Impacts of Clinician-Mediated Report-Back

NCT ID: NCT06074159

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-25

Study Completion Date

2024-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study trains clinicians to return personal exposure results to study participants in pregnancy cohorts, and measures outcomes for environmental health literacy for both clinicians and study participants.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To design and implement clinic-based report-back for endocrine disrupting compounds and analyze the impacts of doing so, investigators train clinicians to report-back individual chemical results to study participants in two pregnancy cohorts and then evaluate outcomes for both clinicians and patients, including shifts in environmental health behaviors, using interviews and pre-and post-tests. All study participants will get a personal exposure report and 200 participants from each cohort (N Total= 400) are randomly selected and assigned equally to one of two groups: 1) those who only receive their personal results online and 2)those who receive them in-clinic to measure additional benefits of clinical report-back for participant learning, exposure-related behaviors, and relationships to the study and clinical care.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Health Knowledge, Attitudes, Practice

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

All study participants in two pregnancy cohorts will get a personal exposure report for chemicals measured during their pregnancy. 200 participants from each cohort (N Total= 400) are randomly selected and assigned equally to one of two groups: 1) those who only receive their personal results online and 2)those who receive in-clinic to measure differences in participants' environmental health literacy. Pre-and post-tests are administered before and after report-back.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

In-clinic report-back

200 participants receive their personal exposure results from a clinician

Group Type OTHER

In-clinic report-back

Intervention Type BEHAVIORAL

Investigators measure whether report-back from a clinician improves environmental health literacy, including leading to greater shifts in exposure-reducing health behaviors

Online

200 participants receive their personal exposure results from a website online

Group Type OTHER

In-clinic report-back

Intervention Type BEHAVIORAL

Investigators measure whether report-back from a clinician improves environmental health literacy, including leading to greater shifts in exposure-reducing health behaviors

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

In-clinic report-back

Investigators measure whether report-back from a clinician improves environmental health literacy, including leading to greater shifts in exposure-reducing health behaviors

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participants are of reproductive age

Exclusion Criteria

* Under 18 years old or past reproductive age
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Puerto Rico

OTHER

Sponsor Role collaborator

Northeastern University

OTHER

Sponsor Role collaborator

Harvard University

OTHER

Sponsor Role collaborator

Silent Spring Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jennifer Ohayon, PhD

Role: PRINCIPAL_INVESTIGATOR

Silent Spring Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Harvard T.H Chan School of Public Health

Boston, Massachusetts, United States

Site Status

University of Puerto Rico Medical Sciences Campus

San Juan, , Puerto Rico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Puerto Rico

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R21ES032934-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R21ES032934-01A1b

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Doulas as Environmental Educators and Partners Study
NCT06032143 ACTIVE_NOT_RECRUITING NA