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ALDH2 Genetic Testing in East Asian Community

ConditionsHealthy AdultFlushing
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18 or older

Self-identified as East Asian and/or East Asian American

Flush when they drink alcohol or have a family member who flushes when they drink

Able to read and speak English

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Genetic Test Results Return

    Behavioral

    Returning genetic test results for alcohol flushing genes (i.e., ALDH2, ADH1B)

  • Alcohol Flushing Education

    Behavioral

    Administering alcohol flushing educational module.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Alcohol Flushing Education OnlyActive comparator 1 intervention
Group B: Alcohol Flushing Education AND Genetic TestingExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Feasibility of Alcohol Flushing Genetic Testing in Primary Care

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.

Time frame
From enrollment to the end of data collection at 8 weeks.

Secondary outcomes

1

Acceptability of Alcohol Flushing Genetic Testing in Primary Care

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.

Time frame
From enrollment to the end of data collection at 8 weeks.
2

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. This results in 3 alcohol outcome measurements total for both arms of the study.

Time frame
Alcohol consumption outcome measurements at baseline and one month after educational modules are shared AND after genetic testing results are received.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: