Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents
Phase: NA
Conditions: Type 2 Diabetes, Depression, Insulin Resistance, Obesity, Adolescent Development
Sponsor: Colorado State University

(c) 2026 Lauren Shomaker, all rights reserved
Cover Page
: Mindfulness-Based Intervention for Depression and Insulin Resistance in 
Adolescents  
: Study Protocol and Analysis Plan
: NCT04992299
: 10/24/2023, version 10.0

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Version 10.0 
 
 
24 October 2023 
Study Protocol:
Mindfulness-Based Intervention for Depression and  
Insulin Resistance in Adolescents 
A multisite, randomized controlled pilot and feasibility trial
Principal Investigator: 
Lauren Shomaker, Ph.D., Associate Professor, Human Development & Family Studies, 
College of Health and Human Sciences, Colorado State University and
Assistant Clinical Professor, Pediatric Endocrinology, Children’s Hospital 
Colorado/University of Colorado Anschutz Medical Campus 
Supported by: 
 National Institutes of Health (NIH)/National Center for Complementary and Integrative 
Health (NCCIH), Grant# 1U01AT011008/5R01AT011008 
 
Colorado Multiple IRB Protocol# 20-2649 
Version 10.0 
24 October 2023 

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Version 10.0 
 
 
24 October 2023 
Revision History
Version Number: 1.0 
Version Date: 9 April 2021 
Summary of Revisions Made: N/A, original protocol 
Version Number: 2.0 
Version Date: 29 June 2021 
Summary of Revisions Made: Listed specific recruitment methods by site; adjusted language 
regarding provision of consent form copy; clarified use of immediate glucose analyzer for 
prompt determination of eligibility; clarified use of the independent monitoring committee (IMC) 
and provided more detail on IMC and the data safety and monitoring plan (DSMP); included 
food preferences and puberty questionnaires; provided more details on some assessments 
(e.g., eating in the absence of hunger paradigm) and data management; corrected clerical 
errors. 
Version Number: 3.0 
Version Date: 23 August 2021 
Summary of Revisions Made: The Children’s National site name has been changed to more 
accurately represent the official title of their institution. Additionally, Isabella Conte has been 
removed from the protocol, as her last day on the study is August 31, 2021.  
Version Number: 4.0 
Version Date: 28 September 2021 
Summary of Revisions Made: Supplemented details of intervention training, delivery plans, and 
fidelity monitoring, including that expert raters will be non-blinded for mock session review and 
inclusion of non-participant/non-expert raters of adherence; added procedure for re-screening if 
baseline occurs >6 months from intervention initiation; protocol revision history log updated for 
version/date clarity and to comply with COMIRB and NCCIH document naming guidelines; 
clarified that lead coordinator will use the REDCap randomization module; supplemented details 
of inclusion/exclusion criteria for clarity and consistency across documents/tables; ensured 
consistency in referring to Children’s National Medical Center site-specific consent/assent 
documents and added their planned use of recruitment business card; clarified inclusion of 
finger prick as backup to venipuncture for glucose measurement/eligibility; noted flexibility in 
timing of some assessments (e.g., pubertal exam, standard procedures regarding re-wear of 
home collection devices to maximize compliance); added stress test anticipated risks; updated 
study roster; corrected clerical errors.  
 
Version Number: 5.0 
Version Date: 1 December 2021 
Summary of Revision Made: Clarified language regarding supervision by Drs. Lucas-Thompson 
and Gulley; corrected clerical error on height/weight measurement in first screening; added 
explicit note about study completion letter/referrals list at the end of participant’s time in the 
study. 
 
Version Number: 6.0 
Version Date: 24 February 2022 
Summary of Revisions Made: Made clarifying edits to the inclusion and exclusion criteria 
wording based on feedback from the IMC, such as specifying in the table the English-speaking 
eligibility inclusion criterion for adolescents, as groups will be led in English, clarifying that 

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exclusion criteria apply for current problems, and referencing an internal guide the IMC has 
reviewed and the study team will maintain throughout the trial for multisite consistency; added 
flexibility for some questionnaires to be completed at either screening visit 1 or screening visit 2; 
added clarifying language that the physical exam may occur at screening visit 1 or 2 to 
accommodate participant and medical provider availability; and added Michele Chen to the 
study roster. 
 
Version Number: 6.1 
Version Date: 3 April 2022 
Summary of Revisions Made: In response to feedback from the Colorado Multiple IRB’s 
review of protocol v6.0 approved by NCCIH, “English speaking” was removed as an inclusion 
criterion specified in Table 5 of the protocol. This modification is in line with the IRB’s preference 
to instead specify within the Colorado Multiple IRB application document (IRB-specific form) the 
need to enroll adolescents who speak English, with the rationale that they will need to speak 
English in order to participate in group programs that will be facilitated in English. We had 
previously added “English speaking” in the table of the protocol v6.0 to respond to preferences 
of the study’s IMC, yet with this version (6.1) we revert back to comply with COMIRB’s 
preferences. 
 
Version Number: 7.0 
Version Date: 6 May 2022 
Summary of Revisions Made: Supplemented recruitment methods for Colorado State University, 
Children’s Hospital Colorado, and Children’s National Hospital. Updated staff roles at 
UCD/CHCO. 
 
Version Number: 8.0 
Version Date: 25 October 2022 
Summary of Revisions Made: In response to IMC guidance and NCCIH approval, modified the 
Schedule for Affective Disorders and Schizophrenia for School-Aged Youth (KSADS) interview 
to only administer the suicidality and self-harm module, with the presence of current active 
ideation or self-harm continuing to serve as an indicator of depression severity and need for 
exclusion/alternative treatment referrals at baseline. This modification alleviates participant 
burden, staff burden, and is in alignment with predominant views of depression symptoms as 
existing on a continuum. Added clarification that exclusionary diagnoses will continue to be 
assessed with medical/health history interview conducted by research staff with the parent and 
teen, with this interview already including assessment of adolescent mental health diagnostic 
history. While retaining the total enrollment target (N=120), omitted specific recruitment 
numbers by site to allow for more flexibility to recruit the target sample. Added recruitment 
strategies supported by IMC, NCCIH, and additional community stakeholder engagement 
efforts. Noted adjusted timeline and milestones established in conjunction with NCCIH. Made 
clerical and administrative updates, including updating the study roster and clarifying the 
physical examination protocol.  
 

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Version Number: 9.0
Version Date: 16 August 2023 
Summary of Revisions Made: Added clarification to one-year physical exam section to 
accurately reflect procedures and to match sponsor approved case report forms.  
 
Version Number: 10.0 
Version Date: 24 October 2023 
Summary of Revisions Made: Updated staff roster to reflect current key personnel for all study 
sites. Adjusted timeline to initiate staff focus groups once 1-year follow ups have been initiated, 
rather than waiting until this endpoint is complete, in order to maximize the viewpoints of staff 
members who have been working on the project since the recruitment phase. Revised the 
assessment of therapeutic alliance to include observational ratings on the Therapy Process 
Observational Coding System, rather than facilitator survey ratings which inadvertently were not 
collected. All of these proposed modifications have been approved by the study sponsor 
program official.  
 

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TABLE OF CONTENTS
Page 
Revision History........................................................................................................................ 2
TABLE OF CONTENTS.................................................................................................. 5
STUDY TEAM ROSTER / PARTICIPATING SITES .......................................................... 7
PRÉCIS...................................................................................................................................... 8
1. STUDY OBJECTIVES ................................................................................................ 9
1.1
Primary Objective ......................................................................................................... 9
1.2
Secondary Objectives .................................................................................................. 9
2. BACKGROUND AND RATIONALE ......................................................................... 10
2.1
Background on Condition, Disease, or Other Primary Study Focus.................. 10
2.2
Study Rationale .......................................................................................................... 11
3. STUDY DESIGN ....................................................................................................... 13
3.1   Design of Trial................................................................................................................ 13
3.2  Primary Outcomes .......................................................................................................... 13
4. SELECTION AND ENROLLMENT OF PARTICIPANTS .......................................... 18
4.1
Inclusion Criteria ......................................................................................................... 18
4.2
Exclusion Criteria ....................................................................................................... 18
4.3
Study Enrollment Procedures .................................................................................. 19
5.       STUDY INTERVENTIONS .................................................................................. 22
5.1
Interventions................................................................................................................ 22
5.2
Prohibited Interventions ............................................................................................ 24
5.3 
Allowed Interventions .................................................................................. 24
5.4
Adherence Assessment ............................................................................................ 24
6. STUDY PROCEDURES............................................................................................ 24
6.1
Schedule of Evaluations ............................................................................................ 25
6.2
Description of Evaluations ........................................................................................ 27
6.2.1 Phone Screening Evaluation ....................................................................... 27
6.2.5 Blinding........................................................................................................ 32
6.2.6 Follow-up Visits ........................................................................................... 32
6.2.7 Completion/Final Evaluation ........................................................................ 34
7. RISK ASSESSMENTS.............................................................................................. 34

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7.3
Specification of Safety Parameters ......................................................................... 38
7.4
Adverse Events and Serious Adverse Events....................................................... 39
7.5
Follow-up for Adverse Events .................................................................................. 39
7.6
Safety Monitoring ....................................................................................................... 39
8. STATISTICAL CONSIDERATIONS.......................................................................... 40
8.1
General Design Issues.............................................................................................. 40
8.2
Sample Size and Randomization ............................................................................ 40
8.3 
Definition of Populations ........................................................................................... 41
8.4
Interim Analyses and Stopping Rules ..................................................................... 41
8.5
Outcomes .................................................................................................................... 41
8.5.1 Primary Outcome ........................................................................................ 41
8.5.2 Secondary Outcomes.................................................................................. 41
8.6
Data Analyses ............................................................................................................. 42
8.6.1 Primary Analyses ............................................................................................... 42
9.       DATA COLLECTION AND QUALITY ASSURANCE......................................... 44
9.1
Data Collection Forms............................................................................................... 44
9.2
Data Management ...................................................................................................... 45
9.3
Quality Assurance...................................................................................................... 47
9.3.1 Training ....................................................................................................... 47
9.3.2 Metrics......................................................................................................... 47
9.3.3 Protocol Deviations ..................................................................................... 47
9.3.4 Monitoring.................................................................................................... 47
10. PARTICIPANT RIGHTS AND CONFIDENTIALITY................................................ 47
10.1
Institutional Review Board (IRB) Review................................................................ 47
10.2
Informed Consent Forms .......................................................................................... 48
10.3
Participant Confidentiality ......................................................................................... 48
10.4
Study Discontinuation................................................................................................ 48
11.      PUBLICATION OF RESEARCH FINDINGS ...................................................... 48
12.      REFERENCES................................................................................................... 48
  

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STUDY TEAM ROSTER / PARTICIPATING SITES
Table 1 displays the study team roster for key study team members and their roles by study 
site. Data enrollment will occur at all four sites. 
Table omitted for privacy of coordinators/staff. 
 

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PRÉCIS
Study Title  
Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents  
Objectives  
Primary objectives: 
a) Test multisite fidelity of training and implementation of 6-week group mindfulness-based 
intervention (MBI), 6-week group cognitive-behavioral therapy (CBT), and 6-week group 
health education (HealthEd), to adolescent girls and boys at risk for type 2 diabetes 
(T2D) with depression symptoms 
b) Evaluate multisite feasibility/acceptability of recruitment, retention, and adherence for a 
protocol involving randomization to 6-week group MBI, CBT, or HealthEd with 6-week 
and 1-year follow-up  
Secondary objectives:  
a) Modify intervention training/implementation and protocol procedures for a future, fully 
powered multisite randomized controlled efficacy trial   
Design and Outcomes   
This is a multisite, pilot randomized controlled trial designed to test multisite fidelity, feasibility, 
and acceptability in preparation for a future multisite efficacy trial. The study will be carried out 
at four geographically diverse sites in order to recruit a total sample of N=120 adolescent girls 
and boys at risk for T2D. Adolescents, ages 12-17 years, who are at risk for T2D and who have 
elevated depression symptoms will be randomized to either 6-week group MBI, 6-week group 
CBT, or 6-week group HealthEd, and followed directly after the intervention (6-week follow-up) 
and 1-year later.  
Interventions and Duration  
Three behavioral group interventions are being compared in this trial: 
1. Active/Experimental Treatment: MBI, using the Learning to BREATHE curriculum 
2. Active/Standard-of-Care Treatment Comparator: CBT, using the Blues Program  
3. Didactic Control: HealthEd, adapted from the Hey-Durham health knowledge program  
All interventions involve ~6 total contact hours, spread over 1-hour weekly group-based 
interventions format. Each participant will be enrolled in the study for approximately 15 months 
(~1- to 3-month window for screening and baseline assessment; 6-week intervention phase; 6-
week follow-up assessment; 1-year follow-up assessment). 
Sample Size and Population  
The target population includes adolescent girls and boys, 12-17 years old, who are at risk for 
T2D by virtue of having overweight/obesity (body mass index [BMI kg/m2] 
age and sex) and a family history of T2D. Adolescents will not have T2D or another major 
medical illness. Also, adolescents will report elevated depression symptoms, but will not have a 
psychiatric disorder that would impede compliance and necessitate more intensive treatment. A 
total of N=120 adolescents will be enrolled, with approximately one-third of the sample 
randomized to each arm (MBI: n=40, CBT: n=40, HealthEd: n=40).  

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1. STUDY OBJECTIVES
1.1 
Primary Objective 
a) We aim to test multisite fidelity of training/implementation of 6-week group 
mindfulness-based intervention (MBI), cognitive-behavioral therapy (CBT), and 
health education (HealthEd) to adolescent girls and boys at risk for type 2 
diabetes (T2D) with depression symptoms.  
We expect that facilitators can be trained consistently and competently across sites 
to achieve competence.  
 
The primary endpoint is that facilitators will score >80% on post-training 
knowledge/competency evaluations.  
 
Secondary endpoints are that adherence and competence ratings of mock 
group sessions of MBI, CBT, and HealthEd will be >8 (1=poor to 
10=exceptional); and adherence and competence ratings of pilot trial group 
sessions of MBI, CBT, and HealthEd ratings will be >8 (1=poor to 
10=exceptional). 
b) We aim to evaluate multisite feasibility/acceptability of recruitment, retention, 
and adherence for a protocol involving randomization to 6-week group MBI, 
CBT, or HealthEd with 6-week follow-up and 1-year follow-up.  
We anticipate that strategies used successfully in local trials will result in timely 
recruitment, adequate retention, and excellent adherence.  
 
The primary endpoint is that >80% of eligible adolescents will enroll in the 
study.  
 
The secondary endpoints are attainment of a target N=120 within a 12-month 
period; >80% of adolescents will attend 5 out of 6 (80% dose) of the MBI, 
CBT, and HealthEd group sessions; >80% of adolescents will endorse 
liking/credibility ratings >4 (1=not at all to 5=extremely); qualitative themes 
will be indicative of acceptability of interventions, as derived from grounded 
theory/qualitative analysis of adolescent focus-groups at 6-week follow-up; 
>80% retention at 6-week follow-up and >70% retention at 1-year follow-up; 
and  >95% accuracy on standardized protocol checklists for all assessments. 
1.2 
Secondary Objectives 
a) We aim to modify training/implementation and protocol procedures in 
preparation for a future multisite trial based upon the information gathered 
through the primary objectives, as well as focus groups conducted with study 
personnel toward the end of the data collection phase.  
We will seek to optimize training, recruitment, intervention delivery, retention, and 
assessment in the following ways:  
 
Training optimization: Revise MBI, CBT, and HealthEd training protocols 
using expert feedback on videoed trainings and trainee survey feedback.  
 
Recruitment optimization: Select strategies most effective across multiple 
sites and tailor to local sites to maximize efficiency and increase rate of 
recruitment in a subsequent NCCIH/NIH UG3/UH3 grant application. 
 
Intervention optimization: Modify MBI, CBT, and HealthEd delivery based 

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upon focus group feedback from adolescents and intervention facilitators.
 
Retention optimization: Solidify retention strategies based upon focus group 
feedback from research staff. 
 
