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

Sponsor
Pacifica Salud Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05979571
Collaborator
Sistema Nacional de Investigación Senacyt Panamá (Other)
10
1
7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Mobile health app
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Development of Educational Intervention Through Technological Platform to Support Exclusive Breastfeeding up to Six Months Pilot Study
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental

Other: Mobile health app
Breastfeeding knowledge and promotion information will be delivered through the AmiBreastfeed app platform

Outcome Measures

Primary Outcome Measures

  1. Mobile application rating scale (MARS) [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. First pregnancy

  2. Third trimester

Exclusion Criteria:
  • twin pregnancies fetal defects or newborns with malformations

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Pacifica Salud Hospital
  • Sistema Nacional de Investigación Senacyt Panamá

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pacifica Salud Hospital
ClinicalTrials.gov Identifier:
NCT05979571
Other Study ID Numbers:
  • 2880
First Posted:
Aug 7, 2023
Last Update Posted:
Aug 11, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pacifica Salud Hospital

Study Results

No Results Posted as of Aug 11, 2023