NCT06748300

Brief Summary

The present study was conducted as a randomized controlled trial to evaluate the effectiveness of web-based and face-to-face breastfeeding education given to primipara adolescent pregnant women. The study was conducted between March 2023 and December 2023 at the University of Health Sciences Van Training and Research Hospital Obstetrics and Gynecology Polyclinics. A total of 135 primipara adolescent pregnant women who met the inclusion criteria were included in the study, including 45 in the Booklet Supported Face-to-Face Breastfeeding Education Program (KİDYEP), 45 in the Web-Based Video Supported Breastfeeding Education Program (WEBVİDEP) and 45 in the control group. Pre-test data were collected in the third trimester by applying socio-demographic data form, breast milk and breastfeeding information form, and breastfeeding self-efficacy short form scale (antenatal form) to the groups. After the pre-test data were collected, a face-to-face breastfeeding education program with a breastfeeding education booklet was administered to the KİDYEP group, and a web-based video-assisted breastfeeding education program was administered to the WEBVİDEP group. Data were collected by applying breast milk and breastfeeding information form, LATCH breastfeeding identification and evaluation scale and breastfeeding self-efficacy short form scale (postnatal version) to the groups at the first (midtest) and sixth (posttest) weeks after delivery. As a result of the present study, the rate of exclusive breastfeeding, the total duration of considering breastfeeding, breast milk and breastfeeding knowledge levels, breastfeeding self-efficacy levels and breastfeeding success of the mothers in the KİDYEP and WEBVİDEP groups were found to be higher than the control group, and both the booklet-supported face-to-face breastfeeding education program and the web-based video-supported breastfeeding education program were found to be similarly effective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 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

May 5, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2024

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

December 18, 2024

Last Update Submit

December 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • breastfeeding self-efficacy scale

    breastfeeding self-efficacy scale

    pre-test post-test (approximately seven month)

Study Arms (3)

Web taban

EXPERIMENTAL
Behavioral: web- based education

face to face

EXPERIMENTAL
Behavioral: web- based education

control

NO INTERVENTION

Interventions

breastfeeding education

Also known as: face to face education
Web tabanface to face

Eligibility Criteria

Age15 Years - 19 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged between 15 and 19 years
  • Being 19 years old and above
  • Being literate
  • Being primigravida
  • Having a single baby (not twins or more)
  • Being a volunteer to participate in the study
  • Having no health problems for the mother and the baby
  • Having a computer, tablet or smart phone and the ability to use it
  • Having regular internet access

You may not qualify if:

  • The mother being 18 years of age or younger
  • Being multigravida and/or multiparous
  • Having a health problem related to the mother or the baby
  • Not having a smart phone or wireless internet during the study period
  • Not filling out the survey forms incompletely and not watching videos about hygienic care of the newborn

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emine KURTCAN

Van, Lütfen Seçiniz., Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

December 18, 2024

First Posted

December 27, 2024

Study Start

May 5, 2024

Primary Completion

November 10, 2024

Study Completion

November 25, 2024

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations