NCT07025265

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

August 5, 2026

Status Verified

August 1, 2026

Enrollment Period

8 months

First QC Date

June 9, 2025

Last Update Submit

August 2, 2026

Conditions

Keywords

Adolescent MothersBreastfeeding CounselingPrenatal EducationPostpartum Follow-UpLactation

Outcome Measures

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.

    Baseline and postpartum week 6

Secondary Outcomes (3)

  • Intervention Group Satisfaction With Breastfeeding Support

    Postpartum Week 6

  • Change From Baseline in Breastfeeding Knowledge Score

    Baseline and postpartum week 6

  • Change From Baseline in Breastfeeding Attitude Score

    Baseline and postpartum week 6

Study Arms (2)

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

EXPERIMENTAL

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

Control Group: Routine Antenatal and Postpartum Care

NO INTERVENTION

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

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

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

Eligibility Criteria

Age16 Years - 19 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Health Centers Affiliated With the Eyyübiye District Health Directorate

Sanliurfa, Şanlıurfa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the intervention, participants, the intervention provider, and the outcomes assessor were not blinded to group allocation. The intervention and posttest data collection were conducted by the same researcher. Statistical analyses were performed by an independent statistician who was blinded to the group codes.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This was a two-arm, parallel-group randomized controlled trial. Adolescent pregnant women were assigned in a 1:1 ratio to either the intervention group or the control group. The intervention group received two sessions of theory-based antenatal breastfeeding education, weekly text-message support until birth, one home visit during the first postpartum week, and five weekly telephone counseling sessions during postpartum weeks 2-6. The control group received routine antenatal and postpartum care. Outcomes were assessed at baseline and at postpartum week 6.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate in Obstetrics and Gynecology Nursing

Study Record Dates

First Submitted

June 9, 2025

First Posted

June 17, 2025

Study Start

March 17, 2025

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

August 5, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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

Locations