The Effect of Motivational Interviews Based on Information, Motivation, Behavioral Skills Model on Breastfeeding

January 29, 2026 updated by: Sevilay Aydın Çelik, Saglik Bilimleri Universitesi
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Turkey
      • Istanbul, Turkey, Turkey (Türkiye), 34668
        • Health Sciences University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: control group
Experimental: motivational interviews group
Other: Motivational interviewing based on the knowledge motivation behavior skills model
Breastfeeding education that includes motivational interviews based on the knowledge motivation behavior skills model

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
10 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Breastfeeding Motivation
Time Frame: 10 months
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.
10 months
Motivational Interviewing Importance and Confidence-Competence Levels
Time Frame: 10 months
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.
10 months
Breastfeeding Diagnosis
Time Frame: 10 months
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.
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SBU-SBE-SAC-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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