Breast FeedingNCT06775444
Evaluation of the Effectiveness of a Breastfeeding Education Program Based on Planned Behavior Theory
A study testing Breastfeeding Education Program Based on Planned Behavior Theory and Routine Breastfeeding Training in people with Breast Feeding, run by Ankara University.
Trial summary
The aim of the research is to examine the effect of a breastfeeding training program based on the theory of planned behavior on Pregnant Womens' Breastfeeding Adaptation, Motivation, Self-Efficacy And The Tendency To Early Weaning. 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
- Breast Feeding
- What is being tested?
- Breastfeeding Education Program Based on Planned Behavior Theory and Routine Breastfeeding Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Mar 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those who are over 18 years old
- Pregnant women in their last trimester (pregnant women who are 27 weeks or more)
- Those who receive breastfeeding training at the Pregnancy School
- Speak and understand Turkish
- Do not have a risky pregnancy diagnosis
- Do not have multiple pregnancies
Show all 14Show fewer
- Do not have a psychiatric or neurological disease that will affect their cognitive functions
- Have the WhatsApp application on their phone
- Volunteer to participate in the research
- Want to breastfeed their baby
- Have given birth at >37 weeks of pregnancy
- Have a baby weighing at least 2500 grams
- Have a single healthy baby in the postpartum period
- Mothers who do not have breast problems that prevent breastfeeding, do not use medication that passes into breast milk, or have any disease (such as active tuberculosis, HIV) were determined as follows.
Who cannot join
- Those who could not continue the study for any reason
- Those who did not participate in all final tests
- Those who did not participate in all training
- Those who could not be reached more than 5 times in each planned telephone/face-to-face meeting.
- Those whose babies were hospitalized in neonatal intensive care after birth (except for babies hospitalized for more than 24 hours - due to neonatal jaundice)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect Of The Theory Of Planned Behavior Based Breastfeeding Education Program Given To Pregnant Women On Breastfeedıng Adaptation, Motivation, Self-Efficacy And The Tendency To Early Weaning.
The aim of the research is to examine the effect of a breastfeeding training program based on the theory of planned behavior on Pregnant Womens' Breastfeeding Adaptation, Motivation, Self-Efficacy And The Tendency To Early Weaning.
Read the detailed description
The aim of the study is to examine the effects of a breastfeeding education program based on the theory of planned behavior on breastfeeding adaptation, motivation, self-efficacy, and the tendency to stop breastfeeding.
The study was planned to be conducted as a single-center, parallel group, randomized controlled experimental, prospective study in a pretest-posttest design.
The study was planned to be conducted in the pregnancy school/breastfeeding counseling polyclinic of Düzce Atatürk State Hospital. The sample of the study will consist of pregnant women in the last trimester who meet the inclusion criteria. Considering the losses that may occur during the study process, it is planned to continue the study with a total of 88 pregnant women.
The data of the study will be collected from the patient based on the "Introductory Information Form", "Information Form Regarding Birth and Breastfeeding Process", "Breastfeeding Adaptation Scale", "Breastfeeding Motivation Scale (For Primiparous Mothers)", "Breastfeeding Motivation Scale (For Multiparous Mothers)", "Antenatal Breastfeeding Self-Efficacy Scale-Short Form", "Breastfeeding Self-Efficacy Scale-Short Form", "Breastfeeding Discontinuity Scale" and "Breastfeeding Follow-up Form".
In the study, the "Breastfeeding Education Program Based on Planned Behavior Theory" consisting of 2 sessions will be applied to the intervention group, while the routine breastfeeding education in the hospital where the study is conducted will be applied to the control group. The breastfeeding process will be followed for 6 months after birth in both groups.
In the analysis of the study, it is planned to analyze descriptive statistics (number, percentage, mean and standard deviation), significance test of the difference between two means in independent groups (t test), t test in dependent groups, multi-way and one-way variance analysis in repeated measurements, Pearson correlation analyses for the relationships between the dimensions determining the scale levels, and the chi-square homogeneity test for whether the intervention and control groups are homogeneous in terms of characteristics.
- Conditions
- Breast Feeding
- Being tested
- Breastfeeding Education Program Based on Planned Behavior Theory, Routine Breastfeeding Training
- Keywords
- Theory Of Planned Behavior, Breastfeeding, Self Efficacy, Motivation, Breastfeeding Adaptation
- 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 Education Program Based on Planned Behavior TheoryBehavioural
In addition to routine breastfeeding training at the hospital where the study is conducted, the intervention group will be given a 2-session Breastfeeding Training Program Based on Planned Behavior Theory.
Education Content:
The importance of breast milk, the benefits of breastfeeding, the dangers of artificial feeding, putting the baby to the breast, signs of hunger in the baby, the harms of bottle and pacifier, breastfeeding positions, breast-related problems, information sources about breastfeeding, birth and breastfeeding leave for working mothers, breastfeeding in the community, the importance of environmental and professional support during breastfeeding. Insufficient milk anxiety, increasing milk intake and production, situations where milk should be expressed, milk expression methods, storage conditions of breast milk, alternative feeding methods with expressed milk, methods to be applied to increase breast milk, differences between breast milk and formula milk.
Routine Breastfeeding TrainingBehavioural
The control group will receive routine breastfeeding education at the hospital where the study is conducted. Routine breastfeeding education includes the importance of breast milk and breastfeeding (benefits of breast milk and breastfeeding, correct breastfeeding technique and breastfeeding positions, time for the first feeding of the newborn, feeding method, expressing and storing breast milk, techniques for giving expressed breast milk as close as possible to breastfeeding, harms of bottle use, breast problems and coping methods). Pregnant women who give birth at the hospital where the study is conducted receive routine breastfeeding education from the breastfeeding nurse in the ward before being discharged.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | In addition to the routine breastfeeding training in the hospital where the study was conducted, the intervention group will be given a 2-session "Breastfeeding Education Program Based on the Theory of Planned Behavior". Receives: Behavioral: Breastfeeding Education Program Based on Planned Behavior Theory |
| Control group | Sham comparator | The control group will receive routine breastfeeding training at the hospital where the study is conducted. Receives: Behavioral: Routine Breastfeeding Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Attrition Prediction Tool (BAPT)
Breastfeeding Attrition Prediction Tool (BAPT) is a scale consisting of 90 questions on a 5-point Likert-type scale based on the theory of planned behavior. There are four different sub-dimensions in the scale, which does not have a total score. These are "Negative Breastfeeding Attitude", "Positive Breastfeeding Attitude", "Social and Professional Support" and "Breastfeeding Control" and each sub-scale is scored separately. A high scale score indicates that the mother has high breastfeeding control.
Measured: Pre-test application after routine breastfeeding education, Post-test application after the Breastfeeding Education Program Based on Planned Behavior Theory, 7-14 days postpartum, 4-6 weeks postpartum, 4th month postpartum, Postpartum 6th month
Secondary outcomes (5)
Breastfeeding Self-Efficacy Scale Short Form (Antenatal Breastfeeding Self-Efficacy Scale)
A 14-item short form of the Breastfeeding Self-Efficacy Scale was created. He stated that the short version of the Breastfeeding Self-Efficacy Scale could also be used during pregnancy by using the phrase "future tense" in its items. The short form of the scale provides ease of application and accurately evaluates self-efficacy. Cronbach's alpha value of the scale was found to be 0.94. The scale was created on a five-point Likert type, where 1 = not at all sure and 5 = always sure. A minimum of 14 and a maximum of 70 points can be obtained from the scale. As the score increases, it means that breastfeeding self-efficacy increases
Measured: 1. A pre-test will be applied before the Breastfeeding Education Program Based on Planned Behavior Theory. 2. Postpartum 7-14 days 3. Postpartum 4-6 weeks 4. Postpartum 4th month 5. Postpartum 6th month
Breastfeeding Adaptation Scale (BFAS)
The 27-item scale evaluates breastfeeding adaptation. It has 8 sub-dimensions: emotional change between the mother and her baby (4 items), breastfeeding confidence (5 items), sufficient breast milk (3 items), baby's nutritional capacity and growth (4 items), familiarity with the baby (4 items), discomfort during breastfeeding (3 items), preservation of breast milk volume (2 items) and receiving social support (2 items). It was developed on a 5-point Likert type scale, where 1=Strongly agree, 5=Strongly disagree. A minimum of 27 and a maximum of 135 points can be obtained from the scale. The higher the score obtained from the scale, the higher the breastfeeding adaptation.
Measured: 7-14 days postpartum
Breastfeeding Motivation Scale (For Primiparous Mothers)
Breastfeeding motivation scale (For primiparous mothers) consists of 5 sub-dimensions and 23 items. Scale items are graded from 1=I strongly disagree to 4=I strongly agree. The scale is a 4-point Likert type, and each item is scored between 1-4. There is no total score for the scale. The scores of the sub-dimensions are calculated by taking the average of the scale sub-dimension scores. As the score obtained from the scale sub-dimension increases, the motivation representing that sub-dimension also increases. The Cronbach Alpha coefficient of the scale is 0.88.
Measured: 1.Postpartum 7-14 days, 2. Postpartum 4-6 weeks, 3. Postpartum 4th month, 4. Postpartum 6th month
Breastfeeding Motivation Scale (For Multiparous Mothers)
Breastfeeding motivation scale (For Multiparous Mothers) consists of 6 sub-dimensions and 24 items. The Cronbach alpha value of the scale is 0.914. Scale items are graded from 1=I strongly disagree to 4=I strongly agree. The scale is a 4-point Likert type, and each item is scored between 1-4. There is no total score for the scale. The scores of the sub-dimensions are calculated by taking the average of the scale sub-dimension scores. As the score obtained from the scale sub-dimension increases, the motivation representing that sub-dimension also increases.
Measured: 1.Postpartum 7-14 days, 2. Postpartum 4-6 weeks, 3. Postpartum 4th month, 4. Postpartum 6th month
Breastfeeding Tracking Form
The "Breastfeeding Tracking Form" includes the baby's feeding style, breastfeeding frequency, giving additional food other than breast milk, problems with breastfeeding, desire to continue breastfeeding, doctor's evaluation of the baby's weight gain, daily urine amount, and a chart for tracking pacifier and bottle use in order to track the breastfeeding process after birth.
Measured: 1. The first 48 hours after birth, 2.Postpartum 7-14 days, 3. Postpartum 4-6 weeks, 4. Postpartum 4th month, 5. Postpartum 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionMar 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.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research was planned to be conducted as a single-center, parallel group, randomized controlled experimental, prospective study in a pre-test-post-test design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin Tozluoğlu, Ankara University
- Investigators
- Başak Demirtaş, Principal investigator, Ankara University Faculty of Nursing Department of NursingAylin Tozluoğlu, Study chair, Ankara University Health Sciences Institute PhD student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775444
- Sponsor's protocol ID
- AnkaraÜ-HF-AT-01
- Status last verified
- Jan 2025
- First submitted
- 15 Dec 2024
- Last updated
- 15 Jan 2025
- 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 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of The Theory Of Planned Behavior Based Breastfeeding Education Program Given To Pregnant Women On Breastfeedıng Adaptation, Motivation, Self-Efficacy And The Tendency To Early Weaning.
- ClinicalTrials.gov ID
- NCT06775444
- Acronym / sponsor ID
- AnkaraÜ-HF-AT-01
- Conditions
- Breast Feeding
- Keywords
- Theory Of Planned Behavior, Breastfeeding, Self Efficacy, Motivation, Breastfeeding Adaptation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 15 Jan 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.
The aim of the research is to examine the effect of a breastfeeding training program based on the theory of planned behavior on Pregnant Womens' Breastfeeding Adaptation, Motivation, Self-Efficacy And The Tendency To Early Weaning.
Detailed description
The aim of the study is to examine the effects of a breastfeeding education program based on the theory of planned behavior on breastfeeding adaptation, motivation, self-efficacy, and the tendency to stop breastfeeding.
The study was planned to be conducted as a single-center, parallel group, randomized controlled experimental, prospective study in a pretest-posttest design.
The study was planned to be conducted in the pregnancy school/breastfeeding counseling polyclinic of Düzce Atatürk State Hospital. The sample of the study will consist of pregnant women in the last trimester who meet the inclusion criteria. Considering the losses that may occur during the study process, it is planned to continue the study with a total of 88 pregnant women.
The data of the study will be collected from the patient based on the "Introductory Information Form", "Information Form Regarding Birth and Breastfeeding Process", "Breastfeeding Adaptation Scale", "Breastfeeding Motivation Scale (For Primiparous Mothers)", "Breastfeeding Motivation Scale (For Multiparous Mothers)", "Antenatal Breastfeeding Self-Efficacy Scale-Short Form", "Breastfeeding Self-Efficacy Scale-Short Form", "Breastfeeding Discontinuity Scale" and "Breastfeeding Follow-up Form".
In the study, the "Breastfeeding Education Program Based on Planned Behavior Theory" consisting of 2 sessions will be applied to the intervention group, while the routine breastfeeding education in the hospital where the study is conducted will be applied to the control group. The breastfeeding process will be followed for 6 months after birth in both groups.
In the analysis of the study, it is planned to analyze descriptive statistics (number, percentage, mean and standard deviation), significance test of the difference between two means in independent groups (t test), t test in dependent groups, multi-way and one-way variance analysis in repeated measurements, Pearson correlation analyses for the relationships between the dimensions determining the scale levels, and the chi-square homogeneity test for whether the intervention and control groups are homogeneous in terms of characteristics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The research was planned to be conducted as a single-center, parallel group, randomized controlled experimental, prospective study in a pre-test-post-test design.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Behavioral: Breastfeeding Education Program Based on Planned Behavior TheoryIn addition to the routine breastfeeding training in the hospital where the study was conducted, the intervention group will be given a 2-session "Breastfeeding Education Program Based on the Theory of Planned Behavior". |
| Control group | Sham comparator | Behavioral: Routine Breastfeeding TrainingThe control group will receive routine breastfeeding training at the hospital where the study is conducted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Those who are over 18 years old
- Pregnant women in their last trimester (pregnant women who are 27 weeks or more)
- Those who receive breastfeeding training at the Pregnancy School
- Speak and understand Turkish
- Do not have a risky pregnancy diagnosis
Key exclusion criteria (5 listed)
- Those who could not continue the study for any reason
- Those who did not participate in all final tests
- Those who did not participate in all training
- Those who could not be reached more than 5 times in each planned telephone/face-to-face meeting.
