Breast FeedingNCT07478341
Hybrid Breastfeeding Education in Late Pregnancy: Effects on Antenatal Attachment and Breastfeeding
A study testing Individualized Hybrid Breastfeeding Education in people with Breast Feeding and Exclusive Breast Feeding, run by Emel GÜÇLÜ CİHAN at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aims to examine the effect of individualized hybrid breastfeeding education provided during late pregnancy on antenatal attachment and breastfeeding behaviors among first-time mothers. Participants will be randomly assigned to either the intervention or control group. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Exclusive Breast Feeding, Maternal-Fetal Attachment
- What is being tested?
- Individualized Hybrid Breastfeeding Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-35 years,
- At 36 weeks of gestation or later,
- Experiencing their first pregnancy (primiparous),
- Having a singleton pregnancy,
- Able to read and write in Turkish and capable of communication,
- Having access to a smartphone or the internet,
- Free from any physical or mental health problems that would prevent participation in the education,
- Willing to voluntarily participate in the study and provide written informed consent.
Who cannot join
- Presence of chronic physical illness or pregnancy complications (e.g., preeclampsia, gestational diabetes),
- Multiple pregnancy,
- Gestation earlier than 36 weeks,
- Inability to actively participate in the education due to communication barriers or cognitive impairment,
- Lack of access to a smartphone or the internet,
- Failure to attend any stage of the educational program or voluntary withdrawal from the study,
- Refusal to participate in the study or failure to sign the informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Elbistan Devlet Hastanesi
Elbistan, Kahramanmaraş, 46040
Asst. Prof., 03443004901, emel_guclu4606@hotmail.com
About this study
Official title: The Effect of Individualized Hybrid Breastfeeding Education in Late Pregnancy on Antenatal Attachment and Breastfeeding Behaviors in Primiparous Women
This randomized controlled study aims to examine the effect of individualized hybrid breastfeeding education provided during late pregnancy on antenatal attachment and breastfeeding behaviors among first-time mothers. Participants will be randomly assigned to either the intervention or control group. Women in the intervention group will receive individualized hybrid breastfeeding education beginning at the 36th week of pregnancy. The program includes a face-to-face individual breastfeeding education session at 36 weeks of pregnancy and a reinforcement and practice session at 38 weeks. Participants will also have access to personalized digital educational materials, short educational videos, and online consultation support. In the postpartum period, participants will receive an online support session during the first week after birth and a follow-up session through online communication or telephone at the sixth postpartum week. The control group will receive routine hospital education during pregnancy. After completion of the study, the same educational materials will be provided to the control group in accordance with ethical principles. Data will be collected using the Demographic Information Form, Breastfeeding Behavior Evaluation Form, Antenatal Attachment Inventory, and Breastfeeding Self-Efficacy Scale. Written informed consent will be obtained from all participants prior to enrollment.
Read the detailed description
Maternal emotional attachment to the fetus during pregnancy is an important factor influencing breastfeeding success and the quality of mother-infant interaction in the postpartum period. Higher levels of antenatal attachment have been associated with earlier initiation of breastfeeding and stronger emotional bonding with the infant after birth. Educational and psychosocial interventions during pregnancy may therefore play an important role in strengthening the maternal-infant relationship and improving breastfeeding outcomes.
Breastfeeding is not only a nutritional practice but also a biological and psychosocial process that supports the development of secure attachment between mother and infant. Sustained breastfeeding contributes to maternal responsiveness and supports the infant's emotional security and development. First-time mothers often experience lower breastfeeding self-efficacy and may require additional professional guidance and support during the breastfeeding process.
Educational interventions implemented during pregnancy can enhance maternal knowledge, confidence, and emotional readiness for breastfeeding. Hybrid educational models that combine face-to-face and online approaches may increase accessibility while accommodating the physical and time limitations experienced during late pregnancy. Personalized digital educational materials and online counseling can further support mothers by providing flexible access to breastfeeding information and professional guidance.
However, studies examining individualized hybrid breastfeeding education programs initiated during the late stages of pregnancy for first-time mothers remain limited. Evaluating the effectiveness of such programs may contribute to improving antenatal attachment and promoting positive breastfeeding behaviors after birth.
Therefore, the purpose of this randomized controlled study is to evaluate the effect of individualized hybrid breastfeeding education initiated during late pregnancy (approximately at the 36th week of gestation) on antenatal attachment and breastfeeding behaviors among primiparous women.
