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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mark Vander Weg, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00113074
First received: June 3, 2005
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention
Cardiovascular Diseases
Heart Diseases
Hypertension
Drug: Nicotine Replacement Therapy
Behavioral: Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Blood Pressure Control in Hypertensive Smokers

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Change in BP among people who have quit smoking [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in body weight [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • Dietary intake [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • Urinary sodium excretion [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • Relapse to smoking [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]

Enrollment: 376
Study Start Date: September 2004
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113074

Locations
United States, Iowa
University of Iowa, Carver College of Medicine, Department of Internal Medicine, Division of General Internal Medicine
Iowa City, Iowa, United States
United States, Minnesota
Mayo Clinic College of Medicine
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Mark W. Vander Weg, PhD University of Iowa, Carver College of Medicine, Department of Internal Medicine
  More Information

No publications provided

Responsible Party: Mark Vander Weg, Mark W. Vander Weg, PhD, University of Iowa, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00113074     History of Changes
Other Study ID Numbers: 179, R01HL072782
Study First Received: June 3, 2005
Last Updated: January 7, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Hypertension
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014