Assessment optimization: Update assessment protocols with focus group 
feedback from research staff and compliance with standardized protocol 
checklists. 
2. BACKGROUND AND RATIONALE 
2.1 
Background on Condition, Disease, or Other Primary Study Focus 
Adolescent-onset type 2 diabetes (T2D) is a major healthcare problem. A serious chronic 
disease affecting 28 million Americans and 415 million individuals worldwide,1,2 T2D costs over 
$245 billion annually in U.S. healthcare expenditures.1 T2D is a leading cause of severe health 
complications including cardiovascular and peripheral vascular disease and stroke, retinopathy 
and blindness, renal failure, and amputations.3-5 Individuals with T2D have a twofold higher risk 
of mortality than those without T2D, and mortality linked to T2D is the 7th leading cause of 
death in the U.S. and 9th leading cause of death worldwide.1,2 Although T2D was previously 
limited to older adults, there has been an alarming rise in rates of adolescent-onset T2D that 
presents a serious healthcare challenge.6,7 Adolescent-onset T2D has an exacerbated disease 
course with more rapid deterioration, greater comorbidities, and earlier mortality.7-9 Adolescent-
onset T2D disproportionately affects racial and ethnic minorities, including Hispanic/Latino, 
American Indian/Native American, and Black/African American youth.6 Stressful life 
experiences, namely poverty, family psychopathology, domestic violence, and abuse/neglect, 
are commonly faced by teenagers who present with T2D and those at risk for T2D.10-12 
Unfortunately, effective treatment options remain elusive.8,13 Given poor health outcomes and 
lack of effective treatment options, prevention of adolescent-onset T2D is a critical priority. 
Decreasing insulin resistance is key to T2D prevention. T2D is preventable,14,15 and 
prevention focuses on decreasing insulin resistance, the major physiological antecedent to 
T2D.16 Insulin resistance refers to diminished sensitivity of the hormone insulin to uptake, utilize, 
and metabolize glucose by almost all of the body’s tissues.17 It is well-established that 
progression of worsening insulin resistance triggers the onset of T2D.18 Therefore, development 
of effective interventions to decrease insulin resistance would significantly reduce T2D among 
at-risk youth.16,19-21 Because obesity
 for age and 
sex), is a contributor to insulin resistance,22 the standard-of-care for T2D prevention involves 
lifestyle intervention to decrease energy intake and increase physical activity, with the primary 
goal of weight loss.14,15,23 Although this approach has demonstrated efficacy for diminishing T2D 
risk in adults,14,15 lifestyle programs unfortunately show insufficient effectiveness in adolescents, 
particularly racial and ethnic minority and low-income youth.24,25 Despite some promising short-
term effects, lifestyle programs are costly and intensive (e.g., 2-3 sessions per week for 6 
months), making adherence a challenge and weight regain common following the program’s 
termination.26-29
Adolescence is a sensitive period to intervene to potentially alter the long-term course of insulin 
resistance and T2D.18 Puberty is characterized by a natural rise in insulin resistance,30,31 and 
continued exacerbation of insulin resistance in adolescents at risk for T2D plays a key role in 
the trajectory toward T2D.18 Furthermore, adolescence is characterized by highly dynamic 
emotional, cognitive, and behavioral changes that affect insulin resistance,30-32 offering a 
window of opportunity for psychological-physical integrative health interventions to decrease 
psychological distress, improve insulin resistance and, consequently, lessen T2D risk in at-risk 

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teenagers.
Depression in adolescence is common and a risk factor for insulin resistance/T2D. 
Depression is projected to be the 2nd leading cause of disability and premature mortality 
worldwide by 2020.33,34 Depression is among the most common psychological problems, with 
the 12-month prevalence of major depressive disorder (MDD) estimated to be ~11% in girls and 
~5% in boys in national cohorts of adolescents.35 Individuals from racial and ethnic minority 
groups and low-income backgrounds have higher rates of early-life and chronic depression.36-38 
Depression markedly heightens early cardiovascular disease risk, partially through its impact on 
increasing the likelihood of developing T2D.39 Although full-syndrome MDD often manifests in 
young adulthood (early to mid-20s),34,40 adolescence (12-17 years) is a high-risk period for 
developing elevated depression symptoms: symptoms that do not fully meet MDD diagnostic 
frequency and/or duration criteria.41 Youth’s elevated depression symptoms, if untreated, are a 
strong predictor of developing MDD.41-44 As much as 1 out of 3 adolescents report current, 
elevated depression symptoms,45 and elevated depression symptoms are up to 3 times more 
likely in T2D as compared to community samples or individuals with type 1 diabetes (T1D).46-48
Data from our group and others have shown that depression symptoms relate to higher insulin 
resistance in adolescents, even after accounting for current BMI or body fat.49-53 In a cohort of 
youth with overweight and obesity, we found that depression symptoms predicted the worsening 
of insulin resistance 5-6 years later, even after accounting for initial BMI and BMI change over 
time.54 Other data show that adolescents’ and young adults’ depression symptoms are 
associated with a two-fold greater odds of developing T2D in young adulhood.55 Thus, elevated 
depression symptoms appear to be a novel, potentially modifiable risk factor for worsening of 
insulin resistance and the onset of T2D. Intervening to decrease depression symptoms in 
adolescents at risk for T2D is, therefore, anticipated to prevent worsening insulin resistance and 
lessen T2D risk. 
2.2 
Study Rationale 
Behavioral health interventions have promise to decrease depression and ameliorate 
insulin resistance. We conducted an initial single-site, randomized controlled efficacy trial 
(NIH/NICHD Grant# K99HD069516) to determine if intervening to decrease depression with the 
standard-of-care—cognitive-behavioral therapy (CBT)—would ameliorate insulin resistance in 
adolescents at-risk for T2D. Teens were randomized to a 6-week group CBT vs. 6-week health 
education (HealthEd) control group. In adolescents with elevated depression, CBT (vs. 
HealthEd) led to greater decreases in depression at post-treatment,56 and lower 2-hour insulin 
after an oral glucose challenge at 1-year follow-up.57 Also among those with elevated 
depression symptoms, CBT (vs. HealthEd) indirectly led to greater post-treatment to 1-year 
decreases in insulin resistance through decreasing depression during treatment.58 All of the 
effects from this trial were independent of initial BMI, body fat, and body fat change.56-58 These 
findings laid a foundation for the notion that brief, behavioral health interventions to decrease 
elevated depression symptoms may lessen T2D risk in adolescents, even in the absence of 
weight loss. 
Mindfulness-based intervention (MBI) for psychological-physical integrative health. There 
has been rising scientific and clinical interest in MBI to decrease psychological distress59,60 (e.g., 
depression) and improve physical health (e.g., cardiometabolic health).61-63 A principal MBI goal 
is increasing dispositional mindfulness, the propensity to pay attention on purpose to one’s 
present-moment experiences with an attitude of non-judgment and equanimity.64 From the 
framework of Monitor and Acceptance Theory,65,66 MBI is postulated to decrease depression 
and improve stress-related behavior and physiology through (i) increased attention to monitoring 
of present-moment experiences, combined with (ii) increased acceptance of experiences 

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regardless of their valence, mechanisms supported in recent MBI dismantling studies.65,67-69 As 
show in Figure 1 below, MBI is theorized to be particularly fitting for decreasing depression and 
improving insulin resistance in teen at-risk for T2D. MBI is postulated to: (a) alleviate ruminative, 
negative thoughts that perpetuate and exacerbate depression,70-72 (b) ameliorate dysregulated 
stress physiology including cortisol dysregulation and stress reactivity, shown to promote insulin 
resistance and adverse metabolic outcomes,73,74 and (c) lessen stress-related behavior such as 
hedonic eating, or eating for reward/pleasure as opposed to physiological hunger,75 and 
physical inactivity.76 Adolescent depression symptoms relate to increases in cortisol 
dysregulation,77,78 stress reactivity,79 hedonic eating,80-82 and physical inactivity,83 which, in turn, 
have each been related to increased insulin resistance independent of obesity.84-97 Enhanced 
monitoring and acceptance of thoughts, emotions, and body sensations as they unfold moment-
to-moment is theorized to improve stress-related behavior/physiology through its impact on 
decreasing depression; yet, one distinctive benefit of MBI may be its potential to offer direct, 
salutary effects for stress behavior/physiology. MBI may improve identification of cues (e.g., 
negative affectivity) that prompt behaviors triggered by stress, and to tolerate distress without 
acting habitually.98 MBI also may improve executive function, including the ability to flexibly 
deploy attention away from cues that prompt stress-behavior and heighten stress 
physiology.59,99
Figure 1. Theoretical MBI, vs. CBT, effects on depression & insulin resistance by 
decreasing (a) depression, (b) stress physiology, and (c) stress-related behavior
In light of these theoretically informed, potentially distinctive benefits, we carried out a single-
site, pilot randomized controlled trial of MBI vs. an active treatment, CBT, in adolescents at-risk 
for T2D with elevated depression symptoms (NIH/NICHD Grant# R00HD069516). The main aim 
was to test feasibility/acceptability of a 6-week/6-session MBI group, Learning to BREATHE, in 
teens at-risk for T2D. There was excellent attendance (median 6:6 MBI vs. 5:6 CBT sessions, 
p=.06), and acceptability ratings were positive. In exploratory analyses, we observed that both 
conditions decreased depression, but MBI led to greater decreases than CBT at post-treatment 
(Cohen’s d=0.56)100 and 1-year (d=0.68; 52% vs. 35% symptom reduction).101 Whereas CBT 
was associated with stable insulin resistance, MBI decreased insulin resistance at post-
treatment (Cohen’s d=0.93)100 and 1-year follow-up (Cohen’s d=0.73).100 These data must be 
considered preliminary,102 but they support the notion that MBI could offer distinctive 
psychological and physical health benefits to adolescents at-risk for T2D with depression 

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symptoms.103 If MBI leads to more clinically meaningful reductions in depression and insulin 
resistance in adolescents at-risk for T2D, this stands to inform our healthcare approach to T2D 
prevention. 
Most existing research on MBI and diabetes has focused on MBI delivery in adults who already 
have T2D or samples combining adults with T2D and type 1 diabetes (T1D).104-106 Randomized 
trials in adults with T2D/T1D show moderate MBI effects for decreasing depression, relative to 
waitlist, diabetes education, and treatment-as-usual controls, from post-treatment to 1-year 
follow-up.104,106-112 Some of these trials show significant MBI effects on improved glycemic 
control (e.g., HbA1c, fasting glucose) and overall health.104,107,110,112 Yet, not all studies have 
found physical health benefits, particularly trials combining T2D/T1D, which represent very 
different patient populations, and trials that included patients who already had good glycemic 
control.106-109,111 From an alternative, prevention lens, MBI delivery to at-risk adolescents in order 
to decrease depression and ameliorate insulin resistance warrants testing and offers potential 
as a novel approach for targeted prevention of T2D. MBI may be especially valuable in 
adolescence, as marked developments in executive function, pubertal insulin resistance, high 
reward sensitivity, and openness to new experience render this period highly malleable.113-117
Few randomized controlled trials have compared MBI to active treatments. In the current 
research program, we will lay the groundwork for a multisite efficacy trial comparing MBI to CBT 
and to a didactic control group, HealthEd, for decreasing depression symptoms and insulin 
resistance in adolescents at-risk for T2D. Comparison of MBI to another active treatment is 
crucial to distinguish whether MBI is superior (or equivalent) to CBT, and to what extent there 
are distinctive benefits of monitoring and acceptance, above and beyond the time, attention, 
non-specific group/facilitator support, as well as training in thought restructuring, behavioral 
activation, and stress management, provided by CBT.   
3. STUDY DESIGN
3.1   Design of Trial 
This trial is a multisite, randomized controlled pilot and feasibility trial with three arms, including 
two active behavioral treatments, mindfulness-based intervention (MBI) vs. cognitive-behavioral 
therapy (CBT), and one didactic/attention control, health education (HealthEd). After a 
screening to determine eligibility and to collect baseline assessments, eligible adolescents will 
be randomized to participate in one of the arms. Each intervention is a 6-week group program. 
Follow-ups will be conducted at 6-weeks after the intervention and 1-year after the intervention.  
3.2  Primary Outcomes 
The primary outcomes for each study aim are described in Table 2 below. 
Table 2. Primary endpoints for each study aim of this multisite, randomized controlled pilot and feasibility 
trial 
Aim 1: Test multisite fidelity of training/implementation of 6-week group MBI, CBT, and HealthEd to 
adolescent girls and boys at-risk for T2D with depression symptoms 
Objective 
Endpoint
Metric; Analysis 
Intervention Fidelity 
(Primary) 
12-months 
MBI, CBT, and HealthEd adolescent group sessions (1=poor to 
10=exceptional) 
 

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Aim 2: Evaluate multisite feasibility/acceptability of recruitment, retention, and adherence for a protocol 
involving randomization to 6-week group MBI, CBT, or HealthEd with 6-week and 1-year follow-up 
Objective 
Endpoint
Metric; Analysis 
Recruitment 
Feasibility (Primary)
12-months 
3.3 Secondary Outcomes 
The secondary endpoints for each aim are shown in Table 3. 
Table 3. Secondary endpoints for each study aim of this multisite, randomized controlled pilot and 
feasibility trial 
Aim 1: Test multisite fidelity of training/implementation of 6-week group MBI, CBT, and HealthEd to 
adolescent girls and boys at-risk for T2D with depression symptoms
Objective
Endpoint
Metric; Analysis
Training Fidelity 
(Secondary) 
6-months 
-training knowledge/ 
competency tests of MBI, CBT, and HealthEd 
Training Fidelity 
(Secondary) 
6-months 
MBI, CBT, and HealthEd mock group sessions (1=poor to 
10=exceptional) 
Aim 2: Evaluate multisite feasibility/acceptability of recruitment, retention, and adherence for a protocol 
involving randomization to 6-week group MBI, CBT, or HealthEd with 6-week and 1-year follow-up 
Objective 
Endpoint
Metric; Analysis 
Recruitment 
Feasibility  
(Secondary) 
12-months 
Attainment of target N=120 within a 12-month period; 
CONSORT flow/number of months to reach recruitment goal 
Intervention 
Feasibility 
(Secondary) 
6-weeks
sessions 
Intervention 
Acceptability 
(Secondary) 
6-weeks
1=not at all to 
5=extremely) 
Intervention 
Acceptability 
(Secondary) 
6-weeks
Themes indicative of acceptability of interventions, as derived 
from grounded theory/qualitative analysis of adolescent focus-
groups at post-intervention 
Retention Feasibility
(Secondary) 
12-months 
-treatment follow-
-year follow-up
Assessment 
Feasibility 
(Secondary) 
18-months 
standardized protocol checklists for all 
assessments 
3.4 Study Population 
The sample will be N=120 adolescents at risk for T2D with elevated depression symptoms. We 
will exclude and provide referrals to adolescents with active suicidal ideation or current 
psychiatric disorder that would impede compliance and necessitate more intensive treatment. 
Likewise, adolescents who have T2D or another major medical illness will be excluded and 

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referred. 
3.5 Study Location 
This trial will take place at four sites, with two sites in Colorado (Colorado State University [CSU] 
and Children’s Hospital Colorado/University of Colorado Anschutz Medical Campus [CHCO]) 
and two in Maryland/Washington, D.C. (Uniformed Services University of the Health Sciences
[USU] and Children’s National Medical Center [CNMC].  
3.6 Study Timeline 
An overview of the projected 4-year study timeline with key tasks is provided in Table 4 below. 
Table 4. Estimated study timeline**
Year 1  2020-2021 
Year 2  2021-2022 
Year 3  2022-2023 
Year 4  2023-2024 
Quarter 1   
August-
October 
Multisite study
start-up: 
Hire personnel; 
Assign roles & 
responsibilities for all 
personnel; 
Obtain single IRB 
(sIRB), 
institution agreements 
& regulatory approvals; 
Convene data safety 
and monitoring board 
(DSMB) and create 
Charter; 
Establish data 
coordinating center, 
including 
randomization string, 
surveys, & data 
management systems 
in REDCap; 
Finalize standard 
operating procedures  
 
Multisite pilot 
randomized 
controlled trial 
and post-
intervention 
follow-up: 
Initiate recruitment;
Track rate, 
sources, & all 
aspects of 
recruitment; 
Conduct 
screenings/ 
baseline 
assessments for 
Cohort 1; 
Monitor protocol 
compliance at all 
sites 
 
Multisite feasibility/ 
acceptability of 
interventions: 
Evaluate intervention 
attendance/homework 
completion/acceptability 
ratings (Aim 2); 
Carry out qualitative 
data analysis of 
participant focus groups 
Evaluate participant 
recruitment, retention, 
and protocol 
adherence through 1-
year 
follow-up final endpoint 
(Aim 2); 
Summarize, 
disseminate, discuss 
fidelity & 
feasibility/acceptability 
results to local sites & 
across sites; 
Refine multisite study 
protocols based upon 
data (Aim 3) 
 
Dissemination & 
future directions: 
Submit key results to 
conference 
proceedings; 
Draft NCCIH UG3/UH3 
grant for multisite 
randomized controlled 
efficacy trial 
Quarter 2   
November-
January
Deliver Cohort 1 
MBI, CBT, & 
HealthEd;* 
Conduct weekly 
intervention 
supervision; 
Conduct Cohort 1
6-week follow-ups 
and focus groups; 
Conduct 
screenings/ 
baseline 
assessments for 
Cohort 2; 
Monitor protocol 
compliance at all 
sites
Summarize, 
disseminate, discuss 
fidelity & initial 
feasibility/acceptability 
results to local sites & 
across sites 
 
1-year follow-up of 
multisite pilot 
randomized 
controlled trial: 
Conduct Cohort 1 
1-year follow-ups 
 
 

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Year 1  2020-2021
Year 2  2021-2022
Year 3  2022-2023
Year 4  2023-2024
Quarter 3   
February-
April 
Multisite trainings for 
study protocols & 
interventions: 
Conduct live/video 
trainings of standard 
operating procedures;
Design recruitment 
materials & finalize 
recruitment methods; 
Conduct live, in-person 
trainings in MBI, CBT, 
& HealthEd in 
Colorado & 
Maryland/D.C.; 
Evaluate fidelity and 
feasibility/acceptability 
of study protocol and 
MBI, CBT, & HealthEd 
training (Aim 1) 
 
 
Deliver Cohort 2 
MBI, CBT, & 
HealthEd; 
Conduct weekly 
intervention 
supervision; 
Conduct Cohort 2 
6-week follow-ups 
and focus groups; 
Monitor protocol 
compliance at all 
sites 
 
Conduct Cohort 2
1-year follow-ups 
Present key results at    
conference 
proceedings; 
Prepare manuscripts;
Submit NCCIH 
UG3/UH3 grant for 
multisite randomized 
controlled efficacy trial 
Quarter 4   
May-July 
Multisite fidelity 
of intervention 
delivery: 
Evaluate fidelity of 
MBI, CBT, & 
HealthEd delivery 
(Aim 1) 
Multisite feasibility/ 
acceptability of study 
protocols: 
Conduct facilitator/ 
staff focus groups; 
Carry out qualitative 
data analysis of 
facilitator/staff focus 
groups 
Publish results in 
peer-reviewed 
journals;
Revise NCCIH 
UG3/UH3 grant for 
multisite randomized 
controlled efficacy trial 
 
* Note: Planned enrollment is n=5 adolescents and n=5 parents/guardians per arm x 3 arms (i.e., MBI, CBT, 
HealthEd) x 4 sites x 2 cohorts, amounting to a total N=240. MBI: mindfulness-based intervention. CBT: cognitive-
behavioral therapy. HealthEd: health education. 
** Study timeline delayed. Updated GANNT chart and milestones created, and approved by NCCIH, in August 
2022. Cohorts revised to ongoing enrollment across sites: n=15 per cohort x 8 cohorts: N=120. 
Recruitment and enrollment was anticipated to occur ~August 2021-March 2022, with 
enrollment anticipated to be completed no later than within a 12-month period from initiation of 
recruitment (i.e., August 2022). On account of delays, actual enrollment began in May 2022 and 
it is anticipated to finish in July 2023.  
3.7 Description of Interventions and Administration 
MBI: The group MBI active/experimental intervention program is Learning to BREATHE, a 
manualized curriculum118 derived from mindfulness-based stress reduction64 and adapted for 
adolescents by incorporating experiential activities and guided discussions to teach standard 
mindfulness skills. Adolescents meet for six group weekly sessions for 60-minutes each week. 
Each letter in the BREATHE acronym corresponds to a theme: B: Body, R: Reflections/ 
Thoughts, E: Emotions, A: Attention, T: Tenderness/Self-Compassion, H: Habits (of Healthy 
Living), for the overall goal of E: Empowerment. Example activities include breath awareness, 
body scanning, mindful eating, sitting meditation, loving-kindness practice, and gentle yoga. 
Brief homework (~10 minutes/day), including formal practices (e.g., meditation audio-
recordings) and informal practices (e.g., personalizing mindfulness in daily living), is assigned 
weekly. Adolescents are given digital meditation audio-recordings, a yoga mat, a meditation 
cushion, a homework log, and worksheets. The original curriculum was designed to offer 
flexibility in delivery timing and selection of exercises.118 We developed a manualized version of 
BREATHE for consistency in timing and content,100,119 but minimally modified content from its 
original format. In session 1 (“B), we added a brief justification (~1 minute) of how program 
participation may help adolescents to lessen T2D risk through feeling happier, less stressed, 
and engaging in healthier ways of coping with stress. BREATHE is well-liked by at-risk, 
racially/ethnically diverse adolescents, including adolescents at-risk for obesity and T2D,100,119 

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increases dispositional mindfulness, and decreases depression symptoms and insulin 
resistance up to 1-year later in pilot randomized trials.100,101,119-122  
CBT: The group CBT active/standard-of-care intervention comparator, the Blues Program, is a 
depression prevention program designed to prevent future major depressive disorder (MDD) 
among at-risk youth with current elevated depression symptoms.123-125 Adolescents meet for six 
weekly group sessions for 60-minutes each week. Content includes psychoeducation on the 
cognitive-behavioral model of interrelated thoughts, emotion, and behavior; instruction in self-
monitoring; tools for restructuring negative thoughts; behavioral activation by encouraging 
engagement in pleasant activities; use of self-rewards/reinforcement; and coping with stress. 
Sessions are interactive and activity-based to maximize engagement. Brief homework (~10 
minutes/day) is assigned weekly, including a daily journal and scheduling activities. The Blues 
Program has demonstrated efficacy for decreasing depression symptoms and preventing MDD 
onset in diverse adolescents groups, compared to assessment-only and active control 
conditions, from 6 months to 2 years after treatment.124,126 Further, we have shown that CBT 
decreases depression at post-treatment and stabilizes indices of insulin resistance 1-year later 
among adolescents at-risk for T2D with moderately elevated depression symptoms.56,57
HealthEd: The group HealthEd didactic/control program is derived from Hey-Durham, a didactic 
program for middle/high school age adolescents to increase health knowledge.127 We created 
an abbreviated, manual used in multiple, previous studies.56,119,128,129 Adolescents meet for six 
weekly group sessions for 60-minutes each week. This manualized curriculum covers 6 topics: 
i) domestic violence, ii) substance use, iii) nutrition/body image, iv) depression/signs of suicide, 
v) gang violence/conflict resolution, and vi) sun safety. The depression/suicide module focuses 
only on descriptive prevalence, relation to other health issues, and how to identify signs. 
Content does not overlap with MBI or CBT.56,57 No direct advice is given unless in a psychiatric 
crisis, in which case a treatment referral is facilitated. 
Administration: All three interventions will be delivered by a clinical or counseling psychologist. 
Programs will be co-facilitated by a graduate student in clinical or counseling psychology, social 
work, prevention science, or related field, or a research associate with a master’s degree in 
clinical or counseling psychology, social work, prevention science, or related field. Psychologists 
and co-facilitators will participate in MBI, CBT, and HealthEd training. Sessions will be audio-
recorded and reviewed weekly by Dr. Lucas-Thompson (MBI) and Dr. Gulley (CBT, HealthEd) 
for adherence and competence. Feedback will be provided in weekly supervision. Facilitators 
with drift or deficiencies will be re-trained via “booster sessions” as needed. To minimize 
facilitator effects, psychologist facilitators at each site will facilitate all three programs. 
3.8 Randomization and Stratification 
A separate randomization sequence will be created for each site. Within site, we will create four 
strata by crossing sex (male, female) and age (12-14 years, 15-17 years) and we will use 
permuted blocks within each stratum to ensure the three intervention conditions are balanced. A 
statistician in the Children’s Hospital Colorado’s Biostatistics Core, other than the study lead 
statistician Dr. Pyle, will create the computerized randomization sequence and enter the 
sequence into REDCap’s randomization module. The randomization sequence will be created in 
randomly permuted blocks stratified by site, sex, and age. Permuted blocks will be restricted so 
that for each cohort of n=15, the conditions will be balanced. REDCap’s randomization module 
conveniently conceals the randomization sequence. The lead research coordinator will be 
responsible for using the REDCap randomization module to carry out randomization of eligible 
participants. 
3.9 Blinding 

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Trainers of the interventions will not be blinded in order to provide weekly supervision and 
feedback to the group facilitators. Independent reviewers will complete fidelity ratings of 
facilitators’ delivery of the interventions with participants, and these reviewers will be blinded. 
Raters of quantitative group cohesion also will be blinded.  
The research coordinators – and all study personnel – will remain blinded to allocation during 
the screening/baseline assessment phase, however during the intervention and follow-up 
phases, the research coordinators at each site, the group intervention facilitators, and trainers 
will be not be blinded to assignment. The unblinded coordinators will assist in preparation of any 
data reports to the IMC that necessitate unblinded data.  
The PI (Dr. Shomaker) and the statistician (Dr. Pyle) will be blinded until the database is locked. 
Research staff conducting medical and physical health assessments, including insulin 
resistance, body composition, puberty and physical exams, will be blinded.   
Research assistants (e.g. graduate research assistants) responsible for conducting depression 
and eating interviews and the laboratory stress and eating tasks will be blinded. Blinded 
research assistants also will be responsible for completing standardized protocol checklists at 
all sites.  
Facilitators of adolescent focus groups at post-intervention and facilitators of personnel focus 
groups after initiation of 1-year follow-ups will not be blinded, because focus group guides will 
include open-ended and targeted questions to elicit information specific to intervention condition 
and site. Focus group facilitators will not be involved in any other aspects of data collection for 
this study.    
4. SELECTION AND ENROLLMENT OF PARTICIPANTS 
4.1 
Inclusion Criteria 
Participants must meet all of the following inclusion criteria in order to participate in this study: a) 
12-
and sex; c) elevated depression symptoms, as determined by a total score that exceeds 20 on 
the Center for Epidemiologic Studies-Depression Scale (CES-D); d) at least 1 first- or second-
degree relative with T2D, prediabetes, or gestational diabetes; e) good general health, as 
determined by medical history and physical examination, and f) parent/guardian of qualifying 
participant. These criteria are outlined in Table 5. 
Table 5. Inclusion criteria 
Inclusion Criteria 
a) Adolescent: Age 12-17 years 
At-risk for T2D:
b) Overweight/obesity: BMI 85 percentile for age and sex 
c) Family history of T2D: 
T2D, prediabetes, or gestational diabetes in first- or 
second- degree relative, referring to a biological parent, sibling, aunt, uncle, or grandparent 
d) Elevated depression symptoms: Center for Epidemiological Studies – Depression Scale (CES-D) 
total score >20
e) Good general health: Medical history/physical examination
f) Parent/guardian: Parent/guardian of qualifying participant
4.2 
Exclusion Criteria 
All candidates for this trial meeting any of the following exclusion criteria at baseline will be 
excluded from study participation: a) current major renal, hepatic, endocrinologic (e.g., T2D or 

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T1D), rheumatologic, cardiac, or pulmonary medical problem that would be likely to affect mood, 
weight, and/or insulin sensitivity; b) current major depressive disorder (MDD) diagnosis with 
high acuity, as assessed by the Suicidality and Self-Harm Module of the Schedule for Affective 
Disorders and Schizophrenia for School-Aged Youth-Computerized Version (KSADS-COMP, 
semi-structured clinical interview), or other psychiatric diagnosis reported by parent and/or 
adolescent, that in the opinion of the study investigators would impede compliance and/or 
necessitate more intensive treatment, including anorexia nervosa, bipolar disorder, bulimia 
nervosa, conduct disorder, , obsessive compulsive disorder, panic disorder, posttraumatic 
stress disorder, psychosis, and substance/tobacco/alcohol use disorder; c) current regular 
medication use affecting mood, insulin, cortisol, insulin sensitivity, and/or weight (e.g. anti-
anxiety medications, anti-depressants, anti-psychotics, insulin sensitizers, mood stabilizers, 
stimulants, and/or weight loss drugs); d) current active suicidal ideation or behavior; e) ongoing 
regular psychotherapy or structured weight loss treatment; and/or f) current pregnancy or 
breastfeeding in females. Table 6 summarizes exclusion criteria for this trial. The study team 
will maintain an internal guide detailing exclusionary and non-exclusionary medical and 
psychological concerns, medications, alternative treatments, and more, in order to ensure 
consistency across sites. 
Table 6. Exclusion criteria 
4.3 
Study Enrollment Procedures  
Identifying and recruiting candidates: We will recruit youth and their parent/guardian to 
participate from four data enrollment sites, with two sites in Colorado (Colorado State University 
and Children’s Hospital Colorado) and two in Maryland/Washington, D.C. (Uniformed Services 
University and Children’s National Medical Center). Recruitment methods will be effective 
strategies from each site’s prior and ongoing studies delivering interventions to adolescents with 
overweight/obesity (e.g., NCT#s 03085160, 02218138, 01425905, 03263351, 03527641, 
03086161, 03869749, 00081328, 02310724, 01775813, 03120871, 02671292, 02334202, 
00680979, 00263536). Recruitment methods for each site are as follows: 
Colorado State University:  
i) 
Flyers/letters/postcard mailings to area families with adolescents 12-17 years of age  
ii) Flyers/letters/postcards to area physicians, including practice-based research 
networks  
Exclusion Criteria 
a) Major medical problem: including T2D, assessed at baseline/screening 
mg/dL or 2-
current medical condition reported during 
the medical history/physical examination likely to affect mood, weight, and/or insulin sensitivity  
b) Major psychiatric problem: current psychiatric diagnosis, that in the opinion of the study 
investigators would impede compliance and/or necessitate more intensive treatment, including but not 
limited to anorexia nervosa, bipolar disorder, bulimia nervosa, conduct disorder, major depressive 
disorder (MDD) with high acuity (suicidality/self-harm), obsessive compulsive disorder, panic disorder, 
posttraumatic stress disorder, psychosis, and substance/tobacco/alcohol use disorder 
c) Regular medication use affecting mood, insulin, and/or weight: current anti-anxiety medications, 
anti-depressants, anti-psychotics, insulin sensitizers, mood stabilizers, stimulants, and weight loss 
drugs
d) Current active suicidal ideation or behavior
e) Regular ongoing psychotherapy or structured weight loss treatment
f) Current pregnancy or breastfeeding: as reported by adolescent participants (females)

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iii)
Advertisements on school/parent listservs, other community-area listservs, radio, 
newspapers or newsletters, social media (e.g. Facebook), and institutional websites  
iv) Flyers posted in hospitals, clinics, community health centers, fitness centers, and 
other area locations  
v) Informational booths/presentations at health fairs and/or schools, walk/run events, 
and T2D dining clubs or similar programs for adults, who may have adolescent 
children or grandchildren at risk for T2D  
vi) Phone, email, and/or letters/flyers to potentially eligible adolescents and their families 
through Health Data Compass and Research Match 
vii) Notices to Colorado State University Extension rural health agents
viii) Phone, email, and/or letters/flyers/postcards to potentially eligible adolescents and 
their families who have been screened by the Colorado State University team for 
previous studies and have stated that they may be contacted for future research 
opportunities
ix) Outreach at healthcare visits or via phone calls, emails, and flyer/letter mailings to 
patients and families receiving care at Fort Collins/Northern Colorado-area 
healthcare practices of medical provider associate investigators at the CSU site (e.g. 
Sheena Crowe, MSN, ACNP-BC, FNP-C; Alexandra Paz-Cox, NP), who will refer 
eligible adolescents and/or notify families with diabetes 
x) Outreach at healthcare visits or via phone calls, emails, and flyer/letter mailings to 
patients and families receiving care from study team investigators who are affiliated 
with Fort Collins/Northern Colorado-area healthcare practices (e.g., UC Health 
pediatrics and family medicine practices) that serve potentially eligible adolescents 
and/or families with diabetes
Children’s Hospital Colorado:
i) 
Flyers/letters/postcard mailings to area families with adolescents 12-17 years of age 
ii) Flyers/letters/postcards to area physicians, including practice-based research 
networks 
iii) Advertisements on school/parent listservs, other community-area listservs, radio, 
newspapers or newsletters, social media (e.g. Facebook), and institutional websites  
iv) Flyers posted in hospitals, clinics, community health centers, fitness centers, and 
other area locations
v) Informational booths/presentations at health fairs, walk/run events, and T2D dining 
clubs or similar programs for adults, who may have adolescent children or 
grandchildren at risk for T2D 
vi) Phone, email, and/or letters/flyers to potentially eligible adolescents and their families 
through Health Data Compass and Research Match 
vii) Direct outreach at clinical visits or via phone calls, emails, postcard mailings, and 
patient care portal messages to patients receiving care at the Children’s Hospital 
Colorado Networks of Care: Drs. Kelsey, Gulley, Shomaker (PI) all see patients in 
obesity and specialty clinics and will refer eligible adolescents 

