- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04906122
Breastfeeding Counseling Approach Involving Grandmothers (BAKED) (BAKED)
"Breastfeeding Counseling Approach Involving Grandmothers (BAKED) in Breastfeeding Empowerment ,
Adequate nutrition during infancy and early childhood are fundamental to the development of a child. It is well recognized that the period from birth to two years of age is a "critical window" for the promotion of optimal growth, health, and behavioral development. The World Health Organization, the American Academy of Pediatrics, and the National Association of Pediatric Nursing Practitioners, UNICEF and CDC acknowledge that breastfeeding is the ideal diet for babies and recommend exclusive breastfeeding for the first 6 months of life, and continuing breastfeeding until the age of 2. postpartum breastfeeding is widespread in Turkey. According to the 2018 Turkey Demographic and Health Survey (2018 TDHS) data, 98% of the last-born children in the two years before the study were breastfed. However, 41% of children younger than six months are only fed with breast milk.
In many studies, it is stated that the education of both the mother, her relatives and the healthcare personnel plays a key role in breastfeeding success. Postpartum social support is important for the protection of both mother and baby health. Culturally, in Turkish society, the postpartum period, which mothers and grandmothers spend more often together, and the positive support of the mother are very important for both the short and long term maternal and infant health. In the literature, it is emphasized that the most important factors in starting additional food and formula in the early period are the influence of the immediate environment and family and that grandmothers are vital in baby care and feeding In addition, inadequate or misguided grandmothers due to lack of knowledge and traditional attitudes during this period can have a negative effect on the continuation of breastfeeding. Although there are studies in the literature on breastfeeding training given to mothers and healthcare personnel, there are very few studies on inclusive breastfeeding counseling for grandmothers who have a primary support role. However, there is RCT study regarding the application of breastfeeding counseling involving grandmothers who have been followed up in a clinical setting, and no project has been found in our country on this subject. With this planned project, this effect will be investigated for the first time. For this reason, it is thought that the results of this project will have positive effects on the strengthening of breastfeeding and mother-baby health and will have extremely important outputs for its applicability in clinical and public health centers. In this direction, this research aims to increase only breast milk intake in the first 6 months in the short term and to have longer breastfeeding periods in the long term. It was planned for breastfeeding counseling to empower grandmothers who support postnatal mother and baby care, increase their knowledge about breastfeeding, and support mothers by developing a positive attitude.
The research was planned as a randomized controlled study. Voluntary postpartum primiparous mothers who have recently given birth and their accompanying grandmothers will be randomly assigned to the intervention and control group. The grandmothers in the intervention group will be given breastfeeding counseling before discharge. Home monitoring will be performed in the 2nd week, 3rd and 6th months after the counseling. In each follow-up, breastfeeding knowledge and attitudes of the grandmothers, breastfeeding success of mothers, attitude towards breastfeeding, perception of postpartum support and newborn growth parameters will be determined. As a result of the research, the effect of breastfeeding training given to grandmothers will be evaluated breastfeeding status of the first 6 months, self-efficacy, attitude, social support perceptions, breastfeeding continuity and newborn growth parameters of primiparous mothers who have just given birth.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ruşen Öztürk, Dr.
- Phone Number: 00905447171151
- Email: rusen.ozturk@ege.edu.tr
Study Contact Backup
- Name: Mehmet Yekta ÖNCEL
- Email: dryekta@gmail.com
Study Locations
-
-
-
İ̇zmi̇r, Turkey
- Recruiting
- Ege University Nursing Faculty
-
Contact:
- YEKTA M. ÖNCEL
- Email: dryekta@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being a newly born primipara mother
- No complications developed in mother and baby after birth
- Having the grandmother for caring the baby
- The grandmother's role in baby care with the family after discharge
- At least primary school graduate for mother and grandmother
- Speak Turkish
- Volunteering to participate in further follow-up or research
Exclusion Criteria:
- Not willing to participate in the study
- Not actively participate in all training
- Not willing to fill in the questionnaire
- Having mental and psychological diseases
- Illiterate mothers and grandmothers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
The grandmothers in the intervention group will be given breastfeeding counseling before discharge.
