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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The aims of this project are: Aim 1: Determine the extent to which an environmental health literacy educational intervention designed for doulas improves their environmental health literacy of endocrine disrupting chemicals (EDCs) in personal care products. Hypothesis 1a. Doulas who participate in an environmental health literacy course will have a higher environmental health literacy score based on quantitative questionnaire evaluation post-course compared to pre-course. Hypothesis 1b. Doulas who participate in the environmental health literacy course will have a higher environmental health literacy scores post-course compared to doulas who do not take the environmental health literacy course. Aim 2: Determine the extent to which pregnant people counseled by doulas with training in environmental health literacy have higher environmental health literacy scores and lower usage of personal care products containing EDCs following doula counseling. Hypothesis 2a. Compared to pregnant people not counseled by doulas on EDCs in personal care products, pregnant individuals counseled by doulas on these EDCs will have improved scores in environmental health literacy. Hypothesis 2b. Compared to pregnant people not counseled by doulas on EDCs in personal care products, pregnant individuals receiving counseling will use fewer personal care products associated with containing EDCs based on a validated questionnaire. Aim 3: Determine whether concentrations of EDC biomarkers decreased after the intervention for the intervention group. Hypothesis 3: Urinary phthalate metabolite concentrations will be lower post-course compared to pre-course for the intervention group.

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 data supports the effectiveness of the treatment Doula Environmental Education for Health Literacy?

Research shows that patient education, especially when it involves clear communication and self-management support, can improve health outcomes for people with limited health literacy. Additionally, behaviorally-oriented programs that focus on changing the environment where patients manage their health have been successful in improving health outcomes. ^{1 2 3 4 5}

How does the Doula Environmental Education for Health Literacy treatment differ from other treatments?

This treatment is unique because it focuses on increasing environmental health literacy, which involves understanding and using environmental health information to make informed choices and reduce health risks. Unlike traditional medical treatments, this approach emphasizes education and community involvement to improve health outcomes. ^{6 7 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Interventions to Improve Care for Patients with Limited Health Literacy. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Strategic planning in patient education. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

[Does patient knowledge improve treatment outcome?]. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Does patient education in chronic disease have therapeutic value? [2019]

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

Putting the pieces in place: the patient education puzzle. [2019]

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

The Emergence of Environmental Health Literacy-From Its Roots to Its Future Potential. [2018]

7. Italy pubmed.ncbi.nlm.nih.gov

Environmental health literacy within the Italian Asbestos Project: experience in Italy and Latin American contexts. Commentary. [2017]

8. England pubmed.ncbi.nlm.nih.gov

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

9. Switzerland pubmed.ncbi.nlm.nih.gov

Increasing Environmental Health Literacy through Contextual Learning in Communities at Risk. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

What Do Childcare Providers Know about Environmental Influences on Children's Health? Implications for Environmental Health Literacy Efforts. [2021]