Web-based Smoking Cessation Program for Tribal College Students

• Sponsor: Won Choi, PhD, MPH (Other)
• Overall Status: Completed
• CT.gov ID: NCT02050308
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 251
• Locations: 2
• Arms: 2
• Duration (Months): 47
• Patients Per Site: 125.5
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation	Other: Internet-All Nations Breath of Life (I-ANBL); Other: Honoring the Gift of Heart Health; Drug: Nicotine gum, Patch, or Lozenge or Zyban® or Chantix®	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 251 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Web-based Smoking Cessation Program for Tribal College Students
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: Mar 31, 2019
• Actual Study Completion Date: Mar 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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; 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.; Other Names: Nictotine Replacement Therapy (Nicotine gum, Patch, or Lozenge) or Pharmacotherapy (Zyban® or Chantix®)
Active Comparator: 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.	Other: 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.; Other Names: Nictotine Replacement Therapy (Nicotine gum, Patch, or Lozenge) or Pharmacotherapy (Zyban® or Chantix®)

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Number of Quit Attempts [6 months]

   comparison of the number of serious quit attempts between the two groups using Poisson regression

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
2	Salish Kootenai College	Pablo	Montana	United States	59855

Sponsors and Collaborators

• Won Choi, PhD, MPH
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Won Choi, PhD, MPH, University of Kansas Medical Center

Study Documents (Full-Text)

• Study Protocol - Jan 25, 2017
• Statistical Analysis Plan - Jun 6, 2019

More Information

Publications

None provided.

• Responsible Party: Won Choi, PhD, MPH, Professor, University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT02050308
• Other Study ID Numbers: 13613; R01CA174481
• First Posted: Jan 30, 2014
• Last Update Posted: Dec 7, 2021
• Last Verified: Nov 1, 2021

• Additional relevant MeSH terms: Nicotine; Varenicline

Study Results

Participant Flow

Arm/Group Title	Honoring the Gift of Heart Health	Internet-All Nations Breath of Life (I-ANBL)
Arm/Group Description	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.). Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy.	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). Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy.
Period Title: Overall Study
STARTED	127	124
COMPLETED	28	22
NOT COMPLETED	99	102

Baseline Characteristics

Arm/Group Title	Honoring the Gift of Heart Health	Internet-All Nations Breath of Life (I-ANBL)	Total
Arm/Group Description	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.). Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy.	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). Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy.	Total of all reporting groups
Overall Participants	127	124	251
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	127 100%	124 100%	251 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	67 52.8%	61 49.2%	128 51%
Male	59 46.5%	63 50.8%	122 48.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	127 100%	124 100%	251 100%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	127 100%	124 100%	251 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With 7-day Point Prevalence Abstinence
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Honoring the Gift of Heart Health	Internet-All Nations Breath of Life (I-ANBL)
Arm/Group Description	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.). Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy.	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). Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy.
Measure Participants	127	124
Count of Participants [Participants]	9 7.1%	9 7.3%

2. Secondary Outcome

Title	Cigarettes Per Day
Description	effect of intervention on the number of cigarettes smoked daily among those who continue to smoke at Month 6
Time Frame	Change from Baseline in number of cigarettes smoked daily at 6 months

Outcome Measure Data

Analysis Population Description

Smokers who were randomized to the Internet All Nations Breath of Life intervention or the Heart Healthy arm focusing on increasing fruits and vegetables. Due to very low retention rate at 6 months (less than 20%), no data were collected at 6 months. Therefore, the data below are baseline mean number of cigarettes smoked by intervention arm.

Arm/Group Title	Internet All Nations Breath of Life	Honoring the Gift of Heart Health
Arm/Group Description	Internet based All Nations Breath of Life Smoking Cessation program	Internet based heart healthy program to increase fruits and vegetables
Measure Participants	124	127
Mean (Standard Deviation) [Cigarettes/day]	4.00 (5.15)	5.43 (5.42)

3. Secondary Outcome

Title	Number of Quit Attempts
Description	comparison of the number of serious quit attempts between the two groups using Poisson regression
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Overall retention at 6 months was low at 20% so no data were collected at 6 months.

Arm/Group Title	I-ANBL	Honoring the Gift of Heart Health
Arm/Group Description	Internet All Nations Breath of Life	Increasing fruit and vegetable consumption
Measure Participants	0	0

4. Secondary Outcome

Title	Number of Participants Who Participated in All Sessions Over the Course of 6 Months.
Description	Number of participants who participated in all online sessions and study protocol procedures over the course of 6 months
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

The overall retention rate at 6 months was low at 20% so no data were collected at 6 months.

Arm/Group Title	Internet All Nations Breath of Life	Honoring the Gift of Heart Health
Arm/Group Description	Internet Based All Nations Breath of Life Smoking Cessation Program	Increasing fruit and vegetable consumption
Measure Participants	0	0

Adverse Events

Time Frame	6 months
Arm/Group Title	Honoring the Gift of Heart Health		Internet-All Nations Breath of Life (I-ANBL)
Arm/Group Description	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.). Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy.		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). Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy.
All Cause Mortality
	Honoring the Gift of Heart Health		Internet-All Nations Breath of Life (I-ANBL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/127 (0%)		0/124 (0%)
Serious Adverse Events
	Honoring the Gift of Heart Health		Internet-All Nations Breath of Life (I-ANBL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/127 (0%)		0/124 (0%)
Other (Not Including Serious) Adverse Events
	Honoring the Gift of Heart Health		Internet-All Nations Breath of Life (I-ANBL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/127 (0%)		0/124 (0%)

Limitations/Caveats

Significant loss to follow-up, lower than expected salivary collection rates, and lower long-term retention of participants.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.