The effect of group counseling on health promotion behaviors in middle-aged women
Design
Randomized clinical trial with control group, without blinding
Settings and conduct
This study will be conducted on 90 middle-aged women referred to the outskirts health centers of Urmia city who randomly divided into the intervention and control groups.Intervention (group counseling) will be held for six weeks and each weekly session will be 90-60 minutes, and the number of people in each group will be 7-10 subjects. The control group will not receive any counseling and will receive routine care. There will not be blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 40-60 years, Having no recent stressful events in the past 6 months, Having no history of specific or acute disease (such as cancer or mental disorder). No-entrance criteria: Unwillingness to participate in the study
Intervention groups
Intervention group will receive group counseling. Intervention (group counseling) will be held for six weeks and each weekly session will be 90-60 minutes, and the number of people in each group will be 7-10 subjects. The control group will not receive any counseling and will receive routine care.
Main outcome variables
Mean scores of health promoting behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180926041148N1
Registration date:2018-10-14, 1397/07/22
Registration timing:prospective
Last update:2018-10-14, 1397/07/22
Update count:0
Registration date
2018-10-14, 1397/07/22
Registrant information
Name
marziyeh Ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
mebrahimi11@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-06, 1397/09/15
Expected recruitment end date
2019-06-05, 1398/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group counseling on health promotion behaviors in middle-aged women who referred to outskirts health centers of Urmia city in 2018
Public title
The effect of group counseling on health promotion behaviors in middle-aged women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 40-60 years
Having no recent stressful events in the past 6 months
Having no history of specific or acute disease (such as cancer or mental disorder)
Exclusion criteria:
Unwillingness to participate in the study
Age
From 40 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Using random allocation software, the participants in the study were divided into the intervention and control groups.
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 Urmia University of Medical Sciences
Street address
Urmia University of Medical Science Orjhans Street, Resalat Blvd Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2018-02-07, 1396/11/18
Ethics committee reference number
IR.UMSU.REC.1396.398
Health conditions studied
1
Description of health condition studied
The effect of group counseling on health promotion behaviors in middle-aged women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mean scores of health promoting behaviors
Timepoint
before intervention and one month after intervention
Method of measurement
Health-promoting lifestyle questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group will receive group counseling. Intervention (group counseling) will be held for six weeks and each weekly session will be 90-60 minutes, and the number of people in each group will be 7-10 subjects.
Category
Behavior
2
Description
Control group: The control group will not receive any counseling and will receive routine care. After completion of the study, a session will also be held for the control group and a training pamphlet will be presented to them.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia University of Medical Sciences
Full name of responsible person
Javad Aghazadeh
Street address
Urmia University of Medical Science Orjhans Street, Resalat Blvd Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
info@urmia.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Urmia University of Medical Science Orjhans Street, Resalat Blvd Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
info@urmia.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Marziyeh Ebrahimi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Urmia University of Medical Sciences, Nazlo Blv, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3346 9931
Fax
Email
mebrahimi11@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Marziyeh Ebrahimi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Urmia University of Medical Sciences, Nazlo Blv, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3346 9931
Fax
Email
mebrahimi11@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Marziyeh Ebrahimi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Urmia University of Medical Sciences, Nazlo Blv, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3346 9931
Fax
Email
mebrahimi11@umsu.ac.ir
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
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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Yes - There is 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 completion of the study, final decision will be made.
When the data will become available and for how long
Six months after the completion of the study
To whom data/document is available
All collage researchers
Under which criteria data/document could be used
Just for scientific research
From where data/document is obtainable
Email
What processes are involved for a request to access data/document