Status:
COMPLETED
Preventing Weight Gain and Controlling Blood Pressure During Smoking Cessation in Hypertensive Smokers
Lead Sponsor:
Mark Vander Weg
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiovascular Diseases
Heart Diseases
Eligibility:
All Genders
Phase:
NA
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 c...
Eligibility Criteria
Inclusion
- Smoke at least 5 cigarettes/day (or have quit within the last 6 weeks to enter the study for the weight gain prevention and BP control interventions)
- Pre-hypertensive or Stage I hypertension (systolic BP from 120 to 159 and/or diastolic BP from 80 to 99 mm Hg). Antihypertensive medications are not criteria for exclusion provided that BP is not over 160/100 mm Hg)
- Access to a telephone
Exclusion
- History of unstable cardiovascular disease, including myocardial infarction, stroke, and unstable angina within three months of study start
- Coronary artery bypass grafting or angioplasty/stent within three months of study start
- Cardiac dysrhythmia treated with anti-arrhythmia medication, except stable atrial fibrillation
- Untreated hyperthyroidism or pheochromocytoma
- History of congestive heart failure (NYHA Class III or IV)
- ECG evidence of 2nd or 3rd degree atrioventricular block
- Uncontrolled or Stage II Hypertension as defined as BP consistently above 160/100 mm Hg
- History of severe liver or kidney failure
- Current substance abuse (includes alcohol use in excess of 21 drinks a week)
- Presence of an unstable psychiatric condition
- Severe chronic obstructive pulmonary disease
- Symptomatic peripheral vascular disease
- Pulmonary hypertension with shortness of breath
- Congenital or valvular heart disease with shortness of breath
- Current use of a medication that may interfere with primary study endpoints or that may increase the risk of side effects from study medication that cannot be discontinued
- Pregnant or plans to become pregnant within the next year
- Planning to move out of the area or travel extensively during the intervention
- Any medical condition that would preclude any additional changes in diet
- Unable to further modify physical activity routine
- Cannot engage in moderate intensity exercise (e.g., walking)
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT00113074
Start Date
September 1 2004
End Date
June 1 2011
Last Update
April 29 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Iowa, Carver College of Medicine, Department of Internal Medicine, Division of General Internal Medicine
Iowa City, Iowa, United States
2
Mayo Clinic College of Medicine
Rochester, Minnesota, United States, 55905