Feasibility Trial of the iAMHealthy Intervention for Healthy Weight in Rural Children Recruited From Primary Care Clinics
Phase: NA
Conditions: Obesity; Rurality
Sponsor: IDeA States Pediatric Clinical Trials Network

 
 
 
 
 
Feasibility Trial of the iAMHealthy Intervention for Healthy Weight in Rural 
Children Recruited From Primary Care Clinics 
 
NCT04142034 
 
Protocol (March 4, 2021) 

Feasibility Trial of the iAmHealthy Intervention for Healthy 
Weight in Rural Children Recruited from Primary Care 
Clinics  
UAMS IRB (cIRB) Protocol Number: 249932 
Version Number: 13 
04 March 2021 
 
Operational Principal Investigator:  
Jessica Snowden, MD (University of Arkansas for Medical Sciences) 
 
Principal Investigators:  
Ann Davis, PhD (University of Kansas Medical Center)  
Paul Darden, MD (University of Oklahoma Medical Center) 
 
Funded by: National Institutes of Health (NIH) 
 
 
 
 
 
 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
1 of 94 
Protocol Version #13 
Date:  March 2021 
 
Summary of Changes from Version 01 to Version 02: 
(Primarily responses to pre-review contingencies) 
Affected 
Section(s) 
Summary of Revisions Made 
(01 to 02) 
Rationale 
Compliance 
Statement 
Deleted references to FDA regulations 
21 CRF Parts 50, 56, 312, and 812 
This is not an FDA-regulated 
study. 
5.5 Recruitment of 
Clinics 
Add the following to the last bullet of the 
section: “The clinic nurse will only 
provide contact information (of potential 
participants) to the ISPCTN site 
personnel and provide IRB-approved 
recruitment materials to potential 
participants.  The clinic nurse will also 
ask potential participants if it is okay for 
the ISPCTN site personnel to contact 
the potential participants.” 
Clarification requested by 
UAMS IRB. Clarification 
concerns role of clinic nurse 
and whether or not clinics are 
considered engaged in 
research. 
5.5 Retention 
Plans Table 
Change column header FROM 
“newsletter-only” to “retention contact” 
and deleted “after each weekly group 
session” and “after each monthly 
session” from tables. 
Simple corrections. 
7.1 Participant 
Consent/Screening 
and Baseline Visits 
To first “consent” paragraph, added that 
the research-trained designee will be 
from the ISPCTN site 
To second “consent” paragraph, added 
“The link will be sent to the primary 
caregiver by a member of the ISPCTN 
awardee site or a member of the 
ISPCTN DCOC.” 
Clarifications requested by 
UAMS IRB. Clarifications 
concern whether or not clinics 
are considered engaged in 
research. 
7.1 Participant 
Consent/Screening 
and Baseline Visits 
To “randomization” paragraph, added 
that the backup site staff member will 
be an ISPCTN site staff member. 
Clarifications requested by 
UAMS IRB. Clarifications 
concern whether or not clinics 
are considered engaged in 
research. 
7.2 Administration 
and Feasibility 
Study Intervention 
Added that the backup site staff 
member will be an ISPCTN site staff 
member. 
Clarification requested by 
UAMS IRB. Clarification 
concerns whether or not 
clinics are considered 
engaged in research. 
 
 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
2 of 94 
Protocol Version #13 
Date:  March 2021 
Summary of Changes from Version 02 to Version 03: 
(Responses to expedited review contingencies + additional corrections) 
Affected 
Section(s) 
Summary of Revisions Made 
(02 to 03) 
Rationale 
Glossary of terms 
Added “Backup Assessor” and 
definition. 
Requested by IRB. 
4.3, subsection 
“Justification for 
Delivering …” 
Deleted “In addition we will lock the 
tablets and only allow participants to 
use them for intervention-related 
materials.” 
This is not part of the tablet 
preparation process for this 
study. 
5.5, subsection 
“Recruitment of 
clinics” 
Added: 
(a) “The clinic nurse will not conduct 
study procedures such as data 
collection.”  
(b) The clinic nurse would, “upon 
being instructed by the 
unblinded coordinator, distribute 
tablets to those participants 
assigned to the tablet group.” 
 
(a) Requested change by 
IRB. 
 
(b) Procedural correction. 
 
5.5, subsection 
“retention plans” 
Added paragraph on compensation for 
participants. 
Requested change by IRB. 
5.5 subsection 
“retention plans” 
Revised content of tables for weeks 
1-12 and for weeks 13-24. 
Changes include: 
- 
Deletion of requirement to send  
“kid questions.” 
- 
Changed “texting/emailing” 
questions for caregivers to asking 
question during phone call about 
AEs/SAEs. 
- 
Added footnotes regarding 
schedule for AE/SAE calls. 
- 
Deletion of requirement to send 
exercise tips. 
- 
Deletion of requirement to send 
recipes. 
- 
Deletion of requirement to send 
summary of materials 
covered/presented to date. 
Simplification and procedural 
changes required because 
newsletter-only group is not 
required to have electronic 
devices. 
5.5, subsection 
“Tracking 
Retention Plans” 
• 
Changed who will be sending and 
tracking. Changed from “DCOC” to 
“unblinded coordinator.” 
• 
Deleted paragraph about texting 
sites and paragraph about sending 
branded emails. 
• 
Method was changed for 
who will be tracking. 
• 
Texting and branded 
emails will not be sent for 
retention because 
newsletter-only 
participants are not 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
3 of 94 
Protocol Version #13 
Date:  March 2021 
Affected 
Section(s) 
Summary of Revisions Made 
(02 to 03) 
Rationale 
required to have 
electronic devices. 
7.2, Subsection 
“Acquisition and 
Preparation of 
Tablets. 
Deleted statement that tablets will be 
locked from non-study-related apps and 
programs. 
The tablet preparation does 
not include this process. 
8.1, 
Discontinuation of 
Study Intervention 
Deleted statement requiring collection 
of data if trial is discontinued. 
Response to IRB 
contingencies.  Statement 
should not have been in 
protocol. 
9.2, subsection 
“Time period and 
frequency for 
event assessment 
and follow-up 
Added schedule for AE/SAE calls to 
participant and changed who the DCOC 
personnel will contact for SAE follow-up 
(changed from “participant” to 
“unblinded coordinator”). 
Clarifications and simple 
correction. 
11.1, subsection 
“Confidentiality 
and Privacy” 
Noted that “other oversite offices” may 
have access to participants’ 
information. 
Requested change by IRB. 
 
Summary of Changes from Version 03 to Version 04: 
Affected Section(s) 
Summary of Revisions Made 
(03 to 04) 
Rationale 
Header and footer 
Formatting changes 
Font consistent with protocol 
text 
Throughout protocol 
ISPCTN to ECHO ISPCTN 
NIH-requested branding 
change  
Table of 
Abbreviations 
Updated ISPCTN definition to include 
ECHO 
NIH-requested branding 
change 
1.1 Synopsis 
Changed Objectives to coincide with 
changes in Section 10.1.  
DSMB requested change 
3 Objectives and 
Endpoints 
Objective 1: updated to coincide with 
changes in Section 10.1. 
DSMB requested change 
5.5 subsection 
“Recruitment of 
Clinics” 
5th bullet: Updated to correct what 
clinic nurse will do 
Protocol correction 
5.5 subsection 
“Retention Plans” 
Deleted: Immediately in timeline for 
first retention card.  
End of Week 12 retention contact 
Participant/caregiver thank you with 
diploma attachment 
Added: Text similar to what will be 
included on each card  
Protocol correction 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
4 of 94 
Protocol Version #13 
Date:  March 2021 
Affected Section(s) 
Summary of Revisions Made 
(03 to 04) 
Rationale 
7.1 subsection 
“Participant 
Consent/Screening…” 
Deleted: The link will be sent by a 
member of the ISPCTN awardee site 
or a member of the ISPCTN DCOC 
 
Added: If the primary caregiver does 
not want to complete the iAmHealthy 
Demographics Form during the 
consent/assent visit 
Protocol correction 
7.2, subsection, 
Acquisition and 
Preparation of 
Tablets” 
Corrected process for tablet 
distribution 
Protocol correction 
7.3 Measures to 
Minimize Bias… 
Changed number of child/caregiver 
pairs sites can randomize from 28 to 
32 
 
Deleted the system will bind site 
coordinator from other data collection 
time points 
Protocol correction 
8.1 Discontinuation of 
Study Intervention 
Added: as specified in the MOP 
Protocol clarification 
8.2 Participant 
Discontinuation… 
Changed number sites can consent 
up to from 28 to 32 
Protocol clarification 
9.1, subsection 
“Secondary Outcome 
Measures” 
Deleted: Harpenden Hotain 
Stadiometer, model 603 (Holtain, 
Crymych, UK), Bluetooth SECA digital 
scale, model 703 (SECA, Hamburg, 
Germany), and the sentence about 
Model 703 accuracy. 
Add: Detecto Portable Height Rod 
(PHR) (Detecto, Webb City, MO) 
Seca 813 High Capacity Digital Flat 
Scale for Individual Patient Use (Seca 
North America, Chino, CA) 
Protocol update 
9.1, subsection 
“Secondary Outcome 
Measures” 
Deleted: we and monthly 
Halt screening/baseline 
Added: The ECHO ISPCTN site 
coordinator  
Weekly (reliability assessment) 
Starting (to consent process) 
Simplification of process 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
5 of 94 
Protocol Version #13 
Date:  March 2021 
Affected Section(s) 
Summary of Revisions Made 
(03 to 04) 
Rationale 
9.2, subsection “Time 
period and 
Frequency… 
Added “contact the ECHO ISPCTN 
unblinded coordinator 
Update protocol 
9.2, subsection 
“Reporting of 
Pregnancy” 
Added: If a participant reports 
pregnancy 
Clarify process 
10.1, subsection 
“Primary Objective” 
Added: Hypothesis 2 
DSMB request 
10.4, subsection 
“Analysis of Primary 
Endpoints” 
Add: Second paragraph to Objective 
1B 
DSMB request 
11.1, subsection 
“Data Collection and 
Management 
Responsibilities” 
Deleted: included in the MOP 
A 21 CRF Part 11 compliant EDC 
system 
Added: an EDC system that complies 
with HIPAA regulations 
Protocol correction 
11.1, subsection “Key 
Roles and Study 
Governance” 
Basic formatting changes for 
consistency 
Updated address of Operational PI 
Add Medical Monitor 
Address change to reflect 
recent move 
 
Summary of Changes from Version 04 to Version 05: 
 
Affected 
Section(s) 
Summary of Revisions Made 
(04 to 05) 
Rationale 
Throughout 
protocol 
Two-week run-up changed to four-week 
run-up 
Procedural correction 
7.2, subsections 
Acquisition and 
Preparation of 
Tablets; Tablet 
Delivery and 
Storage 
Changed process for distributing and 
returning tablets 
Procedural correction 
7.3 Measures to 
Minimize Bias: 
Randomization 
and Blinding 
Clarified randomization process 
Procedural clarification 
9.1, subsection 
Secondary 
Outcome 
Measures 
Clarified inter-rater reliability process 
Procedural clarification 
Glossary of Terms 
Correct alphabetized list  
Protocol correction 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
6 of 94 
Protocol Version #13 
Date:  March 2021 
 
 
Summary of Key Changes from Version 05 to Version 06 
Affected 
Section(s) 
Summary of Revisions Made 
(05 -06) 
Rationale 
1.3 SOA 
Add asterisks to Baseline and Height and 
Weight rows. Add footnote that consent and 
baseline activities can occur during the same 
visit. 
 
Merge cells in Demographics row to show that 
the demographics questionnaire can be 
completed anytime during consent/screening 
baseline (Word will not track this change) 
 
Add “X” in Study Personnel Time Assessment 
Row under consent/screening column and 
baseline column. Deleted “X” under Weeks 25-
28. This assessment will be completed during 
consent/screening and baseline and not during 
post-intervention.  
 
Study Personnel Satisfaction Survey: Merged 
cells in Day 0 and Week 1-4 and added “X” to 
show that this survey will be done during this 
time and during post-intervention.  
Procedural change 
Section 5.5, 
Subsection 
Recruitment Goals 
and Monitoring 
3rd paragraph: added the following text:  
 
If sites successfully recruit 16 participants in 
recruitment month two, sites can continue 
recruiting in the same recruitment option up to 
32 participants without waiting for the two-week 
recruitment extension period. If sites are not 
successful in recruiting 16 participants, sites 
must continue recruiting in the recruitment 
option until 16 participants are recruited or the 
recruitment option ends. During the two-week 
recruitment extension, all sites can recruit 
participants using the recruitment option in 
which the site was most successful, up to the 
cap of 32 participants/site.   
Procedural change to 
allow sites to continue 
recruiting once they 
reach the 16 
participants without 
waiting for recruitment 
period extension. 
Section 5.5, 
Subsection 
Retention Plans 
Corrected sentence structure 
 
Deleted “with message outlining next steps” 
and substituted “card” for “information packet” 
Increase readability 
and comprehension; 
correct sentence 
structure 
 
Procedure change 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
7 of 94 
Protocol Version #13 
Date:  March 2021 
Affected 
Section(s) 
Summary of Revisions Made 
(05 -06) 
Rationale 
Section 5.5, 
Subsection 
Tracking Retention 
Plans 
1st Paragraph 
 
Deleted “and touchpoint information packets”  
 
Deleted “ECHO ISPCTN site coordinator will 
request that the”  
 
Substituted “randomization and intervention” 
for “the results of the participant screening” 
 
Deleted last sentence describing contents of 
information packet and packet tracking 
 
2nd Paragraph 
 
Deleted “which touch point card was mailed” 
 
Deleted “was mailed” and added “track” 
 
Deleted “and track” to sentence about 
participant responses to touch-point cards 
 
 
 
Procedure change 
 
 
 
7.1 Screening and 
Consent 
Deleted “we” and added “the ECHO ISPCTN 
site coordinator and/or site investigator” 
Clarify protocol 
7.1 Screening and 
Consent, 
Subsection 
Participant 
Consent/Screening 
and Baseline Visits 
Added “screening/baseline” to the sentence 
about when the demographics form can be 
completed. 
 
Deleted “assent” 
Procedure change 
7.3 Measures to 
Minimize Bias: 
Randomization 
and Blinding 
Added “consent/screening” to the sentence 
about when the site coordinators can take 
height and weight measurements. 
Procedure change 
7.4 Study 
Intervention 
Compliance 
Change the amount of sessions that the 
supervising psychologists will assess for 
reliability. 
 
From 25% of selected sessions to 25% of all 
sessions for primary assessor and 50% of 
these sessions for the second assessor. 
Protocol correction 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
8 of 94 
Protocol Version #13 
Date:  March 2021 
Affected 
Section(s) 
Summary of Revisions Made 
(05 -06) 
Rationale 
9.1 Efficacy 
Assessment, 
Subsection 
Secondary 
Outcome 
Measures 
Deleted “we.” Added “ECHO ISPCTN site 
coordinators and/or site investigators.” 
 
Deleted “calibrate.” Added, “conduct an 
accuracy check on equipment.”  
Protocol clarification 
9.1 Efficacy 
Assessment, 
Subsection Other 
Measures; 
Demographics 
Added “during consent/screening/baseline” 
Procedure change 
9.1 Efficacy 
Assessment, 
Subsection Other 
Measures; Study 
Personnel Time 
Assessment 
Added “During the recruitment phase the 
DCOC will weekly send a time assessment 
survey” 
Procedure change 
and clarification of 
process 
9.1 Efficacy 
Assessment, 
Subsection Other 
Measures; Study 
Personnel 
Satisfaction 
Survey 
Added, “The DCOC will ask all study personnel 
to complete a brief satisfaction survey shortly 
after the recruitment period ends and after the 
final measurements are completed.”    
Procedure change 
9.1 Efficacy 
Assessment, 
Subsection Other 
Measures, Time 
Period and 
Frequency for 
Event Assessment 
and Follow-up 
Deleted “by monthly asking the participant 
about the severe AE” 
 
Added “inquire/follow severe AEs via monthly 
participant phone calls” to unblinded 
coordinators responsibilities 
Procedure change 
Throughout 
Corrected minor typographical errors. 
Simple corrections. 
 
Summary of Key Changes from Version 06 to Version 07 
Affected Section(s) 
Summary of Revisions Made 
(06 to 07) 
Rationale 
1.2 Schema 
Updated to show new timeline 
Reflect changes due to 
enrollment halt because 
of pandemic 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
9 of 94 
Protocol Version #13 
Date:  March 2021 
Affected Section(s) 
Summary of Revisions Made 
(06 to 07) 
Rationale 
1.3 Schedule of Activities 
Added SOA table 2 to show new timeline 
and activities because of enrollment pause. 
In both SOA tables merged columns to 
show individual sessions occur throughout 
intervention period for iAmHealthy 
behavioral intervention participants 
Illustrate changes in 
timeline because of 
enrollment halt and to 
show that individual 
sessions occur 
throughout intervention 
period 
2.1 Enrollment Halt 
Added explanation for enrollment halt 
Explanation of 
enrollment halt because 
of pandemic 
5.5, subsection Recruitment 
Option 1: Consecutive 
Added “If the clinic staff can produce a list 
from electronic medical records that shows 
the BMI percentages of potential 
participants, this back and forth procedure 
is not required.“ 
Flexibility in procedures 
5.5, subsection Recruitment 
Goals and Monitoring 
Changed recruitment extension window 
from 2 to 4 weeks 
Increase recruitment 
time because of 
enrollment halt 
5.5, subsection Stopping 
Rule 
Changed recruitment time from 2.5 months 
to 12 weeks 
Consistency with 
recruitment time 
extension 
5.5 subsection Retention 
Plans, Compensation 
Clarified when participants will receive 
compensation. Increased ending 
compensation to $100 
 
Added that unblinded coordinators will 
make monthly retention calls  
Clarify procedure; 
increase participant 
compensation because 
of enrollment halt 
 
Clarified purpose of 
unblinded coordinators 
calls.  
6 Training 
Added that the DCOC will train coordinators 
and study staff on teleconsent informed 
consent process and documentation and in 
remote height and weight procedures 
 
Clarified procedure for behavioral 
intervention team reporting severe AEs and 
SAEs to unblinded coordinator 
Additional training 
needed for virtual study 
procedures 
 
Consistency with rest of 
protocol 
6.1 Height and Weight 
Measurement Training 
Added section to describe how blinded 
ECHO ISPCTN coordinators will practice 
taking virtual height and weight 
measurements. Moved interrater reliability 
description from section 9.1, subsection 
Secondary Outcome measures to section 
6.1 
 Better organize 
information and have all 
training information in 
training section 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
10 of 94 
Protocol Version #13 
Date:  March 2021 
Affected Section(s) 
Summary of Revisions Made 
(06 to 07) 
Rationale 
Throughout 
Updated heading numbers. Corrected typos 
or minor errors, and changed six-months to 
post-intervention.  
Updates and clarity 
7.1 Consent, Screening, 
Baseline, and Post-
Intervention   
Changed subsection Participant 
Consent/Screening and Baseline Visits to 
Consent/Assent and Other Informational 
Documents Provided to Participants 
 
Moved text that was in section 11.1 to 
section 7.1 
 
 
 
 
 
Added that ECHO ISPCTN coordinators can 
conduct the consent/assent process either 
in person or by teleconsent.  
 
Added how participants indicated 
assent/consent. 
 
Added instructions for how the consent 
process will be conducted. Added that the 
clinic nurse can give potential participants 
study information via email, fax, or in 
person.  
  
Changed how participants will receive a 
signed copy of consent form.  
 
Protocol clarification 
 
 
 
Move all information 
and procedure 
description about 
consent to same section 
of protocol for better 
organization. 
 
Added teleconsent 
consent/assent, how 
participants can indicate 
consent/assent, and 
consent and assent 
process to allow study 
procedures to continue 
during quarantine.  
 
Added methods for 
clinic nurse to give 
potential participants 
information so clinic 
patients can receive 
study information 
during quarantine.  

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
11 of 94 
Protocol Version #13 
Date:  March 2021 
Affected Section(s) 
Summary of Revisions Made 
(06 to 07) 
Rationale 
Section 7.1 Consent, 
Screening, Baseline, and 
Post-Intervention 
Added Screening subsection. Updated 
screening procedures for virtual screening 
 
 
 
Updated Baseline subsection to Baseline 
Measurements subsection and clarified 
baseline procedures and timing  
 
 
 
 
Added Post-Intervention Measurements 
Subsection. For clarity, changed 6-month 
measurements to post-intervention 
measurements. Added that post-
intervention remote height and weight 
measurements will be taken in parallel with 
in-clinic height and weight measurements. 
Moved text from section 9.1, subsection 
Secondary Outcome Measures.  
Process update to allow 
enrollment and 
screening to continue 
during quarantine.  
 
Because of enrollment 
halt, all baseline 
measurements will 
occur after 
enrollment/recruitment 
ends. 
 
Clarify when 
measurements will 
happen and procedure 
update. Moved text for 
better organization and 
for measurement 
procedures to be in the 
same place.  
8.1 Discontinuation of Study 
Intervention 
Changed when the study will track and 
record safety events; changed relevant to 
significant 
Consistency with SOA 
and consistency within 
protocol 
8.2 Participant 
Discontinuation/Withdrawal 
from the Study 
1st paragraph, 3rd bullet – clarified severe 
AE. Updated when lost to follow up 
procedures would begin to account for 
virtual study procedures 
Clarification and change 
in study procedures 
9.1 subsection Objective 1 – 
Participant Recruitment 
Rate 
Changed recruitment period for each option 
from one month to four weeks  
Clarification of 
recruitment period 
9.1 subsection Other 
Measures 
Updated how these measures will be 
conducted or distributed 
 
Demographics form – updated when the 
form has to be completed (by 
randomization) 
Update procedure to 
allow study to resume 
as virtual study and that 
some procedures may 
take longer because of 
virtual study.   
9.2 subsection Definition of 
Adverse Events 
Updated definition of adverse event to 
match DCOC standard operating procedure 
Consistency with DCOC 
SOP 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
12 of 94 
Protocol Version #13 
Date:  March 2021 
Affected Section(s) 
Summary of Revisions Made 
(06 to 07) 
Rationale 
9.2 subsection Time Period 
and Frequency for Event 
Assessment and Follow-Up 
Updated procedure for interventionists if 
suspect severe AE or SAE 
 
Add when the unblinded coordinators will 
start making safety calls 
 
Added that the ECHO ISPCTN coordinator 
will track SAEs and update how long 
unblinded coordinators will track SAEs 
Clarify and update 
procedure 
 
Text consistent with 
SOA 
 
Procedure update and 
clarification 
9.3 subsection Definition of 
Unanticipated Problems 
Updated definition to match DCOC standard 
operating procedure. Change in definition 
caused a change in reference numbers 
Consistency between 
protocol and 
coordinating center 
SOPs 
10.4 Statistical Analysis, 
subsection Sensitivity 
Analysis 
Added a sensitivity analysis to account for 
participants who qualified for the study pre-
enrollment halt, but do not qualify for the 
study at baseline measures 
New sensitivity analysis 
to allow already 
enrolled participants to 
stay in the study  
11.1 subsection Data 
collection and Management 
Responsibilities 
Clarified best practice for case report forms 
Clarified procedure 
Table 5 
Updated to coincide with DCOC SOPs 
Make protocol 
consistent with DCOC 
SOPs 
 
Summary of Key Changes from Version 07 to Version 08 
Affected Section(s) 
Summary of Revisions Made 
(07 to 08) 
Rationale 
7.1 Consent, Screening, 
Baseline, and Post-
Intervention, subsection 
Screening 
Added the list of equipment participants 
will receive for remote height and weight 
measurements.  
 
Added a statement that participants who 
qualify for the study will keep the remote 
height and weight equipment, and 
participants who do not qualify for the 
study will return the equipment in a study-
team provided postage-paid box.  
Addition requested by 
UAMS IRB 
7.1 Consent, Screening, 
Baseline, and Post-
Intervention, subsection 
Baseline Measurements 
Added a phrase to specify when baseline 
measurements will end.  
Clarify process 
 
 
 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
13 of 94 
Protocol Version #13 
Date:  March 2021 
Summary of Key Changes from Version 08 to Version 09 
Affected Section(s) 
Summary of Revisions Made 
(08 to 09) 
Rationale 
1.3 Schedule of Activities, 
SOA 2 
Updated: 1st column, 2nd row to allow list to 
contain patients seen in past 12-24 months 
 
Added: Header row, Baseline column – 
added asterisks 
 
Changed: Day 0 to Week 0 
 
Added: footer – added explanation for 
asterisks 
Allow more potential 
participants to be 
contacted 
 
Allow for more time to 
screen participants 
 
Allow more time for 
randomization and 
participant 
communication 
Section 5.1 Inclusion 
Criteria 
Last sentence, last paragraph 
Deleted: 6 month 
 
5.5 Strategies for 
Recruitment and Retention, 
subsection Recruitment 
Option 1: Consecutive 
Increased number of months patient visit 
data could include – from 12 to 24 months 
Allow more potential 
participants to be 
contacted 
5.5 Strategies for 
Recruitment and Retention, 
subsection Recruitment 
Goals and Monitoring 
Deleted the text below from the 3rd 
paragraph, 2nd sentence 
“and we will ask all clinics to recruit the 
exact number of missing participants using 
the recruitment option at which the clinic 
was most successful” 
Clarify process 
7.1 Consent, Screening, 
Baseline, and Post-
intervention 
Added: Screening and Baseline subsection. 
Explains that participants enrolled before 
the enrollment halt must have baseline 
measurements taken during the baseline 
period. Participants enrolled after the halt, 
should have screening done during the 
consent/screening period, but can conduct 
screening during baseline period, in 
conjunction with baseline measurements.   
Clarification of process 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
14 of 94 
Protocol Version #13 
Date:  March 2021 
Affected Section(s) 
Summary of Revisions Made 
(08 to 09) 
Rationale 
7.1 Consent, Screening, 
Baseline, and Post-
intervention, subsection 
Screening 
2nd paragraph, 3rd sentence 
Added: The ECHO ISPCTN site coordinator 
or staff member will mail or ship 
participants the scale and tape measure 
listed below or suitable replacements, 
approved by the iAmHealthy leadership 
team. Please see the iAmHealthy MOP for a 
complete list of equipment. 
 
Deleted: The ECHO ISPCTN site coordinator 
or staff member will mail participants the 
equipment listed below or suitable 
replacements, approved by the iAmHealthy 
leadership team.  
 
