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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA174481 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet-All Nations Breath of Life (I-ANBL) | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-All Nations Breath of Life (I-ANBL) | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Quit Attempts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Won Choi, PhD, MPH | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States | ||
| Salish Kootenai College |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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.). Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy. |
| FG001 | 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). Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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.). Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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.). Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy. |
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Significant loss to follow-up, lower than expected salivary collection rates, and lower long-term retention of participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Won S. Choi | The University of Kansas Medical Center | (913) 588-4742 | wchoi@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 25, 2017 | Jul 10, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 6, 2019 | Jul 10, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000074164 | Nicotine Chewing Gum |
| D057968 | Transdermal Patch |
| D016642 | Bupropion |
| D000068580 | Varenicline |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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|
| Honoring the Gift of Heart Health | Other | 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. |
|
| Nicotine gum, Patch, or Lozenge or Zyban® or Chantix® | Drug | 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. |
|
|
comparison of the number of serious quit attempts between the two groups using Poisson regression
| 6 months |
| 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 |
| Pablo |
| Montana |
| 59855 |
| United States |
| BG001 | 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). Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | The row populations only includes participants with available data. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| 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). Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy. |
|
|
| Secondary | Cigarettes Per Day | effect of intervention on the number of cigarettes smoked daily among those who continue to smoke at Month 6 | 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. | Posted | Mean | Standard Deviation | Cigarettes/day | 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 | Overall retention at 6 months was low at 20% so no data were collected at 6 months. | Posted | 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 | The overall retention rate at 6 months was low at 20% so no data were collected at 6 months. | Posted | 6 months |
|
|
| 0 |
| 127 |
| 0 |
| 127 |
| 0 |
| 127 |
| EG001 | 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). Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy. | 0 | 124 | 0 | 124 | 0 | 124 |
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| Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D061485 | Tobacco Use Cessation Devices |
| D013812 | Therapeutics |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D004864 | Equipment and Supplies |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011810 | Quinoxalines |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|