ALDH2 Genetic Testing in East Asian Community

February 4, 2026 updated by: Jennifer Young, Northwestern University

A Community-Based Approach for ALDH2 Genetic Testing in East Asian Americans

The goal of this clinical trial is to learn whether education plus genetic testing for ALDH2*2 and ADH1B*2 is feasible and acceptable and whether it influences modifiable health behaviors in East Asian American adults who experience alcohol flushing when they drink alcohol or have a family history of flushing. The main questions it aims to answer are:

  1. Is providing education plus ALDH2*2/ADH1B*2 genetic testing feasible and acceptable in a clinical care context?
  2. Does receiving genetic testing results plus education lead to changes in modifiable health behaviors compared with education alone? Researchers will compare education plus genetic testing (intervention arm) to education only (control arm) to see if adding genetic testing improves feasibility/acceptability and supports health behavior change.

Participants will:

  1. Complete an education module about alcohol flushing and ALDH2/ADH1B
  2. Be randomized to either: (A) Receive genetic testing for ALDH2*2 and ADH1B*2 with results disclosure, or (B) Receive education only.
  3. Complete follow-up measures about feasibility, acceptability, and modifiable health behaviors

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Alcohol flushing syndrome affects an estimated >500 million individuals worldwide and is strongly associated with functional variants in alcohol metabolism genes, particularly ALDH2 (e.g., ALDH2*2) and ADH1B (e.g., ADH1B*2). ALDH2*2 reduces aldehyde dehydrogenase activity, contributing to acetaldehyde accumulation and is associated with increased risk for alcohol-related morbidity, including certain cancers and cardiometabolic outcomes. Despite the public health relevance, ALDH2/ADH1B implementation in clinical care remains limited, and evidence-based strategies are needed to support equitable and ethical adoption, especially for populations underrepresented in genomics research. This study will engage the East Asian American community to evaluate implementation strategies for ALDH2*2 and ADH1B*2 genetic testing and education in clinical settings and to examine the behavioral impact of returning genetic risk information. Using a pragmatic, randomized comparative effectiveness pilot design, East Asian American adults who self-report alcohol flushing and/or a family history of flushing will be randomized to either: (1) education plus ALDH2*2/ADH1B*2 genetic testing with genotype-informed result disclosure, or (2) education alone. Primary outcomes are feasibility and acceptability of the testing-and-education approach; secondary outcomes include changes in modifiable health behaviors (e.g., alcohol-related decision-making) following education with or without genetic result return. Findings will inform scalable implementation pathways and contribute to equitable integration of genomic testing into routine care for populations experiencing healthcare disparities.

Study Type

Interventional

Enrollment (Estimated)

100

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

Study Contact Backup

Study Locations

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:

  1. Age 18 or older
  2. Self-identified as East Asian and/or East Asian American
  3. Flush when they drink alcohol or have a family member who flushes when they drink
  4. Able to read and speak English

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Alcohol Flushing Education Only
Behavioral: Alcohol Flushing Education
Administering alcohol flushing educational module.
Experimental: Alcohol Flushing Education AND Genetic Testing
Behavioral: Alcohol Flushing Education
Administering alcohol flushing educational module.
Behavioral: Genetic Test Results Return
Returning genetic test results for alcohol flushing genes (i.e., ALDH2, ADH1B)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Alcohol Flushing Genetic Testing in Primary Care
Time Frame: From enrollment to the end of data collection at 8 weeks.
Feasibility of Intervention Measure (FIM) will be administered to primary care clinicians to measure the extent to which alcohol flushing genetic testing can be successfully used or carried out within a primary care setting. Post-intervention, we will quantitatively assess feasibility of ALDH2 education and genetic testing via 1 questionnaire (4 items total): Feasibility of Intervention Measure (FIM). This 4-item psychometrically-validated measure captures the extent to which individuals believe an implementation strategy is feasible.
From enrollment to the end of data collection at 8 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of Alcohol Flushing Genetic Testing in Primary Care
Time Frame: From enrollment to the end of data collection at 8 weeks.
Acceptability of Intervention Measure (AIM) assess how agreeable, palatable, or satisfactory alcohol flushing genetic testing is to primary care clinicians. Post-intervention, we will quantitatively assess acceptability of ALDH2 education and genetic testing via 1 questionnaire (4 items total): Acceptability of Intervention Measure (AIM). This 4-item psychometrically-validated measure captures the extent to which individuals believe an implementation strategy is acceptable.
From enrollment to the end of data collection at 8 weeks.
Change(s) in Alcohol Consumption
Time Frame: Alcohol consumption outcome measurements at baseline and one month after educational modules are shared AND after genetic testing results are received.
Alcohol consumption outcome measurements at baseline and one month after educational modules are shared AND after genetic testing results are received. This results in 3 alcohol outcome measurements total for both arms of the study.
Alcohol consumption outcome measurements at baseline and one month after educational modules are shared AND after genetic testing results are received.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Northwestern University Feinberg School of Medicine

Investigators

  • Principal Investigator: Jennifer L Young, PhD, Northwestern U

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

September 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00222224
  • 1K01HL173859-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Consent language approved by IRB board did not include broad data sharing AND IDP may be identifiable.

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.

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