BreastfeedingNCT07177664
Effect of a Nurse Navigation Program on Breastfeeding Self-Efficacy and Motivation in Primiparous Women
A study testing Breastfeeding Consultation Provided through the Nurse Navigation Program in people with Breastfeeding and Breastfeeding Education, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Objective: To evaluate the effects of a nurse navigation program on breastfeeding self-efficacy and breastfeeding motivation in primiparous women. The research will be conducted as a randomized controlled trial with a pretest-posttest 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
- Breastfeeding, Breastfeeding Education
- What is being tested?
- Breastfeeding Consultation Provided through the Nurse Navigation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 1 Oct 2027
- 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
- Being primiparous,
- Not having a health problem that would prevent breastfeeding,
- Being in the 28th-32nd weeks of pregnancy,
- Being between the ages of 18 and 35,
- Having at least a primary school degree,
- Residing in the city center of Erzurum,
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- Not having a hearing or vision problem,
- Not having been diagnosed with a psychiatric illness,
- Being fluent in Turkish,
- Being able to use a telephone,
- Women who voluntarily agreed to participate in the study will be included in the sample.
Who cannot join
- Having given birth before 37 weeks of gestation,
- Having a health problem requiring the newborn to be in intensive care,
- Having a health problem/birth complication that would prevent breastfeeding during the study period,
- Withdrawal from the study at the woman's request,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of a Nurse Navigation Program on Breastfeeding Self-Efficacy Perception and Breastfeeding Motivation in Primiparous Women: A Randomized Controlled Trial
Objective: To evaluate the effects of a nurse navigation program on breastfeeding self-efficacy and breastfeeding motivation in primiparous women. The research will be conducted as a randomized controlled trial with a pretest-posttest control group.
Read the detailed description
The study aims to evaluate the effect of a Nurse Navigation Program on breastfeeding self-efficacy perception and breastfeeding motivation in primiparous women. The study population will consist of women aged 18-35 years between the 28th and 32nd weeks of gestation who apply to Yıldızkent, Yenişehir, Adnan Menderes, and Şerif Efendi Family Health Centers between October 2025 and October 2026. Sample size was determined through a priori power analysis using G*Power 3.1.9.4, and repeated measures analysis of variance (ANOVA) was planned. To achieve a power of over 80% at a significance level of 0.05 with a medium effect size, 48 participants were required. Considering potential withdrawal or exclusion, the sample was increased to 100 participants (50 intervention, 50 control). Participants meeting inclusion criteria will be selected by simple random sampling, with allocation to intervention or control groups through randomization. The researcher cannot be blinded, but the statistician will be blinded to group assignment. Data from groups coded as A and B will be analyzed by an independent statistician. The study will follow CONSORT 2010 Flow Diagram guidelines.
Data Collection Data will be collected using the Personal Information Form, Prenatal Breastfeeding Self-Efficacy Scale, Prenatal Breastfeeding Motivation Assessment Checklist, Breastfeeding Self-Efficacy Scale-Short Form, and Primiparous Breastfeeding Motivation Scale. The intervention group will receive structured breastfeeding counseling via the Nurse Navigation Program from the prenatal period until six months postpartum. Scheduled follow-up visits will occur over approximately eight months. The control group will receive routine care only, with data collected in parallel.
Intervention Group
Participants will attend six sessions:
First Meeting: Study orientation, informed consent, baseline assessments including personal information, prenatal self-efficacy, and motivation.
Second Meeting: After 36 weeks, breastfeeding training using a newborn mannequin and educational booklet; post-training reassessment.
Third Meeting: Within seven days postpartum; reinforcement of breastfeeding education and administration of postnatal scales.
Fourth Meeting: End of postpartum 6th week; continued training and scale reassessment.
Fifth Meeting: Fourth postpartum month; conducted online or by phone, infant feeding status assessed.
Sixth Meeting: Sixth postpartum month; online or phone session to evaluate exclusive breastfeeding continuation versus complementary feeding initiation.
Control Group Participants will attend six assessment points corresponding to the intervention group but will receive routine care only. Assessments will be conducted face-to-face, via home visits, or online depending on participant preference.
Data Analysis Data will be coded and analyzed using SPSS version 25. Descriptive statistics will include frequency, percentage, mean, and standard deviation. Normality will be evaluated using skewness and kurtosis coefficients. Appropriate statistical tests will be applied based on data type, including Chi-square, independent samples t-test, Mann-Whitney U, ANOVA, Kruskal-Wallis, paired t-test, Wilcoxon, or Friedman tests. Significance level is p < 0.05. Internal consistency of scales will be assessed with Cronbach's alpha, and effect sizes calculated using Cohen's d or eta-squared for relevant comparisons. All ethical principles will be strictly observed throughout the study.
