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

ArmDescriptionAssigned Intervention
Active Comparator
Tailored 		Tailored texting program for quit smoking
  • Other: Cultural Smoking Cessation Program
    A free text message smoking cessation program that provides 24/7 encouragement, advice, and tips to those trying to quit smoking and has been developed for American Indian and Alaska Native persons.
Placebo Comparator
Standard 		Standard texting program for quit smoking
  • Other: Smoking Cessation Program
    A free text message smoking cessation program that provides 24/7 encouragement, advice, and tips to those trying to quit smoking.

Recruiting Locations

Masonic Cancer Center
Minneapolis, Minnesota 55455
Contact:
Dana Carroll, PhD, MPH

More Details

Status
Recruiting
Sponsor
Masonic Cancer Center, University of Minnesota

Study Contact

Dana Carroll, PhD
612-624-0132
dcarroll@umn.edu

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/).