The effect of a mobile-based self-management intervention for non-alcoholic fatty liver patients with obesity
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 140 patients. Random numbers inside the envelope are used for randomization
Settings and conduct
The location is performed in the private office of the physician and the patients of Mashhad Cohort Center or Persian Cohort that is located in Imam Reza Hospital - next to the multi-storey car park. Facing Ibn Sina 5, are used and the patients are divided into control and intervention groups blindly and randomly using random numbers inside the envelope.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-People aged 18 and over.
2- Diagnosis of non-alcoholic fatty liver for the patient.
3-Ability to access the patient.
4- Having a smart phone
5-literacy.
6- Informed satisfaction and interest in participating in the study.
7-Not having comorbidity
Exclusion criteria :
Grade 4 liver
Intervention groups
To evaluate the effect of the designed intervention, patients are randomly divided into two groups of control and intervention. Educational content is given to both control and intervention groups. It is also given to the mobile app intervention group. The two groups of control and intervention are evaluated for 3 months in terms of ALT(alanine aminotransferase) ، AST(aspartate aminotransferase) and patients' level of knowledge and adherence to diet protocol and physical activity in a clinical trial study.
Effect of mobile-based self-management intervention on liver function in overweight patients with Non-Alcoholic Fatty Liver Disease
Public title
Effect of mobile-based self-management intervention on liver function in overweight patients with Non-Alcoholic Fatty Liver Disease
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Not having Comorbidity
Diagnosis of non-alcoholic fatty liver for the patient
Having a cell phone
Adults up to 65 years
Patient informed consent and interest in participating in the study
Access to patients
Literacy
Exclusion criteria:
Grade 4 liver
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Researcher after preparing a list of non-alcoholic fatty liver patients whose condition
The research is divided into two groups of experimental and control by simple random sampling method. Randomization unit is individual. As in this
Study of 140 people randomly selected (sealed envelopes in
Inside the envelopes are written the letters C (meaning control and I (intervention)) and in two groups of intervention and
The controls are divided and assigned a code to each participant
It will be given .
Blinding (investigator's opinion)
Double blinded
Blinding description
1- Non-alcoholic fatty liver patients who meet the research conditions are divided into two groups of experimental and control by simple random sampling method. Randomization unit is individual. In this study, 140 people were randomly selected (sealed envelopes inside the envelopes are written the letters C means control and M means intervention) and are divided into two groups of intervention and control and each Participants are assigned a code.
2- Outcome assessor who evaluates the occurrence or non-occurrence of outcome in participants.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
No 237, Seydrazi Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9188753431
Approval date
2021-06-28, 1400/04/07
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.152
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
Liver enzymes : ALT(alanine aminotransferase) and AST(aspartate aminotransferase)
Timepoint
At the beginning of the study and then 3 months after the intervention according to expert opinion
Method of measurement
Blood test
Secondary outcomes
1
Description
Weight
Timepoint
Weekly
Method of measurement
Ordinary weight measuring device
Intervention groups
1
Description
Intervention group: Motivational messages in the categories of nutrition, physical activity and knowledge to increase the patient's knowledge of his disease and fully personalized messages according to the score that the patient gives each week to adhere to his diet and physical activity and Also, the weight changes that he reports every week, which are based on two theories of behavior change and cognitive therapy, due to the low motivation of patients and their lack of follow-up, result in increasing patient adherence to diet and physical activity recommendations. Finally, improve the patient's condition. According to the questionnaire that has been designed and evaluated, the patient is classified into two categories: low motivation and high motivation. According to the documents, for a group with low motivation, 4 summary shorter messages, and for a group with a higher motivation, 3 longer complete messages are presented.
Category
Treatment - Other
2
Description
Control group: Receive a diet plan and routine physical activity recommendations on paper base
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Cohort Center or Persian Cohort
Full name of responsible person
Dr. Saeed Eslami
Street address
Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9188753431
Phone
+98 51 3180 6812
Email
kheirdoustha@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Saeed Eslami
Street address
Park Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9188753431
Phone
+98 51 3602 9000
Email
EslamiS@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Saeed Eslami
Position
Supervisor
Latest degree
Medical doctor
Other areas of specialty/work
Medical Informatics
Street address
MELLAT Park Square
City
Mashhad
Province
Razavi Khorasan
Postal code
918875331
Phone
+98 51 3800 2429
Email
EslamiS@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Saeed Eslami
Position
Supervisor
Latest degree
Medical doctor
Other areas of specialty/work
Medical Informatics
Street address
Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9188753431
Phone
+98 51 3800 2429
Email
EslamiS@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Azam Kheirdoust
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Medical Informatics
Street address
Seyd Razi Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9188753431
Phone
+98 51 3605 1393
Email
kheirdoustha971@mums.ac.ir
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