Bulleted list of equipment: deleted 
Fiskars 01 005358 Wooden Ruler (model 
number 01 005358) 
Scotch® Home and Office Masking Tape, 3/4 
inch x 54.6 yards tan (3436) 
No residue blue masking tape, 9 pack blue 
painter tape 2 inches x 15 yard/roll for 
decoration and painting, art and craft 
Ticonderoga my first pencils, wood-cased 
#2 HB soft, pre-sharpened with eraser   
Provide flexibility for 
study equipment 
9.1 Efficacy Assessments, 
subsection Secondary 
Outcome Measures 
#2, 2nd paragraph 
Changed: six months to post-intervention 
Clarify time point 
 
Summary of Key Changes from Version 09 to Version 10 
Affected Section(s) 
Summary of Revisions Made 
(09 to 10) 
Rationale 
SOA 2 
Expanded asterisk definition to include that 
height and weight measurements captured 
during the baseline period would be used 
for screening and baseline 
Clarify definition  

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
15 of 94 
Protocol Version #13 
Date:  March 2021 
Affected Section(s) 
Summary of Revisions Made 
(09 to 10) 
Rationale 
5.5, Subsection Stopping 
Rule 
Clarified stopping rule to include the 
baseline period in the assessment and 
updated the number of participants 
reached to consented and screened-in 
participants 
Per DSMB request 
5.5, Subsection Additional 
Retention Plans 
Removed the phrase “and before the 
intervention begins” 
Protocol correction 
5.5, Subsection Touch-point 
Cards 
Added that cards could be sent via USPS or 
FedEx 
Changed this to add 
flexibility 
7.1, Subsection ActiGraph 
Activity Monitor and Diet 
Recall 
Deleted that this has to occur after 
screening 
Clarification of Process 
7.1, Subsection Baseline 
Measurements 
Added when feasible to the 4th sentence 
specifying that height and weight 
measurements have to be taken in triplicate 
Clarify process 
7.2 Randomization 
Updated the measures that must be 
complete to randomize a participant 
Per DSMB and 
clarification of 
randomization criteria 
7.3, Subsection 
Administration of 
Newsletter Intervention 
Add that newsletters could be sent via 
FedEx, or suitable replacement 
Provide flexibility in 
process 
9.2, Subsection Time Period 
and Frequency for Event 
Assessment 
changed operational PI to ECHO ISPCTN site 
investigator in 3rd paragraph 
Protocol correction  
 
Summary of Key Changes from Version 10 to Version 11 
Affected Section(s) 
Summary of Revisions Made 
(10 to 11) 
Rationale 
4.4 
Removed last sentence in this section 
Remove lost to follow 
up process 
5.5, Subsection Retention 
Plans 
Removed specific weeks from retention 
tables. Added feedback phone call question 
to weeks 9-12 
Provide more time to 
mail newsletter sent 
and include feedback 
call during weeks 9-12 
8.2 
Removed lost to follow up as a criterion for 
participant discontinuation/withdrawal and 
process for lost to follow up. 
 
Removed lost to follow up process 
Allow participants to 
stay in study longer  

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
16 of 94 
Protocol Version #13 
Date:  March 2021 
Affected Section(s) 
Summary of Revisions Made 
(10 to 11) 
Rationale 
9.2, Subsection Time Period 
and Frequency for Event 
Assessment and Follow-up 
Removed lost to follow up as a criterion for 
stop tracking severe AEs. 
 
Changed unblinded iAmHealthy coordinator 
to unblinded ECHO ISPCTN coordinator 
Removed lost to follow 
up from protocol and 
from severe AE process. 
 
Protocol correction  
 
Summary of Key Changes from Version 11 to Version 12 
Affected Section(s) 
Summary of Revisions Made 
(11 to 12) 
Rationale 
7.3, Subsection Group 
Sessions 
Changed that dieticians will lead makeup 
sessions instead of psychologist/social 
worker.  
Protocol correction 
8.2 Participant 
Discontinuation/Withdrawal 
from the Study 
Added that ECHO ISPCTN site coordinators, 
site investigators, or unblinded ECHO 
ISPCTN coordinators can ask child/caregiver 
pairs why they chose to withdraw from the 
study and that the pair can choose not to 
answer this question.  
Process update 
 
Summary of Key Changes from Version 12 to Version 13 
Affected Section(s) 
Summary of Revisions Made 
(12 to 13) 
Rationale 
1.3, Schedule of Activities 
(SOA) 2 
Added 4 weeks to post column for activity 
monitor return and activity monitor data 
entry. 
 
Added footnote that study leadership can 
grant an extension to complete post-
intervention activities. 
Extension added 
because shipping and 
postal delays can cause 
a 2-week delay in sites 
receiving activity 
monitors.  
 
Allow sites extra time to 
complete post-
intervention activities 
under extenuating 
circumstances.  
5.5, Retention plans 
Changed when the last card is sent to 
participants. 
To allow more time to 
send cards 
 
 
 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
17 of 94 
Protocol Version #13 
Date:  March 2021 
 
TABLE OF CONTENTS 
STATEMENT OF COMPLIANCE ..................................................................................................................................... 20 
Glossary of Terms ........................................................................................................................................................ 20 
Table of Abbreviations ................................................................................................................................................. 21 
1 
PROTOCOL SUMMARY .................................................................................................................................. 23 
1.1 
SYNOPSIS ....................................................................................................................................................... 23 
1.2 
Schema .......................................................................................................................................................... 27 
1.3 
Schedule of Activities (SOA) .......................................................................................................................... 28 
SOA 1 ............................................................................................................................................................. 28 
SOA 2 ............................................................................................................................................................. 29 
2 
INTRODUCTION ............................................................................................................................................. 31 
2.1 
Study Rationale ............................................................................................................................................. 31 
2.2 
Background.................................................................................................................................................... 31 
Pediatric Obesity among Rural Populations .................................................................................................. 31 
Rationale for Feasibility Study and Objectives .............................................................................................. 32 
Treatment of Pediatric Obesity ..................................................................................................................... 34 
Rationale for Newsletter Control Arm .......................................................................................................... 34 
Rationale for Individual-Level Assignment .................................................................................................... 35 
Rationale for Clinic-level assignment ............................................................................................................ 35 
2.4 
Risk/Benefit Assessment ............................................................................................................................... 35 
Known Potential Risks ................................................................................................................................... 35 
Known Potential Benefits .............................................................................................................................. 36 
Assessment of Potential Risks and Benefits .................................................................................................. 36 
3 
OBJECTIVES AND ENDPOINTS ........................................................................................................................ 36 
4 
STUDY DESIGN ............................................................................................................................................... 38 
4.1 
Overall Design ............................................................................................................................................... 38 
4.2 
Scientific Rationale for Study Design ............................................................................................................. 39 
Primary Objective .......................................................................................................................................... 39 
Secondary Objectives .................................................................................................................................... 39 
Tertiary Objectives ........................................................................................................................................ 40 
4.3 
Justification for Intervention Model.............................................................................................................. 40 
Justification for Delivering the iAMHealthy Intervention via Mobile Technology ........................................ 40 
iAmHealthy Behavioral Intervention in Clinic Settings .................................................................................. 41 
4.4 
End of Study Definition ................................................................................................................................. 42 
5 
STUDY POPULATION ...................................................................................................................................... 42 
5.1 
Inclusion Criteria ........................................................................................................................................... 42 
5.2 
Exclusion Criteria ........................................................................................................................................... 43 
5.3 
Lifestyle Considerations ................................................................................................................................ 44 
5.4 
Screen Failures .............................................................................................................................................. 44 
5.5 
Strategies for Recruitment and Retention .................................................................................................... 44 
Enrollment Halt ............................................................................................................................................. 44 
Recruitment of Clinics ................................................................................................................................... 44 
Randomization of Clinics ............................................................................................................................... 45 
Recruitment of Participants .......................................................................................................................... 46 
Retention Plans ............................................................................................................................................. 49 
Tracking Retention Plans ............................................................................................................................... 51 
6 
TRAINING ....................................................................................................................................................... 52 
6.1 
Height and Weight Inter-Rater Reliability ..................................................................................................... 52 
6.2 Clinical Helpline and Email ................................................................................................................................. 53 
7 
STUDY INTERVENTION ................................................................................................................................... 53 
7.1 
Consent, Screening, Baseline, and Post-Intervention ................................................................................... 53 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
18 of 94 
Protocol Version #13 
Date:  March 2021 
Consent/Assent and Other Informational Documents Provided to Participants .......................................... 53 
Screening and Baseline .................................................................................................................................. 55 
Post-intervention Measurements ................................................................................................................. 57 
7.2 
Randomization .............................................................................................................................................. 57 
7.3 
Administration of Feasibility Study Intervention .......................................................................................... 57 
Newsletter Intervention (Both Arms) ............................................................................................................ 58 
iAmHealthy Behavioral Intervention ............................................................................................................. 58 
Acquisition and Preparation of Tablets ......................................................................................................... 61 
Selection of Tablets and Internet Providers .................................................................................................. 61 
Tablet Delivery and Storage .......................................................................................................................... 62 
7.4 
Measures to Minimize Bias: Randomization and Blinding ............................................................................ 62 
7.5 
Study Intervention Compliance ..................................................................................................................... 62 
7.6 
Concomitant Therapy .................................................................................................................................... 63 
8 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL ........... 63 
8.1 
Discontinuation of Study Intervention .......................................................................................................... 63 
8.2 
Participant Discontinuation/Withdrawal from the Study ............................................................................. 64 
9 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................................... 64 
9.1 
Efficacy Assessments ..................................................................................................................................... 64 
Primary Outcome Measures.......................................................................................................................... 65 
Secondary Outcome Measures ..................................................................................................................... 66 
Tertiary Outcomes ......................................................................................................................................... 67 
Other Measures ............................................................................................................................................. 67 
9.2 
Adverse Events/Serious Adverse Events ....................................................................................................... 68 
Definition of Adverse Events ......................................................................................................................... 68 
Definition of Serious Adverse Events ............................................................................................................ 68 
Classification of an Adverse Event ................................................................................................................. 69 
Time Period and Frequency for Event Assessment and Follow-Up ............................................................... 70 
Adverse Event Reporting ............................................................................................................................... 71 
Serious Adverse Event Reporting .................................................................................................................. 71 
Reporting Events to Participants ................................................................................................................... 72 
Events of Special Interest .............................................................................................................................. 72 
Reporting of Pregnancy ................................................................................................................................. 72 
9.3 
Unanticipated Problems ................................................................................................................................ 73 
Definition of Unanticipated Problems ........................................................................................................... 73 
Unanticipated Problem Reporting................................................................................................................. 73 
Reporting Unanticipated Problems to Participants ....................................................................................... 73 
10 
STATISTICAL CONSIDERATIONS ..................................................................................................................... 74 
10.1 Statistical Hypotheses ................................................................................................................................... 74 
Primary Objective .......................................................................................................................................... 74 
Secondary Objectives .................................................................................................................................... 74 
10.2 Sample Size Determination ........................................................................................................................... 75 
10.3 Populations for Analyses ............................................................................................................................... 76 
10.4 Statistical Analyses ........................................................................................................................................ 76 
General Approach ......................................................................................................................................... 76 
Analysis of the Primary Endpoint(s) .............................................................................................................. 76 
Analysis of the Secondary Endpoint(s) .......................................................................................................... 78 
Analysis of Tertiary Endpoint(s) .................................................................................................................... 78 
Safety Analyses .............................................................................................................................................. 79 
Baseline Descriptive Statistics ....................................................................................................................... 79 
Planned Interim Analyses .............................................................................................................................. 79 
Sub-Group Analyses ...................................................................................................................................... 79 
Sensitivity Analysis ........................................................................................................................................ 79 
Tabulation of Individual Participant Data ...................................................................................................... 79 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
19 of 94 
Protocol Version #13 
Date:  March 2021 
11 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .................................................... 80 
11.1 Regulatory, Ethical, and Study Oversight Considerations ............................................................................. 80 
Informed Consent Process ............................................................................................................................ 80 
Study Discontinuation and Closure ............................................................................................................... 80 
Confidentiality and Privacy ............................................................................................................................ 80 
Future Use of Stored Specimens and Data .................................................................................................... 81 
Key Roles and Study Governance .................................................................................................................. 82 
Safety Oversight ............................................................................................................................................ 83 
Clinical Monitoring ........................................................................................................................................ 83 
Quality Assurance and Quality Control ......................................................................................................... 84 
Data Handling and Record Keeping ............................................................................................................... 84 
Study Deviations ............................................................................................................................................ 85 
Publication and Data Sharing Policy .............................................................................................................. 85 
Conflict of Interest Policy .............................................................................................................................. 86 
Appendix A: SAMPLE NEWSLETTER ............................................................................................................................. 87 
REFERENCES ................................................................................................................................................................. 89 
 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight  
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 20 of 94 
Protocol Version #13 
Date: 04 March 2021 
STATEMENT OF COMPLIANCE 
This trial will be carried out in accordance with International Conference for Harmonisation (ICH) Good Clinical 
Practice (GCP) and the United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR 
Part 46). 
National Institutes of Health (NIH)-funded investigators and clinical trial staff who are responsible for the 
conduct, management, or oversight of NIH-funded clinical trials have completed Human Subjects Protection and 
ICH GCP Training. 
The Data Coordinating and Operations Center (DCOC) will submit the protocol, informed consent form(s), 
recruitment materials, and all participant materials to the Central Institutional Review Board (cIRB) for review 
and approval. ECHO ISPCTN site awardees must use the cIRB-approved protocol and informed consents. The 
Central IRB must approve any amendment to the protocol before site awardees implement changes to the trial. 
In addition, all changes to the consent form must be cIRB approved; the DCOC will determine if site awardees 
need to obtain a new or revised consent form from participants who provided consent on a previously approved 
consent form. 
GLOSSARY OF TERMS 
We use the following terms throughout this protocol and fully explain them in the relevant sections of the 
protocol.  
Backup Assessor:  someone from the ECHO ISPCTN site who will take over blinded assessments in the event that 
the primary ECHO ISPCTN site coordinator is unblinded for any reason. 
Blinded Assessor: The ECHO ISPCTN site coordinator and research-trained designated backup.  
Body Mass Index (BMI): A person's weight in kilograms divided by his or her height in meters squared. NIH now 
defines normal weight, overweight, and obesity according to BMI, rather than the traditional height/weight 
charts. 
Body Mass Index z-score (BMIz): A relative measure of child weight adjusted for age and sex. BMIz refers to the 
number of standard deviations away from the median BMI for a reference population of a specific age and sex. 
Body Mass Index adjusted z-score (BMIaz): A relative measure of child weight calculated similarly to BMIz, but 
that adjusts for compression over 97th percentile. In this study, BMIaz is calculated according to the method of 
Freedman.1  
Clinic: One of the four primary care clinics where the ECHO ISPCTN site awardee personnel will consent 
participants.  
Clinic nurse: The nurse contact employed at the primary care clinic.  
Clinic provider: The healthcare provider contact at each clinic. 
Consecutive recruitment option (recruitment option 1): Clinic personnel will approach potential participants 
based on past (retrospective) or current (prospective) appointments.  
Consented Participants: Participants who have completed the consent process.  
DCOC: Data Coordinating and Operations Center for the IDeA States Pediatric Clinical Trials Network.  
ECHO ISPCTN site awardee(s): The institution from an IDeA state that received a U24 grant to participate in the 
ECHO ISPCTN.  
ECHO ISPCTN site coordinator: The research/nurse coordinator employed at the ECHO ISPCTN site awardee who 
will coordinate the iAmHealthy feasibility trial in the IDeA state in which the coordinator is employed. 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight  
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 21 of 94 
Protocol Version #13 
Date: 04 March 2021 
ECHO ISPCTN site investigator: The site principal investigator for the iAmHealthy project. 
EDC: electronic data capture 
iAmHealthy behavioral intervention: In addition to receiving the American Academy of Pediatrics (AAP) 
newsletter, child/caregiver pairs participating in the iAmHealthy behavioral intervention arm will receive group 
sessions and individual sessions with the iAmHealthy behavioral intervention team via an electronic tablet 
provided by the sponsor. 
iAmHealthy behavioral intervention arm: The intervention arm that will receive the iAmHealthy behavioral 
intervention and AAP newsletter for six months.  
iAmHealthy behavioral intervention teams: Each team will be composed of a dietician, who will lead the 
individual session, and either a fully licensed psychologist (PhD or MA) or a licensed clinical social worker, who 
will lead the group sessions, with experience in weight management. These teams will be responsible for 
delivering the group sessions and the individual sessions to the iAmHealthy behavioral intervention arm.  
Newsletter intervention: A behavioral intervention in the form of an AAP newsletter that all participating 
child/caregiver pairs, whether they are in the newsletter-only intervention arm or in the iAmHealthy behavioral 
intervention arm, will receive for each month of this six-month trial.  
Newsletter-only intervention arm: The intervention arm that will receive only the AAP newsletter for 
six months. 
Primary Caregiver: The adult/adults principally responsible for the participating child, typically a parent.  
Randomized Participants: Participants who have completed the consent process as well as the screening and 
baseline measures and have been randomized to an intervention arm.  
Screen Failure: Participants who were evaluated for participation in the study but did not meet the criteria for 
participation. 
Traditional recruitment option (recruitment option 2): Methods focused on participant self-identification, such 
as hanging flyers in clinics, distributing flyers at check-in, and any other common contact methods used to reach 
their patients, such as newsletters, email or social media, or other means as they deem appropriate, etc., with 
IRB approval. 
Unblinded ECHO ISPCTN coordinator: A research coordinator within the ECHO ISPCTN who will know 
randomized participant intervention arm assignment (unblinded)and will inform participants of their 
intervention arm, will make monthly contact participants to inquire about severe AEs and SAEs, and will record 
severe AEs and SAEs.     
USPSTF: United States Preventive Services Task Force. An independent group of national experts in prevention 
and evidence-based medicine that works to improve the health of all Americans by making evidence-based 
recommendations about clinical preventive services such as screenings, counseling services, or preventive 
medications. 
TABLE OF ABBREVIATIONS 
 
 
AAP 
American Academy of Pediatrics 
AE 
Adverse Event 
ALCOA-C 
Attributable, Legible, Contemporaneous, Original, Accurate and Complete (standard practice for 
completing source documents per ICH E6(R2)) 
BMI 
Body Mass Index 
BMIaz 
Body Mass Index adjusted z-score 
BMIz 
Body Mass Index z-score 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight  
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 22 of 94 
Protocol Version #13 
Date: 04 March 2021 
CAPA 
Corrective and Preventative Action 
CFR 
Code of Federal Regulations 
cIRB 
Central Institutional Review Board 
DCOC 
Data Coordinating and Operations Center 
DSMP 
Data Safety Monitoring Plan 
DSMB 
Data Safety and Monitoring Board 
ECHO 
Environmental Influences on Child Health Outcomes 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICC 
intraclass correlation coefficient 
ICH E6 (R2) 
International Conference for Harmonisation Good Clinical Practice Integrated Addendum 
IDeA 
Institutional Development Award  
ECHO 
ISPCTN 
Environmental influences on Child Health Outcomes IDeA States Pediatric Clinical Trials Network 
ITT 
Intent-to-Treat 
KUCTT 
University of Kansas Center for Telemedicine and TeleHealth 
MOP 
Manual of Procedures 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
OHRP 
Office for Human Research Protections 
PHI 
Protected Health Information  
PI 
Principal Investigator 
PP 
Per-Protocol Population 
QA 
Quality Assurance 
QC 
Quality Control 
RCT 
Randomized Controlled Trial 
RUCA 
Rural-Urban Commuting Area Codes 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMART IRB 
Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform 
SOA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
TAU 
Treatment As Usual 
TBD 
To Be Determined 
UAMS 
University of Arkansas for Medical Sciences 
UP 
Unanticipated Problem 
UPIRTSO 
Unanticipated Problems Involving Risks To Subjects or Others 
US 
United States 
USDA 
United States Department of Agriculture 
USPSTF 
United States Preventive Services Task Force 
 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight  
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 23 of 94 
Protocol Version #13 
Date: 04 March 2021 
1 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
Title: 
Feasibility Trial of the iAmHealthy Intervention for Healthy Weight in Rural 
Children Recruited from Primary Care Clinics 
Study Description: 
Conduct a multisite feasibility trial for the iAmHealthy intervention with 
two randomized controlled recruitment options (consecutive recruitment 
and traditional recruitment). We will examine retention, dose, and 
blinding that will inform the development of a larger, treatment-outcome 
fully powered randomized controlled trial (RCT) of the iAmHealthy 
behavioral intervention in the ECHO ISPCTN.  
Objectives: 
 
Primary Objectives. Conduct a rigorous feasibility trial for a future RCT 
(iAmHealthy versus newsletter) in four clinics affiliated with ECHO ISPCTN 
site awardees to assess key variables: participant recruitment, participant 
retention, intervention dose, and blinding. 
Objective 1. Participant Recruitment Rate  
A) Evaluate the two proposed recruitment options to determine 
which are feasible for recruitment of rural participants. 
Hypothesis: The percent of randomized participants, among those 
contacted with each recruitment option, will be greater than 20%. 
B) Compare the two proposed recruitment options. Hypothesis 1: 
The consecutive recruitment option (option 1) will yield a higher 
percent of participants randomized than those contacted through 
the traditional recruitment option (option 2). Hypothesis 2: Option 
1 will require less “time to full recruitment” than option 2. 
Objective 2. Participant Retention - Evaluate the percentage of 
randomized participants that remain in the study through the final 
measurement time point (sixth month) in both arms (i.e., iAmHealthy 
behavioral intervention and newsletter only). Hypothesis: The study will 
retain greater than 75% of the randomized participants through the final 
measurement (sixth month) in each arm. 
Objective 3. Dose - Evaluate the percentage of participants in the 
iAmHealthy behavioral intervention arm and retained through the final 
measurement who receive a sufficient dose (i.e., 80% [20.8 hours] of the 
26 planned contact hours) of the intervention. Hypothesis: 80% of the 
participants randomized to the iAmHealthy behavioral intervention arm 
who are retained through the final measurement will receive a sufficient 
dose (i.e., 80% [20.8 hours] of the 26 planned contact hours) of the 
intervention. 
 
Objective 4. Staff Blinding - Evaluate the agreement between the blinded 
assessor’s estimation of participant arm assignment and actual participant 
arm assignment. Hypothesis: The study will achieve blinding in both arms, 
as determined by calculating the New Blinding Index score with a 95% 
confidence interval that includes 0.2,3 
Secondary Objectives  

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight  
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 24 of 94 
Protocol Version #13 
Date: 04 March 2021 
1. Obtain a preliminary estimate of effectiveness of the iAmHealthy 
behavioral intervention on change in child BMIaz, compared to the 
newsletter-only intervention, from the baseline measurement to 
the final measurement time point (sixth month). 
2. Obtain a preliminary estimate of the effectiveness of the 
iAmHealthy behavioral intervention on change in child BMI, 
compared to the newsletter-only intervention, from the baseline 
measurement to the final measurement time point (sixth month). 
3. Obtain a preliminary estimate of the effectiveness of the 
iAmHealthy behavioral intervention on change in primary 
caregiver BMI, compared to the newsletter-only intervention, 
from the baseline measurement to the final measurement time 
point (sixth month). 
4. Obtain a preliminary estimate of the effectiveness of the 
iAmHealthy behavioral intervention on child nutrition (i.e., fruits, 
vegetables, etc.; see Section 7.2, subsection Individual Sessions), 
compared to the newsletter-only intervention, from the baseline 
measurement to the final measurement time point (sixth month). 
5. Obtain a preliminary estimate of the effectiveness of the 
iAmHealthy behavioral intervention on moderate to vigorous 
physical activity (child), compared to the newsletter-only 
intervention, from the baseline measurement to the final 
measurement time point (sixth month). 
Tertiary Objectives 
1. Assess the reasons that parents decline to participate in the 
iAmHealthy study and whether those reasons differ by 
recruitment option or clinic. 
2. Assess recruitment options by determining the total number of 
participants randomized via each recruitment option at each clinic 
and assess whether each clinic met its goal of at least eight 
randomized participants via each recruitment option.  

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight  
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 25 of 94 
Protocol Version #13 
Date: 04 March 2021 
Endpoints: 
Primary Endpoints 
1. Whether or not each participant contacted was randomized 
2. Whether or not each randomized participant attended the final 
(sixth month) measurement 
3. The number of contact hours received by participants randomized 
to the iAmHealthy intervention and whether or not these 
participants attended the final (sixth month) measurement  
4. Each blinded staff member will indicate to which intervention arm 
each participant was assigned 
Secondary Endpoints  
1. Measurement of change in BMIaz (child) from baseline to final 
measurement (sixth month) 
2. Measurement of change in BMI (child) from baseline to six-month 
measurement (end of intervention) 
3. Measurement of change in primary caregiver BMI from baseline to 
final measurement (sixth month) 
4. Measurement of change in the number of servings of sugar-
sweetened beverages, servings of “red foods” (i.e., foods with ≥7 
grams of fat and/or ≥12 grams of sugar per serving), and servings 
of fruits and vegetables, as measured by 24-hour food recall 
(child), at baseline and final measurement (sixth month) 
5. Measurement of change in number of minutes of moderate to 
vigorous physical activity, as measured by physical activity 
monitoring (child), from baseline to final measurement (sixth 
month) 
Tertiary Endpoints 
1. For each child whose parent(s) decline participation, reasons for 
nonparticipation will be collected from the parent(s) 
2. For each clinic, the number of randomized participants for each 
recruitment option will be determined 
 
Study Population: 
We estimate that we will approach up to 560, with the goal of randomizing 
112 participants (Per clinic [4 clinics]: 28 participants, 14 participants per 
treatment arm); Children ages 6 to 11 years of age with BMI ≥85th 
percentile.  
Phase: 
N/A 
Description of 
Sites/Facilities 
Consenting 
Participants: 
The study team will perform the iAmHealthy trial in four ECHO ISPCTN site 
states. Specifically, the study team will perform the iAmHealthy trial in one 
clinic per state.  
Recruitment Options: 
Randomization of recruitment options occurs at the clinic level. Each clinic, 
in a randomly ordered sequence, will implement two methods of 
recruitment. See Section 5.5, subsection Recruitment of Participants, for 
more detail on the methods of the two recruitment options.  

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight  
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 26 of 94 
Protocol Version #13 
Date: 04 March 2021 
Description of Study 
Intervention: 
Randomization of participants into intervention arms will occur at the 
individual level. 
Newsletter-only Intervention Arm 
Child/caregiver pairs in the newsletter-only intervention arm will receive: 
• 
usual care at their clinic for all issues, including overweight and 
obesity; 
• 
a monthly newsletter that focuses on general child health. The 
child/caregiver pairs will receive six newsletters (one per month) 
during the six-month intervention period. 
 
iAmHealthy Behavioral Intervention Arm 
Child/caregiver pairs in the iAmHealthy behavioral intervention arm will 
receive: 
• 
usual care at their clinic for all issues, including overweight and 
obesity; 
• 
a monthly newsletter that focuses on general child health. The 
child/caregiver pairs will receive six newsletters (one per month) 
during the six-month intervention period (same newsletter 
provided to the newsletter-only intervention participants); 
• 
weekly group sessions for the first three months, followed by 
monthly group sessions during the next three months, for a total 
of 15 group sessions. The trial’s iAmHealthy behavioral 
intervention psychologist or social worker (one team per clinic) 
will deliver these group sessions via an electronic tablet that the 
trial sponsor will supply; 
• 
11 hours of individual “homework” sessions with the iAmHealthy 
behavioral intervention dietician. 
Note: The iAmHealthy behavioral intervention psychologists/social worker 
will individualize group sessions and the iAmHealthy behavioral 
intervention dietician will adapt individual sessions by focusing on local 
cultural, religious, and ethnic factors relevant to the recommended 
changes in eating and activity habits. 
Per the 2017 USPSTF guidelines, the iAmHealthy behavioral intervention 
includes 26 contact hours (15 hours of group sessions and 11 hours of 
individual sessions). 
Participant Duration: 
From randomization to sixth months 
 
 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight  
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 27 of 94 
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Date: 04 March 2021 
1.2 
SCHEMA 
Figure 1 shows the planned schema of activities during this feasibility trial. Section 5.5, subsection Recruitment 
of Participants, details the participant recruitment options and implementation. 
Clinic Recruitment 
Participating ECHO ISPCTN-site awardees recruit clinics in their state that meet the 
specified clinic-eligibility criteria. 
 
 
4-week Run-up Period 
The four participating clinics will provide patient-visit data (i.e. billing data and 
electronic medical record) to ECHO ISPCTN site staff who will organize this list from 
more recent clinic visit dates to older visit dates. ECHO ISPCTN site staff will use an 
honest broker, when required. Then, the list will be unduplicated by patient (potential 
participant list) and an abbreviated list returned to clinic staff to identify BMI percentiles 
(see Section 5.5, subsections Recruitment Option 1 and Recruitment Option 2) 
 
 
Recruitment, Consent, 
& Screening 
(Weeks -10 through -5) 
Four clinics will implement recruitment options 1 and 2 in random order, as assigned by 
the DCOC. ECHO ISPCTN site staff with the assistance of clinic staff will identify and 
contact potential participants (see Section 5.5, subsections Recruitment Option 1 and 
Recruitment Option 2). The ECHO ISPCTN site coordinator will screen and consent 
participants. (See Figures 3 and 4 for details about recruitment options and Table 2 for 
recruitment options randomization sequence.) By the time participant randomization 
occurs, participants will complete the 24-hour food recall and physical activity 
monitoring. 
 
 
Baseline  
Measures 
(Weeks -4 through -1) 
The ECHO ISPCTN site coordinator will obtain height and weight measurements of child 
participant and primary caregiver.  
Randomization  
(Day 0) 
Participant randomization 
(Both groups will receive usual care throughout the trial.) 
 
 
 
 
 
 
 
 
 
Months 1-3 
(Weeks 1-12) 
• 
Weekly sessions 
• 
Monthly newsletter 
• 
Individual sessions (homework) 
• 
Monthly newsletter 
 
 
 
Months 4-6 
(Weeks 13-24) 
• 
Monthly sessions 
• 
Monthly newsletter 
• 
Individual sessions (homework) 
• 
Monthly newsletter 
 
 
 
Post-Intervention 
Assessment 
(Weeks 25-28) 
• 
24-hour food recall and physical 
activity monitoring 
• 
Height and weight of child and 
primary caregiver 
• 
24-hr food recall and physical activity 
monitoring 
• 
Height and weight of child and 
primary caregiver 
Figure 1. Schema of the iAmHealthy Feasibility Trial 
 
 
iAmHealthy 
behavioral 
intervention  
Newsletter-only 
intervention  

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight  
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 28 of 94 
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Date: 04 March 2021 
1.3 
SCHEDULE OF ACTIVITIES (SOA) 
SOA 1 
The SOA 1, shown below, is the pre-coronavirus enrollment pause SOA. Please see SOA 2 for the post-
enrollment pause schedule of activities. 
Trial Period 
 
Screening/ 
Baseline 
Measures 
Intervention 
Post 
4-week run-up 
Consent/Screening 
Weeks -15 to -3 
Baseline* 
Weeks -3 to -1 
Day 0 
Week 1-4  
Week 5-8 
Weeks 9-12 
Weeks 13-16 
Weeks 17-20 
Weeks 21-24 
Weeks 25-28 
Clinic provide patient-visit data 
X 
 
 
 
 
 
 
 
 
 
 
Develop list of consecutively seen 
patients in past year and who 
meet eligibility criteria 
X 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
 
X 
 
 
 
 
 
 
 
 
Informed Consent/Assent 
 
X 
 
 
 
 
 
 
 
 
 
Randomization 
 
 
 
X 
 
 
 
 
 
 
 
Heighta,b* 
 
 
BA 
 
 
 
 
 
 
 
BA 
Weighta,b* 
 
 
BA 
 
 
 
 
 
 
 
BA 
24-hour food recallc,d,e 
 
X 
 
 
 
 
 
 
 
X 
Physical activity monitoringc,f 
 
BA 
 
 
 
 
 
 
 
BA 
Newslettera 
 
 
 
 
X 
X 
X 
X 
X 
X 
 
Weekly session (for iAmHealthy 
behavioral intervention arm)a,d,g 
 
 
 
 
X 
X 
X 
 
 
 
 
Monthly session (for iAmHealthy 
behavioral intervention arm)a,d,h 
 
 
 
 
 
 
X 
X 
X 
 
Individual sessions (iAmHealthy 
behavioral intervention arm)a,d 
 
 
 
 
11 hours of homework help via remote 
technology 
 
Severe AE, SAE, and UP review  
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
Calculation of participant 
recruitment rate, retention, dose, 
& New Blinding Index 
 
 
 
 
 
 
 
 
 
 
X 
Demographicsi 
 
X 
 
 
 
 
 
 
 
 
Technology feasibilityi 
 
 
 
 
 
 
 
 
 
X 
Post-trial questionnairei 
 
 
 
 
 
 
 
 
 
 
X 
Study Personnel Time Assessment 
 
X 
X 
 
 
 
 
 
 
 
 
Study Personnel Satisfaction 
Survey 
 
 
 
X 
 
 
 
 
 
X 
Abbreviations: AE=adverse event; SAE=serious adverse event; UP=unanticipated problem; BA=blinded assessor 
a child and caregiver; b at clinic; c child only; d remotely; e Participants will complete one three-day 24-hour food recall at 
baseline and one three-day 24-hour food recall (three days is two week days [Mon. – Fri.] and one weekend day [Sat. or 
Sun.] at post-intervention. f Collected via ActiGraph monitor and data transferred to USB and downloaded by site 
coordinator. g There must be at least five days, but not more than nine days, between weekly sessions. h There must be at 
least three weeks, but not more than five weeks, between monthly sessions. i Caregiver will complete. 
* Consent and baseline activities can occur during the same visit. 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight  
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 29 of 94 
Protocol Version #13 
Date: 04 March 2021 
SOA 2 
The table below shows the schedule of activities once enrollment resumes.  
 
 
Clinic provide patient-visit data
X
Develop list of consecutively 
seen patients in past 12-24 
months and who meet eligibility 
criteria
X
Inclusion/Exclusion Criteria
X
Informed Consent/Assent
X
Randomization
X
Heighta*
BA
BA
Weighta*
BA
BA
24-hour food recallc,d,e
X
Physical activity monitoringc,f
BA
BA
Newslettera
X
X
X
X
X
X
Weekly session (for iAmHealthy 
behavioral intervention arm)a,d,g
X
X
X
Monthly session (for 
iAmHealthy behavioral 
intervention arm)a,d,h
X
X
X
Individual sessions (for 
iAmHealthy behavioral 
intervention arm)a,d
Severe AE, SAE, and UP review 
X
X
X
X
X
X
X
Calculation of participant 
recruitment rate
X
Calculation of participant 
retention
X
Calculation of dose
X
Calculation of New Blinding 
Index
X
Demographicsi
Technology feasibilityi
X
Post-trial questionnairei
X
Study Personnel Time 
Assessment
X
X
Study Personnel Satisfaction 
Survey
X
**Sites may collect activity monitors, score activity, and record activity monitor data in source document and EDC. Sites may 
not send activity monitors to participants during weeks 29-33.
***Under extenuation circumstances, the study-team leadership may grant a site an extension for post-intervention activity 
completion. 
Weeks 29-33***
Post
Abbreviations: AE=adverse event; SAE=serious adverse event; UP=unanticipated problem; BA=blinded assessor
a child and caregiver; c child only; d remotely; e Participants will complete one three-day 24-hour food recall at baseline and one three-
day 24-hour food recall (three days is two week days [Mon. – Fri.] and one weekend day [Sat. or Sun.] at post-intervention. f Collected 
via ActiGraph monitor and data transferred to USB and downloaded by site coordinator. g There must be at least five days, but not 
more than nine days, between weekly sessions. h There must be at least three weeks, but not more than five weeks, between 
* Consent/screening and baseline activities can occur during the same visit. If this occurs, height and weight measurements will be 
used for screening & baseline
Intervention
Weeks 1-4 
Weeks 5-8
Weeks 9-12
Weeks 13-16
Weeks 17-20
Consent/Screening 
Weeks -10 - -5
Baseline*           
Weeks -4 - -1
X
X
11 hours of homework help via remote 
technology 
BA
Weeks 21-24
X
Weeks 25-28**
Trial Period
Screening/Baseline 
Measures
4-week run-up
Week 0

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 30 of 94 
Protocol Version #13 
Date: 04 March 2021 
Table 1. Data and Collector 
Data 
Source 
Collector 
Blinded/Unblinded 
Eligibility: Patient-visit data 
Medical records and/or billing data 
Clinic staff and ECHO ISPCTN site research 
team 
Unblinded/NA collected 
prior to randomization 
List of consecutively seen patients, 
potential participants, for 
potential consent/assent  
Medical records and/or billing data, if needed supplemented 
with chart review 
Clinic staff and ECHO ISPCTN site staff 
Prior to randomization 
Parental reasons for declining to 
participate 
Primary caregiver 
ECHO ISPCTN site coordinator 
Blinded/NA collected prior 
to randomization 
Height/Weight 
Participants 
ECHO ISPCTN site coordinator 
Blinded 
24-hour food recall 
Participants 
Dietetics & nutrition team member 
Blinded 
Physical activity monitoring 
ActiGraph data 
ECHO ISPCTN site coordinator 
Blinded 
Attendance at weekly and 
individual sessions 
Participants who attended each session 
iAmHealthy behavioral intervention team 
Unblinded 
Demographic information 
Demographic questionnaire 
Primary caregiver provides via link 
Unblinded 
Contamination effects and 
newsletter use 
Post-trial questionnaire 
Primary caregiver provides via link 
Unblinded 
Technology problems 
Technology feasibility (as part of group and individual session 
attendance forms and post-trial parent questionnaire) 
iAmHealthy behavioral intervention team 
Primary caregiver 
Unblinded 
ECHO ISPCTN site and clinic staff 
satisfaction with recruitment 
options, intervention arms, and 
trial  
Study Personnel Satisfaction Survey 
DCOC 
Unblinded 
BMI/BMIaz 
BMI and BMIaz: Standard formulas/equations  
ECHO ISPCTN site coordinator 
Blinded 
Potential participants 
Recruitment option 1: patients seen in the last year or 
scheduled patients who meet inclusion criteria 
 
Recruitment option 2: not defined 
ECHO ISPCTN site coordinator 
Blinded/NA collected prior 
to randomization 
Potential participants approached 
Recruitment option 1: # of participants approached by ECHO 
ISPCTN site coordinator 
 
Recruitment option 2: # of self-referred potential participants 
ECHO ISPCTN Site awardee coordinator 
Blinded/NA collected prior 
to randomization 
Participants randomized 
# of participants randomized from each site-associated clinic 
Unblinded ECHO ISPCTN coordinator 
Unblinded 
Estimation of treatment 
assignment 
ECHO ISPCTN site coordinator and backup 
N/A: ECHO ISPCTN site coordinator and 
backup will enter their answers into EDC 
Blinded 
AEs/SAEs 
Participant, primary caregiver, ECHO ISPCTN site study 
personnel, or behavioral intervention team members 
Unblinded ECHO ISPCTN coordinator 
Unblinded 
 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 31 of 94 
Protocol Version #13 
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2 
INTRODUCTION 
2.1 
STUDY RATIONALE  
Feasibility Trial. A goal of the ECHO ISPCTN is to involve rural children in state-of-the-art clinical trials.4,5 
The ECHO ISPCTN explores and develops its ability to reach consent, and randomize rural children and 
families in these trials, and as such, the proposed feasibility trial will serve as a model for reaching rural 
children through their primary care clinic. Rural children are difficult to reach for clinical trials. Utilizing 
primary care clinics takes advantage of clinics’ access to well and sick rural children as well as their 
influence on needed care.6,7 The proposed feasibility trial will explore different options for identifying 
and consenting rural children in clinical trials through primary care clinics (i.e. participant recruitment 
rate), while also measuring retention, dose, and blinding. The long-term goal of the feasibility trial in 
four clinics in the ECHO ISPCTN states is to assess the feasibility of conducting a large, fully powered 
treatment-outcome trial of iAmHealthy in all 17 ECHO ISPCTN states. There is an iAmHealthy trial in 
process in rural schools (R01 NR016255), but it has several limitations that we could address by a trial in 
primary care clinics. Namely, the school-based trial struggled to reach school-level recruitment goals and 
hence school-based interventions of this nature may be limited in their ability to reach all segments of 
the target population.  Further, the limitation of school-based recruitment may result in a study 
population that yield different study outcomes from those observed in a clinic-based sample.  A large 
clinic-based trial may help reach segments of the population that the school-based study team could not 
reach, and a large clinic-based trial could help determine if study outcomes might vary across the two 
populations. However, before we can conduct a fully powered trial, we must gather important 
information regarding participant recruitment, participant retention, intervention dose, and blinding in 
clinics serving rural children. Thus, these are the foci of the current feasibility study.  
Obesity. It is also important to note that delivering obesity treatment would address a pressing issue in 
the health of rural children and their families. The prevalence of pediatric obesity is high among all 
children and disproportionately affects children from rural and/or medically underserved areas.8,9 There 
are few interventions specifically targeting pediatric obesity treatment among rural and medically 
underserved children, a factor that contributes to health disparities. Previous research indicates that 
mobile health (mHealth), the use of mobile technology for the purposes of medical care, is feasible and 
acceptable for the delivery of pediatric obesity interventions to rural/medically underserved children.10-
12 This type of intervention lowers children’s body mass index z-score (BMIz) and helps children and 
families improve their health behaviors. However, the trial detailed herein extends this research in a 
new and innovative direction—it moves the iAmHealthy mobile technology intervention into family 
homes, simultaneously increasing convenience and dose (i.e., contact hours). As described in more 
detail elsewhere (see Section 7.2, subsection Description of the iAmHealthy Behavioral Intervention), the 
iAmHealthy behavioral intervention is composed of group and individual/family-level components, 
based on new research that indicates this combination is highly effective. 13 
2.2 
BACKGROUND  
Pediatric Obesity among Rural Populations 
The iAmHealthy behavioral intervention, for which this study acts as a feasibility pilot, addresses 
pediatric obesity.  The prevalence and incidence of pediatric obesity in the US remains a critical public 
health concern. Data from the Centers for Disease Control and Prevention (2015-2016) indicate that 
18.5% of US children and adolescents (ages 2 to 19 years) are classified as obese (BMI >95th percentile) 
and 35.1% are either overweight or obese (BMI ≥85th percentile).14 Childhood obesity continues to be 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 32 of 94 
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Date: 04 March 2021 
associated with short-term health consequences and long-term risk for obesity and other health 
problems.15  
Pediatric obesity disproportionately affects children in rural areas.16 According to the 2015 National 
Survey of Children’s Health, children living in rural areas are more likely to be overweight and obese 
when compared to urban children (38% rural versus 30% urban children).17 Rural children experience 
higher rates of overweight and obesity than their urban counterparts, and rural children have a 50% 
higher probability of being obese than urban children.18 Similarly, research completed in Kansas 
concurred that there was a higher prevalence of pediatric obesity in rural areas than in urban areas. In 
Kansas, 43% of rural children were either overweight or obese.19  
Although prevention efforts can be helpful, experts agree that treatment programs are necessary to 
combat the pediatric obesity epidemic.20,21 Few treatments target children and families from rural areas 
or those who live in medically underserved areas. These individuals face unique challenges, such as 
having to travel longer distances to receive intensive obesity care, lack of nutrition education, poor 
access to healthcare providers, lower socioeconomic status, and fewer opportunities for physical 
exercise.16 Research indicates that there are also differences in the health behaviors of rural and urban 
children (e.g., rural children are more likely to eat junk food, skip breakfast, engage in lower levels of 
moderate to vigorous physical activity, and engage in higher rates of sedentary activity than their urban 
counterparts).19  
Rationale for Feasibility Study and Objectives 
There are many challenges to conducting clinical trials. Medically underserved populations, including 
rural families, have low participation in clinical trials.22 Also, traditional methods of recruitment in 
clinical trials may result in samples that are not representative of the relevant population.23 Among both 
urban and rural patients, common patient-reported barriers to participation in clinical trials include fear 
of clinical trials, concerns about side effects, limited understanding of clinical research, limited 
incentives for participation, and mistrust of healthcare system. Rural participants emphasized the time 
commitment for participation.24 Interestingly, rural participants were more motivated to enroll by 
benefit to their family while urban patients mentioned individual benefit while both groups agreed that 
financial incentives would encourage participation.24 The most common investigator-reported barriers 
include communication about and awareness of clinical trials by participants.22 Experts agree, “building 
clinical trials around patients in their homes and community through remote visits and monitoring could 
enhance recruitment and increase convenience for participants.” Recruitment of clinics that care for 
rural patients and the recruitment of rural patients themselves into research can be challenging, which 
may be why rural participants are under-represented in clinical trials.25 However, some research 
indicates that engagement of local resources and providers as research sites can increase participation, 
16 and that rural clinics may be more likely to engage in network-type research. Regarding participant 
recruitment specifically into behavioral obesity trials, common recruitment barriers include family and 
study logistics, family economics, lack of provider interest, invasive protocols, stigma, clinician time 
restraints, lack of patient interest, and lack of acceptance of weight status.26  
Bjorn et al examined clinical trials that used different methods of recruitment.23 These researchers 
compared clinical trials involving adult cardiac participants that research staff consecutively screened 
and enrolled to similar trials that used traditional recruitment methods. Bjorn et al found that 
consecutive enrollment resulted in better enrollment (17 to 26% versus 4 to 7% with traditional 
recruitment), in a trial population that was systematically different, and in better outcomes than the 
traditionally enrolled trials.23 Our recruitment option 1 (Figure 2) involves consecutive screening and 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 33 of 94 
Protocol Version #13 
Date: 04 March 2021 
consenting, while option 2 is a more traditional screening and consenting. This will allow us some insight 
into how different recruitment options affect the populations consented and their outcomes. 
Researchers have proposed facilitators to enhance recruitment into clinical trials, including 
accommodating visits outside of regular clinic hours, incentivizing participants, cultivating relationships 
with clinics in advance of recruitment, emphasizing potential benefits to participants, and, for obesity 
trials, focusing on health, rather than obesity.26 Other research has indicated that the main reasons 
individuals enroll in clinical trials are physician recommendation to participate in a clinical trial, 
expectation of personal benefit, and altruism.27 In terms of the most frequently used recruitment 
options, the USPSTF systematic review indicates that 26% of studies used specific screening methods, 
21% relied only on physician referral, and most studies used multiple methods of recruitment within 
each clinic.28 This is important as other research indicates that relying on multiple methods of 
recruitment can result in a more representative sample.29  
A trial that reported on the recruitment options that we are testing, the “Obesity Prevention Tailored for 
Health (OPT)” study30, a project of Kaiser-Permanente of Southern California, enrolled families with a 
healthy 11 to 12 year-old child, irrespective of overweight or obesity. Periodically, researchers randomly 
selected potential participants from patient lists. Study personnel mailed parents of these children 
introductory letters and then contacted them; the patient’s physician knew about the study and 
reviewed the recruitment list but did not participate in recruitment. Overall, study personnel sent 4,730 
letters. These letters resulted in 222 (4.7%) of the potential participants being ineligible, 1,360 (28.8%) 
declined, 2,385 (50.4%) were uncontactable, and 763 (16.1%) accepted. Of the 763 who accepted, study 
personnel scheduled 66.8% of the potential participants for a baseline appointment. Note that of the 
763 potential participants who accepted, study personnel consented and randomized 361 (47.3%), 
which was 7.6% of the potential participants initially contacted.30 The most frequent reason for not 
participating in the study was lack of interest from the parent or child (49.6%), with 23.1% citing lack of 
time to participate. Results indicate that factors associated with trial participation include children being 
overweight or obese, the child or parent having had more outpatient visits, and the child or parent 
having received influenza vaccine.30 
Another trial, Hamilton-Shield et al, reported on the recruitment of obese children, 5 to 11 years of age, 
into the “Community Mandolean Randomised Controlled Trial (ComMando)” in the United Kingdom.31  
One of the specific aims of this pilot project was to assess recruitment strategies. The recruitment 
strategies assessed were general practitioner-initiated recruitment, healthcare professional-initiated 
recruitment, recruitment through advertisement and record screening, and recruitment through school. 
Except for recruitment through advertisement, all of these recruitment strategies relied on on-site staff 
to identify, screen, and refer potentially eligible participants. The intervention in this trial was intensive. 
It involved participants putting food on a plate connected to a computer, and researchers measuring the 
change in meal weight over time. Using general-practitioner mailouts, study personnel sent 10,077 
mailouts and 116 responded (1.2%). Of the 116 respondents, 37 (31.9%) were randomized. General 
practitioner and healthcare professional referral recruitment methods resulted in 35 respondents with 
12 (34.3%) randomized. For all other recruitment strategies, there were 31 responses and 12 (38.7%) 
randomized. 
Both Hamilton-Shield and Ghai have shown that there are substantial challenges to recruitment. We are 
likely to encounter these same challenges, along with the challenges associated with recruiting 
participants who live in rural areas. However, unlike Hamilton-Sheild, 31 we have enhanced our 
likelihood of success by relying on ECHO ISPCTN awardee-sites for recruitment, rather than solely relying 
on clinic personnel for participant identification and recruitment. We will compare two recruitment 
strategies previously used in clinical trials. Recruitment option 1 will be a consecutive recruitment 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 34 of 94 
Protocol Version #13 
Date: 04 March 2021 
strategy where clinic personnel will approach potential participants based on past (retrospective) or 
current (prospective) appointments. Recruitment option 2 will be a traditional recruitment strategy. 
Using both strategies will provide key information on the relative effectiveness of each strategy, 
something rarely studied in clinical trials research. To optimize success, we will approach patients who 
recently visited the participating clinic (option 1), which should enhance our ability to contact them, 
avoiding the contact issues Ghai encountered by using random selection from patient lists.30 Through 
these methods, our trial will answer the question: What is the efficacy of each recruitment strategy in 
primary care clinics for rural participants? 
Beyond recruitment, additional challenges include concerns regarding retention of patients to study 
completion, retention of patients in the treatment group to receive the proper “dose”, and staff blinding 
in small rural clinics. Regarding retention, data from the USPSTF systematic review indicate that 
retention rates across studies range from 63.4% to 100%.28 Another published literature review 
indicates that average retention rates in pediatric obesity trials are 86%,32  and data from a recent three-
arm trial, with a similar intervention dose to our proposed trial, show retention rates of 92%, 97%, and 
89% for each of the three arms.33 However, we know little about retention of rural parents and children 
in a behavioral obesity intervention trial, especially when researchers recruit these individuals from their 
primary care clinics. Because ECHO ISPCTN researchers understand that rural patients and families face 
greater barriers to participation, it stands to reason that these rates may be lower than those found with 
non-rural participants. Regarding dose, it stands to reason that if rural families encounter more barriers 
to participation in research, then they may also have difficulty achieving a sufficient dose of the 
proposed behavioral obesity intervention. Previous research indicates that several factors may influence 
retention in obesity trials, including the amount of child body mass change, child starting body mass, 
child quality of life, and parent educational level.34 However, these factors may not have been studied in 
rural populations. Another concern is maintaining proper staff “blind” in small rural clinics, whereby the 
staff recording the height and weight measurements remain blinded to patient/family arm assignment, 
although there is little published research regarding this concern.14 In this trial, we will add to the 
literature in this area and increase our likelihood of maintaining staff blind by blinding the ECHO ISPCTN 
site coordinator (and ECHO ISPCTN site backup assessor), not the clinic staff.  
Treatment of Pediatric Obesity 
The most common treatment for pediatric obesity is family-based behavioral groups. Research 
consistently demonstrates that these treatments are among the most effective and scalable treatments 
for pediatric obesity. 18,35,36 The recent USPSTF review indicates that these types of treatments are more 
effective if parents participate in treatment, include at least 26 hours of intervention contact, focus on 
healthy nutrition and physical activity, and include the use of behavioral and cognitive-behavioral 
techniques, such as goal setting, self-monitoring, positive reinforcement, and stimulus control.28 It is also 
important to note that group treatment is very practical, allowing a single healthcare provider to treat 8 
to 10 families in a single one-hour session. Recent research indicates that including individual coaching 
sessions with families to help them overcome family-level factors can improve treatment success of 
these behavioral groups.18,37 Our study will build on this research by incorporating child/caregiver group 
and individual sessions delivered via video conference (similar to Skype) on tablets that will focus on 
healthy behaviors.   
Rationale for Newsletter Control Arm 
Experts agree that the most appropriate control arm for effectiveness trials is treatment as usual 
(TAU).38 However, TAU is not appropriate for many ECHO ISPCTN site awardees that indicate they must 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 35 of 94 
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Date: 04 March 2021 
offer some sort of treatment to all participants. A recent review shows that a common alternative to 
TAU is enhanced “standard care,” which is used in approximately 44% of obesity treatment trials,39 
including those published by experts39-42 and those in NIH-funded projects (e.g., HD073237 Bentley; 
DK084331 Elder; MD007634 Farrell). This type of control arm “most often involved the receipt of 
standard off-the-shelf print material addressing health behaviours.”39 Data indicate that these types of 
control arms cause negligible effects on weight (median = +0.1 kg; IQR = −0.85 kg to +0.8 kg), and 
discussions with key stakeholders indicate that this type of intervention will increase palatability to 
participants and providers across the ECHO ISPCTN. We will us an enhanced standard-of-care control 
that will include a newsletter intervention and will also serve as a retention device (see Section 5.5), 
since research indicates that repeated contact is key to retention in longitudinal clinical studies.40 
Rationale for Individual-Level Assignment 
This study will randomize participants at the individual level, rather than the clinic level. In individual 
level randomization, it is important to guard against contamination of treatment arms, as this is a 
serious threat to validity.43 Contamination occurs when individuals do not receive their assigned 
intervention, and in this case, when there is a potential for the newsletter-only arm to receive a 
behavioral intervention. In school-based treatment and prevention studies focused on pediatric obesity, 
there is some evidence of contamination across the assigned arms.44 However, in clinic-based studies, 
such as those in the 2017 USPSTF literature review, the risk of contamination was extremely low. The 
current study further decreases this risk since all treatment takes place via a tablet in participant homes, 
and individuals in the newsletter-only arm cannot access these tablet-delivered sessions. 
Rationale for Clinic-level assignment 
We will randomly implement two recruitment options in each clinic so that, in each recruitment month, 
two clinics will implement each recruitment option (Table 2). This will allow us to compare recruitment 
options within and between clinics. The purpose of studying two recruitment options is not to compare 
one to another. Rather, it is to ensure that both recruitment options result in sufficient number of 
participants and should be included in the larger trial. This is especially useful since clinics differ in many 
aspects. In an examination of 61 clinics in 8 practice-based research networks, substantial differences 
were shown between practices by within practice clustering of factors of interest, including 
demographics, age (intraclass correlation coefficient [ICC]=.151), race (ICC=.265), behaviors, and 
unhealthy diet (ICC=.206).45 There is also substantial variation between practices in the delivery of 
medical treatments, such as immunizations. When examining 15 clinics from 11 states in a national 
practice-based research network, researchers found that immunization rates varied by 40 to 50 
percentage points, depending on the measure used.46 The proposed random order of implementation 
within each clinic will allow us to compare the recruitment options within and between clinics, balancing 
the clinic-level differences.  
2.4 
RISK/BENEFIT ASSESSMENT  
Known Potential Risks  
A potential identified risk for this trial is loss of confidentiality. There is also the possibility that 
participants could engage in unhealthy weight loss habits, feel burdened by participation, or concerned 
that participating may negatively affect family interactions. There is also a possibility that participants 
could experience minor sprains or strains because of physical activity recommendations; however, the 

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risk of sprains or strains because of physical activity is relatively small compared to the health risks faced 
by participants who engage in no physical activity at all. 
These concerns are not supported as a potential risk by the 2005 summary of the evidence from the 
USPSTF.47 The 2010 USPSTF systematic review also identified no reported harms from obesity 
management behavioral interventions.48 
Known Potential Benefits  
The primary potential benefits of trial participation include health education and obesity treatment, 
which may lead to improved health habits and, later, to improved health. There could also be 
improvement in caregiver and child self-efficacy and social cohesion of families participating in the 
group intervention, as well as a lessening of family conflict about health behaviors. However, research 
has not documented these additional benefits. 
Assessment of Potential Risks and Benefits  
The trial has minimal possible risks, and the potential benefits of health education and obesity 
treatment outweigh the potential risks. 
3 
OBJECTIVES AND ENDPOINTS 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
 
 
Objective 1. Participant Recruitment 
Rate – Hypothesis: A) The percent of 
randomized participants, among those 
contacted with each recruitment 
option, will be greater than 20%. 
Hypotheses: B) 1. The consecutive 
recruitment option (option 1) will yield 
a higher percent of participants 
randomized than those contacted 
through the traditional recruitment 
option (option 2). Hypothesis 2. Option 
1 will require less “time to full 
recruitment” than option 2. 
Whether or not each participant 
contacted was randomized 
This percentage is a 
measure of the feasibility 
of each of the 
recruitment options 
Objective 2. Participant Retention – 
Hypothesis: The study will retain 
greater than 75% of the randomized 
participants through the final 
measurement (sixth months) in each 
arm.  
Whether or not the each randomized 
participant attended the final (sixth 
month) measurement 
This percentage is to 
determine if participants 
consented through one 
recruitment option are 
more likely to be 
retained, as compared to 
participants consented 
through the other 
recruitment option 
Objective 3. Dose – Hypothesis: 80% of 
the participants randomized to the 
iAmHealthy behavioral intervention 
arm who are retained through the final 
The number of contact hours received by 
participants randomized to the 
iAmHealthy intervention and whether or 
This percentage is a 
measure of the feasibility 
of the proposed 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
measurement will receive a sufficient 
dose (i.e., 80% [20.8 hours] of the 26-
planned contact hours) of the 
intervention. 
not these participants attended the final 
(sixth month) measurement  
iAmHealthy behavioral 
intervention 
Objective 4. Staff Blinding - Hypothesis: 
The study will achieve blinding in both 
arms, as determined by calculating the 
New Blinding Index 95% confidence 
interval that includes 0.2,3 
Each blinded staff member will indicate 
to which intervention arm each 
participant was assigned 
The Index is a measure of 
the feasibility of the 
proposed blinding 
measures  
Secondary 
 
 
1. Obtain a preliminary estimate of 
effectiveness of the iAmHealthy 
behavioral intervention on change 
in child BMIaz, compared to the 
newsletter-only intervention, at 
the final measurement time point 
(sixth month) and the baseline 
measurement. 
Measurement of change in BMIaz (child) 
from baseline to final measurement 
(sixth month) 
Change in BMIaz at sixth 
months is a measure of 
intervention effectiveness 
2. Obtain a preliminary estimate of 
the effectiveness of the 
iAmHealthy behavioral 
intervention on change in child 
BMI, compared to the newsletter-
only intervention, from the 
baseline measurement to the final 
measurement time point (sixth 
month). 
Measurement of change in BMI (child) 
from baseline to six-month measurement 
(end of intervention) 
Change in BMI at sixth 
months is a measure of 
intervention effectiveness 
3. Obtain a preliminary estimate of 
the effectiveness of the 
iAmHealthy behavioral 
intervention on change in primary 
caregiver BMI, compared to the 
newsletter-only intervention, from 
the baseline measurement to the 
final measurement time point 
(sixth month). 
Measurement of change in primary 
caregiver BMI from baseline to final 
measurement (sixth month)  
Change in primary 
caregiver BMI is a 
measure of intervention 
effectiveness 
4. Obtain a preliminary estimate of 
the effectiveness of the 
iAmHealthy behavioral 
intervention on child nutrition 
(i.e., fruits, vegetables, etc.; see 
Section 7.2, subsection Individual 
Sessions), compared to the 
newsletter-only intervention, from 
the baseline measurement to the 
final measurement time point 
(sixth month). 
Measurement of change in the number 
of servings of sugar-sweetened 
beverages, servings of “red” foods (i.e., 
foods with ≥7 grams of fat and/or ≥12 
grams of sugar per serving), and servings 
of fruits and vegetables, as measured by 
24-hour food recall (child), at baseline 
and final measurement (sixth month)  
Food recall for 24-hour 
periods (taken during 
three days) may explain 
changes in BMI 
5. Obtain a preliminary estimate of 
the effectiveness of the 
iAmHealthy behavioral 
Measurement of change in number of 
minutes of moderate to vigorous physical 
activity, as measured by physical activity 
Physical activity 
monitoring may explain 
changes in BMI 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
intervention on moderate to 
vigorous physical activity (child), 
compared to the newsletter-only 
intervention, from the baseline 
measurement to the final 
measurement time point (sixth 
month). 
monitoring (child), from baseline to final 
measurement (sixth month) 
Tertiary 
 
 
1. Assess the reasons that parents 
decline to participate in the 
iAmHealthy study and whether 
those reasons differ by 
recruitment option or clinic. 
For each child whose parent(s) decline 
participation, reasons for 
nonparticipation will be collected from 
the parent(s) 
This is a measure of the 
feasibility of each of the 
recruitment options 
2. Assess participant randomization 
by determining the total number 
of participants randomized via 
each recruitment option at each 
clinic and assess whether each 
clinic met its randomization goal of 
at least eight randomized 
participants via each recruitment 
option. 
For each clinic, the number of 
randomized participants for each 
recruitment option will be determined 
 
This is a measure of the 
feasibility of each of the 
recruitment options 
Abbreviations: BMI=body mass index; BMIaz=body mass index (adjusted z-score) 
4 
STUDY DESIGN  
4.1 
OVERALL DESIGN 
This feasibility trial is a multisite, RCT of two different methods of identifying and recruiting participants 
into the iAmHealthy behavioral intervention. Children and caregivers in both arms will receive the usual 
care for all existing medical conditions throughout the trial period. They will also receive a monthly 
newsletter for six months (see Section 7.2; subsection Newsletter Intervention). In addition to the 
newsletter, child/primary caregiver pairs in the iAmHealthy behavioral intervention arm will receive 
both group and individual sessions (see Section 7.2, subsection iAmHealthy Behavioral Intervention). The 
trial intervention period will last for six months, and it will consist of 15 hours of group sessions and 
11 hours of individual sessions (see Section 7.2, subsection Description of iAmHealthy Behavioral 
Intervention) for 26 contact hours. This falls within the 26- to 51-contact hour category, which is 
significantly more effective than the 6- to 25-contact hour category, per the recent USPSTF guidelines.49 
This feasibility trial will provide information toward the implementation of a fully powered, multisite, 
randomized behavior intervention trial that will compare the effectiveness of the iAmHealthy behavioral 
intervention to a newsletter-only intervention for the treatment of obesity among rural and 
underserved children and their primary caregivers.  
See the Participant Schedule of Activities in Section 1.3 for a more detailed overview of time points for 
the activities noted above. 

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4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
The objectives and hypotheses for this trial are as follows. 
Primary Objective  
Primary care practices often differ dramatically in their patient demographics, patient behaviors, 45 and 
delivery of needed services.46,50 Because of these differences between the patients and capabilities of 
practices, we will test recruitment options both within and between clinics. This will be a feasibility trial 
for the iAmHealthy intervention with randomized controlled recruitment options. We will examine 
retention, dose, and blinding that will inform the development of a larger, fully powered RCT of the 
iAmHealthy behavioral intervention in the ECHO ISPCTN. The objectives and hypotheses for this trial are 
as follows.  
Primary Objective: Conduct a rigorous feasibility trial of a future RCT (iAmHealthy versus newsletter) in 
four clinics affiliated with ECHO ISPCTN site awardees to assess key variables (participant recruitment 
rate, participant retention, intervention dose, blinding)  
Objective 1. Participant Recruitment Rate.  
A) Evaluate the two proposed recruitment options to determine which are feasible for 
recruitment of rural participants. Hypothesis: The percent of randomized participants, among 
those contacted with each recruitment option, will be greater than 20%.  
B) Compare the two proposed recruitment options. Hypothesis: The consecutive recruitment 
option (option 1) will yield a higher percent of participants randomized among those contacted 
than the traditional recruitment option (option 2). 
Objective 2. Participant Retention. Evaluate the percentage of randomized participants that remain in 
the study through the final measurement time point (sixth month) in both arms (i.e., iAmHealthy 
behavioral intervention and newsletter only). Hypothesis: The study will retain greater than 75% of the 
randomized participants through the final measurement (sixth month) in each arm. 
Objective 3. Dose. Evaluate the percentage of participants in the iAmHealthy behavioral intervention 
arm and retained through the final measurement who receive a sufficient dose (i.e., 80% [20.8 hours] of 
the 26 planned contact hours) of the intervention. Hypothesis: 80% of the participants randomized to 
the iAmHealthy behavioral intervention arm who are retained through the final measurement will 
receive a sufficient dose (i.e., 80% [20.8 hours] of the 26 planned contact hours) of the intervention. 
Objective 4. Staff Blinding. Evaluate the agreement between the blinded assessor’s estimation of 
participant arm assignment and actual participant arm assignment. Hypothesis: The study will achieve 
blinding in both arms, as determined by calculating the New Blinding Index score with a 95% confidence 
interval that includes 0.2,3 
Secondary Objectives  
1. Obtain a preliminary estimate of the effectiveness of the iAmHealthy behavioral intervention on 
change in child BMIaz, compared to the newsletter-only intervention, from the baseline 
measurement to the final measurement time point (sixth month). 
2. Obtain a preliminary estimate of the effectiveness of the iAmHealthy behavioral intervention on 
change in child BMI, compared to the newsletter-only intervention, from the baseline 
measurement to the final measurement time point (sixth month). 

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3. Obtain a preliminary estimate of the effectiveness of the iAmHealthy behavioral intervention on 
change in primary caregiver BMI, compared to the newsletter-only intervention, from the 
baseline measurement to the final measurement time point (sixth month). 
4. Obtain a preliminary estimate of the effectiveness of the iAmHealthy behavioral intervention on 
child nutrition (i.e., fruits, vegetables, etc.; see Section 7.2, subsection Individual Sessions), 
compared to the newsletter-only intervention, from the baseline measurement to the final 
measurement time point (sixth month). 
5. Obtain a preliminary estimate of the effectiveness of the iAmHealthy behavioral intervention on 
moderate to vigorous physical activity (child), compared to the newsletter-only intervention, 
from the baseline measurement to the final measurement time point (sixth month). 
Tertiary Objectives 
1. Assess the reasons that parents decline to participate in the iAmHealthy study and whether 
those reasons differ by recruitment option or by clinic. 
2. Assess recruitment options by determining the total number of patients randomized via each 
recruitment option at each clinic and assess whether each clinic met its goal of at least eight 
randomized participants via each recruitment option.  
4.3 
JUSTIFICATION FOR INTERVENTION MODEL 
For the feasibility trial, we will evaluate two proposed recruitment options (see Section 5.5, subsection 
Recruitment of Participants, for a description of recruitment options). Based on published literature, as 
well as own clinical trials work and our conversations with ECHO ISPCTN site awardees, the two 
proposed recruitment options are the ones most used in clinics recruiting for clinical trials.   
The NIH ECHO ISPCTN is ideally suited to study participant recruitment, participant retention, 
intervention dose, and staff blinding, as well as for the delivery of an empirically supported pediatric 
obesity treatment program to rural families through primary care clinics. Previous research indicates 
that primary care clinics are the most trusted informational source for parents regarding their child’s 
health and medical needs, and as such, it is the ideal venue for recruitment into pediatric obesity 
treatment services. Because the goal of the ECHO ISPCTN is to involve rural children in state-of-the-art 
clinical trials,4 the current proposal will serve as a feasibility trial not only of iAmHealthy, but more 
broadly of future clinical trials recruiting rural children from primary care clinics.  
Justification for Delivering the iAMHealthy Intervention via Mobile Technology 
Although the use of mobile health technology in intervention research is innovative in and of itself, 
research indicates that many clinics and centers are now building these types of infrastructures to reach 
their patients for clinical purposes, making the technology widely available for other uses. Specific to 
obesity treatment, experts agree that face-to-face or in-person obesity treatment can be expensive47 
and even impractical for most rural and medically underserved families, making health technology 
interventions especially appealing. Outside of the medical system, adults increasingly use mobile 
technologies across varying geographies and socioeconomic statuses, with two-thirds of Americans 
having smartphone access and 42% of adults owning tablets.51 Data also indicate that 74.4% of all 
families in the US have Internet in their homes, and 83.8% have a computer.52 Finally, data also indicate 
that 80% of all Internet users have searched for a health-related topic online,53 indicating that many 
consumers are already using technology to look for answers regarding health issues. 

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Delivery of health services to pediatric patient homes with mobile health technology has been widely 
recommended across various disease states.54,55 A recent Strategic Policy Agenda by the American Heart 
Association listed delivery of treatment research to rural populations using telehealth and mobile health 
technology as a major strategic priority for 2017 to 2020.56 However, no studies exist regarding the 
direct delivery of pediatric obesity treatment to family homes with mobile health technology, making 
this area of study extremely innovative. It is surprising that no studies exist in this area given that 
experts uniformly agree that technology-based approaches, such as that proposed in the iAmHealthy 
trial, are both cost effective and highly scalable. Previous research suggests that home-based technology 
approaches not only save significant costs for patients and families but also save costs for providers and 
healthcare systems. In a recent review of the literature,57 the authors concluded that the limited 
evidence suggests mobile health technology is a “promising approach to pediatric weight management, 
particularly for rural families with limited access to treatments.”57 The iAmHealthy trial will allow the 
ECHO ISPCTN to capitalize on the growing use of technology-based approaches by conducting the first 
study to determine the effectiveness of an empirically supported intervention for pediatric obesity that 
will be delivered directly into rural family homes. 
The iAmHealthy trial will be a multicomponent behavioral intervention primarily composed of group and 
individual sessions for caregivers and children. These sessions will focus on nutrition, physical activity, 
and behavior change. The iAmHealthy behavioral intervention teams (one per clinic) will deliver these 
sessions via video conference to participants who will remotely attend through study-provided tablets. 
Current 2017 data indicate that among American adults 88% use the Internet and more than 75% have 
broadband access at home, and these proportions are even higher (>95% for Internet use) in the likely 
age range of parents who will participate in this trial.58  If the outcome of this trial is positive, we will be 
able to disseminate iAmHealthy to future children and families via their own devices and home 
broadband access. We will assess participating caregivers’ Internet availability and usage to facilitate 
future dissemination in the unique communities served in this trial.  
Note: Data suggest that Internet services are widely available; however, there is a possibility that these 
data are not representative of Internet use/availability among the unique populations available in the 
ECHO ISPCTN. Therefore, we will provide tablets equipped with cellular data service to child/caregiver 
pairs to equalize performance of the video conference software that we will use to deliver the group 
and individual sessions.  For more information, see Section 7.2; subsection Acquisition and Preparation 
of Tablets.  
iAmHealthy Behavioral Intervention in Clinic Settings 
Adequately addressing overweight and obesity in children requires investigation in many settings, 
including those in which children typically access medical care. In this vein, we will test the iAmHealthy 
behavioral intervention in primary care clinics to determine if we can overcome the barriers 
encountered when delivering iAmHealthy in the currently funded iAmHealthy Schools R01 (NR016255), 
which targets rural elementary school children and their families in Kansas. Of note, primary care clinics 
have a fundamental interest in preventing, identifying and treating obesity. In the iAmHealthy Schools 
trial, our team developed a research program using interactive video conference (similar to Skype) to 
treat pediatric obesity among rural children and families. These studies led to the development of the 
iAmHealthy behavioral intervention. Data59,60 for previous participants in rural schools indicate that the 
mean child BMIz score decreased from 1.88 (SD = 0.52) to 1.76 (SD = 0.52) in the treatment arm (t = 
3.02, P = .007). 
The iAmHealthy Schools trial has experienced strong participant recruitment and retention, with 30% to 
50% of eligible children/caregivers consented and enrolled, and 97.2% (n = 36) of treatment participants 

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and 100% of control arm participants (n = 38) are still active. (Active for the treatment arm equals 
attending monthly weigh-ins and more than 80% of intervention sessions; active for the control arm 
equals attending monthly weigh-ins.) Because the study is in the initial phases, outcome data are 
unavailable. Feasibility data, however, indicate that delivering this type of intervention via technology to 
rural families is highly feasible, and participants spontaneously report high satisfaction with the 
intervention and the mobile technology.  
However, the iAmHealthy Schools trial has also highlighted the many difficulties in delivering this type of 
treatment program through schools. While approximately 85% of US children attend public schools, 
schools must be active participants in the project to reach these children. This has proven challenging 
because state funding of kindergarten through 12th-grade schools has sharply declined since the 2008 
recession, there is a significant increase in students with a simultaneous decrease in teachers, and the 
No Child Left Behind law, passed in 2002, increased testing and achievement standards. These stressors 
have heightened schools laser focus on educational outcomes and achievement, making schools 
challenging partners in health promotion programs, like iAmHealthy. In the current iAmHealthy Schools 
trial, we have completed two annual school recruitment cycles, and thus far, both years have fallen 
short of our school recruitment goals (which are separate from our participant recruitment goals). The 
major barrier reported by schools, who expressed interest but subsequently did not participate, was lack 
of time.  
In the proposed iAmHealthy study, we will attempt to determine if targeting primary care clinics and 
consenting their patients will show a difference in the population reached and intervention effect, as 
compared to the results in iAmHealthy Schools. Data indicate that children and families are more likely 
to engage in health-related activities recommended by their medical provider, and that health 
promotion programs conducted through schools and those conducted through medical clinics may reach 
somewhat different population segments. In addition, because pediatric obesity is so prevalent, many 
have argued that offering (and therefore, testing) health promotion programs across many sectors, 
including both schools and medical clinics, is necessary. 
4.4 
END OF STUDY DEFINITION 
The trial will end at the time point when all child/caregiver pairs complete the six-months of 
intervention (as shown in the Schedule of Activities in Section 1.3), technology feasibility survey, and 
post-trial questionnaire.  
5 
STUDY POPULATION 
5.1 
INCLUSION CRITERIA 
To be eligible to participate in the proposed trial, a child/caregiver pair must attend a qualifying primary 
care clinic and meet all of the following inclusion criteria. 
1. Child is rural. The child lives in a rural area, as defined by the United States Department of 
Agriculture (USDA) Rural-Urban Commuting Area (RUCA) codes (greater than or equal to 4). We 
will calculate this using the 2010 Zip Code, RUCA Code crosswalk.  
2. Child is ages 6-11 years at the time of consent. At the time of consent, a child must be 6 to 11 
years of age. A narrow age range is necessary to decrease developmental variability. ECHO 
ISPCTN site coordinators may consent a child no earlier than her or his sixth birthday (6 years, 0 
months, 0 days), and may consent a child up to her or his 12th birthday (11 years, 11 months, 30 
days).  

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3. Child BMI percentile is ≥85th. We will use the 85th percentile as a minimal cutoff for 
participation, as this is the minimal criteria for the definition of overweight. There is no upper 
limit on BMI percentile for inclusion. 
4. Child and primary caregiver speak English. For the initial feasibility pilot, we will ask that both 
the child and primary caregiver speak English. For the larger trial that will follow, we will 
accommodate Spanish-speaking participants. 
5. For the iAmHealthy behavioral intervention arm, the child and primary caregiver are available 
when the behavioral intervention team offers the intervention for the participating clinic. The 
child and primary caregiver must be available for most of the iAmHealthy behavioral 
intervention sessions when the behavioral intervention psychologist/social worker offers the 
group sessions at the participants’ clinic. The behavioral team will conduct these sessions via 
video conference and families will attend via tablets.  
Adult participants must be primary caregivers of child participants (biological or adoptive parent or legal 
guardian), and adult participants have no inclusion/exclusion criteria other than those stated in Sections 
5.1 and 5.2. Only one adult identified as the primary caregiver will be the official measured participant, 
although any other adults in the household may also attend the sessions. 
Note: There are no inclusion criteria regarding home technology; we will provide all required technology 
devices (including the tablet). The research team will supply participants with tablets equipped with 
cellular data services that can access the Internet even if the household does not have Internet service. 
We provide further information about selecting Internet providers to ensure connectivity in rural areas 
in Section 7.2, subsection Selection of Tablets and Internet Providers. Caregivers will complete the 
technology feasibility questionnaire (see Section 9.1, subsection Other Measures) at 
consent/screening/baseline (as part of the demographics questionnaire, iAmHealthy Demographics 
Form) and at the end of the intervention will assess technology available in homes for this feasibility trial 
and for future dissemination efforts.  
5.2 
EXCLUSION CRITERIA 
We will exclude from the trial an individual who meets any of the following criteria.  
1. Child has a physical limitation or injury that substantially limits physical mobility or has a 
planned medical treatment during the course of the trial that will substantially limit physical 
mobility. Because this trial recommends physical activity, we will exclude children who cannot 
comply with this health behavior.  
2. Child has a known medical issue that could affect protocol compliance (e.g., cancer). If a child 
has a significant medical issue known to the clinic that could affect protocol compliance, we will 
exclude this child, as the protocol involves an intense intervention commitment. 
3. Child and/or primary caregiver has a developmental delay or cognitive impairment that could 
affect protocol compliance. We will exclude primary caregivers and/or children with a known 
developmental delay, as this could negatively affect participation and measurement completion. 
4. Child is enrolled in a weight-loss trial. If a child is enrolled in a weight-loss trial, we will exclude 
the child to avoid cross-pollination of trial interventions.  

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5. Child has a sibling who has already consented in the trial. If multiple children from the same 
family attempt to enroll, the statistical team will randomly select one child for consent. We will 
always allow siblings to attend the intervention, but we will not officially consent them. 
5.3 
LIFESTYLE CONSIDERATIONS 
The iAmHealthy behavioral intervention arm will make a number of health recommendations to 
child/caregiver pairs that include improving healthy eating and diet choices, increasing physical activity, 
decreasing sedentary activity, and improving caregivers’ behavior-management skills. This trial will also 
encourage primary caregivers to spend time reading the AAP newsletter on general child health.  
In the iAmHealthy behavioral intervention arm, primary caregivers will need to participate in the group 
and individual sessions with their child. A culturally competent registered dietician will provide 
individual health coaching sessions to assist child/caregiver pairs with tailoring the general 
recommendations to meet the pairs’ specific religious, ethnic, and/or cultural beliefs and customs. The 
training of the iAmHealthy behavioral intervention teams will ensure a standardized approach (see 
Section 7.4), and the constituents of the groups will influence the discussions, providing content that is 
specific to religious, ethnic, and/or cultural beliefs and customs (see Section 7.2 subsection Individual 
Sessions). 
5.4 
SCREEN FAILURES 
We define screen failures as child/caregiver pairs who consent to screening for the trial but who do not 
meet all of the criteria for participation.  
The information that ECHO ISPCTN site coordinators must record and retain for screen failures includes, 
but is not limited to, demography, screen failure details, and eligibility criteria.  
ECHO ISPCTN site coordinators may rescreen individuals who do not meet the criteria for participation 
in this trial (i.e., screen failure), up to two times, until the end of the recruitment period. If rescreened 
child/caregiver pairs subsequently qualify for the trial, clinic sites should assign them the same 
participant number as at the initial screening. Once the intervention period begins, we will no longer 
allow individuals to rescreen. For the assessment of recruitment options, the individual will be assigned 
to the recruitment option under which the successful consent occurred.  
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
Enrollment Halt 
The iAmHealthy study team halted enrollment on March 13, 2020, due to the coronavirus pandemic, in 
an effort to protect the safety of study participants and personnel. Enrollment will resume when (1) the 
DSMB, NIH, and UAMS IRB approve the proposed changes for remote consent and baseline measures 
and extension of enrollment and baseline periods; and (2) all four sites can participate in remote 
research activities.  
See sections 7.1, subsection Participant Consent/Screening and Baseline Visits for remote consenting 
and baseline measures. 
Recruitment of Clinics 
The ECHO ISPCTN site awardee will identify the primary care clinics selected for participation based on 
previous work and must meet these criteria: 

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• 
The clinic must have previously collaborated with an ECHO ISPCTN site awardee in research or 
quality improvement projects. 
• 
The clinic must have at least 40% of its pediatric patient visits covered by Medicaid.61 
• 
The clinic will qualify if they have seen a minimum of 100 potential participants (rural, 6 to 11 
years of age) who are overweight or obese during the last year: We will recruit four clinics from 
among the participating ECHO ISPCTN site awardees, and we will individually enroll each clinic. 
For clinic qualification, we will assume that 33% of potential participants are overweight or 
obese (see Section 2.2, subsection Pediatric Obesity among Rural Populations).17,19 This means 
that clinics will qualify if they have seen a minimum of 300 children who are rural and 6 to 11 
years of age. We will provide instructions for clinic personnel to assess qualification criteria 
based on one year of patient-visit data. This data will include visit date, birthdate, and zip code. 
We will use zip codes to define rurality by using the zip code RUCA code crosswalk. Our 
instructions will include sending a file containing only zip codes to the research team for 
classification into rural versus not rural based on zip code RUCA code crosswalk (rural is RUCA ≥ 
4, See 5.2 Inclusion Criteria). Clinic personnel perform qualification and research personnel do 
not view protected health information (PHI).   
• 
The clinic must have an electronic medical records system.  
• 
The clinic must have appropriate resources, including private space to consent participants, to 
hold height and weight measurement equipment, and to securely store, in a locked cabinet, 
tablets and activity monitors. The clinic must also have staff to serve as the nurse contact and 
backup person (approximately 10% time). The clinic nurse will not conduct study procedures 
such as data collection. The clinic nurse will only complete the following tasks: (1) provide 
contact information (of potential participants) to the ECHO ISPCTN site personnel, (2) provide 
IRB-approved recruitment materials to potential participants, and (3) collect names of potential 
participants who opt-out of the study. 
We provide additional details on recruiting clinics in the MOP. 
Randomization of Clinics 
The DCOC will sequentially and randomly randomize clinics to the two participant recruitment options 
(see Table 2). The total recruitment period is two months (one month for each recruitment option).  
Table 2. Clinic Randomization to Recruitment Options 
Clinic 
Month 
 
A 
B 
A 
1 
2 
B 
2 
1 
C 
1 
2 
D 
2 
1 
Note: Two clinics will implement each recruitment option during the recruitment months. 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 46 of 94 
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Recruitment of Participants  
For each clinic, the randomized participant goal will be a total of 28. The minimum is 16 participants, 
and the maximum is 32. We determined the upper and lower recruitment limits by the feasibility of 
leading groups via electronic tablet, and our experience suggests that the ideal group size is 8 to 16 
participants. Individual randomization will occur within each clinic, and the DCOC will randomize 
child/caregiver pairs to the iAmHealthy behavioral intervention arm or to the newsletter-only 
intervention arm (see Section 7.3 for more information on randomization).  
We describe a framework for evaluating consent in Primary Outcome Measures (Section 9.1). Figure 2 
(below) provides the potential participant flow diagram for the different recruitment options in each 
clinic. 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 47 of 94 
Protocol Version #13 
Date: 04 March 2021 
 
Figure 2. Potential Participant Flow Diagram 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 48 of 94 
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Date: 04 March 2021 
RECRUITMENT OPTION 1: CONSECUTIVE  
Retrospective. There will be a four-week run-up period where clinical staff with the assistance of ECHO 
ISPCTN site research staff will search their electronic medical records and/or billing software to develop 
a list of patients seen consecutively by clinicians in the last year and who meet the inclusion criteria (see 
Section 5.1). Specifically, clinic staff will provide ECHO ISPCTN site staff with 12 to 24 months of patient-
visit data (e.g., billing records). The site staff will organize this list from more recent clinic visit dates to 
older visit dates. Then, the list will be unduplicated by patient (potential participant list). Because we 
expect that clinics may not be able to easily classify patients as overweight or obese from billing data, 
the ECHO ISPCTN site research staff will group the list into 60 potential participant segments. Then, the 
ECHO ISPCTN site research staff will give the abbreviated list to the clinic staff and ask them to provide 
BMI percentiles within the last year for the potential participants. Once ECHO ISPCTN site research staff 
receive the BMI percentiles, they will begin approaching potential participants, and the clinic staff will 
begin providing BMI percentile for the next 60 most recently seen participants. ECHO ISPCTN site 
research staff will continue to provide abbreviated potential participant lists until enrollment has been 
satisfied. If the clinic staff can produce a list from electronic medical records that shows the BMI 
percentages of potential participants, this back and forth procedure is not required.  
Prospective. From appointment data, each week, clinic staff will send ECHO ISPCTN site research staff a 
list that includes age and zip code of patients who medical personnel will see the coming week. ECHO 
ISPCTN site research staff will revise this list according to rurality and age to identify patients meeting 
inclusion criteria. Site research staff will then return the list to the clinic and ask clinic staff to approach 
patients who meet the inclusion criteria, including BMI percentile, during the patient’s visit.  
Potential participants may contact the ECHO ISPCTN site research staff or the clinic to inquire about the 
iAmHealthy trial while a clinic is implementing recruitment option 1. ECHO ISPCTN site research staff will 
develop a log to capture the self-referrals who inquire about the trial, and they will evaluate these 
potential participants for consent. The log will include how the potential participant learned about the 
study, the contact outcome (consented or not), and reason for not consenting, if applicable (e.g., out of 
age range, non-rural zip code, not overweight or obese, or declined).  
RECRUITMENT OPTION 2: TRADITIONAL 
Clinics will engage in traditional clinical trial recruitment methods focused on participant self-
identification. The DCOC will provide a menu of options from which clinics can choose, such as hanging 
flyers in clinics, distributing flyers at check-in, newsletters, email, or social media, or other means in 
consultation with the DCOC communication team. The DCOC will obtain IRB approval for all recruitment 
materials. These recruitment materials will ask interested parties to contact ECHO ISPCTN site staff. For 
those potential participants who contact the clinic for the information, clinic personnel will provide 
information about the study (see next paragraph). As in recruitment option 1, ECHO ISPCTN site staff will 
develop a log to capture the self-referrals who inquire about the trial. The log will include how the 
potential participant learned about the study, the contact outcome (consent or not), and reason for not 
consenting, if applicable (out of age range, non-rural zip code, not overweight or obese, or declined).  
POTENTIAL PARTICIPANTS WHO CONTACT THE CLINIC 
For both recruitment options, if the caregiver of a potential participant contacts the clinic nurse or 
provider, he or she will provide basic information about the research trial to the caregiver/child pair. The 
clinic nurse or provider may send basic information by mail or email, or the nurse or provider may 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 49 of 94 
Protocol Version #13 
Date: 04 March 2021 
present the information to the caregiver/child pair when they come to the clinic. The informational 
material will include contact information for the ECHO ISPCTN site staff.   
RECRUITMENT GOALS AND MONITORING 
There will be goals for each of the recruitment options. For each clinic, the recruitment goal for both 
options will be 28 participants total or 14 participants per treatment arm. The minimum recruitment for 
each recruitment option is eight participants (16 total), and the maximum for each recruitment option is 
16 participants (32 total). 
During recruitment, the DCOC and trial PIs will hold weekly calls between the ECHO ISPCTN site 
investigator, research staff, and clinic staff. The ECHO ISPCTN research staff affiliated with each clinic will 
present their progress on recruitment and receive supervision on tracking potential participants and 
potential participants approached, and participants consented. During these calls, if one of the clinics in 
a specific recruitment option has not met the minimum target (eight participants) and the other clinic in 
that recruitment option has reached the  goal (14 participants), then we will ask the clinic meeting its 
goal to continue its current recruitment option up to a maximum of 16 participants.  
At the end of recruitment month two, if sites have not met the randomized target (112 participants), we 
will notify all participating ECHO ISPCTN sites during the weekly call. We will extend the recruitment 
window for up to four weeks. If sites successfully recruits 16 participants in recruitment month two, 
sites can continue recruiting in the same recruitment option up to 32 participants without waiting for 
the four-week recruitment extension period. If sites are not successful in recruiting 16 participants, sites 
must continue recruiting in the recruitment option until 16 participants are recruited or the recruitment 
option ends. During the four-week recruitment extension, all sites can recruit participants using the 
recruitment option in which the site was most successful, up to the cap of 32 participants/site.   
Stopping Rule. Our target is 112 randomized participants. At the end of 12 weeks of implementing the 
recruitment options and the baseline period, we will assess the overall recruitment. If we have not 
reached 64 consented and screened-in participants (minimum of eight per each intervention group per 
clinic, and four clinics), then study PIs will recommend stopping the iAmHealthy feasibility trial to the 
DSMB.  
Retention Plans 
Compensation.  Participant families will receive compensation for their time. Sites will prorate this 
compensation based on the months of participation and will dispense compensation during the study.  
Each participant family will receive $20.00 when the site receives the signed informed consent and/or 
assent, if applicable. Participant families will also receive $20.00 for each month they remain in the 
study, during the six-month intervention period. When a participant family completes the post-
intervention measurements, diet recalls, activity monitoring, and returns all study equipment (e.g., 
ActiGraph, tablet computer), the participant family will receive $100. The total possible compensation is 
$240 ($20 [consent] + $120 [$20 each month of intervention period] + $100 [post-intervention activities 
completed and equipment returned]). 
 
 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 50 of 94 
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Date: 04 March 2021 
Additional retention plans. After a participant gives consent, the unblinded coordinators will make 
retention calls approximately monthly to participants using IRB approved scripts. Additional processes to 
aid in retention are described in the following tables. 
Study Timeline 
Consent/Screening, 
Baseline,  
Day 0 
Retention Contact 
After consent/screening 
Thank-you card sent after screening  
 
Touch-point card sent with a message thanking the participant for her or his 
patience during the screening process. The message could be similar to the text 
below.   
 
“Thank you for joining the iAmHealthy study! We appreciate your patience 
while we recruit other participants. Soon, you will receive information from our 
team about setting a time when you can come back to the clinic to measure 
your weight and height.” 
Randomization 
Touch-point card sent with message similar to text below. 
 
Congratulations! You have been placed in the XX (newsletter or electronic 
tablet) group. 
 
Text for newsletter group: In about 4 weeks, you will receive in the mail a 
HealthyChildren.org newsletter. Please read this newsletter or have someone 
read it to you. You should receive a HealthyChildren.org newsletter every 
month for the next 6 months. You will receive a phone call from a member of 
our team who will ask about the newsletter, how you are doing in the study 
and if you have experienced any problems while participating in the study. 
 
Text for electronic tablet group: In the next couple of weeks, you will receive an 
electronic tablet and instructions for getting the tablet ready for use. Please 
follow these instructions and contact the name and number on the instruction 
sheet if you have problems setting up the tablet.  We will also contact you to 
set up the group sessions in which both you and your child will participate, and 
after that, to set up your individualized family health coaching sessions.  
 
You will also receive a phone call from a team member monthly who will ask 
how you are doing in the study and if you have experienced any problems 
while participating in the study. 
 
 
Study Timeline 
Study Activated 
Weeks 1-12 
Retention Contact 
After 1st newsletter sent 
Follow-up card with message similar to text below 
 
Thank you for continuing to participate in the iAmHealthy! We’re glad to have 
you in our study. Keep up the good work. 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 51 of 94 
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Weeks 1-4 
Feedback phone call question for caregiver at time of call about AEs/SAEs1 
After 2nd newsletter sent 
Follow-up card with message similar to text below 
 
Thank you for making our study a success. All of your hard work is helping us 
learn more about ways to improve health, and we will use this to help other 
families like yours. Thank you for contributing to the future and for building a 
healthy foundation for your family. 
Weeks 5-8 
Feedback phone call question for caregiver at time of call about AEs/SAEs1  
After 3rd newsletter sent 
Follow-up card with message similar to text below 
 
Congratulations! You’ve made it half way. We’re so proud of you for sticking 
with it! (refrigerator magnet included with card) 
Weeks 9-12 
Feedback phone call question for caregiver at time of call about AEs/SAEs1  
1 This table is for retention materials.  For schedule for AE/SAE calls, see sub-section “Time Period and 
Frequency for Event Assessment and Follow-Up” within section 9.2, Adverse Events/Serious Adverse 
Events. 
Study Timeline 
Weeks 13-24 
Retention Contact 
After 4th newsletter sent 
Follow-up card with message similar to text below 
 
Hi There! Keep up the good work in the iAmHealthy study. We’re rooting for 
you! 
Weeks 13-16 
Feedback phone call question for caregiver at time of call about AEs/SAEs1  
After 5th newsletter sent 
Follow-up card with message similar to text below 
 
Attention VIP (Very Important Participant)! Thanks for choosing to be healthy. 
Keep up the good work! 
Weeks 17-20 
Feedback phone call question for caregiver at time of call about AEs/SAEs1 
After 6th newsletter sent 
Follow-up card with message similar to text below 
 
You’ve almost made it! The iAmHealthy study only has a few weeks to go. 
Don’t lose steam in the last few weeks. Thanks for all you do! 
Weeks 21-24 
Feedback phone call question for caregiver at time of call about AEs/SAEs1 
After post-intervention 
measurements complete 
Touch-point card sent with message similar to text below.  
 
Congratulations!! You’ve graduated from the iAmHealthy study. We’re very 
proud of you! You’ll find your iAmHealthy diploma in this package. Thank you 
again for participating in this study. The knowledge we’ve gained wouldn’t be 
possible without you. 
1 This table is for retention materials.  For schedule for AE/SAE calls, see sub-section “Time Period and 
Frequency for Event Assessment and Follow-Up” within section 9.2, Adverse Events/Serious Adverse 
Events. 
Tracking Retention Plans 
Thank-You Cards. The unblinded coordinator will send thank-you cards to participants and caregivers. 
The unblinded coordinator will track to whom he or she mailed the cards, as well as the mailing and 
delivery date. The unblinded coordinator will mail thank-you cards to participants and caregivers, as 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 52 of 94 
Protocol Version #13 
Date: 04 March 2021 
close as possible to the schedule outlined in the Retention Plans subsection above, to keep participants 
and caregivers engaged while waiting for randomization and intervention.  
Touch-point Cards. The unblinded coordinator will USPS mail or FedEx (or use a suitable substitute) 
touch-point cards to participants and caregivers, as close as possible to the schedule outlined in the 
Retention Plans subsection, above. The unblinded coordinator will record the date he or she mailed the 
card and track any responses from the participant or caregiver. The unblinded coordinator will record 
responses the participant or caregiver may have to the cards, and the ECHO ISPCTN site coordinator or 
designee, as applicable, will record any response the participant or caregiver has to the cards, if 
applicable.  
6 
TRAINING 
To ensure participant safety and consistent and high-quality data submission in compliance with 
protocol and study operations, the DCOC and iAmHealthy study team will train ECHO ISPCTN site study 
staff and behavioral intervention team members. The DCOC expects all ECHO ISPCTN site study staff and 
behavioral intervention team members to take responsibility for learning the iAmHealthy study, 
primarily by studying the protocol and MOP, to ensure compliance with the protocol and GCP. The ECHO 
ISPCTN site study staff will receive training through the following methods: a mandatory training session 
in the form of an Investigator Meeting, one-on-one ECHO ISPCTN site-specific training, and other 
targeted training as needed. Dr. Ann Davis will host mandatory training for the behavioral intervention 
team on the iAmHealthy behavioral intervention.  
DCOC personnel will train all ECHO ISPCTN site study staff, unblinded coordinators, and behavioral 
intervention team members on the protocol, reporting procedures for study deviations, potential study 
deviations, and noncompliance, as well as essential documentation for study conduct. The DCOC will 
train ECHO ISPCTN site study staff on in-person and teleconsent informed consent processes and 
documentation. The DCOC will train all ECHO ISPCTN site coordinators, investigators, and backups in 
standard in-person research anthropometric measurement techniques based upon World Health 
Organization procedures for assessing height and weight.62 Previous data indicate that staff trained in 
these techniques have 95% reliability with an expert in their fidelity to the measurement protocol. The 
DCOC will also train all ECHO ISPCTN site coordinators, backups, and investigators in coaching 
participants in taking remote height and weight measurements, according to the instructions in the 
MOP. This training will include how to instruct participants on taking their own height and weight 
measurements.  
ECHO ISPCTN site study staff and behavioral intervention team members must document all training and 
provide the DCOC with this training documentation. The DCOC will train the behavioral intervention 
team on identifying severe adverse events (AEs) and serious adverse events (SAEs) and if these events 
occur to refer the participant to his or her primary care physician and to inform the unblinded ECHO 
ISPCTN coordinator. 
The DCOC will train ECHO ISPCTN site study staff and behavioral intervention team members on any 
relevant study electronic data capture (EDC) system(s) to ensure that staff understand how to utilize the 
system to perform study-specific data collection and other necessary processes.  
6.1 
HEIGHT AND WEIGHT INTER-RATER RELIABILITY 
If not previously completed and when social distancing measures have been decreased or eliminated, 
blinded ECHO ISPCTN site coordinators will measure height and weight for three people at her or his 
site, using the instructions provided in the MOP. The backup-blinded assessor will re-measure height 
and weight for the same three people, as a measure of inter-rater reliability. At each re-measurement, if 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 53 of 94 
Protocol Version #13 
Date: 04 March 2021 
the difference between initial and re-measured height and weight measurement is more than 5% 
(difference = [Initial – re measured]/Initial x 100), then the study team will retrain both assessors before 
starting/restarting the consent process. 
Please see the MOP for remote height and weight measurement inter-rater reliability instructions.  
6.2 CLINICAL HELPLINE AND EMAIL 
If needed, ECHO ISPCTN site coordinator or investigator can call the iAmHealthy clinical help line to 
speak with the feasibility PI (Paul Darden, MD) or the content expert and PI (Ann Davis, PhD) regarding 
specific protocol questions. We will provide this phone number and a study-specific email address in the 
MOP.  
7 
STUDY INTERVENTION 
7.1 
CONSENT, SCREENING, BASELINE, AND POST-INTERVENTION  
As outlined above, each of the four clinics will use two randomly assigned recruitment options (see 
Table 2). See Section 5.5, subsection Recruitment of Participants, for more information about the staff 
procedures during this part of the feasibility study. After identification of potential participants, the 
ECHO ISPCTN site coordinator and/or site investigator will schedule a visit, telephone call, or video chat 
to begin the consent process (see Section 1.3).  
Consent/Assent and Other Informational Documents Provided to Participants 
IN-PERSON CONSENT 
Once a potential participant has agreed, ECHO ISPCTN site coordinators or research-trained designee 
will coordinate with clinic staff to schedule a series of days for consent/screening and baseline visits for 
the primary caregiver/child pair. If a potential participant is identified during a regular clinic visit that 
coincides with previously scheduled consent/screening or baseline visits, the ECHO ISPCTN site 
coordinator or a research-trained designee (from the ECHO ISPCTN site) will conduct these 
consent/screening/baseline activities during that visit; otherwise, the clinic nurse will schedule the 
potential participant for a consent/screening/baseline visit. ECHO ISPCTN site coordinators or research-
trained designee will verify eligibility and conduct the consent/assent process.  
TELECONSENT 
Once ECHO ISPCTN site coordinator or research-trained designee assesses eligibility criteria, they will 
contact the potential participant to describe the study. If the participant can complete the 
consent/assent and/or screening processes at that time, the ECHO ISPCTN site coordinator or research-
trained designee will conduct these procedures. If the participant cannot conduct these procedures at 
that time, the ECHO ISPCTN site coordinator or research-trained designee will schedule an appointment 
to conduct these procedures via teleconsent/assent and internet for screening procedures.  
If a potential participant is identified during a regular clinic or telemedicine visit, the clinic nurse can 
give, fax, or email the participant iAmHealthy study information (e.g., study pamphlet) and can give, fax, 
or email the participant contact information to the ECHO ISPCTN staff. ECHO ISPCTN staff may contact 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 54 of 94 
Protocol Version #13 
Date: 04 March 2021 
the potential participant to describe the study and, if participant agrees, complete the consent/assent 
process, including verifying eligibility. 
 
INFORMED CONSENT PROCESS 
ECHO ISPCTN site coordinators or research-trained designee will provide (e.g., hand deliver, postal mail, 
email, fax, REDCap, or electronic platform) participants consent forms describing in detail the trial 
intervention, trial procedures (including that study personnel will access participants’ medical records, 
alternative contact information [as described in Participant Discontinuation/Withdrawal from the 
Study], and record group sessions), and risks. We will require written documentation of the informed 
consent prior to starting or administering the intervention. We will submit the informed consent and 
assent forms with this protocol. 
Informed consent is a process that starts before a participant agrees to participate in the trial and 
continues throughout the individual’s trial participation. For this trial, participants include one primary 
caregiver plus one child. Children meeting the reviewing IRB’s requirements for signing an assent will 
sign the assent form. The IRB will approve consent and assent forms, and ECHO ISPCTN site coordinators 
or research-trained designee will ask participants to read and review the document(s). Via 
telecommunication or in person, the ECHO ISPCTN site coordinators or research-trained designee will 
explain the research trial to the participant(s) in terms the participant(s) can understand and answer any 
questions that may arise. The explanation will state the purposes, procedures, and potential risks of the 
trial and describe participants’ rights as research participants. Participants will have the opportunity to 
carefully review the consent form and ask questions before signing. The ECHO ISPCTN site coordinator 
or research-trained designee will give participants the opportunity to discuss the trial with their family 
or surrogates or think about participating in the trial prior to agreeing to participate. The primary 
caregiver, and child, if applicable, can do any of the following to indicate consent/assent to the study: 
1 
Sign the form and hand it back to the ECHO ISPCTN site investigator or coordinator  
2 
Sign the form and postal mail it back to the ECHO ISPCTN site investigator or 
coordinator; 
3 
print, sign, scan, and electronically or fax return to the ECHO ISPCTN site investigator or 
coordinator; 
4 
print, sign, photograph the signature page, and text or email a picture of the signature 
page to the ECHO ISPCTN site investigator or coordinator; 
5 
type the signature and date into the electronic version of the consent document, save, 
and electronically return to the ECHO ISPCTN site investigator or coordinator with a 
note stating that this is the legal authorized representative’s electronic signature. If this 
method is used ECHO ISPCTN site investigators or coordinators will confirm the returned 
consent/assent forms contain the same text as the consent/assent forms sent to the 
participant; 
6 
have the participant send a well-worded email back to the ECHO ISPCTN investigator or 
coordinator that states the name of the study, that the participant has read and 
discussed the consent document (and assent document, if applicable), and that the 
participant gives consent to participate. 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 55 of 94 
Protocol Version #13 
Date: 04 March 2021 
Any of the above will be completed prior to any trial-specific procedures.  
The ECHO ISPCTN site coordinator or a research-trained authorized designee will inform participants 
that participation is voluntary, that they may withdraw from the trial at any time without prejudice, and 
that nonparticipation will not adversely affect their medical care if they decline to participate in the trial. 
The ECHO ISPCTN site coordinator or research-trained authorized designee will ask the participant to 
keep a signed copy of the consent and assent forms for her or his record. Please see the iAmHealthy 
MOP for instructions.   
ASSENT PROCESS  
Assent is a process for children who have not reached the age of majority, but are old enough to 
understand, in general, the proposed research, its expected risks and possible benefits, and the activities 
expected of them as participants. The age at which participants must give assent is dependent on the 
IRB of record and any local site requirements for relying sites. UAMS IRB will be the IRB of record, and 
the age of assent is seven years old. All children who are seven years old or older must agree to be 
participants in the trial. Simply not disagreeing to participate does NOT constitute assent. Assent 
requires an expression of willingness to participate in research. 
ECHO ISPCTN site coordinators or a research-trained authorized designee will conduct the informed 
consent process, as well as the child’s assent process, via telecommunication or in person. They will 
document the processes in the source documents. Consent and assent documentation will include, at a 
minimum: 
(1) the title of the trial, 
(2) the date the participant entered into the trial, 
(3) the name of the clinic physician or primary physician 
(4) the name of the ECHO ISPCTN site investigator, 
(5) the name of the person(s) obtaining the informed consent and assent, and 
(6) a statement that the participant or legally authorized representative received a copy of the 
signed form. 
The DCOC strongly recommends the following additional documentation, but it is not required: 
(1) a description of how the consent/assent process occurred, including how the consent/assent 
form was transmitted and signed   
(2) a list of who else was present during the process, 
(3) a description of the type of questions asked by the participant, 
(4) a list of witnesses and what they witnessed 
(5) a summary of details that demonstrate the participant understood the information, and 
(6) a description other specific details related to that case.  
Screening and Baseline 
For participants consented and screened before the enrollment pause, sites will take baseline 
measurements during the baseline period. Baseline measurements consist of height and weight 
measurements for the child and primary caregiver participants. 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 56 of 94 
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Date: 04 March 2021 
For participants consented after the enrollment pause, sites will conduct screening measurements 
during the consent/screening period. If sites cannot take screening measures during the 
consent/screening period, sites may take these measurements during the baseline period. Screening 
measurements consist of height and weight measurements for the child participant.   
SCREENING  
Screening will occur after consent and will include the process of confirming the participant meets all of 
the inclusion criteria and none of the exclusion criteria. The screening process will include height and 
weight measurements of the child participant to verify the participant qualifies for the study. The ECHO 
ISPCTN site coordinator or staff member will coach the participant, via telecommunications, in taking 
height and weight measurements at their home or where the participant is sheltering in place, or the 
ECHO ISPCTN site coordinator or staff member will take the height and weight measurements in person 
in the clinic. If the participants are taking measurements themselves, the ECHO ISPCTN site 
coordinators/investigators will watch via mobile device/computer camera. If the participant does not 
have Internet access, the KUCTT will loan the participant a tablet. These will be the same tablets 
described in Section 7.3, subsections Acquisition and Preparation of Tablets and Selection of Tablets and 
Internet Providers. Participants will receive instructions on how to take measurements, and the ECHO 
ISPCTN site coordinator/investigator will coach the participant in taking these measurements. ECHO 
ISPCTN study personnel will instruct participants to take measurements after voiding, in light clothing, 
and without shoes. Please see the iAmHealthy MOP for specific instructions on height and weight 
measurements.  
Participants will take height and weight measurements on provided standardized equipment. The 
participant will tell the ECHO ISPCTN coordinator/investigator the measurement results, and the 
coordinator/investigator will enter these measurements on the appropriate CRFs. The ECHO ISPCTN site 
coordinator or staff member will mail or ship participants the scale and tape measure listed below or 
suitable replacements, approved by the iAmHealthy leadership team. Please see the iAmHealthy MOP 
for a complete list of equipment. If the participant qualifies for the study, the participant will keep the 
equipment. If the participant does not qualify for the study, the participant will return the equipment in 
postage-paid box that the ECHO ISPCTN site coordinator or staff member will provide.  
• 
Etekcity Digital Body Weight Bathroom Scale With Step-On Technology (model number 
025706343039) 
• 
Amazon Basics Tape Measure (model number DS-TAM10-16ft) 
If measurements are taken in the clinic, ECHO ISPCTN study staff will use the standardized equipment 
described in the MOP.  
These measurements will not be the baseline measurements. Baseline measurements will occur at a 
separate time (see Baseline subsection).  
ActiGraph Activity Monitor and Diet Recall. The ECHO ISPCTN site coordinator will provide participants 
with the activity monitor and instructions and information regarding how to schedule the 24-hour food 
recalls (see Section 9.1, subsection Secondary Outcome Measures) and instructions for completing the 
food recalls. Participants will complete one consent/screening/baseline three-day 24-hour food recall. 
The ECHO ISPCTN staff can postal mail or email the iAmHealthy Demographics Form (see Section 9.1, 
subsection Other Measures), link to the primary caregiver, or can ask the primary caregiver the 
questions via telecommunications and write the answers on the Demographics Form. This form must be 
completed before randomization. ECHO ISPCTN site awardee or clinic staff can obtain participant 
contact information to send the primary caregiver a link to the demographics questionnaire.  

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
Page 57 of 94 
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Date: 04 March 2021 
BASELINE MEASUREMENTS  
Baseline measurements will occur after the enrollment period ends and will end before randomization. 
Baseline measurements will include height and weight measurements of the child and primary 
caregiver. An ECHO ISPCTN site staff member will either virtually coach participants in taking their own 
height and weight measurements or will take height and weight measurement in person. These 
measurements will be taken in triplicate, when feasible. The process for taking baseline measurements 
will be the same as the process for taking screening measurements. Please see the iAmHealthy MOP for 
baseline procedures instructions.  
Post-intervention Measurements 
For post-intervention measurements, ECHO ISPCTN site coordinators/investigators will take remote 
height and weight measurements in parallel with clinic-site height and weight measurements. However, 
if a participant cannot come to the clinic site, the participant can complete the post-intervention 
measurements following the same procedures for baseline measurements.  
For clinic site post-intervention measurements, the ECHO ISPCTN site coordinator/investigator will use 
provided standardized equipment. 
During the post-intervention measurements and if the equipment is used for screening or baseline 
measurements, the ECHO ISPCTN site coordinator will weekly assess all equipment for reliability, and he 
or she will conduct an accuracy check on equipment during post-intervention, and throughout the study, 
as necessary. The ECHO ISPCTN site coordinator will take all measures in triplicate, and the ECHO ISPCTN 
site coordinator will weigh the child and caregiver after they void and only in light clothing and no shoes.  
Participants will also complete activity monitoring and dietary recalls at post-intervention. ECHO ISPCTN 
study personnel will follow the same process as outline in the Screening subsection. 
7.2 
RANDOMIZATION 
Randomization will occur after completion of the following measures. 
1. Demographics form: completion of the child’s age and gender 
2. Height Weight Form Baseline/Follow-up: 1 child height and weight and 1 parent height and 
weight 
3. Diet Recall- NDSR form: 1 day of dietary recall completion 
After randomization, the unblinded ECHO ISPCTN coordinator will notify child/caregiver pairs about the 
intervention assignment and will encourage continued participation. The ECHO ISPCTN site coordinator 
and a backup ECHO ISPCTN site staff member will remain blinded to intervention assignment and will 
perform outcome assessments.  
7.3 
ADMINISTRATION OF FEASIBILITY STUDY INTERVENTION  
This section details the content and administration of the interventions in this trial. Please note that the 
ECHO ISPCTN site coordinator and the ECHO ISPCTN backup site staff member will remain blinded to 
intervention assignment.  

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Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
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Newsletter Intervention (Both Arms) 
All child/caregiver pairs participating in the trial—in both the iAmHealthy behavioral intervention arm 
and the newsletter-only intervention arm—will receive one newsletter per month for months one 
through six. See Appendix A for a sample of the newsletter that we will use. 
DESCRIPTION OF NEWSLETTER INTERVENTION 
All newsletters used in the trial will be from the website HealthyChildren.org, a website developed and 
maintained by the AAP. The AAP publishes two newsletters per month that focus on child health topics, 
such as back-to-school illness, injury prevention, and antibiotic use. You can find the entire archive of 
AAP Healthy Children newsletters at: https://www.healthychildren.org/English/tips-
tools/newsletters/Pages/default.aspx. 
The AAP writes the newsletter at a fourth-grade reading level and designs it for the whole family. The 
intention is that the primary caregiver and child, if able, will read the newsletter and share/discuss 
relevant content with the child in the home. 
ADMINISTRATION OF NEWSLETTER INTERVENTION 
The unblinded ECHO ISPCTN site coordinator will send the newsletter each month to child/caregiver 
pairs. The unblinded ECHO ISPCTN coordinators can ship the newsletters via FedEx (or suitable 
replacement), or the unblinded ECHO ISPCTN coordinators can mail the newsletters via priority mail 
with the US Post Office, which includes tracking services. 
See Section 7.4 for information regarding intervention compliance.  
iAmHealthy Behavioral Intervention 
In addition to the newsletter intervention, the child/caregiver pairs in the iAmHealthy behavioral 
intervention arm will receive the iAmHealthy behavioral intervention that includes the group and 
individual sessions. 
Each clinic will have its own iAmHealthy behavioral intervention team that will include a fully licensed 
psychologist (PhD or MA) or a licensed clinical social worker with experience in weight management. 
These individuals will be responsible for delivering the group sessions.  
Each iAmHealthy behavioral intervention team will also include a registered dietician, who will be 
responsible for delivering the individual sessions and co-facilitating the group sessions (see Section 7.2, 
subsections Individual Sessions and Group Sessions). 
DESCRIPTION OF THE IAMHEALTHY BEHAVIORAL INTERVENTION 
All participants randomized to the iAmHealthy behavioral intervention arm will receive this intervention, 
composed of a previously developed, participant tailored, telemedicine intervention that is family based 
and provides information on the following behavioral, nutritional, and physical activity topics.19,59,63,64 
• 
Goal setting and sticker charts 
• 
Reading food labels  
• 
Stop Light Diet 
• 
Energy balance 
• 
Primary caregiver health behavior 
changes 
• 
Use of privileges (trip to library, family 
walk) 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#: 249932 
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• 
Decreasing sedentary activity and 
increasing physical activity for 
caregivers and children 
• 
Self-esteem 
• 
Family exercise ideas 
• 
Cooking with a limited budget 
• 
Praising and ignoring 
• 
Making healthy choices 
• 
Parties, barbeques, and eating out 
• 
Monitoring screen time 
• 
Nutrient density 
• 
Portion sizes 
• 
Healthy foods in the home 
The iAmHealthy behavioral intervention content is founded on cognitive behavioral theory65 and child 
weight theory of Davison and Birch.66 The topics of the iAmHealthy behavioral intervention include all 
child and caregiver behaviors/characteristics from child weight theory67 and those identified as key in 
previous qualitative research with rural parents.64 The iAmHealthy behavioral intervention builds on 
previous research by delivering this intervention to families in their homes (see Section 4.3 for a detailed 
description of the significance and innovation of this intervention).  
The iAmHealthy behavioral intervention is composed of 26 contact hours: 15 hours of group sessions 
and 11 hours of individual sessions (see Section 4.1). 
CONTENT OF IAMHEALTHY BEHAVIORAL INTERVENTION 
The content of the iAmHealthy behavioral intervention focuses on behavioral, nutritional, and exercise 
topics and contains both activities and didactic lessons. These topics are discussed at the individual, 
family, and community level, allowing families to discuss barriers and facilitators unique to their rural 
communities and to develop social connectivity among participants. Topics covered include the 
following: 
• 
Decreased focus on fast food/junk food 
• 
Increased focus on healthy eating at social gatherings 
• 
Increased information on exercise activities for children that can be done alone (due to poor 
proximity to neighbors, etc.)  
• 
Resources and support available in the community 
• 
Increased attention to self-esteem 
The behaviorial intervention team will make dietary and physical activity recommendations to the 
child/caregiver pairs during the group (see Section 7.2, subsection Group Sessions) and individual 
sessions (see Section 7.2, subsection Individual Sessions). Child/caregiver pairs will be taught meal 
preparation and exercise ideas as part of the intervention. Each iAmHealthy behavioral intervention 
team will refer child/caregiver pairs to tools that are available online, and the group sessions will allow 
child/caregiver pairs to share tools and activities available in their communities. 
ADMINISTRATION OF THE IAMHEALTHY BEHAVIORAL INTERVENTION 
The iAmHealthy behavioral intervention teams will work with the participating child/caregiver pairs to 
deliver the iAmHealthy behavioral intervention using video conference and a tablet computer.  
Both members of the behavioral intervention team will be experienced in pediatric obesity intervention 
work and will receive additional training specific to the iAmHealthy behavioral intervention. Both 
behavioral intervention team members will follow the iAmHealthy intervention manual and will receive 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
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four to eight hours of training with Dr. Davis, PI, prior to the start of their intervention groups. This 
training will focus on proper delivery of the treatment groups via video conference. Treatment sessions 
will focus on making the groups fun and getting caregivers and children interacting and involved during 
the sessions. 
We will centrally engage and hire behavioral interventionists and assign them to cohorts based upon a 
variety of factors, including familiarity with the population and coordination of availability. This central 
model of behavioral intervention team engagement greatly increases feasibility and efficiency of the 
iAmHealthy behavioral intervention. Of note, we have engaged the appropriate number of experienced, 
ethnically appropriate interventionists for implementation of the current proposed trial.  
For more information regarding trial intervention compliance, see Section 7.4. 
GROUP SESSIONS  
The iAmHealthy behavioral intervention period is six months. This includes weekly group sessions for the 
first three months, followed by monthly group sessions for three months (Table 3 and Schedule of 
Activities, Section 1.3). Each child/caregiver pair consented from the same clinic will attend each group 
session. 
The iAmHealthy behavioral intervention 
psychologist/social worker and dietician will 
deliver one-hour group sessions via video 
conferencing technology on the tablet to 
child/caregiver pairs at times convenient 
for the child/caregiver pairs within the 
group (typically evenings and weekends). 
Previous work using these modalities shows feasibility for finding one hour during the week (evening or 
weekend) that accomodates all participating child/caregiver pairs.59,63 If participating child/caregiver pair 
miss a group session, the pair will receive a makeup phone call from the behavioral intervention 
dietician. The dietician will review all content that was covered in the missed group session. (see Section 
8.2 for information on participant discontinuation and/or withdrawal). This makeup session will count as 
a regularly attended session, and the dietician will document the attendance and contents covered in 
the makeup session. 
Each session will begin with a review of progress since the last meeting and will end with primary 
caregivers and children setting goals. Primary caregivers and children will work together throughout 
each session, and both must be present for the entire meeting.  
INDIVIDUAL SESSIONS 
The iAmHealthy behavioral intervention also includes 11 hours of individual sessions (or “homework”) 
for each participating child/caregiver pair that the pair must complete during the six months of the trial. 
The iAmHealthy behavioral intervention dietician will flexibly schedule the individual sessions and the 
content will be the same as outlined above. Based on individual pace, the homework time may exceed 
11 hours.  
We will preload the individual session assignments onto the tablet and each child/caregiver pair will 
complete the session with the iAmHealthy behavioral intervention dietician. For example, after the 
Week 3 Stop Light Diet lesson, the iAmHealthy behavioral intervention dietician will ask child/caregiver 
pairs to identify all of the food items in their cabinets/refrigerators as “red,” “yellow,” or “green” by 
using stickers mailed to the participant prior to this lesson. “Red” foods are food items with ≥7 grams of 
Table 3. Intervention Timeline 
 

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in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
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fat and/or ≥12 grams of sugar per serving. The iAmHealthy behavioral intervention dietician will 
encourage child/caregiver pairs to eat fewer “red” food items and more “green” food items (fruits and 
vegetables with nothing added) and to eat “yellow” food items (foods that are not green but do not 
meet the threshold for “red”) in moderation. The iAmHealthy behavioral intervention dietician will be 
able to help each individual child/caregiver pair complete this homework activity through the video 
conferencing technology, actually looking into the child/caregiver pair’s cabinets with them and helping 
them to appropriately categorize foods according to their labels. 
The culturally competent registered dietician will work with each child/caregiver pair during the 
individual sessions to tailor any content to their family, ethnic, or cultural beliefs, and/or their 
community, as needed. Examples might include how to exercise in religious garments or how to cook 
without meat. The iAmHealthy behavioral intervention dietician and child/caregiver pairs will discuss 
common behavioral concepts (e.g., goal setting, problem solving, reinforcement, and tracking) in their 
individual sessions, and iAmHealthy behavioral intervention psychologist/social worker will also teach 
these same concepts in the group sessions.  
We have tailored all materials to the targeted age group in this intervention. The goal is that the child 
and caregiver will complete these assignments together, with the help of the iAmHealthy behavioral 
intervention dietician. If a child/caregiver pair misses an individual session, it will be rescheduled at a 
more convenient time. 
Acquisition and Preparation of Tablets 
The KUCTT will purchase and format tablets for the trial. Once KUCTT properly formats the tablets, 
KUCTT will ship two tablets to each ECHO ISPCTN site for the ECHO ISPCTN site coordinators to use 
during consent/screening/baseline measures and during the post-intervention measures. KUCTT will 
also ship the appropriate number of tablets (one tablet for each family in the iAmHealthy behavioral 
intervention arm) to the ECHO ISPCTN unblinded coordinator, who will distribute them to the 
appropriate child/caregiver pairs. If a participating child/caregiver pair loses the tablet or if a tablet 
breaks or malfunctions, KUCTT or the DCOC will replace it. 
The iAmHealthy behavioral intervention team will not receive tablets. They will connect to the group 
and individual sessions through their computer or mobile device.   
KUCTT will format the tablets to ensure that no PHI is stored on the tablet. KUCTT will preload the 
tablets with the intervention manual, the video conferencing software, recommended applications, and 
other trial-related educational materials.  
Once the intervention period is complete, ECHO ISPCTN site coordinators will instruct participants to 
return the tablets to KUCTT via the prepaid shipping materials that participants will receive with the 
tablet. All tablets will be “cleaned” of information after the trial, and they will be available for future 
ECHO ISPCTN needs. The KUCTT technology team has proven strategies for tablet retrieval and tracking 
that it has used in several other NIH-funded protocols. 
Selection of Tablets and Internet Providers 
The technology team will select tablets that include the most efficient technology and functionality for 
this trial-related software, as well as a strong case with a stand feature for the tablet. The technology 
team will load the tablets with fully functional unlimited cellular data plans, selected by the technology 
team to be the optimal provider for the use area. 

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Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
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The technology team will select Internet providers based on high-quality coverage in the specific region 
where participants live. In past studies, the technology team has obtained high-quality video 
conferencing streaming service in 24 rural areas. If child/caregiver pairs encounter difficulties, as a back-
up plan, they will be able to call into the meeting via a toll-free telephone number. Additionally, 
technical support will be available, via one-on-one teleconference or telephone call.  
Tablet Delivery and Storage 
Once tablets are prepared, KUCTT will ship them to the unblinded ECHO ISPCTN coordinators, who will 
store them in a locked cabinet until shipped to the participants in the iAmHealthy behavioral 
intervention arm. The unblinded ECHO ISPCTN coordinators will be responsible for tracking tablets via a 
paper log and for contacting the KUCTT team if any equipment or usage problems arise.  
7.4 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
ECHO ISPCTN site awardees will recruit clinics, and each of those clinics will randomize up to 32 
child/caregiver pairs. Once pairs complete the consent/assent (if appropriate) processes and all baseline 
assessments, the ECHO ISPCTN site coordinator will note this in the EDC. Once all pairs complete the 
consent/assent processes and baseline assessments, the DCOC will randomize participants. The DCOC 
will randomize all child/caregiver pairs into the interventions at one time. The DCOC will inform the 
unblinded ECHO ISPCTN coordinator of the intervention assignments, who will notify child/caregiver 
pairs and distribute tablets as necessary. 
The ECHO ISPCTN site coordinator will remain blinded and serve as the blinded assessor. The ECHO 
ISPCTN site investigator will also designate a research-trained blinded backup coordinator from the 
ECHO ISPCTN site. The blinded coordinators will not have access to clinic charts. The unblinded ECHO 
ISPCTN coordinator will ask participants and their caregiver not to disclose their intervention assignment 
to or discuss previous weights with the blinded ECHO ISPCTN site coordinator. The blinded ECHO ISPCTN 
site coordinator, or the designated backup, will take the height and weight measurements at 
consent/screening/baseline and post-intervention, and the study team will use these measurements to 
evaluate the secondary endpoints. In case the ECHO ISPCTN site coordinator is accidentally unblinded, 
the backup assessor will take over all assessments for that participant.  
At each measurement time point, the blinded assessor will enter data into the EDC system for that time 
point. A member of the Kansas dietetics and nutrition team will perform the 24-hour food recalls at 
consent/screening/baseline and post-intervention. 
Table 4. Blinded and Unblinded Personnel 
Blinded 
Unblinded 
ECHO ISPCTN Site coordinator 
Clinic nurse 
Backup site staff member 
Clinic provider 
ECHO ISPCTN site investigator 
iAmHealthy intervention team 
Medical monitor* 
Statistician 
Dietetics and nutrition team 
Unblinded ECHO ISPCTN coordinator 
*Can be unblinded for safety reasons 
 
7.5 
STUDY INTERVENTION COMPLIANCE 
The iAmHealthy behavioral intervention psychologist/social worker will be responsible for delivering the 
group sessions with assistance from the dietician, and the iAmHealthy behavioral intervention dietician 
will be responsible for delivering the individual sessions for the iAmHealthy behavioral intervention arm 

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Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
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(see Sections 7.2, subsection Administration of the iAmHealthy Behavioral Intervention). To ensure 
compliance, we will assess fidelity to the group and individual sessions of the iAmHealthy behavioral 
intervention through fidelity checklists that each iAmHealthy behavioral intervention team leader will 
keep. The iAmHealthy behavioral intervention team will use fidelity checklists during iAmHealthy 
behavioral interventions to ensure that they cover the appropriate topics. The developed checklists 
include 6 to 10 major topics for each group session, and the iAmHealthy behavioral intervention team 
member will check off each topic as he or she covers it during the session. At the end of the session, a 
member of the iAmHealthy behavioral intervention team will record attendance and topics covered 
using an EDC system.  
The iAmHealthy behavioral intervention teams will receive weekly supervision from a licensed clinical 
psychologist (i.e., supervising psychologist) who has experience delivering pediatric obesity intervention 
programs. The supervising psychologist will review digital video recordings of group sessions and 
provide feedback to the intervention teams. If participants divulge any unanticipated psychological or 
medical issues, these team supervision meetings will allow for general clinical supervision.  
The supervising psychologist will review 25% of all sessions and compare them to the developed fidelity 
checklists. To assess for reliability, a second independent coder (an alternate supervising psychologist) 
will code 50% of the already coded sessions by using the same fidelity checklist. 
In addition, the iAmHealthy behavioral intervention teams will participate in a weekly meeting with 
Dr. Ann Davis, PI, to discuss fidelity findings and to retrain as necessary.  
We will assess fidelity to the newsletter intervention on a post-trial questionnaire (see Section 9.1, 
subsection Other Measures) in which study personnel will ask caregivers about the amount of time they 
spent reading each newsletter. 
7.6 
CONCOMITANT THERAPY 
We will allow child/caregiver pairs to continue any concomitant medications or therapies for which they 
are receiving treatment.  
A post-trial questionnaire (see Section 9.1, subsection Other Measures) will ask child/caregiver pairs 
about concomitant therapies they used during the intervention period. 
8 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
8.1 
DISCONTINUATION OF STUDY INTERVENTION 
Since this is a behavioral intervention trial, the trial team does not expect any intervention-related 
safety events causing the investigator, the medical monitor, the Data Safety Monitoring Board (DSMB), 
or the IRB to suspend or stop the trial. However, there could be events related to emotional distress 
from answering questions regarding nutrition and physical activity.  
If a child or caregiver within any clinic has an intervention-related SAE (see Section 9.2), the ECHO 
ISPCTN site team will review or modify the trial, with input from the DSMB, assessing impact on risk. 
Consented child/caregiver pairs will continue all remaining trial measurement procedures, as indicated 
in the trial protocol. If ECHO ISPCTN site awardees or clinic sites identify a clinically significant finding 
after the intervention period begins, the ECHO ISPCTN site investigator or qualified designee will 
determine if the site needs to change any aspect of participant management. We will report any new 
clinically significant finding as a severe AE. 

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in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
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The ECHO ISPCTN site investigator will determine if a severe AE or SAE is clinically significant, with input 
from the DSMB and/or medical monitor, as appropriate. If a severe AE or SAE is a clinically significant 
event, we will specifically monitor for this event, as specified in the MOP, (as well as any event for which 
the child seeks additional medical care [e.g., emergency department visits or hospitalizations]). Please 
see the MOP for the definition of clinically significant. 
8.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
A child/caregiver pair may withdraw from the trial at her or his own request, or the primary caregiver, 
site investigator, DSMB, and/or DCOC can withdraw a child/caregiver. If a child/caregiver pair withdraws 
from the study, ECHO ISPCTN site coordinators, investigators, or unblinded ECHO ISPCTN coordinators 
can ask the child/caregiver pair why they chose to withdraw. The pair can choose not to answer this 
question. Reasons for withdrawal include: 
• 
Child/caregiver pair is unwilling or becomes unable to comply with the assessment procedures 
required by the protocol. 
• 
Child/caregiver pair is withdrawn for safety reasons (e.g., occurrence of a severe AE). 
• 
Child/caregiver pair meet any exclusion criteria and no longer meet the inclusion criteria, with 
the exception of BMI. 
If a child/caregiver pair no longer receives care at the clinic at which they are consented, the study team 
will make every attempt to retain the participant. ECHO ISPCTN site personnel will record the reasons 
for withdrawal in the trial documentation. 
Clinic sites can replace child/caregiver pairs if they withdraw prior to the start of the intervention; 
however, clinic sites will not replace child/caregiver pairs who withdraw after the start of the 
intervention.  
While it is unlikely, a child’s primary caregiver could change during the trial. If this occurs, we will 
unblind the ECHO ISPCTN site coordinator (and the backup assessor will take over all assessments for 
that participant [see Section 7.3]), and the ECHO ISPCTN site coordinator will contact the new primary 
caregiver to seek their participation, according to applicable local laws. If the new primary caregiver 
chooses to consent, the ECHO ISPCTN site coordinator will remove the original caregiver’s BMI data 
from analyses, but will keep the child’s data and both the new caregiver and child will continue to 
participate. If the new primary caregiver does not consent, the participant will be withdrawn.  
To allow for child/caregiver pairs who do not complete the trial, clinic sites will consent up to 32 
child/caregiver pairs, per clinic, with only 28 child/caregiver pairs needed for a cohort (i.e., each ECHO 
ISPCTN site will consent 28 participants for randomization). We will consider a child/caregiver pair lost 
to follow-up if the clinic team, ECHO ISPCTN site team, or PIs are unable to contact the pair. 
9 
STUDY ASSESSMENTS AND PROCEDURES 
9.1 
EFFICACY ASSESSMENTS  
The following section outlines the assessments and assessment-related procedures. Please note that the 
ECHO ISPCTN site coordinator will remain blinded, but we will not blind the clinic nurse.  
The unit of measurement will be at the participant level. Further details will be included in the statistical 
analysis plan (SAP). 

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Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
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Primary Outcome Measures 
Objective 1 – Participant Recruitment Rate. For each recruitment option, recruitment will occur over 
four weeks (Table 2). There will be three numbers collected: potential participants, potential  
participants approached, and participants 
randomized. We will measure participant 
recruitment rate for both recruitment 
options. The numerator will be the number 
of participants randomized, and the 
denominator will be the number of 
participants approached. Potential 
participants for recruitment option 1 will be 
the number of patients seen in the last year, 
who meet inclusion criteria (retrospective), 
and the number of patients seen during the 
four-week recruitment period, who meet 
inclusion criteria (prospective). We do not 
define the potential participants for 
recruitment option 2. For recruitment 
option 1, the number for potential 
participants approached will be the number 
of potential participants approached by ECHO ISPCTN site coordinator. For recruitment option 2, the 
potential participants approached will be the number of self-referred potential participants. We will 
obtain the number of potential participants and potential participants approached from a list 
maintained by the ECHO ISPCTN site coordinator with the assistance of clinical staff, as needed (see 
Section 5.5, subsection Recruitment Option 1).  ECHO ISPCTN research staff will enter these numbers 
into an EDC system during the recruitment period. We will also discuss the data during the weekly 
study-team calls. Please see Figures 3 and 4 for a graphical representation of these numbers. 
Objective 2 – Participant Retention. We will calculate participant retention as the percent of 
randomized participants who remain in the study through the final measurement time point. The 
numerator will be the number of randomized participants who complete the final measurement time 
point and the denominator will be the total number of randomized participants. We will then calculate 
the retention rate for each clinic site and by treatment arm across all clinic sites.  
Objective 3 – Dose. Among participants randomized to the iAmHealthy behavioral intervention arm who 
are retained through the final measurement, we will calculate the proportion of the participants who 
receive at least 80% of the planned intervention (dose). The planned dose is 26 contact hours, and 80% 
of the planned dose is 20.8 planned contact hours. The iAmHealthy behavioral intervention 
psychologist/social worker will enter into an EDC system participant attendance at each group session, 
and the iAmHealthy behavioral intervention dietician will enter into an EDC system participant 
attendance at each individual session. The total number of sessions possible will serve as the 
denominator and the total number of sessions attended will serve as the numerator; we will calculate 
this dose rate for each child/caregiver pair.  
Objective 4 – Staff Blinding. We will assess blinding with the New Blinding Index.2,3 This index estimates 
the percentage of correct guessing beyond the level expected by chance in each treatment arm. 
Specifically, the ECHO ISPCTN site coordinator and a designated backup will remain blinded and serve as 
the blinded assessor. We will ask the blinded assessor at the time of the final measurements to enter 
into an EDC system her or his estimation of the treatment assignment for each participant. The options 
 
Figure 3. Participant Recruitment Overview in each Clinic 

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Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
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Date: 13 March 2021 
for assessors to select from will include treatment, control, and do not know (options required by the 
New Blinding Index). 
Secondary Outcome Measures 
1. Child and Primary Caregiver Body Mass Index (BMI) and Child BMI adjusted z-score (BMIaz). 
These measures are associated with Secondary Objectives 1 through 3. Although there has been 
debate about the best measure of childhood adiposity,68 the recently released USPSTF 
guidelines indicate that BMI is a widely used metric for pediatric treatment outcome research. 28 
Among adults, BMI is clearly the preferred and most widely used metric of adiposity in large-
scale treatment outcome research. BMI is a measure of adiposity that is also highly feasible, 
based primarily on the measurement of height and weight. To calculate BMI for both children 
and adults, ECHO ISPCTN site coordinators and/or site investigators will use standard 
formulas/equations.  
As a secondary measure, we will use BMIaz to measure childhood adiposity change. BMIaz is a 
recently developed calculation that is designed to be more sensitive to change for children over 
the 95th percentile.1 A comparison between BMI and BMIaz in this large and well-studied sample 
will be a valuable addition to the literature. 
2. 24-hour Food Recall. This measure is associated with Secondary Objective 4. The 24-hour food recall 
is a standardized five-pass method developed by the US Department of Agriculture for use in 
national dietary surveillance. Although there are weaknesses to every method of dietary 
assessment, we selected this method because several large trials, which served as models for the 
current trial, used it.69,70-72 Data suggest that the 24-hour food recall is the most valid and reliable 
method of dietary assessment for children.73  
All child participants will complete the 24-hour food recall at consent/screening/baseline and at 
post-intervention. For each 24-hour food recall assessment period, a member of the Dietetics and 
nutrition team will collect data via telecommunications from child/caregiver pairs for two weekdays 
(i.e., two days during a Monday through Friday time period) and one weekend day (i.e., one day 
during a Saturday and Sunday time period) , as is recommended.73 Regarding school lunches eaten 
away from home, per typical procedures, caregivers will review the school lunch menu with their 
child at the end of each day and have the child report, to the best of his or her ability, what he or 
she consumed for lunch at school that day.  
We will analyze recalls with the Nutritional Data System for Research (version 2018; University of 
Minnesota, Minneapolis, MN). Although much information is available from this analysis, the 
current trial will specifically focus on the number of servings of sugar-sweetened beverages per day, 
the number of “red” food items per day (foods with ≥7 grams of fat and/or ≥12 grams of sugar per 
serving), and the number of servings of fruits and vegetables per day. (For more information on 
“red” food items as part of the Stop Light Diet, see Section 7.2, subsection Individual Sessions).  
An expert in dietary training will train all staff completing dietary recalls to collect the 24-hour food 
recall data using highly standardized probes, and we will require the staff to meet testing 
requirements before we allow them to collect the baseline 24-hour food recall.  
3. ActiGraph Physical Activity Monitors. This measure is associated with Secondary Objective 5. We 
will measure physical activity by using the ActiGraph physical activity monitor (ActiGraph LLC, 
Pensacola, FL), a small, lightweight activity monitor that is worn on an adjustable belt over the hip 
contralateral to the dominant hand, allowing objective measurement of physical activity. The 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
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Date: 13 March 2021 
monitor measures start time and data collection intervals (one-second epochs). The ActiGraph has a 
filter that rejects motion outside normal human movements. The ActiGraph has been shown to 
provide valid assessments of physical activity for adults and children during both laboratory 
activities (treadmill walking/running) 74,75 and daily living activities.76-78  
All child participants will complete physical activity monitoring at consent/screening/baseline and at  
post-intervention, and we will ask child participants to wear the monitor on the same hip during the 
consent/screening/baseline and post-intervention monitoring phases. For each monitoring point 
(consent/screening/baseline and post-intervention), participants will receive detailed instructions 
on wearing and caring for the monitor, and ECHO ISPCTN site coordinator or investigator will ask 
them to wear the monitor for a maximum of seven consecutive days and a minimum of four days 
during a one week period. For analyses, we will consider at least eight hours of wear time in a 24-
hour period a “valid” day (consistent with previous research).79 Participants will wear monitors 
during waking hours, excluding water-based activities (i.e., swimming, bathing). We will provide 
postage-paid mailing supplies for the caregiver to mail, via priority mail, the activity monitor to the 
ECHO ISPCTN site coordinator or investigator. The site coordinator or investigator will be responsible 
for retrieving data for analysis by downloading the data to a computer via a USB port. If a 
participating family loses the activity monitor or if an activity monitor breaks or malfunctions, ECHO 
ISPCTN site or DCOC will replace the activity monitor.  
The DCOC/ISPCTN sites will process all data with ActiLife software, which accounts for age and 
gender cut-offs.80 We will then normalize these data for wear time. The primary outcome will be 
average time spent per day in moderate to vigorous physical activity across valid wear days, as well 
as the percent of time spent in moderate to vigorous physical activity. We will assess the ActiGraph 
monitors for proper functioning before use and between child/caregiver pairs. 
Tertiary Outcomes 
1. Assess the reasons that parents decline to participate in the iAmHealthy trial and whether those 
reasons differ by recruitment option or by clinic. Specifically, ECHO ISPCTN site 
coordinators/investigators will ask every family who declines to participate for the primary reason 
for their negative response. We will code and categorize those reasons by recruitment option and 
clinic, as well as across recruitment options and across clinic.  
2. Assess recruitment options in more detail by determining the total number of participants 
randomized via each recruitment option at each clinic, as well as whether each clinic met its 
recruitment goal of at least eight randomized participants via each recruitment option. Specifically, 
in addition to recruitment rate (Objective 1) study staff will track the total number of participants 
randomized via each recruitment option at each clinic, as well as a dichotomous variable of whether 
or not the clinic met its overall goal by and across recruitment option.  
Other Measures 
Other measures for this trial include a demographics questionnaire (iAmHealthy Demographics Form), 
the Post-Trial Questionnaire, and a technology feasibility log. We will conduct the following measures via 
an EDC link, telecommunications, or postal or electronically mailing the measures to participants, ask 
them to complete and return to the consenting ECHO ISPCTN site coordinator or research-trained 
backup. 
Demographics. This questionnaire (iAmHealthy Demographics Form) will ask about age, race, ethnicity, 
household income, Medicaid/insurance status, caregiver education, and zip code (to determine rurality 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
Page 68 of 94 
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Date: 13 March 2021 
using RUCA codes). Additionally, this questionnaire will assess the availability of home computers, 
high-speed Internet access, tablets, smartphones, or other technology already present in the home that 
participants could use for secure videoconference connections in future studies. In addition, this 
questionnaire will ask participating caregivers how they heard about the iAmHealthy project and if the 
caregiver was approached through other recruitment options. Participating caregivers will complete this 
questionnaire before randomization.  
Post-Trial Questionnaire. To assess for possible contamination effects and to assess use of the 
newsletter, caregivers will complete a short questionnaire asking about any contact they had with their 
primary care physician during the intervention period, as well as other weight loss efforts or health 
behavior change efforts in which the caregiver or the child engaged. In addition, we will ask participants 
to record receipt of the newsletter, how often they read the newsletter, amount of time reading the 
newsletter, and helpfulness in implementing weight loss efforts. Participating caregivers will complete 
this questionnaire during the post-intervention period. 
Technology Feasibility. Individual and group session leaders will keep technology problem logs to record 
difficulties they have 1) connecting to the child/caregiver pairs for the sessions or 2) with technology 
interruptions during sessions. Previous research indicates these problems are rare, but the degree of 
these types of problems when delivering interventions to the home is unknown.  
As a second measure of technology feasibility, participating caregivers will complete the questionnaire 
during the post-intervention time point.  
Study Personnel Time Assessment. During the recruitment phase, the DCOC will weekly send a time 
assessment survey and ask all study personnel (ECHO ISPCTN study personnel, unblinded ECHO ISPCTN 
coordinator, and clinic nurse) to report the time spent on different trial activities during that week. At 
the end of the feasibility study, we will assess these time logs to determine the actual time study 
personnel devoted to the trial activities. 
Study Personnel Satisfaction Survey. The DCOC will ask all study personnel to complete a brief 
satisfaction survey shortly after the recruitment period ends and after the final measurements are 
completed.    
9.2 
ADVERSE EVENTS/SERIOUS ADVERSE EVENTS 
Definition of Adverse Events 
An AE is defined as any untoward occurrence associated with the use of an intervention in humans, 
whether or not considered intervention related (21 CFR 312.32 [a]). We include a list of potential AEs; 
however, we will record and track SAEs, per the definition below. We will only record severe AEs.  
Definition of Serious Adverse Events 
We will consider an AE or suspected adverse reaction "serious" if, in the view of the PIs, medical 
monitor, DSMB, or sponsor, it results in any of the following outcomes:  
• 
Death 
• 
Life-threatening AE 
• 
Inpatient hospitalization or prolongation of existing hospitalization 
• 
Persistent or significant incapacitation or substantial disruption of the ability to conduct normal 
life functions 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
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• 
Congenital anomaly/birth defect.  
Important medical events that may not result in death, be life-threatening, or require hospitalization 
may be considered serious when, based upon appropriate medical judgment, they may jeopardize the 
participant and may require medical or surgical intervention to prevent one of the outcomes listed in 
the SAE definition. Examples of such medical events include allergic bronchospasm requiring intensive 
treatment in an emergency room or at home, blood dyscrasias, or convulsions that do not result in 
inpatient hospitalization, or the development of drug dependency or drug abuse. 
Classification of an Adverse Event 
SEVERITY OF EVENT 
These are the guidelines to describe the severity of AEs: 
Mild. Events require minimal or no treatment and do not interfere with the participant’s daily activities.  
Moderate. Events result in a low level of inconvenience or concern with the therapeutic measures. 
Moderate events may cause some interference with daily functioning. 
Severe. Events interrupt a participant’s usual daily activity and may require systemic drug therapy or 
other treatment. Severe events are usually potentially life threatening or incapacitating. Of note, the 
term “severe” does not necessarily equate to “serious.” 
RELATIONSHIP TO TRIAL INTERVENTION 
All severe AEs and SAEs must have their relationship to trial intervention assessed by the clinician who 
examines and evaluates the participant based on temporal relationship and her/his clinical judgment. 
We will grade the degree of certainty about causality by using the categories below. 
Related. We know the AE occurred with the trial intervention, there is a reasonable possibility that the 
trial intervention caused the AE, or there is a temporal relationship between the trial intervention and 
event. Reasonable possibility means that there is evidence to suggest a causal relationship between the 
trial intervention and the AE. 
Not Related. There is not a reasonable possibility that the administration of the trial intervention caused 
the event, there is no temporal relationship between the trial intervention and event onset, or there is 
an established alternate etiology. 
EXPECTEDNESS  
The ECHO ISPCTN site investigators will be responsible for determining whether a severe AE or SAE is 
expected or unexpected. A severe AE or SAE will be considered unexpected if the nature, severity, or 
frequency of the event is not consistent with the risk information previously described for the trial 
intervention. 
Of note, the evidence report and systematic review for the USPSTF addressing screening for obesity and 
intervention for weight management in children and adolescents did not report any SAEs among 10 
lifestyle-based intervention trials.28 Potential events could include the following.  
• 
Distress from being identified as overweight or obese 
• 
Conflict between parent or family and child related to 
o Recommendations for exercise 
o Recommendations for change in food buying and/or dietary changes 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
Page 70 of 94 
Protocol Version #13 
Date: 13 March 2021 
• 
Increased body image concerns 
• 
Discomfort in social settings where recommended healthy diet may be in conflict with food 
served 
• 
Conflict with peers related to recommendations for a healthy diet 
• 
Soreness related to increased activity 
• 
Injury related to increased activity 
Time Period and Frequency for Event Assessment and Follow-Up 
While not expected, a participant may experience psychological and/or behavioral difficulties during the 
trial. If this occurs, the caregiver may contact the group psychologist or clinical social worker to discuss 
these issues (if the participant is in the iAmHealthy behavioral intervention arm) or contact the ECHO 
ISPCTN unblinded coordinator (if the participant is in the newsletter only arm). If the participant is in 
need of psychological care, a behavioral intervention team member or the operational PI, depending on 
the issue, will ask the parent to contact the participant’s primary care physician for referral, or other 
support as needed. If the group psychologist, clinical social worker, operational PI suspects that a severe 
AE or SAE has occurred, he or she will contact the unblinded ECHO ISPCTN coordinator. If the unblinded 
ECHO ISPCTN coordinator determines that a severe AE or SAE has occurred, he or she will enter this into 
the EDC system. 
Beginning on Week 1 of the intervention period, the unblinded study coordinator will call participants 
approximately monthly to inquire about severe AEs and SAEs. The occurrence of a severe AE or SAE may 
also come to the attention of trial personnel (e.g., ECHO ISPCTN site study personnel or behavioral 
intervention team members) during contact with a trial participant (child or primary caregiver). When 
trial personnel learn of a severe AE or SAE, he or she will refer the participant to his or her primary care 
physician. The trial personnel learning of the severe AE or SAE will also inform the unblinded ECHO 
ISPCTN coordinator, who will record the severe AE or SAE into the EDC and will track the SAE.   
The unblinded ECHO ISPCTN coordinator will record severe AEs, as described in the next section and in 
the MOP. Severe AE data collection typically includes event description, time of onset, if available, 
resolution time and day, if available, and ECHO ISPCTN site investigator’s assessment of severity, 
relationship to study participation or intervention (assessed only by those with the training and 
authority to make a diagnosis), and time of resolution/stabilization of the event. The unblinded ECHO 
ISPCTN coordinator must appropriately document severe AEs occurring during the trial, regardless of 
relationship to the trial. The DCOC safety personnel will track severe AEs until one of the following 
criteria are met: resolution, the condition stabilizes, the event is otherwise explained or is judged by the 
ECHO ISPCTN site investigator to be no longer clinically significant, or the participant is withdrawn from 
the study. DCOC safety personnel will follow all SAEs by asking the unblinded coordinator about the SAE 
every 14 days until resolution or until the ECHO ISPCTN site investigator deems the event to be chronic, 
or until the participant is stable. The DCOC may request other supporting documentation of the event 
and should be provided as soon as possible.  
We will not record any medical condition that is present when the ECHO ISPCTN site coordinator screens 
the participant at consent/screening/baseline as an AE. However, if the trial participant’s condition 
deteriorates at any time during the trial to meet the definition of a severe AE, the unblinded ECHO 
ISPCTN coordinator will record this.  
The unblinded ECHO ISPCTN coordinator will document changes in a severe AE in the source document 
and EDC to allow an assessment of the duration of the event. Severe AEs characterized as intermittent 
require documentation of onset and duration of each episode. 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
Page 71 of 94 
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Date: 13 March 2021 
The unblinded ECHO ISPCTN coordinator will inquire about severe AEs and SAEs via monthly 
(approximately) participant phone calls and will record all reportable events that occur from Week 1 of 
the intervention period. Participants may report severe AEs for seven days post-intervention and SAEs 
for 30 days post-intervention. Unblinded coordinators and/or DCOC safety personnel will record and 
track according to this protocol and DCOC standard operating procedures.  
Adverse Event Reporting  
We will record severe AEs in the EDC system, include them in the statistical analysis, and follow the 
reporting procedures outlined in the trial-specific MOP. The MOP section on reporting severe AEs will 
encompass the requirements of: 
1. Reviewing IRB’s policies and procedures 
2. Standard Operating Procedures (SOPs) for the Streamlined, Multisite, Accelerated Resources for 
Trials IRB Reliance platform (SMART IRB) 
3. ICH E6(R2), Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry  
4. Following local IRB’s policies and procedures, when applicable. If there are discrepancies 
between the procedures, we will follow the most stringent of the procedures.  
We will yearly report severe AEs to the reviewing IRB for its continuing review. The lead trial team will 
report to the Central IRB, as specified in the study-specific IRB communication plan, which is based on 
recommendations of SMART IRB. We will also report severe AEs to the local IRB, per local IRB policies 
and procedures, and make them available to the sponsor (DCOC) on a continuing basis through the EDC 
system. We will report to the DSMB, per the DSMB charter.  
The trial-specific MOP will describe the details of the reporting structure and additional details related 
to timelines for reporting.  
The unblinded ECHO ISPCTN coordinator will record severe AEs and SAEs into the EDC, as described in 
the MOP. The record must include, at a minimum, the following information: 1) description of the 
severe AE and/or SAE, 2) onset time and day of the severe AE, if available, and 3) resolution time and 
day of the severe AE, if available. The unblinded ECHO ISPCTN coordinator must enter all severe AEs and 
SAEs on a severe AE and log. 
The specific regulations of the Food and Drug Administration (FDA) do not apply to this protocol because 
this is not an FDA-regulated trial. 
Serious Adverse Event Reporting  
The unblinded ECHO ISPCTN coordinator will record all SAEs in the EDC, and the DCOC will report SAEs, 
per Table 5, below. The DCOC will notify monitoring personnel (e.g., medical monitor) and monitoring 
bodies (e.g., DSMB), per the DSMB charter. The DCOC will make these reports whether or not the trial 
clinician or medical monitor consider the event trial-intervention related; reports must include an 
assessment of whether there is a reasonable possibility that the trial intervention caused the event.   
Table 5. Serious Adverse Event Reporting 
 
Report to 
Timing 
Notes 
1 
Reviewing IRB (SMART IRB 
definition) 
Yearly (minimum)/at 
continuing review 
For continuing review 
Submitted to IRB via DCOC 
2 
Local IRB 
Per local IRB policies and 
procedures 
 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
Page 72 of 94 
Protocol Version #13 
Date: 13 March 2021 
3 
DCOC (Sponsor, per SMART IRB 
definitions, and lead trial team) 
Immediately, but not later 
than 48 hours after finding 
out about the event 
CO-SOP-012.v1.0/SOP 
4 
Overall PIs (per SMART IRB 
definitions) 
Immediately, but not later 
than 24 hours after finding 
out about the event 
 
5 
Medical Monitor 
Per DSMB charter 
 
6 
DSMB 
Per DSMB charter 
 
 
DCOC safety personnel will track all SAEs until satisfactorily resolved or the ECHO ISPCTN site 
investigator deems the event is chronic or the participant is stable. The DCOC/trial sponsor may request 
other supporting documentation, and sites should provide this as soon as possible. 
The DCOC will ensure the summary and report of SAE data to the reviewing IRB in time for consideration 
at the next continuing review. The DCOC will also create and provide any SAE data summaries requested 
by the monitors or specified in the DSMB charter. The ECHO ISPCTN site investigator will be responsible 
for following their local institution’s requirements. 
The trial-specific MOP has additional details. 
Reporting Events to Participants 
We will notify participants of those trial-related (or potentially trial-related) SAEs that may affect their 
willingness to continue with the trial or the future health of the primary caregiver or child. Any of the 
following can determine if study personnel should contact participants: the IRB, the medical monitor, 
the DSMB, or the PIs. The person or oversight body that makes the determination will inform the DCOC, 
which will instruct the ECHO ISPCTN site investigators and coordinators to contact the participants 
consented through their site. 
ECHO ISPCTN site research staff will record any contact with participants, if necessary, in the EDC and/or 
trial log. 
Events of Special Interest  
We have not identified other reportable events for this trial. 
Reporting of Pregnancy  
In the unlikely event that a child participant becomes pregnant, she will be withdrawn from the trial. If a 
participant reports pregnancy, the site will maintain contact with pregnant study participants to obtain 
pregnancy outcome information. Study personnel will follow the pregnant participant until delivery or 
until the end of pregnancy (in the case of miscarriage or pregnancy termination). 
Healthy weight management clinics during pregnancy are likely different from healthy weight 
management clinics outside of pregnancy, and changes in the outcomes of interest (BMI and BMIaz) 
should be different from those of non-pregnant participants.  
If an adult caregiver becomes pregnant, study personnel will exclude from analysis all data for that adult 
caregiver. However, we will allow the family to remain in the study, and we will use the child’s data in all 
analyses. All nutrition and activity guidance given during either intervention is appropriate for pregnant 
individuals.  

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
Page 73 of 94 
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Date: 13 March 2021 
9.3 
UNANTICIPATED PROBLEMS 
Definition of Unanticipated Problems 
The Office for Human Research Protections (OHRP) considers unanticipated problems involving risks to 
subjects or others (UPIRTSOs) any problem, event, or new information that is: 
• 
Unanticipated or unexpected; 
• 
Related to the research; and  
• 
Involves new or increased risks to subjects or others.  
A UPIRTSO is not necessarily an AE or an SAE. For example, a breach of confidentiality is a potential 
UPIRTSO that is not an AE or SAE. Events that are potential UPIRTSOs must be reported to the central 
IRB, typically via the DCOC, for the central IRB to determine if the event is a UPIRTSO. These potential 
events must also be reported to local IRBs according to local IRB policies and procedures. The 
information that must be included in reports of potential UPIRTSOs is provided in the contemporaneous 
central (UAMS) IRB policy 10.2, Principal Investigator Responsibilities, which is available via 
http://irb.uams.edu/irb-policies/current-irb-policies/principal-investigator-responsibilities/  
The trial-specific MOP provides additional details. 
Unanticipated Problem Reporting 
Study personnel must report potential UPIRTSOs, per this protocol, to the reviewing IRB, via the 
method(s) specified in the MOP, and directly to the DCOC. If the UAMS IRB determines the issue is, 
indeed, a UPIRTSO, the DCOC will notify persons and entities as required by UAMS IRB policies and 
procedures, the study-specific communication plan, and the DSMB charter. Study personnel must also 
report these events to their local institutions according to the rules and regulations of the local 
institution. The reviewing IRB will report the issue to OHRP, per the policies of the reviewing IRB. For the 
University of Arkansas for Medical Sciences (UAMS) IRB, which will be the reviewing IRB for sites in this 
trial, the required reporting times are provided in the contemporaneous version of Policy 10.2,  Principal 
Investigator Responsibilities, which is available via http://irb.uams.edu/irb-policies/current-irb-
policies/principal-investigator-responsibilities/  The times, at the time of the approval of this protocol, 
are in the table below.  
Table 6. Unanticipated Problem Reporting (per UAMS IRB policy  at time of approval of this protocol) 
Unanticipated Problem 
Required Reporting Time to UAMS IRB 
Death or life-threatening 
Immediately to IRB office or IRB Chair 
All other events 
Within 10 days of event or notification of event if non-local 
Reporting Unanticipated Problems to Participants 
For reporting UPIRTSOs to participants, we will follow the same procedures as described for reporting 
event to participants (Section 9.2, subsection Reporting Events to Participants).  

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
Page 74 of 94 
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Date: 13 March 2021 
10 STATISTICAL CONSIDERATIONS  
10.1 
STATISTICAL HYPOTHESES 
Primary Objective  
Our primary objective is to conduct a rigorous feasibility trial of a proposed RCT (iAmHealthy behavioral 
intervention versus newsletter) in four clinics affiliated with ECHO ISPCTN site awardees to assess key 
variables (participant recruitment rate, participant retention, intervention dose, blinding) related to 
feasibility of a larger fully powered treatment-outcome RCT. 
While this is a feasibility trial for the iAmHealthy intervention, this is an RCT of recruitment options. This 
trial does examine the recruitment rate, retention, dose, and blinding that will inform the development 
of a larger, fully powered RCT of the iAmHealthy behavioral intervention in the ECHO ISPCTN. 
Objective 1. Participant Recruitment.  
A) Evaluate the two proposed recruitment options to determine which are feasible for recruitment 
of rural participants. Hypothesis: The percent of randomized participants, among those contacted 
with each recruitment option, will be greater than 20%.  
B) Compare the two proposed recruitment options. Hypothesis 1: Option 1 will yield a higher 
percent of participants randomized among those contacted than option 2. Hypothesis 2: Option 1 
will require less time to full recruitment than option 2. 
Objective 2. Participant Retention. Evaluate the percentage of randomized participants that remain in 
the study through the final measurement time point (six months) in both arms (i.e., iAmHealthy 
behavioral intervention and newsletter-only). Hypothesis: The study will retain greater than 75% of the 
randomized participants through the final measurement (six months) in each arm. 
Objective 3. Dose. Evaluate the percentage of participants in the iAmHealthy behavioral intervention 
arm and retained through the final measurement who receive a sufficient dose (i.e., 80% [20.8 hours] of 
the 26 planned contact hours) of the intervention. Hypothesis: 80% of the participants randomized to 
the iAmHealthy behavioral intervention arm who are retained through the final measurement will 
receive a sufficient dose (i.e., 80% [20.8 hours] of the 26 planned contact hours) of the intervention. 
Objective 4. Staff Blinding. Evaluate the agreement between the blinded assessor’s estimation of 
participant assignment and actual participant arm assignment. Hypothesis: The study will achieve 
blinding in both arms, as shown by the New Blinding Index score with a 95% confidence interval that 
includes 0.2,3  
Secondary Objectives  
1. Obtain a preliminary estimate of effectiveness of the iAmHealthy behavioral intervention on 
change in child BMIaz, compared to the newsletter-only intervention, from the baseline 
measurement to the final measurement time point (sixth month). 
2. Obtain a preliminary estimate of the effectiveness of the iAmHealthy behavioral intervention on 
change in child BMI, compared to the newsletter-only intervention, from the baseline 
measurement to the final measurement time point (sixth month). 
3. Obtain a preliminary estimate of the effectiveness of the iAmHealthy behavioral intervention on 
change in primary caregiver BMI, compared to the newsletter-only intervention, from the 
baseline measurement to the final measurement time point (sixth month). 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
Page 75 of 94 
Protocol Version #13 
Date: 13 March 2021 
4. Obtain a preliminary estimate of the effectiveness of the iAmHealthy behavioral intervention on 
child nutrition (i.e., fruits, vegetables, etc.; see Section 7.2, subsection Individual Sessions), 
compared to the newsletter-only intervention, from the baseline measurement to the final 
measurement time point (sixth month). 
5. Obtain a preliminary estimate of the effectiveness of the iAmHealthy behavioral intervention on 
moderate to vigorous physical activity (child), compared to the newsletter-only intervention, 
from the baseline measurement to the final measurement time point (sixth month). 
10.2 
SAMPLE SIZE DETERMINATION 
We based the sample size on the primary efficacy endpoint, percentage of participants randomized 
among those contacted by recruitment option (Objective 1A). We will evaluate this for each of the two 
proposed recruitment options to determine the options that are feasible for recruitment of rural 
participants in a randomized design trial. We will hypothesize that consecutive recruitment (option 1) 
will yield a higher percent of participants randomized than the traditional recruitment option (option 2). 
We will randomize up to 112 participants. This translates into 28 participants per clinic; participants will 
be 1:1 randomized to the newsletter-only and iAmHealthy intervention arms. For each option, we will 
use a one-sample test of proportions (one-sided) to test that the participant recruitment rate, 
percentage of participants randomized among those contacted, will be greater than 20%.  
We will randomize up to 112 participants (28 participants per clinic) in the study. ECHO ISPCTN site 
coordinators will approach and contact up to 560 potential participants (280 per recruitment option) to 
consent up to 224 participant and randomize up to 112 total participants. A sample size of 280 
contacted potential participants per recruitment option will achieve 90% power to detect a difference 
(P1 to P0) of 0.0700 using a one-sided Z-test for proportions that use S(Phat) to estimate the standard 
deviation and has a continuity correction. The target significance level will be 0.05. The actual 
significance level achieved by this test will be 0.028. These results assume that the population 
proportion under the null hypothesis will be 0.13 and will be greater than 0.20 under the alternative 
hypothesis. 
While we have hypothesized a recruitment rate of 0.20, we may find it to be higher during study 
implementation. Assuming a null hypothesis of 0.13, the table below provides the respective power 
achieved under a range (i.e., 0.2 to 0.6) of higher attained recruitment rates. As shown below (Table 7), 
we will maintain the study’s power at 90% or above under the null hypothesis of 0.13 while detecting a 
difference of 0.07 (i.e., recruitment rate of 0.20). 
Table 7. Power Calculation Table 
 
Alpha 
Randomized per 
method, 
per site 
Recruitment 
rate 
# approached 
per site 
Total over 
4 sites 
 
