Move To Quit - Using Physical Activity to Facilitate Smoking Cessation Among African American Adults

If you agree to take part in this study, you will visit the Windsor Village United Methodist
Church 9 times. You will also receive help to quit smoking. You may or may not also be
enrolled in an exercise program.

Visits to the Windsor Village United Methodist Church:

These visits will be 3, 2, and 1 week(s) before you quit smoking, on your quit day, and 1, 2,
3, 4, and 8 weeks after you quit smoking. Each visit may last about 1 hour to 1 ½ hours.

During these visits:

- You will complete questionnaires about your feelings, moods, smoking habits, and
behaviors (such as physical activity). The questionnaires should take about 45 minutes
total to complete.

- You will complete a breath test. The breath test is used to find the amount of tobacco
smoke that a person consumes. For this test, you will blow air through a tube into a
measuring device.

- At 3 of these visits, your heart rate will also be tested. For this test, you will put
on a wrist watch and a belt band and sit quietly for 5 minutes while the equipment
measures your heart rate.

- At 4 of these visits, your height, weight, and waist and hip circumference will also be
measured. To measure your waist and hip circumference, you may be asked to lift your
shirt to expose your stomach area and lower your pants to expose your mid-hip area.
Height, weight, and waist and hip circumference measurements take about 10 minutes and
are performed in a private area.

Quitting Smoking:

You will receive help to quit smoking, including counseling about quitting smoking and a
6-week supply of the nicotine patch. The counseling will be over the phone about 1-2 weeks
before your scheduled quit day.

Study Groups for Physical Activity:

In addition to the visits listed above, you will be randomly assigned (as in a roll of dice)
to be in 1 of 3 groups. You will have an equal chance of being in any group.

- Group 1 will not include any physical activity.

- Group 2 will start a walking program 2 weeks before their quit day and finish it 2 weeks
after their quit day.

- Group 3 will start the walking program on their quit day and finish it 4 weeks after
their quit day.

All participants (Groups 1, 2, and 3) will wear an accelerometer for 5 weeks during the
study. An accelerometer is a small device that you wear on a belt clip or an elastic belt
near the hip during the day. It records how active you are.

You will receive an accelerometer at your study visit 3 weeks before you quit smoking. You
will wear it during the following times:

- For 14 days in a row beginning 3 weeks before you quit smoking.

- For 7 days beginning on the quit date.

- For 7 days beginning on the visit 2 weeks following your quit date.

- For 7 days beginning on the visit 4 weeks following your quit date.

You should bring the accelerometer to each study visit so it can be recharged and the
information can be downloaded. You will be given a prepaid envelope to return the
accelerometer after the last recording.

Physical Activity Groups 2 and 3:

If you are in Group 2 or 3, you will take part in a walking program for 5 weeks. You will
walk about 150 minutes (about 2 ½ hours) a week.

You will receive a Walking Guide with instructions about how to do the exercises, which will
also contain other tips for the walking program.

Final Visit:

All participants will take part in a final focus group. This focus group will take place
sometime after the study visit 8 weeks after you quit smoking. This will take about 1 hour.
You will be asked what you think about the program, including what you liked, did not like,
and how you think it could be improved. If you want to provide this feedback but you cannot
come to the focus group, you may provide feedback in another way (such as a phone interview
or you could meet the study staff at the church). These focus groups/interviews will be audio
recorded. Your name and identifying information will be deleted from the recording before
being transcribed (typed out) by an outside party.

Length of Study:

You will be off study after the final focus group visit.

Additional Information:

Study staff may call you on your home and/or cell phone or contact you by e-mail to remind
you about your study visits and/or to do your walking activity.

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.

If you do not come to the study visits listed above, researchers may call and ask about your
smoking status. They may also schedule a visit to your home or office to take a breath
sample.

Your home address may be used to access public information about the area where you live.
This is to help researchers learn about how your neighborhood encourages physical activity.
The results from this study will only be reported as a group and you will not be identifiable
from any products resulting from this study (such as research papers). Your home address will
never be released or published in any form. Your address will be stored separately from other
study data, and only the study chair will be able to see the data after the neighborhood
information has been collected.

Other Information:

If the study staff thinks that any of your responses while on the study suggest signs of
severe depression or show you are expressing suicidal ideation, a qualified member of the
study staff will be contacted to review your risk of suicide. Based on that review, study
staff will take steps to protect your safety, which can range from giving you a list of
resources for mental health services to the contacting the police if they feel you are in
immediate danger.

Plan for Data Destruction:

After the study is complete, the data are analyzed, and the manuscript/s are written, access
to the de-identified data files will be limited to the study chair and research staff, who
will keep the files on the MD Anderson computer server in case there are any questions about
the data. Your data will be kept for 10 years after the study is completed but no later than
1/01/2025. After that time, data will be completely deleted.

This is an investigational study. The nicotine patch used in this study is FDA approved and
commercially available.

Up to 45 participants will be enrolled in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. self-reported African-American race

2. age 21-65

3. current daily smoker (has smoked >=100 cigarettes in lifetime per self-report, smoked
>=5 cigarettes per day for the last 6 months per self-report

4. self-reports motivation to quit smoking within the next 2 weeks

5. reports willingness to engage in a physical activity-based smoking cessation
intervention

6. has a home address and a functioning home and/or cell phone number

7. able to engage in moderate intensity physical activity as determined by the Physical
Activity Readiness Questionnaire (PAR-Q) or by physicians clearance (letter from
physician or nurse practitioner) if currently taking medication for blood pressure or
diabetes.

8. willingness to wear the nicotine patches provided in the study as recommended

9. have an expired carbon monoxide (CO) level >/8 parts per million (ppm) suggestive of
current smoking

10. blood pressure practitioner) if blood pressure reading >140/90mm Hg.

Exclusion Criteria:

1. contraindication for nicotine patch use

2. regular use of tobacco products other than cigarettes in the last 30 days (including
black & milds)

3. current or planned future use of any nicotine replacement or pharmacological product
for smoking cessation other than the study patches

4. pregnancy or lactation

5. another household member enrolled in the study

6. a schedule not accommodating to the study procedures, or unwillingness to adhere to
the procedures