NCT06775444

Brief Summary

The aim of the research is to examine the effect of a breastfeeding training program based on the theory of planned behavior on Pregnant Womens' Breastfeeding Adaptation, Motivation, Self-Efficacy And The Tendency To Early Weaning.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

December 15, 2024

Last Update Submit

January 9, 2025

Conditions

Keywords

Theory Of Planned BehaviorBreastfeedingSelf EfficacyMotivationBreastfeeding Adaptation

Outcome Measures

Primary Outcomes (1)

  • Breastfeeding Attrition Prediction Tool (BAPT)

    Breastfeeding Attrition Prediction Tool (BAPT) is a scale consisting of 90 questions on a 5-point Likert-type scale based on the theory of planned behavior. There are four different sub-dimensions in the scale, which does not have a total score. These are "Negative Breastfeeding Attitude", "Positive Breastfeeding Attitude", "Social and Professional Support" and "Breastfeeding Control" and each sub-scale is scored separately. A high scale score indicates that the mother has high breastfeeding control.

    Pre-test application after routine breastfeeding education, Post-test application after the Breastfeeding Education Program Based on Planned Behavior Theory, 7-14 days postpartum, 4-6 weeks postpartum, 4th month postpartum, Postpartum 6th month

Secondary Outcomes (5)

  • Breastfeeding Self-Efficacy Scale Short Form (Antenatal Breastfeeding Self-Efficacy Scale)

    1. A pre-test will be applied before the Breastfeeding Education Program Based on Planned Behavior Theory. 2. Postpartum 7-14 days 3. Postpartum 4-6 weeks 4. Postpartum 4th month 5. Postpartum 6th month

  • Breastfeeding Adaptation Scale (BFAS)

    7-14 days postpartum

  • Breastfeeding Motivation Scale (For Primiparous Mothers)

    1.Postpartum 7-14 days, 2. Postpartum 4-6 weeks, 3. Postpartum 4th month, 4. Postpartum 6th month

  • Breastfeeding Motivation Scale (For Multiparous Mothers)

    1.Postpartum 7-14 days, 2. Postpartum 4-6 weeks, 3. Postpartum 4th month, 4. Postpartum 6th month

  • Breastfeeding Tracking Form

    1. The first 48 hours after birth, 2.Postpartum 7-14 days, 3. Postpartum 4-6 weeks, 4. Postpartum 4th month, 5. Postpartum 6th month

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

In addition to the routine breastfeeding training in the hospital where the study was conducted, the intervention group will be given a 2-session "Breastfeeding Education Program Based on the Theory of Planned Behavior".

Behavioral: Breastfeeding Education Program Based on Planned Behavior Theory

Control group

SHAM COMPARATOR

The control group will receive routine breastfeeding training at the hospital where the study is conducted.

Behavioral: Routine Breastfeeding Training

Interventions

In addition to routine breastfeeding training at the hospital where the study is conducted, the intervention group will be given a 2-session Breastfeeding Training Program Based on Planned Behavior Theory. Education Content: The importance of breast milk, the benefits of breastfeeding, the dangers of artificial feeding, putting the baby to the breast, signs of hunger in the baby, the harms of bottle and pacifier, breastfeeding positions, breast-related problems, information sources about breastfeeding, birth and breastfeeding leave for working mothers, breastfeeding in the community, the importance of environmental and professional support during breastfeeding. Insufficient milk anxiety, increasing milk intake and production, situations where milk should be expressed, milk expression methods, storage conditions of breast milk, alternative feeding methods with expressed milk, methods to be applied to increase breast milk, differences between breast milk and formula milk.

Intervention Group

The control group will receive routine breastfeeding education at the hospital where the study is conducted. Routine breastfeeding education includes the importance of breast milk and breastfeeding (benefits of breast milk and breastfeeding, correct breastfeeding technique and breastfeeding positions, time for the first feeding of the newborn, feeding method, expressing and storing breast milk, techniques for giving expressed breast milk as close as possible to breastfeeding, harms of bottle use, breast problems and coping methods). Pregnant women who give birth at the hospital where the study is conducted receive routine breastfeeding education from the breastfeeding nurse in the ward before being discharged.

Control group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those who are over 18 years old
  • Pregnant women in their last trimester (pregnant women who are 27 weeks or more)
  • Those who receive breastfeeding training at the Pregnancy School
  • Speak and understand Turkish
  • Do not have a risky pregnancy diagnosis
  • Do not have multiple pregnancies
  • Do not have a psychiatric or neurological disease that will affect their cognitive functions
  • Have the WhatsApp application on their phone
  • Volunteer to participate in the research
  • Want to breastfeed their baby
  • Have given birth at \>37 weeks of pregnancy
  • Have a baby weighing at least 2500 grams
  • Have a single healthy baby in the postpartum period
  • Mothers who do not have breast problems that prevent breastfeeding, do not use medication that passes into breast milk, or have any disease (such as active tuberculosis, HIV) were determined as follows.

You may not qualify if:

  • Those who could not continue the study for any reason
  • Those who did not participate in all final tests
  • Those who did not participate in all training
  • Those who could not be reached more than 5 times in each planned telephone/face-to-face meeting.
  • Those whose babies were hospitalized in neonatal intensive care after birth (except for babies hospitalized for more than 24 hours - due to neonatal jaundice)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Başak Demirtaş

    Ankara University Faculty of Nursing Department of Nursing

    PRINCIPAL INVESTIGATOR
  • Aylin Tozluoğlu

    Ankara University Health Sciences Institute PhD student

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
In order to ensure confidentiality in the group distributions, the block randomization assignment of the intervention and control groups will be made by someone outside the research and will be received in pre-prepared opaque envelopes. A separate envelope will be prepared for each pregnant woman participating in the research and she will be asked to choose one. Pregnant women will not know which group they are in. Since the researcher will also be the implementer of the application, blinding will not be possible for the groups that the pregnant women are in. For this reason, only participant and statistician blinding will be provided in the study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The research was planned to be conducted as a single-center, parallel group, randomized controlled experimental, prospective study in a pre-test-post-test design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

December 15, 2024

First Posted

January 15, 2025

Study Start

January 1, 2025

Primary Completion

January 1, 2026

Study Completion

March 1, 2026

Last Updated

January 15, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share