Protocol summary

Study aim
Determining the effect of the educational intervention based on the health belief model on the nutritional behaviors of the elderly with non-alcoholic fatty liver in Tehran.
Design
A trial with a control group, with parallel groups, randomized, on 156 patients, rand function of Excel software was used to randomize the groups.
Settings and conduct
After determining the intervention and control groups, the cognitive status questionnaire will be given and if eligible, the main questionnaire will be given. Then, using the compiled educational program, education is provided to the patients. The educational intervention and completing the questionnaire will be done in the mentioned health centers of Shahid Beheshti University of Medical Sciences in Tehran. Finally, the results are analyzed using the software.
Participants/Inclusion and exclusion criteria
Inclusion criteria: No cognitive impairment, No history of regular alcohol consumption, Elderly with non-alcoholic fatty liver disease, Minimum education at the sixth elementary level, Elderly covered by designated health centers
Intervention groups
The intervention groups receive training in 5 sessions of 40-60 minutes in a period of 2 months once a week in the form of lectures, questions and answers, and pamphlets. Educational content has been collected from authentic books about this disease and related nutrition. During the intervention, the control group will not receive the training and they will only complete the questionnaire 2 times with a gap of one month, and after completing the training in the intervention group, they will receive the same training content in the form of 1-2 sessions for 30-60 minutes.
Main outcome variables
Mean scores of nutritional behavior, perceived susceptibility, perceived severity, perceived threat, perceived benefits, perceived barriers, self-efficacy, guide to action, awareness.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230419057966N1
Registration date: 2023-08-19, 1402/05/28
Registration timing: retrospective

Last update: 2023-08-19, 1402/05/28
Update count: 0
Registration date
2023-08-19, 1402/05/28
Registrant information
Name
Fatemeh Ravaghi ardebili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 3646
Email address
f.ravaghi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of an educational intervention based on the Health Belief Model on the nutritional behaviors of the older people with non-alcoholic fatty liver disease
Public title
Investigating the effect of education on the nutritional behaviors of the elderly with non-alcoholic fatty liver disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
No cognitive impairment No history of regular alcohol consumption Elderly with non-alcoholic fatty liver disease Minimum education at the sixth elementary level Elderly covered by designated health centers
Exclusion criteria:
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 156
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of centers to control and intervention groups is done by generating random numbers in Excel. For example, for 4 centers in the first column of Excel, we write 2 zeros to indicate the two control centers and 2 ones to indicate the two intervention centers. In the next column, we generate random numbers with the rand command and then sort the first column based on the generated random numbers column. The order of two zeros and two ones is arranged randomly, for example, as 0, 1, 1, 0. Then the first center is assigned to group 0, the second is intervention center, the third is intervention center and the fourth is control center.
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
Ethics Committee of Health Faculty and Neuroscience Research Center of Shahid Beheshti University of
Street address
Faculty of Health and Safety, Shahid Beheshti University of Medical Sciences, Daneshju Blvd, Shahid Shahriari Square, Shahid Chamran Highway.
City
Tehran
Province
Tehran
Postal code
1985717444
Approval date
2022-11-29, 1401/09/08
Ethics committee reference number
IR.SBMU.PHNS.REC.1401.105

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
Mean nutritional behavior scores
Timepoint
before the intervention and one month after the intervention
Method of measurement
Compiled questionnaire (based on the researcher's questionnaire for a thesis entitled "Investigation of the effect of education based on the health belief model on the promotion of nutritional behaviors in elderly women covered by health care centers in Ahvaz in 2013" written by Maryam Erfani mehr)

2

Description
knowledge
Timepoint
before the intervention and one month after the intervention
Method of measurement
Compiled questionnaire (based on the researcher's questionnaire for a thesis entitled "Investigation of the effect of education based on the health belief model on the promotion of nutritional behaviors in elderly women covered by health care centers in Ahvaz in 2013" written by Maryam Erfani mehr)

3

Description
Average perceived susceptibility scores
Timepoint
before the intervention and one month after the intervention
Method of measurement
Compiled questionnaire (based on the researcher's questionnaire for a thesis entitled "Investigation of the effect of education based on the health belief model on the promotion of nutritional behaviors in elderly women covered by health care centers in Ahvaz in 2013" written by Maryam Erfani mehr)

