Protocol summary

Summary
This study aimed to compare the effect of Group discussion (first group) with combining group discussion and skill training (second group) and third groups as routine training group (the common approach in the health care system of Iran) on pregnant women breastfeeding knowledge, attitude and skill in three health center of yasuj township in southern of Iran. In each centers 129 pregnant women are randomly selected from eligible participants. Each center will be allocated to one of three study groups. Based on standard educational methods, 129 participant in each groups (Centers) divided into 10 groups of 12 and one groups of 9 participants and will receive interventions in four session with 1.5 hours duration with one week period between each educational session.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2015081823642N1
Registration date: 2017-06-01, 1396/03/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-01, 1396/03/11
Registrant information
Name
Fariba Mahamed
Name of organization / entity
Yasuj University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 9224
Email address
mahamed.fariba@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of yasuj University of Medical Sciences
Expected recruitment start date
2008-10-01, 1387/07/10
Expected recruitment end date
2012-03-02, 1390/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of group discussion and training on knowledge, attitude and practice of pregnant woman: a randomized clinical trial with a control group
Public title
Comparision Group discussion or combining methods in breast feeding
Purpose
Health service research
Inclusion/Exclusion criteria
inclusion criteria pregnant women who were under maternal Services covered by health centers. Delivery informant consent,Gestational age between 12 to 37 weeks Exclusion criteria: breast anomaly, Unwillingness to participate in all training sessions,
Age
To 100 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 387
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized using a random number table

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasuj University Of Medical Sciences
Street address
motaharee ST. -Vice chancellor for research,Yasuj University Of Medical Sciences
City
yasuj
Postal code
7591875114
Approval date
2010-03-17, 1388/12/26
Ethics committee reference number
88.12.26.11

Health conditions studied

1

Description of health condition studied
education breast feeding
ICD-10 code
z34,z40
ICD-10 code description
normal pregnancy Persons encountering health services for specific procedures and health care

Primary outcomes

1

Description
Knowledge
Timepoint
before intervention and after education session
Method of measurement
self made questionnaire

Secondary outcomes

1

Description
attitude
Timepoint
before intervention and after education session
Method of measurement
self made questionnaire

2

Description
practice
Timepoint
before intervention and after intervention and six month after delivery
Method of measurement
self made questionnaire

Intervention groups

1

Description
first intervention group : training by discussion method
Category
Behavior

2

Description
second group : training with combined method , group discussion and skill training
Category
Behavior

3

Description
third Group:training by routine method in health centers
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
shahid madani Health center
Full name of responsible person
Mahamed fariba
Street address
Akbarabad Street, Aryobarzan Square, yasuj
City
yasuj

2

Recruitment center
Name of recruitment center
Shahid Dastgib Health Center
Full name of responsible person
MahamedFariba
Street address
Adjacent to Blood Transfusion Center, Shahid Motahari Boulvard, Yasuj
City
Yasuj

3

Recruitment center
Name of recruitment center
Shahid Ashrafi Health Center
Full name of responsible person
MahamedFariba
Street address
Bahonar4 street, BoyerAhmad Boulvard, Yasuj
City
yasuj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research YasujUniversity of Medical Sciences
Full name of responsible person
Abdmohamad Moosavie
Street address
DeputyOfResearch andTechnology, yasuj universityOf Medical sciences, ShahidMotahariStreet, Yasuj
City
yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research YasujUniversity 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
YasuJ University Of Medical Sciences
Full name of responsible person
FaribaMahamed
Position
Faculty member of health and nutrition school
Other areas of specialty/work
Street address
Health School, Shahid Dastgerdi Street, Emam Hosine Squre, Yasuj
City
Yasuj
Postal code
75918975114
Phone
+98 74 3322 9224
Fax
+98 74 3322 6715
Email
mahamedfariba@yahoo.commahamed.fariba@yums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasuj University Of Medical Sciences
Full name of responsible person
Fariba Mahamed
Position
Faculty Member of health and nutrition school
Other areas of specialty/work
Street address
Health School, Shahid Dastgerdi Street, Emam Hosine Squre, Yasuj
City
Yasuj
Postal code
7591875114
Phone
+98 74 3322 9224
Fax
+98 74 3322 6715
Email
mahamedfariba@yahoo.commahamed.fariba@yums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yasuj University Of Medical Sciences
Full name of responsible person
Ali mousavizadeh
Position
MD,MpH,PhD in Epidemiology ,Faculty Member of health and nutrition
Other areas of specialty/work
Street address
Health School, Shahid Dastgerdi Street, Emam Hosine Squre, Yasuj
City
Yasuj
Postal code
7591875114
Phone
+98 74 3322 9224
Fax
+98 74 3322 6715
Email
health.epid@gmail.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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