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Investigating the effect of breastfeeding counseling based on the information – motivation – behavior skills (IMB) model on the some of maternal and newborn’s health indicators among referees to the breastfeeding counseling center

Protocol summary

Study aim
the effect of breastfeeding counseling based on the information , motivation , behavior skills (IMB) model on the some of maternal and newborn’s health indicators
Design
Clinical trial work with control group, with parallel groups, without blinding, randomized, on 62 mothers and their newborns, Excel software was used for randomization
Settings and conduct
Available sampling, mothers and their babies, infancy period, Bahman 22 centre
Participants/Inclusion and exclusion criteria
Infancy period mother hasn't prohibite from breastfeeding mother hasn't an untreated psychiatric mother doesn't take medicine that prohibits breastfeeding mother should be Iranian / Afghan people who speak Persian Stop breastfeeding no cooperation in filling the questionnaires and checking the study indicators after intervention at 2, 4 and 6 months mother uses a particular diet/exercise in order to decrease weight Diseases disrupt breastfeeding , such as Sheehan's syndrome
Intervention groups
Intervention group: 4 training sessions based on the behavioral motivation information model. Reviews at 2, 4 and 6 months Routine group: a routine training session of the counseling center and face-to-face examinations like the intervention group
Main outcome variables
breastfeeding observation, Latch, weight of the baby on the first day, 2, 4 and 6 months, BMI, blood pressure, and postpartum depression, Infant behavior (only at 6 months)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170611034452N15
Registration date: 2023-04-28, 1402/02/08
Registration timing: registered_while_recruiting

Last update: 2023-04-28, 1402/02/08
Update count: 0
Registration date
2023-04-28, 1402/02/08
Registrant information
Name
Atefeh Ahmadi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5205
Email address
a.ahmadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2025-04-21, 1404/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of breastfeeding counseling based on the information – motivation – behavior skills (IMB) model on the some of maternal and newborn’s health indicators among referees to the breastfeeding counseling center
Public title
Investigating the effect of breastfeeding counseling on the quality and continuity of breastfeeding and the health of mothers and babies
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Infancy period mother hasn't prohibition for breastfeeding mother hasn't an untreated psychiatric mother doesn't take medicine that prohibit breastfeeding mother should be Iranian / Afgan people who spease persian
Exclusion criteria:
Stopping exclusive breastfeeding and then , starting bottle feeding Non cooperation in comple the questionnaiers and checke the study indicators after intervention at 2 , 4 and 6 months If mother use a special diet / exercise in order to decrease weight but it doesn’t cause decrease breastfeeding, it isnot important Diseases disrupt on breastfeeding , such as Sheehan's syndrome
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Mothers and their babies who are eligible will continue to be selected by available sampling method until reaching the sample size (at least 21 people in each group). Using the software (https://www.sealedenvelope.com/simple- randomiser/v1/lists) People are placed in two groups of routine care and intervention with simple randomization method (double blocks).
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
Research Ethics Committees of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, Medical University campus. Haft. Bagh Highway,Kerman ,Iran Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-04-15, 1402/01/26
Ethics committee reference number
IR.KMU.REC.1402.012

Health conditions studied

1

Description of health condition studied
Breastfeeding counseling in mothers with breastfeeding problems
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Breastfeeding counseling based on the IMB model
Timepoint
before the intervention and after the intervention at 2, 4 and 6 months
Method of measurement
WHO breastfeeding observation form checklist, Latch questionnaire

Secondary outcomes

1

Description
Newborn weight
Timepoint
The first day of visit, then at 2, 4 and 6 months
Method of measurement
It is measured using a digital flat scale (874 seca, Germany).

Intervention groups

1

Description
Intervention group: Breastfeeding counseling based on correct breastfeeding teaching based on the model of information, motivation, and behavior to improve some maternal and child health indicators, which is the first face-to-face session immediately after sampling. In the second session if the problem is not resolved the mother will visit face to face the next day. If the mother does not come, the consultant will make a phone call on the 1st-3rd day via WhatsApp or Rubika. the consultant Coordinates with the mother to contact WhatsApp or Rubika. If not possible, a phone call will be made. Follow-ups determin on the 7th, 14th and 21st days from the time of the mother's visit (the second day after giving birth does not include, for example a mother who visited on the 16th day after giving birth, the follow-up date of the mother is determined 7 days later from the time of the visit). the first counseling session (referral day): 1.to state goals and rules 2.to define latch and position trainingthe importance of their correct performance in maternal and newborn outcomes. to state the difference of maternal and newborn outcomes in correct and incorrect breastfeeding. task: performing correct breastfeeding (to the mother). if The mother’s breastfeeding problem does not solve, she can come back the next day or she can give number to call him. If person does not refer or call, counselor call with him on day 1-3. The second counselling session of day 1 to 3: (face to face or by phone) if mother come back counselor revision remaining problem and then following step will be performed and then the following steps will be performed:1. check the correctness of the mother's breastfeeding 2.state the process of correct breastfeeding and its continue based on the relationship between information and motivation and breastfeeding skills3. mention the benefits of proper breastfeeding in the child (based on the indicators examined in this study, if the mother does not come back, counselor will call him). Follow-up on day 7: (phone call)1.check the correctness of mother's breastfeeding2.state maternal benefits of correct breastfeeding (based on the indicators examined in this study). Follow-up on day 14: (phone call) 1.check the correctness of mother's breastfeeding2. motivate the mother to continue correct breastfeeding. Follow-up on day 21: (phone call)1. check the correctness of mother's breastfeeding2.creating self-care and guidance to remove personal, family and environmental obstacles to proper breastfeeding. The third counseling session, the end of the third month: (telephone call)check the correctness of mother's breastfeeding2.creat self-efficacy and guidance to remove personal, family and environmental obstacles to correct breastfeeding. The fourth counseling session, the end of the fifth month: (telephone call)1.check the correctness of the mother's breastfeeding2.creating self-efficacy and guidance to remove personal, family and environmental obstacles to proper breastfeeding. The third counseling session, the end of the third month: (telephone call)1. check the correctness of mother's breastfeeding2. creat self-efficacy and guidance to remove personal, family and environmental obstacles to correct breastfeeding. The fourth counseling session, the end of the fifth month: (telephone call)1.check the correctness of the mother's breastfeeding2. creat self-efficacy and guidance to remove personal, family and environmental obstacles to correct breastfeeding.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Kerman City Referral Center (22 Bahman Center)
Full name of responsible person
Masoume Abdullahi Apoorvari
Street address
22 Bahman comprehensive health service center, after Seyed Jamaluddin Asadabadi St
City
Kerman
Province
Kerman
Postal code
7616745854
Phone
+98 34 3334 2180
Fax
Email
maa13561454@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malekpour Afshar
Street address
Kerman University of Medical Sciences, Medical University campus. Haft. Bagh Highway,Kerman ,Iran Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
intdep2@gmail.com
Web page address
http://vresearch.kmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Atefeh Ahmadi
Position
associate prof
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5220
Email
a.ahmadi@kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefeh Ahmadi
Position
associate prof
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5220
Email
a.ahmadi@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefeh Ahmadi
Position
associate
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5220
Email
a.ahmadi@kmu.ac.ir

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
Yes - There is a plan to make this available
Title and more details about the data/document
all collected deidentified IPD
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
with previous agreement with the corresponding author
From where data/document is obtainable
email address
What processes are involved for a request to access data/document
email address
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