Feeding America Intervention Trial for Health--Diabetes Mellitus
Phase: NA
Conditions: Diabetes Mellitus
Sponsor: University of California, San Francisco

 
 
1 
FAITH-DM Manual of Operations and Procedures 
Version 9.8, 10/5/16 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Manual of Operations and 
Procedures (MOP) 
 
 
 
 

 
 
2 
FAITH-DM Manual of Operations and Procedures 
Version 9.8, 10/5/16 
 
 
 
 
 
 
1 
INTRODUCTION 
7 
1.1 
Overview of the FAITH-DM Trial 
7 
1.2 
Overview of the Manual of Operations (MOP) 
7 
1.3 
MOP Contents and Organization 
8 
2 
STUDY PROTOCOL 
8 
2.1 
Study Organization and Responsibilities 
9 
2.2 
Division of Supervision Responsibilities 
10 
2.3 
Coordinating Center Study Staff Roster 
10 
2.4 
Coordinating Center 
11 
2.5 
Study Sites 
11 
2.6 
Steering Committees 
12 
2.7 
Timeline 
12 
2.8 
Communications Plan 
15 
3 
STUDY INTERVENTION 
15 
3.1 
Testing and monitoring of blood glucose 
15 
3.1.1 
Testing for diabetes and diabetes control among food pantry clients 
15 
3.1.2 
Testing random blood glucose levels 
16 
3.1.3 
Testing Glycosylated Hemoglobin (HbA1c) Levels 
17 
3.1.4 
Monitoring blood glucose control among study participants 
17 
3.2 
Primary care coordination 
18 
3.2.1 
Referrals to a primary care provider (PCP) 
18 
3.2.2 
Referrals from primary care 
19 
3.2.3 
Communication with health care provider 
19 
3.3 
Diabetes-appropriate food boxes 
20 
3.4 
Diabetes self-management education (DSME) and support (SMS) 
22 
3.4.1 
DSME Group Classes 
24 
3.4.2 
Brief 1-on-1 interactions 
26 
3.4.3 
Bi-Monthly Written Materials and Handouts 
27 
3.4.4 
Other diabetes education interventions 
28 
3.5 
Tracking participation in intervention elements 
28 
3.6 
Length and time windows for intervention 
29 
4 
RECRUITMENT AND RETENTION PLAN 
29 
4.1 
Participant Retention 
29 
4.2 
Study Flow 
30 
5 
SCREENING AND ELIGIBILITY CRITERIA 
31 
Table of Contents 

 
 
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5.1 
Screening procedures 
31 
5.2 
Eligibility and Exclusion Criteria 
33 
5.2.1 
Prompts for speaking with ineligible clients 
34 
5.3 
Informed Consent 
35 
5.3.1 
The Informed Consent process for participants with adequate literacy 
35 
5.3.2 
The Informed Consent process for participants with limited literacy 
36 
5.3.3 
Participant update process at T6 
37 
5.4 
HIPAA Authorization 
38 
5.4.1 
Process for obtaining HIPAA authorization 
38 
5.5 
Medical Records Release Form 
39 
6 
BLINDING AND UNBLINDING (MASKING AND UNMASKING) 
39 
7 
STUDY MEASUREMENTS AND PROCEDURES 
39 
7.1 
Universal precautions and safety 
40 
7.2 
Random blood sugar testing 
40 
7.2.1 
Procedure to conduct a blood glucose test 
41 
7.2.2 
Performing a Quality Control Test with the GE100 Blood Glucose Monitor 
42 
7.3 
Point-of-care HbA1c testing 
44 
7.3.1 
Procedure to conduct an HbA1c test 
44 
7.3.2 
Performing a Quality Control Test with the A1C+Now Monitor 
45 
7.4 
Ordering Information for testing supplies 
46 
7.5 
Regulatory requirements for testing 
47 
7.5.1 
CLIA Certificate of Waiver 
47 
7.5.2 
Medical Waste Permitting 
47 
7.5.3 
Additional Screening Requirements 
48 
7.6 
Survey Administration 
48 
7.6.1 
Survey administration procedures 
49 
7.6.2 
Completing surveys when participant needs to leave 
50 
7.6.3 
CASIC instructions for completing surveys at a later date 
51 
7.6.4 
Survey piloting procedures 
52 
7.7 
Health Care Utilization Analysis 
52 
7.7.1 
HCUA Roles and Responsibilities 
53 
7.7.2 
HCUA Activities at Baseline (T0) 
54 
7.7.3 
HCUA Activities at Six Months (T6) 
55 
7.7.4 
HCUA Activities at Twelve Months (T12) 
58 
7.7.5 
Sending Follow-Up Prompts to Primary Care Providers Regarding Survey 
60 
7.7.6 
Financial Incentives for Provider Survey Completion 
60 
7.7.7 
Returning / Receiving the HCU survey 
61 
7.7.8 
Provider Packet Summary Table 
62 
8 
RANDOMIZATION 
63 
9 
PARTICIPANT TIMELINE AND VISIT SCHEDULE 
64 
9.1 
Scope/Schema 
64 
9.2 
Language capacity 
67 

 
 
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9.3 
Compensation 
67 
9.3.1 
Transportation Vouchers 
67 
9.4 
Final Study/Early Discontinuation Evaluations 
68 
10 
ADVERSE EVENTS AND SAFETY REPORTING 
68 
10.1 
Blood glucose < 70 mg/dL (Hypoglycemia) 
69 
10.2 
Blood glucose > 240 mg/dL, or HbA1c > 9% (Hyperglycemia) 
70 
10.3 
Reports of severe depression, suicidality, or homicidality 
71 
10.4 
Reports of Elder Abuse or Neglect 
72 
10.5 
Reports of Poor Food Quality 
73 
10.6 
Study Related Injuries 
74 
10.6.1 
Sharps Injuries and Blood Exposures 
74 
10.6.2 
Fainting and Related Injuries 
74 
10.6.3 
Excessive Bleeding 
75 
10.6.4 
Infection 
75 
11 
STUDY COMPLIANCE 
75 
12 
DATA COLLECTION AND STUDY FORMS 
76 
12.1 
Source Documentation 
76 
12.2 
Participant Binder 
76 
12.3 
General Instructions for Completing Forms 
77 
12.3.1 
Best practices for completing paper forms 
77 
12.3.2 
CASIC Instructions 
78 
12.3.3 
CASIC Remote Syncing Process 
79 
12.3.4 
Downloading Updated Instruments in CASIC Remote 
79 
12.3.5 
Paper survey instructions 
80 
12.3.6 
MS Access database instructions 
80 
13 
DATA MANAGEMENT 
80 
13.1 
Storage and Transmission of Electronic Files 
81 
13.1.1 
Backing up Microsoft Access Databases to UCSF server 
81 
13.1.2 
CASIC Online 
81 
13.1.3 
CASIC Remote 
82 
13.2 
Administrative Forms 
82 
13.3 
Retention of Study Documentation 
82 
13.3.1 
HCUA Data Stored at Food Bank Sites 
83 
13.4 
Data Analysis Plan 
83 
13.4.1 
Sample size estimation 
83 
13.4.2 
Data sources 
84 
13.4.3 
Hypotheses 
84 
13.4.4 
Statistical analyses 
85 
13.5 
Health Care Utilization Data Analysis Plan 
86 
13.5.1 
Participant and provider data collection process 
87 
13.5.2 
Health care utilization indicators and hypotheses 
88 
13.5.3 
Sample size estimation 
89 

 
 
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13.5.4 
Statistical analyses 
89 
14 
QUALITY CONTROL PROCEDURES 
90 
14.1 
Standard Operating Procedures 
90 
14.2 
Site Monitoring 
91 
14.3 
Acceptable Roles for Volunteers 
92 
15 
REPORTS 
92 
15.1 
Reporting Schedule 
93 
16 
DATA AND SAFETY MONITORING BOARD 
93 
17 
STUDY COMPLETION AND CLOSEOUT PROCEDURES 
94 
17.1 
Participant Notification 
94 
17.2 
Site Procedures Post-Study 
94 
17.3 
Ancillary funding 
94 
17.3.1 
Extension plan 
94 
17.3.2 
IRB Approval 
95 
17.3.3 
Revised Project Budgets 
95 
17.3.4 
Description of New and Revised Study Activities 
95 
17.3.5 
List of Revised Forms and Study Materials 
97 
17.3.6 
Reporting 
97 
17.3.7 
Study Closeout 
97 
17.4 
Confidentiality Procedures 
97 
17.5 
Publications and data release 
99 
17.6 
MOP Maintenance 
99 
REFERENCES 
100 
APPENDIX A – LOGIC MODEL 
102 
APPENDIX B – SCREENING LOG 
103 
APPENDIX C – FAITH-DM FLOW CHART 
104 
APPENDIX D – ELECTRONIC FORMS COMPLETED AT EACH STUDY VISIT 
105 
APPENDIX E – SCHEDULE OF EVENTS 
106 
APPENDIX F – PROTOCOL DEVIATION LOG 
109 
APPENDIX G – MOP MODIFICATION LOG 
110 
APPENDIX H – CONSORT 2010 CHECKLIST 
111 
APPENDIX I – PASSIVE DIABETES SELF-MANAGEMENT EDUCATION MATERIALS 
114 
APPENDIX J – SCREENING RESULTS FORM [ENGLISH] 
118 
APPENDIX K – SCREENING RESULTS FORM [SPANISH] 
119 
APPENDIX L – GE100 BLOOD GLUCOSE MONITOR USER MANUAL 
120 
APPENDIX M – GE100 GETTING STARTED GUIDE 
120 
APPENDIX N – A1CNOW+ PROFESSIONAL PROCEDURE GUIDE 
120 
APPENDIX O – DRAFT FOOD BANK – CLINIC MOU 
121 
APPENDIX P – FOOD INSECURITY TRAINING BRIEF (FOR CLINIC PARTNERS) 
126 
APPENDIX Q – GE100 QUALITY CONTROL LOG 
128 

 
 
