NCT04478682

Brief Summary

The research was planned as a randomized controlled experimental study in order to determine the effect of continuous breastfeeding support provided to mothers through WhatsApp messaging application on breastfeeding. Research Hypotheses H0: Continuous breastfeeding support provided to mothers through WhatsApp messaging application has no effect on breastfeeding. H1: Continuous breastfeeding support provided to mothers through WhatsApp messaging application increases the rate of exclusive breastfeeding. H2: Continuous breastfeeding support provided to mothers through WhatsApp messaging application increases the breastfeeding duration of the mothers. H3: Continuous breastfeeding support provided to mothers through WhatsApp messaging application reduces the rate of mothers giving their babies other foods than breast milk. H4: Continuous breastfeeding support provided to mothers through WhatsApp messaging application reduces bottle feeding rates. H5: Continuous breastfeeding support provided to mothers through WhatsApp messaging application reduces the rate of pacifier use. H6: Continuous breastfeeding support provided to mothers through WhatsApp messaging application reduces the incidence of mothers' breastfeeding problems. H7: Continuous breastfeeding support provided to mothers through WhatsApp messaging application affects mothers' breastfeeding attitude positively. H8: Continuous breastfeeding support provided to mothers through WhatsApp messaging application increases the motivation of breastfeeding mothers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

November 29, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

July 16, 2020

Last Update Submit

November 26, 2021

Conditions

Keywords

Breastfeeding supportExclusive breastfeedingWhatsApp messaging applicationMotivationAttitude

Outcome Measures

Primary Outcomes (3)

  • Breastfeeding Attitudes of The Evaluation Scale

    This scale assesses various aspects of attitudes that direct mothers' breastfeeding behavior. Examines breastfeeding as behavior. The scale is a five-point Likert type consisting of 46 items, easy to apply, and which people can answer on their own, and it can be applied to all mothers. Some items in the scale (3, 4, 6, 7, 8, 11, 13, 15, 19, 23, 24, 26, 27, 28, 29, 30, 31, 32, 37, 38, 42, 43) As a positive attitude, I agree with the statement "I totally disagree" to 4-3-2-1-0, while some items (1, 2, 5, 9, 10, 12, 14, 16, 17, 18, 20, 21 (22, 25, 33, 34, 35, 36, 39, 40, 41, 44, 45, 46) are considered negative, and the opposite score is scored as 0-1-2-3-4 from the statement entirely agree. In this way, the total score that can be obtained from the scale is between 0 and 184. As the score increases, breastfeeding attitude is evaluated as positive.

    In our study, will be applied before breastfeeding education in hospital and through online survey at postpartum 6th months for both groups

  • Primipara Breastfeeding Motivation Scale (PBMS)

    This scale evaluates postpartum breastfeeding motivation level in primiparous. The scale consists of 24 items in total. After applying to the sample group, the factor analysis of the scale was made and it was determined to have 5 factors. 1. Intrinsic motivation and integrated regulation 2. Identified regulation 3. Mirrored editing External regulation is examined in two sub-dimensions: 4. External regulation (instrumental needs) 5. External regulation (baby health) Scale items are rated from 1 = Never disagree to 4 = Strongly agree. The scale is in 4-point Likert type, and each item is scored between 1-4. The scale does not have a total score. The score of the sub-dimensions is calculated by taking the average of the scale sub-dimension scores. As the score obtained from the sub-dimension of the scale increases, the motivation representing that sub-dimension increases.

    at postpartum 6th months through online survey for both groups

  • Application Satisfaction Evaluation Form

    Evaluates the satisfaction of mothers from breastfeeding support provided through WhatsApp messaging application. It is a form consisting of 10 questions by the researcher to evaluate the satisfaction of the mothers from the breastfeeding support given through the social media group (WhatsApp) by making use of the literature information. The answer to each question will be evaluated as yes / no. In the tenth question, he will be asked to score the application. There will be a minimum of 1 and a maximum of 10 points.

    at postpartum 6th months through online survey for only experimental group

Study Arms (2)

WhatsApp Messaging Application

EXPERIMENTAL

Continuous breastfeeding support will be provided for the first 6 months through WhatsApp messaging application. Mothers will be contacted once a week through WhatsApp and feedback will be received on the breastfeeding process. The questions of the mother regarding breastfeeding will be answered by text / voice message or video call.

Other: Breastfeeding Support Provided to Mothers Through WhatsApp Messaging Application

Standard breastfeeding support

NO INTERVENTION

She will receive standard breastfeeding support after delivery. Breastfeeding will not receive continuous breastfeeding support for the first 6 months after discharge.

Interventions

Breastfeeding support provided to mothers through WhatsApp messaging application will be maintained for the first 6 months after birth. In the first 1 month, standard information sharing will be made through whatsApp. Also, for the first 6 months, solutions generating shares will be made according to the problems and questions of the mother regarding breastfeeding.

WhatsApp Messaging Application

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details18 years and older who primiparous women who gave birth
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • For the mother;
  • years and older
  • Primipar,
  • Having healthy pregnancy and uncomplicated birth,
  • No health problems preventing breastfeeding (drug use, HIV, etc.),
  • Not having any obstacle to communication (not knowing Turkish, mental retardation etc.),
  • Being literate,
  • Having a smart phone and internet connection,
  • It was determined to be able to use WhatsApp application. For baby;
  • Being healthy and term
  • No health problems preventing breastfeeding (Esophageal atresia, cleft palate, cleft lip etc.)
  • Its weight is between 2500-4000 gr.
  • It was determined that the Apgar Score was above 7.

You may not qualify if:

  • Mothers with multiple pregnancies,
  • Infants lying in NICU due to health problems in the postpartum period will be excluded from the scope of the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep Kamil Women And Chıldren Dıseases Tranıng And Research Hospıtal

Istanbul, Üsküdar, 34660, Turkey (Türkiye)

Location

Related Publications (7)

  • Balaguer Martinez JV, Valcarce Perez I, Esquivel Ojeda JN, Hernandez Gil A, Martin Jimenez MDP, Bernad Albareda M. [Telephone support for breastfeeding by primary care: a randomised multicentre trial]. An Pediatr (Engl Ed). 2018 Dec;89(6):344-351. doi: 10.1016/j.anpedi.2018.02.007. Epub 2018 Mar 22. Spanish.

    PMID: 29576447BACKGROUND
  • Reiss K, Andersen K, Barnard S, Ngo TD, Biswas K, Smith C, Carpenter J, Church K, Nuremowla S, Pearson E. Using automated voice messages linked to telephone counselling to increase post-menstrual regulation contraceptive uptake and continuation in Bangladesh: study protocol for a randomised controlled trial. BMC Public Health. 2017 Oct 3;17(1):769. doi: 10.1186/s12889-017-4703-z.

    PMID: 28974209BACKGROUND
  • Simonetti V, Palma E, Giglio A, Mohn A, Cicolini G. A structured telephonic counselling to promote the exclusive breastfeeding of healthy babies aged zero to six months: a pilot study. Int J Nurs Pract. 2012 Jun;18(3):289-94. doi: 10.1111/j.1440-172X.2012.02040.x.

    PMID: 22621300BACKGROUND
  • Cavalcanti DS, Cabral CS, de Toledo Vianna RP, Osorio MM. Online participatory intervention to promote and support exclusive breastfeeding: Randomized clinical trial. Matern Child Nutr. 2019 Jul;15(3):e12806. doi: 10.1111/mcn.12806. Epub 2019 Apr 11.

    PMID: 30825414BACKGROUND
  • Kapinos K, Kotzias V, Bogen D, Ray K, Demirci J, Rigas MA, Uscher-Pines L. The Use of and Experiences With Telelactation Among Rural Breastfeeding Mothers: Secondary Analysis of a Randomized Controlled Trial. J Med Internet Res. 2019 Sep 3;21(9):e13967. doi: 10.2196/13967.

    PMID: 31482848BACKGROUND
  • Durmaz S, Ergin I, Durusoy R, Hassoy H, Caliskan A, Okyay P. WhatsApp embedded in routine service delivery for smoking cessation: effects on abstinence rates in a randomized controlled study. BMC Public Health. 2019 Apr 8;19(1):387. doi: 10.1186/s12889-019-6727-z.

    PMID: 30961557BACKGROUND
  • Sevda KO, Sevil I. Continuous Lactation Support Provided Through the WhatsApp Messaging Application: A Randomized Controlled Trial. J Hum Lact. 2023 Nov;39(4):666-678. doi: 10.1177/08903344231192948. Epub 2023 Aug 30.

MeSH Terms

Conditions

Breast FeedingBehavior

Condition Hierarchy (Ancestors)

Feeding Behavior

Study Officials

  • Sevda KORKUT ÖKSÜZ, R.A

    Kirsehir Ahi Evran Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

July 16, 2020

First Posted

July 21, 2020

Study Start

December 1, 2020

Primary Completion

February 28, 2021

Study Completion

September 1, 2021

Last Updated

November 29, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations