Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113074
Status:
COMPLETED
Last Update Posted:
2024-04-29
First Post:
2005-06-03
Brief Title:
Preventing Weight Gain and Controlling Blood Pressure During Smoking Cessation in Hypertensive Smokers
Sponsor:
Mark Vander Weg
Organization:
University of Iowa
Study Overview
Official Title:
Blood Pressure Control in Hypertensive Smokers
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 400000 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 eg 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
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 400000 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL072782 | NIH | None | httpsreporternihgovquickSearchR01HL072782 |