NCT07107867

Brief Summary

This study was conducted to determine the effect of breastfeeding counseling given to primiparous pregnant women before birth on breastfeeding self-efficacy and infant feeding attitudes in the postpartum period. Hypotheses of this study: H11: There is a difference in postpartum breastfeeding self-efficacy between the intervention group that received prenatal breastfeeding counseling and the control group. H10: There is no difference in postpartum breastfeeding self-efficacy between the intervention group that received prenatal breastfeeding counseling and the control group. H21: There is a difference between the intervention group that received prenatal breastfeeding counseling and the control group in terms of postnatal infant feeding attitude. H20: There is no difference between the intervention group that received prenatal breastfeeding counseling and the control group in terms of postnatal infant feeding attitude.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

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 16, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

1 month

First QC Date

July 4, 2025

Last Update Submit

August 4, 2025

Conditions

Keywords

breastfeedingbreastfeeding self-efficacyinfant feeding attitude,breastfeeding counselingnursing

Outcome Measures

Primary Outcomes (2)

  • Breastfeeding Self-Efficacy Scale-Short Form

    Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), developed by Dennis (2003) to measure a mother's confidence in her ability to breastfeed.14 Aluş Tokat et al. (2010) adapted the scale for Turkish culture.19 The scale consists of two sub-dimensions: "technical" and "personal thoughts." It uses a Likert-type format ranging from 1 to 5, where 1 means "I am never sure" and 5 means "I am always sure." Scores range from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy. In this study, the scale was used to assess self-efficacy before the breastfeeding counseling intervention. The Turkish adaptation reported a Cronbach's alpha of 0.87.

    Data were collected with the BSES-SF in the prenatal period (enrollment), postpartum first week, postpartum first month and postpartum second month in the training and control groups. The evaluation of the data was made after December 2021.

  • The Iowa Infant Feeding Attitude Scale

    The Iowa Infant Feeding Attitude Scale (IIFAS) was created to assess women's attitudes toward breastfeeding and to predict breastfeeding duration and choice of infant feeding method. The Turkish adaptation was conducted by Ekşioğlu et al. (2016).21 The scale consists of 17 items rated on a 5-point Likert scale, from 1 (strongly disagree) to 5 (strongly agree). Nine items reflect positive attitudes toward breastfeeding, while eight items reflect positive attitudes toward formula feeding; the formula feeding items (items 1, 2, 4, 6, 8, 10, 11, 14, and 17) are reverse scored. Scores can range from 17 to 85.20 There is no cut-off score. In the Turkish adaptation, the Cronbach's alpha was 0.71.

    Data were collected using IIFAS in the prenatal period (enrollment), postpartum first week, postpartum first month, and postpartum second month in the training and control groups. Data analysis was performed after December 2021.

Study Arms (2)

Education Group

EXPERIMENTAL

The researcher, who had received certified training in breastfeeding counseling, conducted face-to-face interviews during the pretest phase. Mothers were informed about the purpose and nature of the study. After obtaining consent, pre-test data were collected from the pregnant women, and their group assignment was determined through randomization.

Behavioral: breastfeding counseling

Control Group

NO INTERVENTION

Mothers in the control group who agreed to participate received only the hospital's standard breastfeeding care, with no additional intervention.

Interventions

Pregnant women assigned to the intervention group then participated in a breastfeeding counseling training program held at the gynecology and obstetrics unit of an university training and research hospital. The training sessions lasted 60 to 90 minutes and included small groups of 5 to 6 participants, based on recommendations from the literature. The training was delivered through a slide presentation, and participants received a printed training booklet beforehand. Visual aids, including a baby model and breast model, were also used to enhance understanding. The training content was developed in line with infant feeding guidelines from UNICEF, the Turkish Ministry of Health, and relevant literature.

Education Group

Eligibility Criteria

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

You may qualify if:

  • Are over 18 years old,
  • Have at least primary school education,
  • Are primiparous,
  • Are in the 27th or more weeks of pregnancy,
  • Have no chronic disease,
  • Have no communication barriers will be included in the study.

You may not qualify if:

  • Those who had multiple pregnancies,
  • Those who were multiparous,
  • Those who had a mental illness,
  • Those who did not want to continue the research process,
  • Those who could not be reached during the follow-up process were excluded from the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordu Üniversitesi Eğitim Araştırma Hastanesi

Altinordu, Ordu, 52000, Turkey (Türkiye)

Location

Related Publications (1)

  • Martin CR, Ling PR, Blackburn GL. Review of Infant Feeding: Key Features of Breast Milk and Infant Formula. Nutrients. 2016 May 11;8(5):279. doi: 10.3390/nu8050279.

    PMID: 27187450BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Nülüfer ERBİL, Prof.

    Ordu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to the intervention or control group using the website www.randomizer.org. This study was designed as a single-blind randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

July 4, 2025

First Posted

August 6, 2025

Study Start

March 16, 2021

Primary Completion

April 15, 2021

Study Completion

December 15, 2021

Last Updated

August 6, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations