Examination of Psychological Tools and Tracking in an Online Intervention for Type 2 Diabetes
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Sponsor: University of Michigan

Examination of Psychological Tools and Tracking in an Online Intervention for Type 2 Diabetes 
 
NCT03037528 
 
Document Date: 01-26-17 
 
Protocol, analysis plan, and consent form 
 
 
 

 2 
Nutritional management is one of the cornerstones of type 2 diabetes treatment, as dietary 
changes can lead to glycemic control and the reduced need for anti-glycemic medications [1]. 
Several dietary approaches are recommended for type 2 diabetes, including a very-low 
carbohydrate (VLC) diet. For example, a recent report by the ADA’s Nutrition Review Committee 
noted the benefits of a reduced-carbohydrate diet and updated the policy guidelines to 
recommend that for people with type 2 diabetes “…not meeting glycemic targets or where 
reducing anti-glycemic medications is a priority, reducing overall carbohydrate intake with a low- 
or VLC eating plan is a viable approach” [2]. Physiologically, carbohydrate intake raises blood 
glucose levels, which in turn increases insulin secretion from the pancreas. Insulin then inhibits 
lipolysis and the subsequent release of fatty acids from cells [3]. Numerous studies indicate that 
a reduced-carbohydrate diet is particularly effective at improving glycemic control, reducing the 
need for glucose-lowering medications, increasing weight loss, and bringing about other positive 
health outcomes in type 2 diabetes [4-7].  
 
However, long term adherence to any diet can be challenging, and it is not clear which 
strategies could help people maintain dietary changes. In this trial, as we screened three 
potentially effective strategies using a full-factorial design. This was informed by the Multiphase 
Optimization Strategy (MOST) framework [8]. This approach suggests that before conducting 
clinical trials of multi-component interventions, particular components of the intervention should 
be tested, especially those which might be costly, burdensome, or simply have not been 
previously tested enough to be clearly appropriate for a particular intervention. Such an 
approach is becoming more common in intervention development, e.g., in the areas of weight 
loss [9], physical activity promotion [10], and in our previous pilot study of VLC diet for type 2 
diabetes [11]. In this case, we tested three low-cost strategies that varied in their 
burdensomeness and level of previous testing in this intervention [12].  
 
In the current trial, we examined three supplemental strategies that we expected may improve 
glucose control over a 12-month period. The first was dietary self-monitoring, varying whether 
participants were encouraged to keep track of what they were eating every day versus monthly 
(in bursts of three days every 4 weeks). Weight loss trials involving dietary changes typically 
encourage daily dietary self-monitoring, as this can help people to become more aware of their 
dietary adherence, and it tends to be associated with weight loss [13]. However, participants 
commonly dislike daily monitoring and their adherence to it tends to fade over time [14, 15]. 
Thus, we compared encouragement to self-monitor diet daily vs. less often, which may still be 
able to help participants self-regulate, but to do so in a less burdensome manner. 
 
The second strategy we included was mindfulness, varying whether or not we taught 
participants how to increase their experience of mindfulness and mindful eating. We included 
exercises to increase awareness of the physical, cognitive, and emotional triggers of overeating; 
the awareness of internal cues that signal hunger, fullness, and taste satisfaction; “surfing” the 
urges to reduce emotional eating; and the cultivation of healthier alternatives [16, 17]. These 
approaches aim to help participants become more aware of their hunger-related bodily 
sensations, food cravings, and eating triggers, so that they can choose to respond more 
deliberately. Previous research shows that mindful eating helps reduce emotional eating, an 
important barrier for dietary adherence [18, 19]; increased mindful eating was correlated with 
decreased fasting glucose levels in participants of a mindful eating weight loss intervention [20]; 
and mindful eating was a mediator of the effect of a mindful eating intervention for weight loss 
[19]. However, mindfulness strategies can backfire, sometimes leading to greater anxiety and 

 3 
depression [21], and the strategies require extra time and attention, which could be 
burdensome.  
 
The third strategy was positive affect skills training, aiming to increase the frequency that 
participants experienced positive emotions, such as focusing on gratitude, using one’s personal 
strengths, conducting acts of kindness, and savoring positive experiences [22]. To adhere to a 
behavioral intervention, participants need to effectively cope with inevitable stressors. According 
to the revised Stress and Coping Theory [23, 24], positive affect can serve as a psychological 
“time-out” from stress and increase adaptive coping [25-27], and interventions that help increase 
the experience of positive affect have been able to reduce depressive symptoms [28]. 
Additionally, hedonic theories of behavior propose that people do more of what they enjoy [29], 
possibly because positive emotional responses to behaviors increase the motivation and 
nonconscious desire to engage in those behaviors [30, 31]. For example, previous research has 
found an association between higher eating plan satisfaction rates and adherence [32, 33]. 
However, positive affect skill interventions may have small to little impact on outcomes [34], and 
they take time to implement, which could be burdensome. 
 
The primary aim of this study was to assess whether several supplementary strategies (daily 
versus monthly dietary self-monitoring, mindfulness skills, and positive affect skills) could 
improve outcomes in this VLC intervention with adults with type 2 diabetes. 
 
Procedure 
The institutional review board at the University of Michigan approved the study materials 
(HUM00115537). We registered this study with clinicaltrials.gov (NCT03037528). We placed 
advertisements or notices of the research online (including Craigslist, University of Michigan’s 
web-based portal for clinical trials, and ResearchMatch) and sent invitation letters to potentially 
eligible participants identified from health plan records at Michigan Medicine. Interested 
participants were directed to the study website, which contained the University of Michigan logo, 
pertinent study information, and a link to an online self-report screening survey (Qualtrics.com). 
Those who were eligible for further screening based on their survey responses were asked to 
provide online electronic consent for the trial and subsequently to undergo a second online 
survey (Qualtrics) which included the eight-item Patient Health Questionnaire (PHQ-8) to 
measure depressive symptoms [35]; a self-administered glycated hemoglobin (HbA1c) test from 
DTI Laboratories, Inc; and 3 days of dietary tracking on MyFitnessPal. We also mailed these 
individuals a body weight scale that connects to its own cellular network (BodyTrace) and 
automatically reports weights to the study team. Those who met all entry criteria (below) were 
invited to participate in the trial.  
 
Participants were eligible to participate if they were aged 21 to 70 years, had a baseline HbA1c 
of 6.5% or higher, had a BMI of 25-45 kg/m2 (based on self-reported height and measured 
weight from the study-provided scale), had regular access to the internet, were willing to check 
their email at least once a week, were comfortable reading and writing in English, had no 
potentially serious comorbidities, such as liver or kidney failure, were planning on living in the 
United States for the duration of the trial, were not vegetarian or vegan, and were not on weight-
loss medications, and were not taking warfarin, Coumadin, or lithium. We also excluded people 
who were pregnant or breastfeeding, had an untreated thyroid condition, had an untreated 
mental health condition, had had weight loss surgery in previous year, or were undergoing 
cancer treatments. Given that this study was conducted remotely, to mitigate the risk of 
hypoglycemia, we excluded participants who reported taking any glucose-lowering medication 
other than metformin. 

 4 
 
This 2x2x2 full factorial experimental design examined the impact of three experimental, 2-level 
components. Once all baseline measurements had been completed, study staff randomized 
participants to one of the eight experimental conditions (see Table 1) using a computer program 
to reveal the next assignment. The order was created using block randomization procedures, 
with blocks randomly allocated to size 8 or 16 and with the seed numbers of 64655102233242, 
64655183677600 from the website Sealed Envelope (Sealed Envelope Ltd. 2015. Create a 
blocked randomization list. [Online] Available from: https://www.sealedenvelope.com/simple-
randomiser/v1/lists [Accessed 14 Jan 2017]). We stratified randomization by gender. 
 
All tested combinations of the three intervention enhancement strategies. 
 
