Active — Not RecruitingNot Applicable

Doulas as Environmental Educators and Partners Study

United States120 participantsStarted 2023-10-20

Plain-language summary

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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * Doulas currently working with pregnant individuals \<30 weeks into their pregnancy * Pregnant individuals working with doulas who are \<30 weeks into their pregnancy Exclusion criteria: * Doulas not currently working with pregnant individuals \<30 weeks into their pregnancy * Pregnant individuals working with doulas who are beyond 30 weeks into their pregnancy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Baseline phthalate environmental health literacy

Timeframe: Up to 2 weeks

Change from baseline phthalate environmental health literacy

Timeframe: Up to 4 weeks

Baseline urinary biomarkers of phthalate exposure

Timeframe: Up to 2 weeks

Change in urinary biomarkers of phthalate exposure

Timeframe: Up to 4 weeks

Trial details

NCT IDNCT06032143

SponsorHarvard School of Public Health (HSPH)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-30

View on ClinicalTrials.gov More Health Knowledge, Attitudes, Practice trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Baseline phthalate environmental health literacy

Timeframe: Up to 2 weeks

Change from baseline phthalate environmental health literacy

Timeframe: Up to 4 weeks

Baseline urinary biomarkers of phthalate exposure

Timeframe: Up to 2 weeks

Change in urinary biomarkers of phthalate exposure

Timeframe: Up to 4 weeks