Breastfeeding Counseling Based on Motivational InterviewingNCT06690580
The Effect of Motivational Interviews Based on Information, Motivation, Behavioral Skills Model on Breastfeeding
A study testing Motivational interviewing based on the knowledge motivation behavior skills model in people with Breastfeeding Counseling Based on Motivational Interviewing, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The research is a randomized controlled experimental type and aims to determine the effect of motivational interviews based on the Knowledge, Motivation, Behavioral Skills Model on breastfeeding. 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 Counseling Based on Motivational Interviewing
- What is being tested?
- Motivational interviewing based on the knowledge motivation behavior skills model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 1 Jan 2026
- 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
Who may be able to join
- Women who speak Turkish,
- Are primigravida,
- Are in their 34th week of pregnancy and above,
- Do not have any chronic disease, diagnosed mental or psychiatric illness,
- Do not have a risky pregnancy,
- Do not have a planned cesarean section were planned to be included in the study.
Who cannot join
- Women who gave birth by Caesarean section,
- Those who developed complications during birth,
- Those whose baby's birth weight was less than 2500 grams, whose APGAR score was 6 or less at the 5th minute, who were admitted to the neonatal intensive care unit,
- Those who did not attend at least one interview,
- Women who wanted to leave the study were planned to be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University
Istanbul, Turkey, 34668
About this study
The research is a randomized controlled experimental type and aims to determine the effect of motivational interviews based on the Knowledge, Motivation, Behavioral Skills Model on breastfeeding. The research will be conducted with 90 people (45 experimental, 45 control group) who meet the sample criteria between October 30, 2024 and July 30, 2025. The experimental group will be given breastfeeding training accompanied by motivational interviews, and the control group will not receive any intervention.
Read the detailed description
Breastfeeding is the healthiest and most effective way for the unique nutrient breast milk to reach the baby. Breastfeeding has many physiological, psychological, social, emotional, societal and economic benefits. Women's inexperience in breastfeeding, the weak value they attribute to breastfeeding, lack of social support systems, and breastfeeding problems they experience can be obstacles to successful breastfeeding. Breastfeeding problems experienced during the lactation process lead to a feeling of exhaustion and inadequacy in the mother and cause mothers to stop breastfeeding. The most common factors that negatively affect breastfeeding are; nipple trauma, breast pain, breast fullness, mastitis, excessive or low breast milk production, difficulty in placing the baby at the breast, breast refusal in the baby, the mother and/or the baby being sick and using medication as a result, fatigue and exhaustion in the mother. Along with these problems, the mother's return to work life is also among the factors that negatively affect breastfeeding. Breastfeeding education and counseling programs are effective in initiating and continuing breastfeeding, solving breastfeeding problems, increasing self-sufficiency, and increasing breastfeeding rates. Nurses, who are important building blocks of the health team, provide support to mothers from the prenatal period to the postnatal period by using their roles as caregivers, decision-makers, patient rights advocates, educators, and consultants. Today, thanks to the development of technology and easy access, traditionally applied trainings have been replaced by trainings provided with newer, modern, visual technologies. These can be listed as peer education, telephone counseling, online and web-based counseling, teach-back, home visits, and model use. Studies have reported that health education programs based on the Information-Motivation-Behavioral Skills Model have a positive effect on individuals' health practices, increase self-sufficiency, and contribute to the development of positive behaviors in individuals. In recent years, motivational interviewing techniques have also been frequently encountered in nursing practices. With the motivational interviewing technique applied during the breastfeeding process, mothers' individual preferences are valued, their indecisiveness is resolved, and their self-sufficiency is supported. In this context, this study aimed to examine the effect of motivational interviews based on the Knowledge, Motivation, Behavioral Skills Model on breastfeeding. The randomized controlled experimental study will be conducted with 90 people (45 experimental, 45 control group) who meet the sampling criteria between October 30, 2024 and July 30, 2025. 4 sessions of motivational interviewing will be applied to the experimental group, and no intervention will be made to the control group. The analysis of the collected data will be done with the SPSS program.
- Being tested
- Motivational interviewing based on the knowledge motivation behavior skills model
- Keywords
- Information, motivation, behavioral skills model, breastfeeding, nursing, motivational interviewing
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewing based on the knowledge motivation behavior skills modelOther
Breastfeeding education that includes motivational interviews based on the knowledge motivation behavior skills model
| Study group | Role | What they receive |
|---|---|---|
| motivational interviews group | Experimental | Not described Receives: Other: Motivational interviewing based on the knowledge motivation behavior skills model |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Self-Efficacy
It is assessed with the Breastfeeding Self-Efficacy Scale-Short Form.The lowest score that can be obtained from the scale is 14, the highest score is 70. Higher scores on the scale indicate higher breastfeeding self-efficacy.
Measured: 10 months
Secondary outcomes (3)
Breastfeeding Motivation
In primiparous women, breastfeeding motivation is evaluated. The "Value Given to Breastfeeding" sub-dimension can receive scores ranging from 13-91 points, the "Self-Efficacy" sub-dimension can receive scores ranging from 7-49 points, and the "Perceived Midwife Support" sub-dimension can receive scores ranging from 4-28 points. The "Expectation of Success" sub-dimension can receive scores ranging from 5-35 points. The evaluation is made by adding the scores obtained in each sub-group in the scale. As the score in the sub-dimension increases, the feature in the sub-dimension and therefore the motivation increases.
Measured: 10 months
Motivational Interviewing Importance and Confidence-Competence Levels
Motivational Interviewing is measured with Importance and Confidence-Competence Scales. scale will evaluate the importance given to breastfeeding, the level of confidence and competence in breastfeeding. The score that can be obtained from the scale varies between 0-10 points. In the importance scale, the individual will be asked the question "How important is breastfeeding to you?" and will be asked to determine the most appropriate score on the scale. A score of 0 means not important at all, and a score of 10 means very important. In the confidence-competence scale, the individual will be asked the question "How confident are you in succeeding in breastfeeding?". They will be asked to give a score between 0-10 to this question. A score of 0 means I do not have confidence at all, and a score of 10 means I have great confidence. The individual will be encouraged to change according to the score they give to the question by discussing the pros and cons.
Measured: 10 months
Breastfeeding Diagnosis
Breastfeeding diagnosis will be made with the LATCH Breastfeeding Diagnostic Measurement Tool. It consists of five evaluation criteria and takes its name from the abbreviation of the first letters of the English equivalents of these criteria. "L; Latch on the breast, A; Audible swallowing, T; Type of the nipple, C; Comfort breast/nipple of the mother and H; Hold/Help position for the baby." Each item is evaluated between 0-2 points. The score that can be obtained from the measurement tool can vary between 0-10, and a high score indicates high breastfeeding success.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start15 May 2025
- Primary completion1 Sep 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding Counseling Based on Motivational InterviewingStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevilay Aydın Çelik, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690580
- Sponsor's protocol ID
- SBU-SBE-SAC-01
- Status last verified
- Jan 2026
- First submitted
- 13 Nov 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interviews Based on Information, Motivation, Behavioral Skills Model on Breastfeeding
- ClinicalTrials.gov ID
- NCT06690580
- Acronym / sponsor ID
- SBU-SBE-SAC-01
- Keywords
- Information, motivation, behavioral skills model, breastfeeding, nursing, motivational interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 15 Nov 2024 (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 research is a randomized controlled experimental type and aims to determine the effect of motivational interviews based on the Knowledge, Motivation, Behavioral Skills Model on breastfeeding. The research will be conducted with 90 people (45 experimental, 45 control group) who meet the sample criteria between October 30, 2024 and July 30, 2025. The experimental group will be given breastfeeding training accompanied by motivational interviews, and the control group will not receive any intervention.