- Those whose babies were hospitalized in neonatal intensive care after birth (except for babies hospitalized for more than 24 hours - due to neonatal jaundice)
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 Education Program Based on Planned Behavior TheoryIn addition to routine breastfeeding training at the hospital where the study is conducted, the intervention group will be given a 2-session Breastfeeding Training Program Based on Planned Behavior Theory. Education Content: The importance of breast milk, the benefits of breastfeeding, the dangers of artificial feeding, putting the baby to the breast, signs of hunger in the baby, the harms of bottle and pacifier, breastfeeding positions, breast-related problems, information sources about breastfeeding, birth and breastfeeding leave for working mothers, breastfeeding in the community, the importance of environmental and professional support during breastfeeding. Insufficient milk anxiety, increasing milk intake and production, situations where milk should be expressed, milk expression methods, storage conditions of breast milk, alternative feeding methods with expressed milk, methods to be applied to increase breast milk, differences between breast milk and formula milk. | Behavioural | Intervention Group |
| Routine Breastfeeding TrainingThe control group will receive routine breastfeeding education at the hospital where the study is conducted. Routine breastfeeding education includes the importance of breast milk and breastfeeding (benefits of breast milk and breastfeeding, correct breastfeeding technique and breastfeeding positions, time for the first feeding of the newborn, feeding method, expressing and storing breast milk, techniques for giving expressed breast milk as close as possible to breastfeeding, harms of bottle use, breast problems and coping methods). Pregnant women who give birth at the hospital where the study is conducted receive routine breastfeeding education from the breastfeeding nurse in the ward before being discharged. | Behavioural | Control group |
Primary outcome
Breastfeeding Attrition Prediction Tool (BAPT)
Time frame: Pre-test application after routine breastfeeding education, Post-test application after the Breastfeeding Education Program Based on Planned Behavior Theory, 7-14 days postpartum, 4-6 weeks postpartum, 4th month postpartum, Postpartum 6th month
Breastfeeding Attrition Prediction Tool (BAPT) is a scale consisting of 90 questions on a 5-point Likert-type scale based on the theory of planned behavior. There are four different sub-dimensions in the scale, which does not have a total score. These are "Negative Breastfeeding Attitude", "Positive Breastfeeding Attitude", "Social and Professional Support" and "Breastfeeding Control" and each sub-scale is scored separately. A high scale score indicates that the mother has high breastfeeding control.
5 secondary outcomes
Breastfeeding Self-Efficacy Scale Short Form (Antenatal Breastfeeding Self-Efficacy Scale)
Time frame: 1. A pre-test will be applied before the Breastfeeding Education Program Based on Planned Behavior Theory. 2. Postpartum 7-14 days 3. Postpartum 4-6 weeks 4. Postpartum 4th month 5. Postpartum 6th month
Breastfeeding Adaptation Scale (BFAS)
Time frame: 7-14 days postpartum
Breastfeeding Motivation Scale (For Primiparous Mothers)
Time frame: 1.Postpartum 7-14 days, 2. Postpartum 4-6 weeks, 3. Postpartum 4th month, 4. Postpartum 6th month
Breastfeeding Motivation Scale (For Multiparous Mothers)
Time frame: 1.Postpartum 7-14 days, 2. Postpartum 4-6 weeks, 3. Postpartum 4th month, 4. Postpartum 6th month
Breastfeeding Tracking Form
Time frame: 1. The first 48 hours after birth, 2.Postpartum 7-14 days, 3. Postpartum 4-6 weeks, 4. Postpartum 4th month, 5. Postpartum 6th month
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 15 Jan 2025.
- 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.
Başak Demirtaş principal investigator
Ankara University Faculty of Nursing Department of Nursing
Aylin Tozluoğlu study chair
Ankara University Health Sciences Institute PhD student
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding Education Program Based on Planned Behavior Theory and Routine Breastfeeding Training in people with Breast Feeding, run by Ankara University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 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 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Aylin Tozluoğlu (+905424555336, aylinozluoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding Attrition Prediction Tool (BAPT) (time frame: Pre-test application after routine breastfeeding education, Post-test application after the Breastfeeding Education Program Based on Planned Behavior Theory, 7-14 days postpartum, 4-6 weeks postpartum, 4th month postpartum, Postpartum 6th month). 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 15 Jan 2025.