Experimental components 
Combination 
Tracking frequency 
Mindfulness  
 
Positive affect  
1 
Daily 
Yes 
Yes 
2 
Daily 
Yes 
No 
3 
Daily 
No 
Yes 
4 
Daily 
No 
No 
5 
Monthly 
Yes 
Yes 
6 
Monthly 
Yes 
No 
7 
Monthly 
No 
Yes 
8 
Monthly 
No 
No 
 
The Basic Intervention 
Once participants were assigned to one of eight groups, they were e-mailed links to online 
intervention materials throughout the 12-month intervention, weekly for the first 4 months and 
then biweekly for the remaining 8 months, for a total of 32 emails. Each of the 32 batches of 
materials focused on a different topic related to following a VLC diet. Emailed links connected 
participants to a) a short survey to assess intervention-related dietary adherence and any health 
concerns, b) a short, embedded video teaching class topics (such as managing their diet during 
holidays or shifting particular meals to be VLC, etc.), c) downloadable handouts to accompany 
the video, and d) links to external online resources supporting class topics. Transcripts of the 
embedded videos were also provided. 
 
The basic intervention included several components that all participants received, regardless of 
assignment. We taught participants to eat a VLC diet per our previous protocol [11], reducing 
carbohydrate intake to between 20-35 non-fiber grams of carbohydrates a day with the goal of 
achieving nutritional ketosis, defined as a positive urine dipstick (Bayer Ketostix), which 
measures ketone acetoacetate. A VLC diet consists of meats, cheeses, eggs, healthy fats, nuts, 
seeds, and low-carbohydrate vegetables, eliminating starchy and sugary foods. Participants 
also had email access to a diet coach whenever they had questions and would receive prompt 
replies with support and resources and who emailed participants a minimum of every two 
weeks. Coaches have generally been found to be effective additions to behavioral interventions 
[36]. Participants received a scale at the start of the intervention and were asked participants to 
track their body weight regularly. Coaches used this information to monitor participant success 
and tailor support. Beginning in week 6 of the intervention, we provided goals for physical 
activity and sleep. Using the Diabetes Prevention Program [37] as a guide, participants were 
encouraged be physically active for at least 150 minutes a week. Participants were also 
encouraged to practice sleep hygiene with the target of 7-9 hours total sleep per day. To 
encourage the adoption and maintenance of the new intervention-related behaviors, participants 

 5 
were sent text messages up to 5 times a week about the targeted behaviors and skills, 
depending on which group they had been assigned to, as reminders about targeted behaviors 
are tied to greater behavioral adherence [38]. To help participants change their dietary patterns 
and increase their self-efficacy around preparing and eating new foods, we mailed cookbooks to 
participants: Keto Living 3 Cookbook: Lose Weight with 101 All New Delicious and Low Carb 
Ketogenic Recipes [39] at baseline, Bacon & Butter, the Ultimate Ketogenic Diet Cookbook [40] 
at month 3, The Wicked Good Ketogenic Diet Cookbook: Easy, Whole Food Keto Recipes for 
Any Budget [41] at month 6, and The Everyday Ketogenic Kitchen With More Than 150 
Inspirational Low-Carb, High-Fat Recipes to Maximize Your Health [42] at month 10.  
 
Experimental Components 
In addition to the core intervention, we randomized participants to one of eight possible 
combinations of the three supplemental components; tracking frequency, positive affect, and/or 
mindfulness. For each, the program materials were altered, including different content added to 
the videos, handouts, and text messages. Each factor was selected for its potential to improve 
participants’ ability and interest in adhering to the assigned diet over 12 months.  
 
1) Daily vs. monthly self-monitoring of dietary intake. We asked participants to track their 
diet using the free web-based and/or mobile application MyFitnessPal [43], which has a wide 
variety of foods in its database that are common to the diet assigned in this trial (reducing 
participant burden and increasing accuracy). Half of participants were asked to track their diet 
daily and the other half were asked to track their diet monthly (for 3 days every 4 weeks). 
 
