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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21ES032934-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Puerto Rico | OTHER |
| Northeastern University | OTHER |
| Harvard University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-clinic report-back | Other | 200 participants receive their personal exposure results from a clinician |
|
| Online | Other | 200 participants receive their personal exposure results from a website online |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Ohayon, PhD | Silent Spring Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard T.H Chan School of Public Health | Boston | Massachusetts | 02115 | United States | ||
| University of Puerto Rico Medical Sciences Campus |
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Only study participants who received personal exposure reports were considered enrolled in the study. Clinicians also took part in the study but were not considered enrolled.
Participants were recruited from two prospective pregnancy cohort studies. For our study, we analyzed outcomes from different approaches to sharing chemical exposure results (self-guided versus in-clinic report-back). For both cohorts, participants were randomly assigned to the clinician-guided or self-guided intervention group and then contacted by phone, email, and/or text to enroll in the study. A pre-test was given after enrolling, participants viewed reports, and then did a post-test.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clinician-guided Report-back | Participants assigned to clinician-guided report-back were scheduled for an appointment to meet with a clinician in-person at a clinic or virtually. |
| FG001 | Self-guided Report-back | Participants assigned to the self-guided report-back group received an access code to view their report online. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Clinician-guided Report-back | Participants receive their personal exposure results from a clinician. |
| BG001 | Self-guided Report-back | Participants receive their personal exposure results from a website online |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Participant responses were excluded if they selected "decline to answer" for any knowledge question at either survey. | Posted | Mean | Standard Deviation | Scores on a scale | Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of 6 weeks. |
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No adverse event data relating to mortality or other serious adverse events was collected. Our study focused on impacts of environmental health report-back, and was evaluated by pre- and post-tests.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | In-clinic Report-back | 200 participants receive their personal exposure results from a clinician |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Liss Ohayon | Silent Spring Institute | 617-332-4288 | ohayon@silentspring.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2026 | Jan 30, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001519 | Behavior |
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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.
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| 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. |
| San Juan |
| 00936 |
| Puerto Rico |
| BG002 | Total | Total of all reporting groups |
| Age in years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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Participants receive their personal exposure results from a clinician |
| OG001 | Self-guided Report-back | Participants receive their personal exposure results from a website online |
|
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| Primary | 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). | Participant responses were excluded if they selected "decline to answer" or "don't know." | Posted | Mean | Standard Deviation | Scores on a scale | Participants completed post-surveys at least 2 weeks after report-back up to a maximum of 6 weeks. |
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| Primary | 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. | Participant responses were excluded if they selected "decline to answer" or "don't know" at either survey. | Posted | Mean | Standard Deviation | Scores on a scale. | Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of 6 weeks. |
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| Primary | 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. | Participant responses were excluded if they selected "decline to answer" or "don't know" for any self-efficacy question at either survey. | Posted | Mean | Standard Deviation | Scores on a scale | Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of 6 weeks. |
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| Primary | 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.' | Participant responses were excluded if they selected "decline to answer" or "don't know" at either survey. | Posted | Mean | Standard Deviation | Scores on a scale | Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of six weeks. |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Self-guided Report-back | 200 participants receive their personal exposure results from a website online | 0 | 0 | 0 | 0 | 0 | 0 |
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| Respected |
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| Worried |
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| Microwave food in a plastic container? |
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| Use air fresheners in your home? |
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| Use chemical pesticides or insecticides? |
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| Use products advertised as antibacterial or antimicrobial? |
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