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viii)Recruiting from colleagues of Drs. Shomaker, Gulley, Kelsey in their clinics, such as 
endocrine, adolescent medicine, obesity clinics, pulmonary, and/or other affiliated 
clinics
xi) Notices to CCTSI community engagement practice-based research networks and 
other physician offices in surrounding areas
xii) Phone, email, and/or letters/flyers/postcards to potentially eligible adolescents and 
their families who have been screened by the Children’s Colorado team for previous 
studies and have stated that they may be contacted for future research opportunities
Uniformed Services University: 
i)
Flyers/letters/postcard mailings to local families with adolescents 12-17 years of age
ii) Flyers/letters/postcards to area physicians who service both military and civilian 
youth, including practice-based research networks
iii) Flyers/letters/postcard mailings to military families with adolescents 
iv) Advertisements on school/parent listservs, radio, newspapers, social media (e.g., 
Facebook), and institutional websites   
v) Flyers posted in civilian and military hospitals, clinics, community health centers, 
fitness centers, and other area locations  
vi) Informational booths/presentations at health fairs, walk/run events, and T2D dining 
clubs and other similar programs for adults, who may have adolescent children or 
grandchildren at risk for T2D 
vii) Phone, email, and/or letters/flyers/postcards to potentially eligible adolescents and 
their families who have been screened by the Uniformed Services University team 
for previous studies and have stated that they may be contacted for future research 
opportunities
Children’s National Medical Center:
i)
Direct outreach at clinical visits or via phone calls, emails, and postcard mailing to 
patients receiving care at Children’s National Medical Center: Drs. Mackey and 
Estrada all see patients in the IDEAL Obesity Clinic and Diabetes specialty clinics 
and will refer eligible adolescents 
ii) Recruiting from colleagues of Drs. Mackey and Estrada in their clinics and/or other 
affiliated clinics (e.g., recruitment business card with link to flyer/REDCap survey) 
iii) Flyers/letters/postcard mailings to area families with adolescents 12-17 years of age 
iv) Flyers/letters/postcards/study business cards to area physicians, including practice-
based research networks 
v) Advertisements on school/parent listservs, radio, newspapers, social media (e.g. 
Facebook), and institutional websites  
vi) Flyers posted in hospitals, clinics, community health centers, fitness centers, and 
other area locations

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vii) Informational booths/presentations at health fairs, walk/run events, and T2D dining 
clubs or similar programs for adults, who may have adolescent children or 
grandchildren at risk for T2D
viii) Phone, email, patient care messages, and/or letters/flyers/postcards/business cards 
to potentially eligible adolescents and their families who have been screened by the 
Children’s National investigative team for previous studies and have stated that they 
may be contacted for future research opportunities
We will record, by site, recruitment strategies used, percentage of phone pre-screen contacts 
from each strategy, percentage enrollment from each strategy, and percentage of eligible youth 
who enroll. 
Procedures for documenting ineligibility and non-participation: At each site, we will 
maintain a parallel, participant tracking log that will contain all participants/families who the 
study team had contact with and/or who completed a phone or in-person screening for the 
study. This log will contain both eligible and ineligible participants. For those who are ineligible, 
or eligible but decided not to participate, we will document all reasons for exclusion, or non-
participation, within this log. The multisite coordinator will be responsible for periodic monitoring 
of each site’s log for thoroughness and completeness of study recruitment flow. Moreover, each 
screening visit has an accompanying progress note that will systematically record whether 
participants meet each eligibility criterion, and these data will be entered on the master tracker, 
in REDCap, and/or other approved, secure information-storing techniques as necessary. 
Consent procedures: The purpose, all testing procedures, program components, and 
randomization will be reviewed, in detail, by a trained member of the study team at each 
respective site. Potential volunteers will be informed of possible risks, inconveniences, potential 
benefits, and right to withdrawal. Participants will be encouraged to ask questions and staff are 
trained to periodically pause to check for questions and for understanding. All participants and 
parents/guardians who choose to volunteer will sign a COMIRB-approved consent/assent form. 
In the event of remote visit consent, e-consent will be obtained using REDCap and explained 
via secure video software (e.g., Vidyo, Zoom) or by phone. Hard-copies and/or electronic copies 
of the consent and assent will be made available to participants for their records, depending 
upon family preference and mode of consent (i.e., in-person/remote). 
Randomization procedure: Upon completion of all screening and baseline assessments, each 
eligible participant will be randomly assigned to either an MBI, CBT, or HealthEd group 
condition. A separate randomization sequence will be created for each site. Within site, we will 
create four strata by crossing sex and age group (12-14y, 15-17y) and we will use permuted 
blocks within each stratum to ensure the intervention group arms are balanced. A statistician in 
the Children’s Hospital Colorado’s Biostatistics Core, other than the study lead statistician (Dr. 
Pyle), will create the computerized randomization sequence and enter the sequence into 
REDCap’s randomization module. REDCap’s randomization module conceals the 
randomization sequence. The lead research coordinator will be responsible for using the 
REDCap randomization module to carry out randomization of eligible participants.  
5. 
STUDY INTERVENTIONS  
5.1 
Interventions  
Overview: In this three-arm multisite, randomized controlled pilot and feasibility trial, 
mindfulness-based intervention (MBI), cognitive-behavioral therapy (CBT), and health education 
(HealthEd) group programs are matched for time, attention, and facilitator training. All 

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interventions will be delivered for six weekly 1-hour group-based sessions. Group sessions will 
either take place via secure videoconferencing or in a conference room at each respective site. 
All interventions will be delivered by a clinical or counseling psychologist. Programs will be co-
facilitated by a graduate student in clinical or counseling psychology, social work, prevention 
science, or related field, or a research associate with a master’s degree in clinical or counseling 
psychology, social work, prevention science, or related field. To minimize facilitator effects, the 
lead psychologist facilitators at each site will facilitate all three programs. All facilitators and co-
facilitators will receive training and weekly supervision as described below. Interventionists 
cannot be blinded to intervention assignment due to the nature of the intervention.  
Intervention Training: All three interventions are manualized. Utilization of manuals for each of 
the three conditions supports fidelity, which will be closely monitored. Prior to delivery of the 
interventions as part of the multisite, pilot clinical trial, lead psychologist facilitators and co-
facilitators will participate in MBI, CBT, and HealthEd training. The training will be 5-days (~3 
days for MBI, ~1 day for CBT, ~1 day for HealthEd). We prefer to conduct the training in-person, 
but if circumstances (e.g., due to COVID-19) are more conducive to remote training, we will 
deliver some or all portions of the training remotely via videoconferencing. All trainings will 
video-recorded for future reference/training by the study team. 
Training will include presentations of theoretical/empirical background, review of manuals, 
modeling of session elements, and role-play in mock-groups. Dr. Lucas-Thompson (Co-I), a 
psychologist completing BREATHE master training certification with Dr. Patricia Broderick 
(Consultant; BREATHE developer), will lead training in BREATHE, the MBI program. Dr. Lucas-
Thompson has expertise delivering BREATHE with high fidelity/competence to at-risk 
teenagers. Dr. Gulley (Co-I), a psychologist trained in the Blues Program by Dr. Eric Stice 
(Consultant) and his team of Blues Program developers (Dr. Paul Rohde, Dr. Heather Shaw) 
and in HealthEd by Dr. Shomaker (PI), will facilitate training in the CBT Blues Program and the 
didactic control program, HealthEd. Gulley has demonstrated high fidelity/competence in CBT 
and HealthEd, as rated by the Blues Program development team and Dr. Shomaker.  
To assess training fidelity: a) MBI, CBT, and HealthEd training sessions will be video-recorded 
and rated by Dr. Broderick, Dr. Rohde, and Dr. Shomaker, respectively, on training fidelity 
forms; b) Facilitators will complete post-training surveys assessing quantitative knowledge of 
MBI, CBT, and HealthEd, following the didactic portion of the training; and c) Facilitators’ 
adherence and competence in conducting mock intervention sessions will be evaluated by 
experts (Drs. Broderick, Stice/Shaw/Rohde, and Shomaker) on standardized ratings scales to 
establish training fidelity prior to delivery to participants. Facilitators also will provide qualitative 
feedback on any recommended modifications to training procedures that they perceive would 
improve the training process, for use in a future NIH/NCCIH UG3/UH3 grant application/multisite 
efficacy trial. For descriptive purposes, facilitators will complete surveys of quantitative 
intervention knowledge prior to the didactic training, as well as feedback following the mock 
session training portion.  
Intervention delivery: Supervision and fidelity monitoring: Sessions will be audio-recorded 
and reviewed weekly by Dr. Lucas-Thompson (MBI) and Dr. Gulley (CBT, HealthEd) for 
intervention fidelity/adherence and facilitator competence. Feedback will be provided in weekly 
supervision. Facilitators with drift or deficiencies will be re-trained via “booster sessions” as 
needed. These protocols have been successful, as evidenced by strong ratings of adherence, 
competence, and absence of cross-contamination.56,57,128,130 Blinded experts will review audio-
recorded sessions and complete standardized/structured rating scales of fidelity/competence in 
administration of MBI, CBT, and HealthEd.  Non-participant/non-experts (e.g., trained 
undergraduate research assistants) also will complete ratings of intervention adherence. 

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Intervention acceptability: Attendance and home practice will be tracked at all sessions. 
Adolescents will report homework completion to facilitators, and also will record completion of 
home practices on journal logs for MBI and CBT. Adolescents will complete a weekly 
acceptability form.131
Group cohesion, therapeutic alliance, and expectancies: We will measure group cohesion 
and therapeutic alliance using two independent raters’ review of audio-recorded sessions using 
the Therapy Process Observational Coding System, which shows good psychometric 
properties.132 Raters will be blind to group assignment.  
Adolescents will complete the reliable and valid 12-item Therapeutic Alliance Scale for 
Adolescents (TASA)133 to assess their perceptions of their emotional bond and task 
collaboration both early (session 1) and at the end (session 6) of the interventions.133-135 Finally, 
as a quantitative index of outcome expectancy, we will ask adolescents to report at the end of 
session 1, their perspective of the likelihood that their stress, mood, and risk for T2D can be 
improved.136
5.2 
Prohibited Interventions  
Adolescents will not be enrolled if they are currently engaged in regular psychotherapy, 
medication treatment that could affect mood, weight, insulin sensitivity, or cortisol secretion, or a 
structured weight loss program. 
5.3 
Allowed Interventions 
Adolescents who are receiving counseling at school or through a non-professional counselor 
(e.g., church or religious affiliation), or adolescents who are not receiving regular weekly or 
biweekly psychotherapy (e.g., once per month) will not be excluded. Adolescents who are taking 
medications that do not affect mood, weight, cortisol, or insulin sensitivity will be allowed to 
participate. Likewise, adolescent females who are stabilized on birth control (~3 months) will not 
be excluded.  
5.4 
Adherence Assessment  
Adolescents’ adherence to the intervention will be measured by their attendance of 
MBI/CBT/HealthEd sessions. The benchmark for intervention adherence will be 5 out of 6 group 
sessions. An intervention session progress note will include an attendance log to track group 
session attendance, as well as make-up sessions. All adolescents who miss a group session in 
any of the three intervention arms will be invited to complete a make-up session to review the 
key material prior to the next group. If interventions overlap with holidays, an alternative day of 
the week will be offered (e.g., Tuesday instead of a Monday) or two consecutive group sessions 
may need to occur 2 weeks apart instead of 1 week (e.g., to avoid winter holiday break when 
many families are unavailable). Brief homework (10 minutes/day) in MBI and CBT will be 
tracked by participants on intervention participant workbooks, and also reported to facilitators at 
the start of session 2-6. Intervention adherence is calculated at the end of each cohort; 
attendance of at least 5 of the 6 group sessions is incentivized ($50). Total intervention 
adherence by arm, across sites, and homework completion will be described at the end of the 
study. Intervention adherence will be presented to the IMC and on the continuing review 
submitted to the IRB.  
6. STUDY PROCEDURES  
The overview of key study procedures for this multisite, pilot clinical trial is provided in Table 7.  

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6.1 
Schedule of Evaluations 
Table 7. Overview of key study procedures/assessments throughout the trial

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Construct: Assessment
Screening/ 
Baseline
Visit 1
Baseline 
At-Home 
Collection
Screening/ 
Baseline
Visit 2
Randomization: MBI, CBT, or HealthEd 
6-week Group  
6-week 
Follow-up 
6-week 
At-Home 
Collection
1-year 
Follow-up 
1-year 
At-Home 
Collection
Informed consent/assent   
X 
 
 
 
 
 
 
BMI indices:  
Height & weight 
X 
X 
X 
X 
Medical & family history 
X 
 
 
X 
 
X 
 
Good general health: 
Physical & puberty exam  
X*
X* 
X 
Depression: CES-D survey 
X  
(pre-screen)
 
 
X 
 
X 
 
Psychopathology: 
Medical history 
& K-SADS interview 
X 
 
  
X 
 
X 
 
Insulin sensitivity: OGTT 
 
 
X 
X 
 
X 
 
Body composition:  
BodPod measurement 
X 
X 
X 
Stress-related behavior 
 
 
 
 
 
 
 
   Hedonic eating:  
Interview, survey, & 
laboratory test meal
X 
X 
X 
Physical activity:   
ActiGraph 
X 
X 
X 
X 
Stress-related physiology
Stress reactivity: 
Trier Social Stress Test
X 
X 
Cortisol dysregulation: 
Saliva  
X 
X 
X 
BMI: body mass index indices derived from height and weight. CBT: cognitive-behavioral therapy; CES-D survey: Center for Epidemiologic 
Studies-Depression Scale, assessed at the phone pre-screen phase; HealthEd: health education; K-SADS: Schedule for Affective Disorders 
and Schizophrenia for School-Age Youth – Computerized Version semi-structured interview; MBI: mindfulness-based intervention; OGTT: oral 
glucose tolerance test; T2D: Type 2 diabetes. *Exam may be completed at either screening visit based upon medical provider availability. 

