Doula Environmental Education for Health Literacy

(DEEP Trial)

Overseen By Kathryn Tomsho, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Harvard School of Public Health (HSPH)

Disqualifiers: Pregnancy beyond 30 weeks

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether educating doulas about harmful chemicals in personal care products can help them inform pregnant individuals about these risks. The goal is to determine if this education improves understanding and reduces the use of products containing endocrine-disrupting chemicals (EDCs). The trial includes two groups: some doulas and pregnant individuals will receive new training, which covers environmental education and discussions about environmental exposures, while others will not, allowing for comparison. Suitable participants are doulas or pregnant individuals who are less than 30 weeks into their pregnancy. As an unphased trial, this study offers participants the chance to contribute to important educational research that could enhance health outcomes for pregnant individuals.

Do I have to stop taking my current medications for this trial?

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

What prior data suggests that this educational intervention is safe for doulas and pregnant individuals?

In a previous study, researchers developed a one-hour online course for health professionals about phthalates, chemicals found in many personal care products. The course aimed to enhance understanding of how these chemicals might affect health. Importantly, participants reported no negative effects from taking this course.

Another study examined the link between phthalate exposure and health issues, such as pregnancy complications. However, learning about these chemicals through a course poses no known risks. Therefore, participating in an educational program like this is considered safe for both doulas and pregnant individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to boost health literacy among pregnant individuals regarding environmental chemical exposures, specifically phthalates. Unlike traditional education methods, this trial uses doulas to engage directly in meaningful conversations and offers an online course for doulas about phthalates, which are linked to reproductive health. These approaches not only aim to improve understanding but also empower pregnant individuals with actionable knowledge, potentially leading to better health outcomes for both mothers and babies.

What evidence suggests that this trial's educational interventions could be effective for improving environmental health literacy?

This trial will compare different educational approaches for doulas and pregnant individuals. Research has shown that teaching doulas about phthalates and their health risks can enhance their understanding and health practices. In this trial, some doulas will receive online training about phthalates, which studies have found helps health professionals better understand how to avoid harmful chemicals. This training could enable them to make safer choices about personal care products, potentially reducing harmful exposure. Early findings suggest that when doulas learn about environmental health, they can share important information with pregnant people, possibly reducing exposure to chemicals that can affect hormones. Meanwhile, other doulas and pregnant individuals will receive education on alternative environmental exposures. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for doulas currently working with pregnant individuals who are less than 30 weeks into their pregnancy, as well as the pregnant individuals themselves. The study aims to improve knowledge about harmful chemicals in personal care products and reduce their use.

Inclusion Criteria

You are a doula currently providing services to individuals who have not yet reached 30 weeks gestation.

You are pregnant and have a doula who is less than 30 weeks along in the gestation period.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Educational Intervention

Doulas participate in an environmental health literacy course about EDCs in personal care products

1 hour

1 visit (virtual)

Counseling and Monitoring

Doulas counsel pregnant individuals on EDCs, and environmental health literacy and urinary biomarkers are measured

4 weeks

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for changes in environmental health literacy and urinary biomarkers post-intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control environmental education
• Environmental exposures conversation
• Online educational phthalate course
• Phthalate conversation

Trial Overview The study tests whether an educational course on environmental health literacy can increase doulas' understanding of endocrine disrupting chemicals (EDCs) and if this knowledge can help expectant mothers make safer choices regarding personal care products.

How Is the Trial Designed?

Group I: Intervention Pregnant Individuals Experimental Treatment 1 Intervention

Pregnant individuals working with intervention doulas will be asked to have a conversation with their doulas about environmental chemicals (phthalates).

Group II: Intervention Doulas Experimental Treatment 1 Intervention

Doulas randomized to the intervention group will engage in a one-hour online course about exposure to phthalates and the relationship with reproductive health.

Group III: Control Pregnant Individuals Placebo Group 1 Intervention

Pregnant individuals working with control doulas will be asked to have a conversation with their doulas about environmental chemicals (distinct from phthalates).

Group IV: Control Doulas Placebo Group 1 Intervention

Doulas randomized to the control group will access a worksheet about an alternative environmental exposure and the relationship with reproductive health.

Who Is Running the Clinical Trial?

Harvard School of Public Health (HSPH)

Lead Sponsor

Trials

283

Recruited

17,030,000+

Published Research Related to This Trial

Environmental health literacy (EHL) is crucial for enabling individuals to make informed choices that reduce health risks and improve quality of life, emphasizing the need for access to scientific information.

The Italian National Asbestos Project has successfully implemented EHL initiatives in both Italy and Latin American countries, focusing on the dangers of asbestos and fluoro-edenite fibers, highlighting the importance of tailored approaches based on local contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Environmental health literacy within the Italian Asbestos Project: experience in Italy and Latin American contexts. Commentary. Marsili, D., Comba, P., De Castro, P.[2017]

The study found that new and expecting mothers encounter approximately three pieces of prenatal and pediatric environmental health information in popular media each day, indicating a consistent presence of this information despite previous declines in environmental health coverage.

While some concerning chemicals like pesticides and cigarette smoke received significant media attention, others, such as lead and phthalates, were underreported, highlighting gaps in the information available to vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Media Coverage of Toxic Risks: A Content Analysis of Pediatric Environmental Health Information Available to New and Expecting Mothers. Mello, S.[2017]

Environmental health literacy (EHL) is emerging as a new subdiscipline that integrates concepts from various fields, aiming to improve understanding and communication about environmental health risks.

The article proposes a refined definition and framework for EHL, suggesting that enhancing EHL can lead to better health outcomes by improving community engagement and addressing health disparities in environmental health research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emergence of Environmental Health Literacy-From Its Roots to Its Future Potential. Finn, S., O'Fallon, L.[2018]

The study involved 53 participants from four Arizona communities and showed that tailored Environmental Health Literacy (EHL) trainings significantly increased knowledge and self-efficacy regarding environmental health risks, particularly in rainwater harvesting and water contamination.

The interdisciplinary approach not only enhanced participants' skills but also fostered trust and collaboration between scientists and community members, highlighting the importance of contextual EHL education in addressing local environmental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Environmental Health Literacy through Contextual Learning in Communities at Risk. Davis, LF., Ramirez-Andreotta, MD., McLain, JET., et al.[2023]

Non-compliance in patients is often due to a lack of information and support from healthcare providers rather than intentional neglect, highlighting the need for better communication and education.

Effective self-management programs, particularly for conditions like type 1 diabetes and severe asthma, can significantly improve treatment outcomes when they provide evidence-based knowledge and empower patients, unlike generic programs that do not target specific diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Does patient knowledge improve treatment outcome?]. Mühlhauser, I., Lenz, M.[2019]

Effective patient education is crucial for enhancing patient satisfaction and improving clinical outcomes, as it has been shown to reduce hospital stays.

The Patient Family Educational Advisory Committee (PFEAC) emphasizes the need for coordinated health education across all care disciplines, focusing on common issues related to culture, documentation, and competency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Putting the pieces in place: the patient education puzzle. Gaynor, S., Patyk, M.[2019]

A study involving semi-structured interviews with 36 childcare providers in Illinois revealed that most had a low understanding of environmental toxicants and their potential risks to children's health.

The findings suggest that increasing environmental health literacy among childcare providers is crucial, as they play a significant role in protecting children from toxicant exposures in their care environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Do Childcare Providers Know about Environmental Influences on Children's Health? Implications for Environmental Health Literacy Efforts. Koester, BD., Sloane, S., Fujimoto, EM., et al.[2021]

Patient education significantly improves compliance with therapeutic regimens in chronic disease management, with an average improvement of 0.67 sigma over control groups, indicating a strong effect.

While patient education also leads to improvements in physiological progress (0.49 sigma) and health outcomes (0.02 sigma), the most effective strategies involve behaviorally-oriented programs that focus on changing the patient's environment rather than just increasing knowledge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does patient education in chronic disease have therapeutic value? Mazzuca, SA.[2019]

About half of U.S. adults have limited health literacy (LHL), which is linked to poorer health outcomes and increased health disparities, highlighting the need for effective interventions.

Implementing evidence-based communication strategies, such as patient-centered communication and clear health education materials, can significantly improve health outcomes for patients with LHL and benefit individuals of all literacy levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to Improve Care for Patients with Limited Health Literacy. Sudore, RL., Schillinger, D.[2022]

Patient education is a structured process that aims to change the knowledge, attitudes, and skills of individuals interacting with health services, ultimately promoting better health behaviors.

The author introduces a strategic planning tool designed to enhance the effectiveness of patient education, helping healthcare professionals support patients and their families in adopting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategic planning in patient education. Close, A.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11675889/

Evaluating the Effect of a Virtual Intervention on Phthalate ... Such interventions could provide knowledge of environmental exposure risks and opportunities to exercise protective measures, improving health outcomes across ...

2. stacks.cdc.gov stacks.cdc.gov/view/cdc/208653

Evaluating the Effect of a Virtual Intervention on Phthalate ... Improving the Health and Environmental Health Literacy of Professionals: Evaluating the Effect of a Virtual Intervention on Phthalate Environmental Health ...

3. ehp.niehs.nih.gov ehp.niehs.nih.gov/doi/full/10.1289/EHP13128

Environmental Reproductive Health Literacy and Phthalates. Our objective is to develop a multidimensional scale characterizing latent factors of phthalate knowledge, risk perception, and self-efficacy.

4. nature.com nature.com/articles/s41370-024-00706-6

Journal of Exposure Science & Environmental Epidemiology The field of environmental health literacy seeks to measure how environmental health information is conceptualized and used to inform behaviors.

5. researchgate.net researchgate.net/publication/386205388_Improving_the_Health_and_Environmental_Health_Literacy_of_Professionals_Evaluating_the_Effect_of_a_Virtual_Intervention_on_Phthalate_Environmental_Health_Literacy

Evaluating the Effect of a Virtual Intervention on Phthalate ... ... environmental exposures ... Background: Substantial evidence exists linking phthalate exposure to adverse reproductive health outcomes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2775531/

Environmental phthalate exposure in relation to ... This review summarizes recent data on human exposure to phthalates at environmental levels and associated health endpoints in humans.

7. acog.org acog.org/clinical/clinical-guidance/committee-opinion/articles/2021/07/reducing-prenatal-exposure-to-toxic-environmental-agents

Reducing Prenatal Exposure to Toxic Environmental Agents Toxic exposures related to reproductive and developmental health primarily have been associated with infertility and miscarriage, obstetric outcomes such as ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0013935124007291

Association of phthalate exposure with reproductive ... This review conducted a systematic evaluation of 16 papers related to phthalate exposure and ART pregnancy outcomes, to provide more aggregated results.

9. stacks.cdc.gov stacks.cdc.gov/view/cdc/208653/cdc_208653_DS1.pdf

Improving the Health and Environmental Health Literacy of ... Thus, reducing perinatal phthalate exposure is advantageous for both parent and child health. The development of educational interventions to ...