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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Ruşen Öztürk, Dr. contact

00905447171151

rusen.ozturk@ege.edu.tr

Mehmet Yekta ÖNCEL contact

dryekta@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Ege University Nursing Faculty

    Izmir

    YEKTA M. ÖNCEL, dryekta@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

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.

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 groups in NCT04906122
Study groupRoleWhat they receive
Experimental groupExperimentalThe 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 GroupNo interventionControl 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted28 May 2021
  2. Study start1 Sep 2021 (estimated)
  3. Primary completion1 Jan 2022 (estimated)
  4. Study completion1 Sep 2022 (estimated)

Resources

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)
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.

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.

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