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

Blood Pressure Control in Hypertensive Smokers

The purpose of this study is to develop effective interventions that assist individuals with high blood pressure to quit smoking and prevent weight gain.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Cardiovascular Diseases; Hypertension
• Intervention / Treatment: Drug: Nicotine Replacement Therapy; Behavioral: Diet

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.

• Study Type: Interventional
• Enrollment (Actual): 376
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States
      • University of Iowa, Carver College of Medicine, Department of Internal Medicine, Division of General Internal Medicine
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Weight management and BP control program	Drug: Nicotine Replacement Therapy; Nicotine replacement therapy program; Behavioral: Diet; Diet program
Active Comparator: 2; Self-help materials targeting lifestyle modification	Drug: Nicotine Replacement Therapy; Nicotine replacement therapy program; Behavioral: Diet; Diet program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in BP among people who have quit smoking	Measured at Year 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in body weight	Measured at Year 1
Dietary intake	Measured at Year 1
Urinary sodium excretion	Measured at Year 1
Physical activity	Measured at Year 1
Relapse to smoking	Measured at Year 1

Collaborators and Investigators

• Sponsor: University of Iowa
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Mark W. Vander Weg, PhD, University of Iowa, Carver College of Medicine, Department of Internal Medicine

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: June 3, 2005
• First Submitted That Met QC Criteria: June 3, 2005
• First Posted (Estimate): June 6, 2005

Study Record Updates

• Last Update Posted (Estimate): January 8, 2013
• Last Update Submitted That Met QC Criteria: January 7, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 179; R01HL072782 (U.S. NIH Grant/Contract)