DESCRIPTION (Adapted from the Applicant's Abstract): 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
is 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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