Intervention Mapping to Adapt a Mindfulness-based Intervention for Adults With Diabetes and Emotional Distress
Phase: NA
Conditions: Type 2 Diabetes, Stress
Sponsor: University of Alabama at Birmingham

  
Intervention mapping to adapt a mindfulness-based 
intervention for adults with diabetes and emotional distress 
 
Principal Investigator: Caroline Presley, MD, MPH 
Sponsor: NCATS 
National Clinical Trial (NCT) Identified Number:  03987841 
 
Version Number:  v1.0 
<10/30/2022> 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
1 
PROTOCOL SUMMARY ............................................................................................................................... 1 
1.1 
Synopsis ................................................................................................................................................ 1 
1.2 
Schedule of Activities (SoA) ............................................................................................................... 2 
2 
INTRODUCTION ............................................................................................................................................ 3 
2.1 
Study Rationale .................................................................................................................................... 3 
2.2 
Background........................................................................................................................................... 3 
2.3 
Risk/Benefit Assessment .................................................................................................................... 3 
2.3.1 
Known Potential Risks ..................................................................................................... 3 
2.3.2 
Known Potential Benefits ................................................................................................ 4 
3 
STUDY DESIGN ............................................................................................................................................. 4 
3.1 
Overall Design ...................................................................................................................................... 4 
3.2 
End of Study Definition ....................................................................................................................... 5 
4 
STUDY POPULATION .................................................................................................................................. 5 
4.1 
Inclusion Criteria .................................................................................................................................. 5 
4.2 
Exclusion Criteria ................................................................................................................................. 5 
4.3 
Screen Failures .................................................................................................................................... 5 
4.4 
Strategies for Recruitment and Retention ........................................................................................ 5 
5 
STUDY INTERVENTION .............................................................................................................................. 6 
5.1 
Study Intervention(s) Administration ................................................................................................. 6 
5.1.1 
Study Intervention Description ....................................................................................... 6 
5.1.2 
Dosing and Administration .............................................................................................. 7 
5.2 
Measures to Minimize Bias: Randomization ..................................... Error! Bookmark not defined. 
5.3 
Study Intervention Compliance .......................................................................................................... 7 
5.4 
Concomitant Therapy .......................................................................................................................... 7 
6 
STUDY INTERVENTION DISCONTINUATION AND SUBJECT 
DISCONTINUATION/WITHDRAWAL ...................................................................................................................... 7 
6.1 
Discontinuation of Study Intervention ............................................................................................... 7 
6.2 
Subject Discontinuation/Withdrawal from the Study ....................................................................... 7 
6.3 
Lost to Follow-Up ................................................................................................................................. 8 
7 
STUDY ASSESSMENTS AND PROCEDURES ....................................................................................... 8 
7.1 
STUDY Assessments .......................................................................................................................... 8 
7.2 
Adverse Events and Serious Adverse Events ................................................................................. 9 
7.2.1 
Definition of Adverse Events (AE) ................................................................................. 9 
7.2.2 
Definition of Serious Adverse Events (SAE) ................................................................ 9 
7.2.3 
Classification of an Adverse Event ................................................................................ 9 
7.2.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 10 
7.2.5 
Adverse and serious adverse Event Reporting ......................................................... 10 
7.3 
Unanticipated Problems .................................................................................................................... 11 
7.3.1 
Definition of Unanticipated Problems (UP) ................................................................. 11 
7.3.2 
Unanticipated Problem Reporting ................................................................................ 11 
8 
STATISTICAL CONSIDERATIONS .......................................................................................................... 11 
8.1 
Statistical Hypotheses ....................................................................................................................... 12 
8.2 
Sample Size Determination .............................................................................................................. 12 
8.3 
Statistical Analyses............................................................................................................................ 12 
8.3.1 
General Approach .......................................................................................................... 12 

  
8.3.2 
Analysis of the Primary Efficacy Endpoint(s) ............................................................. 12 
8.3.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 13 
8.3.4 
Safety Analyses .............................................................................................................. 13 
8.3.5 
Baseline Descriptive Statistics ..................................................................................... 13 
9 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 13 
9.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 13 
9.1.1 
Informed Consent Process ........................................................................................... 13 
9.1.2 
Study Discontinuation and Closure ............................................................................. 14 
9.1.3 
Confidentiality and Privacy ........................................................................................... 14 
9.1.4 
Quality Assurance and Quality Control ....................................................................... 14 
9.1.5 
Data Handling and Record Keeping ............................................................................ 15 
9.1.6 
Protocol Deviations ........................................................................................................ 15 
9.1.7 
Conflict of Interest Policy .............................................................................................. 15 
9.2 
Abbreviations ...................................................................................................................................... 17 
10 
REFERENCES ............................................................................................................................................. 18 
 

<Pilot Study of Mindfulness-Based Diabetes Education> 
Version 1.0 
 
<10/30/2022> 
 
 
1 
STATEMENT OF COMPLIANCE 
The trial will be conducted in accordance with International Conference on Harmonisation Good Clinical 
Practice (ICH GCP) and applicable United States (US) Code of Federal Regulations (CFR). The Principal 
Investigator will assure that no deviation from, or changes to, the protocol will take place without prior 
documented approval from the Institutional Review Board (IRB), except where necessary to eliminate an 
immediate hazard(s) to the trial subjects. All personnel involved in the conduct of this study have 
completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all subject materials will be 
submitted to the local Institutional Review Board (IRB) for review and approval. Approval of both the 
protocol and the consent form must be obtained before any subject is enrolled. Any amendment to the 
protocol will require review and approval by the IRB before the changes are implemented to the study. 
All changes to the consent form will be IRB approved; a determination will be made regarding whether a 
new consent needs to be obtained from subjects who provided consent, using a previously approved 
consent form. 
 
1 
 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
Title: 
Intervention mapping to adapt a mindfulness-based intervention for adults 
with diabetes and emotional distress 
 
Study Description: 
This study will pilot test the content of a Mindfulness-Based Diabetes 
Education program with adults who have type 2. The program integrates 
two evidence-based interventions – Mindfulness-Based Stress Reduction 
and Diabetes Self-Management Education. This pilot study will assess the 
acceptability, feasibility, and preliminary efficacy of the intervention. 
Participants’ input will be used to adapt and improve the program to best 
fit the target study population.. This study will enroll up to 30 participants 
by the University of Alabama at Birmingham in conjunction with Cooper 
Green Mercy Healthcare Services Authority. 
 
Objectives: 
 
To pilot test an integrated Mindfulness-Based Stress Reduction/Diabetes 
Self-Management Education intervention in a small group of participants 
to assess acceptability and feasibility. 
 
