Novel mHealth Physical Activity Intervention for Youth With Type 1 Diabetes Mellitus
Conditions: Type 1 Diabetes
Sponsor: Children's Mercy Hospital Kansas City

Title: Novel mHealth Physical Activity Intervention for Youth With Type 1 Diabetes 
Mellitus 
NCT Number: NCT06018844 
Document date: 5/22/24 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: Novel mHealth Physical Activity Intervention for Youth with Type 1 
Diabetes Mellitus 
  
PRINCIPAL INVESTIGATOR: 
   
Mark Clements, MD, PhD 
Endocrinologist  
Pediatric Clinical Research Unit 
The Children’s Mercy Hospital 
2401 Gillham Road 
Kansas City, MO 64108 
Email: maclements@cmh.edu 
Phone: 816-983-6982 
 
IND/IDE NUMBER: NA 
  
VERSION NUMBER/DATE: Version 4.4 
  
REVISION HISTORY 
  
Revision # 
Version Date 
Summary of 
Changes 
Consent Change? 
 9.2 Clarification of 
PHI 
9.2;10.1; 21.1 
Updated language for 
consistency to Study 
Information Letters 
from Study 
Information and 
Letters/Information 
Letter 
16.1 Clarification of 
consistency regarding 
benefits of patient 
participation  

23.3 Updated 
enrollment log to 
show PHI will be 
temporarily kept and 
reflected that change 
in section 9.2 noting 
an enrollment log 
will be kept 
containing PHI and 
will be destroyed at 
the end of study 
25.0 Virtual visits 
will not be recorded, 
so that box was not 
checked 
31.0 Clarified that a 
CM approved method 
will be used 
 
 3 
March 2023  
Updating formatting 
throughout the 
document (font, 
margins) for 
consistency, survey 
types (section 11), 
accelerometer type 
(section 5.3, 10.1, 
15.1, 25.1, 27.1), 
study objectives 
(2.0), corrected 
references for 
assessments (11, 34). 
Updated section 6 to 
accurately describe 
the Nudge system. 
Updated section 7 to 
include a CGM 
eligibility 
requirement for data 
collection 
requirements 
 Yes 

Updated Section 10 
to clarify the activity 
calendar would just 
ask about scheduled 
physical activity and 
included information 
about the sleep diary. 
Included the sleep 
diary in section 11. 
Updated section 31 
and 32 with 
information about 
collaborators & 
multi-site setup. 
Updated section 23.3 
to clarify that 
collaborators will 
have access to patient 
telephone numbers 
and addresses and 
clarified location of 
the Nudge server 
Updated information 
letter with the 
location of 
collaborating sites, 
surveys, changed 
“Garmin” to 
“actigraph” in the 
study calendar, and 
made the information 
more clear. 
Updated the 
Treatment 
Satisfaction survey to 
correct some 
grammatical errors 
(question 4 did not 
have the correct 
“Yes, Definitely” 
response) 

 4 
May 2023  
Updated section 5, 
10, and 18 to include 
actiwatch recording 
(instead of 
accelerometer) 
Updated study 
population and 
inclusion exclusion 
criteria to 13 YOs to 
streamline study start 
up. Updated payment 
plan per new 
guidelines. 
Updated section 32 to 
include KUMC 
student who will be 
working on the 
protocol. 
Updated information 
letters to include 
information on the 
student worker, 
update the 
accelerometer to 
actiwatch, clarify 
daily surveys, clarify 
the payment 
schedule, and provide 
next steps after study 
enrollment 
Edited survey request 
emails to include 
Nudge in the subject 
line and message 
Edited Baseline survey 
to updated Q 9 in the 
TSRQ and 13 in the 
TSRQ-D to include a 
number box for 
recording the subject 
response 
Yes 

Added “Cell phone 
number” to Baseline 
survey to help with 
contacting participants 
Corrected answers 17-
21 for the POMs in 
Nudge Day 1-7  
Added in messages for 
EMA surveys for 
Nudge Days 1-7 
Added surveys sent to 
parents or patients to 
confirm eligibility and 
receive information 
letter 
Created a letter to link 
participants to a survey 
to alert the study team 
that the study devices 
were received 
Created the study 
device received survey 
Edited EMA surveys to 
the correct survey title 
(EMA day 1 A, etc.), 
and include time 
question (AM vs. PM) 
 4.1 
Updating KU & Kansas 
University term to 
University of Kansas in 
and KUMC to 
University of Kansas 
Medical School for 
clarity in sections 23.3 
and 32. These 
corrections were also 
made in the 
information letters. 
 Yes 
 4.2 
Updated University of 
Kansas Medical School 
to University of Kansas 
Yes

Medical Center in 
section 32. These 
corrections were also 
made in the 
information letters. 
And removed Susanna 
Patton email from intro 
(typo) 
And corrected 
reference 13 & 19 
(typos) 
 
4.3 
 
Corrected and 
confirmed names of 
Kansas University at 
Lawrence and 
KUMC to keep 
institution 
responsibilities clear. 
This was in section 
23.3 and 32. 
Also updated the 
study calendar in 
section 5.3 to correct 
HbA1c to “SOC” and 
Device uploads to 
“Daily” timeframes. 
Calendars in ICFs 
have also been 
updated. 
Yes 
4.4 
August 2023 
Added in insurance 
type as piece of 
information recorded 
in section 25 (and 
table in section 25) 
Added in to study 
information letter 
Updated 25.1 
demographics list, 
and incorporated the 
Diabetes Data Dock
Yes 

at CMKC and using 
the health API and 
diabetes data mart, 
and specifying 
Diabetes Data Dock 
for data storage in 
section 28.1 
Also updated 25.1 to 
specify the Diabetes 
Data Dock will 
verify/ extend 
demographics data 
listed in the list of 
data collected in 
demographics 
surveys 
Added payment for 
exit survey 
completion section 
18.1 
Updated recruitment 
methods to reflect 
primarily virtual 
recruitment section 
9.2 and 10.1 
Updated section 28.1 
to clarify the study 
records will be stored 
per CM policy, and a 
data scientist 
assigned to the study 
will have access to 
the study information 
Also updated the 
RTDA and Diabetes 
Data Mart to diabetes 
Data Dock, as this is 
the new title of the 
data processing 
system. 
Information letter: 
Added in insurance 
type as information 

collected, the 
payment for the Exit 
survey, the study 
contact information, 
and updated the 
language 
coordinators connect 
to for participant to 
connecting to the 
Garmin Health API 
app. Added Claire 
Petty as the lead 
coordinator 
 
5 
February 2024 
See Summary of 
Changes document 
Yes 
5.1 
March 2024 
Section 21 updated 
for clarity 
Section 22 language 
added to reflect 
process of assent 
capture 
Yes 
5.2 
March 2024 
Section 9.1 updated 
to reflect use of self-
referral 
 
Section 21 updated to 
include applicable 
study groups 
 
5.2.1 
March 2024 
Section 32 Nemours 
Children’s spelling 
error corrected 
 
5.3 
May 2024 
Inclusion/Exclusion 
criteria updated to 
include required 
access to smart 
device 
 
  

 
 
 
 
 
  
Table of Contents 
STUDY INFORMATION ................................................................................................................................. 11 
1.0 Study Summary ................................................................................................................................. 11 
2.0 Objectives  ......................................................................................................................................... 12 
3.0 Background  ...................................................................................................................................... 13 
4.0         Study Endpoints ......................................................................................................................... 15 
6.0          Study Intervention/Investigational Agent ................................................................................ 16 
SUBJECT MANAGEMENT ............................................................................................................................. 17 
7.0          Inclusion and Exclusion Criteria ................................................................................................ 17 
8.0          Local Number of Subjects  ........................................................................................................ 19 
9.0         Screening and Recruitment Methods ........................................................................................ 21 
10.0      Procedures .................................................................................................................................. 22 
11.0      Surveys and Psychometric Testing:  ........................................................................................... 25 
12.0      Follow-up - NA  ........................................................................................................................... 27 
13.0      Genetic Analysis Information - NA  ............................................................................................ 27 
14.0      Sharing of Results with Subjects - NA  ........................................................................................ 27 
15.0      Risks to Subjects  ........................................................................................................................ 27 
16.0      Potential Benefits  ...................................................................................................................... 28 
17.0      Investigator Assessment of Risk/Benefits Ratio:  ....................................................................... 28 
18.0      Payment, Reimbursement and Tangible Property provided to subjects ................................... 29 
21.0      Permission/Assent/Consent Process .......................................................................................... 30 
22.0      HIPAA and Confidentiality .......................................................................................................... 32 
23.0     Provisions to Protect the Privacy Interests of Subjects ............................................................... 34 
24.0      Withdrawal of Subjects .............................................................................................................. 36 
DATA MANAGEMENT .................................................................................................................................. 36 
25.0      Data Collection: (This section is required for all studies.) .......................................................... 36 
26.0      Adverse Events and Unanticipated Problems ............................................................................ 38 

27.0      Statistical Analysis  ..................................................................................................................... 39 
28.0      Data and Specimen Management .............................................................................................. 40 
29.0      Storage/Banking of Data and Specimens for Future Research - NA .......................................... 41 
30.0      Provisions to Monitor the Data to Ensure the Safety of Subjects .............................................. 41 
STUDY MANAGEMENT ................................................................................................................................ 41 
31.0      Setting & Locations ..................................................................................................................... 41 
32.0      Multi-Site Research .................................................................................................................... 42 
33.0      International Research - NA ....................................................................................................... 43 
 
 
 
 
 
 
 
 
 
STUDY INFORMATION 
1.0 Study Summary 
1.1  Synopsis 
Study Title 
Novel mHealth Physical Activity Intervention 
for Adolescents and Young Adults with Type 
1 Diabetes (T1D) 
Study Design 
Non-randomized, longitudinal cohort study to 
pilot an intervention  
Primary Objective 
To evaluate feasibility and initial efficacy of a 
novel mHealth intervention to promote 
physical activity in youth and young adults 
with T1D 
Secondary Objective(s) 
To examine if increasing minutes of daily PA 
in youth and young adults with T1D promotes 
more optimal HbA1c levels. 

