Trial Information

Obesity: Cancer Risk Among African Americans-Developing Interventions Through Community Collaboration

Day 1 Study Visit:

If you are found eligible to take part in this study, the following tests and procedures
will be performed on Day 1 (the same day you complete the screening tests and sign this
consent form):

- You will complete a computer-based survey about your mood, diet, and physical activity.
The survey should take about 90 minutes total to complete.

- Your blood pressure will be measured.

- Your height, weight, and waistline will be measured. To measure your waistline
accurately, you may be asked to lift your shirt to expose your stomach area and to
lower your pants to expose your mid-hip area. Waistline measurements will only take
about 10 minutes to complete and will be performed in a private area.

- Your non-fasting blood glucose and cholesterol levels will be measured (with 2 small
finger pricks).

- You will be asked to provide a 7-day record of your physical activity using a small
device called an accelerometer. The accelerometer will be worn on your hip and
measures the amount of physical activity you do. You will be given a prepaid envelope
to return the accelerometer to the study staff.

Study Groups and Study Procedures:

At the Day 1 study visit, you will be randomly assigned (as in the flip of a coin) into 1 of
2 study groups.

If you are in Group 1 or 2, you will receive health education on Day 1, 6 months, and 12
months later. Health education includes:

- A brief counseling session with a study staff member to talk about diet and your
physical activity levels

- Referrals to available resources for help with your diet and physical activity

- Self-help materials that are designed to help you learn how to improve your diet and
physical activity

At Months 6 and 12, you will also:

- Complete the computer-based survey about your mood, diet, and physical activity.

- Have your height, weight, waistline and blood pressure measured.

- Your non-fasting blood glucose and cholesterol levels will be measured.

- Be given an accelerometer to wear for 7 days.You will be given a prepaid envelope to
return the accelerometer to the study staff.

If you are in Group 2, you will also take part in the MAPS program. For the MAPS program,
you will have 12 counseling phone calls over 1 year. Each of these phone calls will be
digitally recorded and should last about 20-30 minutes. You may decline to have your
counseling phone call recorded if it makes you feel uncomfortable. The purpose of the phone
calls are to provide support to you on changes in your diet or physical activity and to
answer any questions you may have about your program.

Length of Study:

You will remain on the study for up to 1 year. Your participation on this study will be over
once you complete the study visit at Month 12.

Other Important Information:

You may be contacted by phone, mail, and/or email at any time while you are taking part in
this study to be reminded about the study visits. You will be asked to give the names and
contact information for family members and/or friends for the study staff to contact in the
event there is trouble reaching you first.

If the accelerometer is lost or stolen, you will not be responsible for the replacement
cost, but you should tell the study staff right away.

All participant's paper files will be stored in locked file cabinets and all data files will
be stored in a password-protected databases. The information discussed during the counseling
phone calls will be kept confidential. Only members of the research team will have access to
the recordings.

This is an investigational study.

Up to 300 participants will take part in this study. All will be enrolled at MD Anderson.