The Effects of Learning Mindfulness Based Stress Reduction on Psychosocial Variables and HbA1c in Adolescents With Type 1 Diabetes
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Sponsor: Duquesne University

Protocol Summary Form 
Denise Van Sant – Smith, PhD Candidate, Duquesne University School of Nursing 
The Psychosocial and Physiological Effects of Teaching Mindfulness Based Stress 
Reduction (MBSR) to Adolescents with Type 1 Diabetes 
Research Questions 
Does a learned mindfulness based stress reduction program offered online increase mindfulness 
and improve quality of life in adolescents with Type 1 diabetes compared to a control group of 
adolescents with Type 1 diabetes?   
 
Does a learned mindfulness based stress reduction program offered online result in the 
physiological benefit of reduced HbA1c measurements in adolescents with Type 1 diabetes 
compared to a control group of adolescents with Type 1 diabetes? 
 
Purpose and significance of the study 
The prevalence of Type 1 diabetes in Americans under age 20 rose by 23 percent between 2001 
and 2009 (Juvenile Diabetes Research Foundation, 2011).  The dependence of individuals with 
Type 1 diabetes on the self-administration of insulin and constant monitoring of blood glucose 
levels related to diet, exercise, health status, growth and sexual maturity make the management 
of this condition intensely demanding (Tilden, Charman, Sharples, & Fosbury, 2005). The fact 
that Type 1 diabetes strikes most often in childhood also has significant implications for disease 
management. Considerable stress is associated in adolescents with Type 1 diabetes (Watts, 
O'Hara, & Trigg, 2010). It is imperative that nurses and other health care professionals find ways 
by which stress can be reduced in the service of improving quality of life.  
 
Mindfulness-based stress reduction (MBSR) programs have been shown to enhance psychosocial 
and physical wellness (Prouix, 2003). Several studies have examined the use of MBSR in 
adolescents in various populations, but to date no study has been specifically designed for 
adolescents with Type 1 diabetes. In addition, several online programs and e-health systems have 
been utilized to enhance delivery of psychoeducation on diabetes management for adolescents 
with Type 1 diabetes (Wittemore, et al., 2013; Tercyak, Abraham, Graham, Wilson, & Walker, 
2009).  
 
Adolescence is often recognized as a particularly challenging time in the growth and 
development of youth even without the complication of a chronic disease.  The existing research 
on adolescents with Type 1 diabetes focused on well-known issues of adolescence such as peer 
pressure and relationships with family (Bernstein, Stockwell, Gallagher, Rosenthal, & Soren, 
2013; Helgeson, Escobar, Siminerio, & Becker, 2010). Few intervention studies have been 
conducted to date that have examined ways by which adolescents can reduce stress associated 
with the demands of diabetes management. Those that have, examined the effects of coping 
skills training (Grey, Boland, Davidson, Li, & Tamborlane, 2000); cognitive behavioral therapies 
(Perfect & Elkins, 2010); motivational enhancement therapy (Ismail, et. al., 2008) and multi-
systemic therapy (Ellis, et.al., 2005).  
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

   
MBSR programs have been used and applied with diverse populations and as an intervention, 
they are increasing in popularity. While the traditional MBSR course is structured with specific 
content and presentation, the intervention has been modified in content and length for 
adolescents (Kerrigan, et.al., 2011; Brown, et.al., 2011) and in delivery format such as online, 
web-based mindfulness training (Davis & Zautra, 2013). MBSR has been used and studied with 
the adolescent population. While it has been seen as an effective intervention for chronic illness 
and for adolescents, it has not been examined in the adolescent population with the chronic 
illness of Type 1 diabetes.  
 
Engel’s biopsychosocial model will be used to guide this study. The model has frequently been 
used to address treatment of those with cancer and diabetes because biological, psychological 
and social components of these chronic illnesses have been found to have a significant impact on 
effective disease management. Based on the autoimmune nature and difficult psychomotor 
demands of Type 1 diabetes management, this study with a focus on adolescents with this 
chronic autoimmune condition, has the potential to provide important data about the relationship 
between stress and effective disease management. The significance of this nursing research study 
is in the potential for improving the quality of life and management of diabetes by reducing the 
HbA1c of adolescents with Type 1 diabetes through the use of MBSR. The use of MBSR could 
provide a stress management technique for this population that would improve management of 
diabetes leading to significant reductions in both physiological complications associated with 
diabetes and psychological stressors associated with the management and care of diabetes in 
adolescents. 
 
Data from this study will advance the science of nursing and provide a better understanding of 
the challenges faced by adolescents with Type 1 diabetes, as well as the importance of a 
comprehensive approach to health and wellness of patients, especially those with a chronic 
illness such as diabetes.  Results of this study may provide diabetes health care professionals 
with evidence of a new and effective approach to improve care of adolescents with Type 1 
diabetes.  The specific aim of this study is to determine if a learned stress reduction method 
provided online will result in improvement of both psychosocial measurements of reported 
quality of life and physiological measurements of blood sugar control measured by HbA1c. 
 
 
Research Design and Procedures  
This study will utilize a between group repeated measures design to measure the effects of the 
learned MBSR intervention over time.  MBSR will be the independent variable.  Dependent 
variables include mindfulness, diabetic quality of life and HbA1c.  Adolescents with Type 1 
diabetes will be randomly assigned to an intervention group or a wait list/control group that will 
be offered MBSR after all data has been collected. The study will utilize a 2 (experimental 
versus wait-list control group) by 3 (pretest [Time 1], posttest [Time 2], and 3 month follow-up 
[Time 3]) to examine within and between group differences overtime on two psychosocial 
measures including mindfulness and quality of life.  The physiological measure understudy, 
HbA1c, reflects glucose control over the previous three month period and will be measured at 
Time 1 and Time 3.  MBSR training will be provided via an online website and secure data 
collection site called MySweetMind.org. 
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

 
Instruments 
Two questionnaires will be used to collect data on psychosocial measures at the three time points 
including:  1) Diabetes Quality of Life Measure for Youths (YDQOL) (Ingersoll & Marrero, 
1991) (Appendix A) and, 2) Mindful Attention and Awareness Scale for Adolescents (MAAS-A) 
(Brown, 2011) (Appendix B).  A researcher-generated demographic sheet (DDS) (Appendix C) 
will also be administered at Time 1 to describe the population.  These questionnaires will be 
administered to the participants via a secure, online data collection site in both the experimental 
and control groups. In addition, HbA1c will be measured at the beginning of the study (Time 1) 
to measure blood glucose over the previous three month period and after three months of 
participation in the study (Time 3) in participants in both the experimental and control group   
 
Diabetes Quality of Life Measure for Youths (YDQOL) (Appendix A) will be used to measure 
adolescents on life satisfaction, diabetes impact, worries about diabetes, school life and peers. 
The YDQOL has a Cronbach alpha of 0.92 (Ingersoll & Marrero 1991). The YDQOL will take 
approximately 15 minutes to complete.    
 
Mindful Attention and Awareness Scale for Adolescents (MAAS-A) (Appendix B) (Brown, 
2011) will be used to measure the effectiveness of mindfulness training in youths and has been 
found to correlate with psychological well-being and healthy self-regulation. Cronbach’s alpha 
varies from .82 to .84 in adolescent populations. The MAAS-A takes approximately 10 minutes 
to complete.  
 
The Demographic Data Sheet (DDS) was researcher generated (Appendix C) and includes 11 
questions about the participants. This information will be used to describe the population 
understudy including age, gender, race, school grade and number of years with diabetes 
including date of diagnosis.  Respondents will also be asked to describe their typical level of 
activity, if they wear an insulin pump or continuous glucose meter (CGM) and if they have 
sibling(s) and/or parent(s) with diabetes.  The DDS will take less than 5 minutes to complete.  
 
Glycated Hemoglobin test (HbA1c) (Appendix D) is a blood test requiring a venipuncture or 
finger stick. For this study, a finger stick will be self-obtained from each participant at Time 1 
and Time 3.  The instant HbA1c requires a drop of blood from the finger stick that provides 
results in 5 minutes.  This measurement is useful because it is less affected by the day to day 
variations in blood glucose levels.  The HbA1c is representative of average blood glucose over a 
90 day period.  
 
The HbA1c test kit will be sent to the home of the participant with simple instructions to place 
one drop of blood on the card provided.  Parents or the adolescent participant will be asked to put 
the card into a reader that provides the results in the form of an electronic read out within 5 
minutes.  Those with Type 1 diabetes are familiar with this process as it is a common diagnostic 
test performed in the Endocrinologist’s office at each visit. It is also the same type of finger stick 
procedure these adolescents use to test their blood sugar as they regularly do approximately 4-8 
times per day.  The parents will then be asked to e-mail this information to the researcher at 
Time 1 and Time 3.  Reminder texts and e-mails (Appendix E) will be sent to the participants in 
both the experimental and control group.  Reminders will also be posted on the website.   
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

 
Sample Selection and Size 
The population under study will include adolescents with Type 1 diabetes between the ages of 12 
and 17. To participate, adolescents will need to have the ability to read English at a sixth grade 
level with no cognitive impairment and have access to a computer and the Internet. A power 
analysis was conducted using a medium effect size of 0.25, power of .80 with alpha set at .05 
using a two tailed test of significance; thus, a total sample size (N) of 86 (n=43), per group will 
be needed. 
   
Recruitment of Subjects 
Recruitment fliers (Appendix F) will be posted at pediatric endocrinology offices in New Jersey.  
In addition, email invitations will be sent through the Diabetes Education and Camping 
Association (DECA).  The primary recruitment method will be through direct promotion to 
parents and campers at two summer camps for adolescents with diabetes, one day camp and 
several other two-week/overnight camps.  Information will be provided at intake and outtake 
days of the camp to the parents and campers.  Both parents and camper will be given a postcard 
with the website address and general information about participating. Secondly, eleven Pediatric 
Endocrinology offices in New Jersey will be contacted in order to gain access to adolescent 
patients diagnosed with Type 1 diabetes.  Physicians will be sent a letter (Appendix G) and asked 
to return an included post card if they are interested in having their patients participate in this 
study and if they are willing to help with recruitment including posting recruitment fliers and 
sending invitations (Appendix H ) to adolescents and the parents of adolescents with Type 1 
diabetes.  Permission to recruit at these sites will be obtained. Additional recruitment activities 
will include word of mouth and announcements placed on the Internet via parent and child 
support groups. 
 
Participants of this study will be able to participate in the privacy of their own home via a 
website for learning the MBSR program.  Study participants will access the intervention through 
a developed website, MySweetMind.org. In addition, collection of all psychosocial data will 
occur via a secure online data collection site.  HbA1c will be obtained via a self-collected finger-
stick blood test at two specific time periods and the results will be sent by the participants’ 
parents via email to the researcher for analysis.  
 
Informed Consent Procedures 
After obtaining approval from Duquesne University Institutional Review Board, recruitment 
activities will begin through the Diabetes Camp and several Pediatric Endocrinology offices.   
 
Once a parent or adolescent contacts the investigator either by phone or e-mail, they will be 
screened via phone conversation for recruitment into the study by the researcher.  Criteria for 
inclusion in the study is:  (a) between the ages of 12 and 17; (b) ability to read English at a 6th 
grade level; (c) diagnosis of Type 1 diabetes; (d) no cognitive impairment as reported by parent; 
and (e) access to a computer and internet. Existing blood sugar control will not be used as 
inclusion or exclusion criteria. If the potential participant qualifies for the study, both adolescent 
and parent will be given the log in information.  
 
 
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

 
 
 
 
The website will be accessible only through log in and is a private website; additional security 
was added by purchasing secure sockets layer (SSL) encryption for the website.  A secure 
connection is created between the participant and the server which provides compliance with 
HIPPA regulations and confirms the security of the data.  Potential participants and parents will 
be able to gain access to the content of the MySweetMind.org website through contact with the 
investigator once they obtain log in instructions via phone or e-mail.  
 
Upon logging in to the website, the process of obtaining parental permission/consent and 
participant assent will begin.  Once potential participants have had a chance to review the content 
and better understand the research study and what will be expected of them, they will have the 
opportunity to ask any additional questions online, via e-mail, or via telephone conversation with 
the researcher.  Once all questions have been answered, assent and parental permission/consent 
forms will be sent via mail and returned via a prepaid envelope. Once obtained, participants and 
their parents will be given the online access code to the MySweetMind.org website.  All assent 
forms and parental permission/consent forms will be stored in a locked cabinet in the PI’s home 
office.  
 
MBSR Online Intervention 
The principles of MBSR will be divided into 6 main modules delivered in the online, web-based 
format via the website: MySweetMind.org (Appendix I). Participants will be given a password to 
access a 6 week module-based site to learn Mindfulness Based Stress Reduction adapted for 
adolescents.  This adaptation of MBSR is based on the work of Dzung X. Vo, MD, FAAP and 
Jake Locke, MD as presented in the book (2015) written by Dr. Vo, The Mindful Teen. The 
major topics included in each module are as follows: Module 1- Introduction to Mindfulness, 
Mindful Eating; Module 2 – Sitting Meditation; Module 3 – Body Scan; Module 4 – Mindfulness 
of Thinking & Everyday Mindfulness; Module 5 – Loving Kindness Meditation & Mindfulness 
Movement; and, Module 6 - Review & Tips for Maintaining a Mindfulness Practice. The key 
concepts for each module are shown in Appendix D.  The website, MySweetMind.org, is 
currently under construction.  The design will be user friendly, attractive and age appropriate. 
Each of the modules listed above will have short video vignettes (5-10 minutes) describing the 
content for current module.  As the participant enters each module they will see images, hear 
music and voice descriptions which describe the mindfulness concept for that module.  Also, the 
participant will see a written outline of the material that can easily be printed out, if the 
participant chooses to.  In addition, suggestions for practice of the material will be given for each 
module.  As the participant completes modules, they receive tokens representative of that 
completion which move forward as progress is made through the modules. The website is being 
designed to work on smaller devices such as phones and tablets as well as a computer.   
 
Collection of Data and Method of Data Analysis 
Upon initial access of the website, the participant will be asked to first complete the DDS, 
YDQOL and MAAS questionnaires delivered online and submitted online.  In addition, the 
participants will be asked to test their HbA1c using a finger stick home testing kit that will be 
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

sent via US mail to the parents of the adolescents who have agreed to participate.  The parent of 
the participant will be asked to e-mail the results of the HbA1c to the PI. 
 
