Path2Quit Tobacco Intervention For African Americans
- Conditions
- Smoking CessationSmoking, Tobacco
- Interventions
- Behavioral: Path2QuitBehavioral: SmokeFreeText
- Registration Number
- NCT03524482
- Lead Sponsor
- Case Comprehensive Cancer Center
- Brief Summary
The purpose of this research is to study a smoking cessation program for adult smokers in Northeast Ohio. The study will also look at how different people respond to the program.
The study includes completing surveys and receiving text messages to help participants become tobacco free.
- Detailed Description
OBJECTIVES Specific Aim 1: Translate a culturally specific video-based tobacco use intervention into a scalable mobile health (mhealth) format.
Specific Aim 2: Conduct a pilot study of the video-text intervention.
Study Design:
2-arm semi-pragmatic randomized design among current tobacco users
Cuyahoga Metropolitan Housing Authority residents will be randomly assigned to receive (1) the newly translated Path2Quit or (2) SmokeFreeText (NCI's publicly available, standard text messaging program) combined with brief behavioral counseling session plus 2 weeks of nicotine replacement therapy (NRT). Primary outcomes will include intervention evaluations (content and format), acceptability, coping strategies, engagement, and NRT adherence. Secondary variables will include 24-hour quit attempts and biochemically verified tobacco use abstinence at the 1-month follow-up. Exploratory mediational analyses will examine the roles of urban hassles, acculturation, neighborhood environment, ethnic discrimination, and psychological distress in intervention effects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
- Self-identify as African American
- Either smoke at least 1 cigarettes/day or have a carbon monoxide (CO) reading of at least 4 ppm
- Consistent with SmokefreeTXT, be willing to set a quit date within the next 14 days.
- Recruited from Cleveland metropolitan housing authority or who report low income based on federal guidelines
- Does not meet all of the above inclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Path2Quit Path2Quit Culturally specific text message intervention SmokeFreeText SmokeFreeText The National Cancer Institute's publicly available, standard text messaging program for tobacco cessation
- Primary Outcome Measures
Name Time Method Proportion of participants who abstain from smoking At 1-month follow-up Abstinence will be coded as a binary variable. Analysis will be conducted with an intent to treat approach
- Secondary Outcome Measures
Name Time Method 24-Hour quit attempts At 1-month follow-up Number of times a participant quits smoking for at least 24 hours
Average score of smoking urges Up to 1-month follow-up This brief, 10 item scale is scores 1-7 (total score 10-70) with higher scores indicating greater agreement
Average score of Intervention Evaluation (IRQ) At 1-month follow-up The IRQ is a 22 item scale scored 0-7 (total score 0-154) where higher scores indicate more satisfaction
Changes in carbon monoxide breath levels from baseline to followup At 1-month follow-up Breath carbon monoxide tests will biochemically confirm self-reported cessation
Number of missed nicotine replacement therapy doses Up to 1-month follow-up Measure of NRT adherence. Number of missed doses will be recorded for each participant
Changes in Contemplation ladder score From baseline to up to 1-month follow-up self-reported score 0-10 where a higher score indicates more readiness to quit
Trial Locations
- Locations (1)
Case Western Reserve University, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States