2) Training vs. no training in mindfulness. Half of participants were taught mindfulness, 
including mindful eating, how to practice it in everyday life, research behind the skills, how the 
skills are expected to help, and targeted suggestions for practicing the skills until the next 
lesson. We asked participants to focus on consciously savoring their food, eating more slowly, 
and noticing the textures, flavors, and aromas of their food more carefully. For example, they 
were asked to practice slowly savoring their food with a snack and were then encouraged to 
practice this skill with at least one meal a day over the next week. 
 
3) Training vs. no training in positive affect skills. Half of participants were taught diet-
focused positive affect skills, how to practice them in everyday life, the supporting research, how 
and why the skills are expected to help, and targeted suggestions for practicing the skills. We 
taught participants ways to feel more positive affect, for example, by focusing on gratitude, 
thinking about and applying their personal strengths, applying their personal strengths.  
 
Assessments 
We measured outcomes at baseline and at 4, 8, and 12 months after baseline. As an incentive 
for continued participation, we paid participants US $25 for completing their outcome 
measurements at 4 months, US $25 at 8 months, and US $50 at 12 months. At each period, we 
measured glycemic control with an at-home kit, body weight using the scale we had mailed to 
participants (participants were asked to stand on the scale twice in five minutes and we used 
the average weight), and depressive symptoms using the PHQ-8 [35].  
 
Statistical analysis  
We conducted two-sided t-tests to assess statistical significance and effect size (Cohen’s d). 
 
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Farias, M., et al., Adverse events in meditation practices and meditation-based 
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A systematic review. Patient education and counseling, 2014. 97(2): p. 147-157. 
37. 
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with 101 All New Delicious and Low Carb Ketogenic Recipes. 2014: Visual Magic 
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Recipes for Any Budget. 2016: Callisto Media Incorporated. 
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 9 
UNIVERSITY OF MICHIGAN 
CONSENT TO BE PART OF A RESEARCH STUDY 
 
 
INFORMATION ABOUT THIS FORM 
You may be eligible to take part in a research study.  This form gives you important information about 
the study.  It describes the purpose of the study, and the risks and possible benefits of participating in 
the study.   
 
Please take time to review this information carefully.  After you have finished, you should talk to the 
researchers about the study and ask them any questions you have.  You may also wish to talk to others 
(for example, your friends, family, or other doctors) about your participation in this study.  If you decide 
to take part in the study, you will be asked to sign this form.  Before you sign this form, be sure you 
understand what the study is about, including the risks and possible benefits to you. 
1.  GENERAL INFORMATION ABOUT THIS STUDY AND THE RESEARCHERS 
1.1 Study title: Examination Psychological Tools and Tracking in an Online Intervention for Type 2 
Diabetes 
 
1.2 Company or agency sponsoring the study: This research is sponsored by the National Institute of 
Health. 
 
1.3 Names, degrees, and affiliations of the researchers conducting the study: Laura Saslow, Ph.D., 
Assistant Professor in the Department of Health Behavior and Biological Sciences in the School of 
Nursing, University of Michigan, Ann Arbor; Sarah Kim, M.D., Assistant Professor, School of Medicine, 
University of California, San Francisco; and James E. Aikens, Ph.D. Associate Professor Department of 
Family Medicine University of Michigan Medical School. 
 
2. PURPOSE OF THIS STUDY 
2.1 Study purpose:  
This study is being done in order to better understand what the ideal diet and lifestyle 
recommendations are for individuals with type 2 diabetes and whether that information can be 
successfully taught over the internet. 
 
3. INFORMATION ABOUT STUDY PARTICIPANTS (SUBJECTS) 
Taking part in this study is completely voluntary.  You do not have to participate if you don't want to.  
You may also leave the study at any time.  If you leave the study before it is finished, there will be no 
penalty to you, and you will not lose any benefits to which you are otherwise entitled.  
 
3.1 Who can take part in this study? 
You may be eligible for this study if you are an adult (aged 21-70) living in the United States with type 2 
diabetes (measured A1c level of 6.5% at the start), who is also overweight, taking either no drugs for 
their diabetes or just metformin, can read English, and has regular access to a personal computer and 
the internet. 
 
3.2 How many people (subjects) are expected to take part in this study?  
We expect 150 people to take part in this study. 
 