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APPENDIX R – A1C+NOW QUALITY CONTROL LOG 
129 
APPENDIX S – MEDICAL WASTE TRACKING LOG 
130 
APPENDIX T – THE INFORMED CONSENT PROCESS 
131 
APPENDIX U – PARTICIPANT BASELINE SURVEY 
135 
APPENDIX V1 – PARTICIPANT T6 FOLLOW-UP SURVEY, INTERVENTION GROUP 
135 
APPENDIX V2 – PARTICIPANT T6 FOLLOW-UP SURVEY, CONTROL GROUP 
135 
APPENDIX W1 – PARTICIPANT T12 FOLLOW-UP SURVEY, INTERVENTION GROUP 
135 
APPENDIX W2 – PARTICIPANT T12 FOLLOW-UP SURVEY, CONTROL GROUP 
135 
APPENDIX X – HIPAA AUTHORIZATION FORM 
136 
APPENDIX Y – HEALTH CARE UTILIZATION PROVIDER LETTERS (1-8) 
136 
APPENDIX Z – HEALTH CARE UTILIZATION SURVEY (HCUS) 
136 
APPENDIX AB – HIPAA FAX COVER SHEET 
137 
APPENDIX AC – FAITH-DM DSME PROGRAM CURRICULUM 
138 
APPENDIX AD – EDUCATION CLASS REMINDER POSTCARD 
139 
APPENDIX AE – FAITH-DM INFORMED CONSENT FORM 
140 
APPENDIX AI – FAITH-DM SCREENING AND REFERRAL FORM 
141 
APPENDIX AJ – SAMPLE RECRUITMENT FLYER 
142 
APPENDIX AK – EDUCATION HANDOUTS FOR SCREENING 
143 
APPENDIX AL – PARTICIPANT COMPENSATION RECEIPT FORM 
144 
APPENDIX AM – PARTICIPANT BASELINE ENROLLMENT FORM 
145 
APPENDIX AN – ADVERSE EVENT REPORTING FORM 
146 
APPENDIX AO – MEDICAL RECORDS RELEASE FORM 
147 
APPENDIX AP – HCUA FLOWCHARTS 
149 
APPENDIX AQ – STUDY FLOW HANDOUT 
152 
APPENDIX AR – SCREENING SUPPLIES 
153 
APPENDIX AS – COGNITIVE IMPAIRMENT ASSESSMENT TOOL 
155 
APPENDIX AT – DATA COLLECTION BEST PRACTICES 
156 
APPENDIX AU – PARTICIPANT FOLLOW-UP TESTING RESULTS FORM 
157 
APPENDIX AV – BARRIERS TO PARTICIPATION IN FAITH-DM ACTIVITIES FORM 
158 
APPENDIX AW – FAITH-DM UPDATES FOR STUDY PARTICIPANTS 
159 
APPENDIX AX – HCU SURVEY COVER SHEET 
161 
APPENDIX AY – DATA SECURITY AND OVERVIEW OF STUDY DATA PROCEDURES 
162 
APPENDIX AZ – HCUA SCRIPT FOR REMINDING PROVIDER SITE TO FILL OUT SURVEY 
169 
APPENDIX BA – GUIDE ON USE OF ENCRYPTED USB DEVICES FOR HCUA DATA 
172 
 
 
 

 
 
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FAITH-DM Manual of Operations and Procedures 
Version 9.8, 10/5/16 
1 Introduction 
1.1 Overview of the FAITH-DM Trial 
The Feeding America Intervention Trial for Health—Diabetes Mellitus (FAITH-DM) is a randomized, 
controlled study of the implementation of a diabetes intervention in food pantry settings.  Every effort 
has been made to enhance the feasibility of implementation while maintaining the rigor of a 
randomized, controlled trial.  The intervention will be implemented in three food banks: Alameda 
County Community Food Bank (Oakland, CA), Gleaners Community Food Bank of Southeastern 
Michigan (Detroit, MI), and the Houston Food Bank, (Houston, TX).  These food banks were chosen 
through a competitive application process after demonstrating their capacity to reach the population 
of interest (English- and Spanish-speaking adults with diabetes receiving food at food pantries) and 
carry out the study procedures according to the instructions laid out in this manual. 
 
This research is critically important.  In the pilot study recently completed, we observed significant 
improvements in self-management skills and competencies such as self-efficacy and medication 
adherence, and a trend toward improved glycemic control (HbA1c) and decreased risk of severe 
hypoglycemic events. Participants were highly satisfied with the diabetes-appropriate food distributed 
as part of the intervention. This work suggested that food pantries are a feasible site to engage 
vulnerable individuals in diabetes self-management efforts. We are excited to be able to determine 
the efficacy of this model. 
 
Funding for FAITH-DM was provided by Feeding America and the Laura and John Arnold 
Foundation. 
 
The study is listed on www.clinicaltrials.gov with identifier: NCT02569060. 
 
FAITH-DM received approval from the Western Institutional Review Board (Protocol Number: 
FADiabetes2015, WIRB#: 2015169). 
 
1.2 Overview of the Manual of Operations (MOP) 
 
A MOP is a handbook that details a study’s conduct and operations. It transforms the study protocol 
into a guideline that describes a study’s organization, operational data definitions, recruitment, 
screening, enrollment, randomization, follow-up procedures, data collection methods, data flow, and 
quality control procedures. The MOP is intended to serve as a study “cookbook” that facilitates 
adherence to study procedures.  It is a reference guide for how each element of the study should be 
carried out. 
 
Implementing a trial is a complex undertaking. The MOP is a dynamic document that will be updated 
throughout the study to reflect any refinements to the study protocol, forms, or procedures.  It should 
be easily accessible, in electronic and/or printed form, at all study sites.  Each page of the MOP 
contains the version number and date in order to allow easy tracking of revisions. As pages are 

 
 
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revised, an updated version number and associated date will replace the original page(s) in the MOP. 
All previous versions should be archived.  
 
1.3 MOP Contents and Organization 
This MOP includes the following information: 
 
a) Study Protocol 
b) Study Organization and Responsibilities 
c) Study Timeline 
d) Study Intervention Overview 
e) Recruitment and Participant Retention Plan 
f) Study Flow 
g) Screening and Eligibility Criteria and Processes 
h) Informed Consent and HIPAA  
i) Study Intervention 
j) Study Measurements and Procedures 
k) Safety Reporting 
l) Study Compliance 
m) Data Collection and Study Forms  
 
n) Data Management 
o) Quality Control Procedures 
p) Reports 
q) Data Safety and Monitoring Board 
r) Study Completion and Closeout Procedures 
s) Study Policies 
t) Appendices: contain additional information and sample forms 
 
 
2 Study Protocol 
For adults with diabetes mellitus, diabetes self-management education (DSME) is critical to achieving 
long-term control of blood sugar levels (glycemic control) and preventing diabetes-associated 
complications. This education is often difficult to access for highly vulnerable and marginalized adults 
in the United States. Furthermore, we know that the appropriate foods for a diabetic diet are often out 
of reach for food insecure households. The purpose of this study is to determine the extent to which 
food banks and food pantries can help reach this population with effective DSME, food, and access to 
primary health care, with the ultimate goal of reducing diabetes complications and mortality. The 
randomized, controlled trial design will allow us to definitively answer this question.  Our primary 
outcome of interest is HbA1c improvement in the intervention group compared to a wait-listed control 
group of food pantry clients living with uncontrolled type 2 diabetes. 
 
