Obesity represents a chronic disease associated with significant cardiovascular disease (CVD) morbidity and mortality. Weight gain in young adults adversely impacts the development of CVD risk factors. Further, there is a clear relationship between weight loss in obese persons and reduction in these CVD risk factors. Unfortunately, young adults are at high risk for weight gain. Although the scientific literature contains a number of reports regarding successful weight loss efficacy studies, young adults are typically underrepresented. Cigarette smoking is the leading preventable cause of morbidity and mortality, but quitting smoking results in significant weight gain. Tobacco quit lines have been shown to help persons quit smoking. However, concerns about post-cessation weight gain have been reported as a significant barrier to quitting. If an efficacious behavioral weight loss program could be combined with an efficacious behavioral smoking cessation program that prevented post-cessation weight gain, then a large public health benefit may result. Such a combined weight loss / smoking cessation program that used targeted intervention strategies to young adults, removed barriers to participation, and utilize interactive technology should be appealing to this age group. To date such a combined program has not been tested in young overweight and obese cigarette smokers trying to quit. Therefore, the objective of this clinical trial is to develop and test a behavioral weight loss intervention delivered through interactive technology that can be used in conjunction with an efficacious tobacco quit line (QL). A total of 330 participants will be necessary to adequately address the following specific aims: Primary Aim: We hypothesize that an efficacious proactive tobacco quit line plus a behavioral weight loss intervention delivered through interactive technology (Intervention Group) will significantly attenuate or prevent weight gain associated with smoking cessation at 2 years after enrollment compared to a proactive tobacco quit line alone (Comparison Group) in young overweight and obese smokers. Secondary Aims: We also plan to assess changes between the groups in: a.) Biochemically verified smoking cessation;b.) Diet and eating behavior;and c.) Physical activity.
|Coday, Mace; Richey, Phyllis; Thomas, Fridtjof et al. (2016) The Recruitment Experience of a Randomized Clinical Trial to Aid Young Adult Smokers to Stop Smoking without Weight Gain with Interactive Technology. Contemp Clin Trials Commun 2:61-68|
|Lytle, Leslie A; Svetkey, Laura P; Patrick, Kevin et al. (2014) The EARLY trials: a consortium of studies targeting weight control in young adults. Transl Behav Med 4:304-13|