 10 
 
4.  INFORMATION ABOUT STUDY PARTICIPATION 
4.1 What will happen to me in this study?   
 
Overview: If you are likely eligible for this study based on your initial web screening survey and/or phone 
call, you will have 4 weeks to do the following: track what you eat for 3 days with MyFitnessPal, a free 
online and mobile application; fill out another online survey (30-45 minutes) about you; and return a 
mail-away diagnostic test kit to measure your blood sugar levels (HbA1c; to confirm a current A1c level 
of 6.5% or higher).  If you continue to be eligible, we will mail you a digital body weight scale, which we 
will ask you to use to measure your weight. You'll have 2 weeks to do this.  
 
Next, you'll be randomly assigned (like tossing a coin) to 1 of 8 groups that may include a combination of 
the following three components: 
 
Recommendations to track what you eat either daily or in 3-day bursts about every 4 weeks. You will be 
asked to track what you eat most days or you will be asked to track periodically, mostly about 3 days 
every 4 weeks or when you are curious to do so. 
 
Recommendations to learn about a practice positive affect skills (yes or no).  You may learn about 
positive affect skills, such as gratitude and positive reappraisal, in order to help you enjoy the program 
more and be able to stick with the program. 
 
Recommendations to learn about mindfulness and mindful eating (yes or no).  You may learn about 
mindfulness and mindful eating skills, such as ways to better pay attention to what you are feeling and 
your level of hunger, in order to help you enjoy the program more and be able to stick with the 
program. 
 
All groups will have an online program to support you and help you lose weight and get your blood sugar 
under control.  
 
Location: All measurements will take place online or in your home.  Class sessions will take place online. 
Study Classes. After all of the above baseline assessments are complete and you are eligible, 
you will complete a short online questionnaire to confirm your interest and availability for the 
study classes and follow-up assessments. You will be asked to follow a diet with little sugar or 
starch taught using weekly online classes over 12 months (online material, including online 
videos and handouts will be sent to you weekly or every 2 weeks).  Each class will take about 
15-60 minutes to complete. In the classes, you will learn how to implement the diet in a healthy 
way, tools to help you stick to the diet, and how to manage stress in your daily life. The total 
amount of out-of-class time will be about 2-5 hours a week.  
Follow-up Assessment:  You will have a follow-up assessment at 4, 8, and 12 months after classes start, 
including a repeat of the baseline surveys described above, the blood measurements, and the body 
weight assessment. 
You will also be asked to provide feedback about the classes and study assessments.  If you feel 
uncomfortable answering some of these questions, you may decline to answer them.  

 11 
How will your study supplies be provided to you?  
Some of your study materials will be shipped directly to you from vendors such as Amazon, 
DTILaboratories, and BodyTrace.  By signing this consent form you are allowing the study team to 
provide the vendors with your name and address.  This is in order for the materials be shipped to your 
home or office.  Study materials include a digital body weight scale and urine ketone test strips mailed 
to you at the start of the study as well as any other gifts that you may receive as part of the study, such 
as diet-relevant books and food.   
 
How will your blood samples be stored and used?  
Your blood will be sent to a lab for immediate testing for HbA1c. 
 
Will your blood be saved for future use?  
No. 
 
Will you receive your test results?  
If you wish, you will receive these blood results from the study staff. 
 
Can you stop being in the study? 
Yes.  You can decide to stop at any time.  You will just tell the study researcher or staff person if you 
wish to stop being in the study. Also, the study researcher may stop you from taking part in this study at 
any time if he or she believes it is in your best interest, if you do not follow the study rules, or if the 
study is stopped.  
 
4.2 How much of my time will be needed to take part in this study?   
Your participation in the study will take about 12 months plus the time it takes for you to do the 
baseline measurements.   Each assessment (at 0, 4, 8, and 12 months) may take several hours to do the 
A1c test, step on the scale, answer the self-report survey information, and track your diet.  Participation 
in the diet and lifestyle program will take varying amounts of time, but the materials may take 1-2 hours 
to read and apply each week. 
 
