Geoffrey T. Fong, Ph.D. - US grants

DESCRIPTION (provided by applicant): The broad objective of the proposed research is to evaluate and understand the impact of a national tobacco control policy. Specifically, the proposed research will evaluate the psychosocial and behavioral effects of the new graphic cigarette package warning labels that were introduced in Canada in December 2000. These labels contain vivid photographs of the negative health consequences of cigarette smoking, with text messages inside the package that include efficacy messages for reducing the threat depicted on the package. In a quasi-experimental design, the participants will be a total of 12,000 students at 9 high schools in Canada and 6 high schools in the United States. Schools in the United States are matched so that they are similar to the Canadian schools. Baseline data confirm that the Canadian and U.S. schools do not differ in smoking behavior. Students will participate in a 30-minute classroom administered survey 2 times a year for 3 academic years. The first wave of data collection was conducted prior to the introduction of the new warning labels. There are six specific aims: (1) to examine whether the graphic warning labels have any effects on smoking behavior; (2) to examine whether the graphic warning labels enhance label-relevant psychosocial variables (e.g., label salience); (3) to examine whether the graphic warning labels diminish general psychosocial variables that are related to smoking behavior; (4) to examine whether the effects of the graphic warning labels will vary as a function of exposure to the labels; (5) to examine whether the effects of the graphic warning labels will vary as a function of individual difference variables such as sensation seeking and time perspective; and (6) to examine whether the effects of the graphic warning labels on smoking behavior are mediated by variables that have been identified by theory to be important in predicting and understanding smoking behavior. Data-analytic methods will be employed that take into account the clustered nature of the data (e.g., random-effects regression models). The proposed research takes advantage of a "natural experiment" in an important tobacco control policy, and thus has the potential to gain insight into the effectiveness of these and other efforts by governments to reduce tobacco use, and could provide an empirical basis for future tobacco control policies in the U.S. and other countries. Moreover, the simultaneous focus on policy evaluation and theory testing may yield insights into the underlying mechanisms that would explain how and why the policy achieved its desired effects (or why it failed to achieve its desired effects).

This Project seeks to evaluate the psychosocial and behavioral effects of national-level tobacco control policies that will be implemented in at least one of four developed countries (U.S., Canada, U.K., and Australia) over the next five years. The tnternationa Tobacco Contro Po icy Evaluation Survey (ITCPES)is a 40-minute telephone cohort survey of 8,300 adult smokers across these four countries, which began in October 2002 with a second wave in May-August 2003. The survey includes measures of smoking behavior, psychosociat predictors of smoking and quitting, and policy-relevant variables in six major tobacco policy domains: (a) warning labels; (b) "light" or "mild" brand descriptors; (c) advertising/promotion; (d) price/taxation; (e) product regulation/alternative nicotine products; and (f) ETS protection laws. The quasiexperimental design includes both between- and within-country controls. This Project has 6 specific aims: (1) examine whether a country's policy will affect self-reported smoking behavior, in comparison to other countries where that policy is not changing; (2) examine whether a policy will enhance policy-relevant psychosocial variables; (3) examine whether a policy will lead to enhancement of psychosocial variables known to be related to smoking and quitting behavior, in comparison to other countries where that policy is not changing; (4) examine whether the effects of tobacco control policies may be offset by compensatory behaviors (e.g., switching to discount brands instead of quitting); (5) examine whether the effects of tobacco control policies are moderated by situational and individual-difference factors; (6) identify the psychosocial mechanisms that underlie the effects of tobacco control policies. Funding is requested to continue the surve with waves every 2 years, with additional analyses involving data from Projects 2 and 3. With the recent adoption of the Framework Convention on Tobacco Control, building the evidence base for tobacco control policies could be used by policymakers worldwide to implement policies of demonstrated effectiveness

