BreastfeedingBreastfeedNCT05322434
The Effect Of Online Breastfeeding Counseling Given At The Post-Birth Period On Breastfeeding Behavior
A study testing The Effect Of Online Breastfeeding Counseling Given At The Post-Birth Period On Breastfeeding Behavior in people with Breastfeeding and Breastfeeding Support, run by Marmara University.
Trial summary
The World Health Organization and the United Nations Children's Fund recommend that every baby be fed with breast milk alone from birth to 6 months, then with additional foods; recommends continuation of breastfeeding until at least 2 years of age. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Breastfeeding Support
- What is being tested?
- The Effect Of Online Breastfeeding Counseling Given At The Post-Birth Period On Breastfeeding Behavior
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 30 Jun 2023
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- volunteer,
- be between 18-45 years old,
- Not having a condition that prevents breastfeeding,
- Being primiparous,
- be a smart phone
Who cannot join
- The form is not completely filled
Trial locations and contacts
No sites are listed yet.
About this study
The World Health Organization and the United Nations Children's Fund recommend that every baby be fed with breast milk alone from birth to 6 months, then with additional foods; recommends continuation of breastfeeding until at least 2 years of age. It has been reported that with the spread of breastfeeding, 823,000 child and 20,000 maternal deaths can be prevented and 300 billion dollars of economic savings can be made every year in the world. The COVID 19 pandemic, which has been affecting the whole world for the last two years, has led to changes in the field of consultancy as well as in all areas. Counseling has created a tendency to be given online due to the rapid spread of the virus, the fact that it is deadly, and the increased risk in closed areas.
There has been a great deal of interest in the subject of breastfeeding behavior in the literature, but it has been observed that there is not enough research on breastfeeding counseling given online. In this study, breastfeeding behavior of mothers in the first six months and the duration of starting solid food will be investigated.
Read the detailed description
Breastfeeding has a biological and emotional effect on mother and baby, and has many immunological, psychological, social and economic benefits for both mother and baby. The content of breast milk is regulated according to the needs of the baby, regardless of the mother's diet. The importance of breastfeeding in laying the foundations of a healthy life is indisputable.The World Health Organization and the United Nations Children's Fund recommend that every baby be fed with breast milk alone from birth to 6 months, then with additional foods; recommends continuation of breastfeeding until at least 2 years of age. It has been reported that with the spread of breastfeeding, 823,000 child and 20,000 maternal deaths can be prevented and 300 billion dollars of economic savings can be made every year in the world.
WHO for the protection, promotion and dissemination of breastfeeding; It recommends the full adoption of the 'International Law on the Marketing of Breastmilk Substitutes (Food Code)' adopted in 1981, the widespread implementation of the 'Ten Steps to Successful Breastfeeding' principles within the scope of the Baby-Friendly Health Institutions Program, and increasing community-based support such as mother support groups and trainings. In addition, it is recommended to provide counseling and support about breastfeeding at every opportunity where the baby and parents can be contacted, such as antenatal-postnatal follow-ups, child health follow-ups and applications due to illness. Eker and Yurdakul stated in their study that it is the midwife and nurse's responsibility to provide continuous monitoring and control of mothers in the postpartum period, and they reported that providing breastfeeding education and counseling after discharge positively affects breastfeeding success.The COVID 19 pandemic, which has been affecting the whole world for the last two years, has led to changes in the field of consultancy as well as in all areas. Counseling has created a tendency to be given online due to the rapid spread of the virus, the fact that it is deadly, and the increased risk in closed areas.
In this study, breastfeeding counseling will be given to women in the postpartum period online in our country, where early cessation of breastfeeding and early initiation of complementary foods is a serious problem. There has been a great deal of interest in the subject of breastfeeding behavior in the literature, but it has been observed that there is not enough research on breastfeeding counseling given online. In this study, breastfeeding behavior of mothers in the first six months and the duration of starting solid food will be investigated.Data will be obtained using the Data Collection Form and the Breastfeeding Self-Efficacy Scale Short Form. Data Collection Form; It was created as a result of scanning and examining the relevant literature by the researcher, which includes socio-demographic characteristics. This form will be applied after completing the informed consent form and obtaining the participant's consent. Breastfeeding Self-Efficacy Scale Short Form; The Breastfeeding Self-Efficacy Scale was first developed by Dennis and Faux as a 33-item scale. This scale evaluates the mothers' feeling of self-sufficiency regarding breastfeeding.