4.3 When will my participation in the study be over?  
The study lasts 12 months long once you have been started on classes. 
 
5.  INFORMATION ABOUT RISKS AND BENEFITS 
5.1 What risks will I face by taking part in the study?  What will the researchers do to protect me 
against these risks? 
 
1. Blood measurements: We will be testing your blood using an FDA-approved non-fasting, finger 
stick, whole blood mail-in test. You will be asked to prick your finger (similar to when you might 
test yourself using a home glucose meter), collect a small amount of blood into a tiny tube, called 
a capillary, and then mail this away.  The risks of pricking yourself for the self-test blood kit 
include temporary discomfort from the stick, localized bleeding, or localized infection. For more 
information about the test see: http://www.dtilaboratories.com/accubase-video.html 
 
2. Questionnaires:  Some of the questions may make you uncomfortable or upset, but you are free 
to decline to answer any questions you do not wish to answer or to discontinue your 
participation at any time. 
 

 12 
3. Diet: 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. Kim, from the University of California, San Francisco).  She will be available on call 
if you have any urgent concerns. 
 
4. Dietary changes: You could find it difficult to change your diet. Also, your friends or family may 
not support the changes you are making to your diet or lifestyle. If this happens, you can speak 
to study staff about this.  
 
5. Home assignments: You may find it inconvenient to complete the home assignments for the 
class. Also, you could experience distressing emotions during some of the home assignments. If 
this happens, you can stop the exercise and speak to the study staff.  
 
As with any research study, there may be additional risks that are unknown or unexpected. 
 
 
5.2 What happens if I get hurt, become sick, or have other problems as a result of this research? 
 
The researchers have taken steps to minimize the risks of this study.  Even so, you may still have 
problems or side effects, even when the researchers are careful to avoid them. Please tell the 
researchers listed in Section 10 about any injuries, side effects, or other problems that you have during 
this study.  You should also tell your regular doctors. 
 
5.3 If I take part in this study, can I also participate in other studies? 
Being in more than one research study at the same time, or even at different times, may increase the 
risks to you.  It may also affect the results of the studies.  You should not take part in more than one 
study without approval from the researchers involved in each study.   
 
5.4 How could I benefit if I take part in this study?  How could others benefit?   
You may receive possible benefits of taking part in this study. These may include improved diabetes 
control, , weight loss, reduced risk for diabetes complications, and decreased feelings of stress, but this 
cannot be guaranteed.  The information that you provide may also provide benefit to other individuals 
with type 2 diabetes by helping health professionals better understand how to help people with type 2 
diabetes improve their health, mood, and lower their risk for diabetes complications, although these 
benefits cannot be guaranteed. 
 
 
5.5 Will the researchers tell me if they learn of new information that could change my willingness to 
stay in this study? 
 
Yes, 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. 
 
6.  OTHER OPTIONS 
6.1 If I decide not to take part in this study, what other options do I have? 

 13 
 
You are free to choose not to participate in this study.  If you decide not to take part in this study, there 
will be no penalty to you.  You will not lose any of your regular benefits, and you can still get care the 
way you usually do.  
 
7.  ENDING THE STUDY 
7.1 If I want to stop participating in the study, what should I do? 
 
You are free to leave the study at any time.  If you leave the study before it is finished, there will be no 
penalty to you. You will not lose any benefits to which you may otherwise be entitled.  If you choose to 
tell the researchers why you are leaving the study, your reasons for leaving may be kept as part of the 
study record. If you decide to leave the study before it is finished, please tell one of the persons listed in 
Section 10 “Contact Information” (below). 
7.2 Could there be any harm to me if I decide to leave the study before it is finished?  
No. 
 
7.3 Could the researchers take me out of the study even if I want to continue to participate? 
Yes. There are many reasons why the researchers may need to end your participation in the study.  
Some examples are: 
ü The researcher believes that it is not in your best interest to stay in the study. 
ü You become ineligible to participate. 
ü Your condition changes and you need treatment that is not allowed while you are taking part in 
the study. 
ü You do not follow instructions from the researchers. 
ü The study is suspended or canceled. 
8.  FINANCIAL INFORMATION 
8.1 Who will pay for the costs of the study? Will I or my health plan be billed for any costs of the 
study?   
 
