Determining the effect of intervention based on family-centered empowerment model on preventive lifestyle risk factors for cardiovascular disease in middle-aged women
Design
The clinical trial includes an intervention and control group that sampling will be done based on the inclusion criteria and randomly (random blocking). The sample size in each group will be 37 people and a total of 74 people.
Settings and conduct
The study site will be comprehensive health service centers in the south of Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Age between 40 to 59 years
Lack of speech and hearing problems
- Literacy
- Do not suffer from known mental disorders (self-expression and apple system)
- The person is at a moderate and higher risk of cardiovascular disease
- Do not have underlying diseases other than diabetes
Exclusion criteria:
- Absence from more than two sessions of training sessions
- Spatial displacement
Intervention groups
After sampling and identification of control and test groups, the intervention based on the family-centered empowerment model will be performed for the test group. Thus, by forming small groups during 6 training sessions, each session will be for half an hour and will be held twice a week, the lifestyle of preventing risk factors for cardiovascular disease using model steps (perceived threat from Through group discussion, promoting self-efficacy through group problem solving, increasing self-esteem (self-confidence) through educational participation) will be taught. In two sessions, a family member will be invited to attend the sessions and participate in training and group discussions. However, in order to comply with ethical considerations, a training session will be held at the end of the intervention for the control group.
Main outcome variables
Improving the preventive lifestyle of risk factors for cardiovascular disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201208049649N1
Registration date:2021-01-07, 1399/10/18
Registration timing:prospective
Last update:2021-01-07, 1399/10/18
Update count:0
Registration date
2021-01-07, 1399/10/18
Registrant information
Name
Fariba Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2275 8177
Email address
farimahosseini2015@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-19, 1399/10/30
Expected recruitment end date
2021-04-20, 1400/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intervention based on family-centered empowerment model on preventive lifestyle of cardiovascular risk factors in middle-aged women
Public title
Effect of intervention based on family-centered empowerment model on preventive lifestyle of cardiovascular risk factors in middle-aged women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 40 to 59 years
Lack of speech and hearing problems- Literacy
Do not suffer from known mental disorders (self-expression and apple system)
The person is at a moderate and higher risk of cardiovascular disease
Do not have underlying diseases other than diabetes
Exclusion criteria:
Absence from more than two sessions of training sessions
Spatial displacement
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:
74
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were randomly assigned to the experimental and control groups in the form of a random permutation block design with four blocks. Thus, the letter A was considered for the intervention and the letter B was considered for the control group. Then all the permutation compounds of letters A, A and B, B, which were 6 different compounds, were written (AABB for cultivar 1, ABBA for cultivar 2…) and from cultivars 1 to 6, one cultivar was randomly selected by substitution. For example, if the number 2 was selected, it meant that the first person in the intervention group, the next two people in the control group and the fourth person in the intervention group, and we continued this operation until the sample size reached the quorum (37 people in each group). ) Receipt
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 Tehran University of Medical Sciences
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat Sharghi St., Tohid Sq., Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2020-10-05, 1399/07/14
Ethics committee reference number
IR.TUMS.FNM.REC.1399.105
Health conditions studied
1
Description of health condition studied
Cardiovascular diseases
ICD-10 code
I50.4
ICD-10 code description
Combined systolic (congestive) and diastolic (congestive) heart failure
Primary outcomes
1
Description
Preventive lifestyle risk factors for cardiovascular disease
Timepoint
Before the intervention, two months after the end of the intervention
Method of measurement
Standard Eating Habits Questionnaire, Metabolic Health Assessment Questionnaire, Baecke Physical Activity Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Intervention group: By forming small groups during 6 training sessions, each session will be for half an hour and will be held twice a week, the lifestyle of preventing cardiovascular disease risk factors using the model steps (perceived threat from Through group discussion, promoting self-efficacy through group problem solving, increasing self-esteem (self-confidence) through educational participation) will be taught. In two sessions, a family member will be invited to attend the sessions and participate in training and group discussions. The educational content includes (nutrition, physical activity ......) which will be based on the family self-care guide and will be designed by the esteemed deputy of health and will have a set of practical recommendations for the prevention of cardiovascular disease risk