4

Description
Mean perceived intensity scores
Timepoint
before the intervention and one month after the intervention
Method of measurement
Compiled questionnaire (based on the researcher's questionnaire for a thesis entitled "Investigation of the effect of education based on the health belief model on the promotion of nutritional behaviors in elderly women covered by health care centers in Ahvaz in 2013" written by Maryam Erfani mehr)

5

Description
Mean perceived threat scores
Timepoint
before the intervention and one month after the intervention
Method of measurement
Compiled questionnaire (based on the researcher's questionnaire for a thesis entitled "Investigation of the effect of education based on the health belief model on the promotion of nutritional behaviors in elderly women covered by health care centers in Ahvaz in 2013" written by Maryam Erfani mehr)

6

Description
Average scores of perceived benefits
Timepoint
before the intervention and one month after the intervention
Method of measurement
Compiled questionnaire (based on the researcher's questionnaire for a thesis entitled "Investigation of the effect of education based on the health belief model on the promotion of nutritional behaviors in elderly women covered by health care centers in Ahvaz in 2013" written by Maryam Erfani mehr)

7

Description
Mean scores of perceived barriers
Timepoint
before the intervention and one month after the intervention
Method of measurement
Compiled questionnaire (based on the researcher's questionnaire for a thesis entitled "Investigation of the effect of education based on the health belief model on the promotion of nutritional behaviors in elderly women covered by health care centers in Ahvaz in 2013" written by Maryam Erfani mehr)

8

Description
Mean self-efficacy scores
Timepoint
before the intervention and one month after the intervention
Method of measurement
Compiled questionnaire (based on the researcher's questionnaire for a thesis entitled "Investigation of the effect of education based on the health belief model on the promotion of nutritional behaviors in elderly women covered by health care centers in Ahvaz in 2013" written by Maryam Erfani mehr)

9

Description
Average practice guide scores
Timepoint
before the intervention and one month after the intervention
Method of measurement
Compiled questionnaire (based on the researcher's questionnaire for a thesis entitled "Investigation of the effect of education based on the health belief model on the promotion of nutritional behaviors in elderly women covered by health care centers in Ahvaz in 2013" written by Maryam Erfani mehr)

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group consists of 5 groups. After completing the questionnaire, the educational intervention will be conducted in the form of 5 educational sessions of 40-60 minutes in a period of 2 months. The intervention will be conducted once a week in the form of lectures, questions and answers, and using pamphlets. The educational content has been collected from authentic books about getting to know the disease, educational programs of the country, ways to improve and prevent the disease from worsening, the role of nutrition in the disease process. From the collected content, 2 educational pamphlets have been prepared, one with the title of healthy nutrition in old age and the other with the title of nutrition and non-alcoholic fatty liver, the content of which is presented in 5 sessions.
Category
Behavior

2

Description
The control group, which consists of 4 groups, did not receive any intervention during the intervention and only completed the questionnaire twice with a time interval of one month, without receiving training. After completing the training in the intervention group, training will be provided to them. The training will be conducted by lectures, questions and answers and by using pamphlets. The educational content has been collected from authentic books about getting to know the disease, educational programs of the country, ways to improve and prevent the disease from worsening, the role of nutrition in the disease process. From the collected content, 2 educational pamphlets, one with the title of healthy nutrition in old age and the other with the title of nutrition and non-alcoholic fatty liver, have been prepared and will be presented to the elderly in a compact form of 1-2 sessions lasting 30-60 minutes.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Nader comprehensive health service center
Full name of responsible person
Fatemeh Ravaghi
Street address
Esfandani St, Jashnvareh St, The second square of Tehranpars, Javadieh neighborhood.
City
Tehran
Province
Tehran
Postal code
1654887171
Phone
+98 21 7732 2277
Email
f77.ravaghi@gmail.com

2

Recruitment center
Name of recruitment center
Salavati Comprehensive Health Service Center
Full name of responsible person
Fatemeh Ravaghi
Street address
No. 59, corner of 1/24 St, 1st Nirou Havaie St, Pirouzi St, Pirouzi neighborhood.
City
Tehran
Province
Tehran
Postal code
1737813111
Phone
+98 21 7742 8070
Email
f77.ravaghi@gmail.com

