Trial Outcomes & Findings for Impacts of Clinician-Mediated Report-Back (NCT NCT06074159)

NCT ID: NCT06074159

Last Updated: 2026-04-24

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

163 participants

Primary outcome timeframe

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

Results posted on

2026-04-24

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure
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.
Self-guided Report-back
Participants assigned to the self-guided report-back group received an access code to view their report online.
Overall Study
STARTED
88
75
Overall Study
COMPLETED
88
75
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impacts of Clinician-Mediated Report-Back

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Clinician-guided Report-back
n=88 Participants
Participants receive their personal exposure results from a clinician.
Self-guided Report-back
n=75 Participants
Participants receive their personal exposure results from a website online
Total
n=163 Participants
Total of all reporting groups
Age, Continuous
34.2 Age in years
STANDARD_DEVIATION 5.4 • n=2 Participants
36.3 Age in years
STANDARD_DEVIATION 5.7 • n=1 Participants
35.2 Age in years
STANDARD_DEVIATION 5.6 • n=3 Participants
Sex: Female, Male
Female
88 Participants
n=2 Participants
75 Participants
n=1 Participants
163 Participants
n=3 Participants
Sex: Female, Male
Male
0 Participants
n=2 Participants
0 Participants
n=1 Participants
0 Participants
n=3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=2 Participants
1 Participants
n=1 Participants
1 Participants
n=3 Participants
Race (NIH/OMB)
Asian
2 Participants
n=2 Participants
1 Participants
n=1 Participants
3 Participants
n=3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=2 Participants
0 Participants
n=1 Participants
0 Participants
n=3 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=2 Participants
3 Participants
n=1 Participants
6 Participants
n=3 Participants
Race (NIH/OMB)
White
47 Participants
n=2 Participants
32 Participants
n=1 Participants
79 Participants
n=3 Participants
Race (NIH/OMB)
More than one race
28 Participants
n=2 Participants
28 Participants
n=1 Participants
56 Participants
n=3 Participants
Race (NIH/OMB)
Unknown or Not Reported
8 Participants
n=2 Participants
10 Participants
n=1 Participants
18 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
73 Participants
n=2 Participants
61 Participants
n=1 Participants
134 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants
n=2 Participants
14 Participants
n=1 Participants
29 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=2 Participants
0 Participants
n=1 Participants
0 Participants
n=3 Participants
Region of Enrollment
United States
88 Participants
n=2 Participants
75 Participants
n=1 Participants
163 Participants
n=3 Participants

PRIMARY outcome

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

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

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).

Outcome measures

Outcome measures
Measure
Self-guided Report-back
n=75 Participants
Participants receive their personal exposure results from a website online
Clinician-guided Report-back
n=87 Participants
Participants receive their personal exposure results from a clinician
Knowledge Before and After Report-back Intervention.
0.02 Scores on a scale
Standard Deviation 0.16
0.06 Scores on a scale
Standard Deviation 0.14

PRIMARY outcome

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

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

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).

Outcome measures

Outcome measures
Measure
Self-guided Report-back
n=74 Participants
Participants receive their personal exposure results from a website online
Clinician-guided Report-back
n=88 Participants
Participants receive their personal exposure results from a clinician
Satisfaction With Report-back After Report-back Intervention
17.57 Scores on a scale
Standard Deviation 2.53
18.58 Scores on a scale
Standard Deviation 2.09

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure
Self-guided Report-back
n=73 Participants
Participants receive their personal exposure results from a website online
Clinician-guided Report-back
n=87 Participants
Participants receive their personal exposure results from a clinician
Feelings About Report-back, Before and After Intervention
Empowered
0.03 Scores on a scale.
Standard Deviation 1.29
0.24 Scores on a scale.
Standard Deviation 1.19
Feelings About Report-back, Before and After Intervention
Respected
0.24 Scores on a scale.
Standard Deviation 1.16
0.26 Scores on a scale.
Standard Deviation 0.98
Feelings About Report-back, Before and After Intervention
Worried
-0.18 Scores on a scale.
Standard Deviation 1.77
0.03 Scores on a scale.
Standard Deviation 1.62

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure
Self-guided Report-back
n=69 Participants
Participants receive their personal exposure results from a website online
Clinician-guided Report-back
n=85 Participants
Participants receive their personal exposure results from a clinician
Perceived Self-efficacy Before and After Report-back Intervention
0.39 Scores on a scale
Standard Deviation 7.82
0.85 Scores on a scale
Standard Deviation 6.94

PRIMARY outcome

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

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

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.'

Outcome measures

Outcome measures
Measure
Self-guided Report-back
n=75 Participants
Participants receive their personal exposure results from a website online
Clinician-guided Report-back
n=88 Participants
Participants receive their personal exposure results from a clinician
Behaviors Before and After Report-back Intervention
Look for information about chemical ingredients when choosing products
0.22 Scores on a scale
Standard Deviation 0.91
-0.01 Scores on a scale
Standard Deviation 1.04
Behaviors Before and After Report-back Intervention
Microwave food in a plastic container?
-0.35 Scores on a scale
Standard Deviation 0.73
-0.25 Scores on a scale
Standard Deviation 0.82
Behaviors Before and After Report-back Intervention
Use air fresheners in your home?
0.08 Scores on a scale
Standard Deviation 1.16
-0.05 Scores on a scale
Standard Deviation 1.03
Behaviors Before and After Report-back Intervention
Use chemical pesticides or insecticides?
-0.05 Scores on a scale
Standard Deviation 1.02
-0.21 Scores on a scale
Standard Deviation 1.02
Behaviors Before and After Report-back Intervention
Use products advertised as antibacterial or antimicrobial?
0.05 Scores on a scale
Standard Deviation 0.60
-0.56 Scores on a scale
Standard Deviation 1.16

Adverse Events

In-clinic Report-back

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Self-guided Report-back

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jennifer Liss Ohayon

Silent Spring Institute

Phone: 617-332-4288

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place