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CompletedNCT07025265Updated Aug 5, 2026

Breastfeeding Self-Efficacy Theory-Based Education and Counseling in Pregnant Adolescents

An interventional study of reastfeeding Self-Efficacy Theory-Based Antenatal Education and Postpartum Follow-Up Counseling in Adolescent Pregnancy, Breastfeeding and Self-Efficacy, sponsored by Saglik Bilimleri Universitesi. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 16 Years to 19 Years. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
16 Years to 19 Years
Sex
Female
01

Study summary

Adolescence is the period between the ages of 10 and 19, during which individuals undergo physiological, biological, psychological, and social development, transitioning from childhood to adulthood. Pregnancies occurring during this period are defined as adolescent pregnancies. In developing countries, approximately 21 million adolescent pregnancies occur annually among individuals aged 15-19, resulting in around 12 million births. According to national demographic data, a certain percentage of adolescent women have already started childbearing. Pregnancies occurring during this stage, when physical and psychosocial development is still incomplete, bring various medical and social challenges.

Adolescent pregnancies are associated with increased maternal and fetal mortality and morbidity risks and are classified as high-risk pregnancies. Therefore, adolescent mothers require close follow-up during both the antenatal and postpartum periods. However, studies indicate that adolescent mothers often fail to attend regular antenatal check-ups, receive inadequate education on breastfeeding, and consequently feel unprepared for motherhood. They tend to have low breastfeeding self-efficacy and develop negative attitudes toward breastfeeding. In the postpartum period, they also experience difficulties in initiating and maintaining breastfeeding.

Research highlights the need for education and counseling for adolescent mothers during the antenatal and postpartum periods. Providing education on breastfeeding is particularly important for improving maternal and infant health outcomes. Current approaches to breastfeeding counseling involve face-to-face training provided by healthcare professionals in medical institutions, as well as various alternative methods such as home visits, online/web-based education portals, theory-based training, text messages, emails, and phone consultations. In breastfeeding counseling, it is essential to not only provide education but also ensure continuous follow-up. Monitoring the process is expected to increase adolescent mothers' breastfeeding self-efficacy, foster positive attitudes toward breastfeeding, and extend the duration of breastfeeding.

This study aims to assess the effects of antenatal education based on the Breastfeeding Self-Efficacy Theory and postpartum follow-up counseling on adolescent mothers' breastfeeding attitudes and self-efficacy. By enhancing their breastfeeding self-efficacy and attitudes, this study is expected to contribute to resolving challenges related to early initiation and continuation of breastfeeding in the postpartum period.

Read the detailed description

Study Population and Sample

The study population consisted of adolescent pregnant women registered at family health centers in Şanlıurfa, Türkiye.

The sample size was calculated using G*Power version 3.1.9.7. The calculation was based on a two-group, two-time-point repeated-measures analysis of variance for the group-by-time interaction, with a medium effect size of f = 0.25, a statistical power of 95%, and a two-sided significance level of 0.05. The required sample size was estimated as 54 participants, with 27 participants in each group. To account for possible attrition, the sample size was increased by approximately 10%. A total of 60 participants were enrolled and randomly assigned to the intervention group or the control group in a 1:1 ratio. Fifty-five participants completed the study.

Study Design and Randomization

This was a two-arm, parallel-group randomized controlled trial. Participants who met the eligibility criteria and provided written informed consent were assigned to the intervention or control group using a computer-generated 1:1 randomization list created through Randomizer.org.

Intervention Group

Participants assigned to the intervention group received two individual, face-to-face antenatal breastfeeding education sessions based on Breastfeeding Self-Efficacy Theory. Each session lasted approximately 55 minutes, with a 10-minute break between sessions.

The education addressed the importance of breastfeeding, breast anatomy and lactation physiology, maternal nutrition during breastfeeding, appropriate breastfeeding techniques, infant hunger and satiety cues, breast care, common breastfeeding problems, expression and storage of breast milk, and the emotional aspects of breastfeeding. Verbal instruction, question-and-answer, demonstration, and hands-on practice were used with a flipchart, an infant model, and a breast model.

The intervention was structured according to the four sources of breastfeeding self-efficacy: mastery experiences, vicarious experiences, verbal persuasion, and physiological and emotional states.

