eHealth Support for Breastfeeding

Recruiting at 2 trial locations

Overseen By Lydia Furman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Disqualifiers: Age under 18 years

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the eHealth for Breastfeeding Support App, HOTSPOT App treatment?

Research shows that eHealth interventions, like apps, can help increase breastfeeding initiation and duration by providing accessible information and support to parents. Although one study found no significant improvement in breastfeeding rates with app use, technology-based resources were preferred by many users, suggesting potential for future development. ^{1 2 3 4 5}

Is the eHealth Support for Breastfeeding app safe for humans?

The research articles reviewed do not provide specific safety data for the eHealth Support for Breastfeeding app or its variants. They focus on usability, satisfaction, and the potential benefits of such apps for breastfeeding support. ^{1 3 6 7 8}

How is the eHealth for Breastfeeding Support App treatment different from other breastfeeding support treatments?

The eHealth for Breastfeeding Support App, also known as the HOTSPOT App, is unique because it leverages mobile health technology to provide breastfeeding support through a smartphone application, offering both professional and peer support in an accessible and interactive online format, which is a novel approach compared to traditional in-person or telephone support methods. ^{6 8 9 10 11}

What is the purpose of this trial?

This is a voluntary research study to test use of a phone app that is intended to support breastfeeding specifically for African American and Black people. This is called a "pilot" study because the app is still in development. The goal of this research is to see if mothers use the app more when they receive text "nudges" to look at it compared to not getting those "nudges". The research project is being conducted by Lydia Furman MD. The purpose of the app (which is currently in clickable "wireframe" status, a "pre" app phase) is to support and promote breastfeeding specifically for mothers and fathers/partners who are African American or Black. Other breastfeeding apps have pictures mainly of White or Asian mothers and information that is not oriented toward African American mothers. This app aims to provide accurate and needed breastfeeding information that is culturally attuned. Up to 24 participants will be enrolled at UHCMC, including up to 20 mothers. Other participants will include up to 4 African American or Black fathers/partners whose partners are interested in breastfeeding.

Research Team

Lydia Furman, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Eligibility Criteria

This trial is for up to 20 African American or Black mothers and up to 4 fathers/partners interested in breastfeeding. It's a pilot study testing an app designed with culturally relevant content to support breastfeeding within this community.

Inclusion Criteria

Maternal participants: Adult women who are expecting (pregnant) and between 24-34 weeks gestation, self-describe as African-American or Black (AA/B), have a smart phone, receive prenatal care at either Ahuja Rainbow Center for Women and Children or MacDonald and Women's Suite 1200 at University Hospitals, either interested in or committed to breastfeeding for their infant

Exclusion Criteria

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Delivery App Use

Participants in the nudge group receive app access and weekly text nudges prior to delivery

Varies (up to delivery)

Weekly virtual interactions

Postpartum App Use

Participants in the nudge group receive biweekly text nudges and app access for 3 months postpartum

3 months

Biweekly virtual interactions

Follow-up

Participants are monitored for app engagement and usability scores

Up to 4 months post-enrollment

Treatment Details

Interventions

• eHealth for Breastfeeding Support App

Trial Overview The study examines if the use of a phone app increases when participants receive text message 'nudges'. Participants will either have access to the app alone or the app with additional text prompts, aiming to enhance breastfeeding support.

Participant Groups

Group I: Maternal participants nudge group Experimental Treatment 1 Intervention

Participants in the app "nudge" group receive access to the app and questions with app cues by text weekly prior to delivery and biweekly (every 2 weeks) after delivery through 3 months postpartum.

Group II: Maternal participants no nudge group Experimental Treatment 1 Intervention

Participants in the app "no nudge" group receive access to the app and no questions with app cues through 3 months postpartum.

Group III: Father/partner participants nudge group Experimental Treatment 1 Intervention

Participants in the app "nudge" group receive access to the app and questions with app cues by text weekly for the first 2 months and then biweekly (every 2 weeks) for another 2 months.

Group IV: Father/partner participants no nudge group Experimental Treatment 1 Intervention

Participants in the app "no nudge" group receive access to the app and no questions with app cues for 4 months.

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Findings from Research

An eHealth intervention designed for breastfeeding mothers and their co-parents was well-received, with 92% of participants finding it useful and 97% stating it was easy to understand, indicating high satisfaction with the resource.

The intervention, which included access to a breastfeeding resource, virtual meetings, and email reminders, effectively engaged both mothers (n=56) and co-parents (n=47), suggesting it could enhance breastfeeding initiation and duration by providing comprehensive support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal and co-parental experiences and satisfaction with a co-parenting breastfeeding eHealth intervention in Canada. Abbass-Dick, J., Sun, W., Newport, A., et al.[2023]

57% of postpartum patients reported using infant feeding tracker apps, with users more likely to have breastfed their infants, indicating that these apps may support breastfeeding practices.

Users of infant feeding tracker apps also engaged with more health apps overall, suggesting a trend towards increased health management among those who utilize these digital tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infant Feeding Tracker Applications: Cross-Sectional Analysis of Use. Dinour, LM.[2022]

The modified mHealth App Usability Questionnaire (m-MAUQ) was successfully translated into Spanish and adapted for breastfeeding support apps, showing high content validity and excellent interrater agreement among experts and users.

The m-MAUQ demonstrated high reliability and internal consistency (Cronbach α = 0.89), making it a valuable tool for evaluating the usability and acceptability of mobile health applications designed for lactating women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spanish version of the mHealth app usability questionnaire (MAUQ) and adaptation to breastfeeding support apps. Quifer-Rada, P., Aguilar-Camprubí, L., Gómez-Sebastià, I., et al.[2023]

Despite the known benefits of exclusive breastfeeding for the first 6 months, less than 35% of infants globally are exclusively breastfed in the first 4 months, highlighting a significant gap in breastfeeding practices.

A systematic review found only one eligible study on Internet-based breastfeeding support, which reported positive outcomes, but methodological issues limit the reliability of these findings, indicating a need for more rigorous research before replacing traditional support methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of the internet in improving breastfeeding outcomes: a systematic review. Giglia, R., Binns, C.[2019]

In a study involving low-income, first-time mothers, increased use of breastfeeding smartphone apps did not lead to higher rates of breastfeeding initiation or sustained breastfeeding compared to lower app usage, with initiation rates of 84.1% versus 78.2% respectively.

Despite the lack of impact on breastfeeding rates, both groups preferred technology-based resources for breastfeeding support, suggesting that further development of such interventions could still be beneficial for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Novel Breastfeeding Smartphone Applications on Breastfeeding Rates. Griffin, LB., López, JD., Ranney, ML., et al.[2022]

A review of 65 mHealth breastfeeding support resources found that 76% of mobile applications were free, primarily targeting postpartum women and focusing on breastfeeding duration and troubleshooting.

While these resources offer valuable informational support, most lack personalization and interactivity, indicating a need for further development to enhance their effectiveness in supporting breastfeeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Support for Breastfeeding in the Era of mHealth: A Content Analysis. Schindler-Ruwisch, JM., Roess, A., Robert, RC., et al.[2019]

A prototype mobile application for breastfeeding was developed and positively assessed by health professionals, indicating its potential as a valuable tool for improving breastfeeding care.

Feedback from certified breastfeeding consultants highlighted areas for content enhancement, ensuring the app aligns with evidence-based practices and meets the needs of health professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of a prototype application on breastfeeding for health professionals. Guimarães, CMS., Fonseca, LMM., Monteiro, JCDS.[2021]

Breastfeeding offers significant health benefits for both mothers and infants, but initiation and continuation rates are influenced by sociodemographic factors in the U.S.

Mobile health (mHealth) interventions, such as online education and smartphone apps, have shown effectiveness in promoting breastfeeding initiation and support, especially during the COVID-19 pandemic, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health Approaches to Breastfeeding. Lewkowitz, AK., Cahill, AG.[2023]

Exclusive breastfeeding is recommended for the first 6 months of life due to its significant health benefits for both infants and mothers, supported by extensive evidence.

The introduction of an online breastfeeding support clinic can enhance access to professional and peer support for breastfeeding mothers, potentially improving breastfeeding duration and infant health across Canada.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and implementation of a novel online breastfeeding support resource: the Maternal Virtual Infant Nutrition Support Clinic. Geoghegan-Morphet, N., Yuen, D., Rai, E., et al.[2019]

Telehealth strategies, including synchronous (like video calls) and asynchronous (like messaging), have been shown to effectively support breastfeeding, enhancing exclusive breastfeeding duration and overall maintenance of breastfeeding practices.

The review of 23 articles indicates that telehealth services are not only viable but also positively received by users, suggesting a strong potential for expanding these services in Brazil and beyond.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth and Breastfeeding: An Integrative Review. Ferraz Dos Santos, L., Borges, RF., de Azambuja, DA.[2021]

This study is testing the feasibility and acceptability of an online instant messaging peer support group for improving breastfeeding outcomes among 40 first-time mothers in Hong Kong, with assessments planned for 6 months postpartum.

The intervention group will receive additional support from trained peer counselors via instant messaging, which could enhance breastfeeding practices compared to standard care alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of an Online WhatsApp Support Group on Breastfeeding: Protocol for a Randomized Controlled Trial. Lok, KY., Ko, RW., Fan, HS., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Maternal and co-parental experiences and satisfaction with a co-parenting breastfeeding eHealth intervention in Canada. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Infant Feeding Tracker Applications: Cross-Sectional Analysis of Use. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

Spanish version of the mHealth app usability questionnaire (MAUQ) and adaptation to breastfeeding support apps. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of the internet in improving breastfeeding outcomes: a systematic review. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of Novel Breastfeeding Smartphone Applications on Breastfeeding Rates. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Social Support for Breastfeeding in the Era of mHealth: A Content Analysis. [2019]

7. Brazil pubmed.ncbi.nlm.nih.gov

Development and validation of a prototype application on breastfeeding for health professionals. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Mobile Health Approaches to Breastfeeding. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Development and implementation of a novel online breastfeeding support resource: the Maternal Virtual Infant Nutrition Support Clinic. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Telehealth and Breastfeeding: An Integrative Review. [2021]

11. Canada pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of an Online WhatsApp Support Group on Breastfeeding: Protocol for a Randomized Controlled Trial. [2022]