eHealth Support for Breastfeeding

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a phone app designed to assist African American and Black mothers and their partners with breastfeeding. The study will determine if text reminders to use the app encourage more frequent use. Participants will be divided into groups, with some receiving these "nudges" and others not. Expectant African American or Black mothers between 24-34 weeks pregnant who are interested in breastfeeding and have a smartphone, along with their partners, may be eligible to join. As an unphased trial, participation offers a chance to contribute to innovative research that could support breastfeeding in the community.

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 prior data suggests that this app is safe for use?

Research shows that eHealth tools for breastfeeding are popular with users. One study found that 92% of participants considered a similar app helpful, and 97% reported a positive experience. This indicates that the app is generally well-liked. No reports have indicated any negative effects from using these apps. The aim is to make breastfeeding easier and more successful for African American and Black families by offering culturally relevant support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the eHealth Support for Breastfeeding app because it offers personalized, timely support to new parents, which is not typically available with standard breastfeeding resources like in-person consultations or printed materials. This app uses "nudges," which are gentle reminders and prompts sent via text, to actively engage both mothers and their partners in the breastfeeding journey. By providing regular, targeted cues before and after delivery, the app aims to enhance breastfeeding practices and improve overall outcomes, offering a modern, tech-savvy approach that can be more accessible and flexible than traditional methods.

What evidence suggests that the eHealth for Breastfeeding Support App is effective for supporting breastfeeding in African American and Black mothers?

Research has shown that internet-based tools can effectively assist women with breastfeeding. One study found that apps providing personalized feedback improved exclusive breastfeeding rates. Another study discovered that real-time virtual support significantly increased breastfeeding during the first six months. Additionally, a review of multiple studies found that virtual support boosts exclusive breastfeeding. In this trial, participants will use the eHealth for Breastfeeding Support App, with some receiving additional "nudges" or prompts. These findings suggest that an app like the one being developed could effectively help mothers and partners overcome breastfeeding challenges. ^{6 7 8 9 10}

Who Is on the Research Team?

Lydia Furman, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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