Protocol summary

Summary
This is a randomized controlled trial that will be done on 120 nulliparous women (35-37weeks of gestation) to determine the effect of increasing self-efficacy Strategies on breastfeeding behavior in pregnant women in Ahvaz, Iran. The primary self-efficacy scores of samples will be measured using Dennis breastfeeding self-efficacy questionnaire. Women will be randomly recruited into two intervention (n=60) and control groups (n=60). The designed educational program based on self-efficacy theory (two training sessions that each will be lasted for 60 minutes, a training package graphics and sending two massages per week using the Short Message Service (SMS)) will be performed for intervention group. The control group only will receive routine prenatal care. Then, the Breastfeeding self-efficacy scale and questionnaires related to breastfeeding behavior will be completed by the study participants, 2 and 8 weeks after childbirth. For data analysis, SPSS software, version 19 will be used

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014061410804N3
Registration date: 2016-06-20, 1395/03/31
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-06-20, 1395/03/31
Registrant information
Name
Marzieh Araban
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
تهران
Email address
m.araban@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Research council of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2014-11-04, 1393/08/13
Expected recruitment end date
2015-01-03, 1393/10/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-efficacy promoting strategies on breast-feeding behavior among nulliparous women
Public title
Effect of self-efficacy promoting strategies on breast-feeding behavior
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:first time pregnancy;healthy women (according to doctor appointments) ;No history of reproductive problems (infertility, recurrent pregnancy loss);gestational age f35-37weeks; having a singleton pregnancy;fluent in Persian(Farsi);having at least basic education;owning a cell phone(for experimental group) exclusion criteria:Complicated pregnancy( vaginal bleeding/ spotting/ gestational hypertension/ leak….);absence in training sessions ;Turn off or unavailability of cell phone
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Avenue
City
Ahvaz
Postal code
159
Approval date
2014-11-04, 1393/08/13
Ethics committee reference number
13930145 Ajums.REC

Health conditions studied

1

Description of health condition studied
breastfeeding self efficacy
ICD-10 code
Z39
ICD-10 code description
Postpartum care and examination

Primary outcomes

1

Description
Breastfeeding self-efficacy score
Timepoint
at 35-37 weeks of pregnancy and 2 weeks and 8 weeks after delivery
Method of measurement
Dennis' Breastfeeding Self-Efficacy Scale-Short Form

Secondary outcomes

1

Description
type of child nutrition and breast feeding behavior
Timepoint
2 and 8 weeks afterdelivery
Method of measurement
Researcher made Questionnaire

Intervention groups

1

Description
Participants in the Intervention group will be received two training sessions by the researcher. Each session will be lasted for 60 minutes. In the first session, educational content based on the learning objectives and self-efficacy theory will be presented by the researcher and women were free to ask their questions. And at the second session, the intervention group will be received a graphical training package. It contains 10 cards with emotional trigger words and phrases for breastfeeding. Also by the end of the study (8 weeks after giving birth), to encourage mothers to breastfeed, two massages per week using the Short Message Service will be sent each week by the researcher.
Category
Behavior

2

Description
The control group only will be received routine prenatal and postnatal cares.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
healthcare center number7, Jondishapour University of Medical Science
Full name of responsible person
Marzieh Araban
Street address
Social Determinants of Health Research Center, Jondishapour University of Medical Science, Golestan Road, Ahvaz, Khuzestan, Iran.
City
Ahvaz

2

Recruitment center
Name of recruitment center
healthcare center number9, Jondishapour University of Medical Science
Full name of responsible person
Marzieh Araban
Street address
Social Determinants of Health Research Center, Jondishapour University of Medical Science, Golestan Road, Ahvaz, Khuzestan, Iran
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Marzieh Araban
Street address
Social Determinants of Health Research Center, Jondishapour University of Medical Science, Golestan Road, Ahvaz, Khuzestan, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Marzieh Araban
Position
PhD/Asistant Professor
Other areas of specialty/work
Street address
Social Determinants of Health Research Center, Jondishapour University of Medical Science, Golestan Road, Ahvaz, Khuzestan, Iran.
City
Ahvaz
Postal code
159
Phone
+98 61 1333 2368
Fax
+98 61 1373 8269
Email
arabanm@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Marzieh Araban
Position
PhD/Asistant Professor
Other areas of specialty/work
Street address
Social Determinants of Health Research Center, Jondishapour University of Medical Science, Golestan Road, Ahvaz, Khuzestan, Iran.
City
Ahvaz
Postal code
159
Phone
+98 611336754360
Fax
+98 61 1373 8269
Email
arabanm@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Marzieh Araban
Position
PhD/ Asistant Professor
Other areas of specialty/work
Street address
Social Determinants of Health Research Center, Jondishapour University of Medical Science, Golestan Road, Ahvaz, Khuzestan, Iran.
City
Ahvaz
Postal code
159
Phone
+98 61 1333 2368
Fax
+98 61 1373 8269
Email
arabanm@ajums.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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