Once all Time 1 data have been obtained, the participant will begin to go through the modules 
learning mindfulness.  Within the website, the participant will be prompted to go to the diary 
page where the time spent on each module and time spent practicing the concepts of it will be 
recorded.  This diary data will be accessible to the researcher.  At the end of the 6 weeks allotted 
for the Module progression, the participants will be asked to take the YDQOL and the MAAS-A 
questionnaires again online.  They will be encouraged to practice the mindfulness modules for 
10-15 minute daily which will continue to be available.  At Time 3, the participants in both the 
experimental and control groups will be asked to take the YDQOL and the MAAS-A 
questionnaires again one last time.   The HbA1c test kit will also be sent to the home again and 
the results of this test will be emailed to the researcher.  Those randomly assigned to the control 
group and thus, not yet had the opportunity to learn MBSR will be asked to take the YDQOL and 
MAAS-A questionnaires again at Time 2 and then the YDQOL and MAAS-A along with another 
HbA1c at Time 3.  Once all data has been collected from those participants randomly assigned to 
the control group, participants will be offered the MBSR intervention.  
 
Participants will be given a $15.00 iTunes or Amazon gift card for completing the first three 
questionnaires and the HbA1c test at Time 1.  The gift card will be sent via U.S. Mail upon 
confirmation of the receipt of the HbA1c results and completion of the questionnaires.  At the 
end of the study, participants will be sent via U.S. Mail an additional $25.00 iTunes or Amazon 
gift card upon receipt of the second HbA1c test results and completed questionnaires.   
 
Procedures for the participants randomized to the control group will follow the same procedures 
as noted above except that they will not have access to the MBSR learning modules until the end 
of the three month data collection period.  Those who were placed in the control group will be 
provided the opportunity to access the website and utilize the modules to learn mindfulness after 
all data have been collected and the intervention was shown to be effective in at least one 
variable measured. 
 
Planned Analysis  
Descriptive statistics will be used to describe the population under study including means, 
standard deviations, ranges, and percentages to summarize the information gathered on the 
demographic data sheet (DDS). Graphs and histograms will be generated to view demographic 
data and data collected on the major variables under study at Time 1 including mindfulness, 
diabetes quality of life and HbA1c.  Assumptions for parametric testing will be tested to 
determine whether or not parametric testing can be done.  Although parametric testing is 
planned, it may be that the equivalent nonparametric test will be used to analyze data.   In 
addition, a correlational matrix will be created to determine whether any two variables co-vary at 
> 0.65.  Two way repeated measures Analysis of Variance (RM-ANOVA) will be used to answer 
the research questions.   
 
Interactions with Subjects and Subjects’ rights 
In the development of this study, careful consideration was given to maintain the 7 principles as 
outlined within the NIH document concerning treatment of research subjects.  Specific to the 
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

interactions with subjects, a fair subject selection will be utilized, IRB approval and informed 
consent will be obtained.  Additionally, respect for enrolled subjects will be demonstrated by 
checking on their well-being as they participate, maintaining confidentiality and sharing results 
with them once the study is complete.  Those subjects who are in the control group will also be 
given the opportunity to learn MBSR at the completion of data gathering since it has been shown 
in many populations to be a benefit and advantage to individuals with varied health conditions.  
 
All information gathered including data, parental permission/consent and assent forms will be 
stored in a locked cabinet with careful attention to the privacy of participants and security of all 
materials.  The website will be accessible only through log in and is a private website; additional 
security was added by purchasing secure sockets layer (SSL) encryption for the website.  A 
secure connection is created between the participant and the server which provides compliance 
with HIPPA regulations and confirms the security of the data.  Only the researcher and advisor 
will have access to the data collected.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

Appendix A 
Diabetes Quality of Life for Youths Questionnaire (DQOL) 
 
A:  
DIRECTIONS: Read each statement carefully. Please indicate how satisfied or 
dissatisfied you currently are with the aspect of your life described in the question. Mark 
[X] the box that matches how satisfied or dissatisfied you feel: 1 = Very Satisfied, 2 = 
Moderately Satisfied, 3 = Neither Satisfied nor Dissatisfied, 4 = Moderately Dissatisfied, 
5 = Very Dissatisfied. There are no right or wrong answers to these questions. We want 
your opinion.                                    
 
 
 
  
                               
 
 
 
 
      Very           Mod.      Neither            Mod.             Very 
                                                                                                                                                     Satisfied     Satisfied                     Dissatisfied    Disatisfied 
A1: 
How satisfied are you with the amount of 
     [1]       [2]      [3]       [4]       [5]   
      
time it takes to manage your diabetes? 
A2: 
How satisfied are you with the    
 
    [1]        [2]      [3]       [4]       [5]   
      
amount of time you spend getting  
checkups? 
A3: 
How satisfied are you with the    
 
  [1]         [2]      [3]        [4]       [5]   
      
time it takes to determine your 
      
blood sugar? 
A4:  
How satisfied are you with your   
 
 [1]         [2]      [3]         [4]      [5] 
current medical treatment? 
A5: 
How satisfied are you with the    
             [1]         [2]      [3]         [4]      [5]   
      
flexibility you have with your diet?     
A6: 
How satisfied are you with the    
 
 [1]         [2]       [3]        [4]        [5]   
      
burden your diabetes is placing 
      
on your family? 
A7: 
How satisfied are you with        
 
 [1]          [2]        [3]       [4]       [5]   
      
your knowledge about your diabetes? 
 