 
 

 
 
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2.1 Study Organization and Responsibilities 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Feeding America National Offices 
Responsibilities: 
 
 
WIRB Approval 
 
Study design 
 
Survey design and distribution 
 
Food bank selection 
 
Educational content development 
 
Food box content development 
 
Training of Food Bank staff 
 
Training for blood glucose and HbA1c 
testing 
 
Technical assistance for regulatory 
oversight, including CLIA certification 
 
Progress reporting to donor 
 
Compliance with donor requirements 
 
Results reporting through Feeding America 
network 
UCSF Center for Vulnerable Populations  
Responsibilities: 
 
 
UCSF IRB Approval 
 
Study design 
 
Survey design and distribution 
 
Food bank selection approval 
 
Educational content development 
 
Training of Research Assistants 
 
Data analysis 
 
Progress reporting to FANO 
 
Results dissemination via scientific journals 
and presentations 
 
PI (Dr. Seligman) will also assume 
responsibility of Lab Director if required by 
local (Alameda County, CA) CLIA and 
NDGHA regulations 
Food Bank 1 
Responsibilities: 
 
FAITH-DM Manager 
 
Assistance to enrolled clients 
 
Blood glucose and HbA1c screening and 
monitoring 
 
Diabetes education 
 
Relationships with health care providers 
 
Preparation and distribution of food boxes 
 
Regulatory compliance for blood glucose and 
HbA1c testing (CLIA, medical waste, NDGHA) 
 
Research Assistants 
 
Pilot all forms on 2-3 participants 
 
Obtain informed consent in English and Spanish 
 
BG and HbA1c screening and monitoring 
 
Randomization 
 
Survey administration in English and Spanish 
 
Data collection (including utilization data) 
 
Data entry, management, and transmission 
 
Participant follow-up and retention 
 
Report standard food box and diabetes food box 
contents every 3 months 
 
Urban Institute 
Responsibilities: 
 
 Urban Institute IRB Approval 
 Design health care utilization evaluation plan and 
delineate data needed from provider and 
participant surveys 
 Train Research Assistants in proper procedures 
for sending de-identified data to Urban for 
utilization analysis 
 Provide consultation to RAs on provider questions 
regarding health care utilization data 
 Receive de-identified provider surveys and 
construct data set using project identifiers 
 Conduct health care utilization analyses, using de-
identified provider data set and de-identified 
participant survey data set received from UCSF 
 Disseminate results  via scientific journals and 
presentations (health care utilization analysis only) 
Food Bank 2 
Responsibilities: 
 
See List for 
Food Bank 1 
Food Bank 3 
Responsibilities: 
 
See List for 
Food Bank 1 

 
 
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2.2 Division of Supervision Responsibilities 
 
 
 
2.3 Coordinating Center Study Staff Roster 
 
Name 
Organization 
Principle Role 
Address 
Email 
Courtney 
Lyles, PhD 
CVP 
UCSF 
Analyst/Statistician 
Box 1364, San 
Francisco, CA 
94143 
Courtney.Lyles@ucsf.edu 
Michelle 
Berger 
Marshall, RD 
FANO 
FANO Director 
35 East Wacker 
Drive, Suite 
2000 Chicago, 
IL 60601 
mbergermarshall@feedingamerica.org 
Justin Morgan 
Urban Institute 
Intern 
 
JMorgan@urban.org  
Kim 
Prendergast, 
RD, MPP 
FANO 
FANO Consultant 
35 East Wacker 
Drive, Suite 
2000 Chicago, 
IL 60601 
kprendergast@feedingamerica.org 
Sophie 
Rosenmoss 
CVP 
UCSF Project 
Coordinator 
Box 1364, San 
Francisco, CA 
94143 
sophie.rosenmoss@ucsf.edu  
Hilary 
Seligman, MD 
CVP 
FAITH-DM 
Principle 
Investigator 
Box 1364, San 
Francisco, CA 
94143 
Hilary.Seligman@ucsf.edu 
 

 
 
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Morgan Smith, 
RN, PHN, CDE 
FANO 
Project Manager 
5715 Baltimore 
Dr., Unit 149 
La Mesa, CA 
91942 
mosmith@feedingamerica.org  
Elaine 
Waxman, PhD 
Urban Institute 
Lead, Health Care 
Utilization Analysis 
 
EWaxman@urban.org  
 
 
2.4 Coordinating Center 
Coordinating center responsibilities will be shared between FANO and UCSF’s Center for Vulnerable 
Populations. These responsibilities include: 
 Development and maintenance of the MOP (UCSF and FANO) 
 
 
 
 Development of the randomization scheme and procedures (UCSF) 
 Development of the data flow and data management procedures including data entry, error 
identification and correction (UCSF and FANO) 
 Adverse event monitoring and reporting to Coordinating Center (FANO) 
 Adverse event reporting to UCSF Committee on Human Research and/or Western Institutional 
Review Board, and/or the Urban Institute IRB as appropriate (UCSF) 
 Central communication with study sites, scheduling of meetings and training sessions, 
responding to and documenting ad hoc communications (FANO) 
 Site visits to ensure adherence to the protocol and procedures (FANO) 
 Quality control procedures (UCSF) 
 Reports (e.g. enrollment, adverse events, participant status, site performance,  quality control) 
(UCSF and FANO) 
 Distribution of all changes, reports, procedures and documents to participating study sites 
(FANO) 
 CITI Certification (FANO and UCSF, as necessary) 
 
