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

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 21, 2025

Completed
4 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
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

June 17, 2025

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

June 9, 2025

Last Update Submit

June 9, 2025

Conditions

Keywords

Adolescent MothersBreastfeeding CounselingPrenatal EducationPostpartum Follow-UpLactation

Outcome Measures

Primary Outcomes (1)

  • Change in Breastfeeding Self-Efficacy Score

    The primary outcome will be assessed using the Postpartum Breastfeeding Self-Efficacy Scale-Short Form (PBSES-SF). This scale evaluates maternal confidence in breastfeeding, with higher scores indicating higher breastfeeding self-efficacy.

    Baseline (before intervention), Postpartum Week 4

Secondary Outcomes (1)

  • Exclusive Breastfeeding Rate at Postpartum Week 4

    Postpartum Week 4

Other Outcomes (1)

  • Maternal Satisfaction with Breastfeeding Support

    Postpartum Week 4

Study Arms (2)

Intervention Group (Breastfeeding Self-Efficacy-Based Education and Counseling)

EXPERIMENTAL

Participants in this group will receive breastfeeding self-efficacy theory-based antenatal education and postpartum follow-up counseling. The education will be provided during the antenatal period, followed by weekly reminder and encouragement text messages until birth. Postpartum, participants will receive home visits in the first week for counseling and follow-up calls in the 2nd, 3rd, and 4th weeks.

Behavioral: Breastfeeding Self-Efficacy-Based Education and Counseling

Control Group (Routine Perinatal Care)

NO INTERVENTION

Participants in this group will receive standard perinatal care without additional breastfeeding education or counseling. Postpartum data will be collected in the 4th week via a follow-up phone call.

Interventions

his intervention consists of breastfeeding self-efficacy theory-based education provided during the antenatal period. The education covers key factors affecting maternal breastfeeding self-efficacy, including previous experiences, vicarious learning, social support, and psychological responses. Weekly reminder and encouragement text messages will be sent until birth. Postpartum follow-up includes a home visit in the first week for counseling and phone-based follow-ups in the 2nd, 3rd, and 4th weeks.

Intervention Group (Breastfeeding Self-Efficacy-Based Education and Counseling)

Eligibility Criteria

Age15 Years - 19 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescent pregnant individuals (ages 14-19)
  • Singleton pregnancy
  • Gestational age of at least 28 weeks at enrollment
  • Planning to breastfeed postpartum
  • Willing to participate in antenatal education and postpartum follow-up counseling
  • Able to provide informed consent

You may not qualify if:

  • Multiple pregnancy (twins, triplets, etc.)
  • Maternal or fetal conditions contraindicating breastfeeding (e.g., galactosemia)
  • Severe maternal complications (e.g., preeclampsia with severe features, placenta previa with bleeding)
  • History of previous breastfeeding difficulties or conditions affecting lactation (e.g., breast surgery)
  • Psychiatric disorders that may interfere with participation
  • Inability to complete follow-ups due to planned relocation or other reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harran Unıversity

Sanliurfa, Şanlıurfa, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Interventions

Counseling

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Hatice N Özgen, PhD Candidate in Nursing

CONTACT

Gülşah KÖK, Assist. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study follows a parallel interventional model where adolescent pregnant women are assigned to either the intervention group, receiving breastfeeding self-efficacy theory-based antenatal education and postpartum follow-up counseling, or the control group, receiving routine perinatal care. Outcomes related to breastfeeding self-efficacy and attitudes are compared between groups.
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

February 21, 2025

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

June 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

The individual participant data (IPD) collected in this study will not be shared due to ethical considerations and confidentiality agreements. Data will only be accessible to authorized researchers involved in the study.

Locations