 
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

 
SPEAKING GENERALLY:                                    
                                                                                            Very              Mod.        Neither        Mod.          Very 
                                                                                                                                        Satisfied      Satisfied                      Dissatisfied   Disatisfied 
A8: 
How satisfied are you with         
           [1]        [2]        [3]      [4]       [5]   
      
your sleep? 
A9: 
How satisfied are you with         
           [1]        [2]        [3]      [4]      [5]   
      
your friendships?                            
 
 
 
 
 
A10: 
How satisfied are you with 
 
          [1]         [2]        [3]     [4]       [5]   
      
your work, school, and household 
      
activities? 
A11: 
How satisfied are you with the    
          [1]        [2]        [3]     [4]       [5]   
      
appearance of your body? 
A12: 
How satisfied are you with the    
         [1]        [2]        [3]     [4]        [5]   
       
time you spend exercising?   
A13: 
How satisfied are you with         
         [1]        [2]       [3]     [4]         [5]   
      
your leisure time?      
A14: 
How satisfied are you with         
        [1]        [2]       [3]      [4]        [5]   
      
life in general? 
A15: 
How satisfied are you with         
        [1]       [2]       [3]      [4]         [5]   
      
performance in school?  
A16: 
How satisfied are you with         
       [1]        [2]       [3]     [4]         [5]   
      
how your classmates treat you? 
A17: 
How satisfied are you with         
       [1]         [2]       [3]     [4]         [5]   
      
your attendance at school? 
 
 
 
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

 
Compared with others your age, would you say your health is: 
 
Excellent 
 
Good      
 
Fair  
 
Poor  
DIRECTIONS: Read each statement carefully. Please indicate How Often the following events happen 
to you. Mark [X] the box that matches how satisfied or dissatisfied you feel: 1 = Never, 2 = Very Seldom, 
3 = Sometimes, 4 = Very Often, 5 = All the time. There are no right or wrong answers to these questions. 
We are interested in your honest opinion.                                           
                         
                                                                                             Never    Very Seldom    Sometimes      Often    All the time        
 
    
 
 
                                                        
B1: 
How often do you feel pain 
 
                 [1]     [2]      [3]      [4]     [5]   
      
associated with the treatment of  
your diabetes? 
B2: 
How often are you embarrassed                              [1]    [2]      [3]      [4]     [5]   
      
by having to deal with your  
diabetes in public? 
B3: 
How often do you feel                                             [1]      [2]      [3]      [4]    [5]   
      
physically ill?  
B4: 
How often does your diabetes      
               [1]     [2]       [3]      [4]     [5]   
      
interfere with your family life? 
B5: 
How often do you have a bad       
              [1]     [2]        [3]     [4]    [5]   
      
night's sleep? 
B6: 
How often do you find your                                  [1]      [2]       [3]      [4]    [5]   
      
diabetes limiting your social 
      
relationships and friendships? 
B7: 
How often do you feel good                                [1]     [2]      [3]      [4]     [5]   
      
about yourself? 
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

 
                                                                                           Never    Very Seldom    Sometimes    Often    All the time                              
B8: 
How often do you feel                                            [1]     [2]     [3]      [4]     [5]   
      
restricted by your diet?    
B9:  
How often does your diabetes      
              [1]      [2]     [3]     [4]     [5]   
      
keep you from driving a car? 
B10: 
How often does your diabetes      
             [1]      [2]     [3]     [4]     [5]   
      
interfere with your exercising? 
B11: 
How often do you miss work,                                [1]      [2]    [3]      [4]     [5]   
      
school or household duties    
      
because of your diabetes? 
B12: 
How often do you find yourself    
             [1]     [2]     [3]     [4]     [5]   
      
explaining what it means to  
      
have diabetes?                                    
B13: 
How often do you find that your diabetes            [1]     [2]     [3]     [4]     [5]   
      
interrupts your leisure time activities? 
B14: 
How often are you teased                                     [1]      [2]    [3]     [4]     [5]   
      
because you have diabetes? 
B15: 
How often do you feel that               
            [1]      [2]    [3]     [4]     [5]   
      
because of your diabetes you go 
      
to the bathroom more than others? 
B16: 
How often do you find you eat     
           [1]      [2]     [3]     [4]    [5]   
      
something you shouldn't rather 
      
than tell someone that you have diabetes? 
B17: 
How often do you hide from        
          [1]       [2]      [3]    [4]     [5]   
      
others the fact that you are 
      
having an insulin reaction? 
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

 
                                                                                           Never    Very Seldom    Sometimes      Often        All the time                              
B18: 
How often do you find that your   
            [1]       [2]      [3]     [4]     [5]   
      
diabetes prevents you from   
        
participating in school activities 
(for example, a school play, playing 
a sport). 
B19: 
How often do you find that                                [1]       [2]       [3]     [4]     [5]   
      
your diabetes prevents you from  
going out to eat with your friends? 
B20: 
How often do you feel that                                 [1]        [2]      [3]     [4]     [5]   
      
your diabetes will limit what job  
you will have in the future? 
B21: 
How often do you find that                                [1]        [2]      [3]     [4]       [5]   
      
your parents are too protective  
of you? 
B22: 
How often do you find that                               [1]        [2]       [3]     [4]      [5]   
      
your parents worry too much  
about your diabetes 
B23: 
How often do you find that                              [1]         [2]       [3]      [4]      [5]   
      
your parents act like diabetes 
is their disease, not yours? 
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

 
DIRECTIONS: Read each statement carefully. Please indicate how often the following events happen to 
you. Check [X] the appropriate box. There are no right or wrong answers to these questions. If the 
question is not relevant to you, check "Does not apply".                                                             
                            
 
 
    
      
                              
 
        
 
                                      Does Not         Never        Seldom     Sometimes   Often       All the 
                                                                                                                                               Apply                                                                                   Time 
C1:  
How often do you worry    
 
 
[0]      [1]     [2]      
[3]     [4]     [5] 
      
about whether you will get married? 
C2:  
How often do you worry    
 
 
[0]      [1]     [2]      
[3]     [4]     [5] 
      
about whether you will have children? 
C3:  
How often do you worry    
 
 
[0]      [1]     [2]      
[3]     [4]     [5] 
      
about whether you will not get  
a job you want? 
C4:  
How often do you worry    
 
 
[0]      [1]     [2]     
[3]     [4]     [5] 
      
about whether you will pass out?      
C5:  
How often do you worry    
 
 
[0]      [1]     [2]      
[3]     [4]     [5] 
      
about whether you will be able to  
complete your education? 
C6:  
How often do you worry    
 
 
[0]      [1]     [2]      
[3]     [4]     [5] 
      
that your body looks different  
because you have diabetes? 
C7: 
How often do you worry    
 
 
[0]      [1]     [2]      
[3]     [4]     [5] 
      
that you will get complications  
from your diabetes? 
C8:  
How often do you worry    
 
 
[0]      [1]     [2]      
[3]     [4]     [5] 
    
whether someone will not go out  
with you because you have diabetes? 
 
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

                                                                                      Does Not     Never     Seldom     Sometimes   Often        All the 
                                                                                                                                     Apply                                                                                  Time 
C9:  
How often do you worry    
 
      [0]      [1]     [2]         [3]        [4]         [5] 
that teachers treat you differently 
because of your diabetes? 
C10:  
How often do you worry    
 
      [0]      [1]     [2]      [3]       [4]          [5] 
that your diabetes will interfere with  
things that you do in school (sports,  
music, drama)? 
C11:  
How often do you worry    
 
     [0]      [1]     [2]       [3]        [4]           [5] 
that your diabetes causes you to do  
things with friends like going on  
dates or going to parties? 
 
 
 
 
 
 
 
 
 
 
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

Appendix B 
Mindful Attention Awareness Scale - Adolescent (MAAS-A) 
Instructions: Below is a collection of statements about your everyday experience.  Using the 1‐6 scale 
below, please indicate how frequently or infrequently you currently have each experience.  Please 
answer according to what really reflects your experience rather than what you think your experience 
should be.  Please treat each item separately from every other item. 
     1                             2                           3                            4                            5                          6               
Almost                    Very                 Somewhat            Somewhat               Very                   Almost  
Always                 Frequently         Frequently          Infrequently         Infrequently           Never 
 
I could be experiencing some emotion and not be conscious of it                     1     2     3     4     5     6 
until some time later. 
 
I break or spill things because of carelessness, not paying attention,               1     2     3     4     5     6  
or thinking of something else. 
 
I find it difficult to stay focused on what’s happening in the present.               1     2     3     4     5     6 
 
I tend to walk quickly to get where Im going without paying                              1     2     3     4     5     6  
attention to what I experience along the way. 
 
I tend not to notice feelings of physical tension or discomfort until                  1     2     3     4     5     6 
they really grab my attention. 
 
I forget a person’s name almost as soon as I’ve been told it                               1     2     3     4     5     6 
for the first time. 
 
It seems I am “running on automatic,” without much awareness of                 1     2     3     4     5     6 
what I’m doing. 
 
I rush through activities without being really attentive to them.                        1     2     3     4     5     6 
 
I get so focused on the goal I want to achieve that I lose touch with                1     2     3     4     5     6 
what I’m doing. 
 
I find myself listening to someone with one ear, doing something                    1     2     3     4     5     6 
else at the same time. 
 