Research Intervention(s)/ Investigational 
Agent(s)  
Novel mHealth intervention (i.e., uses daily 
two-way text messaging) designed to promote 
physical activity in adolescents and young 
adults. 
IND/IDE #  
NA 
Study Population 
Patients 13.00 to 21.99 with T1D  
Sample Size 
250 
Study Duration for Individual Participants 
4.5 months (timeframe between standard of 
care visits) 
Study Specific Abbreviations/F Definitions  
T1D= Type 1 diabetes 
 HbA1c= glycated hemoglobin 
 PA= physical activity 
 YA(s) = young adult(s) 
 MVPA= moderate to vigorous physical 
activity 
NUDGE= Network Underwritten Dynamic 
Goals Exchange 
 EMA= ecological momentary assessment  
  
 
 
2.0 Objectives 
  
 
2.1   Purpose, specific aims or objectives: Describe the purpose, specific aims, or objectives. If 
more than one objective be sure to list separately. 
The study objectives are to examine feasibility of a novel mHealth intervention to promote 
physical activity (PA) in youth and young adults (YAs) with type 1 diabetes mellitus (T1D).   
The study objective is to examine initial efficacy of a novel mHealth intervention to promote PA 
in youth and YAs with T1D. 
2.2   Hypotheses: State the hypothesis to be tested. 
AIM 1: Test feasibility and initial efficacy of a novel mHealth intervention to promote PA 
in youth and YAs with T1D.  
Hypothesis 1: Our application of a novel mHealth intervention to promote PA in youth and YAs 
with T1D will show feasibility based on >50% of daily text messages exchanged between youth 
and the intervention bot. 

Hypothesis 2: Our application of a novel mHealth intervention to promote PA in youth and YAs 
with T1D will show initial efficacy based on the threshold of achieving at least a medium effect 
size for participant’s daily PA. 
AIM 2: Evaluate if increasing minutes of PA in youth and YAs with T1D promotes more 
optimal HbA1c levels.  
Hypotheses 3: Youth and YAs with T1D who increase their daily PA based on our novel 
mHealth intervention will also show an improvement in their HbA1c levels.  
 
 
3.0 Background 
  
 
3.1    Describe the relevant prior experience and gaps in current knowledge.   
There are approximately 200,000 children in the US (0-18 years) living with type 1 diabetes 
(T1D) and nearly 18,000 children diagnosed annually,1-3 making T1D the third most common 
chronic illness of childhood.4 T1D requires a rigorous, complex, and time-consuming daily self-
management routine in order to achieve blood glucose levels that approximate the normal range.5 
One component of this self-management routine is daily PA. The American Diabetes 
Association (ADA) recommends that youth with T1D achieved at least 60 minutes of moderate 
to vigorous physical activity (MVPA) daily.5 Moreover, in a recent consensus statement, the 
authors note a number of unique benefits to youth with T1D who achieve this daily MVPA 
target, including reduced glycated hemoglobin (HbA1c) levels and improved cardiovascular 
disease risk profiles, endothelial function, and blood lipid profiles (viz., triglycerides and total 
cholesterol).6 Yet, despite these health benefits, most studies suggest that youth with T1D do not 
meet daily recommendations for MVPA.7,8  
 
There are examples of previous PA-focused interventions for youth with T1D, but only a few of 
these interventions focused on increasing daily PA in youth’s daily lives (versus targeting 
periodic structured PA training sessions).9 Moreover, there are no examples of PA-focused 
interventions for adolescents and YAs with T1D that use an mHealth approach, despite the high 
likelihood that adolescents and YAs might find this treatment approach more feasible and 
acceptable than a traditional in-person or structured exercise-based intervention10.  Specifically, 
in-person exercise-based interventions may have multiple barriers for youth with T1D as these 
interventions may be time intensive, burdensome, and expensive, with most requiring 
participants to attend weekly sessions over multiple months. Additionally, face-to-face 
interventions could be difficult to disseminate if major segments of the population have limited 
access to healthcare resources necessary to deliver the treatment 11  mHealth interventions 
include interactive and communication technologies to improve health or health care. Eighty-
eight percent of teens own or have access to a cell phone, 12 indicating that mHealth 
interventions in the form of a mobile phone platform would be widely accessible to adolescents. 
Further, previous literature suggests that mHealth interventions 13 have a small but significant 

effect on changing health outcomes in pediatric populations.13 However, most mHealth 
interventions for PA do not utilize behavioral change techniques that are based on theory or are 
empirically supported. 14 Incorporating both theory and empirically based techniques would 
likely increase the effectiveness of mHealth physical activity interventions. 15 
          3.2    Describe any relevant preliminary data. 
Cybernetic control theory is a model of self-regulation that postulates individuals monitor their 
current performance compared to a goal or standard. A negative feedback loop operates to 
reduce any discrepancy between one’s current performance and a set goal. Key behavioral 
change techniques consistent with this model include goal setting, self-monitoring, feedback, and 
goal-review. Prior literature has shown interventionist employing control theory behavioral 
change techniques are effective in changing PA behaviors. 16 Specifically, in a meta-analysis of 
PA interventions, researchers found that PA interventions that included combinations of self-
monitoring with other behavioral change techniques from control theory (i.e., goal setting, 
feedback) were significantly more effective than interventions that did not include these 
combinations. 16 
Previous literature in youth also indicates that self-monitoring is a key behavioral change 
strategy that should be included in mHealth physical activity interventions. 15 For example, in a 
recent review of mHealth interventions, researchers found self-monitoring was a crucial 
component in changing exercise behaviors in adolescents. 15 Currently, the majority of mHealth 
text messaging interventions for PA consist of static or reminder-based text messages. 17 
Developing adaptive interventions, which include personalized feedback and intervention 
content through text messaging, may improve the efficacy of an mHealth PA intervention for 
adolescents. Specifically, ninety percent of adolescents exchange text messages daily. 12  This 
suggests that an mHealth PA intervention utilizing text messages may be an effective way to 
communicate with adolescents. 
          3.3   Provide the scientific or scholarly background for, rationale for, and significance of 
the research based on the existing literature and how it will add to existing knowledge.  
  
Rationale 
Here, we propose to pilot test the application of a novel and brief mHealth intervention to 
promote PA in youth and YAs with T1D. Our intervention, NUDGE (Network Underwritten 
Dynamic Goals Exchange), 18 utilizes intervention strategies consistent with control theory that 
have been shown to increase physical activity by encouraging participants to set daily physical 
activity goals, actively self-monitor progress, receive feedback, and review/revise their future 
goals.18, 19, 20 Further, the adaptive features of NUDGE allow participants to set individualized 
physical activity goals, within a predefined range (i.e., +/- 15 minutes) of their last self-
monitored physical activity value and receive immediate feedback. In a previous trial of NUDGE 
in adolescents without a chronic health condition (n=20 received NUDGE, n=20 controls), we 
found a medium effect size of NUDGE on adolescents’ PA (d=0.63) and a large effect size on 

adolescents’ minutes of sedentary behavior (d=0.87). Therefore, NUDGE appears to be initially 
feasible and effective for youth and YAs in general. Prior data suggests a logical next step may 
be to pilot test NUDGE in a sample of youth and YAs with T1D, a vulnerable patient population 
with below target levels of daily PA. 
Also, see above mentioned literature studies and rationale in 3.1 and 3.2 for additional 
background, significance of existing literature, and rationale.  
  
4.0         Study Endpoints 
 
             4.1    Describe the primary and secondary study endpoints. 
   
 The primary endpoint is to increase daily PA in pediatric patients with T1D. The secondary 
endpoint is to improve HbA1c levels in pediatric patients with T1D.  
 
Initial Efficacy Assessment. We will evaluate initial efficacy based on change in minutes of daily 
MVPA in adolescents from baseline to post-treatment, change in minutes of daily SB in 
adolescents from baseline to post-treatment, and change in HbA1c levels in adolescents from 
baseline to post-treatment.  
 
           4.2   Describe the primary and secondary safety endpoints.  NA 
   
5.0 Study Design 
 
            5.1   Study Design: Describe and explain the study design. 
We propose to pilot NUDGE in youth with T1D and look at treatment effects after at least 3 
months. We anticipate the entire pilot study will last 12 months.   
           5.2   Schema: a schema is a representation of your study design in the form of an outline 
or a model. Including a schema is not a requirement but can be valuable tool in the presentation 
of your study to the IRB. Consider adding a diagram that provides a quick “snapshot” of the 
study.  
Study Visit Procedures    
             5.3   Table of Events 
 
Consent 
(Day -10 to 
-5) 
Visit 1 (Day 
1 to 7) 
Day 25
Visit 2 (Day 
30 to 37) 
  
Day 85
Visit 3 (Day 
90 to 97) 
Daily
PRN (SOC)
I/E Criteria
X
E-Consent PAC
X
Baseline Survey
X

Medical Chart 
Review for 
demographics 
X
Medical Records 
– HbA1c 
X
X
Medical Records 
– device uploads
X
X
PA Calendar
X
PA Goal Set
X
X
Actiwatch 
Shipment  
X
X
X
Actigraph 
Shipment  
X
X
X
Participant 
wears Aciwatch
X
X
X
Participant 
wears Actigraph
X
X
X
Participant to co
mplete   
EMA REDcap Sur
vey (7 days, 
4x/day)  
X
X
X
Treatment 
Satisfaction 
Survey and Post 
Survey 
X
  
 
  
All questionnaires are outlined in Section 11.0. 
 
