Project Take Charge



Status:Recruiting
Healthy:No
Age Range:30 - 70
Updated:1/16/2019
Start Date:December 17, 2017
End Date:November 2019
Contact:Karen Basen-Engquist, PHD, BA, MPH
Email:kbasenen@mdanderson.org
Phone:713-794-5494

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Choosing Health and Cancer Risk Reduction Through Good Eating and Exercise

The goal of this research study is to learn the effects of a 16 week weight loss program with
or without blood sugar monitoring on weight loss and cancer risk in women with a high risk of
developing breast cancer.

This is an investigational study.

Up to 50 participants will be enrolled in the study. All will take part at MD Anderson.

If participant is found eligible and agree, participant will have baseline procedures
performed at this time:

- Participant's weight and height will be measured.

- Blood (about 4 teaspoons) will be drawn to check participant's cholesterol levels and
for biomarker testing. Biomarkers are found in the blood/tissue and may be related to
participant's risk of cancer.

- Participant will complete 5 questionnaires about participant's eating habits. The
questionnaires should take about 15 minutes to complete.

- Participant will create a study-specific MyFitnessPal account to use throughout
participant's participation in the study with the help of study staff. MyFitnessPal is a
free mobile phone application ("app") which participant must use to record the food and
drinks that participant has while on study. Participant's MyFitnessPal data will be
given a code number. No identifying information will be directly linked to participant's
data. All study data will be stored in password-protected computers and/or locked file
cabinets and will continue to be stored securely after the study.

- A member of the study staff will teach participant how to use a continuous blood glucose
monitor (CGM) and make sure that it is set up properly. Participant will insert the CGM
personally, or the study staff will help participant to do this. To do this, participant
will insert a small, flexible sensor under participant's skin. The process is similar to
an injection, and will take about 2 minutes to complete. Participant will wear this CGM
for 7 days and then it will be removed by participant or a member of the study staff at
participant's first weekly training session (described below).

After participant's baseline procedures, participant will take part in a 7-day
Self-Monitoring Period. During these 7 days:

- Participant will continue to wear a CGM to record participant's blood sugar levels.

- Participant will record all food and drinks that participant consumes and any exercise
participant takes part in using the MyFitnessPal app.

- Participant will send time-stamped photographs of everything that participant eats and
drinks (except water). Participant will send these photographs to an email account
created for this study 1 time each day. Participant's photos will be given a code
number. No identifying information will be directly linked to participant's photos. Only
the researcher in charge of the files will have access to the code numbers and be able
to link the files to participant.

- Participant will record participant's hunger on a scale of 1-10 in participant's
MyFitnessPal app.

- Participant will complete a questionnaire about how participant is feeling and
participant's experience wearing the CGM throughout the day. This should take about 15
minutes to complete.

Study Groups:

At the baseline visit, participant will be randomly assigned (as in the flip of a coin) to 1
of 2 study groups. This is done because no one knows if one study group is better, the same,
or worse than the other group.

Group A will take part in the Diabetes Prevention Program (DPP). Group B will take part in
DPP as well as receive Hunger Training.

Diabetes Prevention Program:

DPP is a 16 week program which includes 1 training session each week. At each session,
participant will meet with a member of the study staff for no more than about 1 hour. During
these weekly visits, participant will learn about and receive materials on different
strategies to encourage weight loss.

As part of this program, participant will be offered to take part in supervised exercise
(such as group exercise classes or walks) 2 times each week. Each session will last about 45
minutes. Participation in the exercise sessions is voluntary. Participant does not have to
take part in these exercise sessions in order to take part in this study.

If participant is unable to physically attend a weekly session, some can be conducted over
the phone. If participant takes part in the session over the phone, the call should last no
more than 1 hour. If for some reason participant will miss a session and cannot complete it
over the phone, participant may complete 2 in-person sessions either before or after the
missed session.

Hunger Training:

If participant is in Group B, in addition to the DPP, participant will also take part in
Hunger Training beginning at participant's Week 2 session and lasting until participant's
Week 6 session. This training will help participant to learn how to recognize hunger.

During this time period, participant will need to wear a CGM. Participant will also be asked
to record participant's hunger level on a 1-10 scale and any hunger-related symptoms
participant may be experiencing before participant eats any meal. As part of this training,
participant should try to only eat or drink when participant' blood glucose level is below a
certain level. This level will be chosen for participant by a member of the study staff and
will be based on participant's fasting blood glucose levels recorded during the 7 day
self-monitoring period after participant's baseline visit. During participant's first week of
Hunger Training, a member of the study staff will contact participant to answer any questions
or talk about any concerns that participant may have. This phone call should last about 15
minutes.

Study Visits:

In addition to participant's 16 weekly training sessions, participant will have 2 study
visits at the clinic (Mid-Point and End-of-Study).

At the Mid-point Visit (about Week 8):

- Participant's weight and height will be measured.

- Participant will complete the 5 questionnaires about participant's eating habits.

- Participant will insert participant's CGM. Participant will wear this CGM for 7 days and
then it will be removed by participant or a member of the study staff at participant's
next weekly training session.

At the End-of-Study Visit (about Week 16):

- Participant's weight and height will be measured.

- Blood (about 4 teaspoons) will be drawn to check participant's cholesterol levels and
for biomarker testing.

- Participant will complete the 5 questionnaires about participant's eating habits.

- Participant will insert participant's CGM. Participant will wear this CGM for 7 days and
then it will be removed by participant or a member of the study staff at participant's
next weekly training session.

After each visit, participant will complete the same 7 Day Self-Monitoring that participant
completed after participant's baseline visit.

Length of Study:

Participant's active participation in this study will last for about 19 weeks.

Inclusion Criteria:

1. Women ages 30-70 years old.

2. Body Mass Index (BMI) >/= 27 kg/m2.

3. At high risk of developing breast cancer defined by one or more of the following: Gail
model lifetime risk >20% or a 5 year risk >1.66%, a history of deleterious BRCA1/2
mutation or Mantle radiation, a history of ductal cancer in sit, or a history of high
risk premalignant breast lesion.

4. 12 months without a period/menstrual cycle or having had a bilateral oophorectomy.

5. Ability to take digital time stamped photos.

6. Internet access (daily).

7. Reports being proficient in English (can read/write and speak fluently).

Exclusion Criteria:

1. Previous participation in this trial. Participation is defined as screening.
Re-screening is not allowed.

2. Has a current measured BMI less than 27 kg/m2.

3. Reports being unwilling to use Continuous Glucose Monitor (CGM), which requires daily
blood sampling by finger pricks.

4. Currently being actively treated for cancer other than nonmelanoma skin cancer.

5. Known inability to participate in the ongoing appointments for the four months of the
study and scheduled follow-up tests

6. Reported current diagnosis or history of type I diabetes or type 2 diabetes.

7. Reported use of oral antidiabetic agents (OADs).

8. Current use of any drug (except metformin) or anticipated change in concomitant
medication, which the investigator's opinion could interfere with the glucose
metabolism (e.g. systemic corticosteroids).

9. Previous or current treatment with any insulin regimen other than basal insulin, e.g.
prandial or pre-mixed insulin (short term treatment due to intercurrent illness
including gestational is allowed at the discretion for the investigator).

10. Previous or current treatment with GLP-1 receptor agonists (e.g. exenatide,
liraglutide).

11. Fasting blood glucose level >126 and HbA1c > 7%.

12. Subjects considered by the investigator as unsuitable for the study for reasons not
otherwise stated.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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