Endpoints: 
Feasibility, Acceptability, Preliminary Efficacy 
Study Population: 
Adults with type 2 diabetes  
Phase: 
Single Arm Pilot Study  
Description of Study 
Intervention: 
This is a new program that combines Mindfulness-Based Stress Reduction 
and Diabetes Self-Management Education. If you enter and complete this 
study, you will be in this study for a total of 2 months. The Mindfulness-
Based Diabetes Education program will be held weekly, in-person, in a 
group setting. Over 2 months, you will have eight weekly sessions for the 
program with a trained facilitator and other study participants. You will 

<Pilot Study of Mindfulness-Based Diabetes Education> 
Version 1.0 
 
<10/30/2022> 
 
 
2 
receive a schedule at the beginning of the program with the sessions 
outlined. The group sessions will occur every week. Approximately 5-10 
participants will be assigned to each group. 
 
Study Duration: 
12 months 
Subject Duration: 
2 months 
 
 
1.2 
SCHEDULE OF ACTIVITIES (SOA) 
 
Activity 
Activity Schedule 
Mindfulness-Based Diabetes 
Education program sessions  
Weeks 1 to 8: meet weekly 
Study assessment visits – 2 
1. Enrollment assessment visit 
2. 8-week assessment visit 
Focus Group – 1 
1. Focus group 

<Pilot Study of Mindfulness-Based Diabetes Education> 
Version 1.0 
 
<10/30/2022> 
 
 
3 
INTRODUCTION 
 
1.3 
STUDY RATIONALE  
 
In this study, we will pilot an intervention (integrated mindfulness-based stress reduction and diabetes 
self-management education) in a small group of participants to assess acceptability, feasibility, and 
preliminary efficacy. 
 
1.4 
BACKGROUND  
 
Type 2 diabetes is a chronic disease that is especially common in the Southeastern United States, 
affecting 14% of adults in Alabama. Low-income and racial/ethnic minority adults are disproportionately 
affected by type 2 diabetes. Managing type 2 diabetes requires patients to eat a healthy diet, exercise 
regularly, take all medications as prescribed, and monitor their blood sugar, which can be challenging for 
many patients.  
 
Patients with type 2 diabetes who have elevated diabetes distress are less likely to follow the 
recommended treatment or to have well-controlled diabetes. Although some existing treatments help 
to improve distress, these treatments do not consistently improve diabetes self-management or 
outcomes. Information about how other psychosocial factors is associated with diabetes distress is 
limited. Additionally, the temporal relationship between diabetes distress and diabetes self-
management behaviors has not been clearly elucidated. A better understanding of how diabetes distress 
is associated with other psychosocial factors and diabetes self-management behaviors will allow for the 
development of more effective interventions.  
 
We applied a systematic method to develop an intervention which integrates components of 
mindfulness-based stress reduction and diabetes self-management education. In this study, we will pilot 
test this intervention in a small group of participants to assess acceptability and feasibility. 
 
1.5 
RISK/BENEFIT ASSESSMENT   
 
1.5.1 KNOWN POTENTIAL RISKS  
 
All participants will be treated according to the highest ethical standards. No participant will experience 
a reduction in medical, or any other type of needed service (e.g., social or clinical) that are currently 
available to him/her. Participation may involve completing a questionnaire, semi-structured interviews, 
or participating in the pilot study intervention (Mindfulness-Based Diabetes Education). Semi-structured 
interviews and focus groups will be audio-recorded, but no unique identifiers will be used in the 
collection of their responses. No significant risks are anticipated with this portion of the research plan 
than otherwise experienced in day-to-day living. The participants may experience some discomfort in 
talking about personal health issues, emotional distress, or diabetes management.  
 
Breach of Confidentiality. The main potential risk of this study is breach of confidentiality. This is one of 
the most common risks of participation in clinical research. Accordingly, our team has designed a 
strategy to protect participant confidentiality. All participants will be informed of study procedures and 
gauged for understanding of study tasks. In addition, study personnel will follow regulatory guidelines 

<Pilot Study of Mindfulness-Based Diabetes Education> 
Version 1.0 
 
<10/30/2022> 
 
 
4 
for obtaining informed consent. All interviews and intervention activities will be conducted in a private 
space. For all participants, research data will be stored using a unique participant identification code 
(sequence number based on entry to the study) instead of names or other personal identifiers. Consent 
forms with links to participant study numbers will be kept in a locked file cabinet in a locked office with 
the PI (Dr. Presley) or research assistant. According to UAB regulatory policy, records relating to 
research, including informed consent documents, shall be securely retained for one year after 
completion of the research. All records shall be accessible for inspection and copying by authorized 
representatives of the department or sponsor agency at reasonable times and in a reasonable manner. 
All electronic study data are kept on UAB secure encrypted password protected servers, and will only be 
available to research personnel for this project. All study personnel will complete HIPAA and human 
subjects training in accordance with UAB Institutional Review Board policy. 
 
Emotional Distress. Participants will complete the 17-item DDS measure after informed consent is 
obtained, which will be scored by study personnel to determine eligibility. Additionally, measures of 
emotional distress will be assessed at baseline and 2-month follow-up for intervention participants. The 
measures assess the level of diabetes distress and depressive symptoms that a participant is 
experiencing, these are not diagnostic tests. Our study measures will not ask about suicidality. 
Participants may experience emotional distress related to participating in the intervention, due to the 
focus on emotional distress. Participants will be informed that they may stop participation at any time if 
they feel uncomfortable. Additionally, if a participant appears to be in emotional distress, study staff will 
inquire as to the participant’s well-being and whether they wish to stop the study visit or session. 
Participants who disclose potentially harmful information (e.g., suicidality) will be immediately referred 
for an assessment by behavioral health at CGMHSA. All participants will be provided with a letter 
outlining services that details information on available mental health services at CGMHSA and low-cost 
resources available in Jefferson County. 
Inconvenience. Participating in the study may inconvenience patients because of the time needed to 
collect data and participate in the intervention sessions. 
 
Alternative Treatments and Procedures: All study participants, including those in the single-arm pilot 
intervention, will have full access to all available standard of care clinical services at CGMHSA, and are 
permitted to withdraw or refuse participation at any time. 
 
1.5.2 KNOWN POTENTIAL BENEFITS  
 
Participants may or may not benefit from the study. For participants in the pilot intervention, benefits 
may include improvement in emotional distress, diabetes self-management behaviors, and glycemic 
control. Risks to participants are related primarily to breach of confidentiality and emotional distress. As 
the risk to individual participants is small and potential benefits are significant, the risk/benefit ratio is 
favorable. 
 
