Trial design: blood pressure control and weight gain prevention in prehypertensive and hypertensive smokers: the treatment and prevention study.
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.
Vander Weg
Mark W
MW
Iowa City VA Medical Center, Center for Research in the Implementation of Innovative Strategies in Practice (CRIISP), University of Iowa Dept of Internal Medicine, Iowa City, IA 52246, USA. mark.vanderweg@va.gov
Klesges
Robert C
RC
Ebbert
Jon O
JO
Lichty
Ellen J
EJ
DeBon
Margaret
M
North
Frederick
F
Schroeder
Darrell R
DR
Dubbert
Patricia M
PM
D001521:Behavior Therapy; D001794:Blood Pressure; D002712:Chlorides / Q000652:urine; D005260:Female; D006801:Humans; D006973:Hypertension / Q000628:therapy; D008019:Life Style; D008297:Male; D009043:Motor Activity; D009765:Obesity / Q000517:prevention & control*; D010352:Patient Dropouts; D012107:Research Design; D018401:Sample Size; D012907:Smoking / Q000628:therapy*; D016540:Smoking Cessation; D015430:Weight Gain
D002712:Chlorides
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