  
6.0          Study Intervention/Investigational Agent 
 
            6.1   Description: Describe the study intervention and/or investigational agent (e.g., 
drug, device) that is being evaluated.  
NUDGE mHealth intervention. NUDGE is a brief mHealth text messaging intervention 
designed to promote activity in adolescents by allowing them to set, monitor, and receive 
feedback on daily PA goals through text message. The only PHI required to be entered is a phone 
number to receive the text messages. Messages in the Nudge bot are sent via the Twilio server 

and stored in the SQL firewall protected server. At baseline, the participant will choose a time of 
day when he/she would like to receive a text message to set a daily PA goal. Plus, he/she will 
receive a text message to set an initial goal for daily MVPA that is between 15-60 minutes. The 
NUDGE bot will store this goal in a study-specific database overnight. Then, at the 
predetermined time the next morning, the NUDGE bot will send a text message reminding the 
participant of his/her stored goal. In addition, later in the same day, the NUDGE bot will send a 
text message to prompt the participant to self-monitor his/her PA and share this number (in 
minutes per day) via a text message. Once NUDGE receives this response, it will store the 
response in a study-specific database in order to compare it to the previously obtained goal value 
(from the day before). The NUDGE bot will then provide feedback to the participant indicating 
whether or not he/she met the predefined goal, and it will request a new goal. At this point the 
NUDGE bot will only accept goal values that are between an investigator defined range (e.g., 75-
125%) of the last self-monitored PA value, so that future performance is tied to past performance 
and participants cannot set goals that are too high or too low to be useful. Participants with T1D 
will engage in this intervention for up to four and a half months.  
            6.2   Drugs or Biologics: If this study involves the administration or dispensation of a 
drug or biologic, complete the table below.  NA 
            6.3    Medical Devices.  If this study involves the evaluation of the safety or 
effectiveness of a medical device (including mobile medical apps), or the use of medical device 
with a Humanitarian Use Device designation, include the following information: NA 
            6.4   Behavioral Intervention: If this study involves a behavioral intervention, describe 
the intervention in detail. Be sure to address whether the intervention is experimental or 
considered to be an accepted standard.  
This behavioral intervention includes the use of a mobile app to modify PA. Participants are 
allowed to set their own goals within guidelines. These goals will be monitored by the app and 
provide personalized feedback to promote PA. This study explores cybernetic Control Theory, a 
conceptual model to attain PA goals in pediatric patients which utilizes self-monitoring, 
feedback, goal setting, and goal review to modify behavior as noted in Section 3.0 of this 
protocol under the sub-heading 3.3.  
 
 
SUBJECT MANAGEMENT 
7.0          Inclusion and Exclusion Criteria 
 
            7.1   Eligibility Criteria: Describe the criteria that define who will be included or 
excluded in the final study sample. If the study design includes multiple groups, be sure to list the 
criteria for each group. 
  
Inclusion Criteria:  

Participants 13.00-21.99 years old  
Participants with a physician confirmed T1D diagnosis  
T1D diagnosis was at least 6 months prior to study enrollment  
Participants are on an intensive insulin regiment (either with an insulin pump or multiple 
daily injection) 
Participants must be using a continuous glucose monitor (CGM) 
Participants and parents/LARs of participants less than 18.00 speak/read English 
Participants must have regular access to a smart device capable of Wi-Fi or data usage 
 Exclusion Criteria: 
Participants with evidence of type 2 or monogenic diabetes.   
Participants with a comorbid chronic condition (e.g., renal disease). 
Participants with presence of severe psychiatric disorders. 
Participants with a diagnosis of low vision (vision that cannot be corrected with contact 
lenses or eyeglasses). 
Participants with limited mobility that would prevent participant from engaging in daily 
physical activity, self-assessed by participant.  
  
            7.2   Equitable Selection: Inclusion/exclusion criteria should be both fair and 
appropriate to the research question. If your study involves inclusion/exclusion criteria based on 
demographic characteristics such as sex, race/ethnicity, language, provide rationale for the 
criteria. For example, if excluding non-English speaking subjects, provide rationale for why it is 
not possible to include non-English speaking subjects.  
 
This is a small test of change in preparation for future studies that will include non-English 
speaking populations. 
            7.3   Vulnerable Populations: Check any vulnerable [populations that are being 
targeted for enrollment into the study]: (Members of the following populations may not be 
included as subjects in the research unless selected here.) 
☐ Children/Minors (under 7 years of age) 
☒ Children/Minors (7-17 years of age) 
☐ Neonates (infants less than 30 days old) 
☐ Neonates of Uncertain Viability (infants less than 30 days old) 
☐ Non-Viable Neonates (infants less than 30 days old) 
☐ Wards of the State 
☐ Fetuses 

☒Pregnant Women  
☐ Adults with impaired decision-making capacity         
☐ CM Employees 
☐ CM Students/Residents/ Fellows 
☐ Economically or Educationally Disadvantaged Persons 
☐ Prisoners 
  
 
This study will be inclusive of adolescents from 13.00 to 17.99 years of age, a vulnerable 
population. This inclusion is important to research because T1D affects this age group and more 
information about PA and management of T1D is needed. Many of the procedures required to 
collect data as explained in Section 5.0, Study Design, of this protocol are aspects of routine T1D 
care for youth and thus the risk for coercion/harm in participation is low. Informed assent of 
adolescents 13.00 to 17.99 will be obtained per CM policy and parental/LAR permission assent 
will be obtained for all participants in that age group as explained in Section 9.0, Screening and 
Recruitment Methods, in this protocol.  
If an adolescent subject reaches the age of 18.00 during study participation, he or she will be 
asked to reconsent as an adult to further participation. If active participation is complete, consent 
will not be reobtained. 
Pregnant women may participate as there is no risk beyond that of PA within healthy guidelines 
and will be set in collaboration with the participant. 
  
8.0          Local Number of Subjects 
  
 
            8.1   Indicate the total number of subjects or charts to be enrolled locally as well as the 
accrual goal. If the study includes multiple groups or cohorts, be sure to describe the number of 
subjects required for each cohort. If one of the groups includes a chart review, each chart is 
considered a subject and needs to be reflected in the numbers below.  
Target sample size is one group of 50 participants. 
  
  
Group 1 
Group 2 
Totals
Accrual Goal: 
The number of 
evaluable 
subjects/charts you 
are targeting for 
the required 
50 
NA

endpoint for the 
study.   
This number 
typically is based 
on statistical input 
such as a power 
analysis. 
Anticipated 
Enrolled/Consented: 
This is the 
number reported 
at Continuing 
Review. 
Estimated number 
of subjects/charts 
that you anticipate 
you will need to 
enroll in order to 
meet your accrual 
goal above.   
This can generally 
be calculated as 
accrual goal + 
number of 
anticipated screen 
failures + number 
of potential 
withdrawals/drop 
outs. 
  
70 
  
Anticipated Pre-
Screened (if applicable): 
Estimated number 
of subjects/charts 
you anticipate you 
will screen prior to 
obtaining 
permission/assent/
consent. 
For example, if 
your study 
includes a review 
of medical records 
to identify 
potential 
participants prior 
to obtaining 
permission/assent/
consent, this 
number would be 
the estimated 
number of records 
you anticipate you 
will need to review 
in order to meet 
your accrual goal.
250 
  
  

9.0         Screening and Recruitment Methods 
 
            9.1   Screening and Identification of Potential Subjects: 
How will subjects be identified? (Check all that apply)  
☒ Chart reviews  
☐ After obtaining permission/assent/consent 
             ☒ Prior to obtaining permission/assent/consent (Pre-Screening) 
*NOTE: If pre-screening, you must address Partial Waiver of HIPAA Authorization below in the “HIPAA & Confidentiality” section. 
 ☒ Through Cerner or other CM sources (e.g. databases, billing records, pathology reports, 
admission logs, etc.) May involve access of records by individuals not involved in the patient’s 
care. 
☒ List of candidates provided through the Data Report Request Form  
☒ By their treating physician who will then provide the study team’s contact information to the 
potential subject/family 
☒ By their treating physician who will obtain patient/family permission to share contact 
information with the study team 
☒ Self-refer in response to IRB approved advertisements or websites  
☐ Subjects will roll-over from another research study: Study #___________________ 
☒ Registry of individuals interested in research opportunities   
☐ Past subject list 
☐ Other:  
            9.2   Recruitment of Potential Subjects:  
In clinic, telephone, partial waiver of HIPAA authorization for pre-screening/recruitment only.  
Study staff will pre-screen potentially eligible youth and YAs to see if they meet enrollment 
criteria. Study staff may contact families who appear to meet criteria by reaching out via phone 
or CM approved conferencing platform and approaching families during a standard of care visit 
to receive information about this study. If no one answers the phone, only up to 3 voicemails will 
be left per potential participant and will be tracked on the Pre-screening Log. Recruitment may 
also involve a report generated by IT that will involve a review of the electronic medical record 
(EMR) system to generate a list of potentially eligible families. Potential participants may also 
learn of the study through the intake form, Find A Study page, or the study flyer. The flyer can 
be posted on the Diabetes Clinic intake form that families complete before appointments or in 

clinic spaces. The flyer and Study Information Sheet can be posted on the hospital’s Find a Study 
page.  
 
Study staff will provide youth and their parent/LAR and YA participants information about the 
study and answer any questions they may have in order to help them determine if they would like 
to participate as explained in Section 5.0, Study Design. Participants and parents/LARs of youth 
will have ample time to bring forward any questions or concerns during the period between 
recruitment contact and the e-consent process. Participants and parents/LARs will be presented 
with all study information during the e-consent process. At that time informed parental/LAR 
permission and/or participant assent/consent will be obtained. Study staff will take care to 
answer all questions and place no pressure on any potential participant or their parent/LAR to 
enroll.  
To minimize risk, we will inform all participants, and parents/LARs of adolescent participants, 
that they do not have to participate and that a decision not to participate will not affect their care 
at CM. We will inform all participants and parents/LARs of adolescent participants of the risk of 
breach of confidentiality as well as these steps we will follow to reduce the risk of a breach of 
confidentiality and to protect their privacy (e.g., limiting access to data, de-identifying data, 
securing data in a secure CM network drive). We will inform participants that they can refuse to 
answer any question during the study. Similarly, we will inform participants that they can refuse 
to participate in any component of the study protocol and withdraw from the study at any time 
without penalty or loss of benefits.  
  
