A Mindfulness-based Intervention for Adolescents With Prediabetes or Type 2 Diabetes
Phase: NA
Conditions: Type 2 Diabetes, Prediabetes
Sponsor: Indiana University

A mindfulness-based intervention for adolescents with prediabetes or 
type 2 diabetes 
NCI:  N/A 
Date:  10/31/2025 
 

A mindfulness-based intervention for adolescents with prediabetes or 
type 2 diabetes 
IRB Protocol # 21496 
 
Tamara S. Hannon, MD 
Professor of Pediatrics 
Section of Pediatric Endocrinology 
Indiana University School of Medicine 
Phone: 317-278-5608 
Email: tshannon@iu.edu 
 
Table of Contents: 
Study Schema 
1.0 
Background and Rationale 
2.0 
Specific Aims 
3.0 
Inclusion/Exclusion Criteria 
4.0 
Enrollment/Randomization 
5.0 
Study Procedures 
6.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk to Participants or 
Others 
7.0 
Study Withdrawal/Discontinuation 
8.0 
Statistical Considerations 
9.0 
Privacy/Confidentiality Issues 
10.0 
Follow-up and Record Retention 
11.0 
Data Safety Monitoring Plan 
 
 

Abbreviations 
BMI 
Body mass index 
CBT 
Cognitive behavioral therapy 
HbA1c 
Glycemic control 
L2B 
Learning 2 Breathe 
MBI 
Mindfulness-based intervention 
T2D 
Type 2 diabetes 
 
1.0 
Background and Rationale 
The obesity epidemic is associated with an increase in youth-onset type 2 diabetes (T2D), 1 as well as its 
precursor condition, prediabetes. 2 Approximately, 20% of youth, ages 12-18 years old, have 
prediabetes. 3,4 If prediabetes progresses to T2D, glycemic control is often more difficult to achieve in 
youth as compared to adults. 3,4 Poor glycemic control is associated with diabetes-related complications 
and decreased life expectancy. 3,5 This is especially troubling as obesity and T2D disproportionately affect 
youth from marginalized and minority race/ethnicity backgrounds who often face additional stressors 
and barriers to diabetes care. 6-8 Effective patient-centered, holistic treatments are needed for youth 
with prediabetes or T2D. 7,9  
Mindfulness-based interventions (MBI) may offer additional benefits to traditional health care for youth 
living with prediabetes or T2D. Mindfulness refers to non-judgmental, focused attention on the present 
moment. 10 MBIs teach skills to increase present moment attention and adopt a nonjudgmental attitude 
towards one’s experience which can foster healthy stress coping behaviors and greater self-regulation; 
11 both of which are associated with improved diabetes self-care behaviors. 12,13 MBIs were introduced to 
the clinical population in the 1970’s and have been translated for a variety of populations and health 
conditions including diabetes.  
A systematic review and meta-analysis of eight RCTs investigated the effect of MBIs on glycemic control 
(HbA1c) and psychological outcomes (depression, stress, diabetes-related distress, anxiety) in adults 
with diabetes. 14 The authors found that MBIs had a moderate effect size on decreasing depression and 
stress, and changes were greatest in individuals with higher baseline psychological symptoms. 14 MBIs 
were associated with small reductions in HbA1c and diabetes-related distress, but MBIs did not have a 
consistent effect on anxiety. 14 A longer follow up time (>6 months post baseline) was associated with 
greater improvements in HbA1c. 14 
Few studies have examined the role of MBIs in adolescents for diabetes prevention and management. 
Ellis et. al. (2019) conducted a RCT to evaluate the efficacy of a MBI in urban adolescents with poorly 
controlled type 1 diabetes. Adolescents with a high stress reactivity score at baseline in the MBI group 
experienced the greatest decreases in HbA1c at 6 months (0.70%) compared to those in the cognitive 
behavioral therapy (CBT) group (0.35%) and diabetes support group (0.53%).15 For adolescents with 
elevated levels of stress, MBI may be beneficial for improving glycemic control. 15 
A RCT compared the effectiveness of a six-week MBI vs a CBT group on depression and insulin resistance 
in adolescent girls with risk factors for T2D. 16 Depressive symptoms, perceived stress, insulin resistance, 
and adiposity were measured at baseline, post-intervention, and 6 months. 16 Adolescents in the MBI 
group had greater decreases in depressive symptoms compared to CBT group at post-treatment and 6 
months. 16 The MBI group also had improvements in insulin resistance compared to the CBT group, after 
controlling for adiposity. 16  

