N/A
N=139
Preventing Weight Gain and Controlling Blood Pressure During Smoking Cessation in Hypertensive Smokers
Cardiovascular Diseases · Heart Diseases · Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00113074 ↗Enrolled (actual)
139
Serious AEs
1.4%
Results posted
Apr 2024
Primary outcome: Primary: Change in Systolic Blood Pressure at One Year Among People Who Have Quit Smoking — -1.78; -0.17; -1.64 millimeters of mercury (mmHg)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nicotine Replacement Therapy (Drug); Diet (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Mark Vander Weg
- Primary completion
- Jun 2011
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 | — |
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.
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.