- Being tested
- Individualized Hybrid Breastfeeding Education
- Keywords
- Breastfeeding Education, Hybrid Education, Primiparous Women, Antenatal Attachment, Breastfeeding Self-Efficacy, Mother-Infant Bonding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Hybrid Breastfeeding EducationBehavioural
Also called Standard Prenatal Care
Primiparous pregnant women in the intervention group will receive an individualized hybrid breastfeeding education program planned for late pregnancy. The education consists of a hybrid structure including face-to-face sessions and online educational materials. The content covers the importance of breastfeeding, breastfeeding techniques, common breastfeeding problems, approaches to support mother-infant attachment, and preparation for the postpartum breastfeeding process. The intervention will be provided in addition to standard prenatal care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: Individualized Hybrid Breastfeeding Education | Experimental | Primiparous pregnant women in this group will receive an individualized hybrid breastfeeding education program planned for late pregnancy. The education includes both face-to-face and online components and covers content designed to support breastfeeding knowledge, skills, and mother-infant attachment. Receives: Behavioral: Individualized Hybrid Breastfeeding Education |
| Control Group: Standard Prenatal Care | No intervention | Primiparous pregnant women in this group will not receive any additional intervention during the study period; they will receive routine prenatal care and standard informational services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antenatal Maternal Attachment
The level of antenatal maternal attachment will be assessed using the Maternal Antenatal Attachment Scale (MAAS). The scale consists of 19 items rated on a 5-point Likert scale. Total scores range from 19 to 95, with higher scores indicating stronger antenatal maternal attachment.
Measured: 36-38 weeks of pregnancy
Secondary outcomes (1)
Breastfeeding Self-Efficacy
Breastfeeding self-efficacy will be assessed using the Breastfeeding Self-Efficacy Scale (BSES). The scale consists of 33 items rated on a 5-point Likert scale. Total scores range from 33 to 165, with higher scores indicating greater breastfeeding self-efficacy.
Measured: At 1 and 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start30 Jan 2026
- Primary completion14 Jun 2026
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will use a parallel assignment model. Primiparous pregnant women will be randomly assigned to either the intervention group or the control group. The intervention group will receive individualized hybrid breastfeeding education during late pregnancy, while the control group will receive routine prenatal care. Participants will remain in their assigned group throughout the study period.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emel GÜÇLÜ CİHAN
- Sponsor type
- University, hospital or other
- Collaborators
- Kahramanmaras Sutcu Imam University
- Responsible party
- Sponsor-investigator, Emel GÜÇLÜ CİHAN, Kahramanmaras Sutcu Imam University
- Investigators
- Asst. Prof., Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478341
- Sponsor's protocol ID
- KSU-Hybrid-Emzirme-2025
- Status last verified
- Aug 2026
- First submitted
- 2 Jan 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) from this study will not be shared with other researchers. To protect participant confidentiality, the data will be analyzed solely by the research team and will not be shared with third parties.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Individualized Hybrid Breastfeeding Education in Late Pregnancy on Antenatal Attachment and Breastfeeding Behaviors in Primiparous Women
- ClinicalTrials.gov ID
- NCT07478341
- Acronym / sponsor ID
- KSU-Hybrid-Emzirme-2025
- Keywords
- Breastfeeding Education, Hybrid Education, Primiparous Women, Antenatal Attachment, Breastfeeding Self-Efficacy, Mother-Infant Bonding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Emel GÜÇLÜ CİHANUniversity, hospital or other
- Collaborators
- Kahramanmaras Sutcu Imam University
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 14 Jun 2026 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 17 Mar 2026 (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.
This randomized controlled study aims to examine the effect of individualized hybrid breastfeeding education provided during late pregnancy on antenatal attachment and breastfeeding behaviors among first-time mothers. Participants will be randomly assigned to either the intervention or control group. Women in the intervention group will receive individualized hybrid breastfeeding education beginning at the 36th week of pregnancy. The program includes a face-to-face individual breastfeeding education session at 36 weeks of pregnancy and a reinforcement and practice session at 38 weeks. Participants will also have access to personalized digital educational materials, short educational videos, and online consultation support. In the postpartum period, participants will receive an online support session during the first week after birth and a follow-up session through online communication or telephone at the sixth postpartum week. The control group will receive routine hospital education during pregnancy. After completion of the study, the same educational materials will be provided to the control group in accordance with ethical principles. Data will be collected using the Demographic Information Form, Breastfeeding Behavior Evaluation Form, Antenatal Attachment Inventory, and Breastfeeding Self-Efficacy Scale. Written informed consent will be obtained from all participants prior to enrollment.
