NCT05937139

Brief Summary

The goal of this clinical trial is to determine the effect of breastfeeding education given to fathers via Whatsapp messaging application in the postpartum period on breastfeeding. The main hypotheses it aims to answer are: ,

  • Ho: There is no difference between the "Fathers' Effect on Breastfeeding" scale scores and the Breastfeeding Support Scale scores of the fathers who received breastfeeding training via Whatsapp messaging application in the postpartum period and the scale scores of the fathers who did not receive training.
  • H1: There is a difference between the scale scores of the fathers who received breastfeeding training via Whatsapp messaging application in the postpartum period and the scale scores of the fathers who did not receive education.
  • H2: There is a difference between the "Breastfeeding Support Scale" scores of fathers who received breastfeeding training via Whatsapp messaging application in the postpartum period and the scale scores of fathers who did not receive education. Participants will be received breastfeeding training via Whatsapp messaging application in the postpartum period. If there is a comparison group: Researchers will compare training group and control group to see if effect on breastfeeding.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

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

First Submitted

Initial submission to the registry

June 23, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 30, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

1.1 years

First QC Date

June 23, 2023

Last Update Submit

July 31, 2024

Conditions

Keywords

breastfeedingfathertrainingwhatsappsupport

Outcome Measures

Primary Outcomes (2)

  • Breastfeeding Support Scale

    Breastfeeding support of fathers will be evaluated using this scale. Breastfeeding Support Scale is a 5-point Likert-type scale in which the spouses evaluate theirselves' activity while the mother breastfeeding the baby. The lowest score that can be obtained from the scale is 37, and the highest score is 185. A high total score from the whole scale indicates that fathers have a high contribution to breastfeeding.

    The scale will be administered to the fathers on the 3rd day postpartum.

  • The Partner Breastfeeding Influence Scale

    The effect of fathers on breastfeeding will be evaluated with this scale.It is a scale consisting of 14 items and three factors that measures women's social motivations for breastfeeding and spousal support for breastfeeding.Each item that the woman describes as "there is" is given 1 point. The highest score that can be obtained from the scale is 14, and the lowest score is 0. A high score indicates that fathers' support for breastfeeding is high.

    The scale will be administered to the mothers on the 3rd day postpartum.

Secondary Outcomes (2)

  • Breastfeeding Support Scale

    The scale will be administered to the fathers on the 42nd day postpartum.

  • The Partner Breastfeeding Influence Scale

    The scale will be administered to the mothers on the 42nd day postpartum.

Other Outcomes (2)

  • Breastfeeding Support Scale

    The scale will be administered to the fathers on the 12th week postpartum.

  • The Partner Breastfeeding Influence Scale

    The scale will be administered to the mothers on the 12th week postpartum.

Study Arms (4)

Training group 1

EXPERIMENTAL

After the scales are applied to the fathers in training group 1 on the 3rd postpartum day, breastfeeding education will begin. The training will last 39 days and the scales will be re-administered on the 42nd postpartum day and at the 12th week postpartum.

Other: Breastfeeding education

Training group 2

EXPERIMENTAL

Breastfeeding education will begin to the fathers in training group 2 on the 3rd postpartum day. The training will last 39 days and the scales will be re-administered on the 42nd postpartum day and at the 12th week postpartum.

Other: Breastfeeding education

Control group 1

NO INTERVENTION

The scales will be administered to the fathers in the control group 2 on the 3rd day, 42nd day, and 12th week postpartum.

Control group 2

NO INTERVENTION

The scales will be administered to the fathers in the control group 2 on the 42nd day, and 12th week postpartum.

Interventions

Breastfeeding education will be given to fathers.

Training group 1Training group 2

Eligibility Criteria

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

You may qualify if:

  • Follow-up of the mother in the postpartum clinic of the hospital
  • Feeding the baby with breast milk
  • Being an only baby, being at a gestational age of 37 weeks and above, weighing 2500 g and over, not having a congenital disease
  • The mother does not have any health problems that may prevent breastfeeding
  • The mother and father do not have any barriers to filling out the questionnaire.
  • Literacy of mother and father
  • Availability of a phone and internet where messages can be read
  • Mother and father living in the same house

You may not qualify if:

  • The baby's inability to get breast milk
  • Fathers or mothers have a disability in completing the questionnaire.
  • Lack of a phone and internet where messages can be read
  • Parents living in separate places

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etlik City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Bich TH, Hoa DT, Malqvist M. Fathers as supporters for improved exclusive breastfeeding in Viet Nam. Matern Child Health J. 2014 Aug;18(6):1444-53. doi: 10.1007/s10995-013-1384-9.

  • Moriwaki C, Haku M. Development of a Breastfeeding Support Scale for Couples. J Med Invest. 2016;63(1-2):96-103. doi: 10.2152/jmi.63.96.

  • Rempel LA, Rempel JK, Moore KCJ. Relationships between types of father breastfeeding support and breastfeeding outcomes. Matern Child Nutr. 2017 Jul;13(3):e12337. doi: 10.1111/mcn.12337. Epub 2016 Jul 27.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • zeynep ölçer

    Ankara Medipol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Participants and the health care provider will not know which group the participants are assigned to.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The research is planned to be carried out as an experimental design with four groups of solomon. The randomization of the participants will be made using a computer program and the participants will be assigned to the experimental and control groups in this way
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 23, 2023

First Posted

July 10, 2023

Study Start

September 30, 2024

Primary Completion

October 30, 2025

Study Completion

December 30, 2025

Last Updated

August 1, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

Data sets are to be shared IPD that underlie results in a publication.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
IPD and any additional supporting information will become available for 1 year after publication
Access Criteria
The data supporting the findings of this studywill be available within the article \[and/or\] its supplementary materials.

Locations