PregnancyNCT07040254
Paternal Support and Its Relationship With Breastfeeding Adaptation and Self-Efficacy
A study testing Father-Inclusive Antenatal Education Program in people with Pregnancy and Breastfeeding Education, run by Zehra Gürsoy at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effect of paternal support on breastfeeding adaptation and breastfeeding self-efficacy among mothers attending a structured pregnancy school program. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Breastfeeding Education, Breastfeeding Support
- What is being tested?
- Father-Inclusive Antenatal Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 18 Jun 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women aged 18 to 49 years enrolled in a pregnancy school. Male partners of the enrolled pregnant women, aged 18 to 64 years. Residing in Istanbul during the study period. Able to participate in face-to-face interviews. Able to understand and speak Turkish. Able to communicate via telephone and use digital platforms (e.g., WhatsApp, Telegram, email).
- No physical or mental disability. Willing to participate and provide signed informed consent.
Who cannot join
- Presence of any physical or mental disability. Unwillingness to participate in the study. Irregular attendance in pregnancy school sessions. Prior participation by either partner in the same pregnancy education program.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Women and Children's Diseases Training and Research Hospital
Istanbul
About this study
Official title: The Relationship Between Paternal Support, Breastfeeding Adaptation, and Breastfeeding Self-Efficacy: Evidence From a Pregnancy School
This randomized controlled trial aims to evaluate the effect of paternal support on breastfeeding adaptation and breastfeeding self-efficacy among mothers attending a structured pregnancy school program. The study is conducted at Zeynep Kamil Women and Children's Diseases Training and Research Hospital in Istanbul, Türkiye, and includes pregnant women and their partners.
Participants are assigned to an experimental group (attending the program as a couple) or a control group (mother attends alone) using random allocation. Data are collected through validated self-report scales administered during the postpartum period. The primary outcomes include changes in maternal breastfeeding adaptation and self-efficacy, and paternal breastfeeding self-efficacy. This study addresses a critical gap in perinatal care by actively involving fathers in breastfeeding support and education, aiming to improve breastfeeding outcomes and promote shared parenting roles.
Read the detailed description
Detailed Description This randomized controlled experimental study investigates the effect of paternal support on breastfeeding adaptation and breastfeeding self-efficacy in mothers, using a sample drawn from participants in a pregnancy school. The study is designed in accordance with ethical principles and has received institutional review board approval.
Background and Rationale:
Breastfeeding is universally recognized as the normative standard for infant nutrition due to its numerous short- and long-term benefits for both infants and mothers. According to the World Health Organization (WHO) and UNICEF, exclusive breastfeeding is recommended for the first six months of life, followed by continued breastfeeding up to two years or beyond. Despite this, global breastfeeding rates remain suboptimal. In Türkiye, exclusive breastfeeding rates are approximately 40.7% in the first six months, and only about 30% of children continue breastfeeding until age two (TDHS, 2018).
Multiple factors influence breastfeeding duration and maternal success, one of which is the presence of social and emotional support-particularly from the infant's father. Research shows that paternal attitudes and involvement significantly influence mothers' confidence and determination to breastfeed. Fathers' support in the early postpartum period contributes positively to both maternal mental health and infant care outcomes. However, fathers are often not actively included in perinatal education or breastfeeding promotion strategies, despite evidence supporting their crucial role.
Aim:
The primary aim of this study is to determine the effect of paternal support-facilitated through participation in a structured pregnancy school program-on breastfeeding adaptation and maternal/paternal breastfeeding self-efficacy.
Study Design:
This is a prospective, randomized controlled trial with a post-test-only design. The study is conducted at Zeynep Kamil Women and Children's Diseases Training and Research Hospital between September 1, 2024, and July 1, 2025. It includes mothers and fathers who participated in a six-week structured pregnancy school. The intervention includes educational sessions on pregnancy care, nutrition, labor, pain management, breastfeeding, newborn care, and postpartum recovery.
Participants are randomly assigned to experimental and control groups using a table of random numbers based on order of enrollment in the pregnancy school. Couples who attend sessions together are assigned to the experimental group, while those where only the mother attends are assigned to the control group.
Participants:
Inclusion criteria include:
Women aged 18-49 and men aged 18-64 Residing in Istanbul and able to attend in-person sessions No mental or physical disability Ability to use smartphones or communication apps Voluntary participation with informed consent
Sample Size:
A total of 152 individuals (76 couples) are planned, with at least 38 couples per group, based on power analysis (90% power, α = 0.05).
Data Collection Tools:
Demographic Information Form: Gathers socio-demographic and pregnancy-related data.
