Trial Information

Peer-support Motivational Interviewing Physical Activity Intervention for African American Women

Focus Group:

If you agree to take part in this study, you will take part in a focus group or individual
interview. A focus group is a group of people who are asked questions about certain topics
and then discuss these topics with other group members. During the focus group, you will
talk about ways that African American women may increase their physical activity. You will
also be asked questions about the ways in which you support other women to help them become
more physically active. There will be 4 focus groups, each made up of 8-10 women. The
focus group session should take 1 1/2 to 2 hours.

The focus group will be audiotaped and transcribed (the spoken words will be typed up). Your
individual name will not be used during the focus group and will not be recorded. For
example, you will be listed as Participant #1. After the focus group comments are copied
down, the focus group tapes will be destroyed. The study staff may also interview you
alone. During the individual interview, you will talk about ways that African American women
may increase their physical activity. You will also be asked questions about the ways in
which you support other women to help them become more physically active. The staff will
interview 10 women. The individual interview should take 1 1/2 to 2 hours.

The individual interview will be audiotaped and transcribed. Your individual name will not
be used during the interview and will not be recorded. For example, you will be listed as
Participant #1. After the interview comments are copied down, the interview tapes will be
destroyed.

Length of Study:

You will be on study until you complete the focus group session.

This is an investigational study. Up to 40 women will take part in the focus groups. All
will be enrolled at M. D. Anderson.

Intervention:

You will need a partner (a female friend or family member) to take part in this study. Both
you and your study partner will need to meet the same eligibility requirements, and both of
you will be enrolled as participants. If you choose a partner that is not eligible, you
will will need to choose another eligible partner before you can be enrolled in the study.

Screening:

Before you can take part in this study, you will be asked if you are between the ages of 18
and 65 years old, if you are currently not engaging in physical activity for more than 3
days per week and more than 20 minutes each day, and if you are ready to be physically
active. You will be asked if you have a home address where information can be mailed, are
able to read at a 6th grade level, and are able to participate in a training course that
will take place on a weekend.

You will also be asked if you are pregnant or plan to become pregnant during the next 12
weeks. You will also be asked if you plan to move outside of the Houston area in the next
12 weeks. If you are pregnant, plan to become pregnant, and/or plan to move, you will not be
able to take part in this study.

Baseline Tests:

If you are found to be eligible to take part in this study, you will complete the following
tests and procedures:

- You will be asked how you are feeling and how often you exercise.

- Your height and weight will be measured.

- You will fill out a questionnaire about issues related to your physical activity. It
will take 45-60 minutes to complete.

- You will take a walking test, in which you will walk for 6 minutes at a comfortable
pace.

- You will receive a pedometer (a monitor that shows how far you walk).

- You may receive an accelerometer and complete a 7-day accelerometer assessment. An
accelerometer is a small device that is worn on your hip that measures the amount of
physical activity you do.

Study Groups:

You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an
equal chance of being assigned to either group.

Group 1:

If you are in Group 1, you will take part in an 8-hour training course conducted as 2
in-person 4-hour sessions (for example, scheduled on 2 Saturdays in a row) to help you learn
how to support the exercise habits of your study partner. At this course, a trainer will
give you information and you will take part in activities with your study partner. Sample
activities include role playing and watching a video. This will take place on a weekend.
The goal of the training course is to help you and your partner engage in physical activity.
You will be asked to be physically active for 30 minutes each day.

You will receive a workbook and a DVD about physical activity. You will also be given a form
to complete each time you speak with your study partner about physical activity. You will be
asked to speak with your partner at least 1 time a week about your physical activities.

Each week during Weeks 1-4, 8, and 12 you will be asked to answer questions on the form
given to you at the training course about the conversations you have with your study
partner, and to complete recorded conversations via toll-free number. All telephone diaries
must be completed and returned to research staff members by week 12 of the study.

At Weeks 4 and 8, you will be called and asked several questions about your mood and your
physical activity. The phone call should take about 45 minutes.

At Weeks 5 and 9, you will be mailed a physical activity newsletter.

Group 2:

If you are in Group 2, at Weeks 4 and 8, you will be called and asked several questions
about your mood and your physical activity. The phone call should take about 45 minutes.

At Weeks 5 and 9, you will receive a physical activity newsletter.

End-of-Study Visit:

At Week 12 of the study, you will complete the following tests and procedures:

- You will be asked several questions about your mood and your physical activity.

- Your height and weight will be measured.

- You will take a walking test, in which you will walk for 6 minutes at a comfortable
pace.

- You may receive an accelerometer and complete a 7-day accelerometer assessment. An
accelerometer is a small device that is worn on your hip that measures the amount of
physical activity you do.

Length of Study You will be on study for 12 weeks.

This is an investigational study. Up to 80 women will take part in this study. All will be
enrolled at M. D. Anderson.