Blood Pressure Control in Hypertensive Smokers

The purpose of this research study is to determine the effectiveness of different approaches to weight management and blood pressure control in smokers that have stopped using tobacco.

Informed Consent Document

• Read the informed consent document.

Details

Cigarettes pose significant health risks, especially for those with elevated blood pressure.  Unfortunately, smoking cessation, or quitting, often leads to weight gain, which may worsen blood pressure control in those who already have high blood pressure.

This study has two phases that can not only help you quit smoking, but will assist those who quit with making and maintaining healthy lifestyle changes.  Phase One focuses on helping you quit smoking.  During this time, all participants will receive the nicotine patch combined with smoking cessation counseling to help you achieve this goal.

Phase Two assists you with making and maintaining healthy lifestyle changes, including diet and nutrition counseling.  If you successfully quit smoking, the study will assign you to one of three programs designed to teach you strategies to help manage your weight and control your blood pressure.  There will be morning, afternoon, and evening times offered for each of these programs to best fit your schedule.

If you agree to take part in this study, your involvement will last for approximately 14 months.  Depending on your Phase Two group assignment, there could be as many as 20 visits during that time, lasting from 30 minutes to 3 hours at a time.  These visits will range from days, weeks, and up to 6 months apart.

Participation in this study is voluntary.  Compensation will be offered to those who participate in this research study.

This study is sponsored by the National Institutes of Health (NIH).

Eligibility

Study participants must be in good general health. Specific medical conditions will be reviewed with you during the study’s consenting process.

You may be eligible for the study if:

• Your blood pressure is at least slightly above normal (prehypertensive) or high (hypertensive)
• You presently smoke five (5) or more cigarettes a day
• You are willing to quit smoking or have quit smoking within the past six (6) weeks
• You are able to meet regularly on weekdays or weekday evenings for sessions
• You are between the ages of 18 and 75

You are not eligible for the study if:

• You currently consume more than 21 alcoholic drinks per week
• You are pregnant or breastfeeding, plan to become pregnant, or unwilling to perform a urine pregnancy test (if applicable)
• You plan to travel extensively or move in the next year
• You do not have access to a telephone
• You have recently had unstable angina, heart attack,stroke, coronary bypass, or angioplasty
• You have severe chronic lung disease
• You have moderate to severe heart failure, or a history of severe liver or kidney failure
• You have peripheral vascular disease which causes you to be unable to walk any distance without significant leg pains
• Your blood pressure is consistently greater than 160/10

Apply for Research Study

For additional information, or to enroll in the study over the phone, call (319) 384-5055 or toll free at 1-(800) 348-4692.

In order to determine if you pre-qualify for this study, you will be asked some personal questions about your medical history.  Some of the questions may be sensitive, such as questions about alcohol use or family planning.  Answering these questions is voluntary, and you may stop at any time.

 

Preventive Intervention Center / College of Public Health / The University of Iowa

E 251 GH - 200 Hawkins Drive - Iowa City, IA 52242-1009 - Phone: (319) 384-5064 - Fax: (319) 384-5051

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