Treating Adults at Risk for Weight Gain With Interactive Technology (TARGIT)
|ClinicalTrials.gov Identifier: NCT01199185|
Recruitment Status : Unknown
Verified June 2013 by University of Tennessee.
Recruitment status was: Active, not recruiting
First Posted : September 10, 2010
Last Update Posted : June 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Smoking Body Weight||Behavioral: Smoking Cessation Behavioral: Smoking Cessation plus Weight Loss||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Targeted Approaches to Weight Control for Young Adults|
|Study Start Date :||August 2009|
|Estimated Primary Completion Date :||October 2014|
|Estimated Study Completion Date :||October 2014|
|Active Comparator: Tobacco Quitline Group||
Behavioral: Smoking 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).
|Experimental: Tobacco Quitline plus Interactive Technology Group||
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). 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199185
|United States, Tennessee|
|Department of Preventive Medicine|
|Memphis, Tennessee, United States, 38163|
|Principal Investigator:||Karen Johnson, MD, MPH||University of Tennessee Health Science Center|