We request a HIPAA waiver for the purpose of generating pre-screening lists of qualified 
candidates for research recruitment as described above. Study staff will record information 
collected for the purposes of recruitment in the pre-screening log (e.g., eligibility met, contact 
information, clinic visits where study staff may approach families).  Study staff will store 
personal health information (PHI) on non-participants until completion of enrollment. Study staff 
will do this to reduce the likelihood of re-approaching families or YAs who have already 
declined participation in the study. Upon the completion of enrollment, the study team may 
request a de-identified, aggregate report containing demographic information on individuals who 
declined enrollment. Study staff may use this information to compare recruited individuals to 
non-recruited individuals in dissemination work products (e.g., manuscripts, presentations) so 
that we can report any biases in sampling the eligible populations. Additionally, PHI such as 
name, age, etc. will be kept on the enrollment log until study completion at which time, that 
information will be destroyed.  
  
  
10.0      Procedures 
  

            10.1   Provide a description of research procedures of all research procedures being 
performed and when they are performed, including procedures being performed to monitor 
subjects for safety or minimize risks.  
We will recruit eligible pediatric patients from the Pediatric Diabetes Clinic at Children’s Mercy-
Kansas City (CM) as explained in Section 9.0, Screening and Recruitment Methods of this 
protocol.  We will use a tablet and/or computer and REDCap to collect family survey data, 
collect information from participant’s Electronic Health Record (EHR) upon agreement to 
participate, and instruct participants in how to wear the actigraph and the actiwatch and track, 
and share data with the research team as explained in Section 5.0, Study Design of this protocol.  
Contact with participants via phone/email is explained in detail as well in Section 5.0. This study 
involves no more than minimal risk and procedures to minimize any potential risk to participants 
is also explained in Sections 5.0, 9.0 under subheading 9.2, and 15.0 of this protocol.  
Visit 1: 
Informed permission/assent/consent (PAC) from adult participant or child and parent/LAR will 
be obtained prior to study procedures being performed. All required elements of PAC will be 
documented in REDCap as this study will not be in the medical record per CM policy. 
The study team will conduct a medical chart review to collect demographic information 
including date of birth, age, gender, height, weight, race, ethnicity, medical history, date of T1D 
diagnosis, treatment regimen, T1D-related hospitalizations, number of contacts and visits with 
clinic staff.  
HbA1c is a proxy measure of glycemic control over the past 12 weeks. HbA1c will be collected 
from medical record via POC measures collected during routine diabetes clinic visits.    
Glucometer, CGM, and/or pump uploads from SOC visits may be included to assess frequency 
of blood glucose checks or insulin delivery as a proxy measure of self-management adherence. 
We may also calculate mean daily blood glucose, percent high BG, percent low BG, and percent 
in range for glucose levels21, and insulin BOLUS scores22 from participants’ device uploads.   
Baseline Surveys will be sent to participants via REDCap after informed e-consent PAC is 
completed. This will include Demographics, Treatment Self-Regulation Questionnaire 
(Exercise), Treatment Self-Regulation Questionnaire (Diet), Perceived competence for Exercise 
Questionnaire, Social Support for Exercise Questionnaire, (Family), Social Support for Exercise 
(Friends), Physical Activity Self-Efficacy Questionnaire, and Physical Activity Attitudes 
Questionnaire, Power of Food Scale, and Pediatric Quality of Life (PedsQL) Parent Report.  
We will collect an objective measure of participants’ MVPA based on wrist-worn actigraphs and 
wrist-worn actiwatches￼. Youth and YAs with T1D who consent to participate will receive a 
GT3X actigraph and instructions how to share the data from their GT3X actigraph with the study 
team. Participants will also receive an actiwatch (Garmin Vivosmart 4 or higher as an additional 
measure of MVPA. We will use age-appropriate guidelines to identify and calculate daily 
minutes of MVPA.   

We will ask participants to complete a PA calendar in order to track their scheduled PA. This 
activity calendar will be completed in REDCap. Participants will also answer an open-ended 
question “What would you like to set your initial baseline PA goal as in minutes?” to help to 
anchor PA goals for the NUDGE intervention. 
 
Participants may complete questionnaires outlined in section 11.0 electronically with the survey 
links sent via email or text using Twilio. We will set up the distribution of the EMA REDcap 
Surveys to be completed 4 times per day with family and/or participants for seven days for the 
initial 7-day assessment with the actigraph and actiwatch. The EMA Survey includes Negative 
Affect Scale for Children Questionnaire, Latent Mood Questionnaire, Environment 
Questionnaire, and a sleep diary. The actigraph and actiwatches will be shipped within 10 days 
to participants with instructions on how to use both as well as how to return the devices at the 
end of seven days. 
 
Visit 2: 
Set up distribution of the EMA REDcap Surveys with family and/or participant 4 times per day 
for seven days. The actigraphs and actiwatches will be shipped within 10 days to participants 
with instructions on how to use the devices as well as how to return the devices at the end of 
seven days.  
Visit 3: 
Set up distribution of the EMA REDcap Surveys with family and/or participant 4 times per day 
for seven days. The actigraphs and actiwatches will be shipped within 10 days to participants 
with instructions on how to use the devices as well as how to return the devices at the end of 
seven days.  
 
The REDcap Treatment Satisfaction Survey will be distributed to participants which includes the 
Client Satisfaction Questionnaire and the Exit Interview and Acceptability Questionnaire.  
Returning Study Devices.  We will use one of two procedures to facilitate the return of any 
study-specific devices. First, we will send participants/families a prepaid box in which to return 
all study-related devices to the research team. Second, if necessary, we may make arrangements 
to pick up devices during a routine T1D clinic visit. 
Feasibility Assessment. We will evaluate feasibility based on: the percentage of time 
participants wore the actigraphs during the study period, the percentage of daily PA surveys 
adolescents completed, and the percentage of complete interactions with the NUDGE 
intervention.  
Initial Efficacy Assessment. Refer to Section 4.0, Study Endpoints 
  
       10.2   Blood and Other Specimen Collection: NA 

11.0      Surveys and Psychometric Testing: 
  
 
This study will include questionnaires to assess participants’ motivation for beginning/continuing 
PA, belief in competency/efficacy in regard to PA, social support for engaging in PA, personal 
attitudes toward PA, satisfaction with the intervention and participation in the study, and what 
participants did or did not enjoy about this study/intervention. Additionally, participants will be 
asked about their environment, emotional status, and changes in well-being due to intervention 
engagement. EMA REDcap Survey includes questions from two validated measures: The 
Positive and Negative Affect Scale for Children23 and the Latent Mood Questionnaire24. The 
other measures included in the Baseline survey have also been previously validated: Treatment 
and Self-Regulation Questionnaire25, Physical Activity Attitudes Questionnaire26, Perceived 
Competence for Exercise27, Social Support for Exercise28, the Physical Activity Self-Efficacy 
Questionnaire29, Power of Food Scale30, and Pediatric Quality of Life (PedsQL) Parent Report31. 
 
 
 
Included in Baseline Survey: 
Demographic Survey 
 
Treatment Self-Regulation Questionnaires (Exercise & Diet). The treatment self-
regulation questionnaires assess motivation for eating a healthy diet and engaging in 
healthy physical activity. This measure has 15-items that assess autonomous and 
controlled motivation for engaging in the behavior on a 7-point Likert scale (1= Not at all 
true, 7= Very true)25.  
 
Perceived competence for Exercise.  The Perceived Competence for Exercise 
questionnaire is a 4-item scale that assesses an individual’s perception of their own 
ability to exercise on a regular basis on a 7-point Likert scale (1= Not at all true, 7= Very 
true)27.  
 
Social Support for Exercise (Family). The social support for exercise questionnaire 
assesses to what degree family members provided support for the adolescent to be 
physically active. The measure is comprised of 13-items pertaining to support from 
friends and 13- items pertaining to support from family. Each item is scored on a 5-point 
scale (1= None, 5= Very often)28.  
 
Social Support for Exercise (Friends). The social support for exercise questionnaire 
assesses to what degree friends provided support for the adolescent to be physically 
active. The measure is comprised of 13-items pertaining to support from friends and 13- 
items pertaining to support from family. Each item is scored on a 5-point scale (1= None, 

5= Very often)28.  
 
Physical Activity Self-Efficacy Questionnaire. The physical activity self-efficacy 
questionnaire is an 8-item instrument used to determine the participant’s perception of 
their own ability to be physically active. Each item is scored on a 5-point scale (1= 
Disagree a lot, 5= Agree a lot)29.  
 
Physical Activity Attitudes Questionnaire. The Physical Activity Attitudes Questionnaire 
is a 17-item measure used to assess adolescent’s outcome expectancies for physical 
activity. The instrument has a positive (e.g., being active would give me more energy) 
and negative (being active would make me tired) outcomes scale. Each item is scored on 
a 5-point scale (1= Disagree a lot, 5= Agree a lot)26. 
 
Power of Food Scale. The Power of Food Scale focuses on the psychological appetite for 
food and the enjoyment of food. It has been confirmed as a useful measure of patient’s 
appetite for food and related issues30. The version used is a 30 measure scale, 15 focusing 
on general attitudes, and 15 focusing on attitudes toward food the day of the survey. 
 
Pediatric Quality of Life (PedsQL) Parent Report. The PedsQL is a 23 item measure 
validated for 2-18 Y.O.s, focused on health-related quality of life measures. It is 
applicable to both populations with and without chronic diseases, and utilizes both self-
reported information or parent proxy information31. 
 
 
 
 EMA REDcap Survey: 
Positive and Negative Affect Scale for Children. The Positive and Negative Affect Scale 
for Children is a short form (10-items) of the well-validated Positive and Negative Affect 
Scale that has been adapted and validated for use in children and adolescents. Each item 
is scored on a 5-point scale (1= Not at all, 5= Extremely)23.  
 
Latent Mood Questionnaire. To assess a variety of mood states the current study makes 
use of the three highest loading items for six of the subscales from the Profile of Mood 
States scale. The constructs represented in the current project are: Anger-hostility, 
Depression-dejection, Fatigue-inertia, Tension-anxiety, Vigor-activity, and Friendliness. 
Each item is scored on a 5-point scale (1= Not at all, 5= Extremely)24.  
 

Environment Questions. To obtain information regarding the location of participants 
when beginning each EMA survey, five questions will be asked pertaining to location, 
vegetation, traffic, safety, and the weather. 
 