Home monitoring will be performed in the 2nd week, 3rd and 6th months after the counseling.
In each follow-up, breastfeeding knowledge and attitudes of the grandmothers, breastfeeding success of mothers, attitude towards breastfeeding, perception of postpartum support and newborn growth parameters will be determined.
As a result of the research, the effect of breastfeeding training given to grandmothers will be evaluated breastfeeding status of the first 6 months, self-efficacy, attitude, social support perceptions, breastfeeding continuity and newborn growth parameters of primiparous mothers who have just given birth.
|
The research was planned as a randomized controlled study.
Voluntary postpartum primiparous mothers who have recently given birth and their accompanying grandmothers will be randomly assigned to the intervention and control group.
The grandmothers in the intervention group will be given breastfeeding counseling before discharge.
Home monitoring will be performed in the 2nd week, 3rd and 6th months after the counseling.
In each follow-up, breastfeeding knowledge and attitudes of the grandmothers, breastfeeding success of mothers, attitude towards breastfeeding, perception of postpartum support and newborn growth parameters will be determined.
As a result of the research, the effect of breastfeeding training given to grandmothers will be evaluated breastfeeding status of the first 6 months, self-efficacy, attitude, social support perceptions, breastfeeding continuity and newborn growth parameters of primiparous mothers who have just given birth.
|
|
No Intervention: Control Group
Control Group: No additional attempt or routine call will be made to grandmother and mothers in the control group.
The questionnaires will be given to the mothers at the same time for filling the surveys after birth, one month, 3 and 6 months follow up will be done with grandmothers and mothers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Iowa Infant Feeding Attitude Scale
Time Frame: First 6 months
|
The Iowa Infant Feeding Attitude Scale which is used to assess mother?s
attitudes and behaviours towards breastfeeding, distinguishes between those mothers who intended to breast-feed and those who intended to artificially feed.The IIFAS was [34] designed to assess maternal attitude towards infant feeding methods and to predict breastfeeding intention and exclusivity.
The scale is composed of 17 items with a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
The total IIFAS score can range from 17 to 85 with higher scores reflecting positive attitude towards breastfeeding.
Total IIFAS scores can be further categorized into groups: 1) positive to breastfeeding (IIFAS score 70-85), 2) neutral (IIFAS score 49-69), and 3) positive to formula feeding (IIFAS score 17-48).
|
First 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
LATCH: a breastfeeding charting system and documentation tool
Time Frame: First 6 months
|
LATCH is a breastfeeding charting system that provides a systematic method for gathering information about individual breastfeeding sessions.
The system assigns a numerical score, 0, 1, or 2, to five key components of breastfeeding.
Each letter of the acronym LATCH denotes an area of assessment.
"L" is for how well the infant latches onto the breast.
"A" is for the amount of audible swallowing noted.
"T" is for the mother's nipple type.
"C" is for the mother's level of comfort.
"H" is for the amount of help the mother needs to hold her infant to the breast.
|
First 6 months
|
|
Breast-feeding Self-efficacy Scale
Time Frame: First 3 months
|
The BSES is a 33-item, self-report instrument developed to measure breast-feeding confidence.
The measure contains two subscales: the technique subscale, where the items depict maternal skills and recognition of specific principles required for successful breast feeding; and the intrapersonal thoughts subscale, where the items are related to maternal attitudes and beliefs about breast feeding.
All the items are preceded by the phrase 'I can always' and are anchored with a five-point Likert scale, where 1¼not at all confident and 5¼always confident.
As recommended by Bandura (Dai and Dennis, 2003)
|
First 3 months
|
|
Information Assessment Form of Grandmothers for Breastfeeding (Pre-Test Post-Test Evaluation)
Time Frame: First 3 months
|
The form was prepared by the researchers in line with the information-oriented objectives in accordance with the content of the "Information and Support Module for Breastfeeding Grandmothers" in order to evaluate the knowledge level of grandmothers before and after the consultancy program.
Knowledge questions consisted of 30 items at the first stage.
The questions will be presented to five faculty members who are experts in their field and expert opinion will be taken.
|
First 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Özlem Demirel Bozkurt, Ass.Prof, Ege University Nursing Faculty
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Egenurse2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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