I drive places on “automatic pilot” and then wonder why I went there.           1     2     3     4     5     6 
 
I find myself preoccupied with the future or the past.                                          1     2     3     4     5     6 
 
I find myself doing things without paying attention.                                             1     2     3     4     5     6 
 
I snack without being aware that I’m eating                                                           1     2     3     4     5     6 
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

Appendix C 
Demographic Data Sheet (DDS) 
DIRECTIONS:  Please complete the following information. 
1.  Age:____ 
2. Date of Birth:  ____/_____/_____ 
3. Gender 
_____Male 
_____Female 
 
4. Race and/or Ethnic Origin, may check more than one: 
_____Caucasian 
_____African American 
_____Hispanic 
_____Asian 
_____Native American/Eskimo 
_____Other, Please specify 
           
5.  School Grade:__________ 
 
6.  Level of Activity: 
_____Sedentary (very little physical activity) 
_____Moderately Active 
_____Very Active 
 
7.  How many year with diabetes?______ 
 
8.  Do you have a parent(s) with diabetes? 
_____Yes 
_____No 
 
9. Do you have a sibling(s) with diabetes? 
_____Yes 
_____No 
  
10. Do you wear an insulin pump? 
_____Yes 
_____No 
  
11. Do you wear a continuous glucose meter? 
_____Yes 
_____No 
  
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

Appendix D 
HbA1c Values Associated with Average Blood Glucose Values 
 
 
 
HbA1c 
eAG (estimated average glucose)
(%) 
(mmol/mol)[25] 
(mmol/L)
(mg/dL)
5 
31 
5.4 (4.2–6.7)
97 (76–120) 
6 
42 
7.0 (5.5–8.5)
126 (100–152) 
7 
53 
8.6 (6.8–10.3)
154 (123–185) 
8 
64 
10.2 (8.1–12.1)
183 (147–217) 
9 
75 
11.8 (9.4–13.9)
212 (170–249) 
10 
86 
13.4 (10.7–15.7)
240 (193–282) 
11 
97 
14.9 (12.0–17.5)
269 (217–314) 
12 
108 
16.5 (13.3–19.3)
298 (240–347) 
13 
119 
18.1 (15–21)
326 (260–380) 
14 
130 
19.7 (16–23)
355 (290–410) 
15 
140 
21.3 (17–25)
384 (310–440) 
16 
151 
22.9 (19–26)
413 (330–480) 
17 
162 
24.5 (20–28)
441 (460–510) 
18 
173 
26.1 (21–30)
470 (380–540) 
19 
184 
27.7 (23–32)
499 (410–570) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

 
Appendix E 
 
Reminder Text/email content: 
 
 
Hello,   
This is a reminder that the HbA1c test kit has been sent.  Please take 5 minutes to obtain and 
 email these results.  Thank you. 
 
Please email or text with any questions. 
 
Thanks,  
Denise  
732-330-8871 cell  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

Appendix  F 
Flier to be posted in the Pediatric Endocrinology offices and at Diabetes Camps 
 
Invitation to Participate in a Research Study  
Adolescents ages 12-17 with Type 1 Diabetes  
 
This study will examine the effects of  
Mindfulness Based Stress Reduction (MBSR) 
 
 
 
This Mindfulness program may help positive youth development and resilience by teaching core 
mindfulness practices.  Participants learn valuable strategies to focus on the present and stop 
worrying about the past or future.   
 
The research is done via an online, age-appropriate website.  Participants will be required to have 
access to a computer and the Internet. Participants will receive a $15 iTunes or Amazon 
gift card for completing the first part of the study and then an additional $25 iTunes or 
Amazon gift card at the end of the study.  
 
For additional information please contact: 
Denise Van Sant – Smith, MSN, RN, PhD candidate  
Duquesne University School of Nursing 
732-330-8871 
vansantsmithd@duq.edu 
 
 
 
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

 
Appendix G 
Sample Pediatric Endocrinologist Recruitment Letter 
April 1, 2015 
 
Dr. XXXX 
Pediatric Endocrinology 
Dear Dr. XXXX, 
This letter is to request the participation of your office in research concerning the use of 
Mindfulness as a stress management technique for adolescents with Type 1 diabetes. 
 
I am conducting this study as partial fulfillment of the requirements for the PhD degree in 
Nursing at Duquesne University.  IRB approval to conduct this study has been obtained through 
Duquesne University. 
 
I am asking for your help to recruit adolescents between the ages of 12 to 17 with Type 1 
diabetes to participate in this study.  Participants will be randomized to the experimental group or 
the waitlist/control group.  If interested, the participants will be invited to learn the practice of 
mindfulness via modules on a website, asked to practice the MBSR techniques, and asked to 
respond to questionnaires via a secure online data collection site.  The home page of the website 
where your patient will access the course material is www.mysweetmind.org. 
 
If you agree to help me recruit, business cards and postcards will be provided to you to give to 
your patients and their parents that will contain information about the study.  If your patients are 
interested, they will be asked to contact me directly.  Participants would be under no obligation 
to join the study or continue in the study once they join.   
 
Please complete and send via U.S. Mail the enclosed pre-stamped postcard if you permit this 
study to be advertised in your office.  I am available to meet with you and/or your staff directly 
to describe the study further or answer any questions you may have.   
 
I encourage you to consider this opportunity for your patients.  Mindfulness has become quite 
popular in the last few years and has shown significant benefits for many different individuals 
with varying conditions/illnesses.  The skills that your patient could gain have the potential for 
helping them for a lifetime. 
 
Please do not hesitate to contact me with any questions.  My cell phone number is 732-330-8871 
 
Sincerely, 
 
Denise Van Sant – Smith, MSN, RN, CNE 
PhD Candidate 
Duquesne University 
 School of Nursing  
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

 
Appendix H 
 
Return Post Card 
 
 
___Yes, I am interested in advertising this study in our Pediatric Endocrinology office 
 
 
Please send a packet of information with post card/business cards to my office. 
 
 
 
Name:______________________________________________________ 
Group Name:________________________________________________ 
Address:____________________________________________________ 
____________________________________________________________ 
 
Please check here if you would like an office visit by the investigator ______ 
 
Please check here if you would like to discuss the study via telephone with the 
researcher______ 
 
Please check here if you would like additional information sent via e-mail_____ 
 
Best time/method to contact you________________________________________ 
____________________________________________________________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

Appendix I 
 
Key Concepts for www.mysweetmind.org Module Content 
 
Module 1 – Introduction to Mindfulness and Mindful Eating 
Key Concepts 
Sometimes when you experience a lot of stress, you get stuck in your thoughts and spend a lot of 
time feeling bad about the past or worrying about the future.  This can cause you to feel bad and 
maybe act badly toward yourself or toward others.  
This is why learning how to handle stress is so important 
Mindfulness is defined by Dr. Jon Kabat-Zinn as “Paying attention in a particular way:  on 
purpose, in the present moment, and nonjudgmentally” (1994, 4).  
Mindfulness is about learning to handle stressful situations with kindness and compassion toward 
yourself.  Learning how to be mindful will help you to be more resilient – which means you are 
able to thrive and do well despite stressful situations.  These modules, starting with this one, will 
give you information about specific mindfulness practices and access to audio recordings to 
listen to.  
 
Your body and your brain are constantly sending signals back and forth, they are in 
communication constantly.  
Explain the Hand Model of the Brain – the lizard brain 
Explain Paper Tigers – knowing the difference 
Breathing is the Heart of Mindfulness – recorded track 
Pay careful attention to your breath, you don’t need to change your pattern of breathing – just 
bring your attention to your natural breath. You may want to focus in on that part of your body 
where you notice the breath the most – your nose, your belly, your lungs. 
Eating a Raisin Mindfully  - recorded track 
Module 2 – Sitting Meditation  
Key Concepts  
 
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

Mindfulness is sometimes described as a bird with two wings:  compassion and awareness.   
In order to practice Mindfulness – like flight – you need both wings.   
Awareness will help you recognize that you are feeling stressed. 
Compassion will allow you to look at your situation with kindness – smiling will help you to 
cultivate this self-compassion and compassion toward others.  Be aware if you are being negative 
or self-critical and if this is happening to you simply be aware of it and then meet those thought 
with kindness so they will let go of you. 
Mindfulness of the breath is the foundation of every one of the mindfulness practices – simply 
being aware of the breath is a powerful antidote to stress. Breath and smile.  
Just Sit and do nothing. Shift out of autopilot and switch from “doing” to “being” Just sit and be 
aware of the breath. 
Sitting like a Mountain. – recorded track 
Daily practice is important  
Module 3 – Body Scan 
Key Concepts  
Don’t allow yourself to be pulled away from the present moment, recognize the healing power of 
a simple present-moment experience.  
If you notice yourself thinking about the past or the future or realize your mind has wondered, 
simply return to the present by using your breathing as an anchor.  
Mindfulness will help you to notice the good things that happen in life more because you will be 
more aware of and grateful for the positive things in your life by spending some time in the 
present moment considering those things you are grateful for…. 
Since the mind and the body are deeply connected, releasing stress in your body will help you to 
release stress in your mind.  This is what the body scan allows you to do. It is a gift to your body 
because it is an invitation of energy into the body from your mindfulness practice.   
The body scan is good to practice at night before you go to sleep also.  
Body Scan – recorded track 
Handling Pain and Discomfort with the Body Scan 
 
 
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

Module 4 – Mindfulness of Thinking and Everyday Mindfulness  
Key Concepts 
 
Too busy for mindfulness? Stories of including mindfulness in everyday living 
 
Informal Mindfulness – bringing mindful awareness into routine activities you already have 
 
Mindful Eating 
 
The link between formal and informal mindfulness practice – SOBER 
1. Stop   2.  Observe    3.  Breathe     4.  Expand  5.  Respond 
 
 
Practice mindfulness in small ways everyday 
 
Module 5 – Loving Kindness Meditation & Mindfulness Movement 
Key Concepts 
 
Loving Kindness Meditation 
Your thoughts are powerful and can become your reality 
 
Automatic thoughts exercise.  
 
Mindfulness of thinking – recorded track 
 
Mindful movement is the practice of moving your body intentionally with care and attention to 
what is happening with each movement. 
 
Mindful movement – recorded track 
 
 
Module 6 – Review & Tips for Maintaining Mindfulness Practice 
Key Concepts 
 
Breath 
Awareness and Compassion 
Listen to recordings 
Mindfulness in a Moment and in Everyday Living 
 
 
Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016

 
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Approved: 11-19-2015 
Expiration Date: 11-18-2016

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Duquesne University IRB 
Protocol #2015-10-14 
Approved: 11-19-2015 
Expiration Date: 11-18-2016