Power 
0.05 
14 
0.2 
70 
280 
0.90 
0.05 
14 
0.3 
47 
188 
1.00 
0.05 
14 
0.4 
35 
140 
1.00 
0.05 
14 
0.5 
28 
112 
1.00 
0.05 
14 
0.6 
24 
96 
1.00 
 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
Page 76 of 94 
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Date: 13 March 2021 
Based on the power calculation shown above, the number of contacted potential participants will be 
280 for each recruitment option. We predict that there may be clinic-to-clinic variability (i.e., a small 
intraclass correlation [ICC = 0.01] at four clinical sites), implying that it is reasonable to assume that our 
typical cluster size will be up to m = 70 (280 participants/4 clinics) for each of the recruitment options. 
When participants within a clinic are more similar to one another than participants in other clinics are, 
the model will underestimate its unadjusted variance, and we will increase it to reflect the true variance 
accounting for the clinic-to-clinic variability. The variance inflation factor (VIF) will calculate the 
multiplying factor that we will need to increase the number of contacted potential participants to adjust 
for the clinic-to-clinic variability. The previously described variance inflation factor (VIF = 1 + (m-1)*ICC) 
indicates that we will inflate our variance by 1+(70-1)*0.01 = 1.69. The effective sample size for 
contacted potential participants is 166 (280/1.69). Assuming a reference proportion of 20% per 
recruitment option, we have 90% power to detect a 16-percentage point difference in arms with a two-
sided test at 0.05 significance level, while factoring in VIF.81  
For Objective 1B, we hypothesize that consecutive recruitment will be superior to the traditional 
recruitment option. Under the assumptions outlined above, we will have the power to detect a 
difference of 16 percentage points or the difference between 0.36 and 0.20 across the two recruitment 
options. 
10.3 
POPULATIONS FOR ANALYSES 
Intent-to-Treat (ITT) Population. This population includes all randomized child/caregiver pairs. Analysis 
of the ITT population will be a primary analysis. 
Per-Protocol (PP) Population. This population includes all randomized child/caregiver pairs who met all 
inclusion and no exclusion criteria, completed at least 50% of the assigned intervention, and had no 
major protocol deviations (i.e., a protocol deviation that has a major impact on the participant’s rights, 
safety, or well-being; or the completeness, accuracy, and reliability of the study data). 
We will first use the ITT population to conduct all analyses, and we will consider this the primary set of 
analyses on which to base inferences. We will also conduct analyses with the PP population. 
10.4 
STATISTICAL ANALYSES 
General Approach 
We will conduct all statistical analyses following the statistical principles for clinical trials, as specified in 
ICH Topic E9. We will describe and justify any deviations from the planned analyses in the final 
integrated clinical study report.  
We will separately analyze each treatment arm, and we will summarize descriptive statistics (i.e., 
demographics, a post-trial questionnaire, and technology feasibility) for continuous data by mean and 
standard deviation or median and interquartile range, as appropriate. We will summarize categorical 
data by frequency and percent. We will investigate any outliers detected during data review, and we will 
define methods for handling outliers or data transformation in the SAP. 
We will analyze all data using SAS v9.4 software (SAS Institute Inc., Cary, NC).  
Analysis of the Primary Endpoint(s) 
Objective 1A. Participant Recruitment: Individual Recruitment Options. We will separately calculate 
the percentage of participants randomized among those contacted with each recruitment option across 

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Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
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sites. For participants contacted through more than one recruitment option, these participants will be 
analyzed based on the option in which consent occurred. For each recruitment option, we will use a 
one-sample test of proportions to test that the participant recruitment rate (i.e., percentage of 
participants randomized among those contacted) will be greater than 20% (alternative hypothesis) 
versus 13% (null hypothesis). We will also calculate corresponding 95% confidence intervals for each 
method. 
Objective 1B. Participant Recruitment: Comparison of Recruitment Options. We will compare the 
percent of participants randomized among those contacted between each recruitment option using a 
generalized linear mixed model (GLIMMIX) with a binomial distribution and logit link function. We will 
include a month and recruitment option as fixed effects and clinic as a random effect in the 
model. Using recruitment option 2 as the reference, we will also calculate odds ratios comparing 
recruitment options and their corresponding 95% confidence intervals.  
Comparison of time to full recruitment across the two recruitment options: Four clinics will implement 
the two recruitments options (in random order). Each clinic will recruit 14 participants per recruitment 
option. The time to full recruitment per recruitment option for each clinic is defined as the number of 
days from start of recruitment for first participant to screening and then consent, at which point diet 
and activity monitoring begin for last participant. Thus for each clinic, we will have a paired set of time 
to full recruitment corresponding to the two recruitment options. The DCOC statistical team will use the 
Wilcoxon-signed rank test to compare the difference in time to full recruitment across the two 
recruitment options. 
Objective 2. Participant Retention. We will separately calculate the percentage of randomized 
participants who remain through the final measurement for each intervention arm (iAmHealthy 
behavioral intervention, newsletter only). For each intervention arm, we will use a one-sample test of 
proportions to test if the participant retention is greater than 75%. We will also calculate the 
corresponding 95% confidence intervals for each condition.   
Objective 3. Dose. We will calculate the percentage of families in the iAmHealthy behavioral 
intervention arm who receive a sufficient dose: at least 80% (20.8 planned contact hours) of the 26 
planned contact hours. We will use a one-sample test of proportions to test if the percent of the families 
who receive this dose is greater than 80%. We will also calculate the corresponding 95% confidence 
intervals. 
Objective 4. Staff Blinding. We will measure blinding by evaluating the agreement between the blinded 
assessor’s estimation of participant assignment and actual participant assignment (e.g., iAmHealthy, 
newsletter only). To assess the agreement, a weighted kappa, we will conduct corresponding 95% 
confidence intervals and hypothesis test by using the Blinding Index, proposed by Bang et al (New 
Blinding Index).2,3 Hypothesis testing will be whether the 95% confidence interval excludes zero. We can 
estimate the treatment-specific New Blinding Index and corresponding variance for treatment (i) by 
using the following formulas:  
𝑛𝑛𝑛𝑛𝑛𝑛
ෟ𝐵𝐵𝐼𝐼𝑖𝑖= ൫2𝑟𝑟̂𝑖𝑖|𝑖𝑖−1൯∗(𝑛𝑛𝑖𝑖1 + 𝑛𝑛𝑖𝑖2)/(𝑛𝑛𝑖𝑖1 + 𝑛𝑛𝐼𝐼2 + 𝑛𝑛𝐼𝐼3), for i=1,2 
𝑉𝑉𝑉𝑉𝑉𝑉(𝑛𝑛𝑛𝑛𝑛𝑛
ෟ𝐵𝐵𝐵𝐵𝑖𝑖) = ൛𝑃𝑃1|𝑖𝑖൫1 −𝑃𝑃1|𝑖𝑖൯+ 𝑃𝑃2|𝑖𝑖൫1 −𝑃𝑃2|𝑖𝑖൯+ 2𝑃𝑃1|𝑖𝑖𝑃𝑃2|𝑖𝑖ൟ/𝑛𝑛𝑖𝑖, for i=1,2. 
The numerator, ൫2𝑟𝑟̂𝑖𝑖|𝑖𝑖−1൯∗(𝑛𝑛𝑖𝑖1 + 𝑛𝑛𝑖𝑖2), of the New Blinding Index estimates the number of people 
who guess the treatment correctly beyond chance level. The denominator takes into account the 
number of assessors who thought the participants were assigned to the iAmHealthy behavioral 
intervention, newsletter-only, or “I don’t know”. We will implement the calculations separately to 
answer the questions: 1) Was the treatment arm blinded? and 2) Was the placebo arm blinded? The 

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Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
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following hypotheses will be tested: 𝐻𝐻0: 𝑃𝑃1|1 = 𝑃𝑃2|1 versus 𝐻𝐻𝐴𝐴: 𝑃𝑃1|1 > 𝑃𝑃2|1 for the treatment arm and 
𝐻𝐻0: 𝑃𝑃2|2 = 𝑃𝑃1|2 versus 𝐻𝐻0: 𝑃𝑃2|2 > 𝑃𝑃1|2 for the placebo arm, where 𝑃𝑃𝐽𝐽|𝑖𝑖 (i,j=1,2) is the “conditional” 
probability, and we can estimate it by 𝑃𝑃𝑗𝑗|𝑖𝑖= 𝑛𝑛𝑖𝑖𝑖𝑖𝑛𝑛𝑖𝑖
ൗ
.   𝑃𝑃𝑗𝑗|𝑖𝑖=P(guess j|assigned treatment i) for i=1 
(iAmHealthy, newsletter-only) And j=1 (iAmHealthy), 2(newsletter), 3 (I don’t know). We will conduct 
this test by using the normal approximation to the binomial distribution. The New Blinding Index takes 
on a value between -1 and 1, where a null value of 0 indicates the most desirable situation under 
successful blinding. A positive value implies failure in masking above random accounting (i.e., majority of 
participants correctly guess child/caregiver pairs treatment allocation), and a negative value suggests 
success of masking or failure of masking in the other direction (i.e., more individuals mistakenly name 
the alternative treatment). 
Analysis of the Secondary Endpoint(s) 
1. To assess the effectiveness of the iAmHealthy behavioral intervention on change in child BMIaz, 
compared to the newsletter-only intervention, at six months from the baseline measurement, we 
will use an ANCOVA model. We will include baseline child BMIaz as a covariate in the model. For 
each intervention type (newsletter + iAmHealthy behavioral, newsletter only), we will also calculate 
corresponding 95% confidence intervals. 
2. To assess the effectiveness of the iAmHealthy behavioral intervention on change in child BMI, 
compared to the newsletter-only intervention, at six months from the baseline measurement, we 
will use an ANCOVA model. We will include baseline child BMI as a covariate in the model. For each 
intervention type (newsletter + iAmHealthy behavioral, newsletter only), we will also calculate 
corresponding 95% confidence intervals. 
3. To assess the effectiveness of the iAmHealthy behavioral intervention on change in primary 
caregiver BMI, compared to the newsletter-only intervention, at six months from the baseline 
measurement, we will use an ANCOVA model. We will include baseline primary caregiver BMI as a 
covariate in the model. For each intervention type (newsletter + iAmHealthy, newsletter only), we 
will also calculate corresponding 95% confidence intervals. 
4. To measure the effectiveness of the iAmHealthy behavioral intervention on change in child nutrition 
(i.e., fruits, vegetables, etc.; see Section 9.1, subsection Secondary Outcome Measures), compared 
to the newsletter-only intervention, at six months from the baseline measurement, we will use an 
ANCOVA model. We will use baseline child nutrition as a covariate in the model. For each 
intervention type (newsletter + iAmHealthy behavioral, newsletter only), we will calculate 
corresponding 95% confidence intervals. 
5. To measure the effectiveness of the iAmHealthy behavioral intervention on moderate to vigorous 
physical activity (child) compared to the newsletter-only intervention at six months from the 
baseline measurement as measured by the change in the number of minutes of moderate to 
vigorous physical activity, we will use an ANCOVA model. We will include baseline physical activity 
as a covariate in the model. For each intervention type (newsletter + iAmHealthy behavioral, 
newsletter only), we will calculate corresponding 95% confidence intervals. 
Analysis of Tertiary Endpoint(s) 
We will capture and assess the reasons that parents decline to participate in the iAmHealthy trial to see 
if reasons differ by recruitment option and/or by clinic (see Figure 2, Recruitment Flow Diagram). 

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Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
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We will capture and evaluate the number of participants randomized (numerator) and the number of 
potential participants approached (denominator) across the different recruitment options. Additionally, 
we will capture the number of participants randomized during a one-month period within each 
recruitment option as well as whether that number was at least eight randomized participants (the 
minimum randomized participants for each site and recruitment option). We will use these numbers to 
explore further the number of participants we will need to approach in a future full-scale study to obtain 
the planned number of consented participants. 
Safety Analyses 
We will detail all treatment-related severe AEs and SAEs experienced by the child/caregiver pair, and we 
will summarize these by the treatment condition. We will present summary statistics for each 
recruitment option as overall and by clinics. 
Baseline Descriptive Statistics 
We will summarize baseline and child/caregiver demographic characteristics by each intervention arm, 
and we will apply summary statistics for both continuous and categorical variables. For continuous 
measures, descriptive measures will include number of non-missing values, mean, standard deviation, 
minimum, and maximum. For categorical variables, descriptive statistics will include frequency counts 
and percentages by category. 
Planned Interim Analyses 
We are not planning an interim analysis for this trial. 
Sub-Group Analyses 
We will explore the potential moderating effects of race/ethnicity, insurance status, rurality, age, or 
other demographic factors on primary and exploratory endpoints. 
Sensitivity Analysis 
We will assess the robustness of study findings to “participants’ prior knowledge of recruitment 
options/research team’s previous contact” via a sensitivity analysis. We will analyze the Objective 1 
endpoints by using the aforementioned methods based on a subset of participants who report contact 
by only one recruitment option (i.e. excluding those who report being contacted via a different 
recruitment option).  
We will also assess the robustness of study findings to “study participants who qualified before 
enrollment halt but did not qualify after enrollment halt (when measured at baseline)” via a sensitivity 
analysis. We will analyze the Objective 1 endpoints by using the aforementioned methods based on a 
subset of participants who do not meet the pre-post halt qualification-discrepancy (i.e., excluding those 
participants who qualified before enrollment halt but did not qualify after enrollment halt). 
Tabulation of Individual Participant Data 
DCOC staff will provide a detailed description of child and caregiver disposition across all enrolled clinics. 
We will tabulate the number of consented and randomized participants by treatment arm and clinic, 
and we will present tabulations as counts and percentages. Additionally, we will summarize the number 
of child/caregiver pairs either completing or discontinuing the trial by using counts and percentages. 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
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11 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
11.1 
REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
Informed Consent Process 
CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO PARTICIPANTS 
See subsection 7.1 
CONSENT PROCEDURES AND DOCUMENTATION 
See subsection 7.1 
(7)   
Study Discontinuation and Closure 
The trial may also be suspended or stopped per any stopping/suspension specifications in the DSMB 
charter.  It may also be stopped or suspended by the central IRB. 
Early termination may be permanent if there is sufficient cause. 
The suspending or terminating party will provide, directly or indirectly, written notification documenting 
the reason for trial suspension or termination to the following, as applicable: trial participants, PIs, ECHO 
ISPCTN site investigators, reviewing IRB, local IRBs, NIH, DCOC, and OHRP. Persons and offices notified 
will include those specified in the trial MOP, the reviewing IRB’s policies and procedures, and the SMART 
IRB policies and procedures.  
The suspending or terminating party will also contact trial participants and inform them of any changes 
to the trial visit schedule. Circumstances that may warrant termination or suspension include, but are 
not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Demonstration of efficacy that would warrant stopping  
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
If the trial is temporarily suspended, it may resume once concerns about safety, protocol compliance, 
and data quality are addressed and are satisfactory to the DSMB, the reviewing IRB, the local IRB(s) 
(when applicable), the funding agency, and the sponsor (DCOC). 
Confidentiality and Privacy  
We will conduct all trial activities in as private a manner as possible.  
Records will be maintained as required by the privacy and security rules promulgated by the Health 
Insurance Portability and Accountability Act (HIPAA) (Title 45 of the CFR Part 164).82,83  

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Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
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During the trial, study personnel will keep all trial records in secure locations that only authorized 
personnel can access. Examples of secure locations include, but are not limited to: 1) locked file 
cabinet(s) in a limited (badge or key) access room, or 2) password-protected computer systems. Study 
personnel may only transmit records that contain PHI, as defined by HIPAA, through an open email 
system if the personnel encrypt the data. Password protection alone is insufficient for data transmission 
through an open email system (e.g., Outlook). After trial completion, access to trial records will be 
limited (see next Section).  
Certain bodies/institutions may need to review information, including the participant information, for 
any of the following reasons: to process information or to ensure compliance with the protocol and 
other applicable requirements (such as the policies and procedures of the reviewing IRB). 
Institutions/bodies that may have access to the participants’ information include:  
• 
UAMS IRB and other oversite offices 
• 
IRB for the site through which the participant is consented 
• 
OHRP 
• 
DCOC  
• 
NIH 
Individuals with access to trial records will be: 
• 
PIs 
• 
Site PIs 
• 
Site coordinators 
• 
Data managers at participating site(s) 
 Future Use of Stored Specimens and Data  
No specimens will be collected or stored for this trial. Regarding stored data, study personnel will 
document all trial interactions, and these will be password protected in secured facility/location.  
The study team will place participant’s de-identified data and other limited information, such as race 
and ethnic group, into one or more centralized database(s). The study team will share this data in 
compliance with the NIH data sharing policy.  
For future studies using any procedures or analysis not specified in this protocol, IRB approval is 
required.  
In the event that another investigator/collaborator has a meaningful purpose for accessing the data 
retrieved in this protocol, the DCOC must consult the PIs and the IRB must approve. 

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Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
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Key Roles and Study Governance 
Protocol Chair 
Name, degree, title 
Paul Darden, MD 
Chief, General and Community Pediatrics 
Institution  
University of Oklahoma Health Sciences Center 
Address 
1100 N. Lindsay, Oklahoma City, OK 73104 
Phone Number 
(405) 271-4407 
Email 
paul-darden@ouhsc.edu 
Principal Investigators 
Name, degree, title 
Paul Darden, MD 
Chief, General and Community Pediatrics 
Institution  
University of Oklahoma Health Sciences Center 
Address 
1100 N. Lindsay, Oklahoma City, OK 73104 
Phone Number 
(405) 271-4407 
Email 
paul-darden@ouhsc.edu 
 
 
Name, degree, title 
Ann M. Davis, PhD, MPH, ABPP 
Ralph L. Smith Professor of Pediatrics 
Institution  
University of Kansas Medical Center  
Address 
3901 Rainbow Blvd., MS 4004, Kansas City, KS 66160 
Phone Number 
(913) 588-5928 
Email 
adavis6@kumc.edu  
Operational Principal Investigator 
Name, degree, title 
Jessica Snowden, MD 
Associate Professor, Pediatric Infectious Diseases 
Institution  
University of Arkansas for Medical Sciences 
Address 
13 Children’s Way, Slot 512-35, Little Rock, AR 72202 
Phone Number 
501-364-4693 
Email 
jsnowden@uams.edu 
Statistician 
Name, degree, title 
Milan Bimali, PhD 
Assistant Professor, College of Public Health 
Institution  
University of Arkansas for Medical Sciences 
Address 
4301 West Markham, # 781, Little Rock, AR 72205 
Phone Number 
(501) 526-6724 
Email 
MBimali@uams.edu 
Data and Coordinating Operations Center (DCOC) PI 
Name, degree, title 
Jeannette Lee, PhD 
Professor, College of Public Health 
Institution  
University of Arkansas for Medical Sciences 
Address 
4301 West Markham, # 820, Little Rock, AR 72205 
Phone Number 
(501) 526-6700 
Email 
jylee@uams.edu 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
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Medical Monitor 
Name, degree, title 
Alberta Kong, MD, MPH 
Institution  
University of New Mexico Health Sciences Center 
Address 
915 Camino De Salud NE, Albuquerque, NM 87131 
Phone Number 
(505) 272-5152 
Email 
akong@salud.unm.edu 
 
The clinical trial outlined in this protocol is part of the ECHO ISPCTN, a branch of the Environmental 
influences on Child Health Outcomes (ECHO) program supported by the NIH. 
The data coordination, technical instruction, data standards, quality control (QC) and quality assurance 
(QA), and operational coordination for the clinical trial protocol outlined here (and for the ECHO ISPCTN 
overall) is provided by the DCOC. 
The Steering Committee governs the ECHO ISPCTN and includes representatives from all site awardees, 
as well as representatives from the DCOC and the NIH. Overseeing the work of the Steering Committee 
is the NIH ECHO office, as well as an executive Leadership Committee.  
A team of content experts and DCOC staff completed this protocol, and a pediatric obesity-working 
group within the ECHO ISPCTN reviewed it. The NIH Protocol Review Committee and the DSMB further 
reviewed the protocol.  
Safety Oversight 
Ensuring participant safety is the responsibility of all trial team personnel, especially the PIs, ECHO 
ISPCTN site investigators, site coordinators, behavioral intervention team members, and monitors. A 
medical monitor and the DSMB will provide oversight.  
The medical monitor will be a pediatrician with expertise in childhood obesity and behavioral 
interventions and will be independent of the trial. The NIH will convene the DSMB, and it will meet 
regularly, according to its charter.  
The entities that will receive reports include, but are not limited to, the DCOC and the NIH. The DSMB 
charter will provide additional information. 
Clinical Monitoring 
We will conduct clinical site monitoring to ensure that study personnel are protecting the rights and 
well-being of trial participants, that the reported trial data are accurate, complete, and verifiable, and 
that the conduct of the trial complies with the currently approved protocol/amendment(s), with ICH 
GCP, and with applicable regulatory requirement(s).  
• 
A DCOC team member or designee will remotely monitor site awardees to ensure data quality 
and integrity via weekly phone meetings and queries of EDC entries.  
• 
On-site monitoring visits will also be performed at each site, per the Site Performance Plan, at 
least once during the course of the trial and if needed for cause. 
• 
Clinical site monitors will document details of their activities and findings, per the Site 
Performance Plan. The Site Performance Plan describes the monitoring details (i.e., who will 
conduct, at what frequency, at what level of detail, and distribution of monitoring reports). 

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Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
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We will not conduct independent audits.  
Quality Assurance and Quality Control 
Each IRB-approved research site entering data will perform internal quality management of study 
conduct, data collection, documentation, and completion. Each site will follow the trial-specific MOP 
and any additional written site-specific SOPs. The operating procedures will include, but are not limited 
to: 1) procedures for consent; 2) data collection, entry, review, and submission processes; 3) roles and 
responsibilities of site personnel; and 4) training methods for study staff. The clinics and ECHO ISPCTN 
site awardees will provide direct access to all their facilities, source data/documents, and reports for the 
purpose of monitoring and auditing by the DCOC and inspection by local and regulatory authorities. 
When electronic health records are source data/documents, sites must provide read-only access for the 
monitors and auditors and anyone else authorized to inspect or verify records. 
Following the DCOC monitoring SOPs, the monitors will verify that the clinical trial is conducted and that 
data are generated, documented (recorded), and reported in compliance with the protocol, the 
trial-specific Site Performance Plan, site-specific SOPs, the ICH GCP E6(R2), and applicable regulatory 
requirements.  
We will implement QC procedures for the database and DCOC-maintained records in accordance with 
the Site Performance Plan, MOP, data safety monitoring plan (DSMP), and applicable SOPs. We may 
communicate information about any data anomalies to the site(s) for clarification/resolution. 
We will address issues uncovered during QA, QC, or monitoring activities through simple corrections or 
root-cause analysis, followed by instituting corrective and preventative action (CAPA), as appropriate 
and as described in the MOP.      
Data Handling and Record Keeping  
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
A formal data safety-monitoring plan will describe and document the data and workflow for the trial. 
The data management plan and associated documentation will specify all operations performed on data 
from origination to database lock, including detailed descriptions of source documentation, CRFs, 
instructions for completing forms, data handling and record keeping procedures, procedures for data 
monitoring, and reconciliation procedures and coding dictionaries to be used, if applicable. The data 
management plan will also describe the specific data collection and management responsibilities 
required of the sponsor, PIs, the site PIs, the site awardees, the clinics, and the DCOC. The data-
management plan contents will be consistent with those described in the Good Clinical Data 
Management Practices (GCDMP). The DCOC will provide the data management plan components that 
document operations performed on the data to the PIs for review and approval prior to 
implementation. 
Data collection is the responsibility of the clinical trial staff at the individual ECHO ISPCTN sites under the 
supervision of the site investigator. The site investigator is responsible for ensuring the accuracy, 
completeness, legibility, and timeliness of the data reported. All source documents must be completed 
using standard good documentation practices (i.e., the ALCOA-C method [attributable, legible, 
contemporaneous, original, accurate and complete]). 
It is best practice for ECHO ISPCTN site coordinators to use hardcopies of any data recorded on paper 
case-report forms or trial visit worksheets/assessment forms as source document worksheets for 

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Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
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recording data for each participant consented in the trial. Data recorded in EDC derived from source 
documents must be consistent with the data recorded on the source documents.  
Study personnel will enter clinical data (including demographics, physical examinations, and 
intervention-specific questionnaires) into an EDC system that complies with HIPAA regulations, provided 
by the DCOC at UAMS. The EDC system includes password protection and internal quality checks, such 
as automatic range checks, to identify data that appear inconsistent, incomplete, or inaccurate. Study 
personnel will enter clinical data directly from the source documents. 
STUDY RECORDS RETENTION  
Throughout the course of the trial, all site awardees and clinics will retain the source documents on site 
in accordance with current site-specific medical record storage procedures. 
Sites must retain all trial documents in accordance with local and/or federal regulations, whichever is 
most stringent. Sites will not destroy any records without the written consent of the sponsor, if 
applicable. It is the responsibility of the sponsor to inform all investigators when these documents no 
longer need to be retained. 
Study Deviations  
Study deviations are any instances in which study personnel do not follow the study procedures as 
written in the protocol. Sites must record all deviations in the trial source documents. Whenever a 
deviation occurs, the DCOC will conduct an assessment (which they do not need to write) of the severity 
and risk of the deviation. Depending on the results of the assessment, the DCOC will request/ensure 
that there is either a corrective action or a simple one-time correction, as appropriate. A corrective 
action institutes a process designed to keep the specific problem from reoccurring. Typically, assessors 
will determine the root cause of the problem to develop the most appropriate corrective action plan. 
We will provide the specific methods for handling deviations in the trial-specific MOP and/or trial-
specific SOPs.  
Publication and Data Sharing Policy 
We will conduct this trial in accordance with the following publication and data sharing policies and 
regulations: 
• 
NIH Public Access Policy, which ensures that the public has access to the published results of 
NIH-funded research. It requires scientists to submit final peer-reviewed journal manuscripts 
that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
• 
ECHO ISPCTN Publications and Presentations Policy, which ensures accurate, responsible, and 
efficient communication of findings from ECHO ISPCTN clinical trials. The ECHO ISPCTN Steering 
Committee has approved and ratified the ECHO ISPCTN Publications and Presentations Policy, 
which includes representatives from all site awardees, as well as representatives from the NIH 
and the DCOC.  
• 
NIH Data Sharing Policy and the policy on the Dissemination of NIH-Funded Clinical Trial 
Information and the Clinical Trials Registration and Results Information Submission Rule. We 
will register this trial at ClinicalTrials.gov, and we will submit trial results to ClinicalTrials.gov. In 
addition, we will make every attempt to publish results in peer-reviewed journals. Other 
researchers my request data from this trial by contacting Jeannette Lee, PhD, at the DCOC.  

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
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Conflict of Interest Policy 
The independence of this trial from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical. Therefore, we will disclose and manage any actual conflict of interest of persons who 
have a role in the design, conduct, analysis, publication, or any aspect of this trial. Furthermore, persons 
who have a perceived conflict of interest will be required to have such conflicts managed in a way that is 
appropriate to their participation in the design and conduct of this trial. The trial leadership in 
conjunction with the NIH ECHO office has established policies and procedures for all trial group 
members to disclose all conflicts of interest and will establish a mechanism for the management of all 
reported dualities of interest. 
 
 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
Page 87 of 94 
Protocol Version #13 
Date: 13 March 2021 
APPENDIX A: SAMPLE NEWSLETTER 
 
 
 
 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
Page 88 of 94 
Protocol Version #13 
Date: 13 March 2021 
 
 
 
 

Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
Page 89 of 94 
Protocol Version #13 
Date: 13 March 2021 
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Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
Page 90 of 94 
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Date: 13 March 2021 
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Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
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in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
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Title: Feasibility Trial of the iAmHealthy Intervention for Healthy Weight 
Sponsor: ECHO ISPCTN DCOC 
in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
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in Rural Children Recruited from Primary Care Clinics 
cIRB#:249932 
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