Breastfeeding, ExclusiveBAKEDNCT04906122
Breastfeeding Counseling Approach Involving Grandmothers (BAKED)
A study testing 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 people with Breastfeeding, Exclusive and Grandmother, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Exclusive, Grandmother
- What is being tested?
- 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.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mehmet Yekta ÖNCEL contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ege University Nursing Faculty
Izmir
YEKTA M. ÖNCEL, dryekta@gmail.com
About this study
Official title: "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.
- Conditions
- Breastfeeding, Exclusive, Grandmother
- Being tested
- 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.
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.Other
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 group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Other: 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. |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
The Iowa Infant Feeding Attitude Scale
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).
Measured: First 6 months
Secondary outcomes (3)
LATCH: a breastfeeding charting system and documentation tool
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.
Measured: First 6 months
Breast-feeding Self-efficacy Scale
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)
Measured: First 3 months
Information Assessment Form of Grandmothers for Breastfeeding (Pre-Test Post-Test Evaluation)
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.
Measured: First 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding, ExclusiveStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruşen Öztürk, Ege University
- Investigators
- Özlem Demirel Bozkurt, Ass.Prof, Principal investigator, Ege University Nursing Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906122
- Sponsor's protocol ID
- Egenurse2021
- Acronym
- BAKED
- Status last verified
- May 2021
- First submitted
- 20 Mar 2021
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We don't want to share until published.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Breastfeeding Counseling Approach Involving Grandmothers (BAKED) in Breastfeeding Empowerment ,
- ClinicalTrials.gov ID
- NCT04906122
- Acronym / sponsor ID
- BAKED / Egenurse2021
- Conditions
- Breastfeeding, Exclusive, Grandmother
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: 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.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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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.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. | Other | Experimental group |
Primary outcome
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).
3 secondary outcomes
LATCH: a breastfeeding charting system and documentation tool
Time frame: First 6 months
Breast-feeding Self-efficacy Scale
Time frame: First 3 months
Information Assessment Form of Grandmothers for Breastfeeding (Pre-Test Post-Test Evaluation)
Time frame: First 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Individual participant dataSharing planned: No. We don't want to share until published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Yekta ÖNCEL contact
Özlem Demirel Bozkurt, Ass.Prof principal investigator
Ege University Nursing Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Breastfeeding, Exclusive and Grandmother, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruşen Öztürk, Dr. (00905447171151, rusen.ozturk@ege.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Iowa Infant Feeding Attitude Scale (time frame: First 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.