2.5 Study Sites 
Sites participating in FAITH-DM include: Alameda County Community Food Bank (ACCFB), Gleaners 
Community Food Bank of Southeastern Michigan (GCFB), and the Houston Food Bank (HFB) 
 
The roles and responsibilities of the food banks include: 
 Maintenance of study binder with updated MOP 
 Participation in protocol finalization and preparation of study materials 
 Compliance with protocol, MOP, IRBs (UCSF Committee on Human Research, Western IRB, 
Urban Institute IRB) and Federal and state regulations 
 Accountability for administration of study intervention 
 CITI certification (as necessary) 

 
 
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 Membership in Steering Committee 
 Recruitment, screening, enrollment, and follow-up/retention of participants 
 Protection of participants' rights 
 Data collection from enrollment through study completion, including: survey data, HbA1c, and 
health care utilization data (requiring medical chart abstraction) 
 Transfer of data to Coordinating Center and resolution of all queries  
 Communication of questions, concerns, and/or observations to the Coordinating Center 
(FANO, Morgan Smith) 
 Development and maintenance of MOUs with collaborating health care sites 
 Communication with primary care providers 
 Development of expertise in administration of all intervention components, including diabetes 
education 
 Maintenance and quality control of point-of-care HbA1c machines and glucometers, including 
CLIA Certification and other regulatory requirements (as necessary) 
 Assembly and distribution of food packages 
 Communication and reporting per project guidelines and timeframes with FANO and UCSF 
staff (e.g., progress reports, budget reports, food box content reports, etc.) 
 
2.6 Steering Committees 
The Steering Committee is composed of representatives from FANO, UCSF, and staff from each of 
the three food banks, including the FAITH-DM Manager and the Research Assistant(s). It is 
responsible for the overall direction of the study.   
 
The following areas fall under the purview of the Steering Committee: 
 Review of overall design and implementation of the study 
 Conduct of the study 
 Approval of essential study documents, including the protocol, protocol amendments, MOP, 
and data collection forms 
 Review of data collection practices and procedures 
 Monitoring recruitment and retention of study participants 
 Changes in study procedures as appropriate 
 Allocation of resources based on priorities of competing study demands 
 Review of study progress in achieving goals and taking necessary steps to ensuring the 
likelihood of achieving those goals 
It is FANO and UCSF’s responsibility to make sure the Steering Committee has the necessary data to 
make decisions related to these responsibilities. 
2.7 Timeline 
 
 

 
 
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Timeline 
 
IRB Finalization, Kick-Off call, 
distribution of MOP 
Hire Research Assistants, 
Kickoff Meeting 
Food Bank Planning, Training 
Screening & Enrollment 
INT - Food Boxes & Written 
educational materials 
distributed 
Educational Classes Offered 
as needed per site 
Participant nudges for 
Control group & intervention 
group 
3-month HbA1c tests 
INT Follow-up surveys and 
HbA1c testing – T6 
Control Group Surveys and 
HbA1c testing – T6 
Control Group receives food 
boxes 
Control group final survey 
and HbA1c testing – T12 
Intervention group follow-up 
HbA1c and survey – T12; 
HCUS (extension activities) 
Target #’s participants 
recruited this month per 
food bank 
Total Numbers Recruited 
per food bank 
Total Intervention Group at 
end of the month 
(Estimate) per food bank 
# of participants receiving 
diabetes food boxes 
(assuming full participation 
of control group) 
July 2015 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
August 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
September 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
October 
 
 
X 
X 
X 
X 
X 
 
 
 
 
 
 
10 
10 
5 
5 
October 
Notes 
 
 
 
Classes ideally offered twice this month 
 
 
 
 
 
 
 
 
 
 
November 
 
 
 
X 
X 
X 
X 
 
 
 
 
 
 
20 
30 
15 
15 
December 
 
 
 
X 
X 
X 
X 
X 
 
 
 
 
 
25 
55 
28 
28 
January 
2016 
 
 
 
X 
X 
X 
X 
X 
 
 
 
 
 
25 
80 
40 
40 
February 
 
 
 
X 
X 
X 
X 
X 
 
 
 
 
 
25 
105 
53 
53 
March 
 
 
 
X 
X 
X 
X 
X 
 
 
 
 
 
20 
125 
63 
63 
April 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
30 
155 
73 
78 
April Notes 
 
First intervention group concludes; Team Retreat in Houston (4/20-4/21/16); begin sending and retrieving HCU surveys to all PPT providers 
 
May 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
30 
185 
78 
 93 
June 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
30 
215 
81 
109 
July 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
25 
240 
81 
121 
August 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
20 
260 
78 
131 
August 
Notes 
 
Screening & enrollment concludes (or earlier if goal #’s are achieved) 
 
 
 
 
 
 
September 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
66 
129 

 
 
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October 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
54 
127 
November 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
44 
122 
December 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
29 
109 
January 
2017 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
14 
94 
February 
 
 
 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
 
14 
77 
February 
Notes 
 
Final Food Boxes and Group Classes (Intervention Group); send final HCU surveys to both INT & CONT PPTs’ Providers 
 
 
 
March 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
 
 
 
67 
April 
 
 
 
 
 
 
X 
X 
 
 
X 
X 
X 
 
 
 
52 
May 
 
 
 
 
 
 
X 
X 
 
 
X 
X 
X 
 
 
 
37 
June 
 
 
 
 
 
 
X 
 
 
 
X 
X 
X 
 
 
 
22 
July 
 
 
 
 
 
 
X 
 
 
 
X 
X 
X 
 
 
 
10 
August 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
 
 
 
10 
August 
Notes 
 
Final Food Boxes Distributed (Control Group) 
 
 
 
September 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
 
 
 
 
October 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
October 
Notes 
 
Research Assistants finish all data collection & uploads; final PCP HCUS surveys (INT only at T12);  final transmissions to UCSF; final site grant reports DUE 
 
November 
Data analysis by UCSF and Urban Institute; manuscript preparation (UCSF, UI, & FANO) 
December 
December 
Notes 
 
FAITH-DM concludes 
 
 
 
 
 
 

 
 
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2.8 Communications Plan 
The communication plan includes: 
Steering Committee 
 Monthly meetings by phone 
 Ad hoc phone meetings between monthly meetings as necessary 
 Email communication as necessary 
 
FANO Staff (Morgan Smith), FAITH-DM Managers, and Research Assistants: 
 Weekly meetings by phone during implementation, with frequency reduced to twice or 
once monthly after follow-up period is completed 
 Email communication as necessary 
 Quarterly brief written progress reports (including project information: food box contents, 
DSME activities, clinic referrals, etc.) 
 Annual project and budget reporting (exact dates and forms TBD) 
 
All changes to the study protocol will be clearly documented by email communication and revision of 
the MOP. 
 
 
3 Study Intervention 
There are four components of the intervention. Each is described below. 
 
1. Testing and monitoring of blood glucose levels 
2. Primary care coordination 
3. Diabetes-appropriate food packages 
4. Diabetes self-management education (DSME) and support (SMS) 
3.1 Testing and monitoring of blood glucose 
Sites will follow all local, county, state, and federal regulations to develop and operate a testing, 
screening, and monitoring program that meets compliance requirements.  For specific regulatory 
guidelines, refer to section 7.5. 
3.1.1 Testing for diabetes and diabetes control among food pantry clients 
In order to identify food bank clients who may be eligible for study participation, food bank project 
staff will offer free diabetes screening events at food pantry sites during the recruitment phase of the 
study.  Diabetes screening will be provided at no cost for any food pantry client who is interested in 
and verbally consents to the screening, and is over 18 years of age. Food bank staff will conduct all 
screening activities, emphasizing with food pantry clients that screening tests are not diagnostic and 
that clients should speak directly with their health care providers for diabetes risk assessment, 
evaluation, and treatment. 
 

 
 
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For food pantry clients with no reported history of diabetes, or no known history of diabetes, diabetes 
screening will first include a random blood glucose (RBG) test using a Point-of-Care (POC) 
glucometer and a finger stick capillary whole blood sample.  Clients who have an elevated RBG 
screening result (defined as ≥ 160 mg/dL in non-fasting individuals and ≥ 140 mg/dL in fasting 
individuals) will also receive a screening glycosylated hemoglobin A1C (HbA1c) test using a POC 
device. 
 
All screening tests will be performed by trained study or food bank staff, or by trained food bank 
volunteers. All study staff and volunteers with human subjects contact must have appropriate CITI 
certification and quality and safety training.  Screening staff will complete the information on the 
Screening Log (Appendix B) for every food pantry client who receives a blood glucose and/or HbA1c 
test.  If uncertain, staff can ask the client for specific information in order mark the appropriate boxes 
under “age”, “gender”, and “race/ethnicity” (otherwise, staff can complete that information based on 
their assessment of the client. 
 
For food pantry clients who self-report a history of diabetes, screening will consist of a POC HbA1c 
test using a finger stick capillary whole blood sample performed by trained personnel. 
 
All clients who participate in screening will receive written results of their screening tests (see Client 
Screening Results Form in Appendix J), along with basic information about their results and local 
community health care resources. 
 
Additionally, any food pantry client who receives an HbA1c test will receive an educational handout 
(see Appendix AK) with information about the category in which their result falls: 
 HbA1c result less than 5.7%: normal HbA1c range 
 HbA1c result 5.7% to 6.4%: pre-diabetes range 
 HbA1c result 6.5% to 7.4%: diabetes, controlled 
 HbA1c result equal to or greater than 7.5%: diabetes, poorly controlled 
 
Food pantry clients who have screening HbA1c test results ≥ 7.5% will then be further assessed by 
study staff for eligibility and, if appropriate, enrollment into the study. 
 
3.1.2 Testing random blood glucose levels 
We will test food pantry clients’ current glycemic status using a point-of-care (POC) glucometer that 
measures random blood glucose (RBG). We have chosen a glucometer that is inexpensive, reliable, 
and FDA-approved for use on multiple people. Specific instructions for using the GE100 Blood 
Glucose Monitor can be found in section 7.2. 
 

 
 
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3.1.3 Testing Glycosylated Hemoglobin (HbA1c) Levels 
We will measure HbA1c levels for food pantry clients who report a diabetes history or who have a 
screening RBG result ≥ 160 mg/dL non-fasting or ≥ 140 mg/dL fasting.  We will use a point-of-care 
(POC) HbA1C device using a small sample (1 large drop, 5 microliters [µL]) of capillary whole blood. 
Instructions for using the PTS Diagnostics HbA1c+NOW®™ system can be found in section 7.3. 
 
3.1.4 Monitoring blood glucose control among study participants 
Our primary outcome of interest is change in HbA1c over time for study participants.  Hemoglobin 
A1c testing provides a reliable estimate of general blood glucose control over an approximate three-
month time frame.  We include regularly scheduled HbA1c testing for all study participants throughout 
the course of the study following the timeframes outlined below.  All HbA1c testing will be conducted 
by trained food bank staff or volunteers, who will use the same POC HbA1c devices described above 
(and in specific detail in section 7.3).  We will conduct monitoring tests with study participants at the 
food pantries where participants will be going to receive food bank services.  Study staff can use the 
“Participant Follow-Up Testing Results” form (Appendix AU) to record all follow-up and monitoring 
participant test results.  All test results will be entered into the MS Access database; the database has 
fields for recording test results performed outside of the windows identified below. 
 
 
Intervention Group 
Control Group 
T0 (baseline) 
At enrollment 
At enrollment 
T3 (month 3) 
2 – 4 months (3±1) 
N/A 
T6 (month 6) 
5 – 7 months (6±1) 
5 – 7 months (6±1) 
T9 (month 9) 
N/A 
8 – 10 months (9±1) 
T12 (month 12) 
11 – 13 months (12±1)** 
11 – 13 months (12±1)** 
* 1 month = 30 DAYS ALWAYS 
** Alternatively, T12 HbA1c windows can be manually calculated as 5-7 months after the completion 
date of a participant’s T6 follow-up activities.  This revision will accommodate participants who 
complete their T6 activities at month 5 (earliest part of the window) and maintain a 5-7 month 
separation between the T6 and T12 follow-up activities. 
 
 
Study staff can complete “extra” HbA1c testing for study participants outside of their intervention 
windows (e.g., between T0 and T6 for CONT group, or between T6 and T12 for INT group) if a 
participant requests a test during a pantry visit. Staff should not complete more than 1 extra HbA1c 
test for a participant during their waiting period.  Staff should not promote extra HbA1c testing for 
study participants—the primary purpose for completing extra testing during these periods is to provide 
a positive experience for study participants.  Extra HbA1c test results should be entered in the Access 
database in one of the “extra test” fields. 
 
If a participant does not complete their follow-up HbA1c test at T6 or T12, study staff can still 
complete an HbA1c test with the participant when they are next seen at a pantry or study activity.  

 
 
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Any HbA1c test completed beyond the follow-up windows should be entered in the MS Access 
database as an “extra” test. 
 
3.2 Primary care coordination 
MOUs with clinics require clinic staff to actively reach out to food bank-referred clients and schedule a 
new patient appointment within 3 months.  Food bank staff / RA will need to be able to verify with the 
clinic that the attempt was made and that the client has an appointment for care. 
 
A sample MOU document is included in Appendix O. 
 
Based on lessons learned from the Feeding America / BMSF Diabetes Pilot Project, it is 
recommended that food banks complete the following activities in order to build and sustain effective 
food bank – clinic partnerships: 
 Identify clinic point person (“clinic champion”) who will be the main contact for FAITH-DM staff 
 Meet with clinic staff to brief providers on the FAITH-DM trial, health care utilization analysis, 
food bank resources, and food insecurity screening; attend weekly “huddles” or monthly staff 
meetings to inform, update, and remind clinic staff about the project and partnership 
 
Participating clinic providers will receive a packet from FAITH-DM with: 
 Background info on FAITH-DM RCT 
 Overview of referral process and communication strategy for FB participants referred to clinic 
for care (fax process, appointment verification, etc.) 
o Clinic patients cannot be directly referred into FAITH-DM RCT 
 Overview of study health care utilization plan (consent to share protected health information 
[PHI], HIPAA, data requests) 
 Institutional Review Board (IRB) certification: Western IRB protocol # 20151569 
 Contact info / signatures of UCSF MD, FANO, and participating food bank 
 General information on how to: 
o Conduct food insecurity screening with patients (Appendix P) 
o Refer food insecure clinic patients into local hunger safety net 
3.2.1 Referrals to a primary care provider (PCP) 
 If food pantry client is not (and will not be) enrolled in FAITH-DM, provide resource hand out 
o For clients who report no PCP, complete “Screening and Referral Form” and fax form to 
appropriate provider 
 If participant is enrolled in FAITH-DM, study staff will ask: “Is there a doctor, other health care 
provider, or clinic you usually go to in order to help you manage your diabetes?” 
 Intervention participants who answer “yes” (has PCP) 
o Retrieve PCP information  
 Intervention participants who answer “no” (does not have PCP) 
o Provide written information to participant on PCP resources 

 
 
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o Send active referral to PCP (FAX to PCP and/or phone call to PCP/clinic) using the 
appropriate HCUA provider letter (see section 7.7). 
 Control participants who answer “yes” (has PCP) 
o Retrieve PCP information  
 Control participants who answer “no” (does not have PCP) 
o Provide resource handout 
 
 All study participants will again be asked at T6 and at T12 if they have a PCP; for both 
intervention group and control group participants who report no PCP at T6 or T12, provide: 
o Written information to participant on local PCP resources 
o Active referral to PCP (FAX to PCP and/or phone call to PCP/clinic) using the 
appropriate HCUA provider letter (see section 7.7). 
 
See Appendix AI for the “Screening and Referral Form” to use when sending a food pantry client’s 
screening results to a clinic.  The client must sign this form, giving food bank staff permission to share 
screening results with the clinic and/or provider. 
 
Food banks must also maintain a HIPAA compliant fax to send/receive client information to/from 
health care partners in order to maintain security and protect client/patient medical information.  To 
meet HIPAA standards, food banks should ensure that a dedicated FAITH-DM fax is located in a 
secure area (away from public areas).  Staff should use the HIPAA-compliant fax cover sheet 
(Appendix AB) whenever faxing forms and information connected with the FAITH-DM study.  
Additionally, site staff should follow best practices to maintain protection of participant data: 
 Only authorized personnel are to have access to the fax machine and incoming faxes 
 Destination numbers should be verified before transmission 
 Verified numbers used frequently should be pre-programmed to reduce number entry errors 
 Recipients should be notified that they have been sent a fax 
 Any patient data should be in the fax body and not in any of the data fields 
 Faxes are to be sent to secure destinations; i.e., the fax machine of the recipient must be in a 
secure location, accessible only by those authorized to receive the information 
 Maintain records of fax transmissions in the MS Access database for study participants 
 
3.2.2 Referrals from primary care 
Clinics can refer patients into the local hunger safety net through standard food bank protocols. 
Enrollment into the study for these participants will proceed through the standard process outlined in 
the MOP. We cannot accept referral of clinic patients directly into the study. 
3.2.3 Communication with health care provider 
Communication with the health care provider will be informed by the Health Care Utilization Analysis 
Plan (see section 7.7). 
 

