Protocol summary

Summary
The main objectives of the project: Evaluation of the program designed with the health belief model on improving healthy lifestyle behaviors in people with suspected cardiovascular disease Objectives of the project: Determining and comparing the mean score of healthy lifestyle behaviors in the intervention and control group before and after the intervention, determining and comparing the mean of BMI in the intervention and control groups before and after the intervention, and determining and comparing the mean of activity time Physical characteristics of the intervention and control group before and after the intervention, determining and comparing the mean of blood pressure in the intervention and control groups before and after the intervention, determining and comparing the mean of blood glucose in the intervention and control groups before and after the intervention, determining and comparing the mean Tobacco use in intervention and test groups before and after intervention Design: The design of the study will be based on the health belief model. Implementation: Group intervention in five groups for five weeks continuously Entry requirements: Minimum reading and writing skills, non-severe depression, mental and physical disability. Conditions of Exit: Dissatisfaction with the continuation of the study by the person himself. Interventions: Including training on blood pressure, blood glucose and health promotion behaviors in the intervention group based on the results of the measurement of health belief model structures. Also, in order to enhance training and as a reminder dose, messages will be sent using mass communication applications. Ethical considerations: Provide the right information to the participants in the study on the goals, how to conduct the study, and the informed consent to participate in the study, the confidentiality of the information of the participants in all phases of the study, observance of the principle of usefulness, equity and independence in the participants in the study , Receiving the approval of the University's Ethics Committee and receiving the Ethics Code, providing the intervention to the control group after the completion of the measurements related to the research (if the intervention was effective).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017101625431N3
Registration date: 2017-11-08, 1396/08/17
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-11-08, 1396/08/17
Registrant information
Name
Elham Shakibazadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4293 3210
Email address
shakib@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of School of Public Health, Tehran University of Medical Sciences
Expected recruitment start date
2017-11-21, 1396/08/30
Expected recruitment end date
2017-12-11, 1396/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of promoting healthy lifestyle program among individual at risk of cardiovascular diseases: An application of Health Behavior Model
Public title
Evaluation of promoting healthy lifestyle program among individual at risk of cardiovascular diseases: An application of Health Behavior Model
Purpose
Prevention
Inclusion/Exclusion criteria
Major entry requirements: At least reading and writing literacy; Lack of severe depression; Mental and physical disability Major exclusion criteria: lack of consent to continue study by the person himself
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 170
Randomization (investigator's opinion)
Randomized
Randomization description
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, School of Public Health, Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Enqelab St, Tehran, Iran
City
Tehran
Postal code
Approval date
2017-10-07, 1396/07/15
Ethics committee reference number
IR.TUMS.SPH.REC.1396.3636

Health conditions studied

1

Description of health condition studied
Cardiovascular disease
ICD-10 code
I51.6
ICD-10 code description
Cardiovascular disease, unspecified

Primary outcomes

1

Description
Age
Timepoint
Before intervention
Method of measurement
Questionnaire

2

Description
Eex
Timepoint
Before intervention
Method of measurement
Questionnaire

3

Description
Education
Timepoint
Before intervention
Method of measurement
Questionnaire

4

Description
Income
Timepoint
Before intervention
Method of measurement
Questionnaire

5

Description
Marital status
Timepoint
Before intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Perceived sensitivity
Timepoint
Before intervention, after intervention, three months after intervention
Method of measurement
Questionnaire

2

Description
Perceived severity
Timepoint
Before intervention, after intervention, three months after intervention
Method of measurement
Questionnaire

3

Description
Perceived benefits
Timepoint
Before intervention, after intervention, three months after intervention
Method of measurement
Questionnaire

4

Description
Perceived barriers
Timepoint
Before intervention, after intervention, three months after intervention
Method of measurement
Questionnaire

5

Description
Guidance for practice
Timepoint
Before intervention, after intervention, three months after intervention
Method of measurement
Questionnaire

6

Description
Self-sufficiency
Timepoint
Before intervention, after intervention, three months after intervention
Method of measurement
Questionnaire

7

Description
Body mass index
Timepoint
Before intervention, after intervention, three months after intervention
Method of measurement
BMI

8

Description
Smoking
Timepoint
Before intervention, after intervention, three months after intervention
Method of measurement
Questionnaire

9

Description
Blood pressure
Timepoint
Before intervention, after intervention, three months after intervention
Method of measurement
Blood Pressure Monitor

10

Description
Blood glucose
Timepoint
Before intervention, after intervention, three months after intervention
Method of measurement
Blood glucose meter

Intervention groups

1

Description
Intervention group: Group intervention in five groups for five weeks includes training on blood pressure, blood glucose and health promotion behaviors in the intervention group based on the results of measuring the health belief model.
Category
Lifestyle

2

Description
Control group: The control group did not intervene and only blood pressure and blood glucose were measured twice weekly.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center of Fatima
Full name of responsible person
Dr. Alireza Mohammadzade Fardfini
Street address
Plaque 131, Health Center of Fatima, Taslihat Square, Narmak, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, School of Public Health, Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeiyan
Street address
Tehran University of Medical Sciences, Enqelab St, Tehran, Iran
City
Tehran
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, School of Public Health, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Sohrab Babaei
Position
Student Master
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Enqelab St, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 7726 6553
Fax
Email
sbabaei@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Eelham Shakibazadeh
Position
Phd
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Enqelab St, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21214293
Fax
Email
shakibazadeh@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sohrab Babaei
Position
Student Master
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Enqelab St, Tehran, Iran
City
Tehran
Postal code
Phone
+98 912 388 2387
Fax
Email
sbabaei@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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