Determining the effect of empowerment program on health promotion behaviors in women workers
Design
Clinical trial with intervention and control group and cluster random sampling of samples, Single blind, sample size 80
Settings and conduct
The research environment is the citrus collection and packaging workshops in Sari, and the research community of all women workers working in these workshops will be divided into two groups according to cluster randomized assignment (single blind study).At first, the pre-test is done using the research tool in both groups. The research tool is a demographic characteristics questionnaire and health promoting behaviors questionnaire. After the pre-test, intervention is conducted for the test group, which training on health promotion behaviors. Educational content after confirmation by professors will be taught in six sessions. Finally, the post-test will be done 8 weeks later
Participants/Inclusion and exclusion criteria
Full-time female and Iranian worker working at agricultural workshop for collection and packaging
Lack chronic diseases and psychological disorders
Have at least reading and writing skills
Lack Pregnant and Lactating
Absence in other educational programs
Participation in training sessions
Intervention groups
Implementation of empowerment program in women workers, that is training of health promoting behaviors based on empowerment model that will be done in the intervention group and its results will be compared with the control group.
Main outcome variables
Promoting lifestyle of female workers; Timely diagnosis and complete treatment of many diseases due to increasing women's awareness of health threats; Promoting family health by focusing on the role of women in the family; Helping women's health planners using From the results of the study to implement specific health-oriented programs for women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180628040269N1
Registration date:2018-07-28, 1397/05/06
Registration timing:registered_while_recruiting
Last update:2018-07-28, 1397/05/06
Update count:0
Registration date
2018-07-28, 1397/05/06
Registrant information
Name
Fatemeh Nouri Akandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3368 5054
Email address
fnoori@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-26, 1397/05/04
Expected recruitment end date
2018-08-15, 1397/05/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Empowerment Program on Health Promoting Behaviors in Women Workers
Public title
Impact of empowerment on health promotion behaviors
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Full-time female and Iranian female worker at the workshop
Not being diagnosed with chronic diseases and psychological disorders
At least the reading and writing skills
Not pregnant or breastfeeding
Exclusion criteria:
Attend other educational programs
Unable to attend training sessions
Chronic Diseases and Psychological Disorders
Not reading and writing literacy
Pregnant or lactating
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
According to the list of existing workshops, for random allocation of samples, randomized clustering of all workshops was coded and divided in two groups of tests and control and Sampling of these workshops will be done according to the conditions of entry into the study. Thus, the selected workers from the control group workshops will be placed in the control group and the selected workers from the test group workshops will be placed in the test group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to implement single blinding, workshops are divided into control and test groups based on cluster randomized assignment and selected samples from control workshops in the control group and test workshops in the test group. Accordingly, the participants in the two groups are not related to one another and this study is single blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Central Office of Tehran University of Medical Sciences, Corner of Ghods Street, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-01-31, 1396/11/11
Ethics committee reference number
IR.TUMS.FNM.REC.1396.4396
Health conditions studied
1
Description of health condition studied
Lifestyle and Health Promoting Behaviors
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The overall life style score in the HPLP-2 questionnaire in women workers
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Through health promotion behaviors questionnaire 2
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will be empowered based on the four steps of Empowerment Model (perceived threat, self-efficacy, educational participation and evaluation). The empowerment program is organized in 6 sessions in the classroom by lecture, question and answer, and group discussion on the dimensions of health promotion behaviors for women workers in order to measure the impact of this program on the health promotion behaviors in women workers. The Educational booklet that include all the items taught will be given to this group at the end of this study.
Category
Lifestyle
2
Description
Control group: No training interventions will be conducted for the control group during the duration of the research; however, after the end of the study, the Educational booklet will be provided to the control group.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari Health Center and Treatment
Full name of responsible person
Fatemeh Noori
Street address
Sari Health Center, Rudaki Street, Amir Mazandaran Street
City
Sari
Province
Mazandaran
Postal code
4816711447
Phone
+98 11 3339 8048
Fax
+98 11 3339 8046
Email
ftm07noori@gmail.com
Web page address
http://sari.mazums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
MohammadAli Sahraiean
Street address
Deputy of Research and Technology, Central building of Tehran University of Medical Sciences,Corner of Quds Street, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 7381
Fax
+98 21 8898 9664
Email
msahrai@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Noori
Position
Nursing Postgraduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery College of Tehran University , Dr. Mirkhani avenue (East Nusrat), Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
ftm07noori@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahzad Pashaieepour
Position
Faculty Member of the University
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery College of Tehran University, Dr Mirkhani Street (Eastern Nusrat), Tavid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
pashaeypoor.sh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Noori
Position
Nursing Postgraduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery College of Tehran University, Dr Mirkhani Street (Eastern Nusrat), Tavid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
ftm07noori@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
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
Undecided - It is not yet known if there will be 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
After the end of the project, the result of this study and the outcome of the study and statistical analysis of data will be publicly available.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Researchers working in academic, scientific and industrial institutes
Under which criteria data/document could be used
Use the results of this research
From where data/document is obtainable
Email Fatemeh Nouri
ftm07noori@gmail.com
What processes are involved for a request to access data/document