To determine the effect of peer counseling and routine training delivered by health centers on breastfeeding behavior of primipara mothers
Design
This study is a randomized, controlled field trial with parallel groups without blindness.
Settings and conduct
The study was performed in health centers of Birjand. A total of 80 mothers with inclusion criteria were selected through multi-stage random sampling among mothers referring to Birjand health centers. Also, 10 other mothers with traits maximally similar to those of the target group were identified as the peer support group from among those referring to each region. The intervention group received two 3-hour sessions of training by peers. The controls received the routine training of the health center.
Participants/Inclusion and exclusion criteria
Main inclusion criteria: willingness to collaborate in the study and the first pregnancy or childbirth of the mother. Main exclusion criteria: disabling disease and breast problems in the mother and presence of prohibitions for breastfeeding.
Intervention groups
Intervention group: the group members were trained by the peer counselors during two 3-hour sessions. The contents of the sessions included anatomy, principles and skills of breastfeeding, and proper breastfeeding techniques, etc. according to the guidelines and syllabuses provided by the Ministry of Health and the World Health Organization. The mothers could also contact the counselor at any time via telephone or in person.
Control group: they received the routine training of the health centers in person.
Main outcome variables
Breast feeding behavior
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170316033099N4
Registration date:2018-12-01, 1397/09/10
Registration timing:retrospective
Last update:2018-12-01, 1397/09/10
Update count:0
Registration date
2018-12-01, 1397/09/10
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
roozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-13, 1396/11/24
Expected recruitment end date
2018-08-08, 1397/05/17
Actual recruitment start date
2018-02-13, 1396/11/24
Actual recruitment end date
2018-08-08, 1397/05/17
Trial completion date
2018-08-08, 1397/05/17
Scientific title
Clinical trial comparing the effect of peer counseling and routine training delivered by health centers on breastfeeding behavior in primipara mothers
Public title
Effect of peer counseling on breastfeeding behavior
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to collaborate in the study
Residence in Birjand
Having reading and writing literacy
The newborn being a single child
The first pregnancy or childbirth of the mother
Exclusion criteria:
Disabling disease and breast problems in the mother
Congenital anomalies and oral abnormalities in the newborn
Presence of prohibitions for breastfeeding
Hospitalization of the newborn
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 80 mothers with inclusion criteria were selected through multi-stage random sampling from among mothers referring to Birjand health centers. To select the samples, the city of Birjand was classified into northern and southern regions. From each region, two health bases were randomly selected from the bases covered by the health centers of that area, and one base was placed in the intervention group and one base in the control group. Then, in each base, based on the Integrated Health System, the list of eligible primipara women was extracted, and 20 individuals were subsequently randomly selected from each base. Accordingly, 40 women were in the intervention group and 40 women in the control group.
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 Birjand University of Medical Sciences
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2018-02-12, 1396/11/23
Ethics committee reference number
IR.BUMS.REC.1396.317
Health conditions studied
1
Description of health condition studied
Breastfeeding behavior
ICD-10 code
P92.9
ICD-10 code description
Feeding problem of newborn, unspecified
Primary outcomes
1
Description
Breastfeeding behavior
Timepoint
Before intervention; immediately after the intervention; at the end of the first, second and third months after intervention
Method of measurement
B-R-E-A-S-T-Feeding Observation Form
Secondary outcomes
1
Description
Complementary milk consumption
Timepoint
Immediately after the intervention, at the end of the first, second and third months after intervention
Method of measurement
Asking the mother
Intervention groups
1
Description
Intervention group (Peer counseling): the intervention group completed B-R-E-A-S-T-Feeding Observation Form before intervention. They were trained and supported by the peer counselors during two 3-hour sessions. The contents of the sessions included anatomy, principles and skills of breastfeeding, problems and incorrect beliefs about breastfeeding and infant nutrition, and proper breastfeeding techniques, etc. according to the guidelines and syllabuses provided by the Ministry of Health and the World Health Organization. The mothers could contact the sponsor at any time, via telephone or in person, and raise problems concerning their baby's breastfeeding and nutrition. The counselor also had a weekly phone call with mothers to encourage them to continue and perform proper breastfeeding skills. Immediately after the intervention, at the end of the first, second and third months after intervention, the standard B-R-E-A-S-T-Feeding Observation Form was completed.
Category
Behavior
2
Description
Control group (Routine training): the control group completed B-R-E-A-S-T-Feeding Observation Form before intervention. They received the routine face-to-face training at the health bases at the time of referral. Immediately after the intervention, at the end of the first, second and third months after intervention, the standard B-R-E-A-S-T-Feeding Observation Form was completed.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghadir Healthcare Center
Full name of responsible person
Nasimeh Azimi Tabas
Street address
Ghadir Boulevard
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3241 4486
Email
na.azimi1395@gmail.com
2
Recruitment center
Name of recruitment center
Reja'i Healthcare Center
Full name of responsible person
Nasimeh Azimi Tabas
Street address
Kargaran Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3231 6815
Email
na.azimi1395@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Nasimeh Azimi Tabas
Position
MSc Student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Meghdad Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 1514
Email
na.azimi1395@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Ahmad Nasiri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 1415
Email
A.nasiri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
Translator
Latest degree
Master
Other areas of specialty/work
Others
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5641
Email
hadirooz@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Deidentified Individual Participant Data Set
When the data will become available and for how long
when the extracted paper from the project will be published and for 6 months
To whom data/document is available
all readers of the paper
Under which criteria data/document could be used
research purposes
From where data/document is obtainable
personal correspondence with the corresponding author
What processes are involved for a request to access data/document