Attachment 11_InformedConsentDocumentUCH

COMIRB
APPROVED
For Use
02-Sep-2015
01-Sep-2016

Consent and Authorization Form

Principal Investigator: Jacinda Nicklas, MD, MPH, MA
COMIRB No: 15-0238
Version Date: September 2, 2015
Study Title: Balance After Baby Intervention: 2

You are being asked to be in a research study. This form provides you with information
about the study. A member of the research team will describe this study to you and
answer all of your questions. Please read the information below and ask questions
about anything you don’t understand before deciding whether or not to take part.
Why is this study being done?
This study plans to learn more about a lifestyle program designed for women with
recent gestational diabetes mellitus (GDM). It is designed to help women lose the
weight gained during pregnancy and to reduce the risk of getting type 2 diabetes.
Women with a history of GDM have a higher risk of developing type 2 diabetes than
women who do not have a history of GDM. Studies show that a lifestyle program
focusing on healthy eating and physical activity may lead to less type 2 diabetes. This
study will test whether a lifestyle program given during the first year after giving birth will
lead to a lower risk of getting type 2 diabetes. You are being asked to be in this
research study because you had GDM during your most recent pregnancy.
Other people in this study
Up to 277 subjects will take part in this study. 40% of the participants will be in Denver,
Colorado and 60% will be in Boston, Massachusetts.
What happens if I join this study?
If you join the study you will participate for 24 months after your delivery. During this
time, we will ask you to come to 5 study visits that will each take about 3 hours.
If you agree to participate in this study, you will be randomized (like a flip of a coin) to
one of two groups: the lifestyle group or the control group. You and the study doctor will
not be able to choose your study group.
Women in both groups will be asked to come to 5 study visits at either the Clinical
Translational Research Center (CTRC) at the Anschutz Medical Campus or at Denver
Health. The visits will be at 6 weeks, 6 months, 12 months, 18 months, and at 24
months after delivery.
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At each of the study visits the following will happen:
 We will ask you not to eat or drink anything, other than water, after midnight the
night before each study visit. We will also ask you to skip breakfast the morning
of your study visit.
 The study staff will measure your height, weight, waist circumference, and blood
pressure.
 The study staff will ask for an update on your medical history
 At each visit we will take up to a little more than a tablespoon of blood from your
arm to measure levels of glucose (sugar), cholesterol (level of blood fat), HbA1c
(marker for type-2 diabetes), and thyroid stimulating hormone (TSH).
 We will ask you to complete a study questionnaire that will take about 40 minutes
to complete. The questionnaire will tell us about your current diet, physical
activity levels, mood, and levels of stress. You can skip any questions you do not
want to answer. Your answers to this questionnaire will not be shared with
anyone outside of the study staff.
 The study visits will each take about 3 hours each.
 In addition, you will be asked to take a urine pregnancy test at the 6, 12, 18, and
24 month study visits. If you become pregnant before the end of the study, you
can no longer participate. We will ask your permission to obtain your medical
records from your pregnancy.
At three of the study visits (6 weeks, 12 months, and 24 months after delivery), we
will also perform an oral glucose tolerance test (OGTT):
 We use this test to find out how well your body uses up glucose (sugar), which is
produced when your body digests food. This test is used to diagnose diabetes.
The OGTT completed at your 6 week visit will be part of your routine clinical care.
The OGTT at 12 and 24 months are for research only.
 You will first have your blood drawn and then will be asked to drink about 1 cup
of a sugary drink (“glucola”) over a 5 minute period. This is the same sugary drink
you received during your pregnancy to test for gestational diabetes, but the
amount is less than what was used in pregnancy. 2 hours after you finish the
drink, you will have your blood drawn again.

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Schedule of Study Visits
Procedure

Visit 1

Visit 2

Visit 3

Visit 4

Visit 5

(6 wk)

(6 mo)

(12 mo)

(18 mo)

(24 mo)

