NCT00113074

Preventing Weight Gain and Controlling Blood Pressure During Smoking Cessation in Hypertensive Smokers

Blood Pressure Control in Hypertensive Smokers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Mark Vander Weg · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to develop effective interventions that assist individuals with high blood pressure to quit smoking and prevent weight gain.

Detailed description

BACKGROUND: High blood pressure (BP), or hypertension, is a major risk factor for cardiovascular morbidity and mortality. Hypertension is associated with an elevated risk for several cardiovascular complications, including coronary heart disease, peripheral vascular disease, congestive heart failure, and stroke, as well as an increased risk for renal disease. Although there have been significant advances in the detection and treatment of high BP, approximately one in four adults in the United States is hypertensive. Cigarette smoking accounts for more than 400,000 premature deaths each year in this country alone, making it the leading cause of morbidity and mortality. Evidence from several epidemiological studies has demonstrated that, at any level of BP, smoking substantially increases the risk for all cardiovascular complications associated with hypertension. While cigarette smoking and hypertension both increase the risk of cardiovascular disease, these two risk factors act synergistically to produce a greater risk than their combined independent effects. Despite the considerable health risks, smoking among people with hypertension is very common, with a prevalence approaching that observed among those with normal BP. Unfortunately, although quitting smoking is especially important for patients with high BP, smoking cessation produces a nontrivial weight gain, averaging 5 kg, which may exacerbate hypertension in many patients with the disorder. Several studies have documented significant elevations in BP following smoking cessation, as well as increases in the prevalence of hypertension after quitting smoking. As such, it is important to develop effective interventions that assist in quitting smoking and preventing weight gain. DESIGN NARRATIVE: The objective of the trial is to recruit 750 smokers with Stage 1 hypertension or prehypertension (based on JNC VII criteria). The trial will provide all participants with a brief, validated, combined behavioral and pharmacologic smoking cessation intervention. Additionally, the study will randomly assign participants who are abstinent from smoking upon completing the cessation intervention to either a 12-week weight management and BP control program or self-help materials targeting lifestyle modification. The primary endpoint is change in BP among quit smokers at a one-year follow-up. Secondary endpoints include changes in body weight, dietary intake, urinary sodium excretion, physical activity, and relapse to smoking. Exploratory endpoints include changes in hypertensive status (e.g., movement from prehypertensive to hypertensive by JNC VII criteria) and changes in BP medication status. This is a multi-site clinical trial, with study locations in Rochester, Minnesota, and Iowa City, IA. The Rochester, MN site is currently closed for recruitment.

Conditions

• Cardiovascular Diseases
• Heart Diseases
• Hypertension

Interventions

Type	Name	Description
DRUG	Nicotine Replacement Therapy	Nicotine replacement therapy program
BEHAVIORAL	Diet	Diet program

Timeline

• Start date: 2004-09-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2005-06-06
• Last updated: 2024-04-29
• Results posted: 2024-04-29

Locations

2 sites across 1 country: United States