Text Messaging vs In-Person Counseling for Maternal Health

Enrolling by invitation at 1 trial location

Overseen By Janna Garcia Torres

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Psychiatric, Developmental disability

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 support healthy lifestyles during pregnancy using two methods. One group receives lifestyle tips through text messages and online videos (Low Touch - Text Messaging Implementation Strategy), while another group participates in sessions with community health workers (trained individuals who assist with health needs) as part of the High Touch - Community Health Worker (CHW) Implementation Strategy. The goal is to determine which method better aids pregnant women in adoption and health outcomes. Participants should be pregnant, less than 20 weeks along, and able to use a smartphone for texts and videos.

As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance health support for pregnant women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on lifestyle counseling, so it's unlikely that medication changes are required, but you should confirm with the trial organizers.

What prior data suggests that these implementation strategies are safe for maternal health?

Research has shown that using Community Health Workers (CHWs) for maternal health is generally safe. Studies indicate that CHWs can improve health outcomes, such as reducing pregnancy loss and early births. Trained to assist with challenges faced by pregnant individuals, their support is usually well-received.

Research has found that the text messaging approach can effectively support maternal health. It can help lower anxiety in pregnant women and improve important health outcomes. Most people find it easy to use and appreciate its convenience.

Previous research considers both strategies safe. They focus on providing support and information rather than medical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to support maternal health. Unlike traditional methods that might involve in-person counseling sessions, this trial investigates a "Low Touch" strategy that uses text messaging to deliver health information through asynchronous videos. This approach is convenient and accessible, allowing expectant mothers to receive guidance right on their phones. On the other hand, the "High Touch" strategy employs community health workers who provide personalized support, addressing social determinants of health and prenatal care barriers. These strategies could vastly improve flexibility and personalization in maternal health support.

What evidence suggests that this trial's treatments could be effective for maternal health?

This trial will compare two strategies for maternal health: the Community Health Worker (CHW) Implementation Strategy and the Text Messaging Implementation Strategy. Studies have shown that CHW programs effectively improve pregnancy outcomes, reducing rates of pregnancy loss and low birth weight in babies. CHWs also facilitate access to health services, such as gestational diabetes testing. Meanwhile, research indicates that text messaging enhances maternal health care by ensuring women receive timely and proper prenatal care. Text messages have increased attendance at prenatal appointments and improved mothers' health knowledge. Both strategies show promise in supporting maternal health during pregnancy. ^{3 6 7 8 9}

Who Is on the Research Team?

Natasha Williams, EdD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for pregnant individuals who can participate in lifestyle counseling to improve maternal health. It's not clear what specific conditions exclude someone from participating, but typically, trials require participants to be over a certain age and have the ability to give informed consent.

Inclusion Criteria

Confirmed pregnant and <20 weeks 0 days gestational age

receiving care at one of the 10 clinics

able to speak and read English or Spanish

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of lifestyle counseling intervention using technology-supported and Community Health Worker-led strategies

12 months

Asynchronous and synchronous sessions

Follow-up

Participants are monitored for adherence, pre-term delivery, and other outcomes postpartum

12 weeks postpartum

Postpartum follow-up visits

Sustainability Evaluation

Evaluation of continued adoption and economic evaluation of implementation strategies

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• High Touch - Community Health Worker (CHW) Implementation Strategy
• Low Touch - Text Messaging Implementation Strategy

Trial Overview

The RESTORE Phase II study is testing two ways of delivering lifestyle advice during pregnancy: one uses text messages and online videos (low touch), while the other involves personal guidance from Community Health Workers (high touch). The study will compare how well each method works and their effects on clinical outcomes.

How Is the Trial Designed?

Group I: Community Health Worker (High Touch Group) Experimental Treatment 1 Intervention

During the intervention period (high touch) asynchronous and synchronous learning whereby content will be delivered by trained M-CHWs who are equipped to directly address social determinants of health-related needs and barriers to prenatal care.

Group II: Technology supported (Low Touch) Strategy Active Control 1 Intervention

During the control period (low touch), asynchronous videos summarizing healthy lifestyle content will be delivered via text messaging.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The mobile job aid developed for community health workers (CHWs) in Dar es Salaam, Tanzania, was found to be highly acceptable by both CHWs and clients, enhancing the quality of family planning services by providing timely and convenient care.

CHWs reported improvements in service quality, including better information and increased method choice for clients, although challenges remain in ensuring that clients are informed about all available contraceptive options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of a family planning mobile job aid for community health workers in Tanzania. Braun, R., Lasway, C., Agarwal, S., et al.[2018]

Community health workers (CHWs) significantly improve population health by connecting individuals to necessary resources, and integrating mobile health (mHealth) tools can enhance their effectiveness, as shown in a review of 64 studies published between 2007 and 2018.

Despite the positive impact of mHealth interventions involving CHWs, challenges remain, including a lack of culturally relevant tools, inconsistent methodologies for assessing outcomes, and the need for better training and communication among health care teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Mobile Health (mHealth) Technologies and Interventions Among Community Health Workers Globally: A Scoping Review. Early, J., Gonzalez, C., Gordon-Dseagu, V., et al.[2020]

In a study involving 66 low-literate traditional midwives and 15 high-literate certified midwives in Liberia, SMS technology was found to be more successfully utilized by certified midwives, highlighting the importance of literacy in data transmission accuracy.

The study revealed that traditional midwives had a significantly higher error rate in SMS reporting compared to certified midwives, suggesting that SMS interventions should be tailored for health care workers with higher literacy levels to improve data collection efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Texting From the Bush: Data Collection Using SMS Text Messaging in Areas of Low Network Coverage From Low-Literacy Providers. Perosky, JE., Munro, ML., Kay, JL., et al.[2022]

In a study conducted in Singida, Tanzania, community health workers (CHWs) trained to use a smartphone application reported improved quality of care and communication during prenatal counseling visits, highlighting the positive impact of mobile health (mHealth) tools on service delivery.

Clients and supervisors perceived smartphone-assisted counseling as a sign of modern healthcare, which enhanced their expectations of health services, suggesting that integrating mHealth into health systems can lead to better maternal and newborn health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'It makes you someone who changes with the times': health worker and client perspectives on a smartphone-based counselling application deployed in rural Tanzania. Hackett, K., Kazemi, M., Lafleur, C., et al.[2020]

A user-centered design thinking approach was successfully used to create a two-way SMS text messaging tool that enhances communication between patients with chronic conditions and community health workers, based on feedback from 127 patients and caregivers.

The final tool evolved from a basic template to a dynamic and personalized system that addresses individual patient needs, including social factors like transportation and appointment reminders, making it more effective for patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Two-Way Interactive Text Messaging Application for Low-Income Patients with Chronic Medical Conditions: Design-Thinking Development Approach. Marko-Holguin, M., Cordel, SL., Van Voorhees, BW., et al.[2020]

Mobile phones significantly empower community health workers (CHWs) by enhancing their influence and status, which can lead to improved community health outcomes.

The advancement of mobile health (mHealth) applications is expected to primarily occur through a 'diffusion of innovation' process rather than solely through formal intervention research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cell phones and CHWs: a transformational marriage? [2021]

Text-message reminders for health workers (HWs) were well-received and appreciated as helpful job aids, but did not significantly improve adherence to case management guidelines due to systemic barriers like high workloads and stock-outs.

The study suggests that while SMS reminders can enhance understanding of treatment guidelines, additional support such as targeted supervision and two-way communication may be necessary to overcome structural challenges and improve clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mobile phone text message reminders on health workers' adherence to case management guidelines for malaria and other diseases in Malawi: lessons from qualitative data from a cluster-randomized trial. Kaunda-Khangamwa, BN., Steinhardt, LC., Rowe, AK., et al.[2020]

Community Health Workers found mobile phone-based text messaging to be a feasible and effective tool for collecting and reporting data on Lymphatic Filariasis morbidity, enhancing their performance and efficiency.

The use of mobile technology significantly reduced paperwork, increased patient access to healthcare services, and allowed for real-time reporting, demonstrating its potential to improve health systems in low- and middle-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The viability of utilising phone-based text messages in data capture and reporting morbidities due to lymphatic Filariasis by community health workers: a qualitative study in Kilwa district, Tanzania. Kalinga, A., Munga, M., Ngenya, A., et al.[2022]

Mobile phone-based information systems can enhance the management and supervision of community health workers (CHWs), as demonstrated in two Randomized Controlled Trials in South Africa.

These systems allow CHWs to initiate intervention visits and receive real-time support from supervisors, potentially improving the quality of health interventions, although the actual impact on community health outcomes still needs further evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value of a mobile information system to improve quality of care by community health workers. Tomlinson, M., Rotheram-Borus, MJ., Doherty, T., et al.[2022]

A study conducted in 100 health centers in north-western China found that mobile phone text messaging significantly improved health workers' knowledge of clinical recommendations compared to traditional training methods, with knowledge scores increasing in the text messaging group but not in the control group.

The use of text messaging also led to a decrease in steroid prescriptions by 5 percentage points among health workers, while the control group saw an increase in both antibiotic and steroid prescriptions, highlighting the potential of text messaging to positively influence prescribing behavior in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of text messages to communicate clinical recommendations to health workers in rural China: a cluster-randomized trial. Chen, Y., Yang, K., Jing, T., et al.[2022]

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Text Messaging vs In-Person Counseling for Maternal Health

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