A Mixed Methods Pilot Study of a Low-Carbohydrate Diabetes Prevention Program Among Veterans With Prediabetes
Phase: NA
Conditions: PreDiabetes
Sponsor: VA Ann Arbor Healthcare System

Low-Carbohydrate Diabetes Prevention Program Among Veterans 
With Prediabetes (VA LC-DPP)
Prepared for ClinicalTrials Resubmission 4/20/21 

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VA INFORMED CONSENT CHECKLIST
*Complete this checklist for each consent obtained and file with the original informed consent document*
RESEARCH STUDY IDENTIFICATION (Required information)
STUDY TITLE: ___________________________________________________________________________
PI: _____________________________________________________________________________________
NAME OF STUDY TEAM MEMBER OBTAINING CONSENT:______________________________________
ROLE OF STUDY TEAM MEMBER OBTAINING CONSENT: ______________________________________
A.
Date ALL required SIGNATURES (Subject, Witness (If required by IRB) and Person 
Obtaining Consent), their PRINTED NAMES and the DATES they signed the informed 
consent document (ICD) have been Checked and Verified Accurate and appear in the proper 
location
B.
DATE AND TIME (ICD) WAS REVIEWED AND DEEMED COMPLETE AND VALID
**Must be prior to date/time of Subject’s First Study Activity**
C.
DATE AND TIME OF THE SUBJECT’S FIRST STUDY ACTIVITY OR INVOLVEMENT 
Verify and Initial each requirement below.
1.  
Informed consent and HIPAA Authorization, if required by VA-IRB was obtained from this 
subject prior to study participation.  
2.
A VA Scope of Practice Form has been signed by the PI and approved by the VA IRB which 
designates me as an authorized agent of the PI and qualified to obtain consent for this study. 
3.
This prospective subject was given adequate time necessary to carefully and fully read the 
Informed consent document (ICD) and all questions were answered to his/her satisfaction.  
4.
All aspects of this subject’s study involvement, including the purpose of the study, known and 
potential risks, possible benefits and alternatives to study participation were explained and 
discussed prior to subject signing the ICD. 
5.
If required, a scanned image of the Research Enrollment Note, Consent Form and/or HIPAA 
Authorization will be entered into the subject’s electronic medical record (CPRS).
6.
Subject has been consented using the most recently approved, VA date-stamped version of 
the consent form (VA Form 10-1086) and HIPAA Authorization Form (VA Form 10-0493).  
7.
A copy of the completed and signed, original informed consent document has been issued to 
this subject and the subject was instructed to retain that copy for reference and to ask any 
and all questions that might arise throughout their study involvement.  
8.
The subject has been shown where in the ICD to locate study team phone number(s) and the 
phone number of the VAAAHS IRB Coordinator. The subject has been reminded to call with 
any questions or concerns.  Cathy Kaczmarek @ 734.845.3439
9.
The subject has been informed that participation is entirely voluntary and that they may 
withdraw their participation at any time and for any reason.  
10.
Original ICDs and all copies are printed and issued as single-sided documents and that the 
original signed ICD must be kept in the investigator’s project files on VA property.
11.
Upon completion of the Informed Consent Process, this subject’s name was added to the 
Master List of All Subjects.  [Per revised VHA Handbook 1200.05 (11/12/14) a MLS is no 
longer required, but a list of all enrolled participants is considered good research practice.]
12.
I know I can contact the VAAAHS IRB Coordinator at 734.845.3439 or the Research 
Compliance Officer at 734.845.4013 if I have questions or concerns regarding the consent of 
this or any individual considering study participation.
RESEARCH SUBJECT IDENTIFICATION: (Required information)
 
  
    |     |     |
         /          /        
Last Name
First Name
Mid. Init.
Last-4 SSN      Todays Date  (mm/dd/yy)
VAAAHS Research IRB
IRB NUMBER: IRB-2019-1183
IRB APPROVAL DATE: 02/13/2020