3

Recruitment center
Name of recruitment center
Mohammadian Comprehensive Health Services Center
Full name of responsible person
Fatemeh Ravaghi
Street address
south side of Lozi square, Nirou Havaie St, Hafeziieh neighborhood.
City
Tehran
Province
Tehran
Postal code
1748833571
Phone
+98 21 7742 3334
Email
f77.ravaghi@gmail.com

4

Recruitment center
Name of recruitment center
Chizer comprehensive health service center
Full name of responsible person
Fatemeh Ravaghi
Street address
No. 4, Neda Square, Andarzgo (Chizar), Chizar neighborgood.
City
Tehran
Province
Tehran
Postal code
1937816154
Phone
+98 21 2221 9085
Email
f77.ravaghi@gmail.com

5

Recruitment center
Name of recruitment center
Jafarian Comprehensive Health Service Center
Full name of responsible person
Fatemeh Ravaghi
Street address
corner of 19th Square, Ghaffari Alley, Rudbari St, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
0123456789
Phone
+98 21 7790 7937
Email
f77.ravaghi@gmail.com

6

Recruitment center
Name of recruitment center
Kadus comprehensive health service center
Full name of responsible person
Fatemeh Ravaghi
Street address
Sojdei St, Jashnvareh St, second floor of Tehranpars, West Tehranpars neighborhood.
City
Tehran
Province
Tehran
Postal code
1655948843
Phone
+98 21 7770 9141
Email
f77.ravaghi@gmail.com

7

Recruitment center
Name of recruitment center
Jafari Comprehensive Health Service Center
Full name of responsible person
Fatemeh Ravaghi
Street address
next to the fire department, Pishahang Station, Hefdah Shahrivar St.
City
Tehran
Province
Tehran
Postal code
1174963191
Phone
+98 21 3313 1812
Email
f77.ravaghi@gmail.com

8

Recruitment center
Name of recruitment center
Niko comprehensive health service center
Full name of responsible person
Fatemeh Ravaghi
Street address
No. 24, next to the Tejarat Bank, at the beginning of the Dezashib St, Bahonar St.
City
Tehran
Province
Tehran
Postal code
1935617353
Phone
+98 21 2275 8817
Email
f77.ravaghi@gmail.com

9

Recruitment center
Name of recruitment center
Imamzadeh Ghasem comprehensive health service center
Full name of responsible person
Fatemeh Ravaghi
Street address
Yas Alley, Imamzadeh Ghasem square, Darband neighborhood
City
Tehran
Province
Tehran
Postal code
1975713713
Phone
+98 21 2270 3030
Email
f77.ravaghi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Arabi St, Daneshjou Blvd, Velenjak.
City
Tehran
Province
Tehran
Postal code
1985717444
Phone
+98 21 8820 0096
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Ravaghi Ardebili
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No. 2, Rahimi Alley, after Chaman park, South Homayunshahr St, Soroush 1st St.Deriano St, Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1455764186
Phone
+98 21 6655 3646
Email
f77.ravaghi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Ramezankhani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Faculty of Health and Safety, Daneshjou Blvd, Shahid Shahriari square, Shahid Chamran Highway.
City
Tehran
Province
Tehran
Postal code
1985717444
Phone
+98 21 2243 2040
Email
aramezankhani@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Ravaghi ardebili
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No. 2, Rahimi Alley, South Homayunshahr St, Soroush 1st St, Dariano St, Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1455764186
Phone
+98 21 6655 3646
Email
f77.ravaghi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Publishable data from this study include: age, sex, marital status, education, occupation, educational intervention based on the health belief model, mean scores (nutritional behavior, perceived susceptibility, perceived severity, perceived threat, perceived benefits , perceived barriers, self-efficacy, guide to action), awareness.
When the data will become available and for how long
After completing the research and obtaining the necessary results, it will be possible to access the mentioned data.
To whom data/document is available
The data obtained from the research will be available to researchers who intend to design a similar study.
Under which criteria data/document could be used
It is possible to use the data to evaluate the impact of training and also perform analyzes that compare the average of the variables.
From where data/document is obtainable
Researchers can contact the study registrar via email f77.ravaghi@gmail.com to receive data.
What processes are involved for a request to access data/document
The applicant must send the proposal file or code of ethics to the research registrar and after review by the research team, the relevant data will be sent to them within one month.
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