Body Weight, Smoking
Conditions
Brief summary
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.
Interventions
BEHAVIORALSmoking Cessation
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).
BEHAVIORALSmoking 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). 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.
Sponsors
University of Tennessee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
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: 1. \*18 to 35 years old 2. BMI \> 22 kg / m2 3. Self report smoking \> 10 cigarettes each day 4. Have access to a telephone and the internet 5. Demonstrate ability to access a specific web site 6. Demonstrate ability to receive and respond to email 7. Willing to accept random assignment 8. \*Intending to be available for a 24 month intervention 9. \*At risk for weight gain (e.g. plan to quit smoking)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body Mass Index | 24 months after randomization |
Secondary
| Measure | Time frame |
|---|---|
| Smoking status | 24 months after randomization |
Countries
United States
Outcome results
None listed