MBIs may be a promising complementary approach for T2D prevention and treatment in youth, and 
thus, warrant further investigation.   
2.0 
Specific Aims 
We propose a MBI for adolescents with prediabetes or T2D.  Specific aims of this proposal include: 
Aim 1: Pilot test the feasibility and acceptability of a mindfulness-based intervention in adolescents 
with prediabetes or type 2 diabetes. 
Aim 2: Explore secondary physical and mental health outcomes of the study cohorts. 
Primary outcomes will assess participant adherence to the study protocol and satisfaction with the 
intervention.  Secondary outcomes will preliminarily assess the effect of the intervention on clinical care 
measures (e.g., HbA1c, BMI) and patient-centered outcomes including quality of life.  We will identify 
factors that support or interfere with the uptake and sustained use of the intervention in the diabetes 
care context to assist in future multi-site, pragmatic, or implementation science trials.  We hypothesize 
that offering mindfulness-based skills will result in improved outcomes and thus would lead to change in 
clinical practice to incorporate such teachings.   
3.0 
Inclusion/Exclusion Criteria 
Adolescents between the ages of 12-18 years old who are referred for treatment of prediabetes or T2D 
are eligible for this study. Participants will have normal cognition and will be English speaking as the 
group is offered in English. Adolescents are not eligible to participate if they have diagnosed cognitive 
disability that would prevent participation in a group or if they are unable to attend the MBI group 
sessions. 
Criteria for inclusion: 
• 
Age 12-18 years 
• 
Referred to clinic for treatment of prediabetes or type 2 diabetes  
• 
English speaking 
Criteria for exclusion: 
• 
Diagnosed cognitive disabilities 
• 
Inability to attend visits due to individual schedules 
 
4.0 
Enrollment 
We aim to recruit 50 individuals with the goal of at least 20 participants to complete the study (two 
groups of 10 participants).   
Recruitment Sites: Diabetes care providers see patients in an outpatient setting at Riley Specialty Care at 
IU Health Methodist in Indianapolis, Indiana.  Additional outreach clinics available for participant 
recruitment include Riley Specialty Care at Riley Outpatient Center, IU North, Bloomington, Fort Wayne, 
and South Bend.   
Recruitment Procedures: Eligible patients will be recruited in one of the following ways: 1) health care 
providers will identify eligible adolescents during clinic visits, 2) a letter will be mailed to patients 
referred for prediabetes or type 2 diabetes who have been seen in one of our clinics within the last 12 
months, or 3) a member of the research team will call eligible patients.  The letter and phone call scripts 
are provided in separate documents.   