X

X

X

X

X

X

X

X

Height

X

Medical History
Update

X

Urine pregnancy test
Weight

X

X

X

X

X

Waist circumference

X

X

X

X

X

Blood Pressure

X

X

X

X

X

Fasting Blood Draw

X

X

X

X

X

Oral Glucose
Tolerance Test

X

Questionnaires

X

X
X

X

X
X

X

Remember that you will be assigned by chance (like a flip of a coin) to either the
lifestyle group or the control group. You will be assigned at your first study visit,
around 6 weeks after delivery.
The study procedures for the lifestyle group and control group are described below.
Lifestyle Group: If you are assigned to the lifestyle group, you will take part in a webbased lifestyle program, designed for new mothers. Lifestyle participants will need
access to a computer connected to the internet. This lifestyle program includes 12
weekly internet-based video sessions held over a period of 12 weeks. Each session will
take about 5-10 minutes to watch on-line. Each of the sessions is designed with new
mothers in mind. The sessions will help you with healthy eating, engaging in physical
activity, and problem-solving to overcome difficulties you might face. As you watch the
videos you will be asked to enter some information into the website. You will also be
asked to enter information about your weight and your exercise.
You will have access to a lifestyle coach during the time you are in the study. Your
lifestyle coach will help you make changes to your diet, increase your physical activity
levels, and help you with possible difficulties that may stop you from reaching your
goals. We will suggest that you have contact with the lifestyle coach at least once each
week during the first 3 months of the program. You can contact her by email or phone.
You may have more contact if you or the lifestyle coach decides that you need more
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help to reach your goals. Between 3 and 6 months we will suggest that you connect with
the lifestyle coach at least once every other week. Once you have been in the study for
7 months, we will suggest you check in with the lifestyle coach at least once each
month.
You will also be able to get extra support for your goals from the other new mothers in
the lifestyle group. On the Balance after Baby website you can give and receive support
from other new mothers. You will have access to a secure blog where you can post
questions and communicate on-line with other new mothers. In addition, you can use
the website to communicate privately with your lifestyle coach.
Subjects in the lifestyle group will receive a pedometer, a small tool that counts the
number of steps you take. This will help keep track of physical activity goals.
Control Group: If you are assigned to the control group, you will have the same 5 study
visits as the lifestyle group. However, you will not have access to the Lifestyle program.
What are the possible discomforts or risks?
Blood Draws
In this study we will need to get a little less than 7 tablespoons of blood from you over
the course of the entire study. We will get blood by putting a needle into one of your
veins and letting the blood flow into a glass tube. You may feel some pain when the
needle goes into your vein. A day or two later, you may have a small bruise where the
needle went under the skin.
Oral Glucose Tolerance Test
The sugary drink ("glucola") has a very sweet taste, and may possibly cause nausea,
or, rarely, vomiting.
Questionnaire
The questionnaire may be tiring to fill out or make you feel uncomfortable, but you will
be given as much time as you need to complete it. Also you can skip any questions you
feel uncomfortable answering.
Weight loss
This program encourages weight loss. There are risks associated with making changes in
your diet. The most common side effects associated with reduced calorie diets are likely
to be hunger and fatigue. Occasionally people can experience constipation, nausea,
abdominal discomfort, or diarrhea when changing their usual diet. It is possible you could
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develop headaches, trouble sleeping, change in your mood, or psychological stress. The
most serious but very rare side effect of reduced calorie diets is gallstone formation,
which usually only occurs with extremely low fat diets.
This program encourages exercise. There are risks associated with exercise. Exercise
may cause sweating, fatigue, or feeling out of breath. These effects are normal. It is
also possible that you could develop soreness or injuries (most commonly in your feet,
knees, legs, hips, or back) during the study. Exercise can rarely cause abnormal
heartbeats, chest pain, passing out, heart attack, stroke, or death. These are extremely
rare events.
There is a risk that people outside of the research team will see your research
information. We will do all that we can to protect your information, but it cannot be
guaranteed.
The study staff and doctors working on this study will monitor you closely during your
time in the study and have years of experience performing the study procedures, so the
anticipated risk to all subjects from this study is minimal.
What are the possible benefits of the study?
This study is designed for the researcher to learn more about a lifestyle program
designed to lower risk for type 2 diabetes for women with recent gestational diabetes
mellitus (GDM). This study is not designed to treat any illness or to improve your health.
Also, there may be risks, as discussed in the section describing the discomforts or risks.
Are there alternative treatments?
Women with a history of gestational diabetes can engage in a healthy lifestyle outside of
this study. An OGTT may be performed by your regular doctor around 6 weeks after
delivery as part of routine care. If you have any further questions about gestational
diabetes, please talk to your doctor.
Who is paying for this study?


This research is being sponsored by the Centers for Disease Control.

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

The sponsor will only pay for procedures not considered standard of care. The
oral glucose tolerance test (OGTT) at 6 weeks is considered standard of care.

Will I be paid for being in the study?
You will receive a $500 stipend for completing all study visits. This stipend will help
cover childcare and transportation costs. You will receive $100 following completion of
the 6 week visit and $100 following the completion of the 12 month visit. $80 following
completion of the 6 month visit and $80 following the completion of the 18 month visit,
and $140 following the 24 month visit. We will pay for the costs of parking at all study
visits. If you leave the study early, or if we have to take you out of the study, you will be
paid only for the visits you have completed.
It is important to know that payments for participation in a study is taxable income.
Will I have to pay for anything?
It will not cost you anything to be in the study.
Is my participation voluntary?
Taking part in this study is voluntary. You have the right to choose not to take part in
this study. If you choose to take part, you have the right to stop at any time. If you
refuse or decide to withdraw later, you will not lose any benefits or rights to which
you are entitled.

Can I be removed from this study?
The study doctor may decide to stop your participation without your permission if the
study doctor thinks that being in the study may cause you harm, or for any other
reason. Also, the sponsor may stop the study at any time.
What happens if I am injured or hurt during the study?
We will arrange to get you medical care if you have an injury that is caused by this
research. However, you or your insurance company will have to pay for that care.

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Who do I call if I have questions?
The researcher carrying out this study is Dr. Jacinda Nicklas. You may ask any
questions you have now. If you have questions, concerns, or complaints later, you
may call Dr. Nicklas at 303-724-9028. You will be given a copy of this form to keep.
You may have questions about your rights as someone in this study. You can call Dr.
Jacinda Nicklas with questions. You can also call the responsible Institutional Review
Board (COMIRB). You can call them at 303-724-1055.
You may also talk to a Subject Advocate at the Clinical and Translational Research
Center (CTRC). The number there is 720-848-6662.
Optional Consent for Data and Specimen Banking for Future Research
Dr. Jacinda Nicklas would like to keep some of the data and blood that is taken
during the study but is not used for other tests. If you agree, the data and
samples will be kept and may be used in future research to learn more about
gestational diabetes, type 2 diabetes, and heart disease. The research that is
done with your samples is not designed to specifically help you. It might help
people who have gestational diabetes, type 2 diabetes, and other diseases in the
future. Reports about research done with your data and samples will not be given
to you or your doctor. These reports will not be put in your health records. The
research using your data and samples will not affect your care.
The choice to let Dr. Nicklas keep the data and samples for future research is up
to you. No matter what you decide to do, it will not affect the care that you will
receive as part of the study. If you decide now that your data and samples can be
kept for research, you can change your mind at any time and contact your study
doctor to let him or her know that you do not want Dr. Nicklas to use your data
and samples any longer, and they will no longer be used for research. Otherwise,
they may be kept until they are used up, or until Dr. Nicklas decides to destroy
them.
If your data and samples are given to other researchers in the future, Dr. Nicklas
will not give them your name, address, phone number or any other information
that will let the researchers know who you are.
Sometimes data and samples are used for genetic research (about diseases that
are passed on in families). Even if your data and samples are used for this kind
of research, the results will not be told to you and will not be put in your health
records. Your data and samples will only be used for research and will not be
sold. The research done with your data and samples may help to develop new
products in the future, but there is no plan for you to be paid.
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The possible benefits of research from your data and samples include learning
more about what causes diabetes and other diseases, how to prevent them and
how to treat them. The greatest risk to you is the release of your private
information. Dr. Nicklas will protect your records so that your name, address and
phone number will be kept private. The chance that this information will be given
to someone else is very small. There will be no cost to you for any data or
sample collection and storage by Dr. Nicklas.
Please read each sentence below and think about your choice. After reading
each sentence, circle “yes” or “no.” If you have questions, please talk to your
doctor or nurse. Remember, no matter what you decide to do about the storage
and future use of your data and samples, you may still take part in the study.
I give my permission for my data and blood to be stored at the University of
Colorado for future use by the study investigators:
1. I give my permissions for my data and blood to be kept by Dr. Nicklas
for use in future research to learn more about how to prevent, detect,
or treat diabetes or heart disease.
Yes

No

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2. I give my permissions for my data, blood and tissue samples to be
used for research about other health problems (for example: causes of
osteoporosis).
Yes

No

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3. I give my permission for my study doctor (or someone he or she
chooses) to contact me in the future to ask me to take part in more
research.
Yes

No

Who will see my research information?
The University of Colorado Denver (UCD) and its affiliated hospital(s) have rules to
protect information about you. Federal and state laws including the Health Insurance
Portability and Accountability Act (HIPAA) also protect your privacy. This part of the
consent form tells you what information about you may be collected in this study and
who might see or use it.
The institutions involved in this study include
 University of Colorado Denver
 University of Colorado Hospital
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 Denver Health
We cannot do this study without your permission to see, use and give out your
information. You do not have to give us this permission. If you do not, then you may
not join this study.
We will see, use and disclose your information only as described in this form and in
our Notice of Privacy Practices; however, people outside the UCD and its affiliate
hospitals may not be covered by this obligation.
We will do everything we can to maintain the confidentiality of your personal
information but confidentiality cannot be guaranteed.
The use and disclosure of your information has no time limit. You can cancel your
permission to use and disclose your information at any time by writing to the study’s
Principal Investigator (PI), at the name and address listed below. If you do cancel
your permission to use and disclose your information, your part in this study will end
and no further information about you will be collected. Your cancellation would not
affect information already collected in this study.
Jacinda Mawson Nicklas, MD, MPH, MA
University of Colorado Denver
Mailstop C263
12348 E. Montview Blvd.
Aurora, CO 80045
Both the research records that identify you and the consent form signed by you may
be looked at by others who have a legal right to see that information, such as:


Federal offices such as the Food and Drug Administration (FDA) and the Office
of Human Research Protections (OHRP) that protect research subjects like you.



People at the Colorado Multiple Institutional Review Board (COMIRB)



The study doctor and the rest of the study team.



The Centers for Disease Control who are sponsoring this research study.



Officials at the institution where the research is conducted and officials at other
institutions involved in this study who are in charge of making sure that we follow
all of the rules for research

We might talk about this research study at meetings. We might also print the results
of this research study in relevant journals. But we will always keep the names of the
research subjects, like you, private.
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You have the right to request access to your personal health information from the
Investigator. [To ensure proper evaluation of test results, your access to these study
results may not be allowed until after the study is completed].
The investigator (or staff acting on behalf of the investigator) will use your
information for the research outlined in this consent form. They will also make all or
some of the following health information about you collected in this study available
to: Brigham and Women’s Hospital and Westat who is the coordinating agency for
this research study.
Information about you that will be seen, collected, used and disclosed in this
study:
 Name and Demographic Information (age, sex, ethnicity, address, phone
number, etc.
 Your social security number (for the purpose of providing you with payment)
 Portions of your previous and current Medical Records that are relevant to this
study, including but not limited to Diagnosis(es), History and Physical, laboratory or
tissue studies, radiology studies, procedure results
 Research Visit and Research Test records
What happens to Data and Blood that are collected in this study?
Scientists at the University of Colorado Denver and the hospitals involved in this
study work to find the causes and cures of disease. The data and blood collected
from you during this study are important to this study and to future research. If you
join this study:






The data, and blood given by you to the investigators for this research no longer
belong to you.
Both the investigators and any sponsor of this research may study your data or
blood collected from you.
If data or blood are in a form that identifies you, UCD or the hospitals involved in
this study may use them for future research only with your consent or Institutional
Review Board (IRB) approval.
Any product or idea created by the researchers working on this study will not
belong to you.
There is no plan for you to receive any financial benefit from the creation, use or
sale of such a product or idea.

HIPAA Authorization for Optional Additional Study Procedures
In this form, you were given the option to agree to additional, optional research
procedures. You must also give us your permission, under HIPAA rules, to use and
disclose the information collected from these optional procedures, as described
above.
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If you decline to give us permission to use and disclose your information, you cannot
take part in these optional procedures, but you can still participate in the main study.
Please initial next to your choice:
_____ I give permission for my information, from the optional procedures I have
agreed to above, to be used and disclosed as described in this section.
_____ I do not give permission for my information for any optional procedures to be
used and disclosed; I understand that I will not participate in any optional
procedures.
Agreement to be in this study and use my data
I have read this paper about the study or it was read to me. I understand the possible
risks and benefits of this study. I understand and authorize the access, use and
disclosure of my information as stated in this form. I know that being in this study is
voluntary. I choose to be in this study: I will get a signed and dated copy of this consent
form.
Signature:

Date:

_____

Print Name:

Consent form explained by:

Date:

Print Name:

Witness Signature: _________________________________

Date:___________

Witness Name: ____________________________________

Date: __________

Investigator: _______________________________

Date: _______

Investigator must sign within 10 days

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