Diabetes Prevention for Hispanics Residing in Rural Communities: A Mobile Web-Based Approach
Phase: NA
Conditions: Type 2 Diabetes
Sponsor: ISA Associates, Inc.

Mobile Diabetes Prevention for Hispanics Living in Rural Areas 
Protocol Number: R44MD014082 
National Clinical Trial (NCT) Identified Number:  NCT05856149 
Principal Investigator*: Debra M. Rios 
Sponsor: ISA Associates, Inc. 
 
Grant Title: Diabetes Prevention for Hispanics Residing in Rural Communities: A Mobile Web-based 
Approach 
Grant Number: R44MD014082-02A1 
Funded by: National Institute on Minority Health and Health Disparities 
Version Number:  v.1 
01/16/2026 
 
 
 
CONFIDENTIALITY STATEMENT 
This document is confidential communication. Acceptance of this document constitutes agreement by the 
recipient that no unpublished information contained herein will be published or disclosed without prior 
approval of the Principal Investigator or other participating study leadership and as consistent with the 
NIH terms of award.  
 

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Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
INVESTIGATOR’S SIGNATURE .............................................................................................................................. 2 
1 
PROTOCOL SUMMARY ............................................................................................................................... 3 
1.1 
Synopsis ................................................................................................................................................ 3 
1.2 
Schema ................................................................................................................................................. 3 
1.3 
Schedule of Activities .......................................................................................................................... 4 
2 
INTRODUCTION ............................................................................................................................................ 6 
2.1 
Study Rationale .................................................................................................................................... 6 
2.2 
Background........................................................................................................................................... 7 
2.3 
Risk/Benefit Assessment .................................................................................................................... 9 
2.3.1 
Known Potential Risks ..................................................................................................... 9 
2.3.2 
Known Potential Benefits ................................................................................................ 9 
2.3.3 
Assessment of Potential Risks and Benefits .............................................................. 12 
3 
OBJECTIVES AND ENDPOINTS .............................................................................................................. 13 
4 
STUDY DESIGN ........................................................................................................................................... 14 
4.1 
Overall Design .................................................................................................................................... 14 
4.2 
Scientific Rationale for Study Design.............................................................................................. 15 
4.3 
Justification for Intervention ............................................................................................................. 15 
4.4 
End-of-Study Definition ..................................................................................................................... 15 
5 
STUDY POPULATION ................................................................................................................................ 15 
5.1 
Inclusion Criteria ................................................................................................................................ 15 
5.2 
Exclusion Criteria ............................................................................................................................... 16 
5.3 
Lifestyle Considerations .................................................................................................................... 16 
5.4 
Screen Failures .................................................................................................................................. 16 
5.5 
Strategies for Recruitment and Retention ...................................................................................... 16 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ............................................ 17 
6.1 
Study Intervention(s) or Experimental Manipulation(s) Administration ...................................... 18 
6.1.1 
Study Intervention or Experimental Manipulation Description ................................. 18 
6.1.2 
Administration and/or Dosing ....................................................................................... 19 
6.2 
Fidelity ................................................................................................................................................. 19 
6.2.1 
Interventionist Training and Tracking .......................................................................... 20 
6.3 
Measures to Minimize Bias: Randomization and Blinding ........................................................... 20 
6.4 
Study Intervention/Experimental Manipulation Adherence.......................................................... 20 
6.5 
Concomitant Therapy ........................................................................................................................ 20 
6.5.1 
Rescue Therapy ............................................................................................................. 20 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL ......................................................................................... 20 
7.1 
Discontinuation of Study Intervention/Experimental Manipulation ............................................. 21 
7.2 
Participant Discontinuation/Withdrawal from the Study ............................................................... 21 
7.3 
Lost to Follow-Up ............................................................................................................................... 21 
8 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 22 
8.1 
Endpoint and Other Non-Safety Assessments .............................................................................. 22 
8.2 
Safety Assessments .......................................................................................................................... 23 
8.3 
Adverse Events and Serious Adverse Events ............................................................................... 24 
8.3.1 
Definition of Adverse Events ........................................................................................ 24 

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8.3.2 
Definition of Serious Adverse Events .......................................................................... 24 
8.3.3 
Classification of an Adverse Event .............................................................................. 24 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 25 
8.3.5 
Adverse Event Reporting .............................................................................................. 26 
8.3.6 
Serious Adverse Event Reporting ............................................................................... 26 
8.3.7 
Reporting Events to Participants ................................................................................. 26 
8.3.8 
Events of Special Interest ............................................................................................. 26 
8.3.9 
Reporting of Pregnancy ................................................................................................ 27 
8.4 
Unanticipated Problems .................................................................................................................... 27 
8.4.1 
Definition of Unanticipated Problems .......................................................................... 27 
8.4.2 
Unanticipated Problems Reporting .............................................................................. 27 
8.4.3 
Reporting Unanticipated Problems to Participants ................................................... 28 
9 
STATISTICAL CONSIDERATIONS .......................................................................................................... 28 
9.1 
Statistical Hypotheses ....................................................................................................................... 28 
9.2 
Sample Size Determination .............................................................................................................. 29 
9.3 
Populations for Analyses .................................................................................................................. 29 
9.4 
Statistical Analyses............................................................................................................................ 29 
9.4.1 
General Approach .......................................................................................................... 29 
9.4.2 
Analysis of the Primary Endpoint(s) ............................................................................ 30 
9.4.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 30 
9.4.4 
Safety Analyses .............................................................................................................. 30 
9.4.5 
Baseline Descriptive Statistics ..................................................................................... 30 
9.4.6 
Planned Interim Analyses ............................................................................................. 30 
9.4.7 
Sub-Group Analyses ..................................................................................................... 31 
9.4.8 
Tabulation of Individual Participant Data .................................................................... 31 
9.4.9 
Exploratory Analyses ..................................................................................................... 31 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 31 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 31 
10.1.1 
Informed Consent Process ........................................................................................... 31 
10.1.2 
Study Discontinuation and Closure ............................................................................. 32 
10.1.3 
Confidentiality and Privacy ........................................................................................... 32 
10.1.4 
Future Use of Stored Specimens and Data ............................................................... 33 
10.1.5 
Key Roles and Study Governance .............................................................................. 33 
10.1.6 
Safety Oversight ............................................................................................................. 34 
10.1.7 
Clinical Monitoring .......................................................................................................... 34 
10.1.8 
Quality Assurance and Quality Control ....................................................................... 34 
10.1.9 
Data Handling and Record Keeping ............................................................................ 35 
10.1.10 
Protocol Deviations ........................................................................................................ 35 
10.1.11 
Publication and Data Sharing Policy ........................................................................... 36 
10.1.12 
Conflict of Interest Policy .............................................................................................. 36 
10.2 
Additional Considerations ................................................................................................................. 36 
10.3 
Abbreviations and Special Terms ................................................................................................... 36 
10.4 
Protocol Amendment History ........................................................................................................... 38 
11 
REFERENCES ............................................................................................................................................. 38 
 

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STATEMENT OF COMPLIANCE 
 
(1) [The trial will be carried out in accordance with International Council on Harmonisation Good 
Clinical Practice (ICH GCP) and the following:  
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812).  
 
National Institutes of Health (NIH)-funded investigators and clinical trial site 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 protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the IRB for review and approval. Approval of both the protocol and the consent 
form(s) must be obtained before any participant is consented. Any amendment to the protocol 
will require review and approval by the IRB before the changes are implemented to the study. All 
changes to the consent form(s) will be IRB approved; a determination will be made regarding 
whether a new consent needs to be obtained from participants who provided consent, using a 
previously approved consent form.] 
 
 

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INVESTIGATOR’S SIGNATURE 
The signature below constitutes the approval of this protocol and provides the necessary assurances 
that this study will be conducted according to all stipulations of the protocol, including all statements 
regarding confidentiality, and according to local legal and regulatory requirements and applicable US 
federal regulations and ICH guidelines, as described in the Statement of Compliance above. 
 
Principal Investigator or Clinical Site Investigator: 
Signed: 
 
Date: 
01/16/2026 
 
Name*: Debra M. Rios 
 
Title*: Research Scientist 
 
Investigator Contact Information 
Affiliation*: ISA Associates, Inc. 
Address: 4501 Fairfax Drive, Ste 601 Arlington VA, 22203 
Telephone: 703-739-0462 
Email: drios@isagroup.com 
 
 
 
 
 

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1 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
 
Title: 
Diabetes Prevention for Hispanics Residing in Rural Communities: A 
Mobile Web-based Approach 
Grant Number: 
R44MD014082 
Study Description: 
Two-arm, parallel-group randomized controlled trial comparing a 
tailored, mobile web app diabetes prevention program with usual care 
control to reduce diabetes risk by at 3 and  6 months among Hispanic 
adults who are at risk of developing Type II Diabetes. 
Objectives*: 
 
Objectives: Primary—evaluate the effect on percent weight loss . 
Secondary—evaluate effects on A1C, diabetes knowledge, eating 
patterns, and physical activity. 
Endpoints*: 
Endpoints: Primary—weight assessed at each study visit (baseline, 2 
post visits). Secondary—validated scale scores at baseline and 2 follow-
ups. 
Study Population: 
Hispanic adults aged 18+, with prediabetes, and smartphone owners in 
South Texas 
Phase* or Stage: 
Phase II clinical trial 
Description of 
Sites/Facilities Enrolling 
Participants: 
Single U.S. community health center in South Texas 
Description of Study 
Intervention/Experimental 
Manipulation: 
The study intervention includes a variety of education series with 
explanatory videos, interactive content, infographics, and engaging 
tools aimed at increasing diabetes risk knowledge, reducing risk 
behaviors, and improving overall health. Participants review the 
intervention across three months. Comparator: Usual care.  
Study Duration*: 
19 nb months 
Participant Duration: 
6 months 
1.2 
SCHEMA  
 
 
 

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Flow Diagram 
Participant Flow Diagram 1.  
 
Study Flow Diagram 2.  
 
 
 
1.3 
SCHEDULE OF ACTIVITIES  
 
The schedule below is provided as an example and should be modified or replaced as appropriate.   
 
 

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Pre-screening 
(Pre-consent) 
  
Appointment 1 
Day 1 
Day 8-91 
Appointment 2 
Day 92 
Appointment 3 
 Day  ~175 
Study information sent to 
potential participants 
X 
 
 
 
 
Confirmatory eligibility 
screening 
X 
 
 
 
 
Informed Consent 
 
X 
 
 
 
Demographics 
 
X 
 
 
 
Outcome Evaluation 
 
 
 
 
 
Weight measurement 
 
X 
 
X 
X 
A1C Measurement 
 
X 
 
X 
X 
Knowledge Questionnaire 
 
X 
 
X 
X 
Health Behavior 
Questionnaire 
 
X 
 
X 
X 
Randomization 
 
X 
 
 
 
Control Intervention  
 
 
X 
X 
 
Experimental Intervention 
 
 
X 
 
 
Adverse Events Reporting 
 
X 
X 
X 
X 

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2 
 
INTRODUCTION 
No text is to be entered in this section; rather it should be included under the relevant subheadings below. 
 
The following subsections should include relevant background information and rationale for the clinical 
trial. This should be a brief overview (e.g., approximately 3-7 pages). Referring to relevant intervention 
manuals for more detail is appropriate. Text for Sections 2.1 and 2.2 may come from the Background and 
Significance section of the grant application. 
 
2.1 
STUDY RATIONALE  
Behavioral interventions have been successful in reducing and delaying diabetes by targeting weight loss 
through modifiable behaviors (e.g., diet and exercise). There remain significant difficulties implementing 
Diabetes Prevention Programs (DPP) in certain populations due to access and resource availability. The 
health disparities seen between individuals living in rural communities versus metropolitan areas are 
evident. Rural communities have a 17% higher rate of type 2 diabetes compared to their urban 
counterparts.  
Previous efforts to culturally adapt the DPP for Hispanics are vital, yet critical gaps remain. Specifically, 
insufficient attention has been paid to Hispanics living in rural settings  and the formidable barriers these 
individuals face. We intend to fill this gap. ISA Associates, in partnership with the Community Action 
Corporation of South Texas (CACOST), has developed a mobile web-based diabetes prevention program 
for Hispanic Americans living in rural communities. STEPS: Small Changes to Prevent Diabetes will be 
designed to increase knowledge and skills to help change lifestyle factors associated with diabetes of 
Hispanics living in rural settings. STEPS will also place a strong emphasis on Hispanic cultural beliefs and 
will include themes of familismo, Mexican inspired recipes, and community health workers (promotoras). 
STEPS will deliver culturally tailored information to users following assessments of their needs and 
personal situation. The program provides users with the information, skills, and tools needed to promote 
health and reduce risk for the development of diabetes. Materials will be multi-modal in format (e.g., 
narration by a program ‘coach’, culturally-appropriate visuals, graphics, interactive assessments with 
feedback, and tailoring of information). The goal of the program will be to promote self-management of 
diet and physical activity and minimize risks associated with diabetes. 
We plan to test the effectiveness of STEPS in a randomized controlled trial with 165 Hispanic adults. 
Participants will be randomly assigned to receive either the mobile STEPS intervention or usual care. 
Before, about 3-months post randomization, and about 6-months  post randomization, we will assess 
anthropometric data including height, weight, a1c; demographic data, diabetes risk and knowledge, 
dietary intake, and self-report PA. 
 

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2.2 
BACKGROUND  
Over half of all U.S. population growth between 2010 and 20191 was among Hispanics, who are now 
the largest racial/ethnic minority group in the United States (U.S.).2 While this expanding population 
faces a myriad of health challenges, none is bigger than diabetes and its cascading effects. More than 
half of all Latinos will develop diabetes in their lifetime.3 And those that do are twice as likely to be 
hospitalized for end-stage renal disease compared to non-Hispanic whites4, are more likely to suffer 
from diabetic retinopathy5, and are at a greater risk of mortality from COVID-19.6 Hispanics are also 50% 
more likely to die from diabetes than non-Hispanic whites.7 Indeed, the problem is only intensifying for 
this growing population; the rate of new cases among Latinos is almost double that of non-Hispanic 
whites.8  
Diabetes Lifestyle Risk Factors. Type 2 diabetes (T2D), which accounts for 90-95% of all cases, is 
largely preventable.8 Consumption of a high fat and high diet caloric (including high caloric drinks); 
insufficient physical activity (PA); and prolonged sedentary time are all linked to the development of 
T2D.9-20,23-28 Further, 52% of Hispanics do not meet the US weekly PA guidelines compared to 42% of 
non-Hispanic whites,22 and get a higher proportion of their daily caloric intake from sugar-sweetened 
beverages.28 Additionally, the risk of T2D increases as Hispanics modify their behavioral norms to be 
more consistent with the dominant culture.29-31 Indeed, higher levels of acculturation among Hispanics 
predicts greater consumption of sugar-sweetened beverages, saturated fats, and fried food.30,32-33 
Consistent with this disparity in poor eating habits and insufficient PA, Latinos are also more likely to be 
overweight/obese as compared to whites.34 Overweight and obesity is a significant risk factor for T2D, 
with virtually all diagnosed cases having a body mass index (BMI) of 25 or higher.8,35-37 The degree of 
acculturation is also positively associated with BMI in Hispanics.37,42  
Prediabetes. It is estimated that 88 million U.S. adults have prediabetes (i.e., a higher than normal 
blood sugar level);8,43 a serious risk factor for developing T2D, heart disease, and stroke.44 Indeed, 70% of 
individuals with prediabetes will go on to develop diabetes.45 Similar to lifestyle risk factors, the rate of 
prediabetes is higher in Hispanics as compared to other non-Hispanic groups.7,46 
Diabetes Prevention Program. Fortunately, a relatively modest reduction in body weight can 
significantly reduce the risk of developing T2D among those with prediabetes.36 This was most clearly 
demonstrated by the Diabetes Prevention Program (DPP).47-48 This landmark intensive behavioral 
intervention focused on healthy eating, PA, and stress management.49 Over one year, participants 
attended 16-sessions (30-60 minutes in length) and bi-monthly in-person maintenance meetings after 
the active intervention phase. Each participant had access to a lifestyle coach and additional resources 
such as on-site PA sessions and food vouchers.49 At 3-year follow-up, those who received DPP training 
lost between 5-7% of their total body weight and lowered their risk of developing diabetes by 58% 
compared to controls.47 These effects persisted at 10-year follow-up.48  
Cultural Adaptations of the DPP. Culturally sensitive behavioral health programs promote higher 
levels of acceptance, greater comprehension, and are more effective than generic programs for minority 
groups, including T2D prevention programs.50-53 Ritchie et al54 compared the effectiveness of the DPP for 
both English- and Spanish-speaking Hispanics to non-Hispanic whites. All groups lost weight, but 
Hispanics attended fewer sessions and were less likely to achieve recommended weight loss targets. As 
a result, it was recommended the DPP curriculum be further tailored, beyond language translation, to 
improve outcomes among Hispanics.54 
To provide a framework for successful adaptations of T2D interventions, Lagisetty and colleagues50 
reviewed 34 culturally tailored diabetes programs. Overall, they found that interventions that were 

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more comprehensively tailored were also more successful. Indeed, they identified four essential 
tailoring domains: facilitators, language, location, and messaging. According to the FiLLM model 
(“Facilitating Interventions through Language, Location, and Message”), those who deliver the program 
should be community members who share core characteristics with the target population (e.g., 
community health workers). The program should also be delivered in the preferred language of 
participants and should be sensitive to literacy levels of typical end-users. Furthermore, access to the 
intervention should be convenient (e.g. community center, churches). Finally, the educational content 
(e.g. culturally tailored diet, family) and the mode of message delivery (i.e. communication channels 
most accepted by users) should be tailored to the intended audience.50 
O’Brien et al55 tailored a version of the DPP across the four FiLLM domains by using promotoras to 
deliver the training in a community-based organization, with cultural dietary components and 
concepts(e.g. familismo). Latinas with prediabetes who went through the intervention significantly lost 
weight, reduced waist circumference and LDL cholesterol, and lowered diastolic blood pressure. 
Similarly, Ockene et al56 utilized community members as facilitators, tailored language and literacy levels 
to the target population, implemented the intervention at a community center, and tailored messaging 
content (e.g., modifying traditional recipes) through a preferred communication channel (e.g. 
telenovela). At 1-year follow-up, at-risk Hispanics in the intervention group experienced a myriad of 
significant salutary effects including weight and hemoglobin A1c (HbA1c) reduction compared to those 
in usual care. Overall, the evidence supports relying on the FiLLM framework to develop a culturally 
tailored diabetes intervention for optimal effectiveness.   
Rural Hispanics: The Forgotten Group. Previous efforts to culturally adapt the DPP for Hispanics are 
vital, yet critical gaps remain. Specifically, insufficient attention has been paid to rural Hispanic 
populations and the formidable barriers these individuals face. This is an important group. Four million 
Hispanics reside in rural areas,57 accounting for 46.2% of the growth in these communities.58 Rural 
communities, in general, are facing significant health challenges.59 Consistent with this, residents of rural 
communities have a higher incidence of T2D compared to urban dwellers.60 Furthermore, Latinos who 
reside in rural settings have significantly higher mortality rates than Latinos living in metropolitan 
areas.61 These morbidity and mortality disparities might be partially explained by the dearth of diabetes 
self-management education and support programs in nonmetropolitan counties.62,63 Almost 2/3 of rural 
residents do not have access to these programs.62 Indeed, access to quality health services, proper 
nutrition and weight status, and diabetes prevention were identified as the top 3 priorities among a 
national sample of rural health stakeholders.64 
It is crucial that any rural T2D interventions account for the specific access and resource barriers 
facing these communities. Most prominently is a lack of readily available community and healthcare 
services, necessitating longer travel to obtain these services.65 This becomes even more burdensome 
due to the lack of public transportation in these geographic areas.66 Thus, multiple on-site sessions are 
impractical. Program curriculum must also be consistent with local resources. There is a lack of 
recreational facilities to engage in PA68-71 and the density of grocery stores is low in rural areas thereby 
leading to cost and transportation barriers to healthful foods.61,67-69.  The per participant cost for the 
initial year of DPP training is $1,39972 (including a program coach).49 While later interventions have 
reduced these costs (to as low as $553 per participant),73 this remains impractical for most rural 
communities given their monetary and healthcare workforce shortages.74 
An often-overlooked aspect to rural programming are the cultural factors that are particularly 
germane to T2D prevention. Research demonstrates that rural women are more likely to be discouraged 
from exercising by others compared to urban women,67,75-76  thereby leading to a social norm against 

