Protocol summary

Summary
The purpose of this study is to determine the effectiveness of educational program related to persuade pregnant women for breast feeding based on theory of planned behavior. In a quasi- experimental study various health centers were selected and randomly assigned to intervention group or control group (each group, n = 45). Pregnant women who had eligible criteria (Including: Primiparous, 30 to 34 weeks gestational age, Singleton pregnancy, no patients treated with breast feeding may interfere and at least basic literacy) were selected. After a pre-test by using a valid and reliable questionnaire for both groups, specific training was provided for the intervention group based on the theory of planned behavior. At the end of the training program, post-test were performed in both groups and the results were analyzed. Ten to fifteen days after delivery breastfeeding was compared between groups. Women who gave birth before the end of the fourth session were excluded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201210305698N8
Registration date: 2012-11-08, 1391/08/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-11-08, 1391/08/18
Registrant information
Name
Mahbobeh Ahmadi
Name of organization / entity
Shahid Beheshti University of Medical & Health Service
Country
Iran (Islamic Republic of)
Phone
+98 21 7747 5651
Email address
mah.ahmadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of educational program related to persuade pregnant women for breast feeding based on theory of planned behavior in Hamadan health centers.
Public title
Effectiveness of educational program related to persuade pregnant women for breast feeding.
Purpose
Other
Inclusion/Exclusion criteria
( inclusion criteria: Primiparous, 30 to 34 weeks gestational age, Singleton pregnancy, no patients treated with breast feeding may interfere and at least basic literacy) (exclusion criteria: Having breast diseases that interfere with breastfeeding, Take delivery before the end of Session 4, Admission to neonatal, Mother admission, Intrauterine fetal death, Lack of cooperation from Mothers).
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
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
Shahid Beheshti University of Medical Sciences
Street address
next to Ayatollah Taleghani Hospital, Evin, Shahid Chamran Highway,Tehran.
City
Tehran
Postal code
Approval date
2012-09-16, 1391/06/26
Ethics committee reference number
400/6220

Health conditions studied

1

Description of health condition studied
Breast feeding
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Breast feeding
Timepoint
10-15 days after delivery
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Knowledge؛ Attitude؛ Subjective norms؛ Perceived behavioral control and behavioral intention
Timepoint
Before and after the intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Educational intervention such as the use of educational booklet, film, lecture, questioning and individual and group counseling with mothers.
Category
Behavior

2

Description
The control group received no intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada Health Center
Full name of responsible person
Ms.Karimi
Street address
Shohada Health Center, Takhti Street, Hamadan
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Masoume Simbar
Street address
School of Nursing and Midwifery, Niayesh blvd Valiasr st cross, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Hamadan University of Medical Sciences
Full name of responsible person
Safoura Jahanara
Position
Midwifery Graduate Student
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street, Hamadan
City
Hamadan
Postal code
Phone
+98 81 1838 0319
Fax
Email
sa_jahanara@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahboubeh Ahmadi
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Niayesh blvd Valiasr st cross, Tehran
City
Tehran
Postal code
Phone
+98 21 8820 2512
Fax
Email
mah1372@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Safoura Jahanara
Position
Midwifery Graduate Student
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street, Hamadan
City
Hamadan
Postal code
Phone
+98 81 1838 0319
Fax
Email
sa_jahanara@yahoo.com
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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