the detailed description
This cross-sectional study will be carried out in collaboration between the Tropical Medicine Department and Public Health Department, Tanta University Hospitals. A questionnaire in both digital and written forms targeting patients with NAFLD/NASH and physicians treating NAFLD/NASH patients in Egypt.
Type of study:
Prospective, cross-sectional survey.
Duration of study:
Study will be carried out from May 2024 to August 2024 or until the target number is reached (about 500 subjects).
Target subjects:
The questionnaire will target a convenience sample of NAFLD/NASH patients and physicians treating NAFLD/NASH patients (about 500 subjects).
The questionnaire will be written and digital in both Arabic and English versions.
Methodology:
After designing the questionnaire, it will be discussed with other experts in the field, validity and reliability will be assessed and a pilot study will be done.
After an informed consent subject will answer a designed questionnaire either written or digital. 2 phases will be done The questionnaire will be divided into 3 sectors Sector 1: Demographic data: questions about [age, sex, residence, educational level, occupation (subspecialty), workplace] for all participants.
Sector 2: Socioeconomic level determination mainly for population :( Socio-economic data will be gathered through questions asking about the number of family members, number of rooms in the apartment, level of education, occupation, and cost per month).
Sector 3: the main work includes questions for patients: (patient awareness of NAFLD before diagnosis, presence and severity of liver fibrosis, presence of comorbidities, the diagnostic term they use to describe their disease, have they disclosed their condition to family or friends, have they experienced stigmatization or discriminations due to their disease and how frequently, how they feel about the words fatty, alcoholic, and metabolic, have they avoided or missed a visit with their physician due to NAFLD, patients concerns about the disease and its progression, barriers, and motivations for lifestyle modifications).
For physicians :(their clinical experience in NAFLD and the number of NAFLD/NASH patients they see per month, what terms they think are considered stigmatizing to their patients "fatty, non-alcoholic, overweight/obese, metabolic associated", does their patients feel discrimination due to their disease, would the name change help their patients, causes of frustration and discomfort when treating NAFLD patients, their opinion of what are the barriers and motivations for lifestyle modifications in their patients)
Ethical considerations:
A written or digital informed consent form authorizing the collection of this data was signed by all subjects The study will be approved by the Ethical Committee of Faculty of Medicine Tanta University.
The risks to the participants and measures needed to minimize these risks:
- The privacy of the data of the patients will be maintained.
- Any unexpected risks appear during the course of research will be cleared to the subjects and the ethical committee on time
Adequate provisions to maintain the privacy of participants and confidentially of data are as follows:
- A code number for each patient will be used, and symbols for the name and address will be kept in a special file.
- The investigators will hide the patients' names when the research is used
- The investigators will use the results of the research only for scientific aims and not use it in other aims.
The endpoint of this study:
Assess the prevalence of NAFLD/MAFLD stigma among both patients and physicians, and the beneficence of name change from NAFLD to MAFLD in Egypt to determine the factors leading to lifestyle modifications in NAFLD/MAFLD patients, thus improving patients' quality of life.
- Conditions
- NAFLD
- Being tested
- Questionnaire
- Keywords
- Metabolic- associated fatty liver disease (MAFLD), Non-alcoholic fatty liver disease (NAFLD), stigma, Metabolic dysfunction-associated steatotic liver disease (MASLD)
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
A questionnaire in both digital and written forms in both Arabic and English versions.
| Study group | Role | What they receive |
|---|---|---|
| NAFLD/NASH patients | Patients ≥ 18 years old diagnosed with NAFLD/ NASH and willing to complete the survey. Receives: Other: Questionnaire | |
| Physicians | Physicians treating patients with NAFLD/NASH (hepatologists, gastroenterologists, endocrinologists, and internal medicine physicians). Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: till August 2024
Secondary outcomes (3)
impact on quality of life
Using a questionnaire to understand the impact of NAFLD vs MAFLD stigma on the quality of life in Egyptian patients
Measured: till August 2024
Motivations to lifestyle changes
Using a questionnaire to evaluate the motivation for lifestyle changes in Egyptian patients
Measured: till August 2024
Barriers to lifestyle changes
Using a questionnaire to evaluate the barriers for lifestyle changes in Egyptian patients
Measured: till August 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 May 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Mamdouh Elkafoury, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503068
- Sponsor's protocol ID
- 36264PR627/4/24
- Status last verified
- Aug 2024
- First submitted
- 1 Jul 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NAFLD Stigma vs MAFLD Stigma and Their Impact on Quality of Life in Egyptian Patients: A Survey Study
- ClinicalTrials.gov ID
- NCT06503068
- Acronym / sponsor ID
- 36264PR627/4/24
- Conditions
- NAFLD
- Keywords
- Metabolic- associated fatty liver disease (MAFLD), Non-alcoholic fatty liver disease (NAFLD), stigma, Metabolic dysfunction-associated steatotic liver disease (MASLD)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This cross-sectional study will be carried out in collaboration between the Tropical Medicine Department and Public Health Department, Tanta University Hospitals. A questionnaire in both digital and written forms targeting patients with NAFLD/NASH and physicians treating NAFLD/NASH patients in Egypt.
Type of study:
Prospective, cross-sectional survey.
Duration of study:
Study will be carried out from May 2024 to August 2024 or until the target number is reached (about 500 subjects).
Target subjects:
The questionnaire will target a convenience sample of NAFLD/NASH patients and physicians treating NAFLD/NASH patients (about 500 subjects).
The questionnaire will be written and digital in both Arabic and English versions.
Methodology:
After designing the questionnaire, it will be discussed with other experts in the field, validity and reliability will be assessed and a pilot study will be done.
After an informed consent subject will answer a designed questionnaire either written or digital. 2 phases will be done The questionnaire will be divided into 3 sectors Sector 1: Demographic data: questions about [age, sex, residence, educational level, occupation (subspecialty), workplace] for all participants.
Sector 2: Socioeconomic level determination mainly for population :( Socio-economic data will be gathered through questions asking about the number of family members, number of rooms in the apartment, level of education, occupation, and cost per month).
Sector 3: the main work includes questions for patients: (patient awareness of NAFLD before diagnosis, presence and severity of liver fibrosis, presence of comorbidities, the diagnostic term they use to describe their disease, have they disclosed their condition to family or friends, have they experienced stigmatization or discriminations due to their disease and how frequently, how they feel about the words fatty, alcoholic, and metabolic, have they avoided or missed a visit with their physician due to NAFLD, patients concerns about the disease and its progression, barriers, and motivations for lifestyle modifications).
For physicians :(their clinical experience in NAFLD and the number of NAFLD/NASH patients they see per month, what terms they think are considered stigmatizing to their patients "fatty, non-alcoholic, overweight/obese, metabolic associated", does their patients feel discrimination due to their disease, would the name change help their patients, causes of frustration and discomfort when treating NAFLD patients, their opinion of what are the barriers and motivations for lifestyle modifications in their patients)
Ethical considerations:
A written or digital informed consent form authorizing the collection of this data was signed by all subjects The study will be approved by the Ethical Committee of Faculty of Medicine Tanta University.
The risks to the participants and measures needed to minimize these risks:
- The privacy of the data of the patients will be maintained.
- Any unexpected risks appear during the course of research will be cleared to the subjects and the ethical committee on time
Adequate provisions to maintain the privacy of participants and confidentially of data are as follows:
- A code number for each patient will be used, and symbols for the name and address will be kept in a special file.
- The investigators will hide the patients' names when the research is used
- The investigators will use the results of the research only for scientific aims and not use it in other aims.
The endpoint of this study:
Assess the prevalence of NAFLD/MAFLD stigma among both patients and physicians, and the beneficence of name change from NAFLD to MAFLD in Egypt to determine the factors leading to lifestyle modifications in NAFLD/MAFLD patients, thus improving patients' quality of life.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAFLD/NASH patients | – | Other: QuestionnairePatients ≥ 18 years old diagnosed with NAFLD/ NASH and willing to complete the survey. |
| Physicians | – | Other: QuestionnairePhysicians treating patients with NAFLD/NASH (hepatologists, gastroenterologists, endocrinologists, and internal medicine physicians). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- Unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireA questionnaire in both digital and written forms in both Arabic and English versions. | Other | NAFLD/NASH patients, Physicians |
Primary outcome
Awareness of NAFLD/MAFLD stigma in Egypt
Time frame: till August 2024
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.
Perception of NAFLD/MAFLD stigma in Egypt
Time frame: till August 2024
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.
3 secondary outcomes
impact on quality of life
Time frame: till August 2024
Motivations to lifestyle changes
Time frame: till August 2024
Barriers to lifestyle changes
Time frame: till August 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NAFLD, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rania M Elkafoury, MD (00201004672358, rania.elkafoury@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Awareness of NAFLD/MAFLD stigma in Egypt (time frame: till August 2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.