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6.2
Description of Evaluations
6.2.1 Phone Screening Evaluation 
We will conduct a phone screen to estimate eligibility. The phone screen will estimate the 
inclusion criteria of: age, height and weight to estimate BMI percentile, and family history of 
T2D; and the exclusion criteria of: major medical problem and exclusionary medication use. At 
this stage, we also will have adolescents complete a REDCap survey of the CES-D depression 
measure to determine the inclusion criterion for elevated depression symptoms (CES-D total 
score >20). Adolescents who cannot easily access REDCap may be screened by CES-D 
interview (i.e., asking the questions by phone). We have used the same approach in previous 
studies (e.g., COMIRB protocol #16-2571). Using this approach, approximately 74% of 
adolescents who meet eligibility criteria by phone screen also meet eligibility criteria when they 
proceed to the consent and screening/baseline assessment phase. 
Adolescents who appear to be eligible following the phone screening phase will be scheduled 
for a series of two screening/baseline assessment appointments. The first screening/baseline 
assessment may take place either remotely via secure video software/phone or in-person. The 
second screening/baseline assessment will be conducted in-person in the laboratory. 
Laboratory assessments will be collected at one of the four sites: (i) the Pediatric Clinical and 
Translational Research Center (CTRC) at Children’s Hospital Colorado, (ii) the Human 
Performance and Clinical Research Laboratory at Colorado State University, (iii) the Military 
Cardiovascular Research Outcomes Program at the Uniformed Services University, or (iv) the 
Children’s Research Institute at Children’s National Medical Center. Ambulatory measures of 
physical activity and cortisol will be assessed in between the first and second 
screening/baseline appointments.  
6.2.2   Consent and First Screening/Baseline Assessment 
The following procedures will occur at the first screening/baseline assessment appointment to 
determine eligibility: 
i. 
Informed consent/assent: The purpose, all testing procedures, program components 
and randomization will be reviewed by a trained member of the study team, in detail, 
at each respective site. Potential participants will be informed of the possible risks, 
inconveniences, benefits, and right to withdrawal. All participants and 
parents/guardians will sign COMIRB-approved consent/assent forms. In the event of 
a remote visit, e-consent will be obtained using REDCap and explained via secure 
video software or by phone. In the event that any changes are made to the 
consent/assent form(s) that require participants and parents/guardians to be re-
consented, a member of the study team will explain the change in detail and have 
participants and parents/guardians sign a new copy of the updated consent/assent 
forms before further study procedures occur. 
ii. 
BMI indices: BMI (kg/m2) will be derived from height by stadiometer and weight by 
calibrated digital scale. BMI %ile137
percentile). If this initial screening/baseline visit is completed remotely, participants 
and parents/guardians will be provided with CDC instructions for obtaining an 
accurate height and weight, which will be used to estimate eligibility. These 
estimates will provide a reasonable estimate of whether youth will meet the BMI 
eligibility criterion. Using this approach in our other studies (e.g., COMIRB Protocol 
#16-2571), 100% of youth meet the BMI criterion at the second screening visit. The 
fasting measurement of weight and measured height collected at the second 
laboratory screening/baseline visit will be used to compute baseline BMI indices and 

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to determine final eligibility for this criterion.
iii. 
Medical and family history: A brief psychiatric and medical health history, including 
T2D, prediabetes, and gestational diabetes, of the participant and family will be 
conducted with a parent/guardian by a trained research staff member. Psychiatric 
history includes parent and teen report of any mental health diagnoses that could be 
exclusionary; if the family reports a current mental health diagnosis (e.g., anorexia 
nervosa, bipolar disorder, bulimia nervosa, conduct disorder, MDD with high acuity, 
obsessive compulsive disorder, panic disorder, posttraumatic stress disorder, 
psychosis, and substance/tobacco/alcohol use disorder), a psychologist will speak 
with the family for further assessment and follow-up/referrals (and exclusion), as 
indicated. Eligibility based upon at least one first- or second-degree relative will be 
determined, as well as medication status. As in our other studies,119,138 females will 
report whether they are or suspect that they could be pregnant. Pregnant females 
will not be included. 
iv. 
Psychopathology: The Schedule for Affective Disorders and Schizophrenia for 
School-Age Children (K-SADS) – Computerized Version139 Suicidality and Self-Harm 
module will be administered to determine if adolescent girls and boys report 
depression acuity that, in the opinion of the study investigators, would warrant study 
exclusion and necessitate a referral for more intensive treatment. Any participant 
with current active suicidal ideation or self-harm, regardless of degree of mood 
concerns, will be referred for treatment (and excluded). If the screening visit is 
completed remotely, a parent or guardian will be asked to be in the home and 
accessible for the duration of the completion of the K-SADS to ensure access for 
communication of any safety concerns. Additionally, the interviewer will confirm the 
child’s physical location prior to starting the interview. Written remote safety protocols 
have been developed in the event that suicidal ideation or other risks concerns arise. 
v. 
Physical exam/puberty staging: Physical exam, including puberty staging as well as 
review of vitals, blood pressure, and waist circumference, will be conducted to 
evaluate adolescent health status. Exam may take place during either the first or 
second screening visit based on participant and provider availability. 
6.2.3   Second Screening/Baseline Assessment 
For the second screening/baseline assessment, participants will be asked to arrive for a 
morning appointment at the Pediatric CTRC at Children’s Hospital Colorado, the Human 
Performance and Clinical Research Laboratory at Colorado State University, the Military 
Cardiovascular Research Outcomes Program at the Uniformed Services University, or the 
Children’s Research Institute at Children’s National Medical Center. They will be asked to 
observe a 10-hour overnight fast, meaning nothing to eating or drink other than water from 
~10:00pm the night prior and the morning of their appointment. The following measurements to 
determine eligibility will be collected at this visit:  
i. 
BMI indices: BMI (kg/m2) will be derived from measured height in triplicate by 
stadiometer and fasting weight by calibrated digital scale. BMI z-score and BMI 
%ile137 will be computed to determine 
 
ii. 
Physical exam/puberty staging: Physical exam including blood pressure in triplicate 
and waist circumference will be conducted to evaluate adolescent health status. 
Exam may take place during either screening visit 1 or 2 based on participant and 
provider availability. 
iii. 
Insulin resistance: Oral glucose tolerance tests (OGTTs) are a well-validated, yet far 

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more practical and less invasive, costly, and labor-intensive method than clamps or 
intravenous glucose tolerance testing, while still permitting screening for T2D.141
Following a 10-hour overnight fast, participants will receive 1.75 g/kg of glucola 
(max=75g). Blood will be sampled for insulin and glucose at fasting and 2-hours. 
Insulin resistance will be estimated from fasting insulin and glucose with the 
homeostasis model assessment of insulin resistance (HOMA-IR),142 and we will 
calculate insulin sensitivity index (ISI) using fasting and 2-hour insulin and 
glucose.143 Extant data suggest that ISI may yield more valid estimates of insulin 
sensitivity than HOMA-IR alone.144-147 OGTT is well validated in youth, practical in 
large pediatric cohorts, and shows excellent convergence with estimates derived 
from more frequent sampling methods.143-145,148,149 While for research purposes, 
blood will be processed and frozen until processing by the University of Colorado 
Core Laboratory for estimation of insulin/glucose to compute HOMA-IR and ISI 
metrics, fasting glucose and two-hour glucose will be checked at the visit, directly 
after each respective draw, for eligibility using an automated point-of-care device 
(e.g., StatStrip). If blood cannot be obtained with venipuncture, blood will be drawn 
using a finger prick by lancet to determine eligibility. Individuals with impaired fasting 
glucose (fasting glucose >=100 mg/dL), impaired glucose tolerance (2-hour OGTT 
glucose >=140 mg/dL), or with values potentially suggestive of T2D (fasting glucose 
>=126 mg/dL or 2-hour OGTT glucose >=200 mg/dL) will be notified and referred to 
their physician. 
6.2.4 Enrollment, Baseline, and Randomization 
Enrollment 
This study uses a single informed consent form (for both parent/guardian and adolescent 
minor), that describe both the screening evaluations and the study procedures. Children’s 
National Medical Center has a site-specific consent form and a separate site-specific assent 
form, reviewed and signed by the parent/guardian and adolescent, respectively. We will track 
the number of parents/participants who sign consent forms. “Enrollment” will be defined as the 
date of randomization. The enrollment date will be recorded on a case report form.  
Baseline Assessments 
As part of the screening process, adolescents will complete measures across both screening 
study visits. Measures may be completed at either visit or remotely, unless otherwise listed 
(e.g., Food Preferences Questionnaire). 
i. 
Adolescents will report eating in response to negative affect on the Emotional Eating 
Scale-Adapted for Children (EES-C).150 Youth rate the frequency of coping with negative 
affect in response to depression, as well as anxiety/anger/frustration and feeling 
unsettled. This measure shows good internal consistency, test-re-test reliability, 
discriminant and convergent validity,150 including with our laboratory test meal studies.86
Adolescents also will complete the Reward-Based Eating Drive Scale (REDS), a 
reliable/valid survey instrument of hedonic eating.151,152 Participants will complete these 
surveys via REDCap. 
ii. 
Theoretical therapeutic mechanisms: Adolescents in all conditions will complete four 
baseline surveys to measure theoretically informed therapeutic mechanisms underlying 
MBI and CBT. All adolescents will complete the Mindful Attention Awareness Scale 
(MAAS).153 They also will complete the 20-item short form of the Five Factors of 
Mindfulness Questionnaire (FFMQ).154 Parents will describe their adolescents on the 
Behavior Rating Inventory of Executive Functioning (BRIEF), assessing everyday 

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behavioral problems related to poor self-monitoring, emotional control, and related 
elements of executive dysfunction.155 Adolescents will report frequency of negative and 
positive thoughts on the Children’s Automatic Thoughts Scale-Negative/Positive.156,157
They will describe frequency and perceived  pleasantness of social and physical 
activities on the Pleasant Events Schedule (PES).158
iii. 
Socioeconomic status: Parents will report on a number of standard demographic and 
socioeconomic factors that are indicators of the multifaceted construct of socioeconomic 
status (SES), including items from the Hollingshead Index,159 the MacArthur Scale of 
Subjective Social Status,160 and the Household Food Insecurity Access Scale.161  
 
In addition to the screening evaluations described in section 6.2.1, the following baseline 
assessments will be collected: 
Screening Visit 1 
At the first screening visit, which will take place either remotely or in-person, the following 
additional survey will be given: 
i. 
Food Preferences Questionnaire: Participants will be asked to rate how much they like 
or dislike the foods that will be served during the laboratory eating paradigm (see below). 
We will assess average liking of lunch meal foods and average liking of snack foods, as 
well as the percentage of foods that were rated as “liked” (>5 on a Likert Scale from 1=I 
hate the food to 10=I love the food) for the lunch meal foods and for the snacks. 
Baseline ambulatory home assessments 
Adolescents will complete the following assessments in between the first screening visit and the 
second screening visit; adolescents will be offered an opportunity to re-wear/recollect home 
measures after the second screening visit, if they are non-compliant, in order to minimize 
missing data: 
i. 
Stress-related behavior: Physical activity: Habitual activity will be measured with the 
ActiGraph GT3X accelerometer (ActiGraph, Pensacola, FL), a lightweight monitor with 
well-established validity, reliability, and low reactivity in diverse child and adolescent 
samples for over 10 years.3 Adolescents will wear the monitor on their right hip during 
waking hours for 7 days. Consistent with recommended protocols, devices will be set to 
record with a 30 Hz sampling frequency and analyzed with 15-second epochs 
throughout the wear period. Adolescents will be given a log to record wear. Data will be 
reduced manually with data output and logs to delete non-wear periods. Following expert 
recommendations, data recorded on the first/last day will be discarded for 
data, including 1 weekend day will be retained in analyses.192,193 Mean ActiGraph 
counts/minute will be classified as moderate-to-vigorous or sedentary time according to 
validated count thresholds determined by Evenson et al.194 and validated in youth.195,196 
ActiGraph offers the advantage of characterizing the entire picture of habitual physical 
activity, including MVPA and sedentary time. 
ii. 
Stress-related physiology: Cortisol diurnal rhythm: Cortisol awakening and diurnal 
rhythm will be assessed with saliva collected in the home on 1 weekday and 1 weekend 
day.200 Samples will be obtained with an oral swab under the tongue for 120 sec at 
awakening, 2, 15, 30, and 45 minutes after awakening, 4:00 pm, and bedtime.201,202
Adolescents will be instructed to refrain from eating/drinking (other than water) until after 
the 45-minute sample and for 15 minute prior to afternoon/bedtime samples. As in our 

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past studies, the use of a participant log, phone/text reminders, and alarms will be used 
to support adherence. We will use color-coded screw-top bottles that record opening 
times to improve accuracy of collection timing, given its high importance.201 Salivary 
cortisol is a well-accepted non-invasive indicator of circulating physiologically active free 
plasma cortisol.203 Latent growth models will model non-linear change in cortisol across 
2 days as awakening response and diurnal rhythm.202
Screening Visit 2 
At the second screening visit in the laboratory, the following additional baseline assessments 
will be evaluated: 
i. 
Pubertal staging: As puberty is related to insulin resistance,18 Tanner staging for 
breast and pubic hair (females) and testicular volume and public hair (males) will be 
performed by a trained medical provider. To accommodate medical provider 
schedules and participant/family schedules, pubertal staging may be carried out at 
screening visit 1 instead. Additionally, Tanner stage will be collected through 
adolescents’ self-report on a validated questionnaire.162 Participants will be asked to 
define their physical development based on illustrations of their external 
characteristics, which corresponded to Tanner stages 1-5 of breast and pubic hair 
development for girls and Tanner stages 1-5 of testicular volume and pubic hair 
development for boys.  
ii. 
Body composition: During a fasted state, fat/fat-free mass will be assessed via air 
displacement plethysmography (BodPod), which shows good test-retest reliability 
and convergence with dual energy x-ray absorptiometry,163 but is far more cost-
effective.  
iii. 
Stress-related behavior: Several measures of hedonic eating, referring to eating for 
reward/pleasure as opposed to physiological hunger,75 will be collected. The 
overeating section of the Eating Disorder Examination (EDE), a semi-structured 
interview, will be administered by a trained research assistant to identify frequency of 
3 types of eating episodes: objective binge (overeating with loss of control), 
subjective binge (loss of control without objective overeating as assessed by the 
interviewer, but viewed as excessive by the interviewee), and objective overeating 
(overeating without loss of control). Tests of the EDE’s discriminant validity, internal 
consistency, concurrent validity and test-retest reliability support its use in 
adolescents.164-166 The EDE may be conducted in-person during the screening visit, 
or alternatively, may be conducted remotely using secure video software or by 
phone.  
A laboratory paradigm138 will be used to observe eating in the absence of hunger, 
which we have shown is related to dispositional mindfulness in adolescents at risk for 
T2D.168 After eating a lunch-type meal until no longer hungry, youth will eat ad libitum 
for 15 minutes from a large, palatable snack food array. Youth are instructed to taste 
and rate their preferences for the snack foods and then to consume as much as they 
would like. Activities (e.g., magazines, coloring sheets, handheld video game like a 
Nintendo Switch) are provided during the snack period. Snacks consumed are 
assessed as changes in weight (g) before-after eating, and total energy intake (kcal) 
in the absence of hunger is calculated using USDA National Nutrient Database for 
Standard Reference and nutrient manufacturer information. 
iv. 
Stress-related physiology: Adolescents will complete the Trier Social Stress Test,169
involving a 10-minute speech and 4-minute mental arithmetic task in front of an 

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evaluator, which is known to induce a physiological stress response.170 Blood 
pressure and heart rate will be monitored approximately every 3 minutes throughout 
the test and summarized as area under the curve. We have shown that dispositional 
mindfulness relates to adolescents’ reactivity in this task.171  
Randomization 
Upon completion of all screening and baseline assessments, a research staff will notify the 
adolescent and their parent/guardian that they completed all screening and baseline 
assessments and are eligible. The ideal window is that screening/baseline assessments will 
occur within 12 weeks/3 months of the start of the intervention phase (first group session); we 
will allow for up to 6 months between screening/baseline and group initiation. In the event that 
more than 6 months transpires since the screening/baseline interval, all interested adolescents 
who appeared to be eligible or who had been determined to be eligible, will be invited to 
complete a re-screening, referring to a repeat of all screening/baseline assessments. Re-
screening will only be offered if there is sufficient opportunity for the participant to take part in a 
subsequent intervention cohort (e.g., originally screened for cohort 1, but after >6 months, could 
be re-screened to be considered for participation in cohort 2). After all screening/baseline 
assessments are complete and prior to randomization, adolescents and parent/guardians will be 
asked to confirm their desire to continue to participate in the study. Adolescents and parents will 
each, independently report their preference for group condition (MBI, CBT, HealthEd, or no 
preference). Adolescents then will be randomly assigned to either a MBI, CBT, or HealthEd 
group using the RedCAP randomization module by the lead study coordinator. Date of 
randomization will be considered date of enrollment.  
6.2.5 Blinding 
The RedCAP randomization module conceals the randomization sequence. Thus, prior to 
randomization, all study personnel will be blind to allocation. Upon randomization, follow-up 
research staff assessors will remain blinded to allocation. These staff include those performing 
follow-up interviews, test meals, body measurements, and insulin resistance. Additionally, raters 
of intervention administration fidelity/competence (Drs. Patricia Broderick and Eric Stice 
research groups, experts in MBI and CBT programs, respectively) will remain blinded to rating 
of the adolescent group intervention sessions, as well as raters of group cohesion. Dr. 
Shomaker and Dr. Pyle will remain blind until the database is locked.  
To protect the blind, the intervention arm allocation will be limited to the minimum number of 
study documents necessary to pragmatically operate the study. Research staff running follow-
up assessments, as well as the expert raters and Drs. Shomaker and Pyle, will not have access 
to any study document that reveals the blind.    
6.2.6 Follow-up Visits 
There are two follow-ups for this study: a 6-week/post-treatment follow-up and a 1-year follow-
up. The 6-week follow-up visit ideal window will be within 4 weeks of the last group session; the 
6-week follow-up will be completed no longer than 8 weeks after the last session of the group 
intervention. The 1-year follow-up visit ideal window will be 12 months (-/+ 4 weeks) after the 
first group session; the 1-year follow-up will be completed no longer than 18 months after the 
first day of the group intervention.   
The following assessments will take place at each follow-up: 
6-week Follow-up Visit 
The following assessments that were collected at baseline will be repeated: 

