NCT06355674

Brief Summary

In low-income and developing countries, 30% of adolescents marry before the age of 18, and 14% marry before the age of 15. Additionally, adolescents between the ages of 15 and 19 are often coerced into marriage or sexual relationships with partners older than themselves. 10% of adolescents under the age of 15 in the world are forced to have sexual intercourse and as a result, unwanted teenage pregnancies occur. In high-income countries like Latin America, there is a high prevalence of adolescent non-marital pregnancies. When considering the fertility, health, and social outcomes of adolescence, it emerges as a significant issue. Adolescent motherhood carries numerous adverse effects from both demographic and social perspectives. In pregnancies occurring during adolescence, both maternal and infant mortality rates are two to three times higher compared to pregnancies at later ages. Many infant and child deaths occur due to preventable causes. Breastfeeding is a significant factor in reducing infant and child mortality. Since infants born to adolescent mothers are at higher risk of death and illness, breastfeeding these infants becomes even more important. However, one of the significant challenges adolescent mothers face during the postpartum period is initiating and maintaining lactation. Research has shown that maternal age plays a significant role in initiating and sustaining breastfeeding, with a strong positive correlation between maternal age and duration of breastfeeding. This study was designed as a randomized controlled trial to examine the effect of breastfeeding education provided to adolescent mothers on maternal breastfeeding self-efficacy, mother-infant attachment, and infant anthropometric measurements.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

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

February 12, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 23, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2024

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

March 23, 2024

Last Update Submit

September 18, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Postnatal Breastfeeding Self-Efficacy Scale-Short Form

    The short form of the scale consists of a total of 14 items and is a 5-point Likert scale. Scores on the scale can range from 14 to 70 points. A higher score indicates higher maternal breastfeeding self-efficacy.

    4 months

  • Maternal-Infant Attachment Scale

    The scale consists of a total of eight items rated on a four-point Likert scale. An increase in scores on the scale indicates an improvement in mother-infant attachment.

    4 months

Study Arms (2)

Breastfeeding education group

EXPERIMENTAL

Adolescent mothers included in the breastfeeding education group will receive practical breastfeeding training using the lactation simulation model and newborn baby mannequin for 1.5-2 hours conducted by the researchers. One week and one month after postnatal day 7, the "Postnatal Breastfeeding Self-Efficacy Scale - Short Form" and the "Maternal-Infant Attachment Scale" will be administered again to mothers in both groups. Anthropometric measurements of all babies will be repeated and recorded at the end of the 1st, 2nd, 3rd, and 4th weeks following postnatal day 7. After the completion of the study, adolescent mothers in the control group who request it will receive breastfeeding education using the lactation simulation model provided by the researchers.

Behavioral: Breastfeeding education provided with Lactation Simulation Model

Control group

NO INTERVENTION

Adolescent mothers in the control group will continue with routine breastfeeding and follow-up at the family health center. One week and one month after postnatal day 7, the "Postnatal Breastfeeding Self-Efficacy Scale - Short Form" and the "Maternal-Infant Attachment Scale" will be administered again to mothers in both groups. Anthropometric measurements of all babies will be repeated and recorded at the end of the 1st, 2nd, 3rd, and 4th weeks following postnatal day 7. After the completion of the study, adolescent mothers in the control group who request it will receive breastfeeding education using the lactation simulation model provided by the researchers.

Interventions

The Lactation Simulation Model (LSM) is a high-fidelity simulator designed for interactive education, which educators can utilize for practical and wearable breastfeeding training. It is wearable like a shirt and is secured onto the chest by passing it over the shoulders and fastening it with a safety belt from the back. This allows the safety belt to be adjusted according to different body types and weights.

Breastfeeding education group

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Giving birth vaginally between the 37th and 40th gestational weeks,
  • Being under 18 years of age,
  • Primigravida,
  • Not having any systemic/chronic diseases,
  • Willing to breastfeed,
  • Having received breastfeeding counseling provided by the hospital,
  • Being able to speak Turkish, and
  • Adolescent mothers in the postnatal 1st and 2nd weeks will be included in the study.

You may not qualify if:

  • Mothers giving birth before the 37th gestational week or after the 40th gestational week,
  • Those with barriers hindering effective communication,
  • Those unable to speak Turkish,
  • Mothers who have not received breastfeeding counseling from the hospital,
  • Non-breastfeeding mothers,
  • Those experiencing interruptions in breastfeeding due to seasonal work or any other reason,
  • Those supplementing breastfeeding with formula,
  • Adolescent mothers who discontinue breastfeeding education provided through LSM will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harran University

Sanliurfa, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 23, 2024

First Posted

April 9, 2024

Study Start

February 12, 2024

Primary Completion

July 17, 2024

Study Completion

July 17, 2024

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations