Impacts of Clinician-Mediated Report-Back

Sponsor

Silent Spring Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT06074159

Collaborator

University of Puerto Rico (Other), Northeastern University (Other), Harvard University (Other)

400

Enrollment

Locations

Arms

3.8

Anticipated Duration (Months)

200

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Health Knowledge, Attitudes, Practice	Behavioral: In-clinic report-back	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Expanding Effective Report-back of Environmental Exposures in Clinic-Based Studies

Actual Study Start Date :

Aug 25, 2023

Anticipated Primary Completion Date :

Dec 20, 2023

Anticipated Study Completion Date :

Dec 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: In-clinic report-back 200 participants receive their personal exposure results from a clinician	Behavioral: 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
Other: Online 200 participants receive their personal exposure results from a website online	Behavioral: 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

Arm

Intervention/Treatment

Other: In-clinic report-back

200 participants receive their personal exposure results from a clinician

Behavioral: 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

Other: Online

200 participants receive their personal exposure results from a website online

Behavioral: 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

Outcome Measures

Primary Outcome Measures

Environmental health literacy as measured by pre-and post-tests (questionnaires). [2 weeks]
2 weeks after completing a pre-test and receiving their personal results, study participants will take a post-test. Pre-and post-tests include true and false, as well as scale questions that measure shifts in environmental health literacy before and after report-back.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Participants are of reproductive age

Exclusion Criteria:

Under 18 years old or past reproductive age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harvard T.H Chan School of Public Health	Boston	Massachusetts	United States	02115
2	University of Puerto Rico Medical Sciences Campus	San Juan		Puerto Rico	00936

Sponsors and Collaborators

Silent Spring Institute
University of Puerto Rico
Northeastern University
Harvard University

Investigators

Principal Investigator: Jennifer Ohayon, PhD, Silent Spring Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Silent Spring Institute

ClinicalTrials.gov Identifier:

NCT06074159

Other Study ID Numbers:

1R21ES032934-01A1b
1R21ES032934-01A1

First Posted:

Oct 10, 2023

Last Update Posted:

Oct 10, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 10, 2023