Postpartum Breastfeeding Self-Efficacy Scale-Short Form: 14-item, 5-point Likert scale assessing mothers' confidence in breastfeeding; validated in Turkish.
Breastfeeding Adaptation Scale: 27-135 point scale with 8 subdimensions evaluating mothers' adaptation to breastfeeding; validated in Turkish.
Paternal Breastfeeding Self-Efficacy Scale-Short Form: 14-item scale assessing fathers' perceptions and support related to breastfeeding.
All instruments have received permission for use and are validated for the Turkish population.
Procedure:
First Interview: Conducted with pregnant couples upon enrollment in the pregnancy school. Those attending with their partners are assigned to the experimental group. Initial informed consent is obtained.
Second Interview: Conducted during the postpartum period, approximately four weeks after birth. Mothers and fathers complete the relevant forms.
A pilot study with 10 participants is conducted prior to full-scale data collection.
Expected Outcomes:
The study aims to demonstrate that paternal participation in perinatal education positively affects both mothers' breastfeeding adaptation and self-efficacy, and fathers' self-efficacy in supporting breastfeeding. It is anticipated that structured, father-inclusive education will improve breastfeeding outcomes and reinforce gender-equitable caregiving roles in the postpartum period.
Significance:
This study fills a significant gap in breastfeeding support strategies by actively involving fathers through a targeted educational intervention. It contributes to the broader goal of promoting sustainable breastfeeding practices and aligns with global and national public health objectives.
- Being tested
- Father-Inclusive Antenatal Education Program
- Keywords
- Parental support, breastfeeding self-efficacy, breastfeeding adaptation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Father-Inclusive Antenatal Education ProgramBehavioural
A structured six-week antenatal education program designed for pregnant women and their spouses. The program included sessions on pregnancy care, labor, breastfeeding, newborn care, and postpartum health. Fathers in the intervention group attended the program alongside their partners and were actively engaged in discussions and learning activities related to breastfeeding support. The goal was to enhance paternal awareness and involvement to improve maternal breastfeeding adaptation and both maternal and paternal breastfeeding self-efficacy. No additional materials were provided beyond the scheduled sessions.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women attending the pregnancy school with their spouses | Experimental | Participants in this group attended a six-week structured pregnancy education program together with their spouses. The program included sessions on pregnancy care, labor, breastfeeding, newborn care, and postpartum health. Data on breastfeeding adaptation and self-efficacy were collected from both mothers and fathers during the postpartum period. Receives: Behavioral: Father-Inclusive Antenatal Education Program |
| Pregnant Women Attending the Pregnancy School Alone | No intervention | Participants in this group attended the six-week structured pregnancy education program without their spouses. While the fathers did not participate in the program or receive any intervention, data were collected from both mothers and fathers during the postpartum period. This group served as a control to evaluate the effects of paternal involvement in antenatal education on breastfeeding outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Breastfeeding Self-Efficacy Scale-Short Form
This scale was developed by Dennis in 2003 to assess breastfeeding self-efficacy during the postpartum period and was adapted into Turkish by Aluş et al. (2008) with validity and reliability established (Tokat Aluş et al., 2010). The scale consists of 14 items on a 5-point Likert scale. There are no reverse-scored items, and total scores range from a minimum of 14 to a maximum of 70. Higher scores indicate greater breastfeeding self-efficacy. The Cronbach's alpha coefficient of the original scale was reported as 0.94.
Measured: 4 week
Breastfeeding Adaptation Scale
This scale was developed by Sun-Hee Kim (2009) to evaluate adaptation to breastfeeding. The Turkish version was validated by Dinçel and Özdilek (2021). It is a 5-point Likert-type scale consisting of 8 subdimensions. Total scores range from 27 to 135, with higher scores indicating greater adaptation to breastfeeding. The Cronbach's alpha coefficient of the scale was reported as 0.78.
Measured: 4 week
Breastfeeding Self-Efficacy Scale-Short Form for Fathers
This scale was developed to assess fathers' perspectives and perceived effectiveness about breastfeeding. The Turkish validity and reliability study was conducted by Kucukoglu et al. (2022). The scale is self-reported, unidimensional, and consists of 14 items rated on a 5-point Likert scale. There are no reverse-scored items, and total scores range from 14 to 70. Higher scores indicate greater paternal breastfeeding self-efficacy. The Cronbach's alpha coefficient of the scale was reported as 0.93.
