Status:
COMPLETED
Strategies to Reduce Weight Gain in Hypertensive Smokers
Lead Sponsor:
University of Tennessee
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiovascular Diseases
Heart Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate the effectiveness of lifestyle modification following a smoking cessation program in preventing weight gain among hypertensive smokers placed at medical risk by the post-cessation weight g...
Detailed Description
BACKGROUND: Obesity and smoking are major risk factors for a variety of health-related disorders, such as heart disease, stroke, certain forms of cancer, and diabetes. Recently, it has been reported ...
Eligibility Criteria
Inclusion
- Smoke cigarettes
- Hypertension or elevated blood pressure (a "high normal" designation by the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure \[JNC VI\] criteria)
Exclusion
- Inability to understand consent procedures
- History of an allergic reaction to nicotine replacement therapy
- History of atopic or eczematous dermatitis
- Chronic or severe dermatosis
- History of unstable heart disease, including heart attack, stroke, and unstable angina in the 6 months prior to study entry
- Coronary artery bypass grafting or angioplasty/stent in the 3 months prior to study entry
- Cardiac dysrhythmia (except atrial fibrillation) treated with anti-arrhythmia medication
- History of congestive heart failure (NYHA Class III or IV)
- ECG evidence of 2nd or 3rd degree AV block
- Uncontrolled or stage II hypertension, defined as blood pressure typically greater than 160/100 mm Hg
- History of severe kidney or liver failure
- Current substance abuse (includes alcohol use in excess of 21 drinks a week)
- Severe COPD
- Insulin-dependent diabetes mellitus
- Fasting blood sugar greater than 160 mg/dl
- Hemoglobin less than 11 g/dl
- Untreated hyperthyroidism
- Severe peripheral vascular disease
- Pheochromocytoma
- Pulmonary hypertension
- Valvular heart disease
- Presence of an unstable psychiatric condition
- Current use of a medication that may interfere with study participation or that may increase the risk of side effects from study medication
- Pregnant or plan to become pregnant within the year following study entry
- Planning to move out of the area or travel extensively during the study
- Current medical condition that would preclude any additional changes in diet; dieters and individuals on a special diet will not be excluded from the study
- Unable to modify physical activity, or cannot engage in moderate intensity exercise (e.g., walking); participants who regularly engage in physical activity will not be excluded from the study
- No access to a telephone
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
459 Patients enrolled
Trial Details
Trial ID
NCT00119821
Start Date
September 1 2004
End Date
June 1 2011
Last Update
December 2 2015
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