Protocol summary

Summary
This study is done with the aim of evaluating the effects of educational multimedia based on Trans-theoretical Model on nutritional behavior for preventing hypertension among women over 30. Inclusion criterions are: Female; being above 30 years; Access to computer or CD player; Ability to use multimedia; and Exclusion criterions are: Not seeing the multimedia. The population includes 370 women over 30, and for model analysis 100 women are selected randomly from those who are in pre-contemplation, contemplation and action stage. After that they are divided into two groups of intervention and control with 50 women placed randomly in each. Group 1 (intervention) has an explanatory session after which a multimedia is given to each person with a booklet for recording their activities. Group 2(control) don’t have any intervention. After 3 month intervention group and control group are evaluated and compared again. Then a multimedia is given to control group, too.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014082018872N1
Registration date: 2014-10-22, 1393/07/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-10-22, 1393/07/30
Registrant information
Name
Azita Mohsennejad
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3367 8632
Email address
a.mohsennejad@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2014-08-06, 1393/05/15
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of educational multimedia based on Trans-theoretical Model on nutritional behavior for preventing hypertension among women over 30
Public title
Effect of multimedia on nutritional behavior for preventing hypertension
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Female; Age more than 30 years; Access to computer or CD player; Ability to use multimedia Exclusion criteria: not watching the multimedia;
Age
From 30 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
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
Arak University of Medical Science
Street address
Health School, Gplestan, Area Mostapha Khomeini
City
Arak
Postal code
3818146851
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
92-156-13

Health conditions studied

1

Description of health condition studied
hypertension
ICD-10 code
115.8
ICD-10 code description
Other secondary hypertension

Primary outcomes

1

Description
fruit and vegetable serving
Timepoint
before intervention and three months after intervention
Method of measurement
questionnaire

2

Description
intake fish
Timepoint
before intervention and three months after intervention
Method of measurement
questionnaire

3

Description
intake salt
Timepoint
before intervention and three months after intervention
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
A multi media based on Trans-theoretical Model is given to the intervention group. This multimedia has four educational sessions which they have to see it, every session in a week. After three months, they will be evaluated by questionnaire again.
Category
Lifestyle

2

Description
Control group don’t have any intervention, but after three months they will be evaluateed with the same questionnaire. After study will be given to the control group of the same multimedia too.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak Health Center
Full name of responsible person
Dr mahboobeh khorsandi
Street address
School of Public Health, Golestan, Mostafa Khomeini Area
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Science
Full name of responsible person
Ali Asghar Yaghoobi
Street address
Basidj SQ, Sardasht
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Science
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
Health School
Full name of responsible person
Mahboobeh Khorsandi
Position
Phd in Health Education
Other areas of specialty/work
Street address
School of Public Health, Golestan, Mostafa Khomeini Area
City
Arak
Postal code
3818146851
Phone
+98 86 3368 4615
Fax
Email
dr.khorsandi@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Science
Full name of responsible person
Mahboobeh Khorsandi
Position
phd in Health Education
Other areas of specialty/work
Street address
School of Public Health, Golestan, Mostafa Khomeini Area
City
Arak
Postal code
3818146851
Phone
+98 86 3368 4615
Fax
Email
dr.khorsandi@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Health School
Full name of responsible person
Azita Mohsennejad
Position
BSc of Health Education
Other areas of specialty/work
Street address
School of Public Health, Golestan, Mostafa Khomeini Area
City
arak
Postal code
3818146851
Phone
+98 86 3367 8632
Fax
Email
a.mohsennejad@arakmu.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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