Cigarette smoking is the leading preventable cause of death, and cancer, for all Americans. African Americans (AAs) have one of the highest smoking rates, up to 60 percent among the most disadvantaged subgroups. Enabling these underserved populations to quit smoking is a national health priority. Using a nicotine inhaler can help smokers quit; however, it has not been studied among AAs or lower SES groups. It is critical that poor and underserved populations are not left behind as new pharmacological aids and counseling strategies are developed. This study comprises AA smokers residing in public housing developments (HDs) whose income levels fall below the poverty threshold. The primary aim of this study is to test, in combination with the nicotine inhaler, the effectiveness of a culturally sensitive and sustained behavioral intervention (Tx) vs a culturally sensitive dietary education program (C) on 7-day point prevalence smoking cessation at 6 months. The investigators will randomly assign 14 HDs (20 smokers in each HD) to either a smoking cessation or dietary change intervention. Randomzation will occur at the level of housing units rather than the individual, thereby minimizing potential contamination. They project 140 smokers for C and 140 smokers for Tx, a total of 280 participants, will be required at baseline to detect proposed treatment effects for the primary outcome. Smokers from each HD will be recruited through health fairs with the assistance of community health educators (CHEs). Tx participants will receive a 8-week course of the nicotine inhaler, two in-person counseling sessions based on Motivational Interviewing (MI) techniques plus three MI phone calls, the Pathways to Freedom smoking cessation guide, a video on proper inhaler use, brief cessation and relapse prevention advice from a CHE, biochemical feedback, and a quit contract. The comparison group will receive culturally sensitive dietary education materials but no materials that exclusively address tobacco or tobacco-related cancers. The study will not have a typical control arm, choosing instead to provide the comparison group with dietary education materials rather than a placebo nicotine inhaler. We chose this design to ensure community buy-in, to gather further data on other cancer prevention-related behaviors and to respond to residents' distrust of being part of a """"""""drug"""""""" study with a placebo. Secondary aims are to test the effects of the treatment on intermediate variables including number of cigarettes smoked and number of quit attempts.
A third aim i s to assess the impact of the dietary intervention. Process objectives will also be studied. Recruitment and retention will be enhanced by use of health fairs, CHEs, incentives for completing evaluation instruments, provision of attractive intervention materials, a community advisory board, and home visits for follow-up. Post-intervention focus groups of quitters and non-quitters will be conducted to assess the project's intervention components. Decreasing the prevalence of smoking among residents in HDs will have a dramatic influence on the morbidity and mortality of this high-risk population.
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