Determining the effect of lifestyle education by micro learning method on non-alcoholic fatty liver
Design
This study is a two-group, parallel and randomized clinical trial on 120 patients with non-alcoholic fatty liver disease. Random selection (APRI Score 0.5-1.5) and then random allocation.
Settings and conduct
Data will be collected using a questionnaire including demographic variables, HPLP2 and APRI Score. The intervention of the present study includes the effect of educational clips produced for 8 sequential weeks on patients with non-alcoholic fatty liver referred to the gastroenterology and liver clinic of Baqiyatallah Hospital (Tehran).
Participants/Inclusion and exclusion criteria
ٍٍEnrollment:
Having non-alcoholic fatty liver confirmed by a doctor and APRI Score between 0.5 and 1.5.
Not having underlying problems such as diabetes and digestive problems.
Having and knowing how to use a smart phone.
Adult patients over 18 years old.
Consent to participate in the study.
Failure to enter:Patients who do not answer the questionnaires completely for any reason or can't do exercising.
Intervention groups
Training through educational clips based on health-promoting lifestyle dimensions, with an emphasis on empowering patients to have healthy nutrition, increasing physical activity along with other lifestyle dimensions through social networks, for a period of 8 weeks will be done in the test group and the control group will receive the usual recommendations and treatments in the gastroenterology and liver clinic.
Main outcome variables
ُSeverity of fatty liver, amount of APRI Score, Quality of Life (HPLP2)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221231056997N1
Registration date:2023-10-04, 1402/07/12
Registration timing:prospective
Last update:2023-10-04, 1402/07/12
Update count:0
Registration date
2023-10-04, 1402/07/12
Registrant information
Name
Rasoul Davoudi Rahaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 5724
Email address
davoudir25@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-06, 1402/07/14
Expected recruitment end date
2023-12-05, 1402/09/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of lifestyle modification by micro learning method on the amount of non-alcoholic fatty liver
Public title
Investigating the effectiveness of lifestyle modification by micro learning method on the amount of non-alcoholic fatty liver
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having non-alcoholic fatty liver confirmed by a doctor and APRI Score between 0.5 and 1.5.
Not having underlying problems predisposing a person to fatty liver, including (diabetes, digestive problems).
Ability to perform physical activities.
Having and familiarity with mobile phones, so much so that she can use multimedia software packages.
Consent to participate in the study.
Adults over 18 years old.
Exclusion criteria:
Patients who do not answer the questionnaires completely for any reason.
Inability to perform physical recommendation
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible samples will be allocated between test and control groups after easy sampling by random allocation method using quadruple blocks.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Working group/committee of ethics in the research of Baqiyatollah al-Azam educational center
Street address
Vanak Square, Mollasadra St., South Sheikh Bahai St., Baqiyatullah University of Medical Sciences (Aj).
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2023-08-14, 1402/05/23
Ethics committee reference number
IR.BMSU.BAQ.REC.1402.044
Health conditions studied
1
Description of health condition studied
Non-alcoholic fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
diet
Timepoint
The beginning of the study (before the intervention) and 4 weeks after the end of the intervention.
Method of measurement
Health promotion lifestyle questionnaire.
2
Description
physical activity
Timepoint
The beginning of the study (before the intervention) and 4 weeks after the end of the intervention.
Method of measurement
Health promotion lifestyle questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After the patient is referred by the gastroenterologist and the entry criteria are met, the goals of the plan are explained to the patient. If desired, the consent form is given to the patient to sign after the study. Then the samples are randomly allocated. They will be allocated between the groups using blocks of 4. The HPLP2 questionnaire and blood tests including aspartate aminotransferase and platelets will be completed before and 4 weeks after the end of the intervention. The test group will receive at least 12 educational clips for 8 weeks through social media messages. Regarding the severity and severity of fatty liver disease, they will receive the benefits and barriers of diet and physical activity based on HPLP2, which also includes other dimensions, and to stabilize the training, a 2-week linear training of the important points of the clips sent the same week. will be placed in the group.
Category
Lifestyle
2
Description
Control group: They are trained and treated by a gastroenterology specialist according to the normal routine.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatullah Hospital (Aj), Gastroenterology and Liver Clinic.
Full name of responsible person
Rasoul Davoudi Rahaqi
Street address
Vanak Square, Mulla Sadra Street, after Sheikh Bahai, Baqiyatullah Hospital (AJ), Gastroenterology and Liver Clinic.
City
Tehran
Province
Tehran
Postal code
141556437
Phone
+98 21 81261
Email
bag@bmsu.ac.ir
Web page address
https://baq.bmsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. Gholamhossein Alishiri
Street address
Mulla Sadra St., South Sheikh Bahai St., Baqiyatullah University of Medical Sciences (Aj).
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
unv@bmsu.ac.ir
Web page address
https://www.bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Rasoul Davoudi Rahaqi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Majid Haddadadal St., plate 87
City
Tehran
Province
Tehran
Postal code
1178865911
Phone
+98 21 3344 1123
Email
Davoudir25@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. Fakhruddin Faizi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Molla Sadra St., South Sheikh Bahai St., Baqiyatullah University of Medical Sciences (Aj)
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
f_f_1346@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Rasoul Davoudi Rahaqi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Majid Haddadadal St., plate 87
City
Tehran
Province
Tehran
Postal code
1178865911
Phone
+98 21 3344 1123
Email
davoudir25@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The personal information of the participants will be kept confidential.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The study protocol and informed consent form will be shared.
When the data will become available and for how long
12 months after the results are published.
To whom data/document is available
Researchers interested in liver diseases, as well as researchers working in academic and scientific institutions, can send a request to receive the mentioned data and documents.
Under which criteria data/document could be used
There are no other special conditions for the use of the mentioned and sendable documents.
From where data/document is obtainable
davoudir25@gmail. com
f_f_1346@yahoo.com
and Baqiyatullah University of Medical Sciences..
What processes are involved for a request to access data/document
The applicant for the mentioned documents can receive the requested documents after submitting her request using the methods mentioned in the previous section, such as sending an email after a few days.