Flushing, Healthy Adult
Conditions
Keywords
East Asian, Alcohol Flushing, ALDH2, ADH1B, Esophageal Cancer, Genetic Testing, Alzheimer's Disease, Cardiovascular Disease
Brief summary
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
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.
Interventions
BEHAVIORALGenetic Test Results Return
Returning genetic test results for alcohol flushing genes (i.e., ALDH2, ADH1B)
BEHAVIORALAlcohol Flushing Education
Administering alcohol flushing educational module.
Sponsors
Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Alcohol Flushing Genetic Testing in Primary Care | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Alcohol Flushing Genetic Testing in Primary Care | 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. |
| Change(s) in Alcohol Consumption | 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. |
Countries
United States
Contacts
CONTACTFiona Y Seung, MS
CONTACTJennifer L Young, PhD
PRINCIPAL_INVESTIGATORJennifer L Young, PhD
Northwestern U
Outcome results
None listed