N/A
Completed N=139
Preventing Weight Gain and Controlling Blood Pressure During Smoking Cessation in Hypertensive Smokers
Source: ClinicalTrials.gov NCT00113074 ↗Enrolled (actual)
139
Serious AEs
1.4%
Results posted
Apr 2024
Primary outcomePrimary: Change in Systolic Blood Pressure at One Year Among People Who Have Quit Smoking — -1.78; -0.17; -1.64 millimeters of mercury (mmHg)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Systolic Blood Pressure at One Year Among People Who Have Quit Smoking |
-1.78; -0.17; -1.64 | — |
| PRIMARY Change in Diastolic Blood Pressure at One Year Among People Who Have Quit Smoking |
-0.35; -1.17; 0.93 | — |
| SECONDARY Changes in Body Weight |
3.07; 2.73; 6.20 | — |
| SECONDARY Dietary Intake - Fruit and Vegetable Consumption |
1.32; -3.46; -0.29 | — |
| SECONDARY Urinary Sodium Chloride Excretion |
.01; .05; -.05 | — |
| SECONDARY Physical Activity: Leisure Time Physical Activity in METs |
293.7; 277.5; -1383.5 | — |
| SECONDARY Relapse to Smoking |
24; 30; 30 | — |
| SECONDARY Dietary Intake - Dietary Fat Consumption |
-2.39; -0.81; -0.88 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT00113074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.