Following the antenatal education, supportive text messages were sent weekly until childbirth. During the first postpartum week, participants received a 45-60-minute home visit to assess breastfeeding practices, identify breastfeeding problems, correct inappropriate practices, and provide individualized counseling and positive feedback.

During postpartum weeks 2-6, five weekly telephone counseling sessions, each lasting approximately 15 minutes, were conducted. The counseling sessions addressed participants' breastfeeding experiences, difficulties, and individual support needs. Posttest data were collected at postpartum week 6.

Control Group

Participants assigned to the control group received routine antenatal and postpartum care provided by healthcare professionals at the family health centers. No additional breastfeeding education, supportive text messages, home visits, or telephone counseling were provided by the research team during the study.

Telephone contact was limited to confirming childbirth information and collecting posttest data at postpartum week 6. After posttest data collection was completed, breastfeeding education was offered to control-group participants who requested it.

Outcome Measures and Data Collection Tools

Breastfeeding self-efficacy was the primary outcome and was assessed using the 14-item Breastfeeding Self-Efficacy Scale-Short Form. The antenatal version was administered at baseline, and the postnatal version was administered at postpartum week 6.

Secondary outcomes included breastfeeding knowledge, breastfeeding attitudes, and satisfaction with the intervention. Breastfeeding knowledge was assessed using a 40-item researcher-developed Breast Milk and Breastfeeding Knowledge Assessment Form. Breastfeeding attitudes were assessed using the 46-item Breastfeeding Attitude Assessment Scale. Satisfaction with the intervention was assessed only among intervention-group participants at postpartum week 6 using a 5-item researcher-developed questionnaire.

Sociodemographic, obstetric, childbirth, and breastfeeding-related characteristics were collected using a researcher-developed Personal Information Form.

Intervention Standardization

All antenatal education sessions, text-message support, home visits, and telephone counseling sessions were delivered by the same researcher using standardized educational content and follow-up forms. The researcher had eight years of professional experience in obstetric and gynecologic nursing. Antenatal education sessions were conducted in private education rooms at the participating family health centers.

Ethical Considerations

Ethical approval was obtained from the Harran University Clinical Research Ethics Committee, and institutional permission was obtained from the Şanlıurfa Provincial Health Directorate. All participants received information about the purpose, procedures, potential benefits, voluntary nature of participation, and right to withdraw from the study without affecting the healthcare services they received. Written informed consent was obtained from all participants before enrollment.

02

Conditions studied

  • Adolescent Pregnancy
  • Breastfeeding
  • Self-Efficacy

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Keywords

  • Adolescent Mothers
  • Breastfeeding Counseling
  • Prenatal Education
  • Postpartum Follow-Up
  • Lactation
03

In context

Breast Feeding

262 studies on the registry are indexed under Breast Feeding; 112 are open to participants now.

This study's enrollment of 60 is below the median of 95 across 210 interventional studies indexed under Breast Feeding.

Browse Breast Feeding studies →

Lead sponsor

Saglik Bilimleri Universitesi is the lead sponsor of 430 studies on the registry; 137 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 19 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Adolescent pregnant women aged 16-19 years
  • Gestational age of 32 weeks or more at enrollment
  • A healthy pregnancy without a known maternal or fetal complication that would interfere with participation in the study
  • No known maternal or fetal condition contraindicating breastfeeding
  • Able to communicate with the researcher and complete the study procedures
  • Access to a reachable telephone
  • Provision of written informed consent
  • Singleton pregnancy
  • Planning to breastfeed postpartum
  • No previous breast surgery
  • No psychiatric disorder
  • No planned relocation

Exclusion criteria

Exclusion Criteria:

  • A maternal or fetal complication identified before enrollment that could lead to pregnancy loss or prevent participation in the study
  • A known maternal condition contraindicating breastfeeding
  • A communication barrier that would prevent completion of the education, counseling, or study assessments
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Intervention Group: Breastfeeding Self-Efficacy Theory-Based Education and Counseling

    Participants assigned to this arm received two individual, face-to-face antenatal breastfeeding education sessions based on Breastfeeding Self-Efficacy Theory. Following the education, weekly supportive text messages were sent until childbirth. Postpartum support included one home visit during the first postpartum week and five weekly telephone counseling sessions during postpartum weeks 2-6. Posttest data were collected at postpartum week 6.