[unreadable] DESCRIPTION (provided by applicant): The broad objective of the proposed project is to evaluate and understand the psychosocial and behavioral effects of several national-level tobacco control policies that are scheduled or likely to be implemented in at least one of the four largest English-speaking countries--United States, Canada, United Kingdom, and Australia--over the next three years. In a prospective cohort design, the participants are 2,000+ adult smokers in each country (total N=9,013) who respond to a 45-minute telephone survey every 8 months for 5 years. The ITC survey had its successful launch in Fall 2002 and second wave in Summer 2003, and funds are being requested to continue support for Years 3-5. The survey includes measures of smoking behavior, psychosocial predictors of smoking and quitting, and policy-relevant variables in five major policy domains: (1) enhancement of warning labels, (2) elimination or restriction of the terms "light" or "mild" as cigarette brand descriptors, (3) elimination or restrictions on advertising and promotion of tobacco products, (4) changes in price and taxation, and (5) alternative nicotine products (e.g., products that heat, rather than burn, tobacco). The quasi-experimental design includes both between-country controls and within-country controls and will thus allow rigorous tests of national-level policies that heretofore have not been systematically evaluated. There are 7 specific aims: (1) to examine whether a policy introduced in one country will affect self-reported smoking behavior, in comparison to other countries where that policy is not changing, (2) to examine whether a policy introduced in one country will enhance policy-relevant psychosocial variables, that is, those that are closely related to the policy, in comparison to other countries where that policy is not changing, (3) to examine whether a policy introduced in one country will lead to enhance levels of psychosocial variables known to be related to smoking and quitting behavior, in comparison to other countries where that policy is not changing, (4) to examine whether the effects of tobacco control policies may be offset by compensatory behaviors (e.g., price increases leading to shifts toward discount brands rather than to quitting), (5) to examine whether the effects of tobacco control policies are moderated by situational and individual-difference factors, (6) to identify the psychosocial mechanisms that may explain how tobacco control policies achieve (or fail to achieve) their goals, and (7) to identify similarities and differences across the four countries in the factors that relate to smoking and cessation. This project has considerable time urgency because of the recently adopted Framework Convention on Tobacco Control-the first-ever international treaty on health-which will obligate over 190 countries (over 90% of the world's population) to tobacco control policies that will be evaluated by this project, and has the potential to inform future tobacco control policies throughout the world. [unreadable] [unreadable] [unreadable] [unreadable]

[unreadable] DESCRIPTION (provided by applicant): The broad objective of this project is to evaluate and understand the psychosocial and behavioral effects of national-level tobacco control policies of the Framework Convention on Tobacco Control (FCTC), the first- ever international treaty on health. In an expansion of over 40 tobacco control experts across 9 countries, we will conduct parallel cohort surveys of adult smokers in two Asian countries that are prominent in the domain of tobacco use: China and South Korea. In a prospective cohort design, the participants in China will be 800 adult smokers and 200 adult non-smokers in each in each of 7 cities (Beijing, Shanghai, Guangzhou, Zhengzhou, Changsha, Yinchuan, and Changsha) who will complete a 30-40 minute face-to-face survey every year for 6 years (2006-2011). The participants in South Korea will be 2000 adult smokers who will complete a 40-minute random digit dialed phone survey every year for 6 years (2005-2011). We are requesting partial funding from NIH to continue each survey for Years 2-6. The sampling design, research protocol and survey instrument are identical or as similar as possible to those of the existing ITC survey in the US, UK, Canada, Australia, Ireland, Thailand, and Malaysia, and includes measures of smoking behavior, psychosocial predictors of smoking and quitting, and policy-relevant variables in 5 major policy domains, covering all of the demand reduction policies of the FCTC (1) enhancement of warning labels, (2) elimination of deceptive brand descriptors (e.g., light or mild) (3) elimination/ restrictions on tobacco advertising and promotion, (4) tax increases, (5) smoke-free laws. The quasi-experimental design includes both between-country controls and within-country controls and will thus allow rigorous tests of national-level policies that here-to-fore have not been systematically evaluated in Asia. We will identify similarities in FCTC policy impact and in the factors that relate to smoking and cessation across the 4 ITC Asian countries (including ongoing cohort surveys in Thailand and Malaysia), and across all ITC countries more generally. The ITC project, whose core funding comes from the Roswell Park TTURC, is the first-ever international cohort study of smoking, and the most substantial research project to evaluate the effectiveness of FCTC policies. The ITC project is now conducting parallel prospective cohort surveys of representative samples of smokers in countries inhabited by 45% of the world's smokers. The proposed project also requests funds to add to the ITC Product Repository, the first ever international repository of cigarettes from which analyses of smoke chemistries physical characteristics, and bio-markers studies are being conducted in an international context, and to conduct a parallel cohort study of bio-markers among 120 Chinese smokers in four cities, with replication 2 years later. The ultimate mission of the proposed project is to provide the evidence base for the FCTC policies as the critical ratification and implementation phases of the FCTC continue to unfold and to understand the mechanisms underlying the impact of public health policies. [unreadable] [unreadable] [unreadable]

DESCRIPTION (provided by applicant): This application seeks to renew funding for the ITC Four Country Survey for five additional years. The objective of the ITC Four Country Survey is to evaluate the psychosocial and behavioural effects of national-level tobacco control policies and to understand the commonality and differences of policy effects in four countries - United States, Canada, United Kingdom and Australia. In a prospective cohort design, the participants are 1,500 adult smokers in each country who respond to a 45-minute telephone survey every year for five additional years. The ITC Four Country Survey is the core survey of the global ITC Project, which is conducting parallel cohort surveys of representative samples of adult smokers in 17 countries, inhabited by over half of the world's smokers. The ITC Project is the only international comparative cohort survey of tobacco users, and its focus on evaluating the impact of policies of the Framework Convention on Tobacco Control (FCTC), the first- ever global health treaty, has placed the ITC Project at a unique and central position in providing the evidence base for the FCTC, which in turn has provided guidance to many countries regarding the implementation of strong evidence-based policies. The ITC survey includes measures of smoking behaviour, psychosocial predictors of smoking and quitting, and policy-relevant measures in five major policy domains (1) enhancement of warning labels, (2) elimination or restriction of the terms light or mild cigarette brand descriptors, (3) elimination or restrictions on advertising and promotion of tobacco products, (4) changes in price and taxation, and (5) smoke-free laws. The quasi-experimental design includes both between-country controls and within- country controls, thus allowing rigorous tests of national-level policies. There are 8 specific aims, which will be addressed by ITC Project: (1) examine whether a policy introduced in one country will affect self-reported smoking behaviour, in comparison to other countries where that policy is not changing, (2) examine whether a policy introduced in one country will enhance policy-relevant psychosocial variables in comparison to other countries where that policy is not changing, (3) examine whether a policy introduced in one country will lead to favourable changes in psychosocial variables known to be related to smoking and quitting behaviour, in comparison to other countries where that policy is not changing, (4) examine whether the effects of tobacco control policies may be offset by compensatory behaviours (e.g., price increases leading to shifts toward discount brands rather than to quitting, (5) examine whether the effects of tobacco control policies are moderated by situational and individual-difference factors, (6) identify the psychosocial mechanisms that may explain how tobacco control policies achieve (or fail to achieve) their goals, (7) identify similarities and differences in the factors that relate to smoking and cessation, and (8) evaluate the impact of the potentially forthcoming FDA regulation of tobacco in the U.S. This project has considerable time urgency as the FCTC has progressed into the implementation phase and FDA regulatory changes may occur soon. PUBLIC HEALTH RELEVANCE: This project evaluates the relative effectiveness of national level public health policies related to tobacco control across four countries. National policies have the ability to effectively improve public health by encouraging healthy behaviors or discouraging unhealthy behaviors. Comparisons made between countries with different policy environments, or within countries over time, will illustrate the effectiveness of specific policies in reducing tobacco consumption, providing public health officials with evidence to make informed decisions.

The International Tobacco Control Policy Evaluation Consortium (i.e., ITC Project), was established in 2002 with the aim of applying rigorous evaluation methods to understand the impact of the tobacco control policies implemented as part of the Framework Convention on Tobacco Control (FCTC). The study design combines quasi-experimental methods and theoretically defined mediational models that allow predictions about how specific policies will influence tobacco use beliefs, attitudes and behaviors. FCTC policies that are evaluated as part of the ITC Project include: (a) enhanced warning labels; (b) elimination of

