American Indian Smokefree Native RCT
Purpose
The aim of this clinical trial is to test the efficacy of a culturally aligned digital smoking cessation resource for American Indian persons who smoke, via a remotely conducted randomized controlled trial.
Condition
- Smoking Cessation
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- AI race based on self-report; - ≥ 18 years of age via photo ID confirmation; - Average smoked cigarettes per day, ≥ 3 in the past 30 days; - considering or willing to make a quit attempt; - self-report having daily access to their own iPhone/Android smartphone or tablet that allows for messaging use; - able to read and speak English.
Exclusion Criteria
- None
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Two-condition, parallel group, RCT design, will examine the efficacy of a culturally aligned digital quit resource versus a general audience version of the resource. This is a multi-site study that will involve participants engaging with their assigned quit resource, and following up with them during months 1, 3 and 6.
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Tailored |
Tailored texting program for quit smoking |
|
|
Placebo Comparator Standard |
Standard texting program for quit smoking |
|
Recruiting Locations
Minneapolis, Minnesota 55455
Dana Carroll, PhD, MPH
More Details
- Status
- Recruiting
- Sponsor
- Masonic Cancer Center, University of Minnesota
Detailed Description
This is a two-arm, parallel group, randomized controlled clinical trial. Eligible participants (n=416) will be randomized to either the culturally aligned resource or the general audience version. Participants will use the assigned resource for 6 months, and partake in surveys at baseline, and 1, 3 and 6 months, during which they will be asked several questions related to use of their assigned resource, and smoking behavior. Carbon monoxide (CO) in exhaled breath will be collected at 1, 3 and 6 months using iCO™ Smokerlyzer® (https://www.icoquit.com/us/).