Won S Choi1, Laura A Beebe2, Niaman Nazir3, Baljit Kaur3, Michelle Hopkins2, Myrietta Talawyma4, Theresa I Shireman5, Hung-Wen Yeh6, K Allen Greiner7, Christine M Daley8. 1. Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, Kansas; Center for American Indian Community Health, University of Kansas Medical Center, Kansas City, Kansas. Electronic address: wchoi@kumc.edu. 2. Department of Biostatistics and Epidemiology, University of Oklahoma Health Science Center, Oklahoma City, Oklahoma. 3. Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, Kansas; Center for American Indian Community Health, University of Kansas Medical Center, Kansas City, Kansas. 4. Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, Kansas; Center for American Indian Community Health, University of Kansas Medical Center, Kansas City, Kansas; Department of Biostatistics and Epidemiology, University of Oklahoma Health Science Center, Oklahoma City, Oklahoma. 5. School of Public Health, Brown University, Providence, Rhode Island. 6. Center for American Indian Community Health, University of Kansas Medical Center, Kansas City, Kansas; Department of Biostatistics, University of Kansas Medical Center, Kansas City, Kansas. 7. Center for American Indian Community Health, University of Kansas Medical Center, Kansas City, Kansas; Department of Biostatistics and Epidemiology, University of Oklahoma Health Science Center, Oklahoma City, Oklahoma; Department of Family Medicine, University of Kansas Medical Center, Kansas City, Kansas. 8. Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, Kansas; Center for American Indian Community Health, University of Kansas Medical Center, Kansas City, Kansas; Department of Family Medicine, University of Kansas Medical Center, Kansas City, Kansas; American Indian Health Research and Education Alliance, Inc., Kansas City, Kansas.
Abstract
INTRODUCTION:American Indians have the highest cigarette smoking prevalence of any racial/ethnic group in the U.S. There is currently no effective empirically based smoking-cessation program for American Indians. The purpose of this study was to determine if a culturally tailored smoking-cessation program, All Nations Breath of Life (ANBL), is more effective than a non-tailored cessation program among American Indian smokers. DESIGN: A multisite RCT was conducted from September 2009 to July 2014; analysis was conducted in 2015. SETTING/PARTICIPANTS: Participants were rural or reservation-based American Indian smokers aged ≥18 years. INTERVENTION: Smokers were group randomized to either the culturally tailored ANBL or non-tailored current best practices (CBP) for a total enrolled sample size of 463 (ANBL, n=243; CBP, n=220). MAIN OUTCOME MEASURES: The primary outcome of interest was salivary cotinine-verified 7-day point prevalence smoking abstinence at 6 months. Results for both responder-only and intent-to-treat analyses for self-reported and cotinine-verified abstinence are presented. RESULTS: Intention-to-treat, imputing all non-responses as smokers, the self-reported point prevalence abstinence rates at 12 weeks were 27.9% in the ANBL arm and 17.4% in the CBP arm (p=0.028). There was a statistically significant difference in self-reported 6-month intent-to-treat point prevalence abstinence rates between ANBL (20.1%) and CBP (12.0%) arms (p=0.029). None of the cotinine-verified results were statistically significant. CONCLUSIONS: The culturally tailored smoking-cessation program ANBL may or may not be an effective program in promoting cessation at 12 weeks and 6 months. Participants in the culturally tailored ANBL program were approximately twice as likely to quit smoking at 6 months compared with the CBP program, using self-reported abstinence.
RCT Entities:
INTRODUCTION: American Indians have the highest cigarette smoking prevalence of any racial/ethnic group in the U.S. There is currently no effective empirically based smoking-cessation program for American Indians. The purpose of this study was to determine if a culturally tailored smoking-cessation program, All Nations Breath of Life (ANBL), is more effective than a non-tailored cessation program among American Indian smokers. DESIGN: A multisite RCT was conducted from September 2009 to July 2014; analysis was conducted in 2015. SETTING/PARTICIPANTS: Participants were rural or reservation-based American Indian smokers aged ≥18 years. INTERVENTION: Smokers were group randomized to either the culturally tailored ANBL or non-tailored current best practices (CBP) for a total enrolled sample size of 463 (ANBL, n=243; CBP, n=220). MAIN OUTCOME MEASURES: The primary outcome of interest was salivary cotinine-verified 7-day point prevalence smoking abstinence at 6 months. Results for both responder-only and intent-to-treat analyses for self-reported and cotinine-verified abstinence are presented. RESULTS: Intention-to-treat, imputing all non-responses as smokers, the self-reported point prevalence abstinence rates at 12 weeks were 27.9% in the ANBL arm and 17.4% in the CBP arm (p=0.028). There was a statistically significant difference in self-reported 6-month intent-to-treat point prevalence abstinence rates between ANBL (20.1%) and CBP (12.0%) arms (p=0.029). None of the cotinine-verified results were statistically significant. CONCLUSIONS: The culturally tailored smoking-cessation program ANBL may or may not be an effective program in promoting cessation at 12 weeks and 6 months. Participants in the culturally tailored ANBL program were approximately twice as likely to quit smoking at 6 months compared with the CBP program, using self-reported abstinence.
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