A Multiple Health Behavior Change Intervention for Weight-Loss and Smoking Cessation among Pre-Bariatric Surgery Patients - PROJECT SUMMARY/ABSTRACT Smoking prevalence among pre-bariatric surgery patients is estimated to be as high as 40%. In addition to quitting smoking, patients are expected to lose weight before surgery, which is challenging as smoking cessation is associated with weight gain. Pre-bariatric surgery patients would significantly benefit from a tailored multiple health behavior change (MHBC) intervention targeting weight loss and smoking cessation concurrently, yet no such interventions have been examined within this patient population. This K23 aims to develop and pilot a MHBC intervention for pre-bariatric surgery patients to evaluate feasibility and acceptability, compare the intervention to a standard of care (SOC) control group in achieving weight loss and smoking cessation at post-treatment, and examine bariatric surgery completion, weight loss, and smoking cessation at 6-month follow-up. This pilot randomized control trial (RCT) will include 64 adult pre-surgical patients that have severe obesity and smoke cigarettes. Participants in the intervention arm (n=32) will complete a 4-month concurrent behavioral weight loss and smoking cessation intervention with medication (Naltrexone 50 mg/day, Bupropion 300 mg/day). Qualitative interviews will be conducted with the first 6 participants to refine the intervention prior to enrolling the pilot RCT sample. The SOC control group (n=32) will follow participants across the same 4-month period. Weight and smoking will be assessed monthly and at post-treatment. Smoking cessation will be measured using timeline follow-back interviews to assess 7-day point prevalence abstinence, and biochemically confirmed through exhaled carbon monoxide. Participants will return 6-months later to re-assess these outcomes and bariatric surgery completion. This pilot RCT is critically important to improve bariatric surgery utilization and reduce risk for smoking relapse post-surgery. This K23 will directly address the PI's training goals to: 1) Obtain training in the development/evaluation of interventions for dual risk behaviors (obesity, cigarette smoking), including mixed methods research to guide intervention development; 2) Gain training and experience in the conduct of clinical trial research using behavioral and pharmacological treatments for obesity and smoking; 3) Obtain statistical training in longitudinal mixed modeling to analyze clinical trial data; 4) Strengthen grants management skills and professional development in research ethics, leadership opportunities, and supervision of trainees. The PI will work with a knowledgeable team of mentors to support career development, and complete/attend workshops, courses, directed readings, conferences, and meetings. These activities will meet the PI's training goals by providing the necessary training to become an independent investigator. The Yale Program for Obesity, Weight, and Eating Research (POWER) is an ideal environment for the proposed K23, as POWER has the facilities and resources needed to support clinical treatment trials. Further, the Department of Psychiatry is one of the nation's leading departments in research activity and productivity and provides a supportive and stimulating environment for interdisciplinary research.
