Pilot Tests to Optimize the Delivery of Energy Balance Interventions

Chronic Lymphocytic Leukemia (CLL) Survivor:

Study Procedures:

If you are found to be eligible to take part in this study, the study staff will schedule a
time, date, and location at MD Anderson for you to receive an accelerometer. The study staff
will also provide you with instructions for wearing the accelerometer for 7 days before your
visit. You will also wear the accelerometer for the 7 days before your 2nd visit (about 4
months later). You will return the accelerometer at each visit.

At the first visit, you will receive a Fitbit (a small device you will wear that will track
your activity), access to the Fitbit website, a Fitbit account with which you can view your
information and record diet and non-walking/running physical activity, a guidebook, and
brochures.

At these visits:

- You will complete multiple fitness tests to measure your strength, flexibility, balance
and endurance. To measure your hand and forearm muscle strength, you will squeeze and
release your hand on a handgrip tool. You will also complete a 6-minute walk test to
measure your endurance. To complete this test, you will walk as fast as you can in an
indoor hallway for 6 minutes. The distance you walk will be recorded. To measure your
flexibility, you will do a sit-and-reach test (reaching in front of you) and a back
scratch test (reaching behind your back). To assess your lower body strength, we will
record how many times you can stand up from a chair and sit back down in 30 seconds. To
assess your upper body strength, we will measure how many arm curls you can do with a
dumbbell weight in 30 seconds. To measure your agility and balance, we will time how
long it takes for you to get up from a chair, walk around a cone that is 8 feet away
from you, and sit back down again.

- Blood (about 1½ tablespoons) will be drawn. You must fast, have nothing to eat or drink
but water for 12 hours before these visits. These samples will be sent to the University
of Houston for analysis. Any remaining blood samples will be stored for future testing
on biomarkers. We will also request your recent blood results from your doctor in order
to compare those results with the blood samples we collect from you. You will not be
informed of any findings from the blood tests.

- Your height, weight, and waist and hip circumference will be measured.

Each visit will take up to 2 and a half hours.

You will be randomly assigned (as in a roll of dice) to 1 of 16 study groups. The study staff
will call you to explain which group you are in and which interventions you will receive. The
16 groups will each receive a different combination of each of the 4 following factors:

1. Weekly telephone coaching or email coaching

2. Text messages or no text messages

3. Resistance training or no resistance training

4. 4-7 days/week self-monitoring or one day/week self-monitoring.

For example, 1 group will receive weekly telephone coaching, text messages, resistance
training, and daily self-monitoring; and 1 group will receive email coaching, no text
messages, no resistance training, and one day/week self-monitoring. The other 14 groups will
receive a combination of each of the 2 different kinds of the 4 factors.

You will receive your interventions for 16 weeks.

If you receive telephone coaching, you will have 30-45 minute telephone calls 1 time each
week with a telephone coach trained in motivational interviewing. These calls will be based
on your Fitbit data. The coach will discuss your diet and fitness goals with you, as well as
any difficulty you may be having with meeting your goals. Telephone sessions may be audio
recorded for quality control. The audio recordings will be destroyed at the conclusion of the
study.

If you receive email coaching, you will be called during the first week to discuss the
interventions. This call will last about 10-15 minutes. You will then receive 1 email each
week in weeks 1-16 in which the coach will provide feedback about your goals and ask 1-2
questions similar to what the telephone coach would ask. If you respond to the coach, the
conversation will continue until you make no further response.

If you receive text messaging, you will receive 7-12 messages each week that will contain
support and/or information about diet and physical activity.

If you receive resistance training, you will be given a set of resistance exercise bands, a
list of exercises and instructional videos on how to do each exercise. You will be asked to
log your resistance exercises on a weekly activity log.

If you are in a 4-7 days/week self-monitoring group, you will enter additional information
about your diet and weight 4-7 days per week. If you are in a one day/week self-monitoring
group, you will do this 1 day each week.

Study Questionnaires:

You will complete online questionnaires at the beginning of the study as well as 8 and 16
weeks after that. The online questionnaires will be sent to you by email, text message,
and/or a letter with a link to the survey. If you prefer to complete a paper questionnaire,
you may request this when you start the study and the study staff will provide you a paper
questionnaire by mail with a self-addressed stamped envelope.

In the questionnaires, you will record your self-measured height and weight. The
questionnaires will also ask you about your demographic information (such as your age),
medical history, body composition, physical activity, readiness to change, and your general
health. These questionnaires should take about 30-45 minutes to complete.

You will complete additional online questionnaires to measure your diet, called the Diet
History Questionnaire (DHQ). You will be provided a secure web link with a username and
password and instructions on how to complete the questionnaire. This DHQ should take about
45-60 minutes to complete.

After your completion of the study, you may be contacted by telephone to complete a brief
follow-up interview. The interview questions will ask for your feedback about the study and
any suggestions for ways to make the study better.

Length of Study:

Your study participation will be over after you complete the questionnaires at Week 16. Your
study participation may be stopped early if you become injured, if you become ineligible (for
example, if you need to have treatment), or if the study staff thinks it is in your best
interest.

High Risk Families:

Study Procedures:

If you are found to be eligible to take part in this study, you will be mailed an
accelerometer, measuring tape, instructions for wearing the accelerometer for 7 days and
measuring hip and waist circumference, and a return mailer for these items. You will also be
mailed a FitBit (a small device you will wear that will track your activity), access to the
FitBit website, a FitBit account with which you can view your information and record diet and
non-walking/running physical activity, a guidebook, and brochures.

You will be randomly assigned (as in a roll of dice) to 1 of 16 study groups. The study staff
will call you to explain which group you are in and which interventions you will receive. The
16 groups will each receive a different combination of each of the 4 following factors:

1. Weekly telephone coaching or email coaching

2. Text messages or no text messages

3. Social networking or no social networking

4. 4-7 days/week self-monitoring or one day/week self-monitoring.

For example, 1 group will receive weekly telephone coaching, text messages, social
networking, and daily self-monitoring; and 1 group will receive email coaching, no text
messages, no social networking, and one day/week self-monitoring. The other 14 groups will
receive a combination of each of the 2 different kinds of the 4 factors.

You will receive your interventions for 16 weeks.

If you receive telephone coaching, you will have 30-45 minute telephone calls 1 time each
week with a telephone coach trained in motivational interviewing. These calls will be based
on your FitBit data. The coach will discuss your diet and fitness goals with you, as well as
any difficulty you may be having with meeting your goals. Telephone sessions may be audio
recorded for quality control. The audio recordings will be destroyed at the conclusion of the
study.

If you receive email coaching, you will be called during the first week to discuss the
interventions. This call will last about 10-15 minutes. You will then receive 1 email each
week in Weeks 1-16 in which the coach will provide feedback about your goals and ask 1-2
questions similar to what the telephone coach would ask. If you respond to the coach, the
conversation will continue until you make no further response.

If you receive text messaging, you will receive 8-12 messages each week that will contain
support and/or information about diet and physical activity.

If you receive social networking, you will be invited to use a private online forum to
discuss your goals with other participants in the study who are receiving social networking.

At the beginning of the study, you will be mailed a Fitbit, as well as instructions on how to
use it. If you are in a 4-7 days/week self-monitoring group, you will enter additional
information about your diet and weight 4-7 days per week. If you are in a one day/week
self-monitoring group, you will do this 1 day each week.

Study Questionnaires:

You will complete online questionnaires at the beginning of the study as well as 8 and 16
weeks after that. The online questionnaires will be sent to you by email, text message,
and/or a letter with a link to the survey. If you prefer to complete a paper questionnaire,
you may request this when you start the study and the study staff will provide you a paper
questionnaire by mail with a self-addressed stamped envelope.

In the questionnaires, you will record your self-measured height, weight, and waist and hip
measurements. The questionnaires will also ask you about your demographic information (such
as your age), medical history, body composition, physical activity, diet, readiness to
change, and your general health. These questionnaires should take about 30-45 minutes to
complete.

After your completion of the study, you may be contacted by telephone to complete a brief
follow-up interview. The interview questions will ask for your feedback about the study and
any suggestions for ways to make the study better.

Length of Study:

Your study participation will be over after you complete the questionnaire at Week 16. Your
study participation may be stopped early if you become injured, if you become ineligible (for
example, if you need to have treatment), or if the study staff thinks it is in your best
interest.

MD Anderson Employees:

Study Procedures:

If you are found to be eligible to take part in this study, the study staff will schedule a
time, date, and location at MD Anderson for you to receive an accelerometer. The study staff
will also provide you with instructions for wearing the accelerometer for 7 days before your
first visit.

You will have 2 study visits at MD Anderson: at the beginning of the study and at the 4 month
time point. At these visits, study staff will measure your height, weight, and waist and hip
circumference. You will also return your accelerometer in person at that time. These study
visits will last no longer than one hour.

