Breastfeeding EducationNCT07107867
The Effect of Breastfeeding Counseling on Postpartum Breastfeeding Self-efficacy and Infant Feeding Attitudes
A study testing breastfeding counseling in people with Breastfeeding Education and Breastfeeding Self-Efficacy, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effect of breastfeeding counseling given to primiparous pregnant women before birth on breastfeeding self-efficacy and infant feeding attitudes in the postpartum period. 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 Education, Breastfeeding Self-Efficacy, Breastfeeding Attitude
- What is being tested?
- breastfeding counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Mar 2021to 15 Dec 2021
- 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
Inclusion Criteria: Pregnant women who agree to participate in the study,
- Are over 18 years old,
- Have at least primary school education,
- Are primiparous,
- Are in the 27th or more weeks of pregnancy,
- Have no chronic disease,
- Have no communication barriers will be included in the study.
Exclusion Criteria: Pregnant women who had medical indications that would prevent breastfeeding,
- Those who had multiple pregnancies,
- Those who were multiparous,
- Those who had a mental illness,
- Those who did not want to continue the research process,
- Those who could not be reached during the follow-up process were excluded from the research.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ordu Üniversitesi Eğitim Araştırma Hastanesi
Altinordu, Ordu, 52000
About this study
Official title: The Effect of Breastfeeding Counseling Provided During Pregnancy on Postpartum Breastfeeding Self-Efficacy and Infant Feeding Attitudes
This study was conducted to determine the effect of breastfeeding counseling given to primiparous pregnant women before birth on breastfeeding self-efficacy and infant feeding attitudes in the postpartum period.
Hypotheses of this study:
Read more
H11: There is a difference in postpartum breastfeeding self-efficacy between the intervention group that received prenatal breastfeeding counseling and the control group.
H10: There is no difference in postpartum breastfeeding self-efficacy between the intervention group that received prenatal breastfeeding counseling and the control group.
H21: There is a difference between the intervention group that received prenatal breastfeeding counseling and the control group in terms of postnatal infant feeding attitude.
H20: There is no difference between the intervention group that received prenatal breastfeeding counseling and the control group in terms of postnatal infant feeding attitude.
Read the detailed description
Breast milk is a natural source of nutrition that provides everything an infant needs for healthy physical growth, brain development, and a strong immune system. Starting breastfeeding within the first hour after birth, continuing exclusively for the first six months, and maintaining it alongside safe and appropriate complementary foods for up to two years or longer is one of the most effective ways to support a child's health and survival. However, only 43% of newborns worldwide are breastfed within that first hour. The highest early breastfeeding rates are found in Eastern and Southern Africa (65%), while the lowest are in East Asia and the Pacific (32%). In Türkiye, 71% of infants begin breastfeeding within the first hour after birth.
Although breastfeeding is a natural and physiological process, it also needs to be learned and it is not always easy to sustain. Several factors can make breastfeeding more challenging. These include the mother's young age, limited maternity leave for working mothers, lack of support from family or a partner, mode of birth, insufficient knowledge about breastfeeding, limited access to prenatal care and health education, low milk supply, difficulties with latching, medical issues affecting either the mother or the baby, and discomfort or embarrassment about breastfeeding in public.
According to the literature, face-to-face support from healthcare professionals promotes breastfeeding among healthy mothers and full-term infants. A mother's decision to start and continue breastfeeding, along with her attitudes and efforts toward it, is closely linked to her level of self-efficacy.
Self-efficacy beliefs play a key role in shaping an individual's behavior, motivation, and actions. Bandura (1977) defines self-efficacy as a person's belief or confidence in their ability to plan and carry out the actions necessary to handle future situations. In breastfeeding, self-efficacy is a crucial factor. It influences whether a mother chooses to breastfeed, how much effort she puts into it, whether she continues despite initial challenges, and how actively she works to improve her breastfeeding skills.
