Objectives: To determine the effect of counseling on health promoting lifestyle in middle-aged women.
Design: A single-blind randomized controlled trial.
Conduct: This study will be conducted on middle-aged women referring to health centers of Tabriz. The researcher will be attended in health centers and a list of middle-aged women will be prepared through record or health volunteers. Researcher will call with them and if they comply with the inclusion criteria and have tendency to participate in study, they will be invited to be present at the health center. After attending health centers and obtaining written informed consent, pre-test questionnaires will be completed. Then, middle-aged women will be randomly assigned to two groups (one group receiving counseling and other groups without counseling) using block randomization with block sizes of 4 and 6 stratified by age (40 to 50 and 50 to 60 years). A person from research team not involved in the sampling will generate allocation sequence.
Participants: 102 middle-aged women with 40-60 years old.
Intervention: Group counseling will be provided to intervention group at three sessions of 45 minutes once a week about topics of spiritual growth, stress management, nutrition, physical activity, health responsibility and interpersonal relations. The main outcome variable is health-promoting lifestyle and secondary outcome is quality of life that will be assessed before, 4 and 8 weeks after the intervention by questionnaires.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015122610324N27
Registration date:2016-02-04, 1394/11/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-02-04, 1394/11/15
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-06-19, 1395/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling on health promoting lifestyle in middle-aged women: a single-blind randomized controlled trial
Public title
The effect of counseling on health promoting lifestyle in middle-aged women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Women ages 40-60 years old; Being interested in participating in the study; Having a contact number for follow-up; Being literate of participants or a family member to read the booklet for the participant.
Exclusion criteria: Having a history of physical illness according to the woman expression; Having a mental illness according to the woman expression; Recent tragic events; Use of cigarette, Alcohol, Drugs and other drugs affect the body and mind of a person; Sever economic poverty; Previous participation in counseling classes for promoting lifestyle.
Age
From 40 years old to 59 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan
City
Tabriz
Postal code
Approval date
2016-01-10, 1394/10/20
Ethics committee reference number
1394.900.TBZMED.REC
Health conditions studied
1
Description of health condition studied
سبک زندگی
ICD-10 code
Y98
ICD-10 code description
Lifestyle-related condition
Primary outcomes
1
Description
Health promoting lifestyle
Timepoint
Before,4 and 8 week after intervention
Method of measurement
Health promoting lifestyle questionnaire for middle-aged women
Secondary outcomes
1
Description
Quality of life
Timepoint
Before, 4 and 8 week after intervention
Method of measurement
Quality of life questionnaire (SF-36)
Intervention groups
1
Description
The intervention group will receive group counseling at three sessions of 45 minutes once a week about topics of spiritual growth, stress management, nutrition, physical activity, health responsibility and interpersonal relations.
Category
Lifestyle
2
Description
The control group will receive no intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Tabriz city
Full name of responsible person
Vahideh Karimlou
Street address
Health centers, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nursing & Midwifery Faculty,Tabriz University of Medical Sciences
Full name of responsible person
Vahideh Karimlou
Position
Ms
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street, Tabriz Tabriz
City
Tabriz
Postal code
6615615733
Phone
+98 41 3479 6770
Fax
Email
vkarimlou@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street, Tabriz
City
Tabriz
Postal code
6615615733
Phone
+98 41 3335 7582
Fax
Email
Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street, Tabriz Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 7582
Fax
Email
Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)