Impacts of Clinician-Mediated Report-Back

NCT06074159 | Completed Results

• 2 other identifiers: 1R21ES032934-01A1b1R21ES032934-01A1
• Study Type: interventional
• Target: 163
• Locations: 2 countries
• Sites: 2

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.

Conditions

Health Knowledge, Attitudes, Practice

Outcome Measures

Primary Outcomes (5)

• Knowledge Before and After Report-back Intervention.

  Participants were asked to respond to a series of 9-11 statements about environmental exposures and select if they were true, probably true, probably false, or false. Responses were re-coded to indicate correctness, and index score was calculated as the fraction of correct responses across all questions for each participant (0-1). Pre-survey knowledge indices were subtracted from post-survey indices to calculate the change after report-back (i.e., pre-post-survey change in knowledge is reported below). A larger reported mean below would indicate that report-back mode resulted in a larger knowledge gain (a better outcome).

  Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of 6 weeks.

• Satisfaction With Report-back After Report-back Intervention

  Participants were asked to rank their agreement with four satisfaction questions at the post-survey using a Likert-scale from 1 (strongly disagree) to 5 (strongly agree). Responses to all four questions were summed to calculate post-report-back sum satisfaction from 4-20. A higher score indicates more satisfaction (a better outcome).

  Participants completed post-surveys at least 2 weeks after report-back up to a maximum of 6 weeks.

• Feelings About Report-back, Before and After Intervention

  Participants ranked the strength of each feeling using a Likert-scale from 1 (not at all) to 6 (very strong). Pre-survey responses were subtracted from post-survey responses to calculate the change after report-back. A higher score for outcomes measures such as empowered and respected indicates a better outcome.

  Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of 6 weeks.

• Perceived Self-efficacy Before and After Report-back Intervention

  Participants were asked to respond to a series of seven statements and rate confidence in their abilities using a Likert-scale from 0 (cannot do it at all) to 6 (highly certain I can do it). Responses to all seven questions were summed to calculate a perceived self-efficacy scale from 0-42. Pre-survey scales were subtracted from post-survey scales to calculate the change after report-back. A higher scores indicates a better outcome.

  Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of 6 weeks.

• Behaviors Before and After Report-back Intervention

  Participants were asked to rate how frequently they engaged in exposure-related behaviors during the previous two weeks using a Likert-scale from 0 (never) to 3 (Always/almost every day). Pre-survey responses were subtracted from post-survey responses to calculate the change after report-back. A higher score indicates a better outcome for questions such as 'look for information about chemical ingredients', whereas a lower score indicates a better outcome for questions such as 'microwave food in plastic containers.'

  Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of six weeks.

Study Arms (2)

In-clinic report-back

OTHER

200 participants receive their personal exposure results from a clinician

Behavioral: In-clinic report-back

Online

OTHER

200 participants receive their personal exposure results from a website online

Behavioral: In-clinic report-back

Interventions

In-clinic report-back BEHAVIORAL

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

In-clinic report-back; Online

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants are of reproductive age

You may not qualify if:

• Under 18 years old or past reproductive age

Sponsors & Collaborators

• Harvard University: collaborator
• Silent Spring Institute: lead
• University of Puerto Rico: collaborator
• Northeastern University: collaborator

Study Sites (2)

Harvard T.H Chan School of Public Health

Boston, Massachusetts, 02115, United States

Location

University of Puerto Rico Medical Sciences Campus

San Juan, 00936, Puerto Rico

Location

MeSH Terms

Conditions

Behavior

Results Point of Contact

• Title: Dr. Jennifer Liss Ohayon
• Organization: Silent Spring Institute

ohayon@silentspring.org

617-332-4288

Study Officials

• Jennifer Ohayon, PhD

  Silent Spring Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: October 10, 2023
• Study Start: August 25, 2023
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: April 24, 2026
• Results First Posted: April 24, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); PR (1)