factors. Educational materials are taught according to the model (perceived threat through group discussion, promoting self-efficacy through group problem solving, increasing self-esteem (self-confidence) through educational participation): Step 1 (perceived threat): In this Step by step group discussion will be used to examine the perceived threat. Examining and evaluating the current situation, individual, environmental and behavioral differences and determining the behavioral and environmental factors that affect the change of behavior will be done in this meeting. Group discussion with the research units will be done in two sessions and each session will last for 30 minutes, in which one person will participate alone and in the next session with a family member. During the sessions, discuss their knowledge and potential solutions, then provide educational materials on the importance of self-care and prevention of cardiovascular disease and its dimensions, including care measures to prevent disease. Cardiovascular, communicating with others as a group discussion to achieve codified and effective programs, promoting self-efficacy through group problem solving, increasing self-esteem (self-esteem) through educational participation of research members and families, the nature of the disease Cardiovascular, signs and symptoms of the disease or exposure and issues related to nutrition and physical activity and blood pressure and smoking will be expressed. Step 2 (Improving self-efficacy through group problem solving): For this step, the method of showing educational videos and pamphlets in two sessions for 30 minutes will be used, so that in one of the sessions, family members with the samples studied They will participate in the meeting, and the necessary training and needs assessment in the first session will be provided to the research members through educational videos and pamphlets. Also, in the meeting in which family members also participate, the research members will be asked. To reach possible solutions to the problem and plan to implement it through group discussion with each other and with family members, through the problem solving process. At the end, a program will be prepared based on standard principles and using publicly available materials and methods and will be provided to members. All material presented from scientific sources will be valid and approved by professors. Step 3 (Increase self-esteem through educational participation): In this stage, which will be done in two sessions and each session will be for 30 minutes, the patient is asked Will participate in training their family members and encourage them to help themselves. Step 4 (Final Evaluation): In this stage, which will be eight weeks after the last family-centered empowerment session, invite the research units Will do to answer the research questionnaire as a post-test. After the completion of this process, the written and text file of the trainings presented in the previous sessions will be presented in PDF format along with the pamphlet files related to all research units (both intervention and control groups).
Category
Prevention
2
Description
Control group: The control group will benefit from the usual programs of the center, but in order to observe ethical considerations, a training session will be held for this group at the end of the intervention, in which the training given to the intervention group will be briefly taught. .
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health service centers in the south of Tehran
Full name of responsible person
Fariba Hosseini
Street address
No. 41, 4th floor, Sadeghi Alley,Farmanieh.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 2275 8177
Email
farimahosseini2015@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahrzad Pashaeipour
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat Sharghi St., Tohid Sq., Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
sh-pashaeipour@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
Fariba Hosseini
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 41, 4th and 7th floors, Sadeghi Alley, Farmanieh, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 2275 8177
Email
farimahosseini2015@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fariba Hosseini
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 41, 4th and 7th floors, Sadeghi Alley, Farmanieh, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 2275 8177
Email
farimahosseini2015@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fariba Hosseini
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 41, 4th and 7th floors, Sadeghi Alley, Farmanieh, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 2275 8177
Email
farimahosseini2015@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data analysis results will be available for use by other experts and researchers after the study
When the data will become available and for how long
One month after data analysis
To whom data/document is available
Researchers, experts and professors in this field, managers, planners and other stakeholders
Under which criteria data/document could be used
There are no special conditions for people to access
From where data/document is obtainable
After publishing the results, they can refer to the site where the results were published
What processes are involved for a request to access data/document
After publishing the results in the journal and the site, it is enough to search for the keywords of the research on the internet page, and also to communicate with the researcher, they can contact him through the email published in the article.