NCT07758114

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Apr 2029

Study Start

First participant enrolled

August 1, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

2.7 years

First QC Date

August 5, 2026

Last Update Submit

August 5, 2026

Conditions

Environmental ExposurePregnancy RelatedPreterm BirthChronic Respiratory DiseaseNeurodegenerative Diseases

Keywords

Safe Seafood ConsumptionEnvironmental ExposureSuperfundFDA Dietary GuidePregnancy

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    3 months and 12 months following completion of the curriculum

Study Arms (1)

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.

Behavioral: Educational Intervention

Interventions

Educational InterventionBEHAVIORAL

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.

Single intervention arm

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Participants will not be considered if they are younger than 18 and are not pregnant, trying, or a mom.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St Vincent's Hope Clinics

Galveston, Texas, 77550, United States

RECRUITING

University of Texas Medical Branch, Galveston

Galveston, Texas, 77555-0133, United States

RECRUITING

MeSH Terms

Conditions

Premature BirthNeurodegenerative Diseases

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Central Study Contacts

Lance Hallberg, PhD

CONTACT

(409)772-3797lmhallbe@utmb.edu

Cynthia Hallmark

CONTACT

(409)772-9110cchallma@utmb.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 11, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Last Updated

August 11, 2026

Record last verified: 2026-08

Locations

US(2)