2 
STUDY DESIGN  
 
2.1 
OVERALL DESIGN 
  
This is a single-arm pilot study of Mindfulness-Based Diabetes Education (an integrated mindfulness-
based stress reduction and diabetes self-management education intervention) in adults with type 2 
diabetes who receive care at a safety-net healthcare system. Participants will complete baseline and 2-

<Pilot Study of Mindfulness-Based Diabetes Education> 
Version 1.0 
 
<10/30/2022> 
 
 
5 
month assessments, as well as a focus group after study completion. Program will be delivered over 8-
weekly group educational sessions, in-person with 5-10 participants per group.  
 
2.2 
END OF STUDY DEFINITION 
 
Date of final visit for participant follow up assessment. 
 
3 
STUDY POPULATION 
 
3.1 
INCLUSION CRITERIA 
 
Inclusion criteria:  
• 
age 19-64 years 
• 
diagnosis of type 2 diabetes 
• 
receipt of care at CGMHSA (one or more visits to primary care or diabetes clinic within the 
prior year) 
 
3.2 
EXCLUSION CRITERIA 
 
Exclusion criteria: 
• 
non-English speaking 
• 
currently pregnant 
• 
personal history or prior diagnosis of bipolar disorder, schizophrenia, or psychosis 
 
3.3 
SCREEN FAILURES 
 <Insert text> 
 
3.4 
STRATEGIES FOR RECRUITMENT AND RETENTION 
 
Study participants will be recruited from Cooper Green Mercy Health System Authority (CGMHSA). At 
CGMHSA, a report of patients who have been referred to diabetes education from 2017-2020 was 
generated to identify potential study participants. Letters will be mailed to participants (letters 
included), followed by a phone call to inform them of the study (phone script included), conduct 
screening listed below, and if participants are interested to schedule a study visit.  
 
Additionally, potential participants may be identified through screening in the CGMHSA diabetes clinic 
or primary care clinic. CGMHSA clinicians will provide contact information (names, phone numbers) for 
potential participants seen in diabetes or primary care clinics who agree to be contacted about the 
study. Similar to the process described above, study personnel will call potential participants by phone 
to inform them of the study (phone scripts included), conduct screening listed below, and if participants 
are interested to schedule a study visit. 
 
Study PI will inform CGMHSA primary care providers of the study and eligibility criteria (providing a 
study recruitment flyer); primary care providers will be asked to have any interested potential 
participants to contact study personnel at the number listed on the flyer.   

<Pilot Study of Mindfulness-Based Diabetes Education> 
Version 1.0 
 
<10/30/2022> 
 
 
6 
If participants contact study personnel after seeing a study flyer or after learning of the study from their 
primary care provider, study staff will speak to potential participants by phone (upon call from potential 
participant or by returning a phone call to the potential participant), provide additional information 
about the study, conduct screening listed below, and if participants are interested to schedule a study 
visit. During the recruitment phone call, study staff will explain the research project. 
 
4 
STUDY INTERVENTION 
 
4.1 
STUDY INTERVENTION(S) ADMINISTRATION 
 
4.1.1 STUDY INTERVENTION DESCRIPTION 
 
We will recruit up to 30 participants to complete the pilot intervention, in groups of 5-10 participants. 
The program will be delivered in 8 weekly sessions of 1.5 to 2 hours duration each, for a total duration 
of 2 months. The pilot intervention will be delivered by study PI, Dr. Caroline Presley, who is an Internal 
Medicine-Pediatrics trained physician with training in delivery of mindfulness-based interventions. We 
have included the intervention manual with this amendment/revision. Program sessions will be 
recorded solely for the purposes of assessing fidelity to intervention content. Any identifying 
information will be removed from transcripts. The  following table provides overview of session content 
with full details in the manual. 
 
Table: Mindfulness-Based Diabetes Education Sessions and Content 
Session 
Session Content 
1 
• 
Introduction to mindfulness; body scan meditation 
• 
Introduction to behavior change and diabetes 
2 
• 
Role of perception, stress responses and reactivity; breath awareness meditation 
• 
Healthy eating module with mindful eating of healthy snack w/reflection on thoughts, emotions, 
physical sensations 
• 
Pleasant events calendar w/focus on events related to diabetes self-management 
3 
• 
Exploration of mind-body connections 
• 
Physical activity (PA) module, mindful walking with attention to thoughts, emotions, physical 
sensations related to PA  
• 
Unpleasant events calendar w/focus on events related to diabetes self-management 
4 
• 
Mindfulness as means to reduce negative effects of stress, mindful yoga 
• 
Healthy eating module 
• 
SMART goal setting focused on diabetes self-management 
5 
• 
Exploration of coping mechanisms, capacity for mindful responding; breath awareness meditation 
• 
Self-monitoring blood glucose module  
• 
SMART goal setting focused on diabetes self-management 
6 
• 
Integration of mindfulness into daily life; breath awareness meditation 
• 
Medication taking module  
• 
SMART goal setting focused on diabetes self-management 

<Pilot Study of Mindfulness-Based Diabetes Education> 
Version 1.0 
 
<10/30/2022> 
 
 
7 
7 
• 
Mindfulness and interpersonal communication; mindful walking 
• 
Problem solving module 
• 
SMART goal setting focused on diabetes self-management 
8 
• 
Focus on continued formal and informal practice; guided reflection 
• 
Framework for mindfulness and influence on diabetes  
 
4.1.2 DOSING AND ADMINISTRATION 
 
The program will be delivered in a group setting for 8 weekly sessions of 1.5 to 2 hours duration each, 
for a total duration of 2 months. 
 
4.2 
STUDY INTERVENTION COMPLIANCE 
 
<Insert text> 
 
4.3 
CONCOMITANT THERAPY 
 
No changes to participants’ medication regimen will be made during the study. Participants will be 
instructed to continue taking medications prescribed by their healthcare provider. Additionally, 
participants who are engaged in mental health treatment, including psychotherapy, will be able to 
continue this treatment unchanged during their participation in this study. 
 
 
5 
STUDY INTERVENTION DISCONTINUATION AND SUBJECT 
DISCONTINUATION/WITHDRAWAL 
 
5.1 
DISCONTINUATION OF STUDY INTERVENTION 
 
This study will be stopped prior to its completion if: (1) the intervention is associated with adverse 
effects that call into question the safety of the intervention; (2) difficulty in study recruitment or 
retention will significantly impact the ability to evaluate the study endpoints; (3) any new information 
becomes available during the trial that necessitates stopping the trial; or (4) other situations occur that 
might warrant stopping the trial. 
 
