Protocol summary

Study aim
Determining Effect of tele counseling on the continuity and duration of breastfeeding in women
Design
In the intervention group, mothers receive tele counseling in form of weekly on the first month and twice in second month and once in the third month. Tele counseling is based on the WHO guidelines (2009). Then the duration Exclusive breastfeeding is recorded in both groups 3 months after delivery and the continuation of exclusive breastfeeding at the end of the first and third months. After data collection , they will be analyzed.
Settings and conduct
This interventional study is randomized and has two groups of test and control. The research environment is urban and rural health centers (including 6 rural centers and 2 urban centers).
Participants/Inclusion and exclusion criteria
Iranian women literacy to complete the questionnaire Access to the phone Healthy Mothers Having a healthy baby (no severe illness) Baby who was borned through Cesarean Exclusive breastfeeding until 3 to 5 days Interested to breastfeeding
Intervention groups
Intervention group: Telephone counseling (totaly seven counseling) includes one call weekly in the first month and one call every two weeks in the second month and one call in the third month with the mothers. Control group: They will Receive routine health care.
Main outcome variables
exclusively Breast feeding

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170707034931N3
Registration date: 2019-03-12, 1397/12/21
Registration timing: retrospective

Last update: 2019-03-12, 1397/12/21
Update count: 0
Registration date
2019-03-12, 1397/12/21
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3523 1518
Email address
saraylouk931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
2015-06-22, 1394/04/01
Actual recruitment end date
2015-09-22, 1394/06/31
Trial completion date
2015-09-22, 1394/06/31
Scientific title
Effect of tele counseling on the continuity and duration of breastfeeding in women
Public title
Effect of tele counseling on the continuity and duration of breastfeeding in women In Minudasht health center on summer 2014
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality literacy to complete the questionnaire Access to the phone Healthy Mothers Having a healthy baby (no severe illness) Exclusive breastfeeding until 3 to 5 days Interested to breastfeeding Cesarean delivery
Exclusion criteria:
Unwilling to participation
Age
No age limit
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 154
Actual sample size reached: 154
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, individual, using random numbers table
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 Golestan University of Medical Sciences
Street address
Seid jamaledin st,Health center, Minoodaht, Golestan state,IRAN
City
Minoodasht
Province
Golestan
Postal code
4981634817
Approval date
2015-02-08, 1393/11/19
Ethics committee reference number
27962893111903

Health conditions studied

1

Description of health condition studied
Breastfeeding
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Breast feeding (continuing and duration)
Timepoint
Before intervention and 3 month after intervention
Method of measurement
questionaire made by researcher

Secondary outcomes

empty

Intervention groups

1

Description
Mothers in the control group will receive only routine care (including postpartum breastfeeding in the hospital, first, second, and third care after delivery by Beverz at the health center based on the current training program for the slave).
Category
Behavior

2

Description
In the intervention group, mothers receive tele counseling in form of weekly on the first month and twice in second month and once in the third month. Tele counseling is based on the WHO guidelines (2009). Then the duration Exclusive breastfeeding is recorded in both groups 3 months after delivery and the continuation of exclusive breastfeeding at the end of the first and third months.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Minoodasht health center
Full name of responsible person
Khadijeh Sarayloo
Street address
Seiad jamaledin st.Health center Minoodasht
City
Minoodasht
Province
Golestan
Postal code
4981634817
Phone
+98 17 3522 1540
Email
ksarayloo@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Golestan university of medical science
Full name of responsible person
Dr Mohammad reza Honarvar
Street address
5 Sari Roads ,Center of Health Technology Development, Golestan University of Medical Sciences, shast colah ,Gorgan,IRAN
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3242 4377
Email
Honarvar@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan university of medical science
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
Golestan university of medical science
Full name of responsible person
Sarayloo Khadijeh
Position
Golestan university of medical science
Latest degree
Ph.D.
Other areas of specialty/work
Family Health
Street address
Health center, Pasdaran Street,Minoodasht,Golestan
City
Minoodasht
Province
Golestan
Postal code
4983153847
Phone
+98 17 3523 1518
Fax
+98 17 3522 1540
Email
ksarayloo@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Minoodasht health center
Full name of responsible person
Khadijeh Sarayloo
Position
PhD student in reproductive health
Latest degree
Master
Other areas of specialty/work
Family Health
Street address
Seid jamaledin st,Health center, Minoodaht, Golestan state,IRAN
City
Minoodasht
Province
Golestan
Postal code
4981634817
Phone
+1 735231518
Fax
Email
saraylouk931@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Golestan university of medical science
Full name of responsible person
Khadijeh Sarayloo
Position
PhD student in reproductive health
Latest degree
Master
Other areas of specialty/work
Family Health
Street address
Seid jamaledin st,Health center, Minoodaht, Golestan state,IRAN
City
Minoodasht
Province
Golestan
Postal code
4981634817
Phone
+98 17 3523 1518
Fax
Email
ksarayloo@yahoo.com
Web page address

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
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