The data obtained from the research will be statistically analyzed using the International Business Machines Statistical Package for Social Sciences Subscription trial version in computer environment. The descriptive characteristics of the participants will be evaluated by number, percentage, lowest and highest values, mean, standard deviation. Breastfeeding Self-Efficacy Scale and ANOVA, t-Test, Mann Whitney U Test, Kruskal Wallis Test, Mean, Standard Deviation will be analyzed.
- Conditions
- Breastfeeding, Breastfeeding Support
- Being tested
- The Effect Of Online Breastfeeding Counseling Given At The Post-Birth Period On Breastfeeding Behavior
- Keywords
- Postpartum period, Breastfeeding, time to start solid food, online, consultancy
- 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 Effect Of Online Breastfeeding Counseling Given At The Post-Birth Period On Breastfeeding BehaviorOther
The aim of the study is to investigate breastfeeding behavior and initiation of solid food by giving breastfeeding counseling to women within the framework of the Health Belief Model for 6 months from birth.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Postpartum breastfeeding training, which is routinely done immediately after birth, and breastfeeding counseling will be provided in the 1st, 2nd, 4th and 6th months after birth. Receives: Other: The Effect Of Online Breastfeeding Counseling Given At The Post-Birth Period On Breastfeeding Behavior |
| control group | No intervention | Postpartum breastfeeding education will be given routinely immediately after birth. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect Of Online Breastfeeding Counseling Given At The Post-Birth Period On Breastfeeding Behavior
The minimum score that can be obtained from the breastfeeding self-efficacy scale is 14, and the maximum is 70. A high score is an indicator of high breastfeeding self-efficacy.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start1 May 2023 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyza Akturk, Marmara University
- Investigators
- Meltem Demirgöz Bal, Assoc. Dr., Study director, Head of Department of Midwifery at Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322434
- Sponsor's protocol ID
- Breastfeeding counseling
- Acronym
- Breastfeed
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Online Breastfeeding Counseling Given At The Post-Birth Period On Breastfeeding Behavior
- ClinicalTrials.gov ID
- NCT05322434
- Acronym / sponsor ID
- Breastfeed / Breastfeeding counseling
- Conditions
- Breastfeeding, Breastfeeding Support
- Keywords
- Postpartum period, Breastfeeding, time to start solid food, online, consultancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 11 Apr 2022 (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.
The World Health Organization and the United Nations Children's Fund recommend that every baby be fed with breast milk alone from birth to 6 months, then with additional foods; recommends continuation of breastfeeding until at least 2 years of age. It has been reported that with the spread of breastfeeding, 823,000 child and 20,000 maternal deaths can be prevented and 300 billion dollars of economic savings can be made every year in the world. The COVID 19 pandemic, which has been affecting the whole world for the last two years, has led to changes in the field of consultancy as well as in all areas. Counseling has created a tendency to be given online due to the rapid spread of the virus, the fact that it is deadly, and the increased risk in closed areas.
There has been a great deal of interest in the subject of breastfeeding behavior in the literature, but it has been observed that there is not enough research on breastfeeding counseling given online. In this study, breastfeeding behavior of mothers in the first six months and the duration of starting solid food will be investigated.
Detailed description
Breastfeeding has a biological and emotional effect on mother and baby, and has many immunological, psychological, social and economic benefits for both mother and baby. The content of breast milk is regulated according to the needs of the baby, regardless of the mother's diet. The importance of breastfeeding in laying the foundations of a healthy life is indisputable.The World Health Organization and the United Nations Children's Fund recommend that every baby be fed with breast milk alone from birth to 6 months, then with additional foods; recommends continuation of breastfeeding until at least 2 years of age. It has been reported that with the spread of breastfeeding, 823,000 child and 20,000 maternal deaths can be prevented and 300 billion dollars of economic savings can be made every year in the world.