5.2 
SUBJECT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Subjects are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue or withdraw a subject from the study for the following reasons: 
 
• 
Significant study intervention non-compliance  
• 
If any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation 
occurs such that continued participation in the study would not be in the best interest of the 
subject 

<Pilot Study of Mindfulness-Based Diabetes Education> 
Version 1.0 
 
<10/30/2022> 
 
 
8 
Subjects who sign the informed consent form and are randomized but do not receive the study 
intervention may be replaced.  Subjects who sign the informed consent form, and are randomized and 
receive the study intervention, and subsequently withdraw, or are withdrawn or discontinued from the 
study, will not be replaced. 
5.3 
LOST TO FOLLOW-UP 
A subject will be considered lost to follow-up if he or she fails to return for 2 scheduled visits and is 
unable to be contacted by the study site staff.  
 
The following actions must be taken if a subject fails to be available for a required study visit: 
• 
The site will attempt to contact the subject and reschedule the missed visit and counsel the 
subject on the importance of maintaining the assigned visit schedule and ascertain if the subject 
wishes to and/or should continue in the study. 
• 
Before a subject is deemed lost to follow-up, the investigator or designee will make every effort 
to regain contact with the subject (where possible, 3 telephone calls and, if necessary, a certified 
letter to the subject’s last known mailing address or local equivalent methods). These contact 
attempts should be documented in the subject’s medical record or study file.  
• 
Should the subject continue to be unreachable, he or she will be considered to have withdrawn 
from the study with a primary reason of lost to follow-up. 
 
 
6 
STUDY ASSESSMENTS AND PROCEDURES 
 
6.1 
STUDY ASSESSMENTS  
 
Participants will complete assessment at baseline and 2 months. Assessments will include interviewer-
administered measures. Participants will also participate in a focus group for acceptability following 
completion of the intervention. Process measures for feasibility will be tracked throughout the study. 
 
Acceptability, focus groups:  
• 
assessment of intervention content 
• 
perceived positive or negative effects 
• 
appropriateness of intervention duration and frequency 
• 
barriers to engagement, suggestions to improve the intervention 
• 
overall satisfaction  
Feasibility of the intervention using process measures:  
• 
percentage of screened participants who are eligible 
• 
percentage of eligible participants who enroll 
• 
distribution of participants by demographics (age, race, ethnicity, gender) 
• 
number of sessions attended 
• 
participant adherence to study tasks 
• 
overall study retention 
Preliminary efficacy: baseline and 2-month follow-up: 
• 
diabetes distress (Diabetes Distress Scale)  
• 
diabetes self-management behaviors (Adherence to Refills and Medications scale, 
Summary of Diabetes Self-Care Activities) 

<Pilot Study of Mindfulness-Based Diabetes Education> 
Version 1.0 
 
<10/30/2022> 
 
 
9 
• 
glycemic control (A1C test results from electronic medical records) 
 
6.2 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
   
6.2.1 DEFINITION OF ADVERSE EVENTS (AE) 
Adverse event means any untoward medical occurrence associated with the use of an intervention in 
humans, whether or not considered intervention-related (21 CFR 312.32 (a)). 
 
6.2.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)  
An adverse event (AE) is considered “serious” if, in the view of either the investigator or sponsor, it 
results in any of the following outcomes: 
 
• 
Death 
• 
A life-threatening adverse event (of note, the term “life-threatening” refers to an event in which 
the subject was at risk of death at the time of the event, rather than to an event which 
hypothetically might have caused death if it were more severe) 
• 
inpatient hospitalization or prolongation of existing hospitalization 
• 
a persistent or significant incapacity or substantial disruption of the ability to conduct normal 
life functions 
• 
or a congenital anomaly/birth defect. 
 
Important medical events that may not result in death, be life-threatening, or require hospitalization 
may be considered serious when, based upon appropriate medical judgment, they may jeopardize the 
subject and may require medical or surgical intervention to prevent one of the outcomes listed in this 
definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment 
in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient 
hospitalization, or the development of drug dependency or drug abuse. 
 
6.2.3 CLASSIFICATION OF AN ADVERSE EVENT 
6.2.3.1 SEVERITY OF EVENT 
For adverse events (AEs), the following guidelines will be used to describe severity:  
 
• 
Mild – Events require minimal or no treatment and do not interfere with the subject’s daily 
activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a subject’s usual daily activity and may require systemic drug therapy 
or other treatment. Severe events are usually potentially life-threatening or incapacitating.  Of 
note, the term “severe” does not necessarily equate to “serious.” 
 
6.2.3.2 RELATIONSHIP TO STUDY INTERVENTION 
All adverse events (AEs) must have their relationship to study intervention assessed by the clinician who 
examines and evaluates the subject based on temporal relationship and his/her clinical judgment. The 
degree of certainty about causality will be graded using the categories below. In a clinical trial, the study 
product must always be suspect.  

<Pilot Study of Mindfulness-Based Diabetes Education> 
Version 1.0 
 
<10/30/2022> 
 
 
10 
 
• 
Related – The AE is known to occur with the study intervention, there is a reasonable possibility 
that the study intervention caused the AE, or there is a temporal relationship between the study 
intervention and event. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study intervention and the AE. 
• 
Not Related – There is not a reasonable possibility that the administration of the study 
intervention caused the event, there is no temporal relationship between the study intervention 
and event onset, or an alternate etiology has been established. 
 
6.2.3.3 EXPECTEDNESS  
The Principal Investigator will be responsible for determining whether an adverse event (AE) is expected 
or unexpected.  An AE will be considered unexpected if the nature, severity, or frequency of the event is 
not consistent with the risk information previously described for the study intervention. 
6.2.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during study visits and interviews of a study subject presenting for medical care, or 
upon review by a study monitor. 
 
All AEs including local and systemic reactions not meeting the criteria for SAEs will be captured on the 
appropriate case report form (CRF). Information to be collected includes event description, time of 
onset, clinician’s assessment of severity, relationship to study product (assessed only by those with the 
training and authority to make a diagnosis), and time of resolution/stabilization of the event. All AEs 
occurring while on study must be documented appropriately regardless of relationship. All AEs will be 
followed to adequate resolution. 
 
Any medical condition that is present at the time that the subject is screened will be considered as 
baseline and not reported as an AE. However, if the study subject’s condition deteriorates at any time 
during the study, it will be recorded as an AE.  
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. AEs characterized as intermittent require documentation of 
onset and duration of each episode. 
 