- Conditions
- Breastfeeding, Breastfeeding Education
- Being tested
- Breastfeeding Consultation Provided through the Nurse Navigation Program
- Keywords
- breastfeeding, Breastfeeding Self-Efficacy, Breastfeeding Motivation, Primiparous Women, Nurse Navigation Program, Breastfeeding Counseling
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding Consultation Provided through the Nurse Navigation ProgramOther
The navigator nurse will meet with the pregnant woman/mother starting at 28-32 weeks of gestation and continuing until the sixth month postpartum. During these meetings, planned breastfeeding education will be provided, women's questions about breastfeeding will be answered, and counseling will be provided to address any concerns.
| Study group | Role | What they receive |
|---|---|---|
| Nurse Navigation Program Group | Experimental | The study includes women meeting inclusion criteria and consenting to participate. For the randomized intervention group, the process will last about eight months.The first meeting at 28-32 weeks gestation will be at the Family Health Center. The Personal Information Form, Prenatal Breastfeeding Self-Efficacy Scale, and researcher-developed Prenatal Breastfeeding Motivation Checklist will be applied as pretests.Each participant will attend at least four face-to-face sessions-two prenatal and two postpartum-with two additional sessions conducted in person or online per preference.Session 1: 28-32 weeks.
S2: After 36 weeks, breastfeeding education and brochure; scales repeated.S3: Within one week postpartum; education reinforced; scales applied.S4: 6th postpartum week; training repeated; scales applied S5: 4th postpartum month, face-to-face or online; breastfeeding continuation assessed.S6: 6th postpartum month, face-to-face or online; exclusive breing or complementary feeding assessed. Receives: Other: Breastfeeding Consultation Provided through the Nurse Navigation Program |
| Routine Care Group | No intervention | Data will be collected from the control group at parallel times with the intervention group, which will only receive routine applications without any intervention. In the data collection process, the Personal Information Form, the Prenatal Breastfeeding Self-Efficacy Scale, and the Prenatal Breastfeeding Motivation Table and Breastfeeding Motivation scales developed by the researcher to assess Breastfeeding Motivation will be used in parallel with the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
There are 15 questions in this form, prepared by the researchers in line with the literature
Measured: 18 months
Prenatal Breastfeeding Self-Efficacy Scale
Prenatal Breastfeeding Self-Efficacy Scale was originally developed to assess pregnant women's perceptions of breastfeeding self-efficacy during the prenatal period. Its validity and reliability for the Turkish context were confirmed in a subsequent adaptation study, which reported a Cronbach's alpha coefficient of 0.86. The scale comprises 20 items, each rated on a 5-point Likert scale ranging from 1 ('Not at all sure') to 5 ('Completely sure'). It is unidimensional, meaning it has no sub-dimensions, and is evaluated based on the total score. The possible total scores range from 20 to 100, with higher scores indicating a greater sense of breastfeeding self-efficacy.
Measured: 18 months
Prenatal Breastfeeding Motivation Assessment Scale
Prenatal Breastfeeding Motivation Assessment Scale was developed by the researcher in the form of a Visual Analog Scale (VAS). Participants are asked to rate their response to the question, "How confident am I that I will be able to breastfeed my baby successfully after birth?" on a scale from 0 = Not confident at all to 10 = Completely confident.
Measured: 18 months
Breastfeeding Self-Efficacy Scale (Short Form)
The original Breastfeeding Self-Efficacy Scale consists of 33 items. The scale was simplified in 2003, resulting in a 14-item short form, referred to as the 'Breastfeeding Self-Efficacy Scale - Short Form.' The scale was culturally adapted into Turkish, and its psychometric properties were evaluated. To determine validity during the antenatal and postnatal periods, construct validity, linguistic validity, and predictive validity analyses were conducted. This is a 5-point Likert-type scale, with responses ranging from '1 = Not at all confident' to '5 = Always confident.' All items are positively worded. Total scores range from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy. Cronbach's alpha coefficient for the scale is 0.93.