WHO for the protection, promotion and dissemination of breastfeeding; It recommends the full adoption of the 'International Law on the Marketing of Breastmilk Substitutes (Food Code)' adopted in 1981, the widespread implementation of the 'Ten Steps to Successful Breastfeeding' principles within the scope of the Baby-Friendly Health Institutions Program, and increasing community-based support such as mother support groups and trainings. In addition, it is recommended to provide counseling and support about breastfeeding at every opportunity where the baby and parents can be contacted, such as antenatal-postnatal follow-ups, child health follow-ups and applications due to illness. Eker and Yurdakul stated in their study that it is the midwife and nurse's responsibility to provide continuous monitoring and control of mothers in the postpartum period, and they reported that providing breastfeeding education and counseling after discharge positively affects breastfeeding success.The COVID 19 pandemic, which has been affecting the whole world for the last two years, has led to changes in the field of consultancy as well as in all areas. Counseling has created a tendency to be given online due to the rapid spread of the virus, the fact that it is deadly, and the increased risk in closed areas.
In this study, breastfeeding counseling will be given to women in the postpartum period online in our country, where early cessation of breastfeeding and early initiation of complementary foods is a serious problem. There has been a great deal of interest in the subject of breastfeeding behavior in the literature, but it has been observed that there is not enough research on breastfeeding counseling given online. In this study, breastfeeding behavior of mothers in the first six months and the duration of starting solid food will be investigated.Data will be obtained using the Data Collection Form and the Breastfeeding Self-Efficacy Scale Short Form. Data Collection Form; It was created as a result of scanning and examining the relevant literature by the researcher, which includes socio-demographic characteristics. This form will be applied after completing the informed consent form and obtaining the participant's consent. Breastfeeding Self-Efficacy Scale Short Form; The Breastfeeding Self-Efficacy Scale was first developed by Dennis and Faux as a 33-item scale. This scale evaluates the mothers' feeling of self-sufficiency regarding breastfeeding.
The data obtained from the research will be statistically analyzed using the International Business Machines Statistical Package for Social Sciences Subscription trial version in computer environment. The descriptive characteristics of the participants will be evaluated by number, percentage, lowest and highest values, mean, standard deviation. Breastfeeding Self-Efficacy Scale and ANOVA, t-Test, Mann Whitney U Test, Kruskal Wallis Test, Mean, Standard Deviation will be analyzed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: The Effect Of Online Breastfeeding Counseling Given At The Post-Birth Period On Breastfeeding BehaviorPostpartum breastfeeding training, which is routinely done immediately after birth, and breastfeeding counseling will be provided in the 1st, 2nd, 4th and 6th months after birth. |
| control group | No intervention | –Postpartum breastfeeding education will be given routinely immediately after birth. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- volunteer,
- be between 18-45 years old,
- Not having a condition that prevents breastfeeding,
- Being primiparous,
- be a smart phone
Key exclusion criteria (1 listed)
- The form is not completely filled
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 Effect Of Online Breastfeeding Counseling Given At The Post-Birth Period On Breastfeeding BehaviorThe aim of the study is to investigate breastfeeding behavior and initiation of solid food by giving breastfeeding counseling to women within the framework of the Health Belief Model for 6 months from birth. | Other | experimental group |
Primary outcome
The Effect Of Online Breastfeeding Counseling Given At The Post-Birth Period On Breastfeeding Behavior
Time frame: 7 months
The minimum score that can be obtained from the breastfeeding self-efficacy scale is 14, and the maximum is 70. A high score is an indicator of high breastfeeding self-efficacy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Meltem Demirgöz Bal, Assoc. Dr. study director
Head of Department of Midwifery at Marmara University
Questions about this trial
What is this clinical trial studying?
A study testing The Effect Of Online Breastfeeding Counseling Given At The Post-Birth Period On Breastfeeding Behavior in people with Breastfeeding and Breastfeeding Support, run by Marmara University.
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 5 inclusion and 1 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 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Beyza Aktürk, Midwife (+905446710467, akturkbeyza0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effect Of Online Breastfeeding Counseling Given At The Post-Birth Period On Breastfeeding Behavior (time frame: 7 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 Mar 2023.