The Study Coordinator will record all reportable events with start dates occurring any time after 
informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of 
study participation.  At each study visit, the Study Coordinator will inquire about the occurrence of 
AE/SAEs since the last visit.  Events will be followed for outcome information until resolution or 
stabilization. 
 
6.2.5 ADVERSE AND SERIOUS ADVERSE EVENT REPORTING  
All serious adverse events must be reported to the IRB according to regulatory requirements. The 
Principal Investigator will immediately report to the sponsor any serious adverse event, whether or not 
considered study intervention related, including those listed in the protocol or package insert and must 
include an assessment of whether there is a reasonable possibility that the study intervention caused 
the event. Study endpoints that are serious adverse events (e.g., all-cause mortality) must be reported 
in accordance with the protocol unless there is evidence suggesting a causal relationship between the 

<Pilot Study of Mindfulness-Based Diabetes Education> 
Version 1.0 
 
<10/30/2022> 
 
 
11 
study intervention and the event (e.g., death from anaphylaxis). In that case, the investigator must 
immediately report the event to the sponsor. 
 
All serious adverse events (SAEs) will be followed until satisfactory resolution or until the Principal 
Investigator deems the event to be chronic or the subject is stable. Other supporting documentation of 
the event may be requested and should be provided as soon as possible. 
 
6.3 
UNANTICIPATED PROBLEMS 
 
6.3.1 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 
The Office for Human Research Protections (OHRP) considers unanticipated problems involving risks to 
subjects or others to include, in general, any incident, experience, or outcome that meets all of the 
following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
subject population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
• 
Suggests that the research places subjects or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
 
6.3.2  UNANTICIPATED PROBLEM REPORTING  
The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB). The UP report will include the following information: 
 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project 
number; 
• 
A detailed description of the event, incident, experience, or outcome;  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP;  
• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP. 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline:   
 
• 
UPs that are serious adverse events (SAEs) will be reported to the IRB within 10 working days of 
the investigator becoming aware of the event.  
• 
Any other UP will be reported to the IRB within 10 working days of the investigator becoming 
aware of the problem.  
 
 
7 
STATISTICAL CONSIDERATIONS  
 

<Pilot Study of Mindfulness-Based Diabetes Education> 
Version 1.0 
 
<10/30/2022> 
 
 
12 
7.1 
STATISTICAL HYPOTHESES 
 
• 
Primary Efficacy Endpoint(s):  
 
No formal hypothesis testing given small sample size. 
 
• 
Secondary Efficacy Endpoint(s): 
 
 
7.2 
SAMPLE SIZE DETERMINATION 
 
Sample size considerations: 
Based on recruitment for prior studies at CGMHS conducted by Dr. Cherrington, we anticipate it will be 
feasible to recruit 30 adults to participate in the pilot intervention. We provide a power calculation to 
further justify our sample size. Assuming a standard deviation of 1.8% for the change in HbA1c (from 
baseline to 2-month follow-up), which was obtained from results of a prior intervention study in adults 
with type 2 diabetes recruited from CGMHS, a sample size of 30 participants, a two-sided paired t-test, 
and a significance level of 0.05, we will have 80% power to detect changes in HbA1c (from baseline to 
follow-up) of 1.0% and greater as being statistically significant.62 This calculation was performed using 
nQuery Advisor + nTerim, version 3. 
 
7.3 
STATISTICAL ANALYSES 
 
7.3.1 GENERAL APPROACH 
 
Given our small sample size and the resultant lack of precision of an estimate of effect size, we will not 
estimate efficacy based on outcome measures. In addition, we will not be testing formal statistical 
hypotheses. 
 
7.3.2 ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT(S) 
 
Initial proposed analysis: To estimate effect size of the pilot intervention, we will perform paired t-tests 
to study the change in the primary outcome, A1C, and secondary outcomes, diabetes distress and 
diabetes self-management behaviors, from baseline to post-intervention. Analysis of covariance will be 
used to examine baseline to 2-month changes in primary and secondary outcomes while controlling for 
potential covariates of interest, such as demographics or disease severity. Distributions of continuous 
outcome variables will be examined for normality using box plots, stem and leaf plots, and normal 
probability plots. Variables that are determined to be non-normally distributed will be transformed or 
analyzed using non-parametric tests, such as Wilcoxon signed-rank test. All statistical tests will be two-
sided using a significance level of 0.05. Statistical analysis will be completed using SAS, version 9.4 or 
later. 
 
Analysis plan: We will generate descriptive statistics, including frequency distribution tables for 
categorical variables, as well as means, medians, standard deviations, and interquartile ranges for 
continuous variables, including diabetes distress. 
 

<Pilot Study of Mindfulness-Based Diabetes Education> 
Version 1.0 
 
<10/30/2022> 
 
 
13 
7.3.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 
We will also generate descriptive statistics, including frequency distribution tables for categorical 
variables, as well as means, medians, standard deviations, and interquartile ranges for continuous 
variables, for feasibility measures. 
 
Qualitative methods will be applied to data collected participants related to acceptability. 
 
7.3.4 SAFETY ANALYSES 
 
Descriptive statistics, primarily frequency distribution tables for categorical variables, will be generated 
for any adverse events. 
 
7.3.5 BASELINE DESCRIPTIVE STATISTICS 
 
Descriptive statistics, primarily frequency distribution tables for categorical variables, will be generated 
to characterize participants. We will also generate descriptive statistics, including frequency distribution 
tables for categorical variables, as well as means, medians, standard deviations, and interquartile ranges 
for continuous variables. 
 
8 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
8.1 
REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
8.1.1 INFORMED CONSENT PROCESS 
 
8.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO SUBJECTS 
Consent forms describing in detail the study intervention, study procedures, and risks are given to the 
subject and written documentation of informed consent is required prior to conducting study screening 
procedures. A separate screening consent form will not be used. 
 
8.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the 
study and continues throughout the individual’s study participation. Consent forms will be Institutional 
Review Board (IRB)-approved and the subject will be asked to read and review the document. The 
investigator will explain the research study to the subject and answer any questions that may arise. A 
verbal explanation will be provided in terms suited to the subject’s comprehension of the purposes, 
procedures, and potential risks of the study and of their rights as research subjects.  Subjects will have 
the opportunity to carefully review the written consent form and ask questions prior to signing. The 
subjects should have the opportunity to discuss the study with their family or surrogates or think about 
it prior to agreeing to participate. The subject will sign the informed consent document prior to any 
procedures being done specifically for the study. Subjects must be informed that participation is 
voluntary and that they may withdraw from the study at any time, without prejudice. A copy of the 
informed consent document will be given to the subjects for their records. The informed consent 
process will be conducted and documented in the source document (including the date), and the form 
signed, before the subject undergoes any study-specific procedures. The rights and welfare of the 

<Pilot Study of Mindfulness-Based Diabetes Education> 
Version 1.0 
 
<10/30/2022> 
 
 
14 
subjects will be protected by emphasizing to them that the quality of their medical care will not be 
adversely affected if they decline to participate in this study. 
8.1.2 STUDY DISCONTINUATION AND CLOSURE 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause.  Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party to regulatory authorities.  If the study is prematurely 
terminated or suspended, the Principal Investigator (PI) will promptly inform study subjects and the 
Institutional Review Board (IRB), will provide the reason(s) for the termination or suspension.  Study 
subjects will be contacted, as applicable, and be informed of changes to study visit schedule. 
  
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to subjects 
• 
Demonstration of efficacy that would warrant stopping    
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
 
Study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the IRB. 
 
8.1.3 CONFIDENTIALITY AND PRIVACY  
Subject confidentiality and privacy is strictly held in trust by the participating investigators and their 
staff. Therefore, the study protocol, documentation, data, and all other information generated will be 
held in strict confidence. No information concerning the study or the data will be released to any 
unauthorized third party without prior written approval of the Principal Investigator.  
 
All research activities will be conducted in as private a setting as possible. 
 
Representatives of the Institutional Review Board (IRB) may inspect all documents and records required 
to be maintained by the investigator, including but not limited to, medical records (office, clinic, or 
hospital) and pharmacy records for the subjects in this study.  
 
The study subject’s contact information will be securely stored at each site for internal use during the 
study. At the end of the study, all records will continue to be kept in a secure location for as long a 
period as dictated by the reviewing IRB and/or Institutional policies. 
 
Study subject research data, which is for the purposes of statistical analysis and scientific reporting, will 
be stored at the UAB Division of Preventive Medicine, Medical Towers offices. This will not include the 
subject’s contact or identifying information. Rather, individual subjects and their research data will be 
identified by a unique study identification number. The study data entry and study management 
systems used by research staff will be secured and password protected.  
 
8.1.4 QUALITY ASSURANCE AND QUALITY CONTROL 

<Pilot Study of Mindfulness-Based Diabetes Education> 
Version 1.0 
 
<10/30/2022> 
 
 
15 
The site will perform internal quality management of study conduct, data collection, documentation and 
completion.  Quality control (QC) procedures will be completed by the Data Manager during data entry 
into the appropriate CRF. Any missing data or data anomalies will be communicated to the Study 
Coordinator for clarification/resolution. 
 
Following written Standard Operating Procedures (SOPs), the monitors will verify that the clinical trial is 
conducted and data are generated are collected, documented (recorded), and reported in compliance 
with the protocol, International Conference on Harmonisation Good Clinical Practice (ICH GCP), and 
applicable regulatory requirements.  
 
The site will provide direct access to all trial related sites, source data/documents, and reports for the 
purpose of monitoring and inspection by local and regulatory authorities. 
 
8.1.5 DATA HANDLING AND RECORD KEEPING  
 
8.1.5.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the 
Principal Investigator. The Principal Investigator is responsible for ensuring the accuracy, completeness, 
legibility, and timeliness of the data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation 
of data.   
 
Hard copies of source document worksheets will be used for recording data for each subject enrolled in 
the study.  Data recorded in the case report form (CRF) derived from source documents should be 
consistent with the data recorded on the source documents.  
 
8.1.5.2 STUDY RECORDS RETENTION  
Study documents should be retained for a minimum of 3 years after the completion of the study. These 
documents should be retained for a longer period, however, if required by local regulations.  
 
8.1.6 PROTOCOL DEVIATIONS  
A protocol deviation is any noncompliance with the clinical trial protocol requirements. The 
noncompliance may be either on the part of the subject, the investigator, or the study site staff. As a 
result of deviations, corrective actions are to be developed by the site and implemented promptly.  
 
These practices are consistent with ICH GCP:  
• 
4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3  
• 
5.1 Quality Assurance and Quality Control, section 5.1.1  
• 
5.20 Noncompliance, sections 5.20.1, and 5.20.2.  
 
It is the responsibility of the Principal Investigator to use continuous vigilance to identify and report 
deviations within 10 working days of identification of the protocol deviation.  Protocol deviations must 
be sent to the reviewing Institutional Review Board (IRB) per their policies. The Principal Investigator is 
responsible for knowing and adhering to the reviewing IRB requirements.  
 
8.1.7 CONFLICT OF INTEREST POLICY 

<Pilot Study of Mindfulness-Based Diabetes Education> 
Version 1.0 
 
<10/30/2022> 
 
 
16 
The independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical.  Therefore, any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts managed in a 
way that is appropriate to their participation in the design and conduct of this trial.   
 
 
 

<Pilot Study of Mindfulness-Based Diabetes Education> 
Version 1.0 
 
<10/30/2022> 
 
 
17 
8.2 
ABBREVIATIONS 
 
AE 
Adverse Event 
ANCOVA 
Analysis of Covariance 
CFR 
Code of Federal Regulations 
CONSORT Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
DHHS 
Department of Health and Human Services 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act  
ICH 
International Conference on Harmonisation  
ICMJE 
International Committee of Medical Journal Editors 
IRB 
Institutional Review Board 
LSMEANS 
Least-squares Means 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SOA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 
 
 
 

<Pilot Study of Mindfulness-Based Diabetes Education> 
Version 1.0 
 
<10/30/2022> 
 
 
18 
9 
REFERENCES  
 
 
 

Page 1 of 5
Version Date: 07/26/21
 CONSENT FORM TO BE PART OF A RESEARCH STUDY – PILOT STUDY
Title of Research:
Intervention mapping to adapt a mindfulness-based intervention for adults with 
diabetes and emotional distress
UAB IRB Protocol #:
IRB-300003578
Principal Investigator: Caroline Presley, MD MPH
Sponsor:
UAB Center for Clinical and Translational Science, UAB Diabetes Research Center
General 
Information
You are being asked to take part in a research study. This research study is voluntary, 
meaning you do not have to take part in it. The procedures, risks, and benefits are fully 
described further in the consent form.
Purpose
The purpose of the study is to pilot test the content of a Mindfulness-Based Diabetes 
Education program with adults who have type 2 diabetes in order to get participants’ 
feedback on the program. This information will be used to adapt and improve the 
program based on participants’ input.
Duration & Visits
You will be in this study for up to 2 months. You are being asked to complete 2 study 
visits at enrollment and at 2 months, as well as to attend 1 focus group at 2 months. The 
study visits will last approximately 30-45 minutes, and participants will be asked to 
complete a questionnaire. The focus group will take approximately 60 minutes, and 
participants will be asked for their thoughts and feedback on the program. 
This study will provide a program called Mindfulness-Based Diabetes Education. This is a 
new program that combines a stress management and a diabetes self-management 
education program. It is an 8-week program with weekly meetings in-person, group 
meetings. Sessions will focus on education and strategies to improve diabetes self-
management including healthy eating, physical activity, medication taking, self-
monitoring, and will also include instruction and practice of mindfulness-based exercises 
to reduce stress. 
Overview of 
Procedures
This study will include 2 study visits and a focus group that will be run by a trained 
facilitator to get participants’ feedback on the Mindfulness-Based Diabetes Education 
program. If you are eligible and choose to participate, you will receive Mindfulness-
Based Diabetes Education program.
Risks
The most common risks include breach of confidentiality, inconvenience, or emotional 
distress. You may experience minor pain or discomfort related to study activities; this is a 
minor risk and is reversible.
Benefits
You may or may not benefit from the study. This research may help develop an 
intervention and benefit future patient care.
Alternatives
Your alternative is not to participate in the research.
Purpose of the Research Study
We are asking you to take part in a research study to reduce stress and improve diabetes self-management in 
adults who have type 2 diabetes. Alabama is 3rd for diabetes among all 50 states in the United States which 
means about 14% of people in the state have diabetes. Diabetes distress is common with adults with type 2 
diabetes and impacts diabetes self-management and blood glucose control. Currently, programs that improve 
both diabetes distress and diabetes self-management are lacking.
This study will pilot test the content of a Mindfulness-Based Diabetes Education program with adults who have 
type 2 diabetes in order to get participants’ feedback on the program. The feedback will be used to improve and 
UAB IRB
Approved
01-Aug-2021

Page 2 of 5
Version Date: 07/26/21
adapt the program to best fit the target study population. The program integrates two evidence-based 
interventions – Mindfulness-Based Stress Reduction and Diabetes Self-Management Education. This pilot study 
will assess the acceptability, feasibility, and preliminary efficacy of the intervention. Participants’ input will be 
used to adapt and improve the program. This study will enroll up to 30 participants by the University of Alabama 
at Birmingham in conjunction with Cooper Green Mercy Healthcare Services Authority.
Study Participation & Procedures
You have been screened and are eligible to participate in this research study. Eligibility: To be eligible to 
participate in this study, you need to complete a prescreening questionnaire, be 19 to 64 years of age, and meet 
eligibility requirements. 
To enroll in this study, a questionnaire will be conducted. If you decide to participate in this study, you will 
attend a total of two study assessment visits including today’s visit, as well as a one focus group. The study visits 
will take place at the beginning of the study and at 2 months. These visits will last about 30-45 minutes and take 
place in a private room at Cooper Green Mercy Healthcare Authority or Medical Towers at UAB or may be 
conducted by remotely by telephone or video-conference. Questionnaires include self-reported measures of 
your mood, stress, self-efficacy, social support, diabetes self-management behaviors, treatment 
satisfaction/burden. The following measures will be collected by trained research staff at each study assessment 
visit:
Measure
Description
Questionnaire
Questions about your mood, stress, self-efficacy, social support, diabetes self-
management behaviors, treatment satisfaction/burden
Hemoglobin A1c Result
Study staff will obtain your most recent hemoglobin A1c result from your medical 
record. No other information will be obtained from your medical record.
The focus group will be held at the completion of the 2-month program and run by a trained facilitator. It will 
last approximately 60-minutes and will ask for participants’ feedback on the program.
If you decide to participate, you will be assigned to receive the Mindfulness-Based Diabetes Education program. 
This is a new program that combines Mindfulness-Based Stress Reduction and Diabetes Self-Management 
Education. If you enter and complete this study, you will be in this study for a total of 2 months. The 
Mindfulness-Based Diabetes Education program will be held weekly, in-person, in a group setting. Over 2 
months, you will have eight weekly sessions for the program with a trained facilitator and other study 
participants. You will receive a schedule at the beginning of the program with the sessions outlined. The group 
sessions will occur every week. Approximately 5-10 participants will be assigned to each group.
Group meetings will be held in person in a conference room at Cooper Green or at Medical Towers. Group 
meetings will last about 90 to 120 minutes each. Group sessions will focus on education and discussion about 
mindfulness-based exercises to reduce stress, as well as modules focused on healthy eating, physical activity, 
medication taking, self-monitoring to improve diabetes management. A trained interventionist will deliver each 
session. If you agree to join the study, the study will not make any changes to your medications.
Activity
Activity Schedule
Mindfulness-Based Diabetes 
Education program sessions 
Weeks 1 to 8: meet weekly
1. Enrollment assessment visit
Study assessment visits – 2
2. 8-week assessment visit
Focus Group – 1
1. Focus group
Risks and Discomforts
The risks for this study are low. You will be assigned to the Mindfulness-Based Diabetes Education program, as 
this is a pilot study testing a new intervention. This program may prove to be less effective or to have more side 