?DESCRIPTION (provided by applicant): The rapidly growing demand for a new generation of vaporized nicotine products (VNPs) seen in many countries suggests these products are having an impact on cigarette consumption. The specific impact that VNPs are having and how VNPs and tobacco use behaviors are being shaped by public health policies are key questions that need to be answered. The goal of this Program Project is to extend the work of the International Tobacco Control Policy Evaluation Project (ITC Project) to characterize the effectiveness of current and potential future policies to regulate VNPs. The timing of this project is opportune since policies regulating VNPs are evolving, and data are needed to help guide policy development. The proposed research is premised on the belief that to thoroughly assess policies regulating VNPs it is essential to do so at both the population level and at the individua-level under controlled experimental conditions. The multi-method approach described will be carried out in three countries - United States (US), England (EN), and Canada (CA)- selected because each have similar smoking rates and histories of cigarette product regulations, but divergent policies regulating VNPs. The proposed set of five inter-related studies and two core services addresses three overall aims: 1) To provide a more thorough understanding of how the policy environment influences uptake of and transitions from smoked tobacco to VNPs. The research team will implement naturalistic studies of broadly representative adult and adolescent samples (Projects 1 & 3) and surveillance of the vaporized nicotine market (Project 2) to allow between country and within-country policy effects to be studied and combining these data with data from experimental studies testing how theoretical policy options might affect the demand for VNPs in nonsmoking youth (Project 3) and adult smokers (Project 4); 2) To contribute to the development of methods for monitoring response to VNPs and future alternative nicotine products. The team will investigate differences in methods in data collection (Projects 1 & 2), study samples (Projects 1, 3 & 4), and experimental protocols (Projects 3 & 4) to see which approaches are most cost-efficient and yield the highest quality data for real-world applications in predicting responses to policy changes; and 3) To develop methods to assist policymakers in forecasting the population health impact of different product regulatory schemes. In Project 5 the group will integrate the data from observational (Projects 1, 2 & 3) and experimental studies (Projects 3 & 4), plus additional data, to model the impact of different policies on population health outcomes. Collectively, the proposed studies comprehensively examine how different VNP policy environments are influencing VNP and smoked tobacco use behaviors in the real world and the measured impact of theoretical policy options in the experimental setting. The end product of this holistic program of policy research will be a unique, multi-country evidence base with strong potential to inform policies and regulations in the US, EN, and CA and perhaps other countries as well.

PROJECT SUMMARY/ABSTRACT This application builds upon the International Tobacco Control (ITC) Policy Evaluation Project's ongoing longitudinal panels of cigarette smokers and recent ex-smokers and extends to regular users of vaporized nicotine products (VNPs) (e.g., products like e-cigarettes). This Project assesses trajectories of the use of VNPs and their interactions with tobacco products, and, in collaboration with Project 3, which assesses non- smoking youth, to evaluate how VNPs and smoked tobacco product regulatory policies differentially influence tobacco and nicotine use behaviors in three countries ? the United States (US), England (EN), and Canada (CA). These three countries were selected for study because they have similar smoking rates and share similar histories of cigarette product regulations but have divergent policies regulating VNPs. This study will involve 10,967 adults aged 18 and older who will answer a 40-minute web survey at three points in time, 18 months apart. The survey, patterned after the ITC tobacco surveys, will include measures of smoking behavior, VNP awareness, trial use, regular use, reasons for VNP use, psychosocial mediators and moderators of continued use versus quitting for cigarettes and VNPs, and policy-relevant measures pertaining to smoking and VNP use, specifically: 1) product related regulations such as licensing, nicotine content, packing requirements, flavor restrictions, and manufacturing standards; 2) price and taxation; 3) place related restrictions such as smoke-free/vapor-free laws; and 4) promotional controls such as limits on advertising. There are three aims: Aim 1: To describe how the patterns of VNP and cigarette use differ among smokers and recent ex-smokers both over time and between important sub-groups (e.g., age groups, gender, income, those planning to quit smoking, nicotine dependence level), in particular whether the interactions between VNP and cigarette use vary across the three countries. Aim 2: To examine how differences in tobacco control and VNP policies between and within the US, EN, and CA are related to differences in the patterns of VNP and cigarette use. In particular, when policies on VNPs and/or cigarettes change in a country, this study will evaluate how these policy changes impact the use of VNPs and cigarettes in comparison to countries where no policy change has occurred. Aim 3: To contribute new information on the methods for monitoring health behaviors such as VNP use by comparing characteristics of the online samples recruited in this study with samples collected by conventional survey methods (e.g., PATH Household survey and other national surveys in EN and CA); and to explore the extent to which the behavior of the self-identified early adopters of VNPs (i.e., regular users who have used VNPs for some years) can provide useful indications of the behavior of the broader sample of adult smokers and hence, the mainstream population.