Smoking Cessation Study

What is the purpose of this study?

The University of Iowa is conducting a study in smokers who would like to stop smoking but are concerned about gaining weight or increasing blood pressure. This research study is being done to evaluate the effectiveness of three programs that are designed to help manage weight and control blood pressure after quitting smoking.

How many people will participate in the study?

The plan is to have 1267 people take part in this study at three different research centers across the United States, including 500 people at the University of Iowa.

What will participation consist of?

This study has two phases: the first to help the smoker quit by providing counseling and the nicotine patch, and the second to help them make and maintain healthy lifestyle changes.

Qualified participants will be assigned, by chance, to one of three treatment groups:

• A 17-session program to help manage weight.
• A 17-session program to control blood pressure through lifestyle change.
• Self-help materials that were designed to help manage body weight and blood pressure.

Those assigned to the blood pressure control program or the weight management program will attend 5 individual and 12 group meetings. Regardless of the group assignment, participants will also return for follow-up visits at 6 months and 12 months.

How long will this study last?

Participants will be enrolled in this study for up to 14 months.

What are the risks and/or benefits to participating?

This study may not make your health better. However, it is possible that your weight and blood pressure control may improve. In addition, you will be taught strategies in an effort to help you to quit smoking.

You may be assigned to one of the groups that include a recommendation for mild to moderate physical activity. Increasing one’s physical activity slightly increases the risk of a cardiac event such as angina or a myocardial infarction (heart attack). Steps will be taken, however, to minimize this risk, including a brief physical examination and measure of your heart activity (electrocardiogram) to ensure that increasing physical activity is appropriate for you.

Who do I contact for questions, now and in the future?

For more information or to participate in this research study, please contact the Preventive Intervention Center at (319) 384-5055 or visit www.PICstudies.org.