Page 3 of 5
Version Date: 07/26/21
effects than alternatives.  If you enter this study, you will be asked to attend group meetings that focus on skills 
you need to reduce stress and improve your diabetes self-management. Risks include discomfort, a loss of 
confidentiality, minor pain, and inconvenience. You may feel some discomfort in talking about personal health 
issues, emotional distress, or diabetes management. You will only be asked to discuss what you feel comfortable 
sharing and you may choose not to share. Study staff will explain to all participants that what is said in group 
meetings is confidential. However, a risk for entering this program is loss of confidentiality. This risk is very 
small, as study staff follow rules to make sure your information is shared only with people who are supposed to 
have it. We take precautions to minimize the risk of loss of confidentiality including storing study information 
with a code only, there is no participant’s name or other identifying information. Access to study information 
will be restricted to study personnel. Study information will be stored electronically on a secure, encrypted, 
password protected server. Program sessions will be audio-recorded to assess fidelity of the program; names or 
other identifying information will be removed from the transcripts and only study staff will have access to these.
You will be encouraged to make changes to your habits around your diabetes self-management (including 
healthy eating, physical activity, self-monitoring, medication taking) as well as to practice mindfulness exercises 
to reduce stress. You may feel tired or hungry when you first make these changes, but this is usually mild and 
often gets better with time. This study will include gentle, non-strenuous physical activity including walking and 
gentle yoga. Participants will be offered modifications based on their physical abilities. You could hurt yourself 
when exercising, such as spraining your ankle. On rare occasions, increased exercise can cause chest pain and 
undue shortness of breath. This is not common, and you will only be asked to make changes that are 
comfortable for you. Over 2-months, you will be asked to attend 2 study assessment visits, 8 group meetings, 
and 1 focus group. These study activities may be inconvenient and take time from your day-to-day activities. You 
will be assigned to the study program, which may prove to be less effective than alternatives.
Benefits
If you participate, you may experience reduced stress and improved diabetes self-management. Improved 
diabetes distress and diabetes self-management behaviors have benefits for diabetes outcomes and reduced 
risks of complications due to diabetes.
Alternatives
The alternative to study participation is that you may choose not to take part at all. There are other available 
diabetes self-management education programs that are not associated with this research study. You may 
discuss these alternative treatment options with your primary care provider.
Confidentiality and Authorization to Use and Disclose Information for Research Purposes
Federal regulations give you certain rights related to your health information. These include the right to know 
who will be able to get the information and why they may be able to get it. The study doctor must get your 
authorization (permission) to use or give out any health information that might identify you.
What protected health information may be used and/or given to others?
All medical information, including but not limited to information and/or records of any diagnosis or treatment of 
disease or condition, which may include sexually transmitted diseases (e.g., HIV, etc.) or communicable diseases, 
drug/alcohol dependency, etc.; all personal identifiers, including but not limited to your name, social security 
number, medical record number, date of birth, dates of service, etc.; any past, present, and future history, 
examinations, laboratory results, imaging studies and reports and treatments of any kind, including but not 
limited to drug/alcohol treatment, psychiatric/psychological treatment; financial/billing information, including 
but not limited to copies of your medical bills; any other information related to or collected for use in the 
research study, regardless of whether the information was collected for research or non-research (e.g., 
treatment) purposes; records about any study drug you received or about study devices used; and consent 
forms from past studies that might be in your medical record.

Page 4 of 5
Version Date: 07/26/21
Who may use and give out information about you?
Information about your health may be used and given to others by Dr. Caroline Presley, the study doctor, and 
study staff. They might see the research information during and after the study.
Who might get this information?
All Individuals/entities listed in the informed consent document(s), including but not limited to, the physicians, 
nurses and staff and others performing services related to the research (whether at UAB or elsewhere). Your 
information may also be given to the sponsor of this research. “Sponsor” includes any persons or companies 
that are working for or with the sponsor, or are owned by the sponsor, or are providing support to the sponsor 
(e.g., contract research organization).
Information about you and your health which might identify you may be given to:

the Office for Human Research Protections (OHRP)

the U.S. Food and Drug Administration (FDA)

the UAB Diabetes Research Center, a sponsor of this research

National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK), a sponsor of this research

the University of Alabama at Birmingham - the physicians and staff working on the research study 
(whether at UAB or elsewhere); the UAB IRB and its staff
Why will this information be used and/or given to others?
Information about you and your health that might identify you may be given to others to carry out the research 
study. The sponsor will analyze and evaluate the results of the study. In addition, people from the sponsor and 
its consultants will be visiting the research site. They will follow how the study is done, and they will be 
reviewing your information for this purpose.
What if I decide not to give permission to use and give out my health information?
By signing this consent form, you are giving permission to use and give out the health information listed above 
for the purposes described above. If you refuse to give permission, you will not be able to be in this research.
May I review or copy the information obtained from me or created about me?
You have the right to review and copy your health information. However, if you decide to be in this study and 
sign this permission form, you will not be allowed to look at or copy your information until after the research is 
completed.
May I withdraw or revoke (cancel) my permission?
Yes, but this permission will not stop automatically. The use of your personal health information will continue 
until you cancel your permission.
You may withdraw or take away your permission to use and disclose your health information at any time. You do 
this by sending written notice to the study doctor. If you withdraw your permission, you will not be able to 
continue being in this study.
When you withdraw your permission, no new health information which might identify you will be gathered after 
that date. Information that has already been gathered may still be used and given to others. This would be done 
if it were necessary for the research to be reliable.
Is my health information protected after it has been given to others?
If you give permission to give your identifiable health information to a person or business, the information may 
no longer be protected. There is a risk that your information will be released to others. Including others outside 
of UAB, without your permission.

Page 5 of 5
Version Date: 07/26/21
Voluntary Participation and Withdrawal
Whether or not you take part in this study is your choice. There will be no penalty if you decide not to be in it. If 
you decide not to be in the study, you will not lose any benefits you are otherwise owed.
You are free to withdraw from this study at any time. Your choice to leave the study will not affect your 
relationship with this institution. Contact the study personnel if you want to withdraw from the study.
Cost of Participation
There will be no cost to you for taking part in the Mindfulness-Based Diabetes Education program and the study. 
The program and visits related to this study will be provided to you at no cost during the 2-month study period. 
Payment for Participation
You will be paid $25 for the completion of the initial study assessment including a questionnaire. You will be 
paid $25 after completing the 2-month visit and $15 for the focus group at the end of the program. The total 
payment you may receive is $65. If you do not finish the entire study, you will only be paid for visits completed 
up to the time you decide to stop taking part in the study. Ask the study staff about the method of payment that 
will be used for this study (e.g., check, cash, gift card, direct deposit). 
Payment for Research-Related Injuries
UAB, UAB Center for Clinical and Translational Science, and UAB Diabetes Research Center have not provided for 
any payment if you are harmed as a result of taking part in this study. If such harm occurs, treatment will be 
provided. However, this treatment will not be provided free of charge.
Significant New Findings
You will be told by the study doctor or the study staff if new information becomes available that might affect 
your choice to stay in the study.
Questions
If you have any questions, concerns, or complaints about the research or a research-related injury including 
available treatments, please contact the study doctor. You may contact Dr. Caroline Presley at 205-934-7609.
If you have questions about your rights as a research participant, or concerns or complaints about the research, 
you may contact the UAB Office of the IRB (OIRB) at (205) 934-3789 or toll free at 1-855-860-3789. Regular 
hours for the OIRB are 8:00 a.m. to 5:00 p.m. CT, Monday through Friday.
Legal Rights
You are not waiving any of your legal rights by signing this consent form.
Signatures
Your signature below indicates that you have read (or been read) the information provided above and agree to 
participate in this study. You will receive a copy of this signed consent form.
 
Signature of Participant
Date
Signature of Person Obtaining Consent
Date