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

2126 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to improve adherence to American Academy of Pediatrics safe sleep (SS) recommendations and improve rates of initiation and duration of partial and exclusive breastfeeding (BF) through direct education of mothers using Mobile Health (mHealth) technologies (ex. text messaging).

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 mHealth Messaging treatment for new mothers?

Research shows that mobile health messaging can improve health behaviors, such as breastfeeding practices, by providing support and information through smartphones. Additionally, safe sleep messaging has been found to increase safe sleep practices, which can be beneficial for new mothers. ^{1 2 3 4 5}

Is mHealth messaging safe for new mothers?

Research on mHealth programs like Text4baby, which sends text messages to pregnant women and new mothers, suggests they are safe and can improve health beliefs and attitudes. These programs have been used in various populations, including military women, without reported safety concerns. ^{3 5 6 7 8}

How is the mHealth Messaging treatment for new mothers different from other treatments?

This treatment is unique because it uses mobile health (mHealth) messaging to provide new and expecting mothers with information and support on breastfeeding and safe sleep practices, which can be more accessible and immediate compared to traditional in-person consultations. Unlike other treatments, it leverages the widespread use of mobile phones to deliver timely and personalized health messages, potentially improving health behaviors and outcomes. ^{1 2 3 5 9}

Research Team

Michael J Corwin, MD

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

The Impact of Breastfeeding and Safe Sleep Mobile Health Messaging on Breastfeeding and Bedsharing. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

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

3. Canada 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. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Developing and testing a mobile application for breastfeeding support: The Milky Way application. [2021]

5. Canada 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Optimizing knowledge and behavioral intention of women and their partners in the perinatal period in South Africa: a randomized control trial study protocol in the Tshwane district, Gauteng province, South Africa. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Dose-response effects of the text4baby mobile health program: randomized controlled trial. [2018]

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

Mobile Health Approaches to Breastfeeding. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Design, development and usability testing of Essential Coaching for Every Mother: A postnatal text message educational intervention. [2021]