The study will pay for research-related items or services that are provided only because you are in the 
study (HbA1c test).   
 
You or your health plan will pay for all the things you would have paid for even if you were not in the 
study, like: 
• 
Health care given during the study as part of your regular care 
• 
Items or services needed to give you study drugs or devices 
• 
Monitoring for side effects or other problems 
• 
Deductibles or co-pays for these items or services. 
If you do not have a health plan, or if you think your health plan may not cover these costs during the 
study, please talk to the researchers listed in Section 10 below or call your health plan’s medical 
reviewer. 
 
By signing this form, you do not give up your right to seek payment if you are harmed as a result of 
being in this study. 
 
8.2 Will you be paid or given anything for taking part in this study? 
You will receive $25 for completing the follow-up information at month 4, $25 for the same tasks at 
month 8, and $50 for these tasks at month 12. You will be paid in Amazon.com gift certificates that will 

 14 
be e-mailed to you. In addition, you will be able to keep the digital body weight scale mailed to you at 
the start of the study as well as any other gifts that you may receive as part of the study.   
 
8.3 Who could profit or financially benefit from the study results? 
This research is done without a financial conflict of interest. 
 
The information below describes how your privacy and the confidentiality of your research records will 
be protected in this study. 
 
9.1 How will the researchers protect your privacy? 
Your information will be stored on encrypted servers. We will mail class information weekly using e-
mail.  You may e-mail or call us about questions pertaining to the study or your health.  Participation in 
research may involve a loss of privacy, but information about you will be handled as confidentially as 
possible. Questionnaire responses are confidential and will not be shared with people outside the study. 
Your personal information may be given out if required by law.  
 
9.2 What information about me could be seen by the researchers or by other people?  Why?  Who 
might see it? 
Signing this form gives the researchers your permission to obtain, use, and share information about you 
for this study, and is required in order for you to take part in the study.  Information about you may be 
obtained from any hospital, doctor, and other health care provider involved in your care, including: 
• 
Hospital/doctor's office records, including test results (X-rays, blood tests, urine tests, etc.) 
• 
Mental health care records (except psychotherapy notes not kept with your medical records) 
• 
Alcohol/substance abuse treatment records 
• 
HIV/AIDS status 
• 
Sexually transmitted disease and/or other communicable disease status 
• 
Genetic counseling/genetic testing records 
• 
Health plan/health insurance records 
• 
All records relating to your condition, the treatment you have received, and your response to 
the treatment 
• 
Billing information 
• 
Demographic information 
• 
Personal identifiers 
• 
Other information 
There are many reasons why information about you may be used or seen by the researchers or others 
during or after this study.  Examples include: 
• 
The researchers may need the information to make sure you can take part in the study.   
• 
The researchers may need the information to check your test results or look for side effects.   
• 
University, Food and Drug Administration (FDA) and/or other government officials, auditors, 
and/or the IRB may need the information to make sure that the study is done in a safe and 
proper manner.    
• 
Study sponsors or funders, or safety monitors or committees, may need the information to:  
o Make sure the study is done safely and properly 
o Learn more about side effects  
o Analyze the results of the study  
• 
The researchers may need to use the information to create a databank of information about 
your condition or its treatment. 

 15 
• 
If you receive any payments for taking part in this study, the University of Michigan accounting 
department may need your name, address, social security number, payment amount, and 
related information for tax reporting purposes.  
• 
If you receive any payments for taking part in this study, the University of Michigan accounting 
department may need your name, address, social security number, payment amount, and 
related information for tax reporting purposes. 
• 
Federal or State law may require the study team to give information to government agencies. 
For example, to prevent harm to you or others, or for public health reasons.  
• 
We will share your name and address with companies, such as Amazon, DTI Laboratories, and 
BodyTrace, so that we can send you study-related materials including an HbA1c test and a digital 
body weight scale.  Where possible, companies have signed confidentiality agreements to not 
disclose your information to anyone besides the SUCCEED team. In the case of Amazon.com, so 
that we can e-mail you gift certificates, we may give them your e-mail address.  
The results of this study could be published in an article, but would not include any information that 
would let others know who you are.  
 