    Behavioral: reastfeeding Self-Efficacy Theory-Based Antenatal Education and Postpartum Follow-Up Counseling

  • No intervention
    Control Group: Routine Antenatal and Postpartum Care

    Participants assigned to this arm received routine antenatal and postpartum care provided by healthcare professionals at the family health centers. No additional breastfeeding education, text-message support, home visit, or telephone counseling was provided by the research team during the study. Telephone contact was limited to confirming childbirth information and collecting posttest data at postpartum week 6. After posttest data collection was completed, breastfeeding education was offered to control-group participants who requested it.

Interventions

  • Behavioralreastfeeding Self-Efficacy Theory-Based Antenatal Education and Postpartum Follow-Up Counseling

    The intervention was developed based on Breastfeeding Self-Efficacy Theory and included antenatal education, supportive text messages, a postpartum home visit, and telephone counseling. The antenatal education consisted of two consecutive individual, face-to-face sessions, each lasting approximately 55 minutes, with a 10-minute break between sessions. The education addressed the importance of breastfeeding, breast anatomy and lactation physiology, maternal nutrition, breastfeeding techniques, infant hunger and satiety cues, breast care, common breastfeeding problems, expression and storage of breast milk, and the emotional aspects of breastfeeding. Verbal instruction, question-and-answer, demonstration, and hands-on practice were used with a flipchart, an infant model, and a breast model. Weekly supportive text messages were sent from completion of the antenatal education until childbirth. During the first postpartum week, a 45-60-minute home visit was conducted. Five telephone counsel

06

What researchers measure

Primary outcomes

  1. Change in Breastfeeding Self-Efficacy Score

    Breastfeeding self-efficacy was assessed using the 14-item Breastfeeding Self-Efficacy Scale-Short Form. The antenatal version was administered at baseline, and the postnatal version was administered at postpartum week 6. Each item is rated from 1 to 5. Total scores range from 14 (minimum) to 70 (maximum). Higher scores indicate a better outcome, reflecting greater breastfeeding self-efficacy. The outcome was defined as the change in the total score from baseline to postpartum week 6.

    Time frame: Baseline and postpartum week 6

Secondary outcomes

  1. Intervention Group Satisfaction With Breastfeeding Support

    Satisfaction with the breastfeeding support program was assessed only among participants in the intervention group using the 5-item researcher-developed Intervention Satisfaction Form. Each item is rated from 0 to 4. Total scores range from 0 (minimum) to 20 (maximum). Higher scores indicate a better outcome, reflecting greater satisfaction with the intervention. The form evaluated satisfaction with the antenatal education, supportive text messages, postpartum home visit, telephone counseling, and overall breastfeeding support

    Time frame: Postpartum Week 6

  2. Change From Baseline in Breastfeeding Knowledge Score

    Breastfeeding knowledge was assessed using the 40-item researcher-developed Breast Milk and Breastfeeding Knowledge Assessment Form. Correct answers are scored as 1 and incorrect answers as 0. Total scores range from 0 (minimum) to 40 (maximum). Higher scores indicate a better outcome, reflecting greater knowledge of breast milk and breastfeeding. The outcome was defined as the change in the total score from baseline to postpartum week 6.

    Time frame: Baseline and postpartum week 6

  3. Change From Baseline in Breastfeeding Attitude Score

    Breastfeeding attitudes were assessed using the 46-item Breastfeeding Attitude Assessment Scale. The scale includes 22 positively worded and 24 negatively worded items. Each item is rated from 0 to 4, and negatively worded items are reverse scored. Total scores range from 0 (minimum) to 184 (maximum). Higher scores indicate a better outcome, reflecting more positive attitudes toward breastfeeding. The outcome was defined as the change in the total score from baseline to postpartum week 6.

    Time frame: Baseline and postpartum week 6

07

Study locations

1 site
  • Family Health Centers Affiliated With the Eyyübiye District Health Directorate
    Sanliurfa, Şanlıurfa, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — There is no current plan to share individual participant data. Data sharing was not included in the original study protocol or informed consent process.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07025265
Lead sponsor
Saglik Bilimleri Universitesi
Responsible party
Hatice Nur Özgen (PhD Candidate in Obstetrics and Gynecology Nursing, Saglik Bilimleri Universitesi) — Principal investigator
First posted
Jun 17, 2025
Start date
Mar 17, 2025
Primary completion
Oct 31, 2025
Completion
Oct 31, 2025
Last update
Aug 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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