Clinical trial NCT02050308: Web-based Smoking Cessation Program for Tribal College Students
Official title: Web-based Smoking Cessation Program for Tribal College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-01-30
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Planning to leave college within next 6 months
* Medically ineligible as a result of screening questions

Primary outcomes:
measure: Number of Participants With 7-day Point Prevalence Abstinence
timeFrame: 6 months
Secondary outcomes:
measure: Cigarettes Per Day
timeFrame: Change from Baseline in number of cigarettes smoked daily at 6 months
measure: Number of Quit Attempts
timeFrame: 6 months
measure: Number of Participants Who Participated in All Sessions Over the Course of 6 Months.
timeFrame: 6 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Pablo
country: United States
facility: Salish Kootenai College
state: Montana
Study officials:
affiliation: University of Kansas Medical Center
name: Won Choi, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: