Developing and Testing an Educational Intervention Through Technological Platform to Support Exclusive Breastfeeding

January 18, 2024 updated by: Pacifica Salud Hospital

Development of Educational Intervention Through Technological Platform to Support Exclusive Breastfeeding up to Six Months Pilot Study

Although breastfeeding provides the infant with all the nutrients necessary for its development, it has been observed that in Panama there are low rates of Exclusive Breastfeeding. Educational interventions, that support exclusive breastfeeding, which begin before delivery and continue to the postnatal period, have been shown to be effective.

The main objective of the study is the development and testing of an educational intervention through web based platform, to support exclusive breastfeeding up to 6 months. This educational intervention will provide guidance with the help of an audiovisual format, with information and breastfeeding techniques, which mothers can reproduce as many times as necessary.

The main objective of the study is the development and testing of an educational intervention through AmiHealth, to support exclusive breastfeeding up to 6 months.

A pilot study will be conducted on a non-random convenience sample.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The team leveraged a user-centered design (UCD) approach to design and develop the initial version of the breastfeeding app. An agile development methodology for content and technology development which integrates feedback from all key stakeholders in the development process to refine the app over time, including the content and app.In parallel with the app design, the educational content for the intervention was developed with experts in the field.

The contents that will be develop for the breastfeeding module, Data operating system will be used for data management and analytical and projection tools.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. First pregnancy
  2. Third trimester

Exclusion Criteria:

  • twin pregnancies fetal defects or newborns with malformations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Other: Mobile health app
Breastfeeding knowledge and promotion information will be delivered through the AmiBreastfeed app platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mobile application rating scale (MARS)
Time Frame: two weeks
The quality of the apps will be asses using MARS. This methodology includes 23 evaluation criteria, clustered within 5 domains: (1) "Engagement," which assesses the entertainment, customization, and interactivity of the app (feedback, reminders, and notifications); (2) "Functionality," which examines the functionality of the app, ease of use, transition between screens, and intuitive design; (3) "Esthetics," which assesses graphic design, visual appeal, and stylistic consistency; (4) "Information," which evaluates the quality of the content (text, measures, and references), determined by the credibility of the source; and (5) "Subjective quality," which determines whether the app could be recommended to people who might benefit from it, if they would be prepared to pay for it, how many times it would be used, and what overall star rating it would be given. Each evaluation criterion was rated from 1 to 5 (1=Inadequate, 2=Poor, 3=Acceptable, 4=Good, 5=Excellent)
two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pacifica Salud Hospital

Collaborators

Sistema Nacional de Investigación Senacyt Panamá

Investigators

  • Principal Investigator: Tania T Herrera, MD, Pacifica Salud Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2024

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

March 15, 2025

Study Registration Dates

First Submitted

July 29, 2023

First Submitted That Met QC Criteria

July 29, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2880

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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