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).
COMPLETED
NA
163 participants
Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of 6 weeks.
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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
Self-guided Report-back
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place