Delwyn Catley - US grants

DESCRIPTION: (provided by the applicant) Tobacco use is the most preventable cause of death in this nation making innovative approaches to smoking cessation a priority. Studies of "scheduled smoking reduction" where smokers smoke only at scheduled times prior to quitting have shown significantly improved treatment outcomes. Unfortunately, little is known about why this approach enhances smoking cessation success and consequently little is known about possible ways to improve this approach. One potential mechanism concerns individual controllability of smoking intake. Basic research in behavioral pharmacology has demonstrated that manipulating the degree of controllability over drug intake may reduce the rewarding effects of drug consumption. Unfortunately, the methodology used in typical scheduled smoking studies does not allow for properly evaluating this mechanism. Basic laboratory research has employed a yoked-box or triadic design that allows for the manipulation of controllability while equating for dosing, consumption pattern, and exposure to other stimuli. The goal of this pilot study is to develop and test the feasibility of a yoking procedure to manipulate controllability over smoke intake for use with human participants in the natural environment. For this preliminary study, a single group of 40 smokers engaged in usual daily activities will be examined under conditions of ad-lib (or controllable) smoking versus yoked (or uncontrollable) smoking using a compact computerized device (personal digital assistant or PDA). Participants will first smoke as usual (i.e., ad-lib) for three days during which they record the exact timing of cigarette consumption via the PDA. In addition, acute responses to cigarette smoking (i.e., satisfaction), mood, and cigarette craving will be assessed via the PDA. Subsequently, each participant will then engage in three days of scheduled (or uncontrollable) smoking where the PDA will prompt smoking according to the exact pattern and number of cigarettes smoked during the first phase. Subjective measures will be collected in a manner identical to the first phase of the study. Such a procedure allows for equating the pattern and number of cigarettes while manipulating the degree of controllability over smoking, thereby allowing us to at least partially focus on the manipulation of control that is less confounded by other group differences. We will use CO assessments taken across each day to assess the degree to which the pattern of smoking was successfully held constant across conditions. The effect of the controllability manipulation on drug responses will be examined by comparing satisfaction from smoking across the ad-lib and scheduled conditions.

DESCRIPTION (provided by applicant): Tobacco smoking remains one of the most significant preventable causes of death in the U.S. Although most smokers are interested in quitting, only one in five are ready to make a quit attempt at any point in time. Unfortunately, few interventions designed to enhance motivation or readiness among smokers who are not ready to quit are available. One intervention method that focuses on enhancing motivation for and commitment to behavior change is Motivational Interviewing (MI). MI has been shown to be effective for addressing a variety of addictive and health behaviors, however findings for smoking cessation have been overwhelmingly negative and all prior studies have significant limitations. One important limitation of prior studies is that they were not designed to directly test whether MI is more effective for smokers who are not ready to quit, and in particular, whether MI was more effective at motivating quit attempts. Moreover, nearly all focused on special populations such as public housing residents, adolescents, and people with mental illness, many of whom face significant environmental and physiological barriers to quitting. Therefore, the primary aim of this study is to test, among a sample of general adult smokers, the effectiveness of MI for motivating quit attempts among smokers not yet ready to quit. We will randomly assign eligible smokers to Motivational Interviewing (MI), a PHS Guidelines-based counseling control (GBC), or brief advice (BA). The primary outcome will be the occurrence (or not) of any self-reported quit attempt lasting at least 24 hours between randomization and 6 month follow-up. The secondary aim will be to examine 6 month follow-up quit rates between the groups in order to provide an effect size estimate that could be used in designing a large scale study with a primary outcome of smoking cessation. Participants in BA will receive 1 session and participants MI and GBC will receive 5 individual sessions (2 in-person, 3 phone) over 7 weeks. All participants who decide to quit will be provided with varenicline (Chantix). We project needing to enroll 255 smokers who are not ready to quit to detect the proposed treatment effect. PUBLIC HEALTH RELEVANCE: Tobacco smoking remains one of the most significant preventable causes of death in the U.S. and although most smokers are interested in quitting, four in five are not ready to make a quit attempt at any given point in time. This project addresses the lack of methods designed to increase readiness to quit by testing a novel counseling method known as Motivational Interviewing. The potential public health impact is large because it could extend the reach of effective cessation interventions to the majority of smokers who are unmotivated and reduce the decades-long lag between smoking initiation and cessation.

? DESCRIPTION (provided by applicant): As a result of globalization and economic advancement countries like South Africa (SA) are experiencing a risk transition in which disease prevalence is shifting from being primarily infectious in nature to being primarily non-communicable in nature. This is presenting significant challenges for the health care systems of countries with scarce resources. In the U.S. evidence from large, rigorous RCT's clearly indicate that lifestyle interventions such as the Diabetes Prevention Program (DPP) can enable overweight individuals to change their diet and physical activity levels and significantly reduce their risk for diabetes mellitus (DM) and cardiovascular (CVD) diseases but the program has not been adapted for delivery in a developing word setting. The purpose of this proposal is to adapt the DPP and evaluate its feasibility and effectiveness in an urban settlement community in SA. Three initial adaptations to the DPP are proposed for this setting: (1) deliver treatment in a group format using community health workers (CHWs); (2) enhance the DPP through interactive text messaging; and (3) enhance CHW's communications skills through simplified Motivational Interviewing (MI) training. The RE-AIM model will be used to guide our intervention adaptations in order to maximize public health impact. Feasibility and effectiveness of the DPP-SA will be assessed in a real world trial using a large team of CHWs currently deployed in this community to help overweight/obese individuals with DM and/or CVD. We plan a 2 year cluster-randomized trial in which we will randomize 54 existing health clubs (N=540) to receive the DPP South Africa (DPP-SA) or usual care (wait-list). The primary outcome analysis will compare percentage of baseline weight loss at Y1 between DPP-SA and usual care; however, after Y1 usual care participants will also receive the DPP-SA and both groups will be followed for another year. This will allow us to assess whether the wait-list group's results after 1 year of treatment are similar to the original group's outcomes and examine whether the original group maintains its outcomes over 2 years. Secondary outcomes will include DM and cardiovascular risk indicators (blood pressure, hemoglobin A1C, lipids), changes in medication use, diet (fat and fruit and vegetable intake), physical activity, and health related quality of life. Feasibilityand process outcomes will be assessed among NGO staff, CHWs, and participants. We will also prepare the DPP-SA for dissemination through development of training curricula, establishing university training courses, engaging other stakeholders who are candidates for dissemination, and assessing the cost-effectiveness of the intervention with respect to cost per kg of weight loss and key secondary outcomes.