mHealth Messaging for New Mothers

(SMARTER Trial)

Overseen By Fiona Rice, MPH

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Boston University

Disqualifiers: Prenatal diagnosis, Minor, others

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 explores ways to help new mothers follow safe sleep guidelines and successfully start and continue breastfeeding. The study uses mobile health technologies, such as text messaging, to educate mothers directly before and after birth. Participants will receive messages focused on safe sleep, breastfeeding, or both. Expectant mothers who are less than 34 weeks pregnant, can text, and plan to live with their baby are well-suited for this trial. As an unphased trial, it offers a unique opportunity to receive personalized support and contribute to improving maternal and infant health practices.

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 mHealth messaging is safe for new mothers?

Research shows that mobile health (mHealth) messages safely assist new mothers with breastfeeding and safe sleep practices. These messages guide mothers to follow safe sleep guidelines without negatively impacting breastfeeding.

For breastfeeding support, mHealth messages effectively help mothers start and continue breastfeeding. Mothers receive them well and find them to offer reliable advice during and after pregnancy.

Regarding safe sleep, research indicates that these messages reduce the frequency of babies sharing a bed with parents, creating a safer sleep environment. Mothers who received these messages were also less likely to accidentally fall asleep while feeding their babies, enhancing infant safety.

Overall, mHealth messages in these areas are safe and well-accepted by mothers. Studies have not reported any major negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these mobile health (mHealth) messaging treatments for new mothers because they offer a personalized and timely approach to prenatal and postnatal care. Unlike traditional methods that rely on in-person consultations and pamphlets, these mHealth messages can be delivered directly to a mother's phone, ensuring she receives consistent and supportive information when she needs it most. This approach can empower mothers with easy access to crucial advice on breastfeeding and safe sleep practices, potentially improving both maternal and infant health outcomes. By leveraging technology, these treatments aim to enhance engagement and adherence to health recommendations, which could lead to better long-term results for families.

What evidence suggests that this trial's mHealth messaging treatments could be effective for improving safe sleep and breastfeeding practices?

Research has shown that sending health messages to new mothers on their phones can help them practice safe sleep habits and breastfeed more effectively. This trial will evaluate different combinations of mobile health messaging. Participants may receive messages focused on prenatal and postnatal safe sleep or breastfeeding. Studies have found that these messages can reduce risky bedsharing without affecting breastfeeding. For breastfeeding, phone messages have increased the number of mothers who exclusively breastfeed and boosted their confidence and emotional well-being. These text programs also keep mothers engaged during the early weeks after birth. Overall, these methods effectively support healthier habits for both mothers and their babies. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael J Corwin, MD

Principal Investigator

Boston University School of Public Health, Dept of Pediatrics, BUSM

Are You a Good Fit for This Trial?

This trial is for pregnant women in the U.S. under 34 weeks gestation, planning to live with their infant post-birth, and who are clients at a participating WIC center. They must speak English or Spanish and have texting capabilities on their mobile phone. It's not for minors or those with prenatal diagnoses affecting breastfeeding/sleep positioning.

Inclusion Criteria

I am pregnant and less than 34 weeks along.

Must be a client at a WIC center participating in the study

Must live in the United States

Exclusion Criteria

A prenatal diagnosis expected to have an impact on infant care practices not compatible with study goals, including contraindications to breastfeeding or supine infant sleep positioning

I am considered a minor by my state's laws.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Intervention

Participants receive mHealth messages focused on safe sleep and/or breastfeeding practices during pregnancy

6 weeks

Weekly virtual messages

Postnatal Intervention

Participants receive mHealth messages focused on safe sleep and/or breastfeeding practices after childbirth

26 weeks

Weekly virtual messages

Follow-up

Participants are monitored for adherence to safe sleep and breastfeeding practices

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Postnatal Breastfeeding Mobile Health (mHealth) Messaging
• Postnatal Safe Sleep Mobile Health (mHealth) Messaging
• Prenatal Breastfeeding Mobile Health (mHealth) Messaging
• Prenatal Safe Sleep Mobile Health (mHealth) Messaging

Trial Overview

The study tests if mHealth messages about safe sleep and breastfeeding sent directly to mothers' phones can increase adherence to safe sleep practices and improve breastfeeding rates. It involves sending educational text messages both before and after birth.

