The effect of education based on the protection motivation theory and theory of planned behavior on the adherence to dietary approaches to stop hypertension
The comparative study of the effect of education based on the protection motivation theory and theory of planned behavior on the adherence to dietary approaches to stop hypertension (DASH) among prehypertension patients
Design
Clinical trials with control group, randomized.
Sample size: 150 subjects in total, 50 sample per groups.
Settings and conduct
Pretest and post test three months after the completion of training sessions.
Three 60-minute sessions of training with group discussion method, lecture and distribution of booklet and pamphlet based on the theory of planned behavior and protection motivation theory were implemented on two groups of intervention separately.
Blood pressure and food program were compared before and after intervention in the three groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Average SBP during two measurements within two minutes must be in the range of 120 to 139 or average DBP must be in the range of 80 to 89
Consent to participate in the study.
Exclusion criteria:
Pregnancy
Disease such as kidney failure and cancer
Not regular attendance in class.
Intervention groups
First intervention group: A diet was received and three 60-minute sessions of training based on the theory of planned behavior were implemented.
Second intervention group: A diet was received and three 60-minute sessions of training based on the protection motivation theory were implemented.
Control group: Received a diet plan.
Main outcome variables
Hypertension,
Food intake
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130707013891N2
Registration date:2019-03-26, 1398/01/06
Registration timing:retrospective
Last update:2019-03-26, 1398/01/06
Update count:0
Registration date
2019-03-26, 1398/01/06
Registrant information
Name
Saeed Dashti
Name of organization / entity
Faculty of Health, Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 2829 3264
Email address
s.dashti@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
2017-12-22, 1396/10/01
Actual recruitment end date
2018-06-22, 1397/04/01
Trial completion date
2018-06-22, 1397/04/01
Scientific title
The effect of education based on the protection motivation theory and theory of planned behavior on the adherence to dietary approaches to stop hypertension
Public title
The effect of education based on the protection motivation theory and theory of planned behavior on the adherence to dietary approaches to stop hypertension
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
average SBP during two measurements within two minutes must be in the range of 120 to 139 or average DBP must be in the range of 80 to 89
Not having diabetes.
Consent to participate in the study.
Exclusion criteria:
During the study, the patient is complications heart attack or stroke.
not regular attendance in class.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Actual sample size reached:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients into two intervention groups Patients are randomly divided into two groups and a control group with a table of random numbers (a random number table is a collection of numbers that are generated without a specific pattern or order and completely randomized, then samples are randomly selected by Randomizer software.
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 Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Bahonar Square, Yazd, Central Organization of Shahid Sadoughi University of Yazd Medical Sciences and Health Services
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2016-11-05, 1395/08/15
Ethics committee reference number
IR.SSU.SPH.REC.1395.103
Health conditions studied
1
Description of health condition studied
Prehypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Hypertension
Timepoint
Before the intervention, and 3 months after intervention
Method of measurement
hypertension high blood pressure according to the millimeters Mercury with the use of digital indicator
Secondary outcomes
1
Description
Food intake
Timepoint
Before the intervention, and 3 months after intervention
Method of measurement
3-day food records.
Intervention groups
1
Description
Control group: Received a meal plan.
Category
Lifestyle
2
Description
First intervention group: A diet was received and three 60-minute sessions of training based on the theory of planned behavior were implemented.
Category
Lifestyle
3
Description
Second intervention group: A diet was received and three 60-minute sessions of training based on the protection motivation theory were implemented.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Delkhah Health Center
Full name of responsible person
Dashti Saeid
Street address
No.21,Motehari Ave.
City
Ferdows
Province
South Khorasan
Postal code
9771956564
Phone
+98 56 3272 6266
Email
saeeddashty88@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mirzaei Masoud
Street address
Bahonar Square, Yazd, Central Organization of Shahid Sadoughi University of Yazd Medical Sciences and Health Services
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 6711
Email
m.morshedian1396@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dashti Saeid
Position
Phd. Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Yazd, Campus, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35331492101
Email
saeeddashty88@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mazloomi sayed saeed
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Yazd, Campus, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2101
Email
mazlomy@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dashti Saeid
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Yazd, Campus, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2101
Email
saeeddashty88@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD