Protocol summary

Summary
The present study is an intervention research from quasi-experimental type. In order to investigate the effect of an educational program on health promoting behaviors among pregnant women by self-efficacy theory in Mahshahr city . In this study, the effect of the independent variable (training program) on dependent variables (stress, physical activity and self-efficacy) will be examined. Considered group is included 78 pregnant women at 12 - 16 weeks gestational age (divided into two groups: 39 people in control group and 39 people in intervention group). Direct educational intervention is done in 5 sessions of 1 hour in 2 days of week. A pre-test and post-test is held one month after the educational intervention. To collect date, a valid questionnaire is used which are included demographic variables, the Persian edition of health-promoting lifestyle profile, symptoms of depression, anxiety and stress, physical activity in pregnancy period and a prepared questionnaire based on the theory of self-efficacy which is completed by pregnant women in both groups before and 1 month after the end of educational intervention

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015073015015N12
Registration date: 2015-09-07, 1394/06/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-09-07, 1394/06/16
Registrant information
Name
Leila Ghahremani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
ghahramanl@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences (SUMS)
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational program on Health-promoting behaviours pregnant women , application of “self-efficacy theory “
Public title
The effect of educational program on Health-promoting behaviours pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women at 12 - 16 weeks gestational age; interest of volunteers for participating in this study; have a pregnancy without risk and no evidence of disease; at least secondary school education without speech or accent problems Exclusion criteria: having more than one session absences in classes; inaccessibility of pregnant women when completing the questionnaire.
Age
From 15 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand Street,-headquarters Shiraz University of Medical Sciences, Shiraz
City
Shiraz
Postal code
71345-2307594
Approval date
2015-07-05, 1394/04/14
Ethics committee reference number
IR.SUMS.REC.1394.61

Health conditions studied

1

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

Primary outcomes

1

Description
Health-promoting lifestyle
Timepoint
Pretest- posttests one month after the intervention
Method of measurement
HPLP Questionnaire

Secondary outcomes

1

Description
Stress
Timepoint
pretest-posttest one month after the intervention
Method of measurement
DASS Questionnaire

2

Description
Pregnancy Physical Activity
Timepoint
pretest-posttest one month after the intervention
Method of measurement
Pregnancy Physical Activity Questionnaire

Intervention groups

1

Description
The control group do not recived any training
Category
Other

2

Description
Direct intervention in 5 sessions of 1 hour for two sessions per week for pregnant women in the intervention group at the end of each session was carried out. The training program, group discussion and Q & A was assigned.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Care Center No.1
Full name of responsible person
Street address
City
Mahshahr

2

Recruitment center
Name of recruitment center
Health Care Center No.2
Full name of responsible person
Street address
City
Mahshahr

3

Recruitment center
Name of recruitment center
Health Care Centers Rah-e Zeinab
Full name of responsible person
Street address
City
Mahshahr

4

Recruitment center
Name of recruitment center
Health Care Center No.3
Full name of responsible person
Street address
City
Mahshahr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences (SUMS), Shiraz, Iran
Full name of responsible person
Dr Seyed Basir Hashemi
Street address
zand street -Shiraz University of Medical Sciences (SUMS), Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences (SUMS), Shiraz, Iran
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
School of Health, Shiraz University of Medical Sciences (SUMS), Shiraz, Iran
Full name of responsible person
Dr Leila Ghahramani
Position
Assistant Professor, School of Public Health, Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
koy zahra-School of Health
City
Shiraz
Postal code
71645-111
Phone
+98 71 3725 1001
Fax
Email
ghahramanl@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences (SUMS), Shiraz, Iran
Full name of responsible person
Dr Leila Ghahramani
Position
Assistant Professor in Health Education, Dept.of Health Education & Promotion, School of Health, SUM
Other areas of specialty/work
Street address
School of Health, SUMS, Shiraz, Iran
City
Shiraz
Postal code
71645-1111
Phone
+98 71 3725 1001
Fax
Email
ghahramanl@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Health, Shiraz University of Medical Sciences (SUMS), Shiraz, Iran
Full name of responsible person
Dr Leila Ghahramani
Position
Assistant Professor in Health Education, Dept.of Health Education & Promotion, School of Health, SUM
Other areas of specialty/work
Street address
School of Health, Shiraz University of Medical Sciences (SUMS), Shiraz, Iran
City
Shiraz
Postal code
71645-111
Phone
+98 71 3725 1001
Fax
Email
ghahramanl@sums.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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