Detailed description
Maternal emotional attachment to the fetus during pregnancy is an important factor influencing breastfeeding success and the quality of mother-infant interaction in the postpartum period. Higher levels of antenatal attachment have been associated with earlier initiation of breastfeeding and stronger emotional bonding with the infant after birth. Educational and psychosocial interventions during pregnancy may therefore play an important role in strengthening the maternal-infant relationship and improving breastfeeding outcomes.
Breastfeeding is not only a nutritional practice but also a biological and psychosocial process that supports the development of secure attachment between mother and infant. Sustained breastfeeding contributes to maternal responsiveness and supports the infant's emotional security and development. First-time mothers often experience lower breastfeeding self-efficacy and may require additional professional guidance and support during the breastfeeding process.
Educational interventions implemented during pregnancy can enhance maternal knowledge, confidence, and emotional readiness for breastfeeding. Hybrid educational models that combine face-to-face and online approaches may increase accessibility while accommodating the physical and time limitations experienced during late pregnancy. Personalized digital educational materials and online counseling can further support mothers by providing flexible access to breastfeeding information and professional guidance.
However, studies examining individualized hybrid breastfeeding education programs initiated during the late stages of pregnancy for first-time mothers remain limited. Evaluating the effectiveness of such programs may contribute to improving antenatal attachment and promoting positive breastfeeding behaviors after birth.
Therefore, the purpose of this randomized controlled study is to evaluate the effect of individualized hybrid breastfeeding education initiated during late pregnancy (approximately at the 36th week of gestation) on antenatal attachment and breastfeeding behaviors among primiparous women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will use a parallel assignment model. Primiparous pregnant women will be randomly assigned to either the intervention group or the control group. The intervention group will receive individualized hybrid breastfeeding education during late pregnancy, while the control group will receive routine prenatal care. Participants will remain in their assigned group throughout the study period.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Individualized Hybrid Breastfeeding Education | Experimental | Behavioral: Individualized Hybrid Breastfeeding EducationPrimiparous pregnant women in this group will receive an individualized hybrid breastfeeding education program planned for late pregnancy. The education includes both face-to-face and online components and covers content designed to support breastfeeding knowledge, skills, and mother-infant attachment. |
| Control Group: Standard Prenatal Care | No intervention | –Primiparous pregnant women in this group will not receive any additional intervention during the study period; they will receive routine prenatal care and standard informational services. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Aged 18-35 years,
- At 36 weeks of gestation or later,
- Experiencing their first pregnancy (primiparous),
- Having a singleton pregnancy,
- Able to read and write in Turkish and capable of communication,
Key exclusion criteria (7 listed)
- Presence of chronic physical illness or pregnancy complications (e.g., preeclampsia, gestational diabetes),
- Multiple pregnancy,
- Gestation earlier than 36 weeks,
- Inability to actively participate in the education due to communication barriers or cognitive impairment,
- Lack of access to a smartphone or the internet,
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 |
|---|---|---|
| Individualized Hybrid Breastfeeding EducationAlso: Standard Prenatal CarePrimiparous pregnant women in the intervention group will receive an individualized hybrid breastfeeding education program planned for late pregnancy. The education consists of a hybrid structure including face-to-face sessions and online educational materials. The content covers the importance of breastfeeding, breastfeeding techniques, common breastfeeding problems, approaches to support mother-infant attachment, and preparation for the postpartum breastfeeding process. The intervention will be provided in addition to standard prenatal care. | Behavioural | Intervention Group: Individualized Hybrid Breastfeeding Education |
Primary outcome
Antenatal Maternal Attachment
Time frame: 36-38 weeks of pregnancy
The level of antenatal maternal attachment will be assessed using the Maternal Antenatal Attachment Scale (MAAS). The scale consists of 19 items rated on a 5-point Likert scale. Total scores range from 19 to 95, with higher scores indicating stronger antenatal maternal attachment.
1 secondary outcome
Breastfeeding Self-Efficacy
Time frame: At 1 and 6 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) from this study will not be shared with other researchers. To protect participant confidentiality, the data will be analyzed solely by the research team and will not be shared with third parties.
Related trials for Breast Feeding
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
Recruiting
Effects of a Mindful Self-Compassion Intervention on Psychological Adjustment in Breast Cancer Survivors
Breast Cancer
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
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.
Asst. Prof. principal investigator
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Hybrid Breastfeeding Education in people with Breast Feeding and Exclusive Breast Feeding, run by Emel GÜÇLÜ CİHAN 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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 26 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asst. Prof. (3443004901, emel_guclu4606@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antenatal Maternal Attachment (time frame: 36-38 weeks of pregnancy). 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 26 Aug 2026.