Environmental ExposurePEEPSNCT07758114
Prenatal Education on Environmental Exposures During Pregnancy Study (PEEPS)
A study testing Educational Intervention in people with Environmental Exposure and Pregnancy Related, run by The University of Texas Medical Branch, Galveston at 2 sites in United States.
Trial summary
The purpose of this project is to reduce maternal environmental exposures to toxicants through a patient education program designed to help pregnant women learn about exposure through consumption of contaminated seafood and to be able to use the lessons they learn to have a better understanding of risk. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Environmental Exposure, Pregnancy Related, Preterm Birth
- What is being tested?
- Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Aug 2026to Apr 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be at least 18 years old
- Must be pregnant, trying, or a mom
- Must not have any conditions that would prevent them from carrying out study activities
- Must be able to complete surveys and understand instructions
Who cannot join
- Participants will not be considered if they are younger than 18 and are not pregnant, trying, or a mom.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
St Vincent's Hope Clinics
Galveston, Texas, 77550
Lance Hallberg, PhD, 409-772-3797, lmhallbe@utmb.edu
Cynthia Hallmark, (409) 772-9110, cchallma@utmb.edu
- Recruiting
University of Texas Medical Branch, Galveston
Galveston, Texas, 77555-0133
Lance Hallberg, PhD, 409-772-3797, lmhallbe@utmb.edu
Cynthia Hallmark, 409-772-9110, cchallma@utmb.edu
About this study
The purpose of this project is to reduce maternal environmental exposures to toxicants through a patient education program designed to help pregnant women learn about exposure through consumption of contaminated seafood and to be able to use the lessons they learn to have a better understanding of risk.
Read the detailed description
The educational project proposed is to fulfill, in part, a mission to develop and adapt best practices to work with residents and local leaders of affected communities to facilitate prevention and intervention strategies that will result in community-level reductions in exposure to PAHs and other Superfund site pollutants. The communities included are those surrounding the Ship Channel, and Superfund sites, including Harrisburg/ Manchester, Galena Park, Channelview, Pasadena, Deer Park, and the Highlands. Many are Environmental Justice (EJ) communities, impacted by industrialization, poverty, and the environmental health effects of sites including the San Jacinto Waste Pits, Patrick Bayou, and dozens of downstream hot spots. An important goal is to test and validate all program materials and outcomes of the training, including satisfaction. To do this, participants will be asked to complete pre- and post-tests, an end-of-course evaluation, and complete a brief follow-up survey through two telephone calls, one completed three months following the training and a second at one year following the training.
- Conditions
- Environmental Exposure, Pregnancy Related, Preterm Birth, Chronic Respiratory Disease, Neurodegenerative Diseases
- Being tested
- Educational Intervention
- Keywords
- Safe Seafood Consumption, Environmental Exposure, Superfund, FDA Dietary Guide, Pregnancy
- Medical subject headings
- Premature Birth, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionBehavioural
The actual curriculum, infographics, and educational materials will be adapted from "Seafood at its Best," a detailed curriculum that covers four primary areas: 1) overview of seafood and seafood sourcing, 2) health benefits of seafood consumption, 3) seafood-borne illnesses and risks from seafood consumption, and 4) tips for selecting, buying, handling, storing, and cooking seafood.
| Study group | Role | What they receive |
|---|---|---|
| Single intervention arm | Experimental | Participants will complete pre- and post-surveys before and following the educational intervention, followed by and end-of-course survey and two follow-up telephone survey interviews to assess intent to alter behavior based upon risk perception, satisfaction with the educational program, and whether the educational program in making food and nutrition choices during and following pregnancy. Receives: Behavioral: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knowledge From Pre-Curriculum to Post-Curriculum Survey
Knowledge change will be measured using a structured survey administered before and immediately after completion of the curriculum. The pre-curriculum survey will assess baseline knowledge of the curriculum content, and the post-curriculum survey will assess knowledge after the educational intervention. The change in knowledge will be calculated by comparing pre-curriculum and post-curriculum survey scores. Higher scores indicate greater knowledge of the curriculum content.
Measured: Baseline (pre-curriculum) and immediately following completion of the curriculum
Behavior Change Measured by Follow-Up Survey
Behavior change will be assessed using a follow-up survey administered at 3 months and 12 months after completion of the curriculum. The survey will evaluate participants' self-reported implementation of behaviors and practices related to the curriculum content. Behavioral change over time will be evaluated by comparing survey responses collected at the 3-month follow-up with responses collected at the 12-month follow-up. Higher scores indicate greater adoption or maintenance of the targeted behaviors.
Measured: 3 months and 12 months following completion of the curriculum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start27 Aug 2026
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine, National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Sponsor
- Investigators
- Lance Hallberg, PhD, Principal investigator, The University of Texas Medical Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758114
- Sponsor's protocol ID
- 20-0026
- Other IDs
- 1P42ES027725-01A1
- Acronym
- PEEPS
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No