Health Knowledge, Attitudes, Practice
Conditions
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.
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.
Interventions
BEHAVIORALIn-clinic report-back
Investigators measure whether report-back from a clinician improves environmental health literacy, including leading to greater shifts in exposure-reducing health behaviors
Sponsors
Silent Spring Institute
University of Puerto Rico
Northeastern University
Harvard University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants are of reproductive age
Exclusion criteria
* Under 18 years old or past reproductive age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge Before and After Report-back Intervention. | 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 | 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 | 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 | 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 | 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.' |
Countries
Puerto Rico, United States
Contacts
PRINCIPAL_INVESTIGATORJennifer Ohayon, PhD
Silent Spring Institute
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 36.3 Age in years STANDARD_DEVIATION 5.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 73 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 28 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 18 Participants |
| Race (NIH/OMB) White | 47 Participants |
| Region of Enrollment United States | 75 Participants |
| Sex: Female, Male Female | 88 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
None listed