Protocol summary

Study aim
Determining the effect of educational intervention based on PRECEDE model on health promoting behaviors of women of reproductive age
Design
This research was a randomized controlled trial conducted on 120 health authorities in Rasht.
Settings and conduct
This study was performed on 120 (60 intervention, 60 controls) married women of reproductive age (15-49 years) who were covered by Shahid Farshad Health Center in the city of yazd in Iran. Data collection tool was a triploid questionnaire that included demographic data, researcher-made questionnaire according to the PRECEDE model and health-promoting lifestyle Profile-II (HPLP-II) questionnaire. Questionnaires were completed by intervention and control groups before and 2 months after training.
Participants/Inclusion and exclusion criteria
The inclusion criteria for this study were as follows: Being married, being in reproductive age (15-49 years); Elementary literacy; Stay in the area of intervention until the end of the study; being willing to participate in the research. Exclusion criteria included: Having a special diet; Restrictions on physical activity; having a special physical and mental illness; Being pregnant
Intervention groups
the intervention group were through seven sessions ( 60-90 minutes ) at a week intervals under the training of healthy lifestyles . Lecture, group discussion, question-and-answer, film, demonstration and teaching aids such as (whiteboard, video projector, computer and educational booklet) were used to present the information. The control group did not receive any training during the intervention.
Main outcome variables
Health promoting behaviors, predisposing factors (knowledge and attitude), reinforcing factors, enabling factors

General information

Reason for update
Acronym
_
IRCT registration information
IRCT registration number: IRCT20191019045160N1
Registration date: 2020-01-14, 1398/10/24
Registration timing: retrospective

Last update: 2020-01-14, 1398/10/24
Update count: 0
Registration date
2020-01-14, 1398/10/24
Registrant information
Name
somayeh mirrezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3222 3474
Email address
mirrezaei25.s@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
2014-07-23, 1393/05/01
Actual recruitment end date
2014-09-23, 1393/07/01
Trial completion date
2016-03-19, 1394/12/29
Scientific title
The effect of educational intervention based on PRECEDE model on health promoting behaviors of women of reproductive age
Public title
health-promoting lifestyle in Women of reproductive age
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being Married being in reproductive age (15-49 years) Elementary literacy Residence in the area until the end of the study Being Willingness to participate in the study
Exclusion criteria:
Having a special diet Restrictions on physical activity having a special physical and mental illness Being pregnant
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Actual sample size reached: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were systematically randomly selected so that the population covered by the health center was divided into the sample size (n =120) and the distance between samples was obtained. Then, by choosing a random number between 1 and K, the first number was chosen. The number of the next person was obtained by adding K to the number of the previous one. Finally, the samples were divided into two groups of control and Intervention by using Random number table.
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 Yazd University of Medical Sciences
Street address
School of Public Health, Shahid Sadoughi University of Medical Sciences, Alam Square, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2014-06-09, 1393/03/19
Ethics committee reference number
17/1/51843/پ

Health conditions studied

1

Description of health condition studied
health-promoting lifestyle
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Women of Reproductive Age
ICD-10 code
ICD-10 code description

3

Description of health condition studied
Precede Model
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Health Promoting Behavior Score
Timepoint
Before and two months after intervention
Method of measurement
health-promoting lifestyle Profile-II (HPLP-II) questionnaire

2

Description
knowledge score
Timepoint
Before and two months after intervention
Method of measurement
researcher-made questionnaire according to the PRECEDE model

3

Description
Attitude score
Timepoint
Before and two months after intervention
Method of measurement
researcher-made questionnaire according to the PRECEDE model

4

Description
Reinforcing factors score
Timepoint
Before and two months after intervention
Method of measurement
researcher-made questionnaire according to the PRECEDE model

5

Description
Enabling factors score
Timepoint
Before and two months after intervention
Method of measurement
researcher-made questionnaire according to the PRECEDE model

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Intervention group:the intervention group were through seven sessions ( 60-90 minutes ) at a week intervals under the training of healthy lifestyles . Lecture, group discussion, question-and-answer, film, demonstration and teaching aids such as (whiteboard, video projector, computer and educational booklet) were used to present the information.
Category
Lifestyle

2

Description
Control group:No intervention and educational program were used in the control group.‎
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Farshad Health Center
Full name of responsible person
Dr. Aref
Street address
Kashani Street, Housing and Urban Development Street
City
yazd
Province
Yazd
Postal code
_
Phone
+98 35 3623 2022
Fax
Email
mirrezaei25.s@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Massoud Mirzaei
Street address
Shahid Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
info@ssu.ac.ir
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
Somayeh Mirrezaei
Position
Graduate of Health Education
Latest degree
Master
Other areas of specialty/work
Public Health
Street address
Shahid Beheshti Square, Dr sefidy Alley
City
Pol Dokhtar
Province
Lorestan
Postal code
6854956844
Phone
+98 66 3222 3474
Email
mirrezaei25.s@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyed Saeed MazloomyMahmoodabad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Public Health, Shahid Sadoughi University of Medical Sciences, Alam Square, Yazd, Iran
City
YAZD
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۶۰
Phone
+98 35 3820 9100
Email
Mazloomy@ssu.ir

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
somayeh mirrezaei
Position
MSc in Health Education
Latest degree
Master
Other areas of specialty/work
Public Health
Street address
Shahid Beheshti Square, Dr sefidy Alley
City
Pol Dokhtar
Province
Lorestan
Postal code
6851946544
Phone
+98 66 3222 3474
Email
mirrezaei.s25@gmail.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
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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