NCT05497245

Brief Summary

Purpose of Research: The purpose of this research is to develop and evaluate the effectiveness of a mobile application-based breastfeeding education program. Research Hypotheses H1: Exclusive breastfeeding rate is higher for mothers in the experimental group than the mothers in the control group in the fourth postpartum week. H2: The mothers in the experimental group had higher scores on the Evaluation of Breastfeeding Problems in the fourth week after delivery than the mothers in the control group. H3: Exclusive breastfeeding rate is higher for the mothers in the experimental group than the mothers in the control group in the eighth postpartum week. H4: The mothers in the experimental group had higher scores on the Evaluation of Breastfeeding Problems at the eighth postpartum week than the mothers in the control group. In the first stage of the research, a mobile application-based breastfeeding education program was developed and piloted. In the second stage of the study, the mobile application-based breastfeeding education program was applied to the primiparous mothers in the experimental group for eight weeks, starting from the first day of postpartum.The control group received only routine health care. 617 / 5.000 Çeviri sonuçları Personal Information Form, Breastfeeding Evaluation Scale and Breastfeeding Problems Evaluation Scale were applied to the mothers in the Experimental and Control groups on the first postpartum day.

  • A mobile application was installed on the phones of the mothers in the experimental group and information was provided. The control group benefited only from routine nursing care.
  • Infants' Physical Development Monitoring Form, Breastfeeding Monitoring Form, Breastfeeding Problems Evaluation Scale will be applied to the mothers in the experimental and control groups in the fourth and eighth weeks postpartum.
  • Mobile Application Evaluation Form was also applied to the experimental group in the eighth week.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

9 months

First QC Date

August 9, 2022

Last Update Submit

August 9, 2022

Conditions

Keywords

breastfeedingbreastmilkmobile health

Outcome Measures

Primary Outcomes (3)

  • breastmilk exclusive

    rate of exclusive breastfeeding for eight weeks

    postpartum 1st day- postpartum 8th week

  • breastfeeding problem

    rate of breastfeeding problem eight weeks

    postpartum 1st day- postpartum 8th week

  • baby's physical development

    development of baby's weight, height and head circumference

    postpartum 1st day- postpartum 8th week

Study Arms (2)

intervention group

EXPERIMENTAL

mobile app-based breastfeeding education

Other: mobile app-based breastfeeding education

control group

NO INTERVENTION

rutin health care

Interventions

The main screen of the application used to be six screens. These six screens; Breastfeeding, Expressing, Contingencies, Frequently asked questions and my Breastfeeding Log and Breastfeeding diary. Mothers could record the number and duration of breastfeeding, milking status, the baby's height and weight, if it was a measure, the breastfeeding problem and solutions they encountered, on the "Breastfeeding Introduction" tab, and they could follow their breastfeeding status in the "Breastfeeding Diary" tab.

intervention group

Eligibility Criteria

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

You may qualify if:

  • years or older,
  • Primiparous,
  • Babies born at term (\> 37 weeks of pregnancy or weight \> 2500 g) and no health problems that prevent suckling
  • Planning to breastfeed,
  • Having a smart phone and effective usage skills,
  • Mothers who agreed to participate in the study for eight weeks were included in the sample.

You may not qualify if:

  • Being the first born,
  • Having multiple pregnancy,
  • Having a physical and/or mental health problem
  • Having a risky newborn,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • Wang CJ, Chaovalit P, Pongnumkul S. A Breastfeed-Promoting Mobile App Intervention: Usability and Usefulness Study. JMIR Mhealth Uhealth. 2018 Jan 26;6(1):e27. doi: 10.2196/mhealth.8337.

    PMID: 29374000BACKGROUND
  • Ferraz Dos Santos L, Borges RF, de Azambuja DA. Telehealth and Breastfeeding: An Integrative Review. Telemed J E Health. 2020 Jul;26(7):837-846. doi: 10.1089/tmj.2019.0073. Epub 2019 Oct 18.

    PMID: 31633467BACKGROUND
  • Doan TTD, Binns C, Pham NM, Zhao Y, Dinh TPH, Bui TTH, Tran TC, Nguyen XH, Giglia R, Xu F, Lee A. Improving Breastfeeding by Empowering Mothers in Vietnam: A Randomised Controlled Trial of a Mobile App. Int J Environ Res Public Health. 2020 Jul 31;17(15):5552. doi: 10.3390/ijerph17155552.

    PMID: 32752026BACKGROUND
  • Schindler-Ruwisch JM, Roess A, Robert RC, Napolitano MA, Chiang S. Social Support for Breastfeeding in the Era of mHealth: A Content Analysis. J Hum Lact. 2018 Aug;34(3):543-555. doi: 10.1177/0890334418773302. Epub 2018 May 22.

    PMID: 29787686BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

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

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 11, 2022

Study Start

November 1, 2021

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

August 11, 2022

Record last verified: 2022-08

Locations