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

Breastfeeding, Exclusive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05979571
• Other study ID #: 2880
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 15, 2024
• Est. completion date: March 15, 2025

Study information

• Verified date: January 2024
• Source: Pacifica Salud Hospital
• Contact: Isabel Blanco, MD
• Phone: 2048000
• Email: iblanco[@]pacificasalud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: March 15, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. First pregnancy

2. Third trimester

Exclusion Criteria:

• twin pregnancies fetal defects or newborns with malformations

Related Conditions & MeSH terms

• Breastfeeding, Exclusive

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pacifica Salud Hospital	Sistema Nacional de Investigación Senacyt Panamá

References & Publications (5)

Alberdi G, O'Sullivan EJ, Scully H, Kelly N, Kincaid R, Murtagh R, Murray S, McGuinness D, Clive A, Brosnan M, Sheehy L, Dunn E, McAuliffe FM. A feasibility study of a multidimensional breastfeeding-support intervention in Ireland. Midwifery. 2018 Mar;58: — View Citation

Huang MZ, Kuo SC, Avery MD, Chen W, Lin KC, Gau ML. Evaluating effects of a prenatal web-based breastfeeding education programme in Taiwan. J Clin Nurs. 2007 Aug;16(8):1571-9. doi: 10.1111/j.1365-2702.2006.01843.x. — View Citation

Meedya S, Fernandez R, Fahy K. Effect of educational and support interventions on long-term breastfeeding rates in primiparous women: a systematic review and meta-analysis. JBI Database System Rev Implement Rep. 2017 Sep;15(9):2307-2332. doi: 10.11124/JBI — View Citation

Spatz DL, Davanzo R, Muller JA, Powell R, Rigourd V, Yates A, Geddes DT, van Goudoever JB, Bode L. Promoting and Protecting Human Milk and Breastfeeding in a COVID-19 World. Front Pediatr. 2021 Feb 3;8:633700. doi: 10.3389/fped.2020.633700. eCollection 20 — View Citation

Vu Hoang D, Cashin J, Gribble K, Marinelli K, Mathisen R. Misalignment of global COVID-19 breastfeeding and newborn care guidelines with World Health Organization recommendations. BMJ Nutr Prev Health. 2020 Dec 22;3(2):339-350. doi: 10.1136/bmjnph-2020-00 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mobile application rating scale (MARS)	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

External Links

•   Sexual and Reproductive Health survey 2014-2015
•   Unicef Breastfeeding Information