Department of Veterans Affairs
Research Consent Form
Title of Study: 
A Mixed Methods Pilot Study of a Low-Carbohydrate Diabetes Prevention Program 
Among Veterans with Prediabetes
Principal Investigator:
Dina Griauzde
VAMC:  VA Ann Arbor 
   Healthcare System
VA Form 10-1086
Page 1 of 8        
[VALID ONLY WITH CURRENT VA IRB DATE STICKER]    
Key Information
WHAT IS THE STUDY ABOUT AND WHY ARE WE DOING IT?
People with prediabetes can avoid getting type 2 diabetes by losing a modest amount of weight. This study is about a 
lifestyle change program that teaches people to follow a low-carbohydrate eating plan and to take part in other healthy 
behaviors (such as increasing physical activity and managing stress). By doing this study, we hope to learn whether this 
program is practical and acceptable to Veterans. The goal is to help more Veterans with prediabetes lose weight and 
avoid type 2 diabetes. This work is unfunded. 
WHAT DOES THE STUDY INVOLVE AND HOW LONG WILL IT LAST?  
Your participation in this research will last about 1 year. 
As part of this study, you will attend a lifestyle change program.  The program consists of: 

16 weekly one-hour group sessions led by a lifestyle coach.

8 additional one-hour sessions once or twice a month. 

Learning how to follow a low-carbohydrate diet. 

Keeping a food and exercise log. 

Completing surveys and laboratory tests at study start, 6, and 12 months.  

You may be asked to take part in an optional interview about the program at 6 and 12 months. 
WHAT ARE KEY REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS STUDY?
Participating in this study will provide instruction and support for following a low-carbohydrate eating plan and increasing 
your physical activity. Following this program may help you to lose weight and may help you avoid getting type 2 
diabetes, but there are no guarantees. 
For a complete description of benefits, refer to the Detailed Information section of this consent.
 WHAT ARE KEY REASONS YOU MIGHT CHOOSE NOT TO VOLUNTEER FOR THIS STUDY?
Taking part in this study will involve attending group sessions, tracking food, and completing surveys which may be 
inconvenient. There is also a small risk you may experience any of the following: 

Side effects from starting a low-carbohydrate eating plan.

Discomfort from the blood tests. 

Harm or injury if you exercise more as a result of taking part in this program. 

Some of the survey questions may bother you. 

Someone outside the study team may see the information we collect from you.  
For a complete description of alternate treatment/procedures, refer to the Detailed Consent.
DO YOU HAVE TO TAKE PART IN THE STUDY?
If you decide to take part in the study, it should be because you really want to volunteer. You will not lose any services, 
benefits or rights you would normally have if you choose not to volunteer. 
RESEARCH SUBJECT IDENTIFICATION: (Required information)
  
    |     |     |
         /          /        
Last Name
First Name
Mid. Init.
Last-4 SSN       Todays Date (mm/dd/yy)
VAAAHS Research IRB
IRB NUMBER: IRB-2019-1183
IRB APPROVAL DATE: 02/13/2020

