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Breastfeeding, ExclusiveNCT05979571

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

A study testing Mobile health app in people with Breastfeeding, Exclusive, run by Pacifica Salud Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Breastfeeding, Exclusive
What is being tested?
Mobile health app
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
15 Aug 2024to 15 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • First pregnancy
  • Third trimester

Who cannot join

  • twin pregnancies fetal defects or newborns with malformations

Trial locations and contacts

No sites are listed yet.

Isabel Blanco, MD contact

2048000 ext. 8751

iblanco@pacificasalud.com

Idalina Cubilla, PhD contact

2048000 ext. 8751

idacubilla@gmail.com

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Mobile health app
Keywords
breastfeeding, mobile health, perinatal care, primary care
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile health appOther

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

Study groups in NCT05979571
Study groupRoleWhat they receive
ExperimentalExperimentalNot described
Receives: Other: Mobile health app

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2023
  2. Study start15 Aug 2024 (estimated)
  3. Primary completion15 Dec 2024 (estimated)
  4. Study completion15 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05979571
Sponsor's protocol ID
2880
Status last verified
Jan 2024
First submitted
29 Jul 2023
Last updated
19 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28902698

  • 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.

    PubMed 33614547

  • 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.

    PubMed 33521544

  • 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.

    PubMed 17655546

  • 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.

    PubMed 29324318

Questions about this trial

What is this clinical trial studying?

A study testing Mobile health app in people with Breastfeeding, Exclusive, run by Pacifica Salud Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Isabel Blanco, MD (2048000 ext. 8751, iblanco@pacificasalud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mobile application rating scale (MARS) (time frame: two weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05979571, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.

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