title: Trial design: blood pressure control and weight gain prevention in prehypertensive and hypertensive smokers: the treatment and prevention study.
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.
authors: 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
authors: Mark W
authors: MW
authors: Vander Weg
authors: Robert C
authors: RC
authors: Klesges
authors: Jon O
authors: JO
authors: Ebbert
authors: Ellen J
authors: EJ
authors: Lichty
authors: Margaret
authors: M
authors: DeBon
authors: Frederick
authors: F
authors: North
authors: Darrell R
authors: DR
authors: Schroeder
authors: Patricia M
authors: PM
authors: Dubbert
mesh_terms: 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
chemical_list: D002712:Chlorides
references: J Consult Clin Psychol. 2004 Oct;72(5):785-96
references: 15482037
references: Nicotine Tob Res. 2002 May;4(2):149-59
references: 12028847
references: Nicotine Tob Res. 2003 Feb;5(1):13-25
references: 12745503
references: Ann Epidemiol. 1995 Mar;5(2):119-29
references: 7795830
references: J Hypertens Suppl. 1990 Sep;8(5):S3-8
references: 2286855
references: Cardiol Clin. 1996 Feb;14(1):51-68
references: 9072291
references: J Hypertens Suppl. 1988 Dec;6(4):S605-7
references: 3241262
references: BMJ. 2001 Nov 10;323(7321):1123-4
references: 11701584
references: J Consult Clin Psychol. 1998 Dec;66(6):987-93
references: 9874912
references: Prev Med. 1991 Sep;20(5):602-20
references: 1758841
references: Am J Public Health. 1992 Sep;82(9):1238-43
references: 1503165
references: J Pers Soc Psychol. 1985 May;48(5):1279-89
references: 3998990
references: JAMA. 1983 Apr 1;249(13):1764-8
references: 6827767
references: Arch Intern Med. 1999 Jun 14;159(11):1229-34
references: 10371231
references: Int J Obes Relat Metab Disord. 2002 Jan;26(1):58-64
references: 11791147
references: Klin Wochenschr. 1985 Jan 15;63(2):62-7
references: 3981952
references: Addict Behav. 1990;15(3):271-83
references: 2378287
references: Am J Epidemiol. 1998 Nov 1;148(9):821-30
references: 9801011
references: Circulation. 2005 Jul 26;112(4):489-97
references: 16027251
references: J Consult Clin Psychol. 1997 Apr;65(2):286-91
references: 9086692
references: Int J Addict. 1988 Jul;23(7):729-50
references: 3192340
references: Hypertension. 1982 Jul-Aug;4(4):494-8
references: 6891373
references: Eur J Clin Nutr. 2000 Dec;54(12):895-9
references: 11114688
references: Arch Intern Med. 1992 Jan;152(1):56-64
references: 1728930
references: JAMA. 1996 May 22-29;275(20):1571-6
references: 8622248
references: J Am Coll Nutr. 1985;4(2):233-9
references: 4040538
references: Bull World Health Organ. 1962;27:645-58
references: 13974778
references: Am Heart J. 1974 May;87(5):558-64
references: 4818700
references: Addict Behav. 1987;12(1):17-21
references: 3565108
references: J Intern Med. 2004 Feb;255(2):266-72
references: 14746564
references: N Engl J Med. 2001 Jan 4;344(1):3-10
references: 11136953
references: J Am Diet Assoc. 2002 Dec;102(12):1764-72
references: 12487538
references: Health Psychol. 1994 Jul;13(4):354-61
references: 7957014
references: J Consult Clin Psychol. 1991 Oct;59(5):739-44
references: 1955608
references: Med Sci Sports Exerc. 2000 Sep;32(9 Suppl):S498-504
references: 10993420
references: Hypertension. 2001 Feb;37(2):194-8
references: 11230270
references: JAMA. 1998 Mar 18;279(11):839-46
references: 9515998
references: BMJ. 1999 Aug 21;319(7208):490-3; discussion 494
references: 10454403
references: JAMA. 2003 May 21;289(19):2560-72
references: 12748199
references: J Hum Hypertens. 2002 Nov;16(11):761-70
references: 12444537
references: Med Sci Sports Exerc. 2003 Aug;35(8):1381-95
references: 12900694
references: Can J Sport Sci. 1992 Dec;17(4):338-45
references: 1330274
references: Am J Clin Nutr. 1986 Apr;43(4):486-94
references: 3962901
references: Am J Public Health. 1992 Jun;82(6):799-803
references: 1585959
references: Ann Nutr Metab. 2001;45(4):169-74
references: 11464000
references: J Am Diet Assoc. 1999 Aug;99(8 Suppl):S12-8
references: 10450289