Web-based Smoking Cessation Program for Tribal College Students
- Conditions
- Smoking Cessation
- Interventions
- Other: Internet-All Nations Breath of Life (I-ANBL)Other: Honoring the Gift of Heart Health
- Registration Number
- NCT02050308
- Lead Sponsor
- Won Choi, PhD, MPH
- Brief Summary
The purpose of this study is to test the effectiveness of a culturally-tailored Internet-based program that helps American Indian (AI) tribal college students quit smoking.
- Detailed Description
Many of the approximately 25,000 American Indian (AI) students enrolled in tribal colleges/universities in the US arrive there as smokers. A 2011 study of high school seniors reported that the smoking prevalence among AI students is approximately 40%, the highest rate among all racial and ethnic groups studied. Although prevalence data on smoking among AI college students are limited, studies have shown that the majority of smokers in high school continue to smoke once they reach college. Prohibited from marketing to adolescents and children, the tobacco industry in recent years has shifted its most intense marketing to college students, resulting in increases in smoking rates among them. The transition to college provides amble opportunities for young adults to acquire new and harmful habits. Many of these habits do not seem so alien to young AIs: Cigarette smoking is the number one cause of preventable death among AIs. Cancer is the second leading cause of death among AIs, and lung cancer is the leading cause of cancer deaths for both AI men and women. Cultural factors, socioeconomic circumstances, and lack of culturally-tailored cessation programs for American Indian tribal college students have prevented access to effective interventions that promote smoking cessation. To date, few studies have focused on methods to encourage smoking cessation among tribal college students and no randomized clinical trials have yet been conducted. To address this public health deficit, we propose an innovative, effective, culturally and individually-tailored smoking cessation programs to promote cessation.
Primary aim is to: To test the effectiveness of a culturally-tailored internet-based smoking cessation intervention (I-ANBL) compared to an internet-based heart healthy diet (I-FV:fruit/vegetable) control condition in a randomized controlled trial with Tribal College students. Our hypothesis is that American Indian tribal college students randomized to the culturally-tailored smoking cessation arm will have significantly higher 7-day point prevalence abstinence (defined as no cigarettes in the past 7 days, biochemically verified) rates at 6 months than those receiving the heart healthy diet intervention.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 251
- Currently enrolled at Salish Kootenai College
- Have a valid telephone number and email address
- Willing to participate in all study components
- Willing to be followed-up for 6 months
- Self identifies as American Indian or Alaska Native
- Is a current smoker
- Planning to leave college within next 6 months
- Medically ineligible as a result of screening questions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Internet-All Nations Breath of Life (I-ANBL) Internet-All Nations Breath of Life (I-ANBL) The culturally-tailored program includes 9 individual Internet-based sessions across a 12 week period and an additional individual Internet-based session at 6 months. Web sessions will last about half-an-hour (30 minutes) and will discuss topics that are important to quitting smoking (like: preparing to quit, dealing with cravings, and support systems, etc.) and topics relevant to American Indian culture (like traditional use of tobacco). We plan to give participants in our cessation program a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy. We choose to give our participants a choice because our experience shows that we would be unlikely to recruit AI participants into a trial that requires pharmacotherapy use. Honoring the Gift of Heart Health Honoring the Gift of Heart Health The culturally-tailored program includes 9 individual Internet-based sessions across a 12 week period and an additional individual Internet-based session at 6 months. Web sessions will last about half-an-hour (30 minutes) and will discuss topics that are important to heart health (like: Assessing risk for heart disease, increasing fruit and vegetable consumption, physical activity, etc.). We plan to give participants in our cessation program a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy. We choose to give our participants a choice because our experience shows that we would be unlikely to recruit AI participants into a trial that requires pharmacotherapy use. Internet-All Nations Breath of Life (I-ANBL) Nicotine gum, Patch, or Lozenge or Zyban® or Chantix® The culturally-tailored program includes 9 individual Internet-based sessions across a 12 week period and an additional individual Internet-based session at 6 months. Web sessions will last about half-an-hour (30 minutes) and will discuss topics that are important to quitting smoking (like: preparing to quit, dealing with cravings, and support systems, etc.) and topics relevant to American Indian culture (like traditional use of tobacco). We plan to give participants in our cessation program a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy. We choose to give our participants a choice because our experience shows that we would be unlikely to recruit AI participants into a trial that requires pharmacotherapy use. Honoring the Gift of Heart Health Nicotine gum, Patch, or Lozenge or Zyban® or Chantix® The culturally-tailored program includes 9 individual Internet-based sessions across a 12 week period and an additional individual Internet-based session at 6 months. Web sessions will last about half-an-hour (30 minutes) and will discuss topics that are important to heart health (like: Assessing risk for heart disease, increasing fruit and vegetable consumption, physical activity, etc.). We plan to give participants in our cessation program a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy. We choose to give our participants a choice because our experience shows that we would be unlikely to recruit AI participants into a trial that requires pharmacotherapy use.
- Primary Outcome Measures
Name Time Method Number of Participants With 7-day Point Prevalence Abstinence 6 months self-reported and biochemically (salivary cotinine) verified point prevalence abstinence, defined as no smoking for the previous 7 days, at the 6-month follow-up.
- Secondary Outcome Measures
Name Time Method Cigarettes Per Day Change from Baseline in number of cigarettes smoked daily at 6 months effect of intervention on the number of cigarettes smoked daily among those who continue to smoke at Month 6
Number of Quit Attempts 6 months comparison of the number of serious quit attempts between the two groups using Poisson regression
Number of Participants Who Participated in All Sessions Over the Course of 6 Months. 6 months Number of participants who participated in all online sessions and study protocol procedures over the course of 6 months
Trial Locations
- Locations (2)
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Salish Kootenai College
🇺🇸Pablo, Montana, United States
University of Kansas Medical Center🇺🇸Kansas City, Kansas, United States