Preventing Weight Gain and Controlling Blood Pressure During Smoking Cessation in Hypertensive Smokers

Not Applicable

Completed

Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension

Interventions: Drug: Nicotine Replacement Therapy
Behavioral: Diet

Registration Number: NCT00113074

Lead Sponsor: Mark Vander Weg

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 400,000 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 (e.g., 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 139

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Diet	Weight management and blood pressure control intervention
3	Nicotine Replacement Therapy	Self-help materials targeting lifestyle modification
1	Nicotine Replacement Therapy	Weight management and blood pressure control intervention
3	Diet	Self-help materials targeting lifestyle modification
2	Nicotine Replacement Therapy	Weight management intervention
2	Diet	Weight management intervention

Primary Outcome Measures

Name	Time	Method
Change in Systolic Blood Pressure at One Year Among People Who Have Quit Smoking	Measured at Year 1	Change in systolic blood pressure in mmHg
Change in Diastolic Blood Pressure at One Year Among People Who Have Quit Smoking	Measured at Year 1	Change in diastolic blood pressure in mmHg

Secondary Outcome Measures

Name	Time	Method
Changes in Body Weight	Measured at Year 1	Change in body weight in pounds from randomization to 12 months.
Dietary Intake - Fruit and Vegetable Consumption	Measured at Year 1	Change in self-reported daily fruit and vegetable consumption from randomization to 12 months. Fruit and vegetable consumption was measured by self-report using a dietary screener, which provides results in the form of number of servings per day.
Dietary Intake - Dietary Fat Consumption	Measured at Year 1	Change in daily dietary fat consumption from randomization to 12 months.
Urinary Sodium Chloride Excretion	Measured at Year 1	Percent change in urinary sodium chloride (NaCL) from randomization to one-year
Physical Activity: Leisure Time Physical Activity in METs	Measured at Year 1	Change in leisure time physical activity in metabolic equivalents (METs) from randomization to one-year. METs reflect the ratio of working metabolic rate relative to resting metabolic rate, and are expressed as the energy expended per unit of time. For this study, METs were measured based on self-reported physical activity using the International Physical Activity Questionnaire (IPAQ) and are reported in the form of MET minutes.
Relapse to Smoking	Measured at Year 1	Number of participants who self-reported tobacco use during the last seven-days.

Trial Locations

Locations (2): University of Iowa, Carver College of Medicine, Department of Internal Medicine, Division of General Internal Medicine
🇺🇸
Iowa City, Iowa, United States
Mayo Clinic College of Medicine
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Rochester, Minnesota, United States