Determining the effect of education based on health belief model on physical activity and dietary intake in nonalcoholic fatty liver disease patients
Design
This is clinical trial with intervention and control group, randomized, on 80 patients with nonalcoholic fatty liver disease.
Settings and conduct
Data will be collected before and after the intervention and finally the effect of the intervention program on nutrition and physical activity and structures of the Health Belief Model and liver enzymes of patients with nonalcoholic fatty liver in Isfahan city will be measured
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of non alcoholic fatty liver disease by physician, patients who agree to participate in the study, 20 to 50 years’ old, Ability to use smartphones and social media (Whats App)؛ Exclusion criteria : Medical prohibition for physical activity or have special diet, Using alcohol, Pregnancy, lactation and menopause in women, Diagnosis of other diseases, including Liver disease, Biliary disease, Autoimmune disease and Cancers
Intervention groups
Education through social network and based on health belief model with emphasis on empowering patients to have healthy nutrition and increase physical activity will be done for two months in intervention group.Control group receive usual care provided in the Glands and Metabolism research center.
Main outcome variables
dietary intake؛ physical activity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210612051546N1
Registration date:2021-07-12, 1400/04/21
Registration timing:prospective
Last update:2021-07-12, 1400/04/21
Update count:0
Registration date
2021-07-12, 1400/04/21
Registrant information
Name
Nafiseh Tamadonpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3265 1509
Email address
tamadonpoor@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based on health belief model on physical activity and dietary intake in nonalcoholic fatty liver disease patients
Public title
The effect of education based on health belief model on physical activity and dietary intake in nonalcoholic fatty liver disease patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of non alcoholic fatty liver disease by physician
20 to 50 years’ old
Patients who agree to participate in the study
Ability to use smartphones and social media (Whats App)
Exclusion criteria:
Medical prohibition for physical activity or have special diet
Using alcohol
Diagnosis of other diseases, including Liver disease, Biliary Disease, Autoimmune disease and Cancers
Pregnancy, lactation and menopause in women
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Candidates who were eligible for participation in the study were randomly chosen and were assigned to the groups according to the random number table
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
کمیته اخلاق دانشگاه علوم پزشکی اصفهان
Street address
Isfahan University of Medical Sciences, Hezar-Jerib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-06-09, 1400/03/19
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.108
Health conditions studied
1
Description of health condition studied
Nonalcoholic fatty liver(NAFLD)
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Dietary intake
Timepoint
At the beginning and end of intervention
Method of measurement
3-day food record
2
Description
Physical activity
Timepoint
At the beginning and end of intervention
Method of measurement
The International Physical Activity Questionnaire
Secondary outcomes
1
Description
AST and ALT
Timepoint
At the beginning and end of intervention
Method of measurement
Blood sample
Intervention groups
1
Description
After referral of the patient from the physician, all patients are examined based on criteria for entering the study and are described the goals of the plan to patients. If the patient wishes to participate in plan, the consent form will be given to sign it after the study. Candidates who were eligible for participation in the study were randomly chosen and were assigned to the groups according to the random number table. Health Belief Model questionnaire, International Physical Activity Questionnaire (IPAQ), 3-day food record will be completed before and after the intervention (2 months after the start of the intervention). also Liver enzymes (ALT, AST) and weight of patients will be measured before and after the intervention. The intervention group will receive messages via Whats App for 2 months, including clips, photos and podcasts about the severity of fatty liver disease, benefits and barriers to regular physical activity and healthy eating, intervention group will receive a self-care book on fatty liver disease, which includes a healthy lifestyle in fatty liver disease and self-assessment tables and the patient will be complete the book tables at the end of each week and send a photo for researcher.
Category
Lifestyle
2
Description
Control group: Control group were follow their routine life for 2 months.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
The Research Center of Glands and Metabolism Hazrat Sedigheye Tahere
Full name of responsible person
Mansour Siavash Dastjerdi
Street address
Hazrat Sedigheh Tahereh Educational, Therapeutic and Research Complex, After the intersection of martyrs, Jomhory Square
City
Isfahan
Province
Isfehan
Postal code
81876-98191
Phone
+98 31 3335 9933
Email
emrc@mui.ac.ir
Web page address
https://emrc.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
َAssistance for Research and Technology, Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
www.research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Nafiseh Tamadonpoor
Position
دانشجوی کارشناسی ارشد
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No.41, Dadsetan Allay, Bozorgmehr Ave
City
Isfahan
Province
Isfehan
Postal code
8154843911
Phone
+98 31 3668 0048
Email
nafisehtamadonpoor@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Asiyeh Pirzadeh
Position
Assistant Professor of Health Education and Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Dept.of Health Education and promotion ; Faculty of Health ; Isfahan University of Medical Sciences ; Hezarjerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3340
Email
as_pirzadeh@hlth.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nafiseh Tamadonpoor
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No.41, Dadsetan Allay, Bozorgmehr Ave
City
Isfahan
Province
Isfehan
Postal code
8154843911
Phone
+98 31 3668 0048
Email
nafisehtamadonpoor@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Study protocol and informed consent form will be shared.
When the data will become available and for how long
The access period starts 12 months after the results are published.
To whom data/document is available
Researchers interested in liver disease , as well as researchers working in academic and scientific institutions, can apply to receive the mentioned data and documents.
Under which criteria data/document could be used
There are no other special conditions for using the mentioned and send able documents.
From where data/document is obtainable
1-email:nafisehtamadonpoor@yahoo.com
2-email:as_pirzadeh@hlth.mui.ac.ir
3-Department of Health Education and Health Promotion, school of Health, Isfahan 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 a few days after submitting his / her application in the ways mentioned in the previous section, such as sending an email .