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Randomized Controlled Trial
. 2008 Mar;29(2):281-92.
doi: 10.1016/j.cct.2007.07.003. Epub 2007 Jul 19.

Trial design: blood pressure control and weight gain prevention in prehypertensive and hypertensive smokers: the treatment and prevention study

Mark W Vander Weg  1 , Robert C Klesges, Jon O Ebbert, Ellen J Lichty, Margaret DeBon, Frederick North, Darrell R Schroeder, Patricia M Dubbert
Affiliations
Randomized Controlled Trial

Trial design: blood pressure control and weight gain prevention in prehypertensive and hypertensive smokers: the treatment and prevention study

Mark W Vander Weg et al. Contemp Clin Trials. 2008 Mar.

Abstract

Background: Cigarette smokers with elevated blood pressure (BP) are at substantially higher risk for cardiovascular events compared to normotensive smokers. Although smoking cessation should be a primary treatment goal for these patients, increases in body weight accompanying smoking abstinence may further increase BP. Intervention strategies that facilitate smoking cessation and modify adverse changes in body weight and BP are needed.

Methods: We describe an ongoing multi-site, two-phase, five-year randomized clinical trial. Participants are cigarette smokers with Prehypertension or Stage I Hypertension. In the first phase, participants receive a smoking cessation intervention combining behavioral counseling and nicotine replacement in an open-label fashion. In the second phase, participants who successfully quit smoking are randomly assigned to one of three lifestyle interventions: 1) weight gain prevention, 2) blood pressure control, or 3) usual lifestyle. Participants are followed for one year to assess changes in blood pressure, body weight, dietary intake, and physical activity.

Conclusions: Results from the proposed study will provide important insights into the efficacy of various approaches to lifestyle modification in smokers at increased risk for cardiovascular events.

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Figures

Figure 1
Figure 1
Design and Study Flow for Study of Lifestyle Approaches to Weight and Blood Pressure Control in Smokers with Prehypertension or Stage I Hypertension.
Figure 2
Figure 2
Anticipated Attrition Over Course of Study.
See this image and copyright information in PMC

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