Consent Procedures: When a family indicates interest, a member of the research team will initiate 
contact with the parent or guardian at the end of a clinic visit (if time allows) or by phone.  The team 
member will describe the study, assess eligibility, and answer questions.  If the adolescent (and 
guardian) is willing to participate in the study, the consent process and baseline questionnaires will be 
completed virtually.  The consent process will be based in REDCap. If a family declines participation, they 
will be asked if they would like to complete the study declination form. This will help to understand 
reason for disinterest in a MBI.  
5.0 
Study Procedures 
Following enrollment, participants will complete baseline surveys and begin attending the 12-week MBI. 
Participants will complete surveys following completion of the MBI and at the 12-month follow up. 
Participants will receive compensation for completing surveys and attending the MBI. 
Data Collection 
Process Measures: Intervention fidelity will be assessed with a checklist of session content to ensure 
that the facilitator is delivering the intervention as intended. Facilitators will follow the manualized 
curriculum and scripts for mindfulness skills practice. 
Feasibility and Acceptability Measures: Feasibility and acceptability measures include study 
participation rate, time to recruit, attendance, study retention rate, study completion rate, data 
completion, and program acceptability. 
Participant Measures: Participants will be emailed a link to complete surveys in REDCap. Surveys will be 
completed at baseline (B), following completion of the MBI at 12-weeks (T1), and at the 12 month follow 
up (T2).  Participants may complete follow-up surveys (12-weeks and 12 months) up to 1 month after 
the designated time point. A guided interview will also be performed at 12-weeks to receive feedback 
about the participants’ experiences in the study. 
Clinical data (HbA1c, BMI, and BMI z-score) will be collected at baseline and at each standard clinical 
prediabetes or diabetes appointment up to 12 months after the intervention. 
Table 1. Study Measures 
Feasibility and Acceptability Measures 
Measure 
Definition 
Study Participation 
Rate 
Number of participants who consented to take part in the study divided by 
the number of patients approached.  We will also document reasons for 
refusal to participate in the study. 
Time to Recruit 
Time required to attain the needed sample for each recruitment wave 
Attendance 
Attendance at each intervention session will be recorded. 
Study Retention Rate 
Number of participants in a study arm who remain in the study and 
maintain communication with study staff (regardless of session attendance) 
divided by the number of participants enrolled in the study. 
Study Completion Rate 
Number of participants who complete all assessments divided by the 
number of participants enrolled in the study arm. 
Data Completeness 
Percentage of questionnaires/study measures completed. 
Program Acceptability  
Acceptability of the intervention to participants as measured by agreement 
(on a 5-point likert scale) with different satisfaction measures. 
Clinical Measures 

Hemoglobin A1c (HbA1c) 
Body Mass Index (BMI) 
BMI z-score 
*When collecting clinical data from prediabetes or diabetes appointments, research team will 
document any changes to medications that impact glycemia and/or BMI. 
Participant-Centered Measures 
Demographics 
Patient-Reported Outcomes Measurement System Emotional Distress-Depression-Pediatric 
Item Bank (PROMIS) 
Screen for Childhood Anxiety Related Emotional Disorders (SCARED-5) 
Perceived Stress Scale (PSS-10) 
Peds QL Generic Core Scales 
Mindful Attention Awareness Scale (MAAS) – Adolescents 
Difficulties in Emotion Regulation Scale (DERS) 
L2B Program Questionnaires 
Post-study guided interview: 
1. What did you like about participating in this study? 
2. What did you dislike about participating in this study? 
3. What were your expectations from participating in this study? 
4. Were those expectations met? 
 
Intervention: 
The MBI will be conducted in a virtual group setting by Zoom, with a target size of 8-12 participants. 
Groups may vary in size based on session attendance.   
Mindfulness-based intervention. The MBI will follow the Learning to BREATHE (L2B) curriculum. L2B is a 
manualized 12-week curriculum that teaches a variety of mindfulness skills including breath awareness, 
body scanning, mindful eating, sitting meditation, loving kindness practice, and mindful movement. 
Weekly group sessions will last 45-60 minutes. Participants will be invited to engage in daily practice of 
mindfulness skills (home practice).  
Table 2. Learning 2 Breathe Curriculum 
Session  
Mindfulness Theme 
Mindfulness Topic 
Mindfulness Practice 
1 
Listen! Your body is trying to tell 
you something. 
Define mindfulness 
Body scan (short 
version) 
2 
Listen! Your body is trying to tell 
you something. 
Mindfulness vs 
automatic pilot 
Body scan (long version) 
3 
Thoughts are just thoughts. 
What thoughts are like 
A common way to 
handle certain 
thoughts 
Mindfulness of thoughts 
4 
Thoughts are just thoughts. 
How thoughts affect 
us 
Mindfulness of thoughts 