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Sep 2024
- Primary completion15 Jun 2025
- Study completion18 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zehra Gürsoy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zehra Gürsoy, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040254
- Sponsor's protocol ID
- 52
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to institutional policy, the data cannot be shared. The findings will be published in the related scientific article.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Paternal Support, Breastfeeding Adaptation, and Breastfeeding Self-Efficacy: Evidence From a Pregnancy School
- ClinicalTrials.gov ID
- NCT07040254
- Acronym / sponsor ID
- 52
- Keywords
- Parental support, breastfeeding self-efficacy, breastfeeding adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Zehra GürsoyUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 18 Jun 2025 (actual)
- First posted
- 27 Jun 2025 (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 trial aims to evaluate the effect of paternal support on breastfeeding adaptation and breastfeeding self-efficacy among mothers attending a structured pregnancy school program. The study is conducted at Zeynep Kamil Women and Children's Diseases Training and Research Hospital in Istanbul, Türkiye, and includes pregnant women and their partners.
Participants are assigned to an experimental group (attending the program as a couple) or a control group (mother attends alone) using random allocation. Data are collected through validated self-report scales administered during the postpartum period. The primary outcomes include changes in maternal breastfeeding adaptation and self-efficacy, and paternal breastfeeding self-efficacy. This study addresses a critical gap in perinatal care by actively involving fathers in breastfeeding support and education, aiming to improve breastfeeding outcomes and promote shared parenting roles.
Detailed description
Detailed Description This randomized controlled experimental study investigates the effect of paternal support on breastfeeding adaptation and breastfeeding self-efficacy in mothers, using a sample drawn from participants in a pregnancy school. The study is designed in accordance with ethical principles and has received institutional review board approval.
Background and Rationale:
Breastfeeding is universally recognized as the normative standard for infant nutrition due to its numerous short- and long-term benefits for both infants and mothers. According to the World Health Organization (WHO) and UNICEF, exclusive breastfeeding is recommended for the first six months of life, followed by continued breastfeeding up to two years or beyond. Despite this, global breastfeeding rates remain suboptimal. In Türkiye, exclusive breastfeeding rates are approximately 40.7% in the first six months, and only about 30% of children continue breastfeeding until age two (TDHS, 2018).
Multiple factors influence breastfeeding duration and maternal success, one of which is the presence of social and emotional support-particularly from the infant's father. Research shows that paternal attitudes and involvement significantly influence mothers' confidence and determination to breastfeed. Fathers' support in the early postpartum period contributes positively to both maternal mental health and infant care outcomes. However, fathers are often not actively included in perinatal education or breastfeeding promotion strategies, despite evidence supporting their crucial role.
Aim:
The primary aim of this study is to determine the effect of paternal support-facilitated through participation in a structured pregnancy school program-on breastfeeding adaptation and maternal/paternal breastfeeding self-efficacy.
Study Design:
This is a prospective, randomized controlled trial with a post-test-only design. The study is conducted at Zeynep Kamil Women and Children's Diseases Training and Research Hospital between September 1, 2024, and July 1, 2025. It includes mothers and fathers who participated in a six-week structured pregnancy school. The intervention includes educational sessions on pregnancy care, nutrition, labor, pain management, breastfeeding, newborn care, and postpartum recovery.
Participants are randomly assigned to experimental and control groups using a table of random numbers based on order of enrollment in the pregnancy school. Couples who attend sessions together are assigned to the experimental group, while those where only the mother attends are assigned to the control group.
Participants:
Inclusion criteria include:
Women aged 18-49 and men aged 18-64 Residing in Istanbul and able to attend in-person sessions No mental or physical disability Ability to use smartphones or communication apps Voluntary participation with informed consent
Sample Size:
A total of 152 individuals (76 couples) are planned, with at least 38 couples per group, based on power analysis (90% power, α = 0.05).
Data Collection Tools:
Demographic Information Form: Gathers socio-demographic and pregnancy-related data.
Postpartum Breastfeeding Self-Efficacy Scale-Short Form: 14-item, 5-point Likert scale assessing mothers' confidence in breastfeeding; validated in Turkish.
Breastfeeding Adaptation Scale: 27-135 point scale with 8 subdimensions evaluating mothers' adaptation to breastfeeding; validated in Turkish.
Paternal Breastfeeding Self-Efficacy Scale-Short Form: 14-item scale assessing fathers' perceptions and support related to breastfeeding.
All instruments have received permission for use and are validated for the Turkish population.
Procedure:
First Interview: Conducted with pregnant couples upon enrollment in the pregnancy school. Those attending with their partners are assigned to the experimental group. Initial informed consent is obtained.
Second Interview: Conducted during the postpartum period, approximately four weeks after birth. Mothers and fathers complete the relevant forms.
