Health Knowledge, Attitudes, PracticeNCT06074159

Impacts of Clinician-Mediated Report-Back

A study testing In-clinic report-back in people with Health Knowledge, Attitudes, Practice, run by Silent Spring Institute at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for: Health Knowledge, Attitudes, Practice
What is being tested?: In-clinic report-back
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 163 participants
Where: 2 sitesin 2 countries
Study dates: 25 Aug 2023to 20 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 55 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Participants are of reproductive age

Who cannot join

Under 18 years old or past reproductive age

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

Harvard T.H Chan School of Public Health
Boston, Massachusetts, 02115

Other trials in United States

Puerto Rico1 site

University of Puerto Rico Medical Sciences Campus
San Juan, 00936

Other trials in Puerto Rico

About this study

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

Read the 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.

Conditions: Health Knowledge, Attitudes, Practice
Being tested: In-clinic report-back
Medical subject headings: Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06074159
Study group	Role	What they receive
In-clinic report-back	Other	200 participants receive their personal exposure results from a clinician Receives: Behavioral: In-clinic report-back
Online	Other	200 participants receive their personal exposure results from a website online Receives: Behavioral: In-clinic report-back

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Aug 202320 Dec 2024

First posted10 Oct 2023
Study start25 Aug 2023
Primary completion20 Dec 2024
Study completion20 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Health Knowledge, Attitudes, PracticeStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 163 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06074159
Sponsor's protocol ID: 1R21ES032934-01A1b
Other IDs: 1R21ES032934-01A1
Status last verified: May 2025
First submitted: 14 Sep 2023
Last updated: 24 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Expanding Effective Report-back of Environmental Exposures in Clinic-Based Studies
ClinicalTrials.gov ID: NCT06074159
Acronym / sponsor ID: 1R21ES032934-01A1b
Conditions: Health Knowledge, Attitudes, Practice
Study type: Interventional
Recruitment status: Completed
Enrolment: 163 participants (actual)
Lead sponsor: Silent Spring InstituteUniversity, hospital or other
Collaborators: University of Puerto Rico, Northeastern University, Harvard University
Study start: 25 Aug 2023 (actual)
Primary completion: 20 Dec 2024 (actual)
Study completion: 20 Dec 2024 (actual)
First posted: 10 Oct 2023 (actual)
Results: Posted 24 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
In-clinic report-back	Other	Behavioral: In-clinic report-back200 participants receive their personal exposure results from a clinician
Online	Other	Behavioral: In-clinic report-back200 participants receive their personal exposure results from a website online

Who may qualify

Ages: 18 to 55 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Participants are of reproductive age

Key exclusion criteria (1 listed)

Under 18 years old or past reproductive age

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
In-clinic report-backInvestigators measure whether report-back from a clinician improves environmental health literacy, including leading to greater shifts in exposure-reducing health behaviors	Behavioural	In-clinic report-back, Online

Primary outcome

Knowledge Before and After Report-back Intervention.
Time frame: Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of 6 weeks.
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).
Satisfaction With Report-back After Report-back Intervention
Time frame: Participants completed post-surveys at least 2 weeks after report-back up to a maximum of 6 weeks.
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).
Feelings About Report-back, Before and After Intervention
Time frame: Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of 6 weeks.
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.
Perceived Self-efficacy Before and After Report-back Intervention
Time frame: Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of 6 weeks.
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.
Behaviors Before and After Report-back Intervention
Time frame: Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of six weeks.
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.'

Results and safety

Results posted to the registry on 24 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Clinician-guided Report-back	88	88
Self-guided Report-back	75	75

Primary outcome: Knowledge Before and After Report-back Intervention.

Time frame: Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of 6 weeks.. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Clinician-guided Report-back n = 87	Self-guided Report-back n = 75
Value	0.06 (0.14)	0.02 (0.16)

Population analysed: Participant responses were excluded if they selected "decline to answer" for any knowledge question at either survey.

Primary outcome: Satisfaction With Report-back After Report-back Intervention

Time frame: Participants completed post-surveys at least 2 weeks after report-back up to a maximum of 6 weeks.. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Clinician-guided Report-back n = 88	Self-guided Report-back n = 74
Value	18.58 (2.09)	17.57 (2.53)

Population analysed: Participant responses were excluded if they selected "decline to answer" or "don't know."

Primary outcome: Feelings About Report-back, Before and After Intervention

Time frame: Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of 6 weeks.. Mean (Standard Deviation). Unit: Scores on a scale.

Measure	Clinician-guided Report-back n = 87	Self-guided Report-back n = 73
Empowered	0.24 (1.19)	0.03 (1.29)
Respected	0.26 (0.98)	0.24 (1.16)
Worried	0.03 (1.62)	-0.18 (1.77)

Population analysed: Participant responses were excluded if they selected "decline to answer" or "don't know" at either survey.

Primary outcome: Perceived Self-efficacy Before and After Report-back Intervention

Time frame: Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of 6 weeks.. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Clinician-guided Report-back n = 85	Self-guided Report-back n = 69
Value	0.85 (6.94)	0.39 (7.82)

Population analysed: Participant responses were excluded if they selected "decline to answer" or "don't know" for any self-efficacy question at either survey.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
In-clinic Report-back	0 of 0	0 of 0	0
Self-guided Report-back	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jennifer Ohayon, PhD principal investigator

Silent Spring Institute

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing In-clinic report-back in people with Health Knowledge, Attitudes, Practice, run by Silent Spring Institute at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knowledge Before and After Report-back Intervention. (time frame: Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of 6 weeks.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06074159.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.