5 
Surf the wave of your emotions. 
Universality of 
emotions 
Emotions and the 
mind-body connection 
Find the feeling (short 
version) 
6 
Surf the wave of your emotions. 
A common way to 
handle certain 
emotions 
Surfing the waves of 
emotions plus gratitude 
7 
Attention to body, thoughts, and 
feelings is good stress 
management. 
Basic concepts about 
stress 
Universality of stress 
Mindful movement 
8 
Attention to body, thoughts, and 
feelings is good stress 
management. 
Effects of chronic 
stress 
Mindful movement 
9 
Learn to be kind to yourself and 
others 
Basic concepts about 
the brain 
Practicing mental 
habits 
Ways we practice 
kindness or meanness 
to ourselves 
Loving kindness 
meditation 
10 
Learn to be kind to yourself and 
others 
Cultivating well-being 
Person just like me 
11 
Habits for a healthy mind. 
Program take-away 
Participant choice 
12 
Habits for a healthy mind. 
Closing Ritual 
Compassion practice 
 
Compensation: 
We will offer $10, $25, and $40 gift cards for the completion of study surveys at baseline (B), the 
completion of the intervention (T1), and 12 months following the intervention (T2), respectively. We will 
offer a $10 gift card per group session for attendance. Participants can earn up to $195 in total. This is 
reasonable because the study encourages the practice of the skills outside of the group sessions. 
Study Personnel Responsibilities and Training: 
Tamara S. Hannon MD is the PI for this study.  Her responsibilities include conceptualizing and designing 
the study, overseeing the recruitment process, supervising data collection and analysis, as well as 
critically reviewing and editing the future manuscript. 
Julie Pike MPH RDN CDCES is the intervention facilitator.  She is a certified diabetes care and education 
specialist as well as a certified facilitator with The Center for Mind-Body Medicine. She completed the 
Learning 2 BREATHE training with L2B developer and clinical psychologist Patricia C. Broderick. Her 

responsibilities include completing the IRB-approval process, recruiting, and consenting participants, 
performing data collection and statistical analysis, and manuscript preparation. 
Kathryn Haberlin-Pittz MPH CHES is the intervention facilitator.  She is a certified health and education 
specialist. She completed the Learning 2 BREATHE training with L2B developer and clinical psychologist 
Patricia C. Broderick. Her responsibilities include completing the IRB-approval process, recruiting, and 
consenting participants, performing data collection, and assisting with further data management needs. 
Luz Machuca CHES will serve as the research coordinator and data manager. She is a certified health and 
education specialist. Her responsibilities include building REDCap data bases, recruiting and consenting 
participants, performing data collection, sending study visit reminders to participants, and assisting with 
further data management needs. 
6.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk to Participants or 
Others 
Adverse events will be monitored by the PI and co-investigators.  As the participants will be receiving 
clinical diabetes care and the intervention does not involve a medical intervention or change in medical 
diabetes therapy, physical adverse events related to the study are not expected.  Potential adverse 
events that could occur include breach of subject confidentiality, loss of privacy in the group setting, 
discomfort with taking the surveys, and discomfort with the mindfulness skills exercises.  Confidentiality 
will be respected and kept secure as described in section 9.0.  Participants will be advised that they do 
not have to take a survey or answer a question if it causes them discomfort.  Participants will be advised 
that they do not have to participate a particular mindfulness exercise if it causes them discomfort.  The 
group covers topics on thoughts and feelings. If a group member discloses suicidal ideation, the 
facilitator will administer the Ask Suicide Risk Screening Questions (ASQ) directly after the group session 
in a one-on one setting to identify the appropriate triage steps. If there is an immediate threat to the 
participant’s safety as indicated by the ASQ, they will be referred to the emergency room for evaluation.  
The research team will report suicide ideation to the participant’s parent or guardian as well as the 
diabetes social worker. Each event will be handled individually.  Adverse events or unanticipated 
problems involving risk to the participants or others will be reported according to IRB standard 
operating procedures.  If the adverse event represents an unanticipated problem and requires changes 
to the research protocol, the informed consent process or document, or other corrective actions to 
protect the safety, welfare, or rights of subjects or others, it will be reported to the IRB using the Prompt 
Reporting Form within five business days of the investigator becoming aware of the event.   
7.0 
Study Withdrawal/Discontinuation 
The research team will terminate the involvement of a given participant in the research study if they 
request to stop participating.  The criteria which would result in removal from the study are if they 
request to withdraw from the study or if there has been no communication with the participant in the 
first two weeks of the study. 
8.0 
Statistical Considerations 
Anticipated statistics for this study will be a combination of descriptive statistics and quantitative 
statistics.  For our primary outcomes, we will examine retention and acceptance, as assessed by overall 
program attendance, program acceptability, and qualitative interviews.  Descriptive statistics will include 
sex, ethnicity, and survey results at B, T1, and T2. 