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BMI: height/weight body measurements 
 
Physical: blood pressure/waist circumference (no Tanner/pubertal staging) 
 
Body composition: BodPod 
 
Depression symptoms: CES-D survey 
 
Suicidality/self-harm: K-SADS-COMP interview to assess suicidality and self-harm only 
since the group program started
 
Insulin resistance: OGTT 
 
Hedonic eating: EDE interview, EES-C, REDS, and laboratory test meal and food 
preference questionnaire
 
Stress reactivity: Trier Social Stress Test 
Therapeutic mechanisms: MAAS, FFMQ, BRIEF-Parent Version, Children’s Automatic 
Thoughts Scale, and PES 
 
Medical health history: Medical health, including treatment history (e.g., new 
medications, initiation of counseling, etc.), will be updated 
 
At-home collection: Adolescents will re-wear ActiGraph assessment of physical activity 
and repeat home saliva collection 
In addition to the repeat assessments, we also will conduct the following evaluations at the post-
treatment/6-week follow-up interval: 
 
Adolescent focus groups: We will conduct adolescent focus groups with each MBI, CBT, 
and HealthEd group. This qualitative strand adds patient voice to this multisite 
intervention refinement and optimization phase, ensuring outcomes of a future, larger 
efficacy trial are meaningful, valuable, and helpful for adolescents.172 Trained 
moderators will facilitate small group discussions, using a mix of open-ended and 
targeted questions designed to engage adolescents and elicit emergent themes that 
may not have been captured through the quantitative strand.173 Focus groups will cover 
adolescents’ subjective experiences of: 1) enabling mechanisms, 2) stress/mood 
management, 3) negative aspects of interventions, 4) facilitators/barriers to home 
practice, and 5) perceptions of group cohesion/facilitator alliance. 
 
Parent acceptability: Parents will complete an adapted program acceptability 
questionnaire131 to assess parents’ knowledge and monitoring of their adolescents’ 
home practice assignments, as well as parents’ perceptions of likeability, credibility, and 
perceived benefits to their teenagers’ stress, mood, health behaviors, and physical 
health and T2D risk. In addition to structured questions, we also will include open-ended 
prompts to provide feedback on enablers/barriers to group participation and home 
practice. 
1-year Follow-up Visit 
The following assessments that were collected at baseline will be repeated: 
 
BMI: height/weight body measurements 
 
Physical/puberty: blood pressure/waist circumference/Tanner staging and self-reported 
puberty questionnaire 
 
Body composition: BodPod 

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Depression symptoms: CES-D survey 
 
Suicidality/self-harm: K-SADS-COMP interview to assess suicidality and self-harm only 
since the last assessment
 
Insulin resistance: OGTT 
Hedonic eating: EDE interview, EES-C, REDS, and laboratory test meal and food 
preferences questionnaire 
 
Stress reactivity: Trier Social Stress Test 
Therapeutic mechanisms: MAAS, FFMQ, BRIEF-Parent Version, Children’s Automatic 
Thoughts Scale, and PES 
 
Medical health history: Medical health, including treatment history (e.g., new 
medications, initiation of counseling, etc.), will be updated
 
At-home collection: Adolescents will re-wear ActiGraph assessment of physical activity 
and repeat home saliva collection 
In addition, adolescents will report their degree of maintenance of techniques or application of 
knowledge learned during the intervention: 
 
Maintenance: Adolescents will report the degree to which they are using MBI, CBT 
techniques and/or application of HealthEd knowledge. 
6.2.7 Completion/Final Evaluation 
The 1-year follow-up visit, including at-home collection evaluations, represents the participant’s 
completion of the study and final evaluation. In line with the intent-to-treat principle, we will 
follow all participants who are enrolled/randomized regardless of their participation in the 
intervention phase. Adolescents who are eligible at baseline but who develop conditions that 
would have been exclusionary will continue to be studied unless there is a concern about safety 
and/or a significant concern about validity (e.g., female who becomes pregnant and is pregnant 
or nursing at the time of the 6-week or 1-year follow-up evaluation). In samples of adolescents 
with overweight/obesity, family history of T2D, and elevated depression symptoms, it is 
anticipated that some adolescents will develop T2D and MDD. Safety assessments are in place, 
as in our other trials, and are addressed in this protocol, section 7. At completion of the 1-year 
follow-up/study endpoint, we will give study participants a letter of appreciation for their 
participation. Because we are working with at-risk adolescents in this study, we will provide a 
site-specific study mental health referral list to all participants at the conclusion of the study. 
Upon initiation of the 1-year follow-ups for the study, we will conduct personnel focus groups 
(e.g., research coordinators, research assistants, intervention facilitators) to qualitatively 
evaluate the protocol. These focus groups will cover personnel’s subjective experiences of: 1) 
enabling mechanisms, 2) negative aspects, and 3) protocol barriers. Information gleaned from 
these focus groups will inform modifications to optimize all aspects of the protocol for a future 
larger scale multisite efficacy trial. 
7. RISK ASSESSMENTS 
7.1      Risks 
The risks associated with participation in the proposed study are consistent with IRB definitions 
of minimal risk. Participants and their parents/guardians will be informed in detail of all potential 
risks during the informed consent and assent process. We anticipate the follow risks: 

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i.
Physical examination: Physical examination by a licensed medical provider, including 
a physician or advanced practice provider, will be performed in a private examination 
room. Although appropriate measures will be taken to protect privacy, some 
adolescents may find this embarrassing.  
ii. 
Phlebotomy: We will draw a blood sample in a fasted state and two-hours after 
glucola administration. We will minimize the pain of blood drawing by offering the 
participant numbing cream prior to the blood draw. Blood will be drawn by 
venipuncture, but finger prick for point-of-care glucose assessment will be offered if 
blood cannot be obtained by venipuncture. Discomforts are common, but minor. In 
about one in 10 cases a small amount of bleeding under the skin will produce a 
bruise (uncommon risk). The risk of a blood clot forming in the vein is about one in 
100, while the risk of infection or significant blood loss is one in 1000 (rare, but 
serious). Amount of blood withdrawal (no more than 3 tablespoons at the screening, 
and 3 tablespoons at each of the 2 follow-up appointments: 6-week and 1-year) is 
well below the NIH and pediatric IRB guidelines for a safe amount of blood 
withdrawal.   
iii. 
ActiGraph: This small device to measure moderate-to-vigorous physical activity and 
sedentary time will be worn on the hip for 7 consecutive days at the baseline period 
and again at the 6-week and 1-year follow-up intervals. Aside from the 
inconvenience of wearing the device and removing it during water-based activities 
(e.g., swimming), as well as the time required to complete the accompanying log to 
record activity, there is no risk involved with these devices.   
iv. 
Air displacement plethysmography (BodPod): Body fat and fat-free mass 
measurements by BodPod involve no risk and are not painful. It is possible that 
some participants may feel slightly claustrophobic because the BodPod requires the 
occupation of a small space for a short period of time. Participants also must wear 
tight-fitting clothing, such as a bathing suit, for the test. Participants can always 
communicate with the experimenter during the test. Any individual who is 
uncomfortable may stop the test at any time. 
v. 
Salivary samples: Saliva samples entail no risk but may be inconvenient.  
vi.
Psychological questionnaires, interviews, and focus group: Psychological testing 
involves no risk but may cause inconvenience because of the time required for 
testing. It also may cause slight discomfort if the wording of some questions makes 
the subject uncomfortable. The scales and interviews used are well-validated 
instruments designed to seek information without undue embarrassment to the 
participants. Qualitative focus group queries will be prepared with the guidance of Dr. 
Thompson (Co-I), a psychologist and qualitative expert, and administrators will be 
thoroughly trained in their proper, standard administration. For all quantitative and 
qualitative measures, participants are not required to answer a question if it makes 
them uncomfortable. Psychological questionnaires will be administered by trained 
research staff. Psychological interviews will be conducted by a psychologist or 
trained post-doctoral fellow, graduate student, or research coordinator.   
vii. 
Laboratory test meals: Food ingestion under controlled conditions involves no risk 
and is not expected to cause any participant discomfort. Participants who report food 
allergies to items on the laboratory test meal will not participate in this assessment 
for safety; based upon our prior implementation of this meal paradigm with 1,000s of 
youth, the vast majority (>99%) are not allergic and report high liking of the foods 
served. Research staff who will be preparing and measuring food for the laboratory 

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test meals will have completed food safety training that focuses upon safe food 
handling, proper temperatures, hand washing, and using gloves for handling foods. 
Staff also will be trained on the weighing/processing of foods for controlled feeding 
studies to ensure consistency in the method and presentation within and across the 
study sites.  
viii. 
Trier Social Stress Test (TSST): The TSST has been used in multiple vulnerable 
populations, including children and adolescents, the elderly, and pregnant women. 
While it may make participants temporarily nervous or uncomfortable, the TSST is 
designed to specifically elicit the physiological response system. Performing this task 
may cause some temporary emotional distress. Typically, this distress does not last 
long. The amount of physiological arousal that the TSST generally elicits is roughly 
comparable to mild physical exertion. Participants are told ahead of the task that they 
have the right to stop the task at any point should they wish. If there is evidence of 
severe distress, researchers are trained to stop the task. All participants are 
debriefed after each visit in which the TSST is administered. 
ix. 
Group participation: In the course of MBI, CBT, and HealthEd, issues arise that may 
be uncomfortable or stressful for some participants. Based upon the participant’s 
level of comfort and relevance of the concern to the group process, such issues may 
be discussed in the group. In querying adolescents about their psychological 
functioning, serious psychiatric disturbances may be uncovered. In addition, topics 
that may be personally sensitive will be discussed in group. Emotional distress is 
typically expected and often an important component necessary to make the 
changes required for improvements in mood or stress. There also may be times of 
conflict between group members. While stress and interpersonal conflict are 
emotionally difficult experiences and may cause distress for participants, they are 
often part of the process of making changes. The goal of the group facilitators and 
the group as a unit is to support each participant through stressful periods in order to 
reduce depressive symptoms and improve mood. Groups will be led by a 
psychologist, who will be fully trained in the programs, and they will receive weekly 
supervision from Dr. Lucas-Thompson (MBI) and Dr. Gulley (CBT, HealthEd). 
7.2    Adequacy of Protection Against Risks 
Subjects will be encouraged to report any discomforts during testing and any illness or change 
in wellbeing immediately to the local site PI or study coordinator at any time during the study. 
The following protection against risks are in place: 
i. 
Phlebotomy: Sterile technique followed by brief compression and utilization of trained 
phlebotomists will minimize risk of infection or bleeding. ELA-Max cream or an over-
the-counter numbing cream (e.g., Anusol) can be applied to minimize pain. 
Participants will rest in bed or chair while phlebotomy is performed to ensure safety. 
Phlebotomy will be collected at Colorado State University (CSU; Site 1) in the 
Human Performance/Clinical Research Laboratory, at Children’s Hospital Colorado 
(CHCO; Site 2) in the Pediatric Clinical and Translational Research Center (CTRC), 
at the Uniformed Services University (USU; Site 3) in the Military Cardiovascular 
Outcomes Research (MiCOR) program, and at Children’s National Medical Center 
(CNMC; Site 4) in the Clinical Research Unit. All units are familiar with blood drawing 
and equipped to perform far more complex procedures (e.g., intravenous glucose 
testing, clamps, biopsies, etc.) than the fasting and two-hour blood draws proposed 
in the current protocol. In addition, a physician or advanced practice provider will 
always be on call. 

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ii.
Emotional assessments, monitoring, and referrals: It is anticipated that within 
samples comprised of adolescents with overweight/obesity and elevated depression 
symptoms, there will be participants who develop more severe depressive symptoms  
or suicidal ideation or behavior. Should a participant demonstrate signs of active 
suicidal ideation or suicidal behavior or worsening depression or mental health, 
referrals to mental health providers will be provided. All participants are carefully 
debriefed and written procedures for managing risk and safety circumstances (e.g., 
suicidality) are in place. During the baseline screening, if the KSADS-COMP 
interview assessment reveals current suicidal ideation or self-harm or if 
parents/teens reports a current exclusionary mental health diagnosis, the participant 
will be referred for treatment and excluded from the study. During the active 
intervention phase, participants’ mood will be monitored weekly on a mood 
monitoring form that includes an assessment of suicidal ideation. During the 6-week 
and 1-year follow-ups, the KSADS-COMP is re-administered to assess for 
suicidality/self-harm. All research KSADS-COMP interviewers and MBI, CBT, and 
HealthEd interventionists will be trained to assess suicidal intent, plan and possible 
method, and they will discuss this assessment with a clinical psychologist supervisor 
at each site. A specific, detailed protocol is in place for addressing concerns about 
worsening mood or reports of suicidality. If indicated, a treatment referral will be 
facilitated with the participant and the family. If the participant is in need of an urgent 
evaluation (e.g., is actively suicidal with a plan and intent to carry out such actions), 
she or he will be immediately referred to the nearest emergency department until the 
participant can be safely referred for outside treatment as recommended.  
Based upon our prior studies,56,57,100,119 we anticipate that depression symptoms will 
improve in both MBI and CBT, with potentially greater improvements in MBI. We also 
anticipate that depression symptoms will improve in adolescents assigned to 
HealthEd, but to a lesser extent than adolescents in MBI and CBT. CBT is a 
treatment of choice for prevention and treatment of depression,174 and the particular 
CBT manualized program used in this study has demonstrated efficacy and 
effectiveness in reducing depression symptoms and preventing future MDD 
occurrence in adolescents over a 1-2 year follow-up.123-125 MBI has less research 
evidence, particularly for long-term follow-up/duration of effects, but our preliminary 
data support the possibility that the particular manualized intervention proposed in 
this trial, Learning to BREATHE, may be superior to CBT, for decreasing depression 
symptoms at post-treatment and up to 1 year later.100,101 Adolescents recruited for 
participation in the current, proposed study will have elevated depression symptoms, 
but will not report a psychiatric diagnosis that, in the opinion of the study 
investigators, necessitates treatment. Likewise, adolescents will not be enrolled who 
report current active suicidality or self-harm. Most adolescents with subthreshold 
depression symptoms, as well as the majority of adolescents with depression 
disorders like MDD, do not seek or obtain treatment. Thus, participation in the study 
holds the prospect, regardless of condition, of increased monitoring than would be 
likely if adolescents did not participate. 
iii. 
Physical assessments, monitoring, and referrals: During the baseline screening, if 
assessments reveal a physical health problem (e.g., T2D), the participant will be 
referred for treatment and excluded from the study. Eligible adolescents who 
proceed to enrollment/randomization will be identified as being at risk for developing 
T2D, but they will not have current T2D. The vast majority of adolescents at-risk for 
T2D do not receive interventions to reduce their risk of developing T2D. Intensive, 
structured lifestyle interventions in clinical trials have demonstrated some short-term 

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success in adolescents, but typically have limited sustainability and poor 
adherence.24 Thus, adolescents who are randomly assigned to the attention- and 
time-matched didactic control condition, HealthEd, will receive more support and 
psychoeducation than they would very likely receive if they did not participate in the 
study. Our preliminary data also are suggestive of the possibility that CBT and MBI 
(Learning to BREATHE) may improve or prevent the worsening of insulin 
resistance.56,57,100    
iv. 
Vulnerable subjects: Adolescent minors (ages 12-17 years) are included as 
vulnerable subjects in the proposed study. In the absence of sufficient evidence-
based programs to address the major public health problems of obesity and 
cardiometabolic disease in adolescents, there is a strong need for the scientific 
advancement of targeted therapies that jointly address depression and insulin 
resistance as the main precursor to T2D. The PI, Co-investigators, and the expert 
Consultants are experienced in working with minors. The research of key members 
on the investigative team, to date, has primarily focused on this vulnerable 
population in an effort to intervene prior to adulthood, at a time when the course of 
depression and insulin resistance is more malleable. Study staff will be thoroughly 
trained in identifying any emotional or physical distress or discomfort and will be 
instructed to terminate the protocol if a participant demonstrates distress. Study staff 
will emphasize to participants that they are able to withdraw from the study at any 
time, without penalty. 
7.3 
Specification of Safety Parameters 
The following key measures and corresponding parameters will guide risk/safety handling: 
i. 
Oral glucose tolerance testing (OGTT): OGTT is conducted at three time points during 
the course of the study, including screening/baseline, 6-week follow-up, and 1-year 
follow-up. If an adolescent has impaired fasting glucose (fasting glucose >=100 mg/dL), 
impaired glucose tolerance (2-hour OGTT glucose >=140 mg/dL), or with values 
potentially suggestive of T2D (fasting glucose >=126 mg/dL or 2-hour OGTT glucose 
>=200 mg/dL) based upon immediate glucose analysis (e.g., StatStrip), they and their 
parent/guardian will be notified and referred to the primary care physician for follow-up. 
Those adolescents with T2D at baseline will be excluded. Adolescents with impaired 
fasting glucose or impaired glucose tolerance will not be excluded, but they and their 
families will be notified at baseline as well as any follow-up assessment. 
ii. 
Medical history/physical exam: A medical history is conducted at baseline/screening and 
updated at the 6-week and 1-year follow-up. A review of physical health is conducted at 
all three of these intervals, with pubertal staging only at baseline/screening and repeated 
at 1-year if a physician/provider reported adolescent to be below tanner staging 5 at 
baseline . Any adolescent with a major medical problem or taking medications that could 
interfere with safety or validity, at baseline, will not be included. Any adolescent with a 
current exclusionary mental health diagnosis reported by parents and/or adolescents will 
not be included. Physicians/medical providers at each site will review medical histories 
during the follow-up interval and if any medical condition develops that was not present 
at baseline, will refer families for medical treatment, as indicated. Likewise, 
psychologists will refer families for psychological treatment, as indicated. 
iii. 
Schedule for Affective Disorders and Schizophrenia for School-Aged Youth – 
Computerized Version (KSADS-COMP) – Suicidality/self-harm module and mood 
monitoring: The KSADS-COMP semi-structured clinical interview – Suicidality and Self-
harm Module is conducted at three time points during the course of the study, including 
screening/baseline, 6-week follow-up, and 1-year follow-up. Mood monitoring is carried 

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out during the 6-week intervention phase, with adolescents completing a mood 
monitoring form at each intervention session, in all conditions (MBI, CBT, and HealthEd). 
As determined on the KSADS-COMP, adolescents who have, at baseline, active suicidal 
ideation or self-harm—a discreet marker of depression severity—will not be studied. The 
KSADS-COMP administered at the two follow-ups re-assesses suicidality/self-harm and 
in the event that an adolescent develops a suicidality or self-harm at either follow-up, the 
adolescent and parent/guardian will be notified and treatment referrals will be provided 
as indicated.  
7.4 
Adverse Events and Serious Adverse Events  
7.4.1 Adverse Events 
An adverse event is defined as any unfavorable and unintended diagnosis, symptom, sign 
(including an abnormal laboratory finding), syndrome or disease which either occurs during the 
study, having been absent at baseline, or if present at baseline, appears to worsen. All adverse 
events will be recoded regardless of their relationship to the study intervention (i.e., study and 
non-study related adverse events, as well as expected and unexpected adverse events).   
7.4.2 Serious Adverse Events 
A serious adverse event is defined as any untoward medical occurrence that results in death, 
is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, 
results in persistent or significant disability/incapacity, or is a congenital anomaly.  
7.4.3 Adverse Events Reporting 
All adverse events, including serious and non-serious, expected and unexpected, will be 
reported to the IRB at the annual continuing reviews in the form of electronic data sheets or 
summary language. Serious adverse events will be reported by the PI verbally and in writing as 
soon as possible to the IRB, IMC, and NCCIH, with a maximum of 7 calendar days for death or 
life-threatening adverse events, and within 15 calendar days for all other serious adverse 
events. All site PIs will be responsible for monitoring adverse events at their respective sites and 
if serious events arise, reporting this immediately to the study PI Dr. Shomaker. 
Adverse event forms will be completed by study coordinators on a form which is saved on 
REDCap or a secure server, which can only be accessed by site personnel using a username 
and password.   
7.5 
Follow-up for Adverse Events 
All adverse events will be reviewed at a weekly coordinators meeting, run by the lead study 
coordinator and attended by all four local site coordinators (CSU, CHCO, USU, and CNMC), as 
well as at a monthly all hands investigator/staff team meeting. For expected adverse events 
(e.g., development of MDD, suicidal ideation, or T2D), we will follow protocol and risk/safety 
management plans, as outlined in section 7.3 of this protocol. For any unexpected, study-
related events, we will use a team-based approach to problem solve a resolution that minimizes 
the likelihood of the event recurring.  
7.6 
Safety Monitoring  
We have formed an independent monitoring committee (IMC) comprised of three individuals 
who are not part of the proposed research and who have experience in the conduct and 
analysis of clinical trials. Dr. Olga Gupta is a physician with expertise in adolescent obesity and 
type 2 diabetes; Dr. Angelica Eddington is a clinical psychologist with expertise in adolescent 

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depression and diabetes; and Dr. John Brinton is a biostatistician who has experience in 
randomization, monitoring, and analysis of clinical trials.    
In the start-up phase of the study (Year 1, Quarters 1-2), we will convene an initial meeting with 
the IMC, including the PI Dr. Shomaker (CSU) and the study statistician, Dr. Pyle, to discuss 
and establish the complete and detailed data safety and monitoring plan (DSMP). The 
investigative leads at each side (i.e., Drs. Kelsey, Tanofsky-Kraff, and Mackey) will review the 
DSMP and be available for consultation and questions. Specifically, we will review the protocol 
methods, steps that will be taken to monitor and maintain confidentiality of data, consent 
documents, all risks and protections to participants, and qualitative and quantitative data 
analytic plans. We will review expected adverse events and planned steps to minimize risks, 
and we will discuss the timeline for reporting of serious adverse events and non-serious adverse 
events to the IMC and IRB. Additionally, we will specify stopping rules.  
Following the initiation of recruitment, a report will be prepared every 6 months by Dr. Shomaker 
and Dr. Pyle, with administrative support from the multisite coordinator, which will include 
information regarding timeline/milestones, participant recruitment, accrual, and attrition by 
condition and site, potential adverse events by condition and site, summary statistics for key 
variables by site, including reports of any missing data, preliminary analyses of fidelity, 
feasibility, and acceptability, as they become available, and any other issues or unanticipated 
problems or challenges that may have arisen during the course of the study.   
The IMC will convene every 6 months to provide feedback on the progress of the study as well 
as assistance in approaching any potential difficulties that may arise. More frequent meetings 
will be scheduled as needed. Dr. Shomaker, as well as the statistician and investigative leads at 
each site, will be available to attend IMC meetings to answer questions during an open session, 
prior to the IMC’s private deliberation. The role and responsibilities of the IMC will include: 
reviewing the protocol and the DSMP; considering any possible major changes to the protocol; 
evaluating the progress of the study, including assessments of data quality, timeliness, 
recruitment, retention, and participant risk vs. benefit; reviewing serious adverse events; and 
considering modifications to the study protocol based upon progress. The IMC will issue a 
formal memo, signed by all members of the IMC, at the conclusion of their deliberations. All 
reports prepared by the study team for the IMC and all memos issued by the IMC on the 
progress of the study will be provided to NCCIH. 
8. STATISTICAL CONSIDERATIONS 
8.1 
General Design Issues  
The current project is a pilot randomized controlled trial implemented at four sites with three 
arms. In line with the NCCIH U01/R01 grant mechanism, the purpose of the project is to gather 
information for use in designing a subsequent trial to compare the efficacy of the three arms.  
8.2 
Sample Size and Randomization 
Aim 1: Assuming that the true proportion of sessions within an intervention arm during which 
175 4 clusters (one facilitator per treatment arm per site), 
16 sessions per cluster, and coefficient of variation of the number of sessions equal to 0.01, 
then the width of the 95% CI is 24%. This estimate indicates that we will have reasonable 
precision in our estimates of fidelity after accounting for the intraclass correlation coefficient 
(ICC). 
Aim 2: Assuming that the true proportion of loss to follow up within an intervention arm is 15%, 

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number of participants equal to 0.11, then the width of the 95% CI is 28%.  In the original power 
calculations, the width of the 95% CI was 26%, so we will still have reasonable precision in our 
estimates of loss to follow up after accounting for the ICC. 
8.3  
Definition of Populations 
The intent-to-treat sample will be all adolescents who are randomized (N=120).  
8.4 
Interim Analyses and Stopping Rules 
Given the pilot nature of this study, no interim analyses or stopping rules are planned outside of 
the outcomes listed subsequently in sections 3 and 8.5. Analyses of primary and secondary 
outcomes will be conducted when all data for the respective outcomes have been collected. In 
line with NCCIH’s recommendations, no analyses of outcomes will be carried out prior to study 
completion. 
8.5 
Outcomes  
Dr. Pyle is the study biostatistician and she will be responsible for conducting the analyses of 
this pilot trial and discussing those results at the all hands investigator/staff monthly meeting. Dr. 
Thompson is the study qualitative expert and she will be responsible for overseeing the 
analyses of the focus groups with adolescents and focus groups with study personnel. Dr. 
Thompson will present these results for discussion, as they become available, at the all hands 
investigator/staff monthly meeting. 
8.5.1 Primary Outcome   
The primary outcomes for each study aim are: 
Aim 1: Test multisite fidelity of training/implementation of 6-week group MBI, CBT, and HealthEd to 
adolescent girls and boys at-risk for T2D with depression symptoms 
Objective 
Endpoint
Metric; Analysis 
Intervention Fidelity 
(Primary) 
12-months 
MBI, CBT, and HealthEd adolescent group sessions (1=poor to 
10=exceptional) 
Aim 2: Evaluate multisite feasibility/acceptability of recruitment, retention, and adherence for a protocol 
involving randomization to 6-week group MBI, CBT, or HealthEd with 6-week and 1-year follow-up
Objective 
Endpoint
Metric; Analysis 
Recruitment 
Feasibility (Primary)
12-months 
8.5.2 Secondary Outcomes   
The secondary endpoints for each aim are: 
Aim 1: Test multisite fidelity of training/implementation of 6-week group MBI, CBT, and HealthEd to 
adolescent girls and boys at-risk for T2D with depression symptoms 
Objective 
Endpoint
Metric; Analysis 
Training Fidelity 
(Secondary) 
6-months 
-training knowledge/ 
competency tests of MBI, CBT, and HealthEd 

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Training Fidelity 
(Secondary) 
6-months
MBI, CBT, and HealthEd mock group sessions (1=poor to 
10=exceptional) 
Aim 2: Evaluate multisite feasibility/acceptability of recruitment, retention, and adherence for a protocol 
involving randomization to 6-week group MBI, CBT, or HealthEd with 6-week and 1-year follow-up
Objective
Endpoint
Metric; Analysis
Recruitment 
Feasibility  
(Secondary)
12-months
Attainment of target N=120 within a 12-month period; 
CONSORT flow/number of months to reach recruitment goal 
Intervention 
Feasibility
(Secondary) 
6-weeks
sessions
Intervention 
Acceptability 
(Secondary)
6-weeks
1=not at all to 
5=extremely) 
Intervention 
Acceptability 
(Secondary) 
6-weeks
Themes indicative of acceptability of interventions, as derived 
from grounded theory/qualitative analysis of adolescent focus-
groups at post-intervention 
Retention Feasibility
(Secondary) 
12-months 
-treatment follow-
-year follow-up
Assessment 
Feasibility 
(Secondary) 
18-months 
standardized protocol checklists for all 
assessments 
8.6 
Data Analyses  
8.6.1 Primary Analyses 
In Aim 1, descriptive analyses will be conducted to: (i) describe post-training 
describe adherence and competence ratings of mock group sessions of MBI, CBT, and 
H
-10 scale with 10 being the most positive valence); and (iii) 
describe adherence and competence ratings of pilot group sessions of MBI, CBT, and HealthEd 
-square analyses will be used to 
explore whether the percentages meeting these criteria vary across conditions (MBI vs. CBT vs. 
HealthEd) and site. In Aim 2, study flow will be described according to CONSORT guidelines for 
the reporting of clinical trials.176,177 Descriptive analyses will be generated to determine: (i) the 
percentage of adolescents who enroll after being determined to be eligible, (ii) number of 
sessions), 
-5 scale, 
with 5 being the most positive valence), (v) percentage of adolescents who complete post-
treatment and 1-year follow-up assessments, and (vi) percentage compliance with standardized 
operating procedure checklists for all assessments. Analyses of variance (ANOVA) and chi-
square will be used to describe any potential differences across the 4 sites and the 3 
intervention arms.  A Tukey adjustment will be used to control for multiple comparisons. For the 
primary analyses in Aims 1 and 2, we do not plan to adjust for covariates as our interest is in 
estimating measures of success independent of participant characteristics. 
8.6.2 Secondary Analyses 

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One goal of the secondary analyses is to assess for a signal of a clinically significant effect of 
the interventions on depression and insulin sensitivity, which would be important outcomes in a 
larger efficacy trial. For these analyses, we will follow the approach of Cocks and Torgesen,178
in which one-sided 80% CI’s are calculated for the treatment effect. If the appropriately powered 
pilot study does not show evidence of an effect, this does not necessarily preclude the main trial 
going forward. Careful consideration for the possible reasons for the lack of effect and regarding 
how the intervention can be strengthened are needed. However, powering a pilot study in this 
way ensures that it provides as much information as possible. Given our final sample size after 
accounting for attrition, the pilot study is powered to detect a standardized effect size of 0.3, 
which is considered a small to medium effect size. 
Another purpose of secondary analyses is to supplement the mixed-methods analyses in Aim 3 
used to refine study procedures and interventions in preparation for a future efficacy trial by 
understanding predictors associated with study outcomes, as well as mediators and moderators 
of intervention effects. This study is not designed as an efficacy study, and we will not 
necessarily have sufficient statistical power for the secondary analyses. However, results of 
these analyses may help inform changes to the interventions. We will examine predictors of 
participant attrition, attendance, and likability/credibility ratings. We will use multilevel mixed-
effects models to examine change over time in measures of depression, insulin resistance, 
stress-related behavior, and stress physiology. These models will allow us to account for and 
estimate the correlation within study site and intervention cohort, as well as the correlation 
between repeated measures within a participant. ICC will be estimated using the method of 
Donner179 for continuous variables and Ridout180 for binary variables. The models will contain 
terms for group, time, and a group by time interaction. We will adjust for the baseline value of 
the outcome, and will also consider adjustment for baseline age, sex, race/ethnicity, particularly 
if these variables are not balanced across study groups.  Models will be adjusted for baseline 
adiposity and change in adiposity to examine whether decreases in depressive symptoms 
improves insulin sensitivity independent of adiposity. If we find significant between-group 
differences in the insulin resistance, stress-related behavior, and stress physiology outcomes, 
we will test whether those effects are moderated by baseline depressive symptom severity 
(CES-D score) by including an interaction term in the model. We will also examine participant 
characteristics associated with these outcomes in order to better understand factors that 
moderate the response to intervention. Mediation analyses, using the product-of-coefficients 
method and bootstrapped standard errors, will be used to explore whether improvements in 
insulin sensitivity (if present) are mediated by changes in stress-related behaviors and stress 
physiology. Quantitative measures of group cohesion, therapeutic alliance, and perceived 
credibility/expectancy, summarized by intervention arm, will inform modifications to facilitator 
training, optimization of interventions, and study design in the larger trial. Finally, we will 
examine theoretical therapeutic mechanisms to explore the hypotheses that in MBI, 
mindfulness, monitoring/acceptance, and executive function will improve and in CBT, thoughts 
and pleasant activities will improve, compared to each other and to HealthEd. 
8.6.3 Qualitative Analysis Plan 
At post-intervention, we will conduct adolescent focus groups with each MBI, CBT, and 
HealthEd, group. This qualitative strand adds patient voice to this U01 multisite intervention 
refinement and optimization phase, ensuring outcomes of a larger efficacy trial are meaningful, 
valuable, and helpful for adolescents.172 Trained moderators will facilitate 24 semi-structured 
small group discussions (n=5), using a mix of open-ended and targeted questions designed to 
engage adolescents and elicit emergent themes that may not have been captured through the 
quantitative strand.173 Focus groups will cover adolescents’ subjective experiences of: 1) 
enabling mechanisms, 2) stress/mood management, 3) negative aspects of interventions, 4) 

