Determining the effect of education of primiparous mothers based on the PRESID model on the self-efficacy of mothers in the field of complementary feeding and infant growth index.
Design
In this clinical trial with a control group, with parallel groups, a blind strain, randomized, will be conducted on 80 primiparous mothers. This study will use the block method to allocate the sample in two groups. and to generate a random sequence from http://www.graphpad.com/quickcalcs/index. cfm is used.
Settings and conduct
In the health center, the researcher will randomly divide the mothers into intervention and control groups. In the intervention group, educational intervention will be provided in 4 sessions of 60 minutes. The educational content will be taught in the form of group training of 5-7 people. The control group will receive routine health center training.
Participants/Inclusion and exclusion criteria
Mothers with four-month-old infants
Intervention groups
Intervention group: educational intervention based on the structures of the Persed model, especially predisposing structures, enabling factors and strengthening factors, will be provided in 4 sessions of 60 minutes (one session per week).
Control group: they will receive only the routine training provided in health centers. The routine training in health centers is in this way that when the mother visits at the end of the fourth month, the necessary training on individual nutrition is provided to the mother.
Main outcome variables
Self-efficacy in the field of complementary nutrition, Child growth indicators
General information
Reason for update
Acronym
no
IRCT registration information
IRCT registration number:IRCT20211211053351N3
Registration date:2023-12-20, 1402/09/29
Registration timing:registered_while_recruiting
Last update:2023-12-20, 1402/09/29
Update count:0
Registration date
2023-12-20, 1402/09/29
Registrant information
Name
sadeghi tahereh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 7313
Email address
sadeghit@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-01, 1402/08/10
Expected recruitment end date
2024-03-12, 1402/12/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educating nulliparous mothers based on Precede model on mothers self-efficacy in complementary nutrition and growth index infants
Public title
The effect of educating nulliparous mothers based on Precede model on mothers self-efficacy in complementary nutrition and growth index infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Complete the informed consent of parents to participate in the research
Be Iranian and a resident of Mashhad
Mother's age should be between 18 and 45 years.
be the first delivery
The age of pregnancy was between 38 and 40
The age of the infant should be between 4 and 5 months
The infant does not have a history of hospitalization during infancy.
Not IUGR
Do not have medical and metabolic problems and FTT.
Exclusion criteria:
Not wanting to continue participating in the study.
Failure to participate in more than two training sessions
Medical problems occurred during the study for infants
Carry out actions such as travel and change of location during the study period, which lead to non-follow-up of counseling sessions and messing up the infant's meal plan..
The infant has a history of hospitalization during the study period.
Age
From 4 months old to 10 months old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block method will be used to allocate the sample in two groups.Randomization will be by block method. In this study, four blocks (AABB(1)- ABAB(2)-ABBA(3)-BBAA(4)- BABA(5)- BAAB(6)) will be the sampling guide. Then the list of blocks will be written and numbers will be assigned to them, then choosing random numbers between 1 to 6 (for example 1 4 5 and ...) using the site http://www.graphpad.com/quickcalcs/index. cfm numbers will be selected, finally specifying the treatment allocation list will be based on the previous random numbers (...AABB-BBAA-BABA-) and to generate a random sequence from http://www.graphpad.com/quickcalcs/index. cfm is used.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding (evaluator, analysts, allocation of sample data to groups)
in the study child evaluator of weight, height and outcome and the health care workers who allocation of sample data to groups and also tantalizer are blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Nursing and Midwifery School , Martyr Dr. Kharazmi Educational Building, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square , Mashhad, Razavi Khorasan, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2023-05-30, 1402/03/09
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.050
Health conditions studied
1
Description of health condition studied
The subject of study is not a disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mother's self-efficacy in the field of complementary feeding
Timepoint
Measuring the self-efficacy of the mother at the beginning of the study (before the start of the intervention) and at the end of the intervention three months later
Method of measurement
In this study, the meaning of self-efficacy is the feeling of competence, sufficiency, self-control and belief in abilities in the field of complementary feeding behaviors of breast-fed infants and will be investigated by a self-efficacy questionnaire.
2
Description
Infant growth index: according to head circumference, height and weight
Timepoint
Measuring the self-efficacy of the mother at the beginning of the study (before the start of the intervention) and at the end of the intervention three months later
Method of measurement
The growth indices of the normal range of height, weight and head circumference are based on the growth index of breast-fed infants under 24 months of the Ministry of Health and Medicine of Iran.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Educational intervention based on PERESED model structures, especially predisposing structures, enabling factors and strengthening factors will be provided during 4 sessions of 60 minutes (one session per week). The educational content will be taught in the form of group training of 5-7 people. In order to educate and gain the support of the family, an educational booklet will be prepared for the training of fathers and will be presented to the intervention group. Educational content will be provided using the teaching methods of lectures, group discussions, questions and answers, role playing, and individual counseling. Three months after the intervention, the mother will be met in health centers to evaluate and complete the questionnaire again.
Category
Lifestyle
2
Description
Control group: The control group will receive only the routine training provided in health centers. The routine training in health centers is in this way that when the mother visits at the end of the fourth month, the necessary training on individual nutrition is provided to the mother.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers Mashhad University of Medical Sciences
Full name of responsible person
Tahereh Sadeghi
Street address
Nursing and Midwifery School , Martyr Dr. Kharazmi Educational Building, University Campus, East Gate ofFerdowsi University of Mashhad, Azadi Square , Mashhad, Razavi Khorasan, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
tahereh.sadeghi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tahereh Sadeghi
Street address
Nursing and Midwifery School , Martyr Dr. Kharazmi Educational Building, University Campus, East Gate o Ferdowsi University of Mashhad, Azadi Square , Mashhad, Razavi Khorasan, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 7313
Email
tahereh.sadeghi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Tahereh Sadeghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School , Martyr Dr. Kharazmi Educational Building, University Campus, East Gate o Ferdowsi University of Mashhad, Azadi Square , Mashhad, Razavi Khorasan, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 7313
Email
tahereh.sadeghi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tahereh Sadeghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School , Martyr Dr. Kharazmi Educational Building, University Campus, East Gate o Ferdowsi University of Mashhad, Azadi Square , Mashhad, Razavi Khorasan, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 7313
Email
tahereh.sadeghi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tahereh Sadeghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School , Martyr Dr. Kharazmi Educational Building, University Campus, East Gate o Ferdowsi University of Mashhad, Azadi Square , Mashhad, Razavi Khorasan, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 7313
Email
tahereh.sadeghi@yahoo.com
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
No - There is not 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