Quit and Fit: A Tobacco Cessation and Energy Balance Pilot for African Americans

1. * Purpose of project (one or two sentences): The feasibility phase of the proposed study is comprised of a two-arm randomized pilot trial to evaluate the feasibility, satisfaction, and preliminary efficacy of 'Quit & Fit'. Women (N=40) will receive 12 weekly smoking cessation telephone counseling sessions. Participants will be randomized to either a fitness intervention (Quit & Fit) or a contact time control (Quit for Life).
2. * Study design (for example, hypothesis, research questions, standard and experimental procedures/drugs/devices or equipment, etc.):

The Quit & Fit intervention will be designed as a 12-week, tailored multiple health outcome intervention to promote smoking cessation, achieve energy balance, and reduce post-cessation weight gain through regular PA and healthy nutrition for AAW smokers. Culturally tailored comprehensive interventions that address smoking-cessation and obesity/weight-control among AAW are needed. The conceptual basis of the proposal is Albert Bandura's social cognitive Theory (SCT), which posits that people learn through observation and modeling of behaviors, attitudes, and emotional reactions. When applied to smoking cessation and health behavior change, social learning can be viewed as a transition through stages of increased knowledge, self-efficacy, and social support, culminating in readiness to change behaviors. The SCT model allows for targeting of factors relevant to a given individual and tailoring messages to each each participant's cultural values. Participants will be randomized into one of the study groups: the 'control arm' or the 'exercise arm'. Both groups will receive 12 weeks of smoking cessation counseling, telephone counseling and and will receive 10 weeks of nicotine replacement therapy (NRT) in the form of nicotine lozenges.

Participants who are randomized to the 'control arm' will be asked to maintain their current daily activities for 12 weeks. They will also be required to visit the study site 3 times per week for 12 weeks to view videos on different wellness topics. Control participants will have anthropometric measurements of weight, height, hip size and waist size taken at the beginning of the study, 6 weeks, and at 12 weeks. Control participants will also have a fitness test on a treadmill, full body scan, blood pressure, heart rate and questionnaires given at the beginning of the study, 6 weeks and at 12 weeks.

Participants who are randomized to the 'intervention arm' will be asked to come to the study site to exercise 3 days per week for 12 weeks. The exercise duration will increase over time from 75 minutes per week to 150 minutes per week. Intervention participants will have anthropometric measurements of weight, height, hip size and waist size taken at the beginning of the study, 6 weeks, and at 12 weeks. Intervention participants will also have a fitness test on a treadmill, full body scan, blood pressure, heart rate and questionnaires given at the beginning of the study, 6 weeks and at 12 weeks.

The proposed design of the intervention is to provide high does of education, support, NR, and structured exercise to optimize success experiences that can build self-doses in the first sessions. As the intervention progresses, support through mobile phones will be used to assist with problem solving and social support as participants transition to self-management. Content will be based on the extant literature on tobacco cessation, nutrition, and exercise interventions, with emphasis given to published descriptions of interventions tailored for AAW. Examples of resources from which content may be drawn include Commit to Quit, Smoke Free Woman (NCI), Pathways to Freedom (2003 version), and the Diabetes Prevention Program. Key content messages will be developed for each counseling session. all print materials will be specifically targeted with visual images and content that has been found to engage AAW. Focus groups will be conducted with women representing the targeting population in order to develop the messages and visual content. These qualitative data will be critical in the development of intervention materials that engage and connect with the women. Focus groups will be conducted during the first 3 months of the award, with the primary goal of furthering tailoring intervention materials and protocols to the lives of African-American women residing in urban District of Columbia (DC) neighborhoods. A total of 4 groups will be run with 8 women in each. The demographic makeup of the groups will resemble that of our target population on such factors as educational attainment and socio-economic status (SES). Participants will be recruited through outreach methods (flyers, community talks) used successfully by Dr. Adams-Campbell's community lab. The multiple principal investigators (MPIs) will refine the focus group facilitator's guide and review focus group transcripts and notes to maintain protocol integrity. Open-ended questions will probe views on target health behaviors as well as preferred information delivery modalities and ways to remain in contact and provide optimal support. All focus groups will be audio-taped, with a research assistant taking notes at each of the sessions. Audiotapes will then be transcribed and translated in order to analyze their content. 3. * Rationale and justification for study (i.e. historical background, investigator's personal experience, pertinent medical literature, etc.): Smoking is the leading cause of preventable morbidity and mortality in the US. African Americans experience clear disparities in disease and death from smoking. African American women (AAW) are an important subgroup to study because they are distinct from non-AAW and their male African American counterparts on biopsychosocial factors that are relevant to smoking behavior. In particular, AAW have lower smoking rates compared to Caucasian women (CAW) yet similar lung cancer rates. Additional evidence indicates that AAW are more likely to develop cancer of the larynx, esophageal cancer, cerebrovascular disease, and cardiovascular disease than CAW. African American smokers are less likely to be screened by providers for tobacco use, receive advice to quit, or use cessation aids during a quit attempt, even after controlling for health service use and socioeconomic factors. Smoking cessation is the single most important preventative health behavior AAW can engage in to significantly reduce their chances of morbidity and premature mortality related to smoking related illnesses. Due to their disparate smoking-related health outcomes, targeted and tailored smoking cessation interventions are extremely critical for AAW.