How Is the Trial Designed?

Group I: Prenatal SS/Postnatal SS Experimental Treatment 2 Interventions

Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages

Group II: Prenatal SS/Postnatal BF Experimental Treatment 2 Interventions

Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages

Group III: Prenatal BF/Postnatal SS Experimental Treatment 2 Interventions

Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages

Group IV: Prenatal BF/Postnatal BF Experimental Treatment 2 Interventions

Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

University of Kentucky

Collaborator

Trials

198

Recruited

224,000+

Published Research Related to This Trial

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]

The Text4baby program significantly improved pregnant women's beliefs about the importance of taking prenatal vitamins and visiting healthcare providers, with odds ratios indicating a strong positive effect on these attitudes.

Despite the positive changes in beliefs, the study did not find any significant behavioral changes among participants, suggesting that while Text4baby influences health attitudes, further research is needed to assess its impact on actual health behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial outcomes from a 4-week follow-up study of the Text4baby program in the military women's population: randomized controlled trial. Evans, WD., Wallace Bihm, J., Szekely, D., et al.[2022]

A pilot study involving 120 pregnant women in Uganda showed that a mobile health messaging app significantly improved attendance at antenatal care visits and skilled deliveries, with 100% of women in the social supporter group attending at least 4 visits.

The app was highly accepted and deemed useful by over 90% of participants, indicating that leveraging social support networks through tailored messaging can effectively promote maternity service use in rural settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Feasibility, Acceptability, and Preliminary Efficacy of SupportMoms-Uganda, an mHealth-Based Patient-Centered Social Support Intervention to Improve the Use of Maternity Services Among Pregnant Women in Rural Southwestern Uganda: Randomized Controlled Trial. Atukunda, EC., Siedner, MJ., Obua, C., 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]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8325083/

The Value of Mobile Health in Improving Breastfeeding ...

Interventions based on mHealth can significantly improve the rate of postpartum exclusive breastfeeding, breastfeeding efficacy, and participants' attitudes ...

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sciencedirect.com

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Text messaging interventions for breastfeeding outcomes

Text messaging interventions that covered antenatal and postnatal periods, delivered weekly were most effective in improving the exclusive breastfeeding rate.

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Effectiveness of a Mobile Breastfeeding Monitoring Tool ...

The results suggest that using the app may have a positive impact on breastfeeding mothers' emotional well-being. This finding is supported by ...

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bmchealthservres.biomedcentral.com

bmchealthservres.biomedcentral.com/articles/10.1186/s12913-023-09581-7

The effects of mHealth interventions on improving institutional ...

The study has found out that mHealth intervention has a significant effect on improving facility delivery, postnatal care utilization, rate of exclusive ...

5.

researchprotocols.org

researchprotocols.org/2021/3/e27138/

Effectiveness of a Postpartum Text Message Program ...

There is some evidence that text messaging programs can enhance maternal and newborn outcomes and engage mothers during the postnatal period [

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9349472/

The Impact of Breastfeeding and Safe Sleep Mobile Health ...

Receipt of safe sleep mHealth messaging was associated with lower rates of bedsharing without negatively impacting breastfeeding rates.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10257264/

The effects of mHealth interventions on improving ...

The study has found out that mHealth intervention has a significant effect on improving facility delivery, postnatal care utilization, rate of exclusive ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04387552?term=nichd%20SIDS&viewType=Table&rank=3

Study Details | NCT04387552 | Social Media and Risk ...

The goal of this study is to assess the effectiveness of mHealth prenatal and postnatal interventions aimed at promoting safe sleep (SS) practices and ...

9.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2589933321002391

Smartphone-based counseling and support platform and ...

This study aimed to investigate the impact of introducing a smartphone-based daily feedback and counseling platform between women after delivery

10.

jamanetwork.com

jamanetwork.com/journals/jama/fullarticle/2645107

The Effect of Nursing Quality Improvement and Mobile ...

A mobile health intervention, but not a nursing quality improvement intervention, improved adherence to infant safe sleep practices compared with control ...