Measured: 18 months
Primiparous Breastfeeding Motivation Scale
The scale is a four-point Likert-type instrument, originally comprising 24 items across five subdimensions. During its original development, Cronbach's alpha coefficients for the subdimensions ranged from 0.56 to 0.89. The scale was subsequently adapted into Turkish, resulting in a 23-item version with five subdimensions, validated for use with primiparous women. Items are rated on a four-point Likert-type scale from '1 = Strongly disagree' to '4 = Strongly agree.' Scores for each subdimension are interpreted separately, with higher scores indicating higher motivation levels, rather than computing a total score. For the Turkish-adapted version, the overall internal consistency, measured by Cronbach's alpha, was 0.88.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Aydin, Ataturk University
- Investigators
- Ayşe AYDIN, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177664
- Sponsor's protocol ID
- Fatma OCAKOGLU
- Status last verified
- Jan 2026
- First submitted
- 9 Sep 2025
- Last updated
- 21 Jan 2026
- 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Nurse Navigation Program on Breastfeeding Self-Efficacy Perception and Breastfeeding Motivation in Primiparous Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07177664
- Acronym / sponsor ID
- Fatma OCAKOGLU
- Conditions
- Breastfeeding, Breastfeeding Education
- Keywords
- breastfeeding, Breastfeeding Self-Efficacy, Breastfeeding Motivation, Primiparous Women, Nurse Navigation Program, Breastfeeding Counseling
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 17 Sep 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.
Objective: To evaluate the effects of a nurse navigation program on breastfeeding self-efficacy and breastfeeding motivation in primiparous women. The research will be conducted as a randomized controlled trial with a pretest-posttest control group.
Detailed description
The study aims to evaluate the effect of a Nurse Navigation Program on breastfeeding self-efficacy perception and breastfeeding motivation in primiparous women. The study population will consist of women aged 18-35 years between the 28th and 32nd weeks of gestation who apply to Yıldızkent, Yenişehir, Adnan Menderes, and Şerif Efendi Family Health Centers between October 2025 and October 2026. Sample size was determined through a priori power analysis using G*Power 3.1.9.4, and repeated measures analysis of variance (ANOVA) was planned. To achieve a power of over 80% at a significance level of 0.05 with a medium effect size, 48 participants were required. Considering potential withdrawal or exclusion, the sample was increased to 100 participants (50 intervention, 50 control). Participants meeting inclusion criteria will be selected by simple random sampling, with allocation to intervention or control groups through randomization. The researcher cannot be blinded, but the statistician will be blinded to group assignment. Data from groups coded as A and B will be analyzed by an independent statistician. The study will follow CONSORT 2010 Flow Diagram guidelines.
Data Collection Data will be collected using the Personal Information Form, Prenatal Breastfeeding Self-Efficacy Scale, Prenatal Breastfeeding Motivation Assessment Checklist, Breastfeeding Self-Efficacy Scale-Short Form, and Primiparous Breastfeeding Motivation Scale. The intervention group will receive structured breastfeeding counseling via the Nurse Navigation Program from the prenatal period until six months postpartum. Scheduled follow-up visits will occur over approximately eight months. The control group will receive routine care only, with data collected in parallel.
Intervention Group
Participants will attend six sessions:
First Meeting: Study orientation, informed consent, baseline assessments including personal information, prenatal self-efficacy, and motivation.
Second Meeting: After 36 weeks, breastfeeding training using a newborn mannequin and educational booklet; post-training reassessment.
Third Meeting: Within seven days postpartum; reinforcement of breastfeeding education and administration of postnatal scales.
Fourth Meeting: End of postpartum 6th week; continued training and scale reassessment.
Fifth Meeting: Fourth postpartum month; conducted online or by phone, infant feeding status assessed.
Sixth Meeting: Sixth postpartum month; online or phone session to evaluate exclusive breastfeeding continuation versus complementary feeding initiation.
Control Group Participants will attend six assessment points corresponding to the intervention group but will receive routine care only. Assessments will be conducted face-to-face, via home visits, or online depending on participant preference.
