- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07713784
Investigating ELSI Issues That May Facilitate or Impede Clinical Translation of Epigenetic Research. Phase 3b
August 25, 2026 updated by: Washington University School of Medicine
Investigating ELSI Issues That May Facilitate or Impede Clinical Translation of Epigenetic Research.
Few people realize that environmental pollution and some behaviors like physical activity and tobacco smoking can affect their health by "turning on" or "turning off" certain genes through a process called "epigenetic modification."
This study will develop and test strategies for communicating about epigenetics that are understandable and that do not increase ethical, legal or social issues (ELSI).
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
1000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Erika Waters, PhD, MPH
- Phone Number: 314-747-5705
- Email: waterse@wustl.edu
Study Contact Backup
- Name: Julia M Maki, PhD
- Phone Number: 314-286-2835
- Email: jmaki@wustl.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- English language speaker,
Identify as one of five racial/ethnic groups:
- Non-Hispanic White
- Non-Hispanic Black,
- Non-Hispanic Asian
- Non-Hispanic Indigenous (i.e., Alaska Native/Native Hawaiians/American Indian/Other Pacific Islander)
- Hispanic (all races)
Exclusion Criteria:
- Self-identify as a genetics expert
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Epigenetics Video
Participants will watch a brief (<5 minute) video about the concept of Epigenetics
|
Video about the concept of epigenetics
|
|
Experimental: Individual Responsibility Video
Participants will watch a brief (<5 minute) video about the concept of Epigenetics as well as a brief (<1 minute) video discussing epigenetics and health with a focus on individual behavioral factors affecting epigenetics.
|
Video about the concept of epigenetics
Video discussing epigenetics and health with a focus on individual behavioral factors affecting epigenetics.
|
|
Experimental: External Responsibility Video
Participants will watch a brief (<5 minute) video about the concept of Epigenetics as well as a brief (<1 minute) video discussing epigenetics and health with a focus on external factors affecting epigenetics.
|
Video about the concept of epigenetics
Video discussing epigenetics and health with a focus on external factors affecting epigenetics.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge & understanding of epigenetics Information
Time Frame: Baseline survey, after intervention video
|
Sum score of correct answers for 11 individual items.
Scale ranges from 0 points to 11 points with higher scores indicating higher epigenetics knowledge.
|
Baseline survey, after intervention video
|
|
Acceptability of epigenetics information
Time Frame: Baseline survey, after intervention video
|
Three constructs including perceived benefits of epigenetic research (7 items, ranging from 1 to 5 with higher scores indicating higher perceived benefits), perceived drawbacks of epigenetic research (3 items, ranging from 1 to 5 with higher scores indicating higher perceived drawbacks), and acceptance of using epigenetic research in medical support (3 items, ranging from 1 to 5 with higher scores indicating higher acceptance of using epigenetic research in medical support).
|
Baseline survey, after intervention video
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceptions of epigenetic information
Time Frame: Baseline survey, after intervention video
|
6 item scale.
Scores range from 1 to 5, with higher scores indicating greater perceptions of epigenetic information.
|
Baseline survey, after intervention video
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Study Registration Dates
First Submitted
July 8, 2026
First Submitted That Met QC Criteria
July 14, 2026
First Posted (Actual)
July 20, 2026
Study Record Updates
Last Update Posted (Actual)
August 28, 2026
Last Update Submitted That Met QC Criteria
August 25, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202606025
- R01ES033743 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.