Sleep Diary. To obtain basic questions about the sleep pattern of the previous night and 
day (length of sleep, any naps, nap lengths), and see if sleep was disturbed due to T1D 
management. 
 Treatment Satisfaction Survey:  
Client Satisfaction Questionnaire (CSQ-8). The Client Satisfaction Questionnaire is an 8-
item measure of client satisfaction with services they receive32.  
  
Exit Interview and Acceptability Questionnaire. This measure assesses the participants 
experience of being in the study.  
 
 
12.0      Follow-up - NA 
  
 
 
13.0      Genetic Analysis Information - NA 
  
            
14.0      Sharing of Results with Subjects - NA 
  
  
15.0      Risks to Subjects 
  
 
            15.1   List the research risks. Research risks are any potential physical, psychological, 
social, legal, privacy, confidentiality risks or economic harms that may come from participating 
in the study. This does not include the risk of any procedures conducted as part of standard care.  
There is a slight risk of skin irritation from the actigraph and actiwatches.  Because the research 
requires the collection of PHI, there is a risk breach of confidentiality. There is a small chance 
that disclosing this information may potentially lead to emotional discomfort for some families. 
There also is a risk to confidentiality when using the internet. Pregnant women may participate 
as there is no risk beyond that of PA within healthy guidelines. No additional costs are associated 
with this study, except the potential of a participant to exceed data allowances for their plan with 
their cell phone carrier.  

If the devices cause more than minimal discomfort, participants will be instructed to notify the 
study team. Minimizing risk of confidentiality is described in section 9.0. Regarding questions 
that may cause emotional discomfort, participants will be instructed that they may decline to 
answer any question that they do not feel comfortable answering. Participants will be informed 
any fees from their cell phone carrier incurred by exceeding their data plan limit will not be 
covered by the study. PA goals for participants that are pregnant will be set in collaboration with 
the participant and limited to healthy guidelines. 
          15.2   Indicate whether the researchers believe the risks involved in this study are 
minimal, or if the study poses greater than minimal risk of harm to subjects.   
The overall risks of participation in this project are no more than minimal. 
            15.3   If applicable, indicate which procedures may have risks to the subjects that are 
currently unforeseeable. NA 
            15.4   If applicable, indicate which procedures may have risks to an embryo or fetus, 
should the subject be or become pregnant. NA 
            15.5   If applicable, describe risks to others who are not subjects (e.g. pregnant partner of 
a male subject) NA 
16.0      Potential Benefits 
  
 
             16.1   Describe the potential of any direct benefits that individual subjects may 
experience from taking part in the research. Include the probability, magnitude, and duration of 
the potential benefits as this will be useful to the IRB in making their risk/benefit determination. 
It is possible that some participants could improve their level of personal fitness and HbA1c 
level based on using the NUDGE intervention. There may not be direct benefit to being in this 
study, but by being in this study their child may help researchers find better treatments for people 
with T1D and how PA may help with managing T1D and other illnesses in the future.  
            16.2   Describe the potential of any benefits to society or others related to the possible 
knowledge gained.  
NUDGE could benefit numerous populations in improving PA and subsequent health benefits 
that result from increased PA. 
  
 
17.0      Investigator Assessment of Risk/Benefits Ratio:  
 
 
            17.1     Please provide an assessment of risk and benefits in the table below.  Note, the 
IRB makes the final determination based upon responses in the two preceding sections. 

  
Select as applicable:
Pediatric Risk Category:
☒ 
Category 1  
Research not involving 
greater than minimal risk  
(45 CFR §46.404 and 21 CFR 
§50.51)  
☐ 
Category 2 
Research involving greater 
than minimal risk but 
presenting the prospect of 
direct benefit to the 
individual subjects. (45 CFR 
§46.405 and 21 CFR §50.52)
☐ 
Category 3 
Research involving greater 
than minimal risk and no 
prospect of direct benefit to 
individual subjects, but 
likely to yield generalizable 
knowledge about the subject's 
disorder or condition.  
(45 CFR §46.406 and 21 CFR 
§50.53)
☐ 
Category 4 
Research not otherwise 
approvable which presents an 
opportunity to understand, 
prevent, or alleviate a 
serious problem affecting the 
health or welfare of children. 
(45 CFR §46.407 and 21 CFR 
§50.54)
Select if applicable:
Adult Risk Category:
☒ 
Not Greater than Minimal 
Risk
☐ 
Greater than Minimal Risk 
  
18.0      Payment, Reimbursement and Tangible Property provided to subjects  
Will subjects receive payment, reimbursement, or tangible property? 
☒  Yes                 ☐  No (If No, delete the following subsections) 
                18.1      Payment to Subjects: If providing payment to subjects (e.g. cash equivalent 
for participation, payment for time off work), select the form of payment: 
 
☒  Greenphire/ClinCard/Rybbon 
☐  Gift Card: (Merchant:_____________) 

☐  Other: __________ 
   
 Payment Schedule:  
Participants will receive up to $648 of compensation for completion of the Study.  See the Table 
below: 
 
Initial 
Study Visit
Wearing 
Actiwatch
Wearing 
Actiwatch 
6/7 days 
Completing 
Each EMA 
Surveys 
Completing 
EMA 
Survey 6/7 
days 
Timely 
Device 
Return 
Completing 
Treatment 
Satisfaction 
Survey
Total 
Compensati
on Possible
$50 
$5/day 
(x21) 
$100 
$2 ($168 
possible) 
$100 
$75 ($25 
each) 
$50 
$648 
 
To receive timely device return compensation, we ask that participants drop-off or schedule a 
package pick-up within a week after their wear week/visit finishes. Participants will have a 
simple two question survey to fill out the based on the date provided and receipt of the item 
within a reasonable/expected period for shipment, participants will qualify to receive 
compensation. Compensation will not be withheld from participants due to issues or delays 
caused by the mail carrier. 
               18.2   Subject Reimbursement:  If providing reimbursement (repayment to research 
participants and/or their families to cover out-of-pocket expenses they incur), select the form of 
reimbursement: NA 
               18.3   Tangible Property:  If providing tangible property or any item of value given to 
research subjects for their participation (e.g. a toy, a tote bag, a water bottle, an electronic 
device), describe: NA           
19.0      Compensation for Research-Related Injury – NA, Minimal Risk 
  
20.0      Economic Burden to Subjects 
  
 
              20.1      Describe any costs that subjects may be responsible for because of 
participation in the research. This may include transportation to appointments, time away from 
work, parking, additional lab tests, et cetera.  
The only costs participants may have from participating in this study could be from their cell 
phone carrier. They may charge participants message and data rates depending on their contract 
with their cell phone carrier. These charges, if any, will not be covered by this research study.  
21.0      Permission/Assent/Consent Process 

☒ Written informed permission of parent/LAR for pediatric participants  
Study group(s) to which this method applies: Parent/LAR of pediatric participants 
☒ Written informed consent of adult participants 
Study group(s) to which this method applies: Adult participants (18 and above) 
☒ Written informed consent of participants turning 18 
Study group(s) to which this method applies: Participants who turn 18 while actively 
participating in study activities   
☒ Waiver of consent of participants turning 18 
Study group(s) to which this method applies: Participants who turn 18 and active participation 
has ended  
               21.1    Summarize the methods of permission/assent/consent that will be used for each 
study group.  For example, “Full written permission and assent will be obtained for pediatric 
subjects in the experimental group.  Verbal consent will be obtained from parents participating 
in the survey portion of the study.  For the historical controls chart review group, we are 
applying for a waiver of parental permission and assent.” 
  
Informed consent will be obtained through e-consent via telephone or CM approved 
conferencing platform. Participants who turn 18 while actively participating in the study will be 
reconsented. 
We request waiver of consent when patients turn 18 whose active participation has ended due 
to continued use of identifiable data. Unnecessary PHI will be destroyed upon completion of the 
study however, some PHI will need to be kept (date of enrollment, dates of visits, dates surveys 
completed) We cannot completely deidentify the data if we are unable to reach the subject.  
This protocol, and any subsequent modifications, as well as patient-facing material will be 
reviewed and approved by the Pediatric IRB at The Children’s Mercy Hospital & Clinics. 
  
Regulatory Criteria: To qualify for a waiver or alteration of parental permission or adult 
consent, ALL of the following must apply.  Explain how the study meets each of the regulatory 
criteria below.   
Waiver of Consent when patients turn 18 whose active participation has ended: 
Criteria
Explain how the study meets the criteria
The research involves no more 
than minimal risk to the 
participants
The research presents no more than minimal risk of harm to 
subjects and involves no procedures for which written permission 
is normally required outside of the research context.
The research could not 
practicably be carried out without 
the requested waiver/alteration 
(i.e., explain why the study could 
not be done if 
permission/assent/consent were 
required)
We request a wavier of consent when participants turn 18 and are 
no longer active in the study because we will need some PHI even 
after study procedures have been completed.  

If the research involves using 
identifiable private information or 
identifiable biospecimens, the 
research could not practicably be 
carried out without using such 
information or biospecimens in an 
identifiable format
We do include PHI as part of our dataset and will need to continue 
to use even after participation has ended.  
The waiver/alteration will not 
adversely affect the rights and 
welfare of the participants
The family will be made aware of this at enrollment. We will not 
keep any PHI that is not necessary for the study.  
Whenever appropriate, the 
participants or legally authorized 
representatives will be provided 
with additional pertinent 
information after participation
Yes 
 
Assent of Pediatric Participants 
☒ Assent of pediatric participants WILL BE SOUGHT following assessment of ability to assent. 
The study team will assess on a case-by-case basis, using best judgement and ensuring there 
were no notes in the medical record that indicates a participant would be unable to 
assent. Parents/LAR and participants will be made aware that participant assent is required upon 
initial contact. Study staff will ask to speak directly to the pediatric participant prior to the e-
consent to answer any questions or concerns. The formal assent discussion will be conducted 
during the e-consent process and documented through REDCap. The length and content of the e-
consent materials offer ample time and information for the participant to make any concerns or 
questions known and is designed to ensure participant comprehension.  
22.0      HIPAA and Confidentiality 
 
HIPAA regulations apply to this study if the data used or accessed relates to: 
The past, present or future physical or mental health or condition of an individual; 
The provision of health care to an individual; OR 
The payment for the provision of health care. 
  