Detailed description
Breastfeeding is the healthiest and most effective way for the unique nutrient breast milk to reach the baby. Breastfeeding has many physiological, psychological, social, emotional, societal and economic benefits. Women's inexperience in breastfeeding, the weak value they attribute to breastfeeding, lack of social support systems, and breastfeeding problems they experience can be obstacles to successful breastfeeding. Breastfeeding problems experienced during the lactation process lead to a feeling of exhaustion and inadequacy in the mother and cause mothers to stop breastfeeding. The most common factors that negatively affect breastfeeding are; nipple trauma, breast pain, breast fullness, mastitis, excessive or low breast milk production, difficulty in placing the baby at the breast, breast refusal in the baby, the mother and/or the baby being sick and using medication as a result, fatigue and exhaustion in the mother. Along with these problems, the mother's return to work life is also among the factors that negatively affect breastfeeding. Breastfeeding education and counseling programs are effective in initiating and continuing breastfeeding, solving breastfeeding problems, increasing self-sufficiency, and increasing breastfeeding rates. Nurses, who are important building blocks of the health team, provide support to mothers from the prenatal period to the postnatal period by using their roles as caregivers, decision-makers, patient rights advocates, educators, and consultants. Today, thanks to the development of technology and easy access, traditionally applied trainings have been replaced by trainings provided with newer, modern, visual technologies. These can be listed as peer education, telephone counseling, online and web-based counseling, teach-back, home visits, and model use. Studies have reported that health education programs based on the Information-Motivation-Behavioral Skills Model have a positive effect on individuals' health practices, increase self-sufficiency, and contribute to the development of positive behaviors in individuals. In recent years, motivational interviewing techniques have also been frequently encountered in nursing practices. With the motivational interviewing technique applied during the breastfeeding process, mothers' individual preferences are valued, their indecisiveness is resolved, and their self-sufficiency is supported. In this context, this study aimed to examine the effect of motivational interviews based on the Knowledge, Motivation, Behavioral Skills Model on breastfeeding. The randomized controlled experimental study will be conducted with 90 people (45 experimental, 45 control group) who meet the sampling criteria between October 30, 2024 and July 30, 2025. 4 sessions of motivational interviewing will be applied to the experimental group, and no intervention will be made to the control group. The analysis of the collected data will be done with the SPSS program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| motivational interviews group | Experimental | Other: Motivational interviewing based on the knowledge motivation behavior skills model |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women who speak Turkish,
- Are primigravida,
- Are in their 34th week of pregnancy and above,
- Do not have any chronic disease, diagnosed mental or psychiatric illness,
- Do not have a risky pregnancy,
Key exclusion criteria (5 listed)
- Women who gave birth by Caesarean section,
- Those who developed complications during birth,
- Those whose baby's birth weight was less than 2500 grams, whose APGAR score was 6 or less at the 5th minute, who were admitted to the neonatal intensive care unit,
- Those who did not attend at least one interview,
- Women who wanted to leave the study were planned to be excluded from the study.
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 |
|---|---|---|
| Motivational interviewing based on the knowledge motivation behavior skills modelBreastfeeding education that includes motivational interviews based on the knowledge motivation behavior skills model | Other | motivational interviews group |
Primary outcome
Breastfeeding Self-Efficacy
Time frame: 10 months
It is assessed with the Breastfeeding Self-Efficacy Scale-Short Form.The lowest score that can be obtained from the scale is 14, the highest score is 70. Higher scores on the scale indicate higher breastfeeding self-efficacy.
3 secondary outcomes
Breastfeeding Motivation
Time frame: 10 months
Motivational Interviewing Importance and Confidence-Competence Levels
Time frame: 10 months
Breastfeeding Diagnosis
Time frame: 10 months
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 2 Feb 2026.
- Individual participant dataSharing planned: No
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 Motivational interviewing based on the knowledge motivation behavior skills model in people with Breastfeeding Counseling Based on Motivational Interviewing, run by Saglik Bilimleri Universitesi 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 6 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: finished, as of the sponsor's last update on 2 Feb 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?
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 (time frame: 10 months). 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 2 Feb 2026.