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facilitators/barriers to home practice, and 5) perceptions of group cohesion/facilitator alliance. 
Upon initiation of 1-year follow up visits, we will conduct personnel focus groups  (e.g., 
coordinators, assistants, facilitators) to qualitatively evaluate the protocol. These focus groups 
will cover personnel’s subjective experiences of: 1) enabling mechanisms, 2) negative aspects, 
and 3) protocol barriers.  
Regarding the analytic plan, for all focus group discussions, an observer will take detailed notes 
and audiotape all dialog. Following the discussion, the facilitator and observer will complete a 
content summary form, briefly describing the context of the group and “memoing” any evolving 
themes.181 Audiotapes will then be transcribed verbatim and uploaded along with observer notes 
and summary forms to a qualitative analytic software program (ATLAS.ti or NVivo). Two 
researchers with training and experience in qualitative methods will jointly analyze the data 
using a constant comparative analytic approach, including open and axial coding within and 
between transcripts.182 Dr. Thompson has expertise in qualitative analyses and grounded theory 
and will lead the creation of focus group moderator guides in collaboration with the study team. 
Dr. Thompson will lead all qualitative data analysis tasks with assistance from a research staff 
member trained in qualitative analysis, and regular consultation and feedback from Dr. Pyle, Dr. 
Shomaker (PI), and additional input from the entire investigative team. Analysis will progress 
iteratively until codes have reached saturation, when data will be triangulated to integrate key 
findings into several broad descriptive themes. Subsequently, these data will be merged with 
the quantitative strand of the study in a convergent parallel design mixed-methods analysis to 
compare and contrast qualitative themes with statistical results.183 A thorough assessment of 
areas of congruence and discordance between the qualitative/quantitative data sets will provide 
a more robust understanding of enabling mechanisms, negative aspects, and any barriers, 
generated from the social experience sustained from participation in each arm (adolescents) 
and from implementation of the protocol (personnel) to inform further refinement and 
optimization.  
9. 
DATA COLLECTION AND QUALITY ASSURANCE
9.1 
Data Collection Forms  
All participant encounters, from initial phone screening through 1-year follow-up, will be carefully 
and thoroughly documented. A data collection checklist and progress note will accompany each 
assessment interval. These forms will be completed by the study staff members who run the 
respective visits. Staff will be responsible for active completion of these forms during the visit 
and for any necessary follow-up regarding documenting – or remedying – missing data, protocol 
deviations, and/or adverse events associated with the evaluation, as well as communicating 
with the lead coordinator and site PI, as indicated. Any issues that arise will be discussed at a 
weekly multisite coordinators meeting. All staff conducting evaluations will be thoroughly trained 
on completion of forms and standard operating procedures for all evaluations prior to running 
visits. The lead coordinator will periodically check/audit forms for thoroughness and provide 
additional trainings as indicated (at minimum, 10% of data every 3 months).  
Surveys will be filled out directly by participants and parents/guardians and housed in REDCap. 
Blood samples collected during each study visit will be tracked with a document that is 
completed by the phlebotomist performing each oral glucose tolerance test (OGTT). Each sheet 
will indicate the exact timing of each draw (i.e., fasting and 2-hour) and ingestion of the glucola, 
and also will provide the phlebotomist an opportunity to document any abnormal occurrence 
during the blood draw. The research staff at the study visit will be responsible for verifying that 
the blood draw form has been thoroughly completed. Timing of saliva samples collection will be 
filled out by adolescent participants using a paper tracking log, and ActiGraph wear will also be 

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tracked using a paper document filled out by participants. The activity data on each ActiGraph 
device will be immediately downloaded upon return from participants and stored on a password 
protected device. The data will then be deleted from the device upon download. The activity 
data will only be linked to participants’ three digit subject ID.  
Participants will be audio-recorded during each Schedule for Affective Disorders and 
Schizophrenia for School-Aged Youth-Computerized Version (KSADS) and Eating Disorder 
Examination (EDE) interview, along with each group session for quality assurance and training 
purposes.  
At all sites, any participant record that includes identifying information will be housed in a locked 
cabinet (hard copies) or password-protected file (electronic) and separated from the remaining 
hard copy/electronic data collection forms. We have used a similar system for other trials and it 
is effective in maintaining the blind for research staff who will be blinded for follow-up data 
collection.   
9.2 
Data Management  
Data will be collected specifically for the research purposes of this study only. Research staff 
administering assessments will be fully trained in their administration. All data will be kept 
confidential, and no individually identifiable information that can be linked to participants will be 
retained in public areas. Data with identifying information will be stored on password-protected 
computers, in the HIPAA-compliant REDcap web-based survey and data management system 
(in a separate database from the primary data entry/survey databases) or other secure 
electronic information-storing techniques as necessary, or in locked filing cabinets in the 
laboratories of each site PI. Only people directly involved with the study, including the PI, site 
PIs, Co-investigators, and study coordinator(s), and who have been certified for human subjects 
by the Colorado Multiple IRB and/or have human subjects protection training, as documented by 
the study team, will have access to identifiable private information. Standard security 
procedures will be used to assure patient confidentiality. Specimens stored and/or sent to the 
laboratory will be labeled with a study ID code only, and this study code is only known by the 
non-blinded study staff. 
Data collection for the current project will take place at four enrollment sites, with two in 
Colorado: (1) Colorado State University (CSU) in Fort Collins, Colorado/Northern Colorado (Site 
1) and (2) University of Colorado School of Medicine/Children’s Hospital Colorado (UCD/CHCO)
in the Aurora/Denver, Colorado metropolitan area (Site 2), and two in the Maryland/Washington, 
DC area: (3) Uniformed Services University (USU) (Site 3) in Bethesda, Maryland, and 
(4) Children’s National Medical Center (CNMC) in Washington, DC (Site 4).   
i. 
Site 1: Colorado State University: Phlebotomy will be conducted in the Human 
Performance/Clinical Research Laboratory (HPCRL) in the College of Health and 
Human Sciences on the Colorado State University main campus. The HPCRL is fully 
equipped to perform phlebotomy, handle blood specimens, and store samples (e.g., -
80¡ C freezers) prior to shipping, all of which will be overseen by Dr. Shomaker (PI). In 
order to establish eligibility and rule out T2D, fasting and two-hour glucose will be 
determined immediately using an automated device (e.g., StatStrip). Also, the HPCRL 
has designated space for laboratory test meal studies, which will be available for the 
current project. Dr. Shomaker has the equipment to perform air displacement 
plethysmography body composition testing (BodPod; COSMED), which is currently 
housed in the HPCRL. Dr. Shomaker also has access to two additional -80 
degrees Celsius freezers for storage of blood and cortisol samples, a refrigerator for the 

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storage of test meal foods, and access to several fully equipped kitchens with scales for 
food preparation and weighing food items.  
ii.
Site 2: University of Colorado School of Medicine/Children’s Hospital Colorado:
Phlebotomy will be collected in the University of Colorado School of Medicine/Children’s 
Hospital Colorado’s (CHCO) Pediatric Clinical and Translational Research Center 
(CTRC). The Pediatric CTRC is fully equipped to perform phlebotomy, process blood 
specimens, and analyze glucose, which will be overseen by Dr. Kelsey (Co-I) and Dr. 
Shomaker (PI). Samples will be transferred directly to the Core Laboratory at the 
University of Colorado School of Medicine or stored in a -80 degrees Celsius freezer, 
designated for Dr. Shomaker’s collaborative studies with Pediatric Endocrinology 
and located on the University of Colorado School of Medicine’s campus. The CTRC also 
houses a BodPod (COSMED) to perform air displacement plethysmography body 
composition testing. The CTRC Nutrition Core is well-prepared to carry out standardized 
laboratory test meal studies with the necessary equipment (refrigerator, food scale) and 
space for food preparation and weighing of food items.   
 
After the appropriate regulatory approvals are obtained and material/data transfer 
agreements are established, samples from Sites 1, 3, and 4 will be shipped by 
authorized personnel at Colorado State University, the Uniformed Services University, 
and Children’s National Medical Center, respectively, to Site 2/University of Colorado 
School of Medicine’s Core Laboratory. The Core Laboratory will be the central 
processing site for research analysis of insulin and glucose blood samples collected 
from oral glucose tolerance testing throughout the proposed multisite pilot trial. Salivary 
cortisol samples will be processed by the Pediatric CHCO Core Laboratory. With support 
from Dr. Kelsey and the multisite coordinator, Dr. Shomaker (PI) will oversee all samples 
that are processed in the Core Laboratory.   
iii. Site 3: Uniformed Services University: Phlebotomy and body composition will be 
collected in the Military Cardiovascular Outcomes Research (MiCOR) program, for which 
Dr. Tanofsky-Kraff (Co-I) serves as Research Director. MiCOR houses a BodPod 
(COSMED) that is dedicated to the research visits at the laboratory and will be available 
for air displacement plethysmography body composition testing. MiCOR also has two 
private exam rooms for blood draws and equipment for processing blood samples and 
immediate glucose analysis, as well as a -80 degrees Celsius freezer to store blood 
samples prior to shipping. MiCOR is equipped with a room to conduct laboratory test 
meal studies as well as a fully furnished kitchen with the necessary equipment (i.e., 
refrigerator, food scale) and storage space to carry out laboratory meal assessments.   
iv. Site 4: Children’s National Medical Center: Phlebotomy will be collected in the Clinical 
Research Unit= located at the main hospital at Children’s National that will provide the 
expertise and infrastructure for the clinical services proposed for the current study. The 
nursing support, overseen by Dr. Estrada (Co-I), will administer phlebotomy and 
collection and storage of blood samples. The Children’s National Clinical Research Unit 
is also able to provide biorepository support to store and safely ship all samples to 
Colorado. Dr. Mackey has access to a BodPod (COSMED), which will be utilized for 
body composition assessments and is currently housed in the Clinical Research Unit.  
Data will be collected at all sites and managed at Site 2/University of Colorado School of 
Medicine/Children’s Hospital Colorado through the web-based REDCap system, a data 
collection and data management system compliance with the Health Insurance Portability 
and Accountability Act of 1996. REDCap is highly conducive to facilitating multisite data 
coordination. FreezerPro, a software application used for tracking biological samples, will be 

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used to manage all saliva and blood samples collected at each site. FreezerPro allows study 
teams to conveniently record where biological specimens are stored (i.e., which boxes, which 
freezers); study identification numbers and intervals that are de-identified will be utilized for 
biological specimens and corresponding tracking within FreezerPro. Participants in the 
proposed study will complete electronic survey measures at all sites on REDCap, and all 
psychological, behavioral, and physiological/biological data will be managed via these systems.  
9.3 
Quality Assurance  
9.3.1 Training 
All research staff administering evaluations will be thoroughly trained in their administration prior 
to collecting data. All research clinicians will receive additional, thorough training by experts in 
MBI, CBT, and HealthEd and will participate in weekly ongoing supervision from experts 
throughout the course of the intervention delivery.  
The multisite coordinator for this project will be responsible for providing or arranging all of the 
trainings to the local site coordinators for evaluations, case reporting documents, and so forth in 
order to ensure protocol fidelity across sites. The multisite coordinator also will monitor fidelity 
regularly throughout the trial. 
9.3.2 Metrics 
Our metrics for quality assurance of data collection will be as follows: For retention to group 
interventions, our threshold is receiving 80% of either mindfulness-based intervention (MBI), 
cognitive behavioral therapy (CBT) or health education (HealthEd). For retention to follow-up 
visits, our threshold is at least 70% of randomized adolescents completing a 1-year follow-up, 
the planned endpoint for the current study.  
9.3.3 Protocol Deviations 
Study coordinators from each site will log protocol deviations as they occur, and they will be 
documented on a form specifically for protocol deviations. Deviations will be discussed at the 
weekly coordinators meeting and also summarized at the all hands monthly investigator/staff 
meeting. Further, the deviations documented will be reviewed by the IMC in the report prepared 
every 6 months, along with the IRB at the time of each continuing review.  
9.3.4 Monitoring 
We will have scheduled site visits from the NCCIH prior to initiating the trial and for supporting 
and assuring protocol compliance. Also, as outlined in section 7.6, monitoring will be performed 
by an IMC, with reports prepared every 6 months. 
10. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
10.1 
Institutional Review Board (IRB) Review  
The Colorado Multiple IRB has agreed to serve as the single IRB (sIRB) for this multisite study. 
Upon Colorado Multiple IRB approval, we will arrange for institutional IRB reliance agreements 
with each of the other sites (Colorado State University [CSU], Uniformed Services University 
(USU), and Children’s National Medical Center [CNMC]) who have agreed to this arrangement 
of allowing the Colorado Multiple IRB to serve as the primary sIRB. The study protocol and the 
informed consent/assent form, along with all key protocol documents, will be reviewed and 
approved by the Colorado Multiple IRB prior to initiating the pilot randomized controlled trial. 
Additionally, all subsequent modifications to these documents will be reviewed and approved by 
the Colorado Multiple IRB.  

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10.2
Informed Consent Forms
A single signed informed consent/assent form will be obtained from each participant’s 
parent/guardian and the participants, who will be 12-17 years of age. Children’s National 
Medical Center has a site-specific informed consent and separate site-specific assent form. In 
the instance that the consent/assent forms are obtained electronically, the process will be 
obtained via secure videoconferencing software or via phone and REDCap to facilitate 
explanation of the consent and provide an opportunity for participants and their 
parents/guardians to ask questions. The purpose, all testing procedures, program components, 
and randomization will be reviewed in detail. Potential participants and their parents/guardians 
will be informed of the possible risks, inconveniences, potential benefits, and right to alternatives 
and withdrawal.  
10.3 
Participant Confidentiality  
This study has been issued a Certificate of Confidentiality from the federal government to help 
protect participant privacy. The Certificate prohibits researchers from disclosing participants’ 
name, or any identifiable information, document, or biospecimen from the research. Consent 
forms include waivers of confidentiality for suicide, child abuse, and homicide, for which we are 
mandated reporters. All sessions begin with a discussion of confidentiality and its limitations, 
and throughout the consent process, confidentiality and its limitations are discussed. Specific 
written procedures have been developed and tested for handling cases that necessitate a 
breach of confidentiality. For cases that involve a breach of confidentiality (i.e., suicide, child 
abuse, and homicide), depending on the individual circumstances, the appropriate authorities, 
such as a parent, are contacted. All distressed adolescents are given a list of referrals that 
include hotlines and crisis centers. We also facilitate referrals to counseling services if the 
situation calls for this. Suspected child abuse is reported to Social Services.  
All data from the protocol will either be stored in REDCap or on a secure server that is 
username and password protected. Any data or records that leave the sites will be identified 
only by a participant identification number to maintain confidentiality. All paper records will be 
kept in a locked file cabinet. Information will not be released without written permission of the 
participant, except as necessary for monitoring by the IRB, IMC, and/or the NCCIH.  
10.4 
Study Discontinuation  
The study may be discontinued at any time by the IRB, the IMC, NCCIH, or other government 
agencies as part of their duties to ensure that research participants are protected. Investigators 
also may terminate a participant’s participation in the study with or without the consent of the 
participant. For example, if a participant develops a medical or psychiatric condition that 
requires treatment, they will be referred for treatment and might not continue in the study.  
11. 
PUBLICATION OF RESEARCH FINDINGS  
All publications resulting from this work will be discussed by the all hands investigators/staff at 
the monthly meeting. The order of authorship and plan for the publication will be determined 
before any work begins. Any presentation, abstract, or manuscript will be made available for 
review by the sponsor and the NCCIH prior to submission.  
12. 
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