22.1 
HIPAA Authorization  
Select all applicable methods of HIPAA Authorization that apply to this study. For each 
selection, click on the “ ” symbol to expand additional information required (if applicable). 
☒  Full Written HIPAA Authorization will be obtained (within the p/a/c form or standalone 
form) 
☒ Partial Waiver of HIPAA Authorization (e.g. waiver for recruitment and pre-screening 
purposes only) 

☒ Other: Waiver of HIPAA Authorization at age 18 (authorization will NOT be obtained) for 
continued use of identifiable data from patients who turn 18 and active participation has ended. 
Regulatory Criteria: To qualify for an alteration of HIPAA Authorization, ALL of the following 
must apply to your study.  Explain how your study meets each of the regulatory criteria below.   
  
Criteria
How your study meets the criteria
The use or disclosure of PHI involves no 
more than minimal risk to the privacy of 
individuals based upon the following:  
Plan to protect PHI from improper use 
and disclosure: 
Plan to destroy PHI at the earliest 
opportunity, unless there is a health or 
research justification for retaining the 
PHI: 
Assurance that PHI will not be reused or 
disclosed to any other person or entity: 
We will protect PHI from improper use and 
disclosure as it will only be made available to 
study staff on an as-needed, IRB approved 
basis as noted in Section 5.0, Study Design, of 
this protocol.  
 
PHI will be destroyed after all publication has 
been completed.  
 
PHI will not be reused or disclosed to any 
other person or entity. 
The research cannot practicably be conducted 
without the waiver, i.e. explain why you 
cannot obtain a signature for HIPAA 
Authorization. 
Partial Waiver of HIPAA Authorization: 
Study staff will need to record information 
collected for the purposes of recruitment in 
the pre-screening log (e.g., eligibility met, 
clinic visits where study staff may approach 
families) as noted in Section 9.0, Screening 
and Recruitment Methods, of this protocol.   
 
Waiver of HIPAA Authorization at age 18: 
Permission/Assent will be obtained.  The 
Waiver is limited to continued use of 
identifiable data from patients who turn 18 
and active participation has ended. 
The research cannot practicably be conducted 
without access to and use of the PHI, i.e. 
explain why you need the PHI to do this 
study. 
 Study staff will store PHI on non-participants 
until completion of enrollment. Study staff 
will do this to reduce the likelihood of re-
approaching families who have already 
declined participation in the study as noted in 
Section 9.0, Screening and Recruitment 
Methods, of this protocol. 
 
All data collected is needed to meet the study 
aims. 
  
             22.2     Indicate how the research team will protect the confidentiality of subjects’     
data during storage, use, and transmission.   (e.g. training, authorization of access, password 

protection, encryption, physical controls, and separation of identifiers and data [master list]).  
Remember: Sensitive CM data, including research data, must be stored on a file server on the 
CM network domain – not on a workstation hard drive.  
 
 
Information pertaining to protection of confidentiality of subject’s data during storage, use, and 
transmission can be found in Sections 5.0 and 23.0 of this protocol. 
  
              22.3     State whether a Certificate of Confidentiality has been issued for this study.  
Certificates are automatically issued for NIH funded research per NIH policy.  For non-federally 
funded research involving identifiable, sensitive information, investigators may apply for a 
Certificate if desired.  See the NIH website on Certificates of Confidentiality for more details. 
  
A Certificate of Confidentiality has not been issued for this study.  
  
23.0     Provisions to Protect the Privacy Interests of Subjects 
 
            23.1    Describe the steps that will be taken to protect subjects’ privacy during 
recruitment and while obtaining permission/assent/consent.  For example, best practice is to 
obtain permission/assent/consent in a separate area where a private conversation can be had.  If 
this is not possible, be sure to explain what steps will be taken to provide as much privacy as 
possible. 
Participation in this research study is voluntary. Study staff will notify adult participants and the 
parents/LARs of youth of the voluntary status of the research at the onset of the study enrollment 
and receive informed permission/assent/consent during their e-consent study visit as explained in 
Section 5.0, Study Design, of this protocol and further explained in Section 9.0, Screening and 
Recruitment Methods, of this protocol. Any potential participant or parent/LAR who declines to 
participate will not incur any penalty or loss of benefits to which they are already entitled. No 
change to the participants’ or parent’s/LAR’s medical care will occur as a result of the 
participation, or nonparticipation in the study. 
Recruitment and consent may take place during a routine clinic visit in a private clinic room, 
over the phone, or over a CM approved conferencing platform. 
           23.2    Describe what steps you will take to make the subjects feel at ease with the 
research situation in terms of the questions being asked and the procedures being performed. 
“At ease” does not refer to physical discomfort, but the sense of intrusiveness a subject might 
experience in response to questions, examinations, and procedures. 
  

 Participants will be told that research is voluntary and that they do not have to answer any 
questions within the surveys that they do not want to answer.  
           23.3    Indicate how the research team is permitted to access any sources of information 
about the subjects and how the research team will protect the confidentiality of subjects’ data.  
Any of the research data collected, with the exception of PHI, may be shared in an aggregated 
form in presentations and publications. At the termination of the study, study staff will destroy 
the enrollment log and pre-screening log.  During the course of the study, study staff will delete 
the PHI (with the exception of name and MRN) collected on potential subjects who do not wish 
to participate. Upon completion of the study, study staff will remove all unnecessary PHI in the 
data collection files and/or convert to a deidentified number. However, certain PHI will be kept: 
date of enrollment, dates of visits, and dates surveys were submitted. 
 
NUDGE data is stored securely in two locations- the Twilio.com server and a secure server at the 
University of Kansas. Twilio uses an encryption protocol to protect the data in messages 
transferred between Twilio and the NUDGE Web application. NUDGE uses the TSL 
cryptographic protocol and HTTP authentication. These are the highest security levels available 
from Twilio at the time of the last software update for the NUDGE web app. Second, data are 
captured on a SQL Server instance behind a HIPAA compliant firewall in the Computing Center 
at the University of Kansas. 
 
Study staff at Children’s Mercy may access and record name, initials, dates of service, date of 
birth, medical record number, hospital account number, street address, fax number, telephone 
number, and email address for research purposes. 
The University of Kansas team will have access to the participant’s telephone number via the 
Nudge application. They will also have access to the participant addresses as part of PA tracking 
device shipment. 
   
Research Team members will only access participant information per the methods approved by 
the IRB. CM approved lockboxes will be utilized to transport any documents containing PHI 
from one location to another and this will only be done when necessary.  Electronic data will be 
stored and accessed per secure methods approved by the IRB. 
 
Study staff will share as soon as it becomes available any new information gathered during the 
course of the study which might impact a family’s desire to continue in the study. 
  

24.0      Withdrawal of Subjects 
 
             24.1    Describe the anticipated circumstances, under which subjects will be withdrawn 
from the research without their consent.  
The only foreseeable circumstances of withdrawal from the research without their consent would 
be subjects not meeting eligibility criteria. 
           24.2    Describe any procedures for orderly termination. 
See Section 23.0, Provisions to Protect the Privacy Interests of Subjects, of this protocol for 
additional information and below in Section 24.3.  
           24.3    Describe procedures that will be followed when subjects withdraw from the 
research, including data retention plans or partial withdrawal from procedures with continued 
data collection. 
Participants may withdraw from the study at any time, and this will not affect their medical care. 
Study staff will not collect any study-related data on participants after their withdrawal from the 
study. Data collected up to withdrawal will be included in the analyses, with the exception of 
those who are withdrawn from the study for not meeting eligibility criteria.  
 Also see Section 23.0, Provisions to Protect the Privacy Interests of Subjects, of this protocol. 
DATA MANAGEMENT 
25.0      Data Collection: (This section is required for all studies.) 
 
            25.1     Provide a general description of the types or categories of data that will be 
collected during the study (e.g., lab tests, procedure outcomes, length of stay, questionnaires, 
surveys). You will provide details on identifiable data and sensitive data below. 
This study will be completely integrated into the Diabetes Data Dock at CMKC. Data will be 
collected and paired with the other wearable devices, such as pump and continuous glucose 
monitor readings.  
The following data may be collected for this study: HbA1c values collected from EHR; device 
uploads, date of birth, age, gender, height, weight, race, ethnicity, address, phone number 
(parent, child, close friend), place of birth, primary language, parent age (mother & father), 
parent education (mother & father), parent occupation (mother & father), family income, parent 
marital status, medical history, (such as date of T1D diagnosis, T1D-related hospitalizations, 
treatment regimen, number of contacts and visits with clinic staff, insurance type, and blood 
glucose data, etc.) physical activity calendars, data from the actigraph, questionnaires and 
surveys as noted in Section 5.0, Study Design.  
 
Demographic data: We will use a data collection form in REDCap33,34 to collect demographic 
data. We may use the Diabetes Data Dock/ electronic health record to verify or extend 
participant demographic data listed above (e.g., T1D diagnosis, history of T1D-related 

complications, T1D regimen). For remote visits, we will share a web URL linking to the 
REDCap survey. Participants may complete Surveys on iPad for in person visit or at home via 
email or text using Twilio as noted in Section 10.0, Procedures. 
   
HbA1c data: We will use routine T1D care POC HbA1c levels to at baseline and at post-
treatment (~3 months post baseline).  
 