Breastfeeding self-efficacy during the prenatal period plays a key role in shaping a mother's intention and readiness to breastfeed after birth. This study examined the impact of breastfeeding counseling provided to pregnant women during the prenatal period on their breastfeeding self-efficacy and infant feeding attitudes in the postpartum period.
Hypotheses of this study:
H11: There is a difference in postpartum breastfeeding self-efficacy between the intervention group that received prenatal breastfeeding counseling and the control group.
H10: There is no difference in postpartum breastfeeding self-efficacy between the intervention group that received prenatal breastfeeding counseling and the control group.
H21: There is a difference between the intervention group that received prenatal breastfeeding counseling and the control group in terms of postnatal infant feeding attitude.
H20: There is no difference between the intervention group that received prenatal breastfeeding counseling and the control group in terms of postnatal infant feeding attitude.
Study Design This study is a single-blind randomized controlled experimental study. Population and Sample of the Study The population of the study consisted of pregnant women who attended the outpatient clinics of the Gynecology and Obstetrics Department at Ordu Training and Research Hospital, located in the Black Sea Region of Türkiye. 138 primiparous pregnant women were included in the study. 69 women were included in the training group and 69 women were included in the control group.
Pregnant women who were 18 years of age or older, had at least primary school education, had given birth for the first time, were in their 27th week of pregnancy or later, had no chronic disease, had no communication barriers, and agreed to participate in the study were included in the study.
Women were excluded from the study if they had any medical condition that might prevent breastfeeding, multiple pregnancy, multiparity, diagnosed mental illness, or were unwilling to continue participating in the study.
The independent variables of the study were age, education level and number of children.
The dependent variables of the study were receiving education on breastfeeding, the Iowa Infant Feeding Attitude Scale score, and the Breastfeeding Self-Efficacy Scale score.
The Control variables included a range of sociodemographic and obstetric characteristics such as age, education level, employment status, income level, spouse's education level, spouse's employment status, gestational week, health problems during pregnancy, structural nipple issues, prior breastfeeding education, and having a person around supporting breastfeeding.
Data Collection Tools Data were collected using several tools: a personal information form covering the participants' sociodemographic characteristics, the Antenatal Breastfeeding Self-Efficacy Scale-Short Form, the Postnatal Breastfeeding Self-Efficacy Scale-Short Form, and the Iowa Infant Feeding Attitude Scale. Before the breastfeeding counseling intervention, pregnant women completed these forms and scales themselves through face-to-face interviews. In the postpartum period, the same tools were completed by the participants via face-to-face interviews, telephone calls, or email.
Ethical Considerations Permission to use the scales was obtained via email from the authors. Ethical approval was obtained from the Ordu University Clinical Research Ethics Committee. Institutional approval was received from the Ordu Provincial Health Directorate. All pregnant women gave written and verbal informed consent to participate in the study.
- Being tested
- breastfeding counseling
- Keywords
- breastfeeding, breastfeeding self-efficacy, infant feeding attitude,, breastfeeding counseling, nursing
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breastfeding counselingBehavioural
Pregnant women assigned to the intervention group then participated in a breastfeeding counseling training program held at the gynecology and obstetrics unit of an university training and research hospital. The training sessions lasted 60 to 90 minutes and included small groups of 5 to 6 participants, based on recommendations from the literature. The training was delivered through a slide presentation, and participants received a printed training booklet beforehand. Visual aids, including a baby model and breast model, were also used to enhance understanding. The training content was developed in line with infant feeding guidelines from UNICEF, the Turkish Ministry of Health, and relevant literature.