This study includes a post-intervention group guided interview at 12-weeks. The facilitator will ask the 
group for feedback about the intervention with the following questions: 1) What did you like about 
participating in this study? 2) What did you dislike about participating in this study? 3) What were your 
expectations from participating in this study? 4) Were those expectations met? 
A paired t test will be used to compare variables of an individual at baseline and at the end of the study 
(pre/post), including HbA1c, BMI, BMI z-score, and survey results. 
This is a pilot feasibility study, therefore there are no data currently available to accurately calculate 
power. There are no similar studies to substitute such data. 
9.0 
Privacy/Confidentiality Issues 
Research material obtained from living human subjects will include medical records, with medical 
information collected by the PI/research team during screening and study visits, as well as data collected 
from surveys. 
Data will be stored in IU REDCap, a secure web platform used to support academic research and is 
compliant with local and federal regulations for data security and integrity.  Access to the study data will 
be restricted to study personnel. 
Any paper records containing identifying information will be kept in locked files accessible only to study 
staff and unlocked only while a study staff member is physically present.  All computer records will 
require password access; computer workstations will be locked when unattended.  
 
10.0 
Follow-up and Record Retention 
Timeline 
 
Year 1 
Year 2 
Qtr 1 
Qtr 2 
Qtr 3 
Qtr 4 
Qtr 1 
Qtr 2 
Qtr 3 
Qtr 4 
Participant Recruitment 
 
 
 
 
 
 
 
 
Intervention 
 
 
 
 
 
 
 
 
Data Collection 
 
 
 
 
 
 
 
 
Statistical Analysis 
 
 
 
 
 
 
 
 
Manuscript Preparation 
 
 
 
 
 
 
 
 
Publication and 
Dissemination 
 
 
 
 
 
 
 
 
 
The duration of record retention will be at least seven years after the study has ended, with the 
probability of indefinite archiving of study records and data. 
 
11.0 
Data Safety Monitoring Plan 

Oversight for the conduct of the study will be provided by the study PI Dr. Tamara Hannon.  While 
adverse events are not anticipated, a process has been established for continuous review of data and 
patient safety.  The PI and study team will conduct at least quarterly review meetings of the data.  Other 
members will be included in these meetings at the discretion of the PI.  Quarterly meeting summaries 
will include the number of patients recruited, rate of recruitment refusal, and subject attrition.  In 
addition, the research team will report (1) all causes of mortality and (2) morbidity (including 
hospitalizations, ER visits, and other injuries/problems resulting from the study protocol).  Any adverse 
events occurring will be documented and reported to the IRB according to the local regulations. 
Cumulative adverse events and study progress summary will be communicated to the IRB at the time of 
continuing review. 
Several measures will be taken to protect patient confidentiality. Paper records will be minimized by 
completing the consenting process and surveys directly in the IU REDCap system, a password-protected 
database with limited access. If a participant requests paper forms, all identifying information collected 
on paper forms will be entered into IU REDCap. Once identifying information are entered into the 
“identification database”, paper forms will be stored in a locked file cabinet. Data provided by 
participants verbally, or through written responses to questionnaires and surveys will be stored in 
individual files, identified by each participant’s study code number with one file for each participant. 
These files will be stored in a locked file cabinet and access to them will be restricted to study personnel 
only. All data provided by participants will be entered into the IU REDCap database that is separate from 
the identification database.  Data records will be destroyed through shredding seven years after 
completion of the study. 
 
 

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