Department of Veterans Affairs
Research Consent Form
Title of Study: 
A Mixed Methods Pilot Study of a Low-Carbohydrate Diabetes Prevention Program 
Among Veterans with Prediabetes
Principal Investigator:
Dina Griauzde
VAMC:  VA Ann Arbor 
   Healthcare System
VA Form 10-1086
Page 2 of 8        
[VALID ONLY WITH CURRENT VA IRB DATE STICKER]    
WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS OR CONCERNS?
The person in charge of the study is Dr. Dina Griauzde of the VA Ann Arbor Healthcare System.  If you have questions, 
suggestions, or concerns about this study or you want to withdraw from the study, her contact information is: 734-845-
5129.
RESEARCH DETAILS
INTRODUCTION
We are inviting you to take part in a research study. The purpose of this consent form is to give you information to help 
you decide if you want to be in the study. Please read this form carefully and ask study staff to explain anything you do not 
understand. You will have a chance to ask questions before you make your decision. This process is called ‘informed 
consent.’ 
WHAT IS THE PURPOSE OF THIS STUDY?
With this research we hope to learn if a group-based lifestyle program teaching a low-carbohydrate eating plan will be 
successful in helping Veterans with prediabetes lose weight and prevent type 2 diabetes. We hope to gain a better 
understanding of the strengths and challenges of this program for Veterans. This will help us design lifestyle programs at 
the VA that are more useful for patients. 
HOW LONG WILL I BE IN THE STUDY?
This research study is expected to last about 2 years. Your personal participation in the project will take about one year. 
This study will include up to 30 Veteran patients from the Ann Arbor VA.
WHAT WILL HAPPEN AND WHAT CAN I EXPECT IF I TAKE PART IN THIS STUDY?
If you choose to take part in this study, you will be asked to complete a survey (about 30 minutes), have 5 mL (about 1 
teaspoonful) of blood drawn to check HbA1c (diabetes screening test) and cholesterol levels, and have your waist 
measured when you join the study. You will be free to skip any survey questions you prefer not to answer. After you 
complete the survey and blood tests, you will be enrolled in the VA Low-Carbohydrate-Diabetes Prevention Program (LC-
DPP).
The VA LC-DPP will be led by a dietitian (lifestyle coach) from the VA Health System who is trained to teach people how 
to follow a low-carbohydrate eating plan. This group-based program consists of 16 weekly sessions followed by 8 
sessions once or twice a month. The sessions will be held at the Ann Arbor VA Hospital. Each session will last one hour. 
You will be asked to attend this program one day a week for 16 weeks. Because sessions may be cancelled during 
holiday weeks or due to weather conditions, these 16 sessions will take place over 6 months. After that, you will be asked 
to attend the program once or twice a month for the next 6 months. 
During the program, you will be encouraged to follow a low carbohydrate diet and monitor your weight at home. You will 
be asked to keep a log of the foods that you eat. You will also be asked to write down the minutes of physical activity that 
you perform daily. The lifestyle coach will review these materials each week and she will provide you with written 
feedback. She will also get your weight using a scale in a private room before the start of each session.
You will be taught to follow a low-carbohydrate eating plan. The sessions are designed to teach you how to make specific 
changes to your meals and snacks so that they meet the low-carbohydrate recommendations. In general, you will be 
advised to eat foods such as leafy greens, non-starchy vegetables, meat, eggs, cheese, berries, nuts and seeds. You will 
be advised to avoid foods such as bread, pasta, potatoes, flour, and beans. You will not need to count calories. Rather, 
VAAAHS Research IRB
IRB NUMBER: IRB-2019-1183
IRB APPROVAL DATE: 02/13/2020

Department of Veterans Affairs
Research Consent Form
Title of Study: 
A Mixed Methods Pilot Study of a Low-Carbohydrate Diabetes Prevention Program 
Among Veterans with Prediabetes
Principal Investigator:
Dina Griauzde
VAMC:  VA Ann Arbor 
   Healthcare System
VA Form 10-1086
Page 3 of 8        
[VALID ONLY WITH CURRENT VA IRB DATE STICKER]    
you will be advised to eat when you are hungry and stop when you are full. The lifestyle coach and study team will be 
available to answer specific questions and address any concerns. 
You will be asked to complete surveys, blood tests, and waist measurements again at 6 and 12 months. You will be free 
to skip any survey questions you prefer not to answer.
You may be invited to take part in a phone interview at 6 or 12 months to answer questions and share thoughts about the 
program. These interviews will be audio-recorded and the recordings will be typed into transcripts. If you would like to take 
part in an interview but don’t wish to be recorded, we will take detailed notes instead. The transcripts and notes of the 
interviews will be analyzed to assess the program. They will not be given to anyone outside the VA. You may decline to 
take part in the interview and still take part in the study.  
We will let your primary health care provider know that you are taking part in this study. We will let you and your provider 
know the results of the blood tests. In the event that we detect a concerning test result (e.g., hemoglobin A1c in the 
diabetes range), we will ensure that you have timely follow-up with your provider to discuss treatment options. We will also 
keep your provider informed of your progress in the program and ask that he/she adjust your medications, if necessary. 
For example, some people need a decrease in blood pressure medications when following a low-carbohydrate diet. 
To summarize, your participation in this study will involve:
AT STUDY START
AT 6 MONTHS
AT 12 MONTHS
THROUGHOUT STUDY
Survey with questions 
about your health 
(about 30 minutes)
HbA1c and cholesterol 
blood tests
Waist measurement
Be enrolled in the VA 
Low-Carbohydrate-
Diabetes Prevention 
Program (LC-DPP)
Survey with questions 
about your health 
(about 30 minutes)
HbA1c and cholesterol 
blood tests
Waist measurement
May be invited to take 
part in a phone 
interview
Survey with questions 
about your health 
(about 30 minutes)
HbA1c and cholesterol 
blood tests
Waist measurement
May be invited to take 
part in a phone 
interview
16 weekly one-hour group 
sessions over first 6 months 
8 one-hour group sessions 
once or twice a month over the 
next 6 months 
Follow a low-carbohydrate 
eating plan
Keep food and physical activity 
logs
Receive written feedback from 
lifestyle coach
If you take part in this study, you will be expected to:

Keep your study appointments. Please contact the investigator or research staff to reschedule as soon as you 
know you will miss an appointment.

Complete the study surveys.

Have your blood drawn.

Participate in the VA Low-Carbohydrate-Diabetes Prevention Program (LC-DPP).

Fill out your food and physical activity logs as instructed.

Ask questions as you think of them.

While participating in this research study, do not take part in any other research project without approval from 
the investigators.  This is to protect you from possible injury from things such as extra blood draws. Taking part 
VAAAHS Research IRB
IRB NUMBER: IRB-2019-1183
IRB APPROVAL DATE: 02/13/2020

Department of Veterans Affairs
Research Consent Form
Title of Study: 
A Mixed Methods Pilot Study of a Low-Carbohydrate Diabetes Prevention Program 
Among Veterans with Prediabetes
Principal Investigator:
Dina Griauzde
VAMC:  VA Ann Arbor 
   Healthcare System
VA Form 10-1086
Page 4 of 8        
[VALID ONLY WITH CURRENT VA IRB DATE STICKER]    
in other research studies without first discussing it with the investigators of this study may invalidate the results 
of this study, as well as that of the other studies. 
WHAT POSSIBLE RISKS OR DISCOMFORTS MIGHT I HAVE IF I TAKE PART IN THIS STUDY?
Any procedure has possible risks and discomforts. The researchers have taken careful steps to minimize the risks of this 
study. The procedures in this study may cause all, some, or none of the risks or side effects listed.  

Inconvenience:
o
You may find it time-consuming and inconvenient to participate in the group sessions or to track your food 
or physical activity minutes.
o
You may find it inconvenient to travel to the VA for the group sessions and study visits. You will not be 
eligible for VA travel pay for these visits.
o
You may also find it inconvenient to complete the surveys or blood tests. 
o
The researchers will minimize this risk by compensating you for the time required to complete the blood 
tests at study start, 6 and 12 months and the surveys at 6 and 12 months. 
o
You may find that following a low-carbohydrate diet adds to your monthly grocery bills.

Blood draws: 
o
There may be some discomfort, bruising, or bleeding at the site where the blood is drawn. Rarely, fainting 
occurs because of drawing blood.
o
Only VA employees with experience drawing blood will collect your blood samples for the study.

Surveys and sessions with the lifestyle coach:
o
Some people become uncomfortable at being asked questions about their health. You may choose to 
skip any questions you don’t wish to answer. You may also end the session at any time.

Diet: 
o
You may experience some side effects when you first reduce the amount of sugars and starches in your 
diet, such as constipation, headache, bad breath, and muscle cramps. These symptoms usually go away 
after the first couple weeks on the diet. If this happens, you can talk to the study staff. If your concerns or 
side effects are severe, you can speak to the study physician (Dr. Dina Griauzde). We have also shared 
information with your primary health care provider regarding the benefits and potential side effects of low-
carbohydrate diets, and he/she should also be able to help you manage your symptoms. If you take 
medications for high blood pressure, the doses of these medications may need to be reduced if you 
experience lightheadedness or dizziness.
o
Elevated LDL cholesterol levels: some people may experience increases in their LDL cholesterol level 
when following a low-carbohydrate diet.  The reason for this elevation is not known. In the event that your 
LDL cholesterol level is increased, we will notify your health care provider. Depending on the degree of 
increase, you may be advised to start a cholesterol-lowering medication. If you are already taking a 
cholesterol medication, you may be advised to increase the dose. You may also be advised to change 
your diet by increasing your intake of carbohydrates. 
o
Some people have developed kidney stones while following a low-carbohydrate diet. People who have 
had prior kidney stones may be more likely to develop stones. During the program, you will learn about 
steps that you can take to help decrease the chance of developing kidney stones. These include (1) 
drinking plenty of water; (2) eating foods high in calcium (e.g., dairy, salmon); (3) limiting intake of certain 
foods that are high in oxalate (e.g., celery, Brussel sprouts, certain nuts); (4) avoiding Vitamin C 
supplementation; and (5) eating a moderate (not high) amount of protein.

Loss of confidentiality:
o
We will not share your answers to survey questions with your doctor or anyone else without your 
permission. However, if we think you are in danger of harming yourself, we are required to get help for 
you.
o
It is possible that someone outside the study team could get access to your study data, although we will 
work hard to prevent this from happening
VAAAHS Research IRB
IRB NUMBER: IRB-2019-1183
IRB APPROVAL DATE: 02/13/2020

Department of Veterans Affairs
Research Consent Form
Title of Study: 
A Mixed Methods Pilot Study of a Low-Carbohydrate Diabetes Prevention Program 
Among Veterans with Prediabetes
Principal Investigator:
Dina Griauzde
VAMC:  VA Ann Arbor 
   Healthcare System
VA Form 10-1086
Page 5 of 8        
[VALID ONLY WITH CURRENT VA IRB DATE STICKER]    
There is always a chance that any procedure can harm you. The procedures in this study are no different.  In addition to 
the risks described above, you may experience a previously unknown risk or side effect.
Risks of the usual care you receive are not risks of this study.  Those risks are not included in this consent form.  You 
should talk with your health care providers if you have any questions about the risks of usual care.  
WHAT ARE THE POSSIBLE BENEFITS OF THIS STUDY?
We do not know if you will get any benefits from taking part in this research study.  However, possible benefits may 
include weight loss, decreased risk of diabetes, and reduction in hemoglobin A1c. Also, while some people may 
experience an increase in LDL cholesterol levels, others may see an improvement in cholesterol levels. Your participation 
in this study may also help the researchers to design and test new ways to help more people prevent type 2 diabetes.
You will receive results of your hemoglobin A1c and cholesterol tests at study start, 6 and 12 months. 
WHAT OTHER CHOICES DO I HAVE IF I DO NOT WANT TO JOIN THIS STUDY?
You are not required to participate in this study, and you may drop out of this study at any time without penalty. If you 
decide not to participate or choose to withdraw, you will not lose any benefits that you are entitled to. You will not lose any 
services, benefits, or rights you would normally have if you choose not to volunteer.
If you choose not to participate in this study, there are other options for preventing the development of type 2 diabetes. 
These include VA MOVE!, traditional Diabetes Prevention Programs and other lifestyle change programs that help you to 
lose weight and exercise more. You may discuss these options with your doctor.
HOW WILL MY PRIVATE INFORMATION BE PROTECTED?
Taking part in this study will involve collecting private information about you. This information will be protected in the 
following ways:

Paper study records will be kept in a locked filing cabinet in a locked VA office.

Electronic study records will be stored in secure study folders on VA servers. 

Only approved research staff will have access to the information.  

If the results of this study are reported in medical journals or at meetings, you will not be identified by name or 
by any other means.  
Your information collected as part of the research, even if information that identifies you is removed, will not be used or 
distributed for future research studies. By law, study records must be kept in a secure location for about six years after the 
study has ended, at which time they will be destroyed. 
While this study is being conducted, you will not have access to your research related health records. This will not affect 
your VA healthcare including your doctor's ability to see your records as part of your normal care and will not affect your 
right to have access to the research records after the study is completed.
Health Information Portability and Accountability Act (HIPAA)
There are rules to protect your private health information. Federal and state laws and the federal medical law, known as 
the HIPAA Privacy Rule, also protect your privacy. By signing this form, you provide your permission called your 
‘authorization,’ for the use and disclosure of information protected by the HIPAA Privacy Rule.
VAAAHS Research IRB
IRB NUMBER: IRB-2019-1183
IRB APPROVAL DATE: 02/13/2020

Department of Veterans Affairs
Research Consent Form
Title of Study: 
A Mixed Methods Pilot Study of a Low-Carbohydrate Diabetes Prevention Program 
Among Veterans with Prediabetes
Principal Investigator:
Dina Griauzde
VAMC:  VA Ann Arbor 
   Healthcare System
VA Form 10-1086
Page 6 of 8        
[VALID ONLY WITH CURRENT VA IRB DATE STICKER]    
The research team working on the study will collect information about you. This includes things learned from the 
procedures described in this consent form. They may also collect other information including your name, address, date of 
birth, and information from your medical records such as medical history, allergies, and lab results.  
The research team may also need to disclose your health information and the information it collects to others as part of 
the study progress. Others may include the Institutional Review Board, Food and Drug Administration (FDA), Office of 
Human Research Protections (OHRP), the VA Office of Research Oversight (ORO), and the Government Accountability 
(GAO).  
Your health information disclosed pursuant to this authorization may no longer be protected by Federal laws or regulations 
and may be subject to re-disclosure by the recipient. 
You can revoke this authorization, in writing, at any time. To revoke your authorization, you must write to the Principal 
Investigator at:
Dina Griauzde 
2800 Plymouth Road
NCRC Bldg 16; Room 16-371C
Ann Arbor, MI 48109
Or you can ask a member of the research team to give you a form to revoke the authorization. Your request will be valid 
when the Study Team receives it. If you revoke this authorization, you will not be able to continue to participate in the 
study. This will not affect your rights as a VHA patient to treatment or benefit outside of the study.
If you revoke this authorization, Dina Griauzde and her research team can continue to use information about you that was 
collected before receipt of the revocation. The research team will not collect information about you after you revoke the 
authorization.
Treatment, payment or enrollment/eligibility for benefits cannot be conditioned on you signing this authorization.  This 
authorization will expire at the end of the research study unless revoked prior to that time.
WHAT ARE THE COST TO ME IF I TAKE PART IN THIS STUDY?
You will not be charged for any treatments or procedures that are part of this study. If you usually pay co-payments for VA 
care and medications, you will still pay these co-payments for VA care and medications that are not part of this study.  
Reimbursement for participation:
You will receive a Visa or Amazon gift card to compensate you for completing each of the following study activities:
-
Baseline labs ($25)
-
6-month survey ($25)
-
6-month labs ($25)
-
12-month survey ($25) 
-
12-month labs ($25)
Those who are invited to take part in an interview at 6 and 12 months will also receive a $25 gift card after completing the 
interview.
WHAT WILL HAPPEN IF I AM INJURED BECAUSE OF MY BEING IN THE STUDY?
VAAAHS Research IRB
IRB NUMBER: IRB-2019-1183
IRB APPROVAL DATE: 02/13/2020

Department of Veterans Affairs
Research Consent Form
Title of Study: 
A Mixed Methods Pilot Study of a Low-Carbohydrate Diabetes Prevention Program 
Among Veterans with Prediabetes
Principal Investigator:
Dina Griauzde
VAMC:  VA Ann Arbor 
   Healthcare System
VA Form 10-1086
Page 7 of 8        
[VALID ONLY WITH CURRENT VA IRB DATE STICKER]    
If you are injured from taking part in this study, the VA will provide necessary medical treatment at no cost to you unless 
the injury occurs because you fail to follow study procedures.
If you should have a medical concern or get hurt or sick from taking part in this study, call:  
Dr. Dina Griauzde (Principal Investigator) at 734-845-5129.
Emergency and ongoing medical treatment will be provided as needed.  
It is important for you to understand that the Ann Arbor VA does not have funds set aside to pay for the cost of any care or 
treatment that might be necessary because you get hurt or sick while taking part in this study. Also, the Ann Arbor VA will 
not pay for any wages you may lose if you are harmed by this study.  
You do not give up your legal rights by signing this form.
 
DO I HAVE TO TAKE PART IN THE STUDY?
It is up to you whether to take part in this study. You may decide not to be in the study at any time. If you choose not to 
take part or choose to stop taking part at any time, you will still receive the same health care and benefits from the VA you 
currently receive. Your decision will not change that in any way.
If you choose to take part in the study but then change your mind, Dr. Dina Griauzde and her research team can continue 
to use the information collected from you up to that point. The research team will not collect information about you after 
you let them know you no longer wish to take part in the study, though they may still collect information about you that is 
available from public records. The blood samples you provide to the study team cannot be withdrawn.
RIGHT OF INVESTIGATOR TO TERMINATE MY PARTICIPATION
The Principal Investigator may withdraw you from the study without your consent for one or more of the following reasons:

She believes that it is not in your best interest to stay in the study. 

You become ineligible to participate. 

You do not follow instructions from the researchers.

Your behavior toward the staff or other participants is disruptive or inappropriate.

The study is suspended or canceled.
WHO DO I CONTACT ABOUT THIS STUDY IF I HAVE QUESTIONS?
If you have any questions, complaints, or concerns about this study, please contact Dr. Dina Griauzde at 734-845-5129. If 
you have questions about your rights as a study participant, or you want to make sure this is a valid VA study, you may 
contact the Institutional Review Board (IRB). This is the Board that is responsible for overseeing the safety of human 
participants in this study. You may call the IRB Coordinators at (734) 845-3440 if you have questions, complaints or 
concerns about the study or if you would like to obtain information or offer input.  
WILL I BE TOLD NEW INFORMATION ABOUT THIS STUDY?
The researchers will tell you if they learn of important new information that may change your willingness to stay in this 
study. If new information is provided to you after you have joined the study, it is possible that you may be asked to sign a 
new consent form that includes the new information.
VAAAHS Research IRB
IRB NUMBER: IRB-2019-1183
IRB APPROVAL DATE: 02/13/2020

Department of Veterans Affairs
Research Consent Form
Title of Study: 
A Mixed Methods Pilot Study of a Low-Carbohydrate Diabetes Prevention Program 
Among Veterans with Prediabetes
Principal Investigator:
Dina Griauzde
VAMC:  VA Ann Arbor 
   Healthcare System
VA Form 10-1086
Page 8 of 8        
[VALID ONLY WITH CURRENT VA IRB DATE STICKER]    
WHO COULD PROFIT FROM THE STUDY RESULTS?
The information and samples that you provide will no longer belong to you. The research may lead to new medical 
knowledge, treatments, or products. These products could have some financial value. There are no plans to provide 
financial payment to you or your relatives should this occur.
FUTURE USE OF DATA AND RE-CONTACT
Your data will not be used in future research and you will not be re-contacted about participating in future research.  
AGREEMENT TO PARTICIPATE IN THE RESEARCH STUDY
The research coordinator has explained the research study to me.  I have been told of the risks or discomforts and 
possible benefits of the study. I have been told of other choices of treatment available to me.  I have been given the 
chance to ask questions and obtain answers. 
 
By signing this document below, I voluntarily consent to participate in this study and authorize the use and disclosure of 
my health information for this study. I also confirm that I have read this consent, or it has been read to me. I will receive a 
copy of this consent after I sign it.  
I agree to participate in this research study as has been explained in this document.
_________________________
Participant’s Name (Print)
____________________________
Participant’s Signature
___________
Today’s Date
Person Obtaining Informed Consent
_________________________
Name (Print)
____________________________
Signature
___________
Today’s Date
VAAAHS Research IRB
IRB NUMBER: IRB-2019-1183
IRB APPROVAL DATE: 02/13/2020