Friday, September 29, 2023
9/29/2023
Program Director/Principal Investigator (Last, First, Middle): Spas, Jayson, J. Abstract Smokers with excess weight are at significantly elevated risk for morbidity and premature death. Despite recent reports specifying the need and importance of this work, there remains a paucity of research on smoking cessation interventions tailored to meet the needs of smokers with excess weight. Although distress tolerance (DT) has proven efficacy for both smoking cessation and weight loss as separate outcomes, it remains unknown whether DT can treat nicotine addiction and excess weight simultaneously. The long-term objective of this research program is to improve smoking cessation interventions for smokers with multiple health behavior risks, including excess weight. The proposed project has two phases. Phase1 will revise and pilot a DT protocol that simultaneously targets smoking cessation and weight loss with 6 subjects (1 group). Subjects will complete an 8-week intervention comprised of seven 2-hour weekly group sessions, two 10-minute individual phone sessions and use of the transdermal nicotine patch (TNP). Phase 2 will conduct a preliminary randomized controlled trial (RCT) with 48 subjects (8 groups with 6 subjects). The aim of this phase is to examine the efficacy of the DT intervention compared to an active health control comprised of standard intervention for smoking cessation and weight loss that equates for intervention contact time. All subjects in both conditions will receive the TNP. We expect that subjects randomized to the DT condition, relative to the control, will have increased rates of 7-day point-prevalence abstinence and weight loss during the intervention and at the 8-, 12- and 26-week post- intervention assessments. We also expect increased latency to smoking and weight lapse and relapse. If we can establish DT’s efficacy in this study, this intervention can be tested in larger-scale randomized controlled trials (RCTs) in future projects. This work would result in improved smoking cessation and weight loss treatment options for smokers with excess weight. The need for this work is particularly great given the significantly elevated health risks associated with smoking and excess weight comorbidity, an apparent stabilization of smoking cessation rates while rates of excess weight increase, and the NIH’s recent summary report on the Science of Behavior Change (2009) identifying simultaneously changing multiple behaviors as a top priority for all of the NIH. OMB No. 0925-0001/0002 (Rev. 03/16 Approved Through 10/31/2018) Page Continuation Format Page
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