CGM or SMBG data: Families will use their personal, prescribed CGM or standard blood 
glucose monitor (SMBG) throughout the study.  Families will share CGM data with the study 
team using their personal, CM connected account. To facilitate data sharing, we will ask 
participants and parent/LAR of youth to please share a .CSV file version of these data. Study 
staff will save participant’s CGM or SMBG in a secured study database using MS Excel or 
equivalent software. Data will be download automatically to the Diabetes Data Dock using API. 
This study database will reside in a secured CM approved location. 
Garmin data and activity monitor: data will be downloaded and stored on the Diabetes Data 
Dock using API connection. Primary physical data will be gathered from the Garmin Connect 
platform.  The anonymous participant Garmin data from the Garmin Connect platform will be 
loaded to a secure database through the Garmin Health API connection developed by Children’s 
Mercy Research Informatics. The Garmin tracker will not collect personal information. Physical 
activity data will be pulled from the actigraph via the Actilife software and uploaded into the 
secure database. Also, the patient study record will be linked to the Garmin tracker and the 
actigraph. The interventionist team will be able to pull the data to Microsoft Azure database to 
evaluate. Coded clinical data will also be collected from EMR. 
Insulin delivery data: Participants will use their personal, prescribed insulin delivery device 
throughout the study. Participants and parents/LARs of adolescents will share participants’ 
insulin device data with the study team using their personal, CM connected account. To facilitate 
data sharing, we will ask families to please share a .CSV file version of these data. Study staff 
will save participant’s insulin device data in a secured study database using MS Excel or 
equivalent software. This study database will reside in a secured CM approved location. 
   
Questionnaire data: We will use REDCap to electronically collect any survey data, including 
participants’ daily activity schedules. We will use a single REDCap database for all study 
participants. This REDCap data base will reside on a CM secured server. 
   
   
Name/Initials
☐ Accessed only 
☒ Recorded 
All elements of date 
(except year) directly 
related to an individual 
(e.g. date of birth, 
admission date, 
discharge date, date of 
death)
☐ Accessed only 
☒ Recorded 

Medical record number 
☐ Accessed only 
☒ Recorded 
Account number 
☐ Accessed only 
☐Recorded 
Health plan 
identification number
☐ Accessed only 
☐ Recorded 
Social Security Number 
☐ Accessed only 
☒ Recorded 
Device identifiers and 
serial number
☐ Accessed only 
☐ Recorded 
Certificate/License 
number
☐ Accessed only 
☐ Recorded 
Telephone number 
☐ Accessed only 
☒ Recorded 
Fax number 
☐ Accessed only 
☒ Recorded 
Email addresses 
☐ Accessed only 
☒ Recorded 
Web addresses (URLs); 
Internet IP addresses
☐ Accessed only 
☐ Recorded 
Street address, city, 
county, precinct, zip 
code or equivalent 
geographical codes
☐ Accessed only 
☒ Recorded 
Full face photographic 
images and any 
comparable images
☐ Accessed only 
☐ Recorded 
Biometric identifiers, 
including finger and 
voice print
☐ Accessed only 
☐ Recorded 
Vehicle identifiers and 
serial numbers, 
including license plate 
number
☐ Accessed only 
☐ Recorded 
Any other unique 
identifying number, 
characteristic or code 
that may help identify 
individual participants 
including their initials 
(e.g. student or 
employee ID number)
☐ Accessed only 
☐ Recorded 
Elements of date, 
including year, for 
persons 90 years or 
older
☐ Accessed only 
☐ Recorded 
Other: Insurance type 
(public vs. private)
☐ Accessed only 
☒  Recorded 
 
26.0      Adverse Events and Unanticipated Problems  
 
             26.1      Monitoring: Describe your process for monitoring subjects and data to identify 
adverse events and other unanticipated problems. 

The only anticipated Adverse Event is potential Breach of Confidentiality. Please see Sections 
9.0 (Screening and Recruitment Methods), 23.0 (Provisions to Protect the Privacy Interests of 
Subjects), 25.0 (Data Management), and 28.0 (Data and Specimen Management), of this protocol 
for procedures to prevent and/or reduce this risk.   
               26.2    Reporting: Confirm that you will be following Policy 5.11 Reportable Events of 
the CM Research Program Policies in regards to reporting adverse events and other 
unanticipated problems to the CM IRB. If you will be deviating from or expanding upon this 
policy, explain why the approved policy would not suffice for this study and the rationale for 
deviating/expanding. 
Policy 5.11 Reportable Events will be followed.  
  
27.0      Statistical Analysis  
 
 
           27.1    Describe the data analysis plan, including any statistical procedures or power 
analysis.  
This is a pilot data collection in order to perform power calculations for a larger study. 
AIM 1 and Hypotheses 1 and 2: Refer to Section 3.0, Objectives for explanation.  
Data Analysis: We will use descriptive statistics to examine feasibility based on the percent of 
daily text messages exchanged between youth and the NUDGE bot. This will serve as our 
primary feasibility assessment. However, we will also consider feasibility based on other 
parameters including percent of days that youth wear the actigraph and the percent of daily PA 
schedules that participants complete. We will use multilevel analyses to determine whether the 
NUDGE intervention increased participants MVPA levels. In particular, we will examine the 
effect size of NUDGE and interpret at least a medium effect size as our threshold of initial 
treatment efficacy.  
AIM 2 and Hypothesis 3: Refer to Section 3.0. Objectives for explanation. 
Data Analyses: We will use multilevel analyses to determine whether the NUDGE intervention 
improved participants HbA1c levels. As explained above, we will focus on measuring the effect 
size for change in participant HbA1c for this hypothesis as well. 
           27.2    Describe how the sample size for the study was determined (e.g. formal sample size 
calculation, convenience sampling). To minimize the risks associated with a possible breach of 
confidentiality, appropriate sample size calculations limit the amount of patient data being 
recorded to just the amount necessary to answer the research question. 
This is a pilot data collection in order to perform power calculations for a larger study. 

28.0      Data and Specimen Management  
 
Specimen Management – NA  
 
             28.1    Data Management: Describe how data will be handled. 
Please see Sections 9.0 (Screening and Recruitment Methods), 23.0 (Provisions to Protect the 
Privacy Interests of Subjects), 25.0 (Data Management), and 28.0 (Data and Specimen 
Management), of this protocol for additional information on what information will be included 
with data, who will have access to that data, and what procedures are in place to mitigate risks.   
 
Data Management: 
   
We will collect and store all study information electronically on a secure division drive on the 
CM network domain or on Microsoft OneDrive or equivalent. A research data will be processed 
and stored in the secure Diabetes D- Data Dock and will be processed in the CMRI Data Center. 
Collection and storage of this data is explained in further detail in Section 10.0, Procedures, of 
this protocol.  
 
Information will be transferred using a secure file sharing service, such as Azure or OneDrive, 
which is institutionally approved. The NUDGE bot will also store information on a HIPAA 
protected server. The NUDGE bot will initially collect phone numbers, but these will be deleted 
at the end of the study. The information collected by the NUDGE bot, the physical activity and 
goals set and exercise times reported, will be transferred to CM for permanent storage on a 
secure CM drive/domain as previously noted. 
A Certificate of Confidentiality has not been issued for this study.  
Approved study staff (including an assigned data scientist for processing CMRI Data Center 
data) will have access to research records as explained in Section 9.0, Screening and Recruitment 
Methods, of this protocol.  Lab & study staff will have access to samples as explained in Section 
5.0, Study Design, of this protocol. The PI is ultimately responsible for receipt or transmission of 
the data or specimens. 
Data will be stored per the Record Retention and Management Policy and the Record Retention 
Schedule. 
   
        28.2    Specimen Management NA 
        28.3    Biospecimen Information NA 
Will this study involve handling, transporting, or shipping any potentially hazardous biological 
material at/from a Children’s Mercy location (e.g., blood, stool, saliva, tissue)? 
☐ Yes 

☒ No 
Will this study involve processing any potentially hazardous biological material at a Children’s 
Mercy location (e.g., blood, stool, saliva, tissue)? 
☐ Yes 
☒ No 
  
  
29.0      Storage/Banking of Data and Specimens for Future Research - NA 
 
 
30.0      Provisions to Monitor the Data to Ensure the Safety of Subjects 
 
This section is required when research involves more than Minimal Risk to subjects.  
Because this intervention presents no greater than minimal risk, we do not propose to assemble a 
Data Safety and Monitoring Board. PI and study staff will assume responsibility for oversight and 
safety of participating child/parent or child/LAR dyads.  Any known breach of confidentiality will 
be reported to the IRB.  
                30.1   In addition to the Principal Investigator, which individual or group will be 
responsible for monitoring the data and safety for this study? NA 
                30.2   Data Safety Monitoring Plan:  If a DSMB charter or other external monitoring 
plan is available, upload under “Other Attachments” on the “Local Documents” page in your 
myIRB submission.  If such a charter/plan is not available, describe: NA 
  
STUDY MANAGEMENT 
31.0      Setting & Locations 
 
Describe the sites or locations where the research will be conducted.  
Identify where research procedures will be performed including any non-CM affiliated locations.  
For any non-CM affiliated locations, upload a letter of support in myIRB which states that the 
site is aware that research will be conducted on their premises: 
The study visits will take place either remotely via a CM-approved telehealth platform or at the 
CM Endocrinology clinic during a routine care visit (if preferred by the participant/ family). 
Non- CM affiliated locations will not be used for research procedures. 

Describe the composition and involvement of any community advisory board: NA 
For research conducted outside of CM and its affiliates describe: 
Regulations or customs affecting the research: NA 
The local scientific and ethical review structure: NA 
Describe the availability of medical or psychological resources that participants might need as a 
result of taking part in the study. NA 
 
32.0      Multi-Site Research  
 Choose ALL relationship types that apply:  
☐    Multi-Site Research: Multiple sites will be engaged in this human research project. Sites 
will use the same protocol to conduct the same human research activities (except for minor 
variations due to local context considerations).   
☒    Collaborative Research: Multiple sites will be engaged in this human research project. Sites 
will not be performing the same research activities. The Site submission will specify the specific 
research activities each site will perform.  
REQUIRED: Enter summary of site-specific activities that differ from the overall protocol: Click 
or tap here to enter text.  
Children’s Mercy: Subject screening, recruitment, consent, data collection, surveys, data 
analysis. 
University of Kansas: App management, data analysis 
Nemours Children’s: Data analysis (deidentified) 
University of Kansas Medical Center: No site-specific activities will occur at this site (Student 
from KUMC will be performing activities Remotely and at Children’s Mercy) 
☒  Student(s):  Student(s) will help with this project and will be engaging their home institution. 
We are engaging with a student from University of Kansas Medical Center who will be involved 
in analyzing patient data and patient interaction (survey follow up) at Children’s Mercy. 
☐    Visiting Resident(s) / Visiting Fellow(s):  Visiting Resident(s) / Visiting Fellow(s) will help 
with this project and will be engaging their home institution.  
  