Data Analysis Data will be coded and analyzed using SPSS version 25. Descriptive statistics will include frequency, percentage, mean, and standard deviation. Normality will be evaluated using skewness and kurtosis coefficients. Appropriate statistical tests will be applied based on data type, including Chi-square, independent samples t-test, Mann-Whitney U, ANOVA, Kruskal-Wallis, paired t-test, Wilcoxon, or Friedman tests. Significance level is p < 0.05. Internal consistency of scales will be assessed with Cronbach's alpha, and effect sizes calculated using Cohen's d or eta-squared for relevant comparisons. All ethical principles will be strictly observed throughout the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse Navigation Program Group | Experimental | Other: Breastfeeding Consultation Provided through the Nurse Navigation ProgramThe study includes women meeting inclusion criteria and consenting to participate. For the randomized intervention group, the process will last about eight months.The first meeting at 28-32 weeks gestation will be at the Family Health Center. The Personal Information Form, Prenatal Breastfeeding Self-Efficacy Scale, and researcher-developed Prenatal Breastfeeding Motivation Checklist will be applied as pretests.Each participant will attend at least four face-to-face sessions-two prenatal and two postpartum-with two additional sessions conducted in person or online per preference.Session 1: 28-32 weeks. S2: After 36 weeks, breastfeeding education and brochure; scales repeated.S3: Within one week postpartum; education reinforced; scales applied.S4: 6th postpartum week; training repeated; scales applied S5: 4th postpartum month, face-to-face or online; breastfeeding continuation assessed.S6: 6th postpartum month, face-to-face or online; exclusive breing or complementary feeding assessed. |
| Routine Care Group | No intervention | –Data will be collected from the control group at parallel times with the intervention group, which will only receive routine applications without any intervention. In the data collection process, the Personal Information Form, the Prenatal Breastfeeding Self-Efficacy Scale, and the Prenatal Breastfeeding Motivation Table and Breastfeeding Motivation scales developed by the researcher to assess Breastfeeding Motivation will be used in parallel with the intervention group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Being primiparous,
- Not having a health problem that would prevent breastfeeding,
- Being in the 28th-32nd weeks of pregnancy,
- Being between the ages of 18 and 35,
- Having at least a primary school degree,
Key exclusion criteria (4 listed)
- Having given birth before 37 weeks of gestation,
- Having a health problem requiring the newborn to be in intensive care,
- Having a health problem/birth complication that would prevent breastfeeding during the study period,
- Withdrawal from the study at the woman's request,
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 |
|---|---|---|
| Breastfeeding Consultation Provided through the Nurse Navigation ProgramThe navigator nurse will meet with the pregnant woman/mother starting at 28-32 weeks of gestation and continuing until the sixth month postpartum. During these meetings, planned breastfeeding education will be provided, women's questions about breastfeeding will be answered, and counseling will be provided to address any concerns. | Other | Nurse Navigation Program Group |
Primary outcome
Personal Information Form
Time frame: 18 months
There are 15 questions in this form, prepared by the researchers in line with the literature
Prenatal Breastfeeding Self-Efficacy Scale
Time frame: 18 months
Prenatal Breastfeeding Self-Efficacy Scale was originally developed to assess pregnant women's perceptions of breastfeeding self-efficacy during the prenatal period. Its validity and reliability for the Turkish context were confirmed in a subsequent adaptation study, which reported a Cronbach's alpha coefficient of 0.86. The scale comprises 20 items, each rated on a 5-point Likert scale ranging from 1 ('Not at all sure') to 5 ('Completely sure'). It is unidimensional, meaning it has no sub-dimensions, and is evaluated based on the total score. The possible total scores range from 20 to 100, with higher scores indicating a greater sense of breastfeeding self-efficacy.
Prenatal Breastfeeding Motivation Assessment Scale
Time frame: 18 months
Prenatal Breastfeeding Motivation Assessment Scale was developed by the researcher in the form of a Visual Analog Scale (VAS). Participants are asked to rate their response to the question, "How confident am I that I will be able to breastfeed my baby successfully after birth?" on a scale from 0 = Not confident at all to 10 = Completely confident.
Breastfeeding Self-Efficacy Scale (Short Form)
Time frame: 18 months
The original Breastfeeding Self-Efficacy Scale consists of 33 items. The scale was simplified in 2003, resulting in a 14-item short form, referred to as the 'Breastfeeding Self-Efficacy Scale - Short Form.' The scale was culturally adapted into Turkish, and its psychometric properties were evaluated. To determine validity during the antenatal and postnatal periods, construct validity, linguistic validity, and predictive validity analyses were conducted. This is a 5-point Likert-type scale, with responses ranging from '1 = Not at all confident' to '5 = Always confident.' All items are positively worded. Total scores range from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy. Cronbach's alpha coefficient for the scale is 0.93.
Primiparous Breastfeeding Motivation Scale
Time frame: 18 months
The scale is a four-point Likert-type instrument, originally comprising 24 items across five subdimensions. During its original development, Cronbach's alpha coefficients for the subdimensions ranged from 0.56 to 0.89. The scale was subsequently adapted into Turkish, resulting in a 23-item version with five subdimensions, validated for use with primiparous women. Items are rated on a four-point Likert-type scale from '1 = Strongly disagree' to '4 = Strongly agree.' Scores for each subdimension are interpreted separately, with higher scores indicating higher motivation levels, rather than computing a total score. For the Turkish-adapted version, the overall internal consistency, measured by Cronbach's alpha, was 0.88.
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 21 Jan 2026.
- 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.
Ayşe AYDIN study director
Ataturk 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 Breastfeeding Consultation Provided through the Nurse Navigation Program in people with Breastfeeding and Breastfeeding Education, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 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: opening soon, as of the sponsor's last update on 21 Jan 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 Ayşe AYDIN (+905434668220, aysea@atauni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Information Form (time frame: 18 months). The study lists 5 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 21 Jan 2026.