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Doulas as Environmental Educators and Partners Study

Study acronym: DEEP
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 30, 2026 → Dec 30, 2026
See other at-risk trials from Harvard School of Public Health (HSPH)

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Primary completion pushed from Jul 30, 2026 to Dec 30, 2026
    • Study completion pushed from Sep 15, 2026 to Mar 15, 2027
    • Eligibility criteria expanded, about 4 words
  2. Notable Primary completion pushed from Jan 30, 2026 to Jul 30, 2026
    • Study completion pushed from Feb 15, 2026 to Sep 15, 2026
    v10
  3. Minor Primary completion date: Sep 30, 2025 to Jan 30, 2026
    • Study completion date: Sep 30, 2025 to Feb 15, 2026
    v9
  4. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Apr 30, 2025 to Sep 30, 2025
    • Site details revised
    v8
  5. Minor Primary and study completion dates: Dec 30, 2024 to Apr 30, 2025v7
Show 5 earlier versionsHide 5 earlier versions
  1. Minor Primary completion date: Aug 30, 2024 to Dec 30, 2024
    • Study completion date: Oct 30, 2024 to Dec 30, 2024
    v6
  2. Minor Primary completion date: Mar 30, 2024 to Aug 30, 2024
    • Study completion date: May 30, 2024 to Oct 30, 2024
    v5
  3. Minor Primary completion date: Nov 30, 2023 to Mar 30, 2024
    • Study completion date: Jan 30, 2024 to May 30, 2024
    v4
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 30, 2023 to Oct 20, 2023
    v3
  5. Notable Start date: Aug 30, 2023 to Sep 30, 2023v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06032143
Lead Sponsor Harvard School of Public Health (HSPH)
Conditions
(from sponsor)
Health Knowledge, Attitudes, Practice
Related terms Behavior
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov