Protocol summary

Summary
In this clinical trial, 150 nursing mothers will be trained by peers (in terms of age, education, and financial and social status) who have been previously trained. In this study, initiation and continuation of breastfeeding of mothers will be examined throughout infancy. Intervention method: Twenty-five volunteer health assistants and trainers in Mother and Infant Centers from district 19 of Tehran, Iran (who agreed to participate in training groups) will be trained in a two-day workshop by experienced instructors and specialists in breastfeeding. Textual and electronic training media will also be provided to them. Next, these trained health assistants will form training committees consisting of volunteer peer mothers. With the cooperation of instructors from the Center for Breastfeeding Research, these health assistants will begin training the volunteer mothers such that after a one-month course, the members will be able to undertake training and advising of their peers in the district. In all stages of training, if need be, health assistants can visit or contact by telephone during predetermined times the instructors and counselors of the Center for Breastfeeding Research and refer cases needing special treatment or intervention. During the work of this group of trained health assistants, the state of affairs of the district in terms of initiation of breastfeeding, continuation of breastfeeding, and effective factors in early discontinuation of breastfeeding will be examined in 150 eligible (according with the study criteria) mothers. After formation of the training groups, they will begin their intervention in the form of training and advice under the supervision of the health assistants and members of the research center. Six months into this intervention, the state of the district will be reevaluated by examination of the 150 eligible mothers who were training during their breastfeeding term. Mothers and trained persons shall participate in this study voluntarily and live in district 19 of Tehran. Demographic data, midwifery experience, history of received training, and infant data will be gathered using questionnaires. Data on the level of awareness and performance of the mothers concerning continuation of breastfeeding will be gathered according to the guidelines and procedure of the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). Study population: Two groups of mothers that have infants from 4 to 20 months of age and live in district 19 of Tehran, Iran. The first group of 150 mothers will be examined under the previously mentioned conditions prior to intervention. After a period of six months from the initiation of intervention, the second group of 150 eligible mothers will be investigated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201504049568N12
Registration date: 2015-05-16, 1394/02/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-05-16, 1394/02/26
Registrant information
Name
Golnaz Rezaeizadeh
Name of organization / entity
Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2357
Email address
mfnhrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences, research departement
Expected recruitment start date
2015-03-01, 1393/12/10
Expected recruitment end date
2017-01-01, 1395/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of breastfeeding mothers by trained volunteers mothers to the initiation and continuation of breastfeeding in district 19 of Tehran
Public title
Effect of breastfeeding mothers by trained volunteers mothers to the initiation and continuation of breastfeeding in district 19 of Tehran
Purpose
Supportive
Inclusion/Exclusion criteria
Breastfeeding mother (4 months-24 months) will included
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
TUMS
Street address
Research departement of TUMS-Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2015-03-16, 1393/12/25
Ethics committee reference number
93-04-105-27808-143712

Health conditions studied

1

Description of health condition studied
Breastfeeding continuation in breastfeed mothers
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Breastfeeding continuation
Timepoint
after intervention
Method of measurement
observation and interview

Secondary outcomes

1

Description
Onset of breastfeeding
Timepoint
after intervention
Method of measurement
observation and interview

Intervention groups

1

Description
education and consultation ,in breastfeeding period -for nursing mother An education plan as a workshop,continued by elongated and continuously face to face consultation,every time is needed
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Breastfeeding Research Center
Full name of responsible person
Dr. Fatemeh Nayeri
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Departement of TUMS
Full name of responsible person
Dr. Younessian
Street address
Blvd. Keshavarz
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Departement of TUMS
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
Breastfeeding Research Center
Full name of responsible person
Fatemeh nayeri
Position
Chief
Other areas of specialty/work
Street address
Vali-asr hospital,Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6659 1316
Fax
Email
bfrc@tums.ac.irmfnhrc@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Breastfeeding Research Center
Full name of responsible person
Fatemeh Nayeri
Position
Associate
Other areas of specialty/work
Street address
Vali-asr hospital
City
Tehran
Postal code
Phone
+98 21 6659 1316
Fax
Email
bfrc@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
breastfeeding Research Center
Full name of responsible person
Mamak Shariat
Position
Associate
Other areas of specialty/work
Street address
Vali-asr Hospital
City
Tehran
Postal code
Phone
+98 21 6659 1316
Fax
Email
mshariat@tums.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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