Is Children’s Mercy (CM) acting as the single IRB of Record (sIRB)? 
☐    No, each site is getting their own IRB approval.  

☒     Yes, some or all sites will rely on the CM as the sIRB.  
 
Reliance is required for non-Exempt NIH or other Federally Funded research where: NA 
o The institution's employees or agents intervene or interact with human subjects for 
research purposes.     
o The institution's employees or agents obtain individually identifiable private information 
or identifiable biospecimens about human subjects for research purposes; or     
o The institution receives a direct HHS award to conduct human subjects research, even 
where all activities involving human subjects are carried out by a subcontractor or 
collaborator.  
If CM is sIRB for another site, complete the chart for that site(s) (Add a new row for each site 
relying on the CM IRB, delete chart if not acting as sIRB): 
Site Name 
Enrollment Goal for 
Site(s) 
Choose One 
Relying on CM IRB?  
University of 
Kansas  
☐  Site Enrollment 
Goal: Insert # 
  
☒ Site will not enroll 
☒ External Site will rely on the CM IRB as 
the IRB of Record using a reliance 
agreement. () 
☐  Not Applicable. Site will not interact or 
intervene with human participants or their 
identifiable data / identifiable biospecimens. 
Site is also not a primary NIH or federal 
grant recipient.   
University of 
Kansas Medical 
Center 
☐  Site Enrollment 
Goal: Insert # 
  
☒  Site will not enroll
 
☐ External Site will rely on the CM IRB as 
the IRB of Record using a reliance 
agreement. () 
☒ Not Applicable. Site will not interact or 
intervene with human participants or their 
identifiable data / identifiable biospecimens. 
Site is also not a primary NIH or federal 
grant recipient.   
 
 
 
 
  
33.0      International Research - NA 
 
 

References  
  
 
1.      Dabelea D. The accelerating epidemic of childhood diabetes. Lancet 2009;373:1999-2000.  
2.     Vehik K, Hamman RF, Lezotte D, et al. Increasing incidence of type 1 diabetes in 0- to 17-
year-old Colorado youth. Diabetes Care 2007;30:503-9.  
3.      Mayer-Davis EJ, Dabelea D, Lawrence JM. Incidence Trends of Type 1 and Type 2 Diabetes 
among Youths, 2002-2012. N Engl J Med 2017;377:301. PMCID: PMC5639715.  
4.      Miller GF, Coffield E, Leroy Z, Wallin R. Prevalence and Costs of Five Chronic Conditions 
in Children. J Sch Nurs 2016;32:357-64. PMCID: PMC5010981.  
5.      American Diabetes Association. 13. Children and Adolescents: Standards of Medical Care in 
Diabetes-2020. Diabetes Care 2020;43:S163-S82.  
6.      Riddell MC, Gallen IW, Smart CE, et al. Exercise management in type 1 diabetes: a consensus 
statement. The Lancet: Diabetes & Endocrinology 2017; 5: 377-390. 
7.     Miculis, CP, DeCampos, W, DaSilva Boguszweski MC (2015) Correlation between 
glycemic control and PA level in adolescents and children with T1D. J Phys Act Health, 12(2): 
232-237.  
8.     Nguyen, T et al., Fitness and PA in youth with T1D in good and poor glycemic control. 
Peds Diabets 2015; 16(1):48-57.  
9.     Tully, C, Aronow, L, Mackey, E, Streisand, R (2016) PA in youth with T1D: A review. 
Curr Diab Rep 16(9): 85.  
 10.   Cushing CC, Mitchell TB, Berjarano CM, Walters RW, Crick CJ, Noser AE. Bidirectional 
associations between psychological states and physical activity in adolescents: A mHealth Pilot 
Study, Journal of Pediatric Psychology, 2017; 42(5): 559-568, 
https://doi.org/10.1093/jpepsy/jsw099             
11.    Cushing, CC. (2017). eHealth applications in pediatric psychology. In M. C. Roberts & R. 
G. Steele (Eds.) Handbook of Pediatric Psychology 5th ed. (pp. 201-211) ISBN: 
9781462529780.  
 12    Lenhart, A. (2015). Teens, Social Media, & Technology Overview. Retrieved from 
http://pewinternet.org/2015/04/09/teens-social-media-technology-2015/    
13.    Fedele, D. A., Cushing, C. C., Fritz, A., Amaro, C. M., & Ortega, A. (2017). Mobile health 
interventions for improving health outcomes in youth: A meta-analysis. JAMA Pediatrics, 
171(5), 461-469.  
14.    Yang, C. H., Maher, J. P., & Conroy, D. E. (2015). Implementation of behavior change 
techniques in mobile applications for physical activity. American Journal of Preventative 
Medicine, 48(4), 452-455.  

15.    Brannon, E. E., & Cushing, C. C. (2015). A systematic review: Is there an app for that? 
Translational Science of Pediatric Behavior Change for Physical Activity and Dietary 
Interventions. Journal of Pediatric Psychology, 40(4), 373-384.  
16.    Michie, S., Abraham, C., Whittington, C., McAteer, J., & Gupta, S. (2009). Effective 
techniques in healthy eating and physical activity interventions: A meta-regression. Health 
Psychology, 28(6), 690-701.  
17.    Militello, L. K., Melnyk, B. M., Hekler, E., Small, L., & Jacobson, D. (2016). Correlates of 
healthy lifestyle beliefs and behaviors in parents of overweight or obese preschool children 
before and after a cognitive behavioral therapy intervention with text messaging. Journal of 
Pediatric Health Care, 30(3), 252-260.  
18.    Cushing, CC; Bejarano, CM; Ortega, A; Sayre, N; Fedele, DA; Smyth, JM. Adaptive 
mHealth Intervention for Adolescent Physical Activity Promotion, Journal of Pediatric 
Psychology, 2021; jsaa125, https://doi.org/10.1093/jpepsy/jsaa125 
19.    Carver, CS; Scheier, MF. (1982) Control theory: A useful conceptual framework for 
personality-social, clinical, and health psychology. Psychological Bulletin. 92(1), 111-135. 
https://doi.org/10.1037/0033-2909.92.1.111. 
20.    Cushing, CC; Steele, RG. A meta-analytic review of eHealth interventions for pediatric 
health promoting and maintaining behaviors. Journal of Pediatric Psychology. 2010; 35: 937-
947. 
https://doi.org/10.1093/her/cyl148https://doi.org/10.1093/jpepsy/jsp040https://doi.org/10.1006/pme
d.2000.0735 
21.    Bergenstal RM, Ahmann AJ, Bailey T, et al. Recommendations for standardizing glucose 
reporting and analysis to optimize clinical decision making in diabetes: the Ambulatory Glucose 
Profile (AGP). Diabetes Technol Ther 2013;15:198-211. PMCID: PMC3737658.  
22.    Patton SR, Clements MA, Fridlington A, Cohoon C, Turpin AL, Delurgio SA. Frequency of 
mealtime insulin bolus as a proxy measure of adherence for children and youths with type 1 
diabetes mellitus. Diabetes Technol Ther 2013;15:124-8. PMCID: PMC3558673.  
23.   Laurent J, Catanzaro SJ, Joiner TE, Rudolph KD, Potter KI, Lambert S, Gathright T. A 
measure of positive and negative affect for children: scale development and preliminary validation. 
Psychol Assess. 1999; 11: pp. 326. 
24.    Terry PC, Lane AM, Lane HJ, Keohane L. Development and validation of a mood measure 
for adolescents. J Sports Sci. 1999;17(11):861-872. doi:10.1080/026404199365425 
25.     Levesque CS, Williams GC, Elliot D, Pickering MA, Bodenhamer B, Finley PJ. Validating 
the theoretical structure of the Treatment Self-Regulation Questionnaire (TSRQ) across three 
different 
health 
behaviors. 
Health 
Educ 
Res. 
2007;22(5). 
691–702. 
https://doi.org/10.1093/her/cyl148 

26.  Nelson TD, Benson ER, Jensen CD. Negative Attitudes Toward Physical Activity: 
Measurement and Role in Predicting Physical Activity Levels Among Preadolescents. J Pediatr 
Psychol. 2010;35(1). 89–98. https://doi.org/10.1093/jpepsy/jsp040 
27.   Fox KR, Corbin CB. The physical self-perception profile: development and preliminary 
validation. J Sport Exerc Psychol. 1989; 11:408-430. 
28.   Duncan TE, McAuly E. Social support and efficacy cognitions in exercise adherence: A latent 
growth curve analysis. J Behav Medicine. 1993;16. 199-218 
29.    Motl RW, Dishman RK, Trost SG, Saunders RP, Dowda M, Felton G, Ward DS, Pate RR. 
Factorial Validity and Invariance of Questionnaires Measuring Social-Cognitive Determinants of 
Physical 
Activity 
among 
Adolescent 
Girls. 
Prev 
Med. 
2000;31(5). 
584-594. 
https://doi.org/10.1006/pmed.2000.0735 
30.     Lowe MR, Butryn ML, Didie ER, et al. The Power of Food Scale. A new measure of the 
psychological influence of the food environment. Appetite. 2009;53(1):114-118. 
doi:10.1016/j.appet.2009.05.016 
31.     Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality 
of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 
2001;39(8):800-812. doi:10.1097/00005650-200108000-0000633.      
32.     Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient 
satisfaction: Development of a general scale. Eval Program Plann. 1979;2(3):197-207. 
33.    Harris PA, Taylor R, Minor BL, et al. The REDCap consortium: Building an international 
community of software platform partners. J Biomed Inform. 2019;95:103208.  
34.    Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data 
capture (REDCap)--a metadata-driven methodology and workflow process for providing 
translational research informatics support. J Biomed Inform. 2009;42:377-81. PMCID: 
PMC2700030.