A pilot study with 10 participants is conducted prior to full-scale data collection.
Expected Outcomes:
The study aims to demonstrate that paternal participation in perinatal education positively affects both mothers' breastfeeding adaptation and self-efficacy, and fathers' self-efficacy in supporting breastfeeding. It is anticipated that structured, father-inclusive education will improve breastfeeding outcomes and reinforce gender-equitable caregiving roles in the postpartum period.
Significance:
This study fills a significant gap in breastfeeding support strategies by actively involving fathers through a targeted educational intervention. It contributes to the broader goal of promoting sustainable breastfeeding practices and aligns with global and national public health objectives.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women attending the pregnancy school with their spouses | Experimental | Behavioral: Father-Inclusive Antenatal Education ProgramParticipants in this group attended a six-week structured pregnancy education program together with their spouses. The program included sessions on pregnancy care, labor, breastfeeding, newborn care, and postpartum health. Data on breastfeeding adaptation and self-efficacy were collected from both mothers and fathers during the postpartum period. |
| Pregnant Women Attending the Pregnancy School Alone | No intervention | –Participants in this group attended the six-week structured pregnancy education program without their spouses. While the fathers did not participate in the program or receive any intervention, data were collected from both mothers and fathers during the postpartum period. This group served as a control to evaluate the effects of paternal involvement in antenatal education on breastfeeding outcomes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women aged 18 to 49 years enrolled in a pregnancy school. Male partners of the enrolled pregnant women, aged 18 to 64 years. Residing in Istanbul during the study period. Able to participate in face-to-face interviews. Able to understand and speak Turkish. Able to communicate via telephone and use digital platforms (e.g., WhatsApp, Telegram, email).
- No physical or mental disability. Willing to participate and provide signed informed consent.
Key exclusion criteria (1 listed)
- Presence of any physical or mental disability. Unwillingness to participate in the study. Irregular attendance in pregnancy school sessions. Prior participation by either partner in the same pregnancy education program.
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 |
|---|---|---|
| Father-Inclusive Antenatal Education ProgramA structured six-week antenatal education program designed for pregnant women and their spouses. The program included sessions on pregnancy care, labor, breastfeeding, newborn care, and postpartum health. Fathers in the intervention group attended the program alongside their partners and were actively engaged in discussions and learning activities related to breastfeeding support. The goal was to enhance paternal awareness and involvement to improve maternal breastfeeding adaptation and both maternal and paternal breastfeeding self-efficacy. No additional materials were provided beyond the scheduled sessions. | Behavioural | Pregnant women attending the pregnancy school with their spouses |
Primary outcome
Postpartum Breastfeeding Self-Efficacy Scale-Short Form
Time frame: 4 week
This scale was developed by Dennis in 2003 to assess breastfeeding self-efficacy during the postpartum period and was adapted into Turkish by Aluş et al. (2008) with validity and reliability established (Tokat Aluş et al., 2010). The scale consists of 14 items on a 5-point Likert scale. There are no reverse-scored items, and total scores range from a minimum of 14 to a maximum of 70. Higher scores indicate greater breastfeeding self-efficacy. The Cronbach's alpha coefficient of the original scale was reported as 0.94.
Breastfeeding Adaptation Scale
Time frame: 4 week
This scale was developed by Sun-Hee Kim (2009) to evaluate adaptation to breastfeeding. The Turkish version was validated by Dinçel and Özdilek (2021). It is a 5-point Likert-type scale consisting of 8 subdimensions. Total scores range from 27 to 135, with higher scores indicating greater adaptation to breastfeeding. The Cronbach's alpha coefficient of the scale was reported as 0.78.
Breastfeeding Self-Efficacy Scale-Short Form for Fathers
Time frame: 4 week
This scale was developed to assess fathers' perspectives and perceived effectiveness about breastfeeding. The Turkish validity and reliability study was conducted by Kucukoglu et al. (2022). The scale is self-reported, unidimensional, and consists of 14 items rated on a 5-point Likert scale. There are no reverse-scored items, and total scores range from 14 to 70. Higher scores indicate greater paternal breastfeeding self-efficacy. The Cronbach's alpha coefficient of the scale was reported as 0.93.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No. Due to institutional policy, the data cannot be shared. The findings will be published in the related scientific article.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Father-Inclusive Antenatal Education Program in people with Pregnancy and Breastfeeding Education, run by Zehra Gürsoy 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 2 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: finished, as of the sponsor's last update on 27 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum Breastfeeding Self-Efficacy Scale-Short Form (time frame: 4 week). The study lists 3 primary outcomes in all. 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 27 Jun 2025.