Protocol summary

Study aim
Determining the effect of educational intervention based on the theory of planned behavior on the lifestyle of administrative staff of Isfahan regional hospitals in 2020-2021
Design
A clinical trial with a control group, with parallel, randomized groups, on 70 administrative staff of Isfahan Regional Hospital. For randomization, first a call will be made to participate in the study and the required sample size will be randomly selected from among the qualified people. After preparing the list of participants, the first number will be assigned to the intervention group and the next number to the control group.
Settings and conduct
Study place: The study place was the administrative department of a regional hospital in Isfahan. Study population: By random sampling method, 35 administrative staff members will be selected as the control group and 35 administrative staff members will be selected as the intervention group. Blinding: In this study, blinding has not been done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness to participate in the study; Formal or contract employment in Isfahan regional Hospitals Non-inclusion criteria: Cardiovascular disease, hypertension and diabetes
Intervention groups
Intervention group: For the intervention group, an educational program will be designed based on the main components of promoting a healthy lifestyle. It is planned to implement a training program in at least four one-hour face-to-face training sessions. Meetings will be subject to change. In addition, sending letters of encouragement and encouragement to staff to improve their lifestyles and encouraging hospital officials to encourage staff to improve their lifestyles, etc. will be part of the intervention program. Control group:None of these actions will be performed for the control group.
Main outcome variables
Lifestyle score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211015052776N1
Registration date: 2021-12-14, 1400/09/23
Registration timing: registered_while_recruiting

Last update: 2021-12-14, 1400/09/23
Update count: 0
Registration date
2021-12-14, 1400/09/23
Registrant information
Name
Ali Jahangiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3320 2789
Email address
hassanpoor37@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-11, 1400/09/20
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
2021-12-11, 1400/09/20
Actual recruitment end date
2022-03-11, 1400/12/20
Trial completion date
2022-03-11, 1400/12/20
Scientific title
Comparison of the effectiveness of education based on the theory of planned behavior on the correct lifestyle for disease prevention and health promotion of hospital staff
Public title
The effect of an educational intervention based on the theory of planned behavior on the lifestyle of administrative staff
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study Formal or contract employment in Isfahan regional Hospitals
Exclusion criteria:
Reluctance to cooperate Cardiovascular disease, hypertension and diabetes
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
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 Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah Hospital; Sheikh Baha'i street
City
Tehran
Province
Tehran
Postal code
1435916274
Approval date
2021-05-08, 1400/02/18
Ethics committee reference number
IR.BMSU.BAQ.REC.1400.008

Health conditions studied

1

Description of health condition studied
lifestyle
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Lifestyle score in the questionnaire
Timepoint
Before the intervention and three months later
Method of measurement
Health Promoting Lifestyle Questionnaire, the standard Persian version of which is available, as well as a theory-based questionnaire by the researcher and based on a study conducted by Banerji et al. In 2019.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Necessary explanations about the plan and the purpose of doing it will be given to the participants (both control and intervention groups) and they will be asked to fill in the form of informed consent to participate in the study to enter the study, then complete the questionnaire. (The method of collecting information in this research will be through a researcher-made questionnaire, which is a two-step form of completing the questionnaires) and employees are asked to answer the questionnaires separately and accurately without consultation, then the questionnaires After analyzing the participants' information, an educational intervention tailored to the educational needs of learners, which will be determined in the pre-test, is designed and considered for the intervention group based on the main components of promoting a healthy lifestyle. In at least four one-hour face-to-face training sessions, the training program should be implemented, which according to the analysis of the information of the first stage, the number of sessions can be changed. Three months after the intervention, the variables will be re-examined, ie at the end of the third month after completing the first questionnaire, the second stage will be performed to determine the effect of the educational intervention and the questionnaire will be completed as a self-report in the presence of the researcher.
Category
Lifestyle

2

Description
Control group: No training program will be designed for the control group, only at the end of the study, educational materials will be provided to the administrative staff of the control group.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Regional Hospital
Full name of responsible person
Ali Jahangiri
Street address
Behdari Lashkar Street; Artesh Square; Isfahan
City
]sfahan
Province
Isfehan
Postal code
8174620314
Phone
+98 31 3624 0021
Email
alijahan1318@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
mohsan saffari
Street address
South Sheikh Baha'i St.Mulla Sadra St.,Vanak Square., Tehran
City
Tehran
Province
Tehran
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 21 8248 3525
Email
alijahan1318@gmail .com
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
Mohsen Saffari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
South Sheikh Baha'i St.Mulla Sadra St.,Vanak Square., Tehran
City
Teharn
Province
Tehran
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 21 8248 3525
Email
alijahan1318@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohsen Saffari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
South Sheikh Baha'i St.Mulla Sadra St.,Vanak Square., Tehran
City
Tehran
Province
Tehran
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 21 8248 3525
Email
alijahan1318@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohsen Saffari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
South Sheikh Baha'i St.Mulla Sadra St.,Vanak Square., Tehran
City
Tehran
Province
Tehran
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 21 8248 3525
Email
alijahan1318@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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...