Web-based Smoking Cessation Program for Tribal College Students

Smoking Cessation Clinical Trial

Official title:

Web-based Smoking Cessation Program for Tribal College Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02050308
• Other study ID #: 13613
• Secondary ID: R01CA174481
• Status: Completed
• Phase: Phase 3
• Start date: May 2015
• Est. completion date: March 31, 2019

Study information

• Verified date: November 2021
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Other:
• Internet-All Nations Breath of Life (I-ANBL)
Participants will be asked to log into the website prior to the first session to allow for any problems with the site to be fixed prior to sessions starting. Topics we anticipate covering include, but are not limited to: preparing to quit, dealing with cravings, support systems, traditional tobacco, stress reduction, weight management, and staying quit, along with other topics determined during program development. For each session, the tribal college student will begin the session by answering a series of questions to produce an individually-tailored report that will be provided on the screen at the end of each week's session so that the smoker can work on strategies during the week before the next internet session Weekly procedures will follow the same format as for the first session
• Honoring the Gift of Heart Health
These sessions help American Indians learn about what they can do to prevent heart disease. We will emphasize the increase consumption of fruits and vegetables as well as addressing other heart healthy activities. Honoring the Gift of Heart Health is a user-friendly program developed especially for American Indians. The manual provides the "how-to" for leading group education sessions. It offers "hands-on" activities that help people build the skills they need to make simple, practical, and lasting changes to help them fight heart disease. The protocol will follow procedures as the I-ANBL arm, however, this fruit and vegetable arm will not include individually tailored components, but just interactive web-based materials related to increasing heart health, including certain activities.

Drug:
• Nicotine gum, Patch, or Lozenge or Zyban® or Chantix®
Regardless of the intervention arm to which subjects are assigned, they will choose the option of nicotine replacement therapy they want, as long as they are eligible for it. All participants are offered the medications, but they do not have to take any medication to participate in the study.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Salish Kootenai College	Pablo	Montana

Sponsors (2)

Lead Sponsor	Collaborator
Won Choi, PhD, MPH	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With 7-day Point Prevalence Abstinence	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.	6 months
Secondary	Cigarettes Per Day	effect of intervention on the number of cigarettes smoked daily among those who continue to smoke at Month 6	Change from Baseline in number of cigarettes smoked daily at 6 months
Secondary	Number of Quit Attempts	comparison of the number of serious quit attempts between the two groups using Poisson regression	6 months
Secondary	Number of Participants Who Participated in All Sessions Over the Course of 6 Months.	Number of participants who participated in all online sessions and study protocol procedures over the course of 6 months	6 months