| Study group | Role | What they receive |
|---|---|---|
| Education Group | Experimental | The researcher, who had received certified training in breastfeeding counseling, conducted face-to-face interviews during the pretest phase. Mothers were informed about the purpose and nature of the study. After obtaining consent, pre-test data were collected from the pregnant women, and their group assignment was determined through randomization. Receives: Behavioral: breastfeding counseling |
| Control Group | No intervention | Mothers in the control group who agreed to participate received only the hospital's standard breastfeeding care, with no additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Self-Efficacy Scale-Short Form
Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), developed by Dennis (2003) to measure a mother's confidence in her ability to breastfeed.14 Aluş Tokat et al. (2010) adapted the scale for Turkish culture.19 The scale consists of two sub-dimensions: "technical" and "personal thoughts." It uses a Likert-type format ranging from 1 to 5, where 1 means "I am never sure" and 5 means "I am always sure." Scores range from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy. In this study, the scale was used to assess self-efficacy before the breastfeeding counseling intervention. The Turkish adaptation reported a Cronbach's alpha of 0.87.
Measured: Data were collected with the BSES-SF in the prenatal period (enrollment), postpartum first week, postpartum first month and postpartum second month in the training and control groups. The evaluation of the data was made after December 2021.
The Iowa Infant Feeding Attitude Scale
The Iowa Infant Feeding Attitude Scale (IIFAS) was created to assess women's attitudes toward breastfeeding and to predict breastfeeding duration and choice of infant feeding method. The Turkish adaptation was conducted by Ekşioğlu et al. (2016).21 The scale consists of 17 items rated on a 5-point Likert scale, from 1 (strongly disagree) to 5 (strongly agree). Nine items reflect positive attitudes toward breastfeeding, while eight items reflect positive attitudes toward formula feeding; the formula feeding items (items 1, 2, 4, 6, 8, 10, 11, 14, and 17) are reverse scored. Scores can range from 17 to 85.20 There is no cut-off score. In the Turkish adaptation, the Cronbach's alpha was 0.71.
Measured: Data were collected using IIFAS in the prenatal period (enrollment), postpartum first week, postpartum first month, and postpartum second month in the training and control groups. Data analysis was performed after December 2021.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start16 Mar 2021
- Primary completion15 Apr 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breastfeeding EducationStudies 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
- Model description
- Participants were randomly assigned to the intervention or control group using the website www.randomizer.org. This study was designed as a single-blind randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NUR FİDAN VARLIK, Ordu University
- Investigators
- Nülüfer ERBİL, Prof., Principal investigator, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107867
- Sponsor's protocol ID
- E-35766460-799
- Status last verified
- Aug 2025
- First submitted
- 4 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martin CR, Ling PR, Blackburn GL. Review of Infant Feeding: Key Features of Breast Milk and Infant Formula. Nutrients. 2016 May 11;8(5):279. doi: 10.3390/nu8050279.
PubMed 27187450
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breastfeeding Counseling Provided During Pregnancy on Postpartum Breastfeeding Self-Efficacy and Infant Feeding Attitudes
- ClinicalTrials.gov ID
- NCT07107867
- Acronym / sponsor ID
- E-35766460-799
- Keywords
- breastfeeding, breastfeeding self-efficacy, infant feeding attitude,, breastfeeding counseling, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 6 Aug 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 study was conducted to determine the effect of breastfeeding counseling given to primiparous pregnant women before birth on breastfeeding self-efficacy and infant feeding attitudes in the postpartum period.
Hypotheses of this study:
H11: There is a difference in postpartum breastfeeding self-efficacy between the intervention group that received prenatal breastfeeding counseling and the control group.
H10: There is no difference in postpartum breastfeeding self-efficacy between the intervention group that received prenatal breastfeeding counseling and the control group.
H21: There is a difference between the intervention group that received prenatal breastfeeding counseling and the control group in terms of postnatal infant feeding attitude.
H20: There is no difference between the intervention group that received prenatal breastfeeding counseling and the control group in terms of postnatal infant feeding attitude.
Detailed description
Breast milk is a natural source of nutrition that provides everything an infant needs for healthy physical growth, brain development, and a strong immune system. Starting breastfeeding within the first hour after birth, continuing exclusively for the first six months, and maintaining it alongside safe and appropriate complementary foods for up to two years or longer is one of the most effective ways to support a child's health and survival. However, only 43% of newborns worldwide are breastfed within that first hour. The highest early breastfeeding rates are found in Eastern and Southern Africa (65%), while the lowest are in East Asia and the Pacific (32%). In Türkiye, 71% of infants begin breastfeeding within the first hour after birth.
Although breastfeeding is a natural and physiological process, it also needs to be learned and it is not always easy to sustain. Several factors can make breastfeeding more challenging. These include the mother's young age, limited maternity leave for working mothers, lack of support from family or a partner, mode of birth, insufficient knowledge about breastfeeding, limited access to prenatal care and health education, low milk supply, difficulties with latching, medical issues affecting either the mother or the baby, and discomfort or embarrassment about breastfeeding in public.
According to the literature, face-to-face support from healthcare professionals promotes breastfeeding among healthy mothers and full-term infants. A mother's decision to start and continue breastfeeding, along with her attitudes and efforts toward it, is closely linked to her level of self-efficacy.
Self-efficacy beliefs play a key role in shaping an individual's behavior, motivation, and actions. Bandura (1977) defines self-efficacy as a person's belief or confidence in their ability to plan and carry out the actions necessary to handle future situations. In breastfeeding, self-efficacy is a crucial factor. It influences whether a mother chooses to breastfeed, how much effort she puts into it, whether she continues despite initial challenges, and how actively she works to improve her breastfeeding skills.
Breastfeeding self-efficacy during the prenatal period plays a key role in shaping a mother's intention and readiness to breastfeed after birth. This study examined the impact of breastfeeding counseling provided to pregnant women during the prenatal period on their breastfeeding self-efficacy and infant feeding attitudes in the postpartum period.
Hypotheses of this study:
H11: There is a difference in postpartum breastfeeding self-efficacy between the intervention group that received prenatal breastfeeding counseling and the control group.
H10: There is no difference in postpartum breastfeeding self-efficacy between the intervention group that received prenatal breastfeeding counseling and the control group.
H21: There is a difference between the intervention group that received prenatal breastfeeding counseling and the control group in terms of postnatal infant feeding attitude.
H20: There is no difference between the intervention group that received prenatal breastfeeding counseling and the control group in terms of postnatal infant feeding attitude.
Study Design This study is a single-blind randomized controlled experimental study. Population and Sample of the Study The population of the study consisted of pregnant women who attended the outpatient clinics of the Gynecology and Obstetrics Department at Ordu Training and Research Hospital, located in the Black Sea Region of Türkiye. 138 primiparous pregnant women were included in the study. 69 women were included in the training group and 69 women were included in the control group.
Pregnant women who were 18 years of age or older, had at least primary school education, had given birth for the first time, were in their 27th week of pregnancy or later, had no chronic disease, had no communication barriers, and agreed to participate in the study were included in the study.
Women were excluded from the study if they had any medical condition that might prevent breastfeeding, multiple pregnancy, multiparity, diagnosed mental illness, or were unwilling to continue participating in the study.
The independent variables of the study were age, education level and number of children.
The dependent variables of the study were receiving education on breastfeeding, the Iowa Infant Feeding Attitude Scale score, and the Breastfeeding Self-Efficacy Scale score.
The Control variables included a range of sociodemographic and obstetric characteristics such as age, education level, employment status, income level, spouse's education level, spouse's employment status, gestational week, health problems during pregnancy, structural nipple issues, prior breastfeeding education, and having a person around supporting breastfeeding.
Data Collection Tools Data were collected using several tools: a personal information form covering the participants' sociodemographic characteristics, the Antenatal Breastfeeding Self-Efficacy Scale-Short Form, the Postnatal Breastfeeding Self-Efficacy Scale-Short Form, and the Iowa Infant Feeding Attitude Scale. Before the breastfeeding counseling intervention, pregnant women completed these forms and scales themselves through face-to-face interviews. In the postpartum period, the same tools were completed by the participants via face-to-face interviews, telephone calls, or email.
Ethical Considerations Permission to use the scales was obtained via email from the authors. Ethical approval was obtained from the Ordu University Clinical Research Ethics Committee. Institutional approval was received from the Ordu Provincial Health Directorate. All pregnant women gave written and verbal informed consent to participate in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to the intervention or control group using the website www.randomizer.org. This study was designed as a single-blind randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Education Group | Experimental | Behavioral: breastfeding counselingThe researcher, who had received certified training in breastfeeding counseling, conducted face-to-face interviews during the pretest phase. Mothers were informed about the purpose and nature of the study. After obtaining consent, pre-test data were collected from the pregnant women, and their group assignment was determined through randomization. |
| Control Group | No intervention | –Mothers in the control group who agreed to participate received only the hospital's standard breastfeeding care, with no additional intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| breastfeding counselingPregnant women assigned to the intervention group then participated in a breastfeeding counseling training program held at the gynecology and obstetrics unit of an university training and research hospital. The training sessions lasted 60 to 90 minutes and included small groups of 5 to 6 participants, based on recommendations from the literature. The training was delivered through a slide presentation, and participants received a printed training booklet beforehand. Visual aids, including a baby model and breast model, were also used to enhance understanding. The training content was developed in line with infant feeding guidelines from UNICEF, the Turkish Ministry of Health, and relevant literature. | Behavioural | Education Group |
Primary outcome
Breastfeeding Self-Efficacy Scale-Short Form
Time frame: Data were collected with the BSES-SF in the prenatal period (enrollment), postpartum first week, postpartum first month and postpartum second month in the training and control groups. The evaluation of the data was made after December 2021.
Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), developed by Dennis (2003) to measure a mother's confidence in her ability to breastfeed.14 Aluş Tokat et al. (2010) adapted the scale for Turkish culture.19 The scale consists of two sub-dimensions: "technical" and "personal thoughts." It uses a Likert-type format ranging from 1 to 5, where 1 means "I am never sure" and 5 means "I am always sure." Scores range from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy. In this study, the scale was used to assess self-efficacy before the breastfeeding counseling intervention. The Turkish adaptation reported a Cronbach's alpha of 0.87.
The Iowa Infant Feeding Attitude Scale
Time frame: Data were collected using IIFAS in the prenatal period (enrollment), postpartum first week, postpartum first month, and postpartum second month in the training and control groups. Data analysis was performed after December 2021.
The Iowa Infant Feeding Attitude Scale (IIFAS) was created to assess women's attitudes toward breastfeeding and to predict breastfeeding duration and choice of infant feeding method. The Turkish adaptation was conducted by Ekşioğlu et al. (2016).21 The scale consists of 17 items rated on a 5-point Likert scale, from 1 (strongly disagree) to 5 (strongly agree). Nine items reflect positive attitudes toward breastfeeding, while eight items reflect positive attitudes toward formula feeding; the formula feeding items (items 1, 2, 4, 6, 8, 10, 11, 14, and 17) are reverse scored. Scores can range from 17 to 85.20 There is no cut-off score. In the Turkish adaptation, the Cronbach's alpha was 0.71.
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 6 Aug 2025.
- Background: PubMed 27187450Martin CR, Ling PR, Blackburn GL. Review of Infant Feeding: Key Features of Breast Milk and Infant Formula. Nutrients. 2016 May 11;8(5):279. doi: 10.3390/nu8050279.
- 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.
Nülüfer ERBİL, Prof. principal investigator
Ordu 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 breastfeding counseling in people with Breastfeeding Education and Breastfeeding Self-Efficacy, run by Ordu 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?
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 6 Aug 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?
Breastfeeding Self-Efficacy Scale-Short Form (time frame: Data were collected with the BSES-SF in the prenatal period (enrollment), postpartum first week, postpartum first month and postpartum second month in the training and control groups. The evaluation of the data was made after December 2021.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07107867, which also lists 1 linked publication.
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 6 Aug 2025.