Investigating the effect of mental health and lifestyle educational intervention on health promoting behaviors in elderly women under the care of a family doctor
Determining the effect of mental health and lifestyle educational intervention on health promoting behaviors in elderly women under the care of a family doctor.
Design
This study is a randomized controlled educational trial with a control group with parallel groups with a pre-test-post-test design. Based on the prepared list of elderly women eligible to enter the study in 2 clinics, the elderly women will be randomly placed in the intervention and control groups.
Settings and conduct
The intervention group will be trained in 7 training sessions, but the control group will not receive training during this period. The location of the study is family doctor's offices in Pasargad city.
Participants/Inclusion and exclusion criteria
Conditions for entering the study
1. Be covered by a family doctor and registered in the electronic health system (Sib). 2. Age over 60 years
3. Absence of mental health disorders in the Sib system
4. The ability to communicate (not suffering from severe vision and hearing defects that cannot be corrected with glasses and hearing aids)
5. Willingness to participate in the study and complete the informed consent form.
Exclusion condition
1. Unwillingness to continue cooperation 2. Absence in more than 1 training session 3. Death or migration of the elderly 4. Failure to complete the questionnaire post test
Intervention groups
For the intervention group, 7 educational sessions will be held weekly for 90 minutes in the form of short lectures, group discussions, questions and answers in 3 groups of 23 elderly women. The control group will not receive training during this period.
Main outcome variables
Improving the mental health and lifestyle of elderly women
Promoting health-promoting behaviors of elderly women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111017007816N20
Registration date:2023-06-07, 1402/03/17
Registration timing:retrospective
Last update:2023-06-07, 1402/03/17
Update count:0
Registration date
2023-06-07, 1402/03/17
Registrant information
Name
Mahin Nazari
Name of organization / entity
School of health
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
manazari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-01, 1402/02/11
Expected recruitment end date
2023-06-01, 1402/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of mental health and lifestyle educational intervention on health promoting behaviors in elderly women under the care of a family doctor
Public title
The effect of mental health and lifestyle educational intervention on health promoting behaviors
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be covered by a family doctor and registered in the electronic health system (Sib).
Age over 60 years old
Not suffering from mental health disorders in the Sib system
Ability to communicate (not suffering from severe vision and hearing defects that Glasses and hearing aids cannot be modified)
Willingness to participate in the study and complete the informed consent form.
Exclusion criteria:
Unwillingness to continue cooperation
Absence in more than 1 training session
Death or migration of the elderly
Failure to complete the questionnaire post test
Age
From 60 years old to 80 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Pasargad health center has 5 family doctor's offices under its coverage. 2 family doctor's offices that will be selected randomly, which will be randomly assigned using the table of random numbers in EXCL software. One family doctor's office will be assigned to the control group and another family doctor's office will be assigned to the intervention group.
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
Shiraz University Of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Province
Fars
Postal code
7153675541
Approval date
2023-04-30, 1402/02/10
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1402.012
Health conditions studied
1
Description of health condition studied
mental disorders
ICD-10 code
F06
ICD-10 code description
Other mental disorders due to known physiological condition
Primary outcomes
1
Description
mental health
Timepoint
Before and one month after the intervention
Method of measurement
Golderg's General Health Questionnaire
2
Description
Health promoting lifestyle
Timepoint
Before and one month after the intervention
Method of measurement
Health-promoting Lifestyle Profile Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, for educational intervention, for elderly women in the intervention group, an educational program will be held in the form of short lectures, discussion groups, questions and answers, and using educational aids such as (pamphlets and PowerPoint). Elderly women will be divided into groups of 23 people and will be trained in 7 90-minute training sessions. The control group will not receive training during this period.
Category
N/A
2
Description
Control group: The control group will not receive training during this period.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Family doctor's office number 1
Full name of responsible person
Behbood Zarei
Street address
Imam Khomeini street
City
Pasargad
Province
Fars
Postal code
7374189154
Phone
+98 917 351 1486
Email
pasargad1@imo.org.ir
2
Recruitment center
Name of recruitment center
Family doctor's office number 2
Full name of responsible person
Mohammad Shiravani
Street address
Imam Khomeini street
City
Pasargad
Province
Fars
Postal code
7374189167
Phone
+98 917 649 5183
Fax
Email
pasargad2@imo.org.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahin Nazari
Street address
Razi St. 10 - Razi Boulevard - Zahra Alley - School of Health - Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1005
Email
manazari@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Raziyeh Asadi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Public Health
Street address
Resalat St
City
Pasargad
Province
Fars
Postal code
7374189181
Phone
+98 71 4956 7975
Email
raziyehasadi12@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mahin Nazari
Position
Associate
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of health Education and promotion, School of public Health, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1005
Email
manazari@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Raziyeh Asadi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Public Health
Street address
Resalat St
City
Shiraz
Province
Fars
Postal code
7374189181
Phone
+98 71 4356 7975
Email
raziyehasadi12@gmail.com
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
Yes - There is 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
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
The total number of people referring to the magazine in which the article was published
Under which criteria data/document could be used
Supervisor
From where data/document is obtainable
Dr. Mahin Nazari Email manazari@sums.ac.ir
What processes are involved for a request to access data/document
The coordinators author takes about 1 week to 1 month