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PA.77-78 This cultural barrier is only reinforced when rural women see their neighbors exercising less 
often compared to urban women.78-79 
Some DPP adaptations have relied on web-based approaches, mobile phones, and 
videoconferencing to overcome these access and resource barriers and have yielded average weight loss 
ranging from 3.3% to 4.7%.80 While clinically meaningful and comparable to in-person programs,81 the 
modal participant across these studies have been white females with higher levels of education.80 To 
address this shortcoming, Omada Health recently developed and evaluated a digital version of the DPP 
for an urban, multi-ethnic/racial Medicaid population.82 Participants in the intervention group lost, on 
average, 4% of their total body weight. Examining only those who completed 9 or more sessions yielded 
even greater weight loss. Overall, these findings suggest that an online version of the DPP can benefit 
low-income multi-ethnic/racial populations.82 While the program was offered in Spanish, additional 
cultural tailoring for the needs of rural Hispanics remain unaddressed. The lack of diabetes prevention 
programs targeting this high-risk, underserved population is a major weakness in the fight against 
T2D.52-53,80 We intend to address this weakness. 
During Phase I, we developed an early version of a culturally-tailored, theoretically-driven mobile 
web-based T2D prevention program for rural Hispanic adults. By digitizing our program, we are reducing 
access barriers and providing diabetes prevention straight to the fingertips of an at-risk population who 
otherwise would be unexposed to this resource. We aim to increase knowledge about diabetes risk, 
enhance skills to prevent new cases, and improve self-efficacy to deploy those new skills by 
interweaving both Hispanic and rural cultural components into our intervention. For example, cultural 
values like Familismo83 will be incorporated by involving la familia in healthy cooking nights utilizing 
traditional Hispanic recipes (e.g. enchiladas with chicken and low-fat cheese). PA regimens will be taught 
in a way that are consistent with rural constraints such as walking at local track fields or being active at 
home.77 Our intervention will capitalize on the strong social support seen among comadres/compadres84 
to encourage healthful behaviors and change social norms on rural exercise.78-79 Further, interactive 
tools that promote self-regulation (e.g. goal setting tool) will provide motivation to end-users and 
increase self-efficacy to adopt and maintain healthy eating and PA. In developing an mHealth diabetes 
prevention program, we are providing a scalable resource that can make a significant impact on Hispanic 
health, thus, presenting vast commercialization potential across rural America.  
2.3 
RISK/BENEFIT ASSESSMENT  
 
The following subsections should include a discussion of known risks and benefits, if any, to human 
participants. Text from the corresponding sections of the Human Subjects section of the grant application, 
and/or IRB package may be used here.  
 
2.3.1 KNOWN POTENTIAL RISKS  
There are minor risks to human subjects from participating in this project, however, protocols have been 
developed to further reduce risk for all participant. 
 
Participation. There are some minor risks associated with participating in the study. Participants will be 
told that participation is completely voluntary and that there are no consequences associated with 
choosing not to participate. Additionally, participation within the Fitbit and Text Message components of 

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the study are also voluntary and participants can opt-out of these components without hindering their 
participation in the full study. When completing any type of study questionnaire or biometric data, 
participants will be told answers are not tied to any indefinable information and that they may skip any 
question or test they do not wish to answer or complete. It is possible that, as a result of hearing or talking 
about diabetes, a participant may become concerned about his or her own diabetes risk. This realization 
may be accompanied by distress. If this should occur, participants will be given contact information for 
the CACOST Health center and will be instructed to contact their primary care provider for additional 
assistance. Participants can stop participating at any time, and their care at CACOST will not be affected.  
They will continue to receive the same level of services from CACOST.  
 
Physical Activity. There are some minor health risks associated with participating in physical activity via 
the STEPS program. To minimize risk, ISA has instituted several protocols to protect participants and 
reduce their risk related to physical activity. To begin, it is an eligibility criteria that participants must PASS 
the PAR-Q+ Physical activity screener AND if yielded from the screener, receive a doctor’s note indicating 
that they are medically cleared to exercise. Additionally, once in the program, there are disclaimers in the 
physical activity modules that remind participants that if at any point they are questioning engaging in 
physical activity due to health or have concerns they will need to contact their primary care provider. 
Contact information for the CACOST Health Center will be included. If a participant reaches out to ISA Staff 
at any point to indicate injuries with physical activity, ISA Staff will advise to stop all physical activity until 
further discussed with their primary care provider. Further, ISA Staff will report to the PI and a report will 
be made.  
 
A1c Test. There are some minor health risks associated with conducting and obtaining information from 
a rapid A1C test. The use of a rapid A1C test is no more of a risk than using a blood glucose meter. It 
does not require blood to be drawn, in large amounts, or using a syringe. It also does not require a 
medical professional to complete. An A1C self-check will be conducted by the participant after being 
provided with instructions by ISA Staff. ISA Staff will monitor to ensure the participant is following 
directions. This test requires a droplet of blood only slightly larger than a traditional glucose monitor 
test. Participants will do the step-by-step instructions and then show ISA Staff their A1C reading. If a 
participant does NOT want to participate in doing the test, they will not be required to. There are 
minimal risks associated with the test. To alleviate the risks, ISA Staff will implement the following 
procedures for the following associated risks. 
First, even though ISA Staff will be instructing the participant to self-test, they will wear a new set of 
latex gloves with each reach in the case they need to assist the participant. They will also throw all 
supplies in a sharps container once the test is completed. They will disinfect the area where the test is 
conducted as well.  
While the blood sample is just a droplet of blood, there might be participants who have anxiety about 
blood and/or may feel light-headed at the sight of blood. Therefore, all participants will be required to 
be seated while they conduct the self-test. Additionally, if a participant feels unwell due to the blood 

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droplet, ISA STAFF will immediately call CACOST Health Center Staff to come assess the participant. 
While highly unlikely, in the case that there is a medical emergency, ISA Staff will immediately contact 
first responders. After the incident has been handled and cleared, ISA Staff will immediately contact the 
PI to inform them of the event and will document details.  
Additionally, there may be associated risks with the participant learning their A1C levels. If a 
participant’s A1C level is in the diabetes range, they will be provided with a sheet with information on 
A1C levels and information about how to contact their primary care physician about their results. This 
sheet will provide CACOST Health Center contact information as well.  
Data. There are some minor risks associated with data safety, however, we have several protocols in 
place to protect the data of all participants. With the exception of the contact forms, consent document, 
and signatures on a receipt log used to track participant payment, ISA will not be collecting written, 
identifiable information from participants.  ISA staff will keep these forms in a locked cabinet. Further, 
contact forms will be shredded once the research study is complete. Consent documents and the receipt 
logs will be kept in a sealed envelope and in the possession of ISA Staff when not at ISA. After returning 
from the data collection, the documents will be stored in a locked filing cabinet to minimize any 
opportunity for breaches in confidentiality.  Given the fact that no identifying information will be 
recorded on any anthropometric data and surveys, and that strict security procedures will protect 
participants personal information gathered on the contact form, consent forms, and receipt logs, the 
protections against any possible breach of confidentiality are likely to be quite successful. To further 
protect against any breaches of confidentiality, all project staff proposed to work on this project have 
received or will receive training on the protection of research risks and are or will be well versed in the 
Code of Federal Regulations (including 45 CFR 46 and 42 CFR) and the Belmont Report.  ISA continually 
obtains information from the Office of Protection from Research Risks at NIH on new regulations 
regarding the protection of human subjects, which is disseminated to all staff. 
2.3.2 KNOWN POTENTIAL BENEFITS  
Include a discussion of known potential benefits from either clinical or nonclinical studies. For behavioral 
or social intervention studies, relevant published literature should provide relevant benefits information. 
For studies including a licensed or approved product, a package insert or device labeling should be used as 
a primary source of benefits information. If the study includes an investigational product, the Investigator’s 
Brochure (IB) should be a primary source of the benefits information.  
 
Describe any physical, psychological, social, legal, or any other potential benefits to individual participants 
or society in general, as a result of participating in the study, addressing each of the following:  
 
• 
Immediate potential benefits 
• 
Long-term potential benefits 
 

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Note that payment to participants, whether as a non-coercive inducement to participate or as 
compensation for time and inconvenience, is not considered a “benefit.” Provision of incidental care is also 
not to be considered a benefit. For details of compensation see Section 5.5, Strategies for Recruitment 
and Retention. 
 
There are several benefits to participating in the proposed research to both the research participants and 
others. There are a number of benefits to participating in the proposed research for both the participants 
and others.  All participants will have access to a state-of-the-art diabetes prevention program that can 
help them improve health behaviors, reduce diabetes risk, and improve overall health. This information 
should not only be of interest to participants but also help them understand the importance of prevention 
behaviors in protecting their health.  This research also has the potential to benefit many other Hispanic 
adults, since ISA will test the effectiveness of this mHealth intervention. If found to be successful, this 
program can help better meet the needs of Hispanic adults and better provide them with information and 
training in how to prevent diabetes.  Given that the potential risks are minimal, the risk to participants 
seems quite reasonable in relation to the benefits. Given that the potential risks are very small, the risk 
to participants seems quite reasonable in relation to the benefits. 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
Include an assessment of known potential risks and benefits, addressing each of the following: 
• 
Rationale for the necessity of exposing participants to risks 
• 
A summary of the ways that risks to participants were minimized in the study design 
• 
Justification as to why the value of the information to be gained outweighs the risks of 
participation in the study  
 
As indicated above, the risks to study participants are small. ISA will protect against any potential risk and 
ensure the confidentiality of the data using multiple methods. First, to protect against psychological risk 
or discomfort in completing the survey, participants will be informed of the confidentiality of the surveys 
(i.e., they will contain no personally identifying information) and the secure nature of the computer-based 
survey tool. In addition, questions will be phrased in a way to minimize discomfort and participants will 
be free to skip questions they do not wish to answer. No one outside the study team will have access to 
the data. Moreover, participants will be told specifically that if, because of reviewing their assigned 
materials or completing the research surveys, they are feeling distressed about their physical health, they 
should discuss their concerns with a CACOST Staff Member. They will also be provided with a list of 
resources in the informed consent that can provide information about diabetes.  
 
To maintain confidentiality of all data collected, no names or other identifying information will be included 
on the survey, or as part of STEPS or the control materials. As noted earlier, the file that will link the 
participant name to the user ID and study phone number will be maintained on a password protected 
computer that will not house the survey data. The only people that will have access to the linking file will 
be the Principal Investigator and her staff. Finally, we will utilize strict security protocols – described 
previously – to protect the confidentiality of all information stored on our secure server as part of the 
STEPS intervention. 
 
To protect against any breaches of confidentiality, all project staff proposed to conduct the data collection 
have received or will receive training on the protection of research participants and are or will be well 

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versed in the Code of Federal Regulations (including 45 CFR 46 and 42 CFR) and the Belmont Report. ISA 
continually obtains information from the Office for Human Research Protections (OHRP) at NIH on new 
regulations regarding the protection of human subjects, which is disseminated to all staff.  
 
After all participants have completed follow-up surveys, the linking file housed on the ISA computer – the 
only file that contains participant’s personal information (e.g., name, phone number) – will be deleted. In 
addition, the Windows Eraser program will be used to completely remove (i.e., “wipe”) the linking file 
from the computer by overwriting it several times using government-sanctioned deletion algorithms.  
Deidentified participant research data from the baseline and follow-up surveys will be retained for 3 years 
from the submission of the final financial report to NIH, in keeping with guidelines described in the NIH 
Grants Policy Statement. 
 
The Phase II evaluation will provide very important information about the efficacy of the STEPS 
intervention to improve the health of Hispanic adults residing in rural areas. This data is critical to 
developing a successful program that can help Hispanic adults reduce their risk of Diabetes. Knowledge 
gained from this field test will be integrated into the final program prior to marketing to FQHCs and other 
health care organizations. We believe that the risks associated with this Phase II effort are reasonable in 
relation to the valuable information we will receive. 
3 
OBJECTIVES AND ENDPOINTS  
Provide a description of the study objectives and endpoints, as well as a justification for selecting the 
particular endpoints, in the table format included below. This will provide clear articulation of how the 
selected primary and secondary endpoint(s) are linked to achieving the primary and secondary objectives 
and an explanation of why endpoint(s) were chosen. Data points collected in the study should support an 
objective or have a regulatory purpose. Therefore, careful consideration should be given prospectively to 
the amount of data needed to support the study’s objectives. 
 
An objective is the purpose for performing the study in terms of the scientific question to be answered. 
Express each objective as a statement of purpose (e.g., to assess, to determine, to compare, to evaluate) 
and include the general purpose (e.g., feasibility, acceptability, engagement of the intervention target, 
identifying mechanisms of action, mediation, moderation, efficacy, effectiveness, dissemination, 
implementation). 
 
A study endpoint is a specific measurement or observation to assess the effect of the study intervention. 
Study endpoints should be prioritized and should correspond to the study objectives and hypotheses being 
tested. Give succinct and precise definitions of the study endpoints used to address the study’s primary 
objective and secondary objectives (e.g., specific diagnostic tests that define safety or efficacy, clinical 
assessments of disease status, assessments of psychosocial characteristics, patient reported outcomes, 
behaviors or health outcomes). A full description of study endpoints, including administration, scoring, 
psychometrics, adjudication of endpoints, etc., belongs in Section 8, Study Assessments and Procedures.   
 
A putative mechanism of action is the theorized explanation for how the intervention functions.   

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Consider whether primary and secondary endpoints should be adjusted for multiple comparisons, family-
wise error rates, alpha inflation, etc. Details of any such adjustments should be included in Section 9.4.2, 
Analysis of the Primary Endpoint(s) and Section 9.4.3, Analysis of the Secondary Endpoint(s).   
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
 
 
To evaluate whether the 
intervention increases percent 
weight loss in Hispanic adults.  
 
 
• 
Weight measured by the 
research staff at each 
study visit 
 
Tests causal mechanism   
Secondary 
 
 
To evaluate whether the 
intervention improves A1C levels, 
diabetes knowledge, and improves 
health behaviors.  
 
• 
A1c levels measured by 
research staff at each 
study visit 
• 
Diabetes knowledge 
• 
Eating pattern behaviors 
• 
Physical activity behaviors 
Tests causal mechanism or 
potential moderating effects 
 
4 
STUDY DESIGN 
No text is to be entered in this section; rather it should be included under the relevant subheadings below. 
 
4.1 
OVERALL DESIGN 
 
This is a Phase II single-site randomized, 2-arm between-subjects study examining differences in diabetes 
risk and knowledge between participants randomized to the experimental intervention and those 
randomized to the attention control condition (usual care). Outcomes were assessed at baseline, three 
months 1 week post baseline, and again at 6-months  1 week post-baseline. We hypothesized that 
experimental participants would have higher rates of percent weight loss and improved knowledge and 
behaviors to reduce diabetes risk than control participants. Participants were assigned to conditions by 
an algorithm programmed into the study computer using a permuted blocks randomization scheme. 
Blocks of size 4 and 6 were used. Assignments within blocks were to be random but balanced among the 
two conditions and the order of the blocks (4 vs 6) also was random. This procedure will ensure that the 
number of participants randomized to each condition was equal, that any imbalance among the 
conditions at any point during the recruitment and randomization was modest, and that it would be very 
difficult to guess the assignment of the next participant. Randomization was administered via computer-
based admin system and triggered by the study coordinator.   
 

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The intervention, STEPS, combines educational videos and content, as well as skill development exercises 
to provide diabetes education, reduce risk of developing Type II Diabetes.  
 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
Those in the control condition will receive UC. Due to the lack of adequate resources for T2D prevention 
in rural communities,62-63 we designed the control to provide the most intensive diabetes prevention 
education a patient could expect from their primary care doctor.118,149 This method has been used in 
prior RCTs examining the effects of T2D prevention programs for Hispanic adults.118,149 This study design 
was chosen to allow for a comparison between the STEPS intervention and what is commonly available 
to Hispanics in rural areas.  
 
4.3 
JUSTIFICATION FOR INTERVENTION 
 
The STEPS intervention is an effective, affordable, and scalable intervention to reduce diabetes risk among 
Hispanic adults. Principles from the Social Cognitive Theory (SCT),53,84,117 Theories of Social Networks and 
Social Support117 will guide development of STEPS. For example, self-regulation is a core concept of SCT117 
and a key component of T2D prevention.98 As such, STEPS will include interactive tools to help end-users 
set PA and eating goals, monitor progress towards meeting those goals, and reinforce success through 
feedback.  Additionally, outcome expectations related to T2D diagnosis and outcomes will be examined 
through a cultural lens. There will be substantial observational learning opportunities through videos and 
interactive activities that will also reinforce self-efficacy in healthy eating and PA. Additionally, the 
Theories of Social Networks and Social Support117 will provide a framework to mobilize social resources at 
both the individual and community levels. Our tool, Connect with Comadres/Compadres, will encourage 
social network appraisal and help users solicit instrumental support to meet their health goals. Lastly, the 
FiLLM50 model will guide cultural tailoring of STEPS to meet the needs of rural Hispanics. 
 
4.4 
END-OF-STUDY DEFINITION 
 
A participant is considered to have completed the study if he or she has completed the baseline 
assessment and the 6-month follow-up assessment. 
 
5 
STUDY POPULATION 
 
5.1 
INCLUSION CRITERIA 
 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
1. Provision of signed and dated informed consent form 
2. 18 years of age and older 

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3. Able to read and write in English or Spanish 
4. Hispanic 
5. Resides in rural area 
6. Has access to a smartphone and internet access 
7. Does not have diabetes 
8. Has prediabetes as per screener 
9. Not currently pregnant 
10. Can participate in physical activity as per screener 
5.2 
EXCLUSION CRITERIA 
 
An individual who meets any of the following criteria will be excluded from participation in this study: 
 
1. Less than 18 years of age 
2. Not able to read and write in English or Spanish 
3. Resides in a metropolitan area 
4. Does not have access to a smartphone and internet 
5. Has been diagnosed with diabetes 
6. Cannot participate in physical activity as per screener 
5.3 
LIFESTYLE CONSIDERATIONS 
 
N/A 
 
5.4 
SCREEN FAILURES 
 
Screen failures are defined as participants who consent to participate in this study but are not 
subsequently assigned to the study intervention or entered in the study. Re-screening is permitted if 
circumstances change.  
 
 
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
Participants will be recruited from Community Action Corporation of South Texas (CACOST) health 
centers through a collaborative effort between CACOST health center employees and the onsite ISA 
Research Assistant. CACOST is a non-profit organization that aims to improve the health and wellness of 
the people of South Texas and includes several health services including primary care, women’s health, 
dental, and mental health services. As key healthcare providers in the South Texas region, CACOST is the 
leading health provider to over 16,000 patients annually. Almost 70% of their patient population is over 
the age of 18 and 87% of patients identify as Hispanic.  

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Similar to our successful Phase I recruitment process, recruitment will occur at CACOST clinics and also 
via CACOST social media platforms. Specifically, Patient Care Coordinators will hand out study flyers 
prior to patient visits with their primary care physician. The Patient Care Coordinators will instruct 
interested participants to contact the on-site research assistant for more information about the project 
and will provide a room number,  a telephone number, and hours in which the research assistant is 
available. Additionally, contact information for the on-site ISA Research Assistant will be listed on study 
flyers (i.e. online and in person). The same study flyer will also be posted on CACOST social media 
platforms to further reach the target audience. We successfully used this strategy to recruit rural 
Hispanic adults from CACOST for focus groups and feasibility testing for the prototype of our proposed 
diabetes prevention program.  
To maximize retention, this study will employ several techniques that have proven successful in previous 
research projects conducted by ISA with similar populations. First, the on-site ISA Research Assistant will 
collect as much contact information as the participant feels comfortable providing (e.g., additional 
phone numbers, email address, preference for calls v. text messages). This will include asking about 
secondary contacts – these are alternate phone numbers where the participant can be reached, such as 
the number of a parent, spouse, or friend. To protect participant’s privacy, the on-site Research 
Assistant will record how the project should be identified when calling each secondary contact (e.g., 
“the diabetes project” v. “the phone study”). We have successfully retained participants whose personal 
phones were temporarily unavailable (e.g., the phone was broken or disconnected, the participant got a 
new number) using this strategy. Second, we will offer reminder texts or calls the day before a 
scheduled appointment. Third, if a participant misses a scheduled appointment, the on-site Research 
Assistant will implement the retention protocol with the goal of rescheduling the missed appointment. 
Specifically, the on-site Research Assistant will contact the participant via their preferred contact 
method the day of the missed appointment and – if they are not reached – every two business days 
thereafter for one week. If the participant is not reached within a week, the ISA Research Assistant will 
begin calling the alternate contacts’ phone numbers. If the participant is not reached after calling each 
alternate contact once, the Research Assistant will continue contacting the primary number every two 
days for an additional week. If the participant is not reached after two weeks, the on-site Research 
Assistant and the Principal Investigator will meet to determine whether additional contacts are 
warranted or if the participant should be categorized as “lost to follow up.” 
In general, we expect the retention rates to be high. CACOST is well regarded in the South Texas region 
and many participants visit regularly for medical care or other services. We believe the proposed study 
will have similarly favorable retention rates.   
 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
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6.1 STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION 
No text is to be entered in this section; rather it should be included under the relevant subheadings below.   
 
6.1.1 STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
 
STEPS is an effective, affordable, and scalable intervention to reduce Type II Diabetes risk in Hispanic 
adults. Principles from the Social Cognitive Theory (SCT),53,84,117 Theories of Social Networks and Social 
Support117 will guide development of STEPS. For example, self-regulation is a core concept of SCT117 and 
a key component of T2D prevention.98 As such, STEPS will include interactive tools to help end-users set 
PA and eating goals, monitor progress towards meeting those goals, and reinforce success through 
feedback.  Additionally, outcome expectations related to T2D diagnosis and outcomes will be examined 
through a cultural lens. There will be substantial observational learning opportunities through videos and 
interactive activities that will also reinforce self-efficacy in healthy eating and PA. Additionally, the 
Theories of Social Networks and Social Support117 will provide a framework to mobilize social resources at 
both the individual and community levels. Our tool, Connect with Comadres/Compadres, will encourage 
social network appraisal and help users solicit instrumental support to meet their health goals. Lastly, the 
FiLLM50 model will guide cultural tailoring of STEPS to meet the needs of rural Hispanics. 
The STEPS 12-week curriculum closely follows the sequence and topics of the original DPP 
intervention.49 Van Name et al118 conducted an RCT on a shortened (14-wk) version of the DPP. At 12-
month follow up, participants who received this modified DPP yielded a 6% weight loss as compared to 
controls. Building off this success, we intend to incorporate all core behavioral learning components of 
successful intensive lifestyle intervention for T2D.98 The first seven modules will focus on building 
foundational knowledge, setting and then working towards diabetes preventive goals, and enhancing 
self-monitoring skills. The latter five modules will focus on maintenance of behavior change. All module 
content will address the psychological, social, and motivational benefits and barriers to regular PA and 
healthy eating specifically among rural Hispanics. 
 
Self-monitoring and social support are integral components of self-regulation, and are critical to 
effective diabetes prevention.98 The Goal Setting tool will utilize a simple interface with drop down 
options and buttons to easily help users define specific and attainable PA and healthy eating goals.98 
Specifically, end-users will be able to 1) name their goal, 2) type in the behavior (e.g., walk two laps at 
the track), and 3) select the frequency (e.g., 3 times per week) and duration (e.g., 4 weeks) of the 
desired behavior. The Goal Setting tool will then finalize their goal (e.g., “I will walk two laps at the track 
3 times a week for 4 weeks.”) This tool will allow users to easily monitoring their goals (e.g. indicate goal 
progression and completion). Once a goal is achieved, users will receive a virtual trophy icon by their 
goal to indicate success. The STEPS Tracker is a highly interactive tool that is synced with a Fitbit 
wearable and allows for self-monitoring of PA, diet, and weight. Within the tool, users can set their daily 
steps goal, will see visuals on their progress (via the Fitbit web API), and will receive notifications for 
achievements. Additionally, users can manually enter their weight and daily dietary consumption by 
selecting foods from a library of common and cultural foods. Users will receive summary statistics and 
figures displaying calories and fat per food item and each day’s consumption, aligned with the original 

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DPP curriculum.49 The STEPS Tracker will provide visual feedback with charts and easy to understand 
diagrams (e.g. total steps walked per day and per week). The Connect with Comadres /Compadres tool 
will allow users to create friend groups within the STEPS program and then exchange support, 
motivation, and successes by using pre-designed messages (e.g. “You’ve got this”, “Great job”). In 
addition, users will be able to post their daily steps from the STEPS tracker tool within their friend 
groups to show successes and encourage others in their PA endeavors. The Health Text Messages tool 
will deliver 46 text messages across the intervention. A meta-analysis examining the effects of text-
messaging for health promotion found that message frequency moderated the effect of health 
interventions.120 Specifically, interventions that decreased the frequency of text messages had larger 
effects than those that relied on low-fixed or high-fixed messaging frequency. Thus, STEPS users will 
receive 5 messages per week  during week 1, 4 messages per week during weeks 3-8, and 3 messages 
per week during weeks 9-12. Topics will cover healthy eating, PA, stress, motivation, and reminders to 
use the program. Examples of text messages include: “Make tonight a healthy eating night con la 
familia! Check out the healthy arroz con pollo recipe in STEPS: <weblink>”; “Stand up and walk in place 
for 5 minutes!”; and “Take a minute to do belly breathing. Try this exercise in STEPS <weblink>”.   
The control group will receive usual care.  
6.1.2 ADMINISTRATION AND/OR DOSING 
 
Participants in the intervention arm receive a fully automated, mobile web app that videos, text, 
animations, and interactive activities. It is entirely accessible on a mobile device. The curriculum phase 
consists of twelve modules that are adapted from the DPP and also align with Effective components of 
Lifestyle Interventions to Reduce Diabetes Risk. These effective components include: Commit to Program; 
Set Goals, Self-monitor (diet, weight, PA);  Reduce overall calorie intake; Build healthier eating patterns; 
Increase PA, reduce sedentary time; Self-regulate energy balance; Manage environmental cues (stimulus 
control); Problem Solving; Manage self-defeating thoughts, lapses; Manage social cues, build social 
support; and Manage motivation, stress, health overall. 
 
Curriculum frequency/intensity. The curriculum comprises 12 modules; for dose accounting, we treat 
each module as a “session,” yielding ~12 sessions for a full curriculum dose (with additional tools available 
or usage).  
 
There are no live interventionists and no participant-to-participant interaction after randomization. All 
contact is and web-based and a pre-recorded Community Health Worker hosts the videos. There is no 
face-to-face or group sessions conducted. 
 
Control arm receives usual care.  
 
6.2 
FIDELITY 
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interventionist(s).  It is distinct from the content of Section 6.4, Study Intervention Adherence, which is 
intended to capture a study participant’s adherence to an intervention. 
 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
 
The intervention is conducted entirely by the curriculum hosted on the mobile web-app. Therefore, there 
is no additional fidelity checks required to ensure the interventionist is conducting the intervention as 
intended. However, the research staff do review the administrative dashboard to ensure the mobile web-
app is functioning appropriately. All issues are noted and resolved within 24 hours.  
 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
 
Participants will be assigned to conditions by an algorithm programmed into the computer-based research 
portal. Randomization will utilize a permuted-blocks randomization scheme. Blocks of size 4 and 6 will be 
used. Assignments within blocks will be random but balanced among the two conditions and the order of 
the blocks (4 vs 6) also will be random. This procedure will ensure that the number of participants 
randomized to each condition will be equal, that any imbalance among the conditions at any point during 
the recruitment and randomization will be modest, and that it will be very difficult to guess the assignment 
of the next participant. Because the intervention and control materials are inherently different, 
participants and research staff cannot be blinded to assignment.  
 
6.4 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
 
Participants’ adherence is tracked entirely through mobile website administration page. Participants are 
given full and immediate access to all 12 modules and mobile web tools. Adherence is assessed by module 
access (dichotomy), number of logins, number of pages visits, and number of minutes in each module and 
tool for the mobile web-app. Control-arm adherence (e.g., usual care) is not collected.  
6.5 
CONCOMITANT THERAPY 
 
N/A 
 
6.5.1 RESCUE THERAPY 
 
N/A 
 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
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7.1 
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 
When a subject discontinues from the intervention but not from the study, remaining study procedures 
will be completed as indicated by the study protocol.  If a clinically significant finding is identified 
(including, but not limited to changes from baseline) after enrollment, the investigator or qualified 
designee will determine if any change in participant management is needed. Any new clinically relevant 
finding will be reported as an adverse event (AE). The data to be collected at the time of study intervention 
discontinuation will include the following: the reason(s) for discontinuing the participant from the 
intervention, and methods for determining the need to discontinue 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
Participants are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue a participant from the study for the following reasons: 
 
• 
Lost-to-follow up; unable to contact subject  
• 
Participant withdraws consent for further participation and/or data use. 
• 
Safety concerns: any SAE or AE judged related to participation that warrants removal, per the 
Data and Safety Monitoring Plan and IRB reporting rules. 
• 
Ineligibility discovered post-enrollment, duplicate enrollment, or other protocol violations that 
compromise data integrity. 
• 
Investigator decision that continued participation poses undue burden or risk (e.g., credible 
threats of harm), consistent with IRB policies. 
 
The reason for participant discontinuation or withdrawal from the study will be recorded on a dedicated 
Case Report Form (CRF). Participants who withdraw or are discontinued after randomization will not be 
replaced; enrollment continues until the target sample size is reached. 
 
7.3 
LOST TO FOLLOW-UP 
 
A participant will be considered lost to follow-up if he or she fails to respond for the 6-month follow-up 
call and study staff are unable to contact the participant after at least 3 attempts.  
 
The following actions must be taken if a participant fails to respond for a required study appointment: 
 
• 
The site will attempt to contact the participant, reschedule the missed baseline or follow-up 
appointment, counsel the participant on the importance of maintaining the assigned visit 
schedule and ascertain if the participant wishes to and/or should continue in the study 

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• 
Before a participant is deemed lost to follow-up, the investigator or designee will make every 
effort to regain contact with the participant (where possible, 3 telephone calls including to a 
secondary contact number). These contact attempts will be documented in the participant’s study 
file.  
• 
Should the participant continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up. 
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
No text is to be entered in this section; rather it should be included under the relevant subheadings below. 
 
8.1 
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
 
This individually randomized, remote trial evaluates a mobile, web app diabetes prevention program 
versus a usual care control. All study activities are conducted in person with a trained research 
coordinator. The research coordinator obtains only weight and instant A1C measures if participant has 
agreed to the measures, and the remaining data is collected via a participant initiated questionnaire.  
 
Screening, eligibility, and enrollment 
• 
Eligibility confirmation window. Up to 30 days prior to enrollment. Research coordinator 
assesses eligibility and pending eligibility (from physical activity readiness questionnaire). For 
those with pending eligibility, the research coordinator must receive a doctor’s signed form 
allowing participation in physical activity for the study.  
• 
Consent. Participants complete electronic informed consent. 
• 
Baseline survey. Immediately post-consent, participants complete a baseline questionnaire. 
• 
Randomization. After baseline completion, participants are assigned to intervention or control. 
Interventions begin (initial administration conditions) 
• 
Intervention arm. Participants are told to immediately wear their fit bit for one week to get 
baseline physical activity measure. One week post baseline visit, they are provided their 
username and password to login and commence the intervention. 
• 
Control arm. Participants are told to immediately wear their fit bit for one week to get baseline 
physical activity measure. They are also told they are in the usual care group and will receive 
access to the intervention post-study. 
Measures and assessments (non-safety) 
Baseline (pre-randomization) 
• 
Demographics and contact details (mobile number required for delivery). 
• 
Diabetes knowledge questionnaire 
• 
Health behavior questionnaire 
• 
A1C and weight biometrics  
During intervention (process/dose) 
• 
The administrative platform will provide all utilization details including login, page numbers, 
minutes used, and additional utilization statistics. These are used for exposure/dose summaries 
and adherence monitoring (not safety). 

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Follow-up (primary outcome window) 
• 
Primary outcome ascertainment: Weight measure is utilized for future calculation of percent 
weight loss.  
• 
Follow-up questionnaire: Repeat weight measurement at each follow up visit is used for 
percent weight loss. 
Outcome definitions (non-safety) 
• 
Percent weight loss: Calculated between weight at three different time points. This is used to 
calculate a percent weight loss in the participant.  
• 
Exposure/dose metrics: Number of modules completed; number of minutes in the intervention; 
and number of times interactive tools utilized.  
Administration, scoring, and data quality 
• 
Administration. All questionnaires are self-administered via computer or tablet.  
• 
Scoring. Multi-item scales are scored per codebook (sum or mean of valid items; higher scores 
reflect greater endorsement or knowledge, as defined). Missing-data rules (e.g., minimum items 
required) are pre-specified. 
• 
Data capture. Survey responses are time-stamped and stored on the study platform’ 
Qualified personnel 
• 
In person visit biometrics: Conducted by trained study staff. 
 
8.2 
SAFETY ASSESSMENTS 
 
The current study gathered two biometric data points: (1) weight and (2) A1C levels using a rapid at-home 
assessment. Given the A1C test, the study followed the following protocol.  
A1C Protocol for Safety Assessment. There are some minor health risks associated with conducting and 
obtaining information from a rapid A1C test. The use of a rapid A1C test is no more of a risk than using a 
blood glucose meter. It does not require blood to be drawn, in large amounts, or using a syringe. It also 
does not require a medical professional to complete. An A1C self-check will be conducted by the 
participant after being provided with instructions by ISA Staff. ISA Staff will monitor to ensure the 
participant is following directions. This test requires a droplet of blood only slightly larger than a 
traditional glucose monitor test. Participants will do the step-by-step instructions and then show ISA 
Staff their A1C reading. If a participant does NOT want to participate in doing the test, they will not be 
required to. There are minimal risks associated with the test. To alleviate the risks, ISA Staff will 
implement the following procedures for the following associated risks. 
First, even though ISA Staff will be instructing the participant to self-test, they will wear a new set of 
latex gloves with each reach in the case they need to assist the participant. They will also throw all 
supplies in a sharps container once the test is completed. They will disinfect the area where the test is 
conducted as well.  
While the blood sample is just a droplet of blood, there might be participants who have anxiety about 
blood and/or may feel light-headed at the sight of blood. Therefore, all participants will be required to 
be seated while they conduct the self-test. Additionally, if a participant feels unwell due to the blood 

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droplet, ISA STAFF will immediately call CACOST Health Center Staff to come assess the participant. 
While highly unlikely, in the case that there is a medical emergency, ISA Staff will immediately contact 
first responders. After the incident has been handled and cleared, ISA Staff will immediately contact the 
PI to inform them of the event and will document details.  
Additionally, there may be associated risks with the participant learning their A1C levels. If a 
participant’s A1C level is in the diabetes range, they will be provided with a sheet with information on 
A1C levels and information about how to contact their primary care physician about their results. This 
sheet will provide CACOST Health Center contact information as well.  
Further safety procedures consist of: (1) AE/SAE identification and follow-up; (2) monitoring for distress 
potentially triggered by educational content; (3) privacy/technology safeguards (e.g., wrong-number 
texting, shared phones). AEs are any unfavorable or unintended psychological or practical effect 
temporally associated with participation in the study’s activities (videos, , surveys), whether or not 
considered related. Examples include: heightened anxiety/distress about diabetes risk, perceived breach 
of privacy (e.g., texts seen by others on a shared device), escalation of medical mistrust that prompts 
clinical concern, and elevated A1C measures that require further doctors assessments. SAEs would be rare 
in this context and are defined per IRB policy (e.g., death, life-threatening event, hospitalization) 
regardless of attribution. 
 
8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
No text is to be entered in this section; rather it should be included under the relevant subheadings below.  
 
8.3.1 DEFINITION OF ADVERSE EVENTS 
 
An AE is defined as an event that is unexpected, related or possibly related to research participation, and 
suggests that the research places subjects or others at a greater risk of harm than was previously known 
or recognized. 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
 
An SAE is defined as an event that results in death, is life-threatening, results in inpatient hospitalization 
or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results 
in a congenital anomaly/birth defect, or may jeopardize the subject’s health and may require medical or 
surgical intervention to prevent one of the other outcomes listed. 
 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
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8.3.3.1 SEVERITY OF EVENT 
 
For adverse events (AEs) not included in the protocol defined grading system, the following guidelines will 
be used to describe severity.  
 
• 
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 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”. 
 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 
All adverse events (AEs) will have their relationship to study procedures, including the intervention, 
assessed based on temporal relationship. The degree of certainty about causality will be graded using the 
categories below.  
 
• 
Related – The AE is known to occur with the study procedures, there is a reasonable possibility 
that the study procedures caused the AE, or there is a temporal relationship between the study 
procedures and the event. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study procedures and the AE. 
• 
Not Related – There is not a reasonable possibility that the study procedures caused the event, 
there is no temporal relationship between the study procedures and event onset, or an alternate 
etiology has been established. 
 
8.3.3.3 EXPECTEDNESS  
 
A member of the research team with appropriate expertise will be responsible for determining whether 
an adverse event (AE) is expected or unexpected. An AE will be considered unexpected if the nature, 
severity, or frequency of the event is not consistent with the risk information previously described for the 
study procedures. 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during study appointments. 
 
All AEs, not otherwise precluded per the protocol, will be captured on the appropriate case report form 
(CRF). Information to be collected includes event description, time of onset, assessment of severity, 

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relationship to study procedures (assessed only by those with the training and authority to make a 
diagnosis), and time of resolution/stabilization of the event. All AEs occurring while on study will be 
documented appropriately regardless of relationship. All AEs will be followed to adequate resolution. 
 
Any medical or psychiatric condition that is present at the time that the participant is screened will be 
considered as baseline and not reported as an AE. However, if the study participant’s condition 
deteriorates at any time during the study, it will be recorded as an AE.  
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. Documentation of onset and duration of each episode will be 
maintained for AEs characterized as intermittent. 
 
The study coordinator will record events with start dates occurring any time after informed consent is 
obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.  At 
each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit.  Events 
will be followed for outcome information until resolution or stabilization. 
 
8.3.5 ADVERSE EVENT REPORTING  
 
Any AE or SAE, whether or not related to study intervention, will be reported to the IRB, NCI, and the 
Office for Human Research Protections (OHRP). SAE’s will be reported to the IRB within 24 hours and AEs 
will be reported to the IRB within 72 hours. All SAE’s and AE’s will be reported to NCI and OHRP within 
two weeks. The initial report will be followed by submission of a completed report to all institutions. 
 
8.3.6 SERIOUS ADVERSE EVENT REPORTING  
 
Any AE or SAE, whether or not related to study intervention, will be reported to the IRB, NCI, and the 
Office for Human Research Protections (OHRP). SAE’s will be reported to the IRB within 24 hours and AEs 
will be reported to the IRB within 72 hours. All SAE’s and AE’s will be reported to NCI and OHRP within 
two weeks. The initial report will be followed by submission of a completed report to all institutions. 
 
8.3.7 REPORTING EVENTS TO PARTICIPANTS  
 
N/A 
 
8.3.8 EVENTS OF SPECIAL INTEREST  
 
N/A 
 

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8.3.9 REPORTING OF PREGNANCY  
 
N/A 
 
8.4 
UNANTICIPATED PROBLEMS 
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8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
 
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human Research 
Protections (OHRP).  OHRP considers unanticipated problems involving risks to participants or others to 
include, in general, any incident, experience, or outcome that meets all of the following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
participant population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized. 
 
8.4.2  UNANTICIPATED PROBLEMS REPORTING  
 
The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB). The UP report will include the following information: 
 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project 
number 
• 
A detailed description of the event, incident, experience, or outcome  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP 
• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline:   
 
• 
UPs that are serious adverse events (SAEs) will be reported to the IRB within 24 hours and to the 
funding agency within two weeks of the investigator becoming aware of the event  

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• 
Any other UP will be reported to the IRB within 72 hours and to the funding agency within two 
weeks of the investigator becoming aware of the problem  
• 
All UPs should be reported to appropriate institutional officials (as required by an institution’s 
written reporting procedures), the supporting agency head (or designee), and the Office for 
Human Research Protections (OHRP) within two weeks of the IRB’s receipt of the report of the 
problem from the investigator. 
 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
 
N/A 
 
9 
STATISTICAL CONSIDERATIONS  
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9.1 
STATISTICAL HYPOTHESES 
 
• 
Primary Endpoint(s):  
We hypothesize that, compared to participants who receive usual care, participants who receive the 
tailored mobile web-app, STEPS, will have a higher percentage of weight loss at 6 months post-
randomization. Alternatively, our null hypothesis is that there will be no difference between arms in 
screening completion at 6 months. 
 
• 
Secondary Endpoint(s): 
 
A1C (3 and 6 months): 
We hypothesize that the intervention arm will report a lower A1C at 3 and 6 months than the control arm; 
the null hypothesis is that there will be no difference between arms. 
 
Diabetes Knowledge (3 and 6 months): 
We hypothesize that the intervention arm will report higher diabetes knowledge (higher total score) at 3 
and  6 months than the control arm; the null hypothesis is that there will be no difference between arms. 
 
Eating Patterns (3 and 6 months): 
We hypothesize that the intervention arm will report better eating patterns aligned with weight loss and 
management (total score) at 3 and  6 months than the control arm; the null hypothesis is that there will 
be no difference between arms. 
 
Physical activity (3 and 6 months): 
We hypothesize that the intervention arm will report higher amounts of physical activity at 3 and  6 
months than the control arm; the null hypothesis is that there will be no difference between arms. 
 

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9.2 
SAMPLE SIZE DETERMINATION 
We examined power using treatment effects from two sources: 1) a meta-analysis examining the 
overall effectiveness of mobile device interventions on weight loss154 and 2) a digital diabetes 
prevention program for low-income patients.85 First, a meta-analysis examining the effects of mobile 
device interventions on weight loss found an average effect size of Cohen’s d: 0.43 (95% CI:0.252-0.609; 
p<0.01) across 11 mobile-based intervention studies.154 This indicates an overall medium effect size. 
Second, Kim et al82 developed and tested a mobile-based diabetes prevention program for a multi-
racial/ethnic population. This study yielded a mean weight loss of 4.4% (SD 7.7%) at 12 months. This 
finding is associated with a Cohen’s d=0.57, which is considered a medium effect size. To ensure our 
study is fully powered, we conducted our power analysis using the smaller effect size (Cohen’s d=0.43) 
from Lyzwinski et al.154, who examined the effects of mobile-based interventions on our primary 
outcome, participant weight loss.  
We estimated power for the paired t-test for %weight loss (primary outcome). The G*Power 3.1 program157 
was used to determine that a Cohen’s d of 0.43 and an α error probability of 0.05 requires a final sample size of 
136 to be sufficiently powered (1 - β error probability) at 0.80. Presuming a 20% attrition rate, randomizing a final 
sample size of 164 participants should be sufficient to detect significant differences in % weight loss across the two 
survey time points (i.e., at baseline and 3 months after the end of the intervention). 
9.3 
POPULATIONS FOR ANALYSES 
 
Because randomization carries the expectation of creating treatment groups equivalent with respect to 
known and unknown prognostic factors, removing randomized participants from the analysis runs the risk 
of tampering with this balance and introducing bias into the treatment comparisons. As a result, an 
intention-to-treat analytic approach will be followed such that all participants randomized into the study 
will be included in all analyses irrespective of protocol violations post randomization. Even with our best 
efforts, we can expect some missing data. For the primary outcome, missing data will be limited to cases 
where we are unable to receive a weight as per participant request. Because we allow participants to opt 
out of any biometric or question, there is the possibility that there is missing data for the primary outcome. 
However, very little missing data is anticipated. For secondary measures, missing data will consist of those 
who fail to complete the 3 or 6-month follow-up survey. We will conduct an initial evaluation of 
missingness by performing a series of logistic regression analyses where the indicator of missing data is 
the outcome and potential explanatory variables (e.g., condition, screening status, demographic 
characteristics) serve as predictors. We will then use imputation to manage missing data. 
 
9.4 
STATISTICAL ANALYSES 
 
9.4.1 GENERAL APPROACH 
 
A paired t-test will be the main analytic technique for the primary measure (percent weight loss) and 
all continuous outcome measures. The test of the intervention effect will be the t-test for the 

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regression coefficient for condition, which will estimate the adjusted difference between the two 
conditions at posttest. That test will be two-tailed with a type I error rate of 5%.  Chi-square testes 
will be used for all categorical outcome data. 
9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
 
The primary outcome is percent weight loss, and secondary outcomes include: HbA1c levels, diabetes 
knowledge, dietary intake, and self-reported physical activity. All but the weight and HbA1C measures (assessed by 
the research coordinator) will be self-reports using established scales that have evidence of reliability (internal 
consistency and/or a test-retest reliability) and validity. A paired t-test will be the main analytic technique for the 
primary measure (percent weight loss) and all continuous outcome measures. The test of the intervention effect will 
be the t-test for the regression coefficient for condition, which will estimate the adjusted difference between the 
two conditions at posttest. That test will be two-tailed with a type I error rate of 5%.  Chi-square testes will be used 
for all categorical outcome data. We will perform the analysis using SAS PROC GLM, Version 9.1.148 We will perform 
these analyses in collaboration with our statistical consultant, Dr. Kaplan. 
 
 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 
The primary outcome is percent weight loss, and secondary outcomes include: HbA1c levels, diabetes 
knowledge, dietary intake, and self-reported physical activity. All but the weight and HbA1C measures (assessed by 
the research coordinator) will be self-reports using established scales that have evidence of reliability (internal 
consistency and/or a test-retest reliability) and validity. A paired t-test will be the main analytic technique for the 
primary measure (percent weight loss) and all continuous outcome measures. The test of the intervention effect will 
be the t-test for the regression coefficient for condition, which will estimate the adjusted difference between the 
two conditions at posttest. That test will be two-tailed with a type I error rate of 5%.  Chi-square testes will be used 
for all categorical outcome data. We will perform the analysis using SAS PROC GLM, Version 9.1.148 We will perform 
these analyses in collaboration with our statistical consultant, Dr. Kaplan. 
 
9.4.4 SAFETY ANALYSES 
 
N/A 
 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
 
All analyses will control for any confounding variables not managed through randomization (i.e., group 
difference p <.10). 
 
9.4.6 PLANNED INTERIM ANALYSES  

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N/A 
9.4.7 SUB-GROUP ANALYSES 
 
Study intervention is only for men. 
 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
Individual participant data will not be listed by measure and time point. 
 
9.4.9 EXPLORATORY ANALYSES 
 
N/A 
 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
No text is to be entered in this section; rather it should be included under the relevant subheadings below. 
 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
No text is to be entered in this section; rather it should be included under the relevant subheadings below. 
 
10.1.1 INFORMED CONSENT PROCESS 
No text is to be entered in this section; rather it should be included under the relevant subheadings below. 
 
10.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
 
 
Consent forms describing in detail the study intervention, study procedures, and risks will be given to the 
participant and written documentation of informed consent will be completed prior to starting the study 
intervention. 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
When a participant arrives for their first visit, they will complete the informed consent procedure. 
Specifically, ISA research staff will explain the research project, the purpose of the mobile phone-based 

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program and how it works, the role of participants in testing this product, and the voluntary nature of 
participation. Our staff will also explain that, although information of a sensitive nature may be raised in 
program materials or while taking the survey, they will have the option to skip any questions that make 
them uncomfortable. ISA Staff will also point out the additional consent areas of Fitbit and Text 
Messaging. Participants will also be informed about monetary incentives related to participation in the 
study. Participants will be given the consent document, which will detail in writing all pertinent 
information about the study and the participant’s rights. All participants will be encouraged to ask ISA 
Staff any questions prior to signing the consent form. Participants who agree to participate will sign the 
consent form before taking the first questionnaire and before collection of any health-related data. A copy 
of the consent document will be given to each participant.  
All participants will be given the opportunity to have the consent form read to them. However, if they 
choose to read the consent form themselves, we will not assume that they understood the main points 
of the study. Instead, we will summarize those points before the participant signs the consent form. 
Moreover, they will be asked if they have any questions before they sign the consent form. 
 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. If the study is prematurely terminated or suspended, the Principal Investigator (PI) will promptly 
inform study participants, the Institutional Review Board (IRB), and sponsor/funding agency and will 
provide the reason(s) for the termination or suspension. Study participants will be contacted, as 
applicable, and be informed of changes to study appointment schedule. 
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Insufficient compliance of study staff to the protocol (ie, significant protocol violations) 
• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
 
The study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the funding agency, sponsor, IRB, , or other relevant regulatory or oversight bodies (OHRP). 
10.1.3 CONFIDENTIALITY AND PRIVACY  
 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, 
the safety and oversight monitor(s), and the sponsor(s) and funding agency. This confidentiality is 
extended to the data being collected as part of this study. Data that could be used to identify a specific 
study participant will be held in strict confidence within the research team. No personally-identifiable 

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information from the study will be released to any unauthorized third party without prior written approval 
of the sponsor/funding agency.  
 
All research activities will be conducted in as private a setting as possible. 
To maintain confidentiality of all data collected, no names or other identifying information will be 
included with the survey data and in-app interactives. As noted earlier, the file that will link the 
participant name to the user ID and study phone number will be maintained on a password protected 
computer that will not house the survey data. The only people that will have access to the linking file will 
be the Principal Investigator and her staff. Finally, we will utilize strict security protocols – described 
previously – to protect the confidentiality of all information transmitted via the web-app.  
To protect against any breaches of confidentiality, all project staff proposed to conduct the data 
collection have received or will receive training on the protection of research participants and are or will 
be well versed in the Code of Federal Regulations (including 45 CFR 46 and 42 CFR) and the Belmont 
Report. ISA continually obtains information from the Office for Human Research Protections (OHRP) at 
NIH on new regulations regarding the protection of human subjects, which is disseminated to all staff. 
Further, participants will have the MRR procedure explained to them and will be asked to complete a 
medical release form before any medical records are extracted. In addition, any ISA staff proposed to 
work on the MRR and EHR extraction are or will be trained in all applicable HIPAA regulations. 
After all participants have completed follow-up surveys, the linking file housed on the ISA computer – 
the only file that contains participant’s personal information (e.g., name, phone number) – will be 
deleted. In addition, the Windows Eraser program will be used to completely remove (i.e., “wipe”) the 
linking file from the computer by overwriting it several times using government-sanctioned deletion 
algorithms.  
It is NIH policy that the results and accomplishments of the activities that it funds should be made available 
to the public (see https://grants.nih.gov/policy/sharing.htm). The PI will ensure all mechanisms used to 
share data will include proper plans and safeguards for the protection of privacy, confidentiality, and 
security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be 
traceable to a specific study participant). Plans for archiving and long-term preservation of the data will 
be implemented, as appropriate.  
 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
Deidentified participant research data from the baseline and follow-up surveys will be retained for 3 
years from the submission of the final financial report to NIH, in keeping with guidelines described in the 
NIH Grants Policy Statement. 
 
 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 

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Provide the name and contact information of the Principal Investigator and the Medical Monitor or 
Independent Safety Monitor. Update table heading to remove non-relevant role. 
Principal Investigator 
Debra M. Rios, DrPH 
ISA Associates, Inc. 
4501 Fairfax Dr, Ste 601 
Arlington, VA 22203 
703-739-0462 
DRIOS@isagroup.com 
 
10.1.6 SAFETY OVERSIGHT 
 
Debra M. Rios, DrPH, the PI, has the responsibility for assessing adverse events (AEs) and serious adverse 
events (SAEs) and the ultimate responsibility for all data and safety monitoring. She will conduct weekly 
reviews of any problems related to quality of data collection, transmission, or analyses and of any AEs and 
SAEs that occurred in the past week.  Further, she will conduct annual reviews of SAEs associated with 
renewal of IRB approval. 
10.1.7 CLINICAL MONITORING 
 
N/A 
 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
 
We will perform internal quality management of study conduct, data collection, documentation and 
completion.  
 
Quality control (QC) procedures will be implemented as follows: 
 
Informed consent --- Study staff will review both the documentation of the consenting process as well as 
a percentage of the completed consent documents.  This review will evaluate compliance, accuracy, and 
completeness.  Feedback will be provided to the study team to ensure proper consenting procedures are 
followed.  
 
Source documents and the electronic data --- Baseline and follow-up survey data will be captured directly 
in the study database.   
 
Intervention Fidelity — Intervention is delivered electronically. Periodic monitoring will check for errors.  
 

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Protocol Deviations – The study team will review protocol deviations on an ongoing basis and will 
implement corrective actions when the quantity or nature of deviations are deemed to be at a level of 
concern. 
10.1.9 DATA HANDLING AND RECORD KEEPING  
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10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
 
Data collection will be the responsibility of the study staff under the supervision of the site investigator. 
The investigator will be responsible for ensuring the accuracy, completeness, legibility, and timeliness of 
the data reported. 
 
All source data will be completed electronically to ensure legibility.   
 
10.1.9.2 STUDY RECORDS RETENTION  
 
Deidentified participant research data from the baseline and follow-up surveys will be retained for 3 years 
from the submission of the final financial report to NIH, in keeping with guidelines described in the NIH 
Grants Policy Statement. No records will be destroyed without the written consent of the sponsor/funding 
agency, if applicable. It is the responsibility of the sponsor/funding agency to inform the investigator when 
these documents no longer need to be retained. 
 
10.1.10 
PROTOCOL DEVIATIONS   
 
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol, 
International Council on Harmonisation Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) 
requirements. The noncompliance may be either on the part of the participant, the investigator, or the 
study site staff. As a result of deviations, corrective actions will be developed by the site and implemented 
promptly.  
 
These practices are consistent with ICH GCP:  
• 
Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3  
• 
Section 5.1 Quality Assurance and Quality Control, subsection 5.1.1  
• 
Section 5.20 Noncompliance, subsections 5.20.1, and 5.20.2.  
 
It will be the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations within 5 working days of identification of the protocol deviation. All deviations will be 

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addressed in study source documents. Protocol deviations will be sent to the reviewing Institutional 
Review Board (IRB) per their policies. The site investigator will be responsible for knowing and adhering 
to the reviewing IRB requirements.  
10.1.11 
PUBLICATION AND DATA SHARING POLICY  
 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
National Institutes of Health (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. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 
such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed 
journals.  Data from this study may be requested from other researchers 10 years after the completion of 
the primary endpoint by contacting ISA.   
 
10.1.12 
CONFLICT OF INTEREST POLICY 
 
The independence of this study from any actual or perceived influence is critical. Therefore, any actual 
conflict of interest of persons who have a role in the design, conduct, analysis, publication, or any aspect 
of this trial will be disclosed and managed. Furthermore, persons who have a perceived conflict of interest 
will be required to have such conflicts managed in a way that is appropriate to their participation in the 
design and conduct of this trial. The study leadership has established policies and procedures for all study 
group members to disclose all conflicts of interest and will establish a mechanism for the management of 
all reported dualities of interest. 
10.2 ADDITIONAL CONSIDERATIONS 
 
N/A 
 
10.3 ABBREVIATIONS AND SPECIAL TERMS 
 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 

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CLIA 
Clinical Laboratory Improvement Amendments 
DPP 
Diabetes Prevention Program 
CRF 
Case Report Form 
DHHS 
Department of Health and Human Services 
GCP 
Good Clinical Practice 
HIPAA Health Insurance Portability and Accountability Act  
ICH 
International Council on Harmonisation  
IRB 
Institutional Review Board 
ITT 
Intention-To-Treat 
MOP 
Manual of Procedures 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
NIH IC NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
RCT 
Randomized Controlled Trial 
SAE 
Serious Adverse Event 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 
 
 
 

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10.4 PROTOCOL AMENDMENT HISTORY 
The table below is intended to capture changes of IRB-approved versions of the protocol, including a 
description of the change and rationale. A Summary of Changes table for the current amendment is 
located in the Protocol Title Page.  
 
Version 
Date 
Description of Change  
Brief Rationale 
n/a 
n/a 
n/a 
n/a 
 
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