Determining the impact of educational intervention on exclusive breastfeeding in primiparous women based on Theory of Planned Behavior
Design
Clinical trial with control group; 150 ladies; Randomized.
Settings and conduct
Pre-test is performed by completing the exclusive breastfeeding questionnaire by intervention and control group.Breastfeeding education is provided in 4 sessions for the intervention group by lecture, question and answer method. The post-test is performed six months after delivery by completing the questionnaire.The location of this study is at Qom Health Center.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The first pregnancy lady,The last three months of pregnancy, Iranian, Literate, Resident of Qom;
Exclusion criteria: There is a prohibition of breastfeeding.
Intervention groups
Intervention and control groups receive routine breastfeeding education at the health center. In addition to routine education, the intervention group is given breastfeeding education for 6 hours in 4 sessions.
The survey on impact of educational intervention on exclusive breastfeeding in primiparous women based on Theory of Planned Behavior
Public title
ٍExclusive breastfeeding
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant lady
The first pregnancy
The last three months of pregnancy
Literate
Iranian
Resident of Qom
Exclusion criteria:
There is a prohibition of breastfeeding.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
There were 150 pregnant women who had criteria for entering the study; according to the list of apple systems, they were randomly assigned to intervention and control groups.The first 75 people are in the control group and the next 75 people are in the intervention group.We call the people to come to the health center and complete the breastfeeding exclusive breastfeeding questionnaire.
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 Qom University of Medical Sciences
Street address
Qom University of Medical Sciences, Saheli street
City
Qom
Province
Ghoum
Postal code
3713649373
Approval date
2017-09-18, 1396/06/27
Ethics committee reference number
IR.MUQ.REC.1396.71
Health conditions studied
1
Description of health condition studied
Exclusive breastfeeding
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Attitude score in exclusive breastfeeding questionnaire between intervention and control groups
Timepoint
Complete the questionnaire before the intervention and six months after delivery
Method of measurement
Exclusive breastfeeding questionnaire
2
Description
Score of abstract norms in exclusive breastfeeding questionnaire between intervention and control groups
Timepoint
Complete the questionnaire before the intervention and six months after delivery
Method of measurement
Exclusive breastfeeding questionnaire
3
Description
Perceived Behavioral Control Score in the exclusive breastfeeding questionnaire between intervention and control groups
Timepoint
Complete the questionnaire before the intervention and six months after delivery
Method of measurement
Exclusive breastfeeding questionnaire
4
Description
Behavioral intention score in exclusive breastfeeding questionnaire between intervention and control groups
Timepoint
Complete the questionnaire before the intervention and six months after delivery
Method of measurement
Exclusive breastfeeding questionnaire
5
Description
Behavioral score in exclusive breastfeeding questionnaire between intervention and control groups
Timepoint
Complete the questionnaire before the intervention and six months after delivery
Method of measurement
Exclusive breastfeeding questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Holding four 90-minute sessions include breastfeeding benefits, how to brew and breed mother's milk, compounds and changes of mother's milk, lactating mother's diet, the correct method of lactating, Common problems in breastfeeding and provide the right solution.
Category
Behavior
2
Description
Control group: Get routine care by health center staff.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Qom Health Center
Full name of responsible person
Reza Karemloufar
Street address
20 m Shahid Beheshti, Imam Khomeini street
City
ًQom
Province
Ghoum
Postal code
3719714953
Phone
+98 25 3660 0017
Email
sphc.muq@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hossein Saghafi
Street address
Qom University of Medical Sciences, Saheli street
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3107 1308
Email
dr.hosseinsaghafi@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Seyedehzahra Haddad
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 71, Fifth alley, Alley 11, Street of Reiskarami,Tohid square
City
Qom
Province
Ghoum
Postal code
3718614433
Phone
+98 25 3882 7732
Email
zhadad@muq.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Gholamreza Sharifi Rad
Position
Full Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Qom University of Medical Sciences, Saheli street
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3107 1308
Email
Dr.sharifirad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Seyedehzahra Haddad
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 71, Fifth alley, Alley 11, Street of Reiskarami,Tohid square
City
Qom
Province
Ghoum
Postal code
3718614433
Phone
+98 25 3882 7732
Email
zhadad@muq.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available