A description of this clinical trial will be available on http://www.clinicaltrials.gov/, as required by U.S. 
Law. This Web site will not include information that can identify you. At most, the Web site will include a 
summary of the results. You can search this Web site at any time. 
 
9.3 What happens to information about me after the study is over or if I cancel my permission? 
 
As a rule, the researchers will not continue to use or disclose information about you, but will keep it 
secure until it is destroyed.  Sometimes, it may be necessary for information about you to continue to be 
used or disclosed, even after you have canceled your permission or the study is over.   
 
Examples of reasons for this include: 
• 
To avoid losing study results that have already included your information  
• 
To provide limited information for research, education, or other activities  (This information 
would not include your name, social security number, or anything else that could let others 
know who you are.)  
• 
To help University and government officials make sure that the study was conducted properly 
As long as your information is kept within the University of Michigan Health System, it is protected by 
the Health System’s privacy policies.  For more information about these policies, ask for a copy of the 
University of Michigan “Notice of Privacy Practices”.  This information is also available on the web at 
http://www.uofmhealth.org/patient+and+visitor+guide/hipaa. Note that once your information has 
been shared with others as described under Question 9.2, it may no longer be protected by the privacy 
regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA).   
 
9.4 When does my permission expire?   
Your permission expires at the end of the study, unless you cancel it sooner. You may cancel your 
permission at any time by writing to the researchers listed in Section 10 "Contact Information" (below).   
 
10. CONTACT INFORMATION 
10.1 Who can I contact about this study? 
Please contact the researchers listed below to: 
• 
Obtain more information about the study 

 16 
• 
Ask a question about the study procedures or treatments 
• 
Talk about study-related costs to you or your health plan  
• 
Report an illness, injury, or other problem (you may also need to tell your regular doctors) 
• 
Leave the study before it is finished 
• 
Express a concern about the study 
 
Principal Investigator: Laura Saslow 
Mailing Address: Office 2178, 400 N Ingalls St, Ann Arbor, MI, 48109 
Telephone: 734-764-7836 
 
You may also express a concern about a study by contacting the Institutional Review Board listed below. 
University of Michigan Medical School Institutional Review Board (IRBMED) 
2800 Plymouth Road 
Building 520, Room 3214 
Ann Arbor, MI 48109-2800 
Telephone: 734-763-4768  (For International Studies:  US Country Code: 001) 
Fax: 734-763-1234 
e-mail: irbmed@umich.edu  
 
If you are concerned about a possible violation of your privacy or concerned about a study you may 
contact the University of Michigan Health System Compliance Help Line at 1-866-990-0111. 
When you call or write about a concern, please provide as much information as possible, including the 
name of the researcher, the IRBMED number (at the top of this form), and details about the problem.  
This will help University officials to look into your concern.  When reporting a concern, you do not have to 
give your name unless you want to. 
 
11.  RECORD OF INFORMATION PROVIDED 
11.1 What documents will be given to me? 
Your signature in the next section means that you have received copies of all of the following 
documents: 
• 
This "Consent to be Part of a Research Study" document.   
 
• 
Other (specify):  
 
 
 
12.  SIGNATURES 

 17 
 
 
 
 
 
 
 
 
 
 
 
Consent/Assent to Participate in the Research Study 
 
I understand the information printed on this form.  I have discussed this study, its risks and potential 
benefits, and my other choices with {Study Team Member Name/s}.  My questions so far have been 
answered.  I understand that if I have more questions or concerns about the study or my participation as a 
research subject, I may contact one of the people listed in Section 10 (above).  I understand that I will receive 
a copy of this form at the time I sign it and later upon request.  I understand that if my ability to consent or 
assent for myself changes, either I or my legal representative may be asked to re-consent prior to my 
continued participation in this study. 
 
In the website, please enter your legal name to consent to this research study.