A Phase 3 interventional study of Smoking Cessation and Smoking Cessation plus Weight Loss in Smoking and Body Weight, sponsored by University of Tennessee. Status unknown at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-18.
Sponsored by University of Tennessee · Phase 3, Interventional, and Prevention
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 frequently results in significant weight gain. Proactive tobacco quit lines using behavioral smoking cessation interventions combined with nicotine replacement therapy (NRT) have been shown to help persons quit smoking. However, concerns about post-cessation weight gain have been reported as a significant barrier to quitting for many smokers particularly young adults.
If an efficacious behavioral weight loss program could be combined with an efficacious behavioral smoking cessation program that prevented or significantly attenuated post-cessation weight gain, then a large public health benefit may result. Such a combined weight loss/ weight gain prevention / 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 adult cigarette smokers. Therefore, the objective of this clinical trial is to develop and test a behavioral weight loss / weight gain prevention intervention delivered through interactive technology that can be used in conjunction with an efficacious tobacco quit line. A total of 330 participants will be necessary to adequately address the following specific aims.
1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.
This study's planned enrollment of 330 is above the median of 64 across 947 interventional studies indexed under Body Weight.
Browse Body Weight studies →University of Tennessee is the lead sponsor of 139 studies on the registry; 21 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
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The selection criteria for the clinical trial are designed to include a wide range of participants such that the study sample will be representative of the broader U.S. population of the Memphis metropolitan area. Those who might be at risk of adverse outcomes from the study interventions will be excluded (see exclusion criteria). All participants will give voluntary consent at the screening visit by signing an informed consent statement which has been approved by the Institutional Review Board (IRB). We will encourage the participation of women and minorities. The study will be open to all persons of any race or gender who are:
Exclusion Criteria:
Persons will be excluded from the TARGIT study for the following:
Behavioral: Smoking Cessation
Behavioral: Smoking Cessation plus Weight Loss
All participants will receive a smoking cessation intervention via the Proactive TARGIT Quit Line. Participants will receive access to the TARGIT Smoking Cessation Handbook which will be a useful tool to guide them through the quitting process and highlight the major points reviewed in all counseling sessions. As part of TARGIT all participants will receive nicotine replacement therapy (NRT).
All participants will receive a smoking cessation intervention via the Proactive TARGIT Quit Line. Participants will receive access to the TARGIT Smoking Cessation Handbook which will be a useful tool to guide them through the quitting process and highlight the major points reviewed in all counseling sessions. As part of TARGIT all participants will receive nicotine replacement therapy (NRT). Participants in the Intervention Group will also receive a Behavioral Weight Loss/ Weight Gain Prevention Intervention delivered via interactive technology. The Intervention group will receive 16 weekly webinar sessions beginning 7 weeks after randomization via Cisco WebEx. The webinar sessions will present the behavioral weight loss/ weight gain prevention program. After the 16 weekly sessions, the webinar sessions will then be scheduled monthly for the next 6 months then quarterly thereafter for 12 months.
Body Mass Index
Time frame: 24 months after randomization
Smoking status
Time frame: 24 months after randomization
This study is status unknown, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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University of Tennessee