At the first visit, you will receive a FitBit (a small device you will wear that will track
your activity), access to the FitBit website, a FitBit account with which you can view your
information and record diet and non-walking/running physical activity, a guidebook, and
brochures.

You will also be randomly assigned (as in a roll of dice) to 1 of 16 study groups. The study
staff will call you to explain which group you are in and which interventions you will
receive. The 16 groups will each receive a different combination of each of the 4 following
factors:

1. Weekly telephone coaching or email coaching

2. Text messages or no text messages

3. Social networking or no social networking

4. 4-7 days/week self-monitoring or one day/week self-monitoring.

For example, 1 group will receive weekly telephone coaching, text messages, social
networking, and daily self-monitoring; and 1 group will receive email coaching, no text
messages, no social networking, and one day/week self-monitoring. The other 14 groups will
receive a combination of each of the 2 different kinds of the 4 factors.

You will receive your specific interventions for 16 weeks.

If you receive telephone coaching, you will have 30-45 minute telephone calls 1 time each
week with a telephone coach trained in motivational interviewing. These calls will be based
on your Fitbit data. The coach will discuss your diet and fitness goals with you, as well as
any difficulty you may be having with meeting your goals. Telephone sessions may be audio
recorded for quality control. The audio recordings will be destroyed at the conclusion of the
study.

If you receive email coaching, you will be called during the first week to discuss the
procedure. This call will last about 10-15 minutes. You will then receive 1 email each week
in weeks 1-16 in which the coach will provide feedback about your goals and ask 1-2 questions
similar to what the telephone coach would ask. If you respond to the coach, the conversation
will continue until you make no further response.

If you receive text messaging, you will receive 8-12 messages each week that will contain
support and/or information about diet and physical activity.

If you receive social networking, you will be invited to use a private online forum to
discuss your goals with other participants in the study who are receiving social networking.

At the beginning of the study, you will be given the Fitbit, as well as instructions on how
to use it. If you are in a 4-7 days/week self-monitoring group, you will enter additional
information about your diet and weight 4-7 days per week. If you are in a one day/week
self-monitoring group, you will do this 1 day each week.

Study Questionnaires:

You will complete online questionnaires at the beginning of the study as well as 8 and 16
weeks after that. The online questionnaires will be sent to you by email, text message,
and/or a letter with a link to the survey. If you prefer to complete a paper questionnaire,
you may request this when you start the study and the study staff will provide you a paper
questionnaire by mail with a self-addressed stamped envelope.

In the questionnaires, you will record your self-measured height, weight, and waist and hip
measurements. The questionnaires will also ask you about your demographic information (such
as your age), medical history, body composition, physical activity, diet, readiness to
change, and your general health. These questionnaires should take about 30-45 minutes to
complete.

Length of Study:

Your study participation will be over after you complete the questionnaire at the 4 month
time point. Your study participation may be stopped early if you become injured, if you
become ineligible (for example, if you need to have treatment), or if the study staff thinks
it is in your best interest.

Inclusion Criteria:

1. Pilots 1 and 2: BMI of 25 or higher OR < 150 minutes of moderate to vigorous exercise
per week OR <5 servings of fruit and vegetables per day

2. Pilots 1, 2 and 3: Capable of participating in moderate-vigorous unsupervised exercise

3. Pilots 1, 2 and 3: Have a cellular telephone and are able and willing to send and
receive text messages

4. Pilots 1, 2 and 3: 18 years old or older

5. Pilots 1, 2 and 3: Able to read and write English

6. Pilots 1, 2 and 3: Have access to internet

7. Pilot 2: BRCA positive OR Lynch Syndrome positive individuals

8. Pilot 2 (family member): Female and male biological and non-biological family members
of BRCA-positive individuals OR Lynch Syndrome positive individuals

9. Pilot 3: CLL survivors

10. Pilot 3: Has experienced fatigue within the past seven days

11. 11. Pilot 3: Less than 150 minutes of exercise per week

12. 12. Pilot 3: Less than 2 days of 15 minutes or more of resistance training per week

Exclusion Criteria:

1. Pilots 1, 2 and 3: Unable to walk without crutches, walker, cane, or other assistive
device

2. Pilots 1, 2 and 3: Women who are pregnant (by self-report)

3. Pilots 1, 2 and 3: Less than 3 months post-surgery

4. Pilots 2 and 3: Currently receiving radiation therapy or cytoxic chemotherapy