NCT05979571

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

July 29, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
1 year until next milestone

Study Start

First participant enrolled

August 15, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

July 29, 2023

Last Update Submit

January 18, 2024

Conditions

Keywords

breastfeeding, mobile health, perinatal care, primary care

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Experimental

EXPERIMENTAL
Other: Mobile health app

Interventions

Breastfeeding knowledge and promotion information will be delivered through the AmiBreastfeed app platform

Experimental

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • First pregnancy
  • Third trimester

You may not qualify if:

  • twin pregnancies fetal defects or newborns with malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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/JBISRIR-2016-002955.

  • 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 2020.

  • 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-2020-000184. eCollection 2020 Dec.

  • 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.

  • 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;58:86-92. doi: 10.1016/j.midw.2017.12.018. Epub 2017 Dec 24.

Related Links

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Tania T Herrera, MD

    Pacifica Salud Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabel Blanco, MD

CONTACT

Idalina Cubilla, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2023

First Posted

August 7, 2023

Study Start

August 15, 2024

Primary Completion

December 15, 2024

Study Completion

March 15, 2025

Last Updated

January 19, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share