A randomized trial to reduce smoking among American Indians in South Dakota: The walking forward study.

BACKGROUND: Lung cancer is an important public health issue, particularly among American Indians (AIs). The reported decline in tobacco use for most racial/ethnic groups is not observed among AIs. This project was designed to address the research question, "Why don't more Northern Plains American Indians alter tobacco use behaviors known to increase the risk of cancer?" METHODS: Guided by the Theory of Planned Behavior, a multi-component intervention study was implemented. Adult AIs, age 18 years or older and currently smoking, were enrolled. Eligible subjects were randomized to one of 15 groups and exposed to either a MINIMAL or an INTENSE level of 4 intervention components. The intervention was delivered face-to-face or via telephone by Patient Navigators (PN). The primary outcome was self-reported abstinence from smoking verified by carbon monoxide measurement. RESULTS: At 18 months post-quit date, 88% of those who were still in the study were abstinent. This included 6% of all participants who enrolled in the study (14/254) and 13% of those who made it to the quit date (14/108). No intervention groups were found to have significant proportions of participants who were abstinent from smoking at the quit date (visit 5) or primary outcome visit (18 months post-quit date, visit 11), but use of pharmacologic support for abstinence was found to be an effective strategy for individuals who continued participation throughout the study. Those who remained in the study received more visits and were more likely to be abstinent. CONCLUSIONS: Use of NRT increased the odds of not smoking, as assessed at the 18-month follow-up visit, but no other interventions were found to significantly contribute to abstinence from smoking. Although the intervention protocol included numerous points of contact between CRRs and participants (11 visits) loss to follow-up was extensive with only 16/254 remaining enrolled. Additional research is needed to improve understanding of factors that influence enrollment and retention in smoking cessation interventions for AI and other populations.

Reality Versus Grant Application Research "Plans".

This article describes the implementation of the American Indian mHealth Smoking Dependence Study focusing on the differences between what was written in the grant application compared to what happened in reality. The study was designed to evaluate a multicomponent intervention involving 256 participants randomly assigned to one of 15 groups. Participants received either a minimal or an intense level of four intervention components: (1) nicotine replacement therapy, (2) precessation counseling, (3) cessation counseling, and (4) mHealth text messaging. The project team met via biweekly webinars as well as one to two in-person meetings per year throughout the study. The project team openly shared progress and challenges and collaborated to find proactive solutions to address challenges as compared to what was planned in the original grant application. The project team used multiple strategies to overcome unanticipated intervention issues: (1) cell phone challenges, (2) making difficult staffing decisions, (3) survey lessons, (4) nicotine replacement therapy, (5) mHealth text messages, (6) motivational interviewing counseling sessions, and (7) use of e-cigarettes. Smoking cessation studies should be designed based on the grant plans. However, on the ground reality issues needed to be addressed to assure the scientific rigor and innovativeness of this study.

Toward an mHealth Intervention for Smoking Cessation.

The prevalence of tobacco dependence in the United States (US) remains alarming. Invariably, smoke-related health problems are the leading preventable causes of death in the US. Research has shown that a culturally tailored cessation counseling program can help reduce smoking and other tobacco usage. In this paper, we present a mobile health (mHealth) solution that leverages the Short Message Service (SMS) or text messaging feature of mobile devices to motivate behavior change among tobacco users. Our approach implements the Theory of Planned Behavior (TPB) and a phase-based framework. We make contributions to improving previous mHealth intervention approaches by delivering personalized and evidence-based motivational SMS messages to participants. Our proposed solution implements machine learning algorithms that take the participant's demographic profile and previous smoking behavior into account. We discuss our preliminary evaluation of the system against a couple of pseudo-scenarios and our observation of the system's performance.