 
 
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3.3 Diabetes-appropriate food boxes 
Through the 6-month intervention, FAITH-DM participants will receive 11 bi-monthly food packages 
(twice monthly).  The main goal of the food packages will be to increase participants’ access to foods 
appropriate for diabetes self-management.  The food packages will aim to provide approximately 25% 
of a participant’s food needs for the month, equating to about 11 meals from each food package.  
Additionally, the food packages will serve as a model for healthy food choices for people living with 
diabetes. 
 
Food group servings for the baseline food package will include a box with non-perishable items 
(canned, boxed, or other shelf-stable vegetables, fruits, grains, meats, beans, etc.), as well as 
supplemental perishable items (e.g. fresh vegetables and fruits, bread, dairy, meat, poultry) in a bag 
intended to serve a household of 1-2 people. In order to address varying household sizes, guidelines 
for distribution of food packages will be as follows:  
 
Household Size (# persons) 
Food Package Guidelines  
 
1 - 2  
1 standard box of non-perishables and 1 
standard bag of perishables  
 
3 - 4  
1 standard box of non-perishables and 2 
standard bags of perishables  
 
5 or more  
2 standard boxes of non-perishables and 
2 standard bags of perishables  
 
  
Food Box Criteria: 
 
Based on USDA guidelines for number of servings of different food groups for an adult male 
 Sufficient food items and variety to create 11 meals  
 Focus on vegetables and fruits, whole grains, low-fat dairy, lean meat  
 Ideal breakdown of food package by servings 
o 30- 40% non-starchy vegetables 
o 10 - 20% fruit 
o 25% grains and other carbohydrates (includes corn and potatoes) 
o 25% lean protein and dairy 
 
 
Food Group  
What equals a choice?   
Number of 
choices per 
food package  

 
 
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Vegetables - non-starchy 
vegetables including a 
variety of types.  Canned 
should be low-sodium or 
“no salt added”. 
 
Fresh vegetables: 1 head, 1 bunch or 1 pound = 
1 choice  
Canned vegetables (no salt added), 15 oz = 1 
choice  
Spaghetti sauce, 15 oz = 1 choice 
Frozen Vegetables, 16 oz = 1 choice 
9  
 
(Ideally 4-5 fresh/ 
perishable and 4-
5 shelf-stable)  
Fruits - include a variety 
of fruits.  Canned should 
be no-sugar added or 
packed in 100% juice.  No 
fruit juice.  
Fresh fruit: 1 bunch, 1 pound, or 4 pieces = 1 
choice  
Frozen Fruit, 12 - 16 oz = 1 choice  
Canned Fruit, 15 oz = 1 choice  
3  
(Ideally 2 
perishable and 1 
shelf-stable)  
Proteins - Meat & Non-
Meat -  
Focus on lean meats  
Canned Beans, 15 oz = 1 choice  
Dried beans, 1 pound = 1 choice  
Peanut Butter, 18 oz = 2 choices  
Dozen eggs = 1 choice  
Frozen meat, fish, poultry, 1 lb = 2 choices 
Canned chicken, tuna, salmon, 5 oz, 1 can = 1 
choice 
Tofu, 14 oz package = 1 choice  
6 
 
Ideally 2-3 
perishable and 3-
4 shelf-stable  
Dairy - Low fat dairy  
1/2 gallon milk, 1% or skim = 1 choice 
Shelf Stable milk, 1% or skim quart = 1 choice  
4 yogurts, 6 oz each = 1 choice  
Cottage Cheese, 8 oz = 1 choice 
Mozzarella, Cheddar, Swiss cheese, 8 oz = 1 
choice  
2 
Grains and other 
starches - at least 50% 
whole grains; ready-to-eat 
cereal < 8g sugar and 3g 
fiber per serving  
Whole grain bread, 1 loaf = 1 choice  
6 rolls or bagels = 1 choice 
Package Tortillas, whole grain = 1 choice  
Brown Rice, 1 bag, 16 oz  = 1 choice  
Pasta, 16 oz = 1 choice  
Oatmeal, 18 oz = 1 choice  
Ready to Eat Cereal, 12 - 16 oz = 1 choice 
Corn, 15 oz = 1 choice  
Potatoes, yams, 1lb bag = 1 choice  
5 
 
2 perishable and 
3 shelf-stable  
Other 
Coffee, tea, spices, low-sodium condiments, 
non-stick pan spray, salad dressing  
Olive oil and/or canola oil to be given out 2 times 
during the intervention   
1-2 items   
 

 
 
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Example Food Package 
 
Box 
Diced tomatoes, no salt added (2-15.5 oz. 
cans) 
Peas, no salt added (1-15.5 oz. can) 
Green Beans, no salt added (1-15.5 oz. can) 
Mixed vegetables, no salt added (1-15.5 oz. 
can) 
Applesauce, no sugar added (1-15.5 oz. can) 
Black beans (1-15.5 oz. can) 
Pinto beans (dry, 1 lb.) 
Salmon (1-14.75 oz. can) 
Peanut Butter (1-18 oz. jar) 
Box pasta, whole wheat (dry, 1 lb) 
Bag Brown Rice (dry, 1 lb) 
Box of high fiber cereal (dry, 18 oz.) 
Olive Oil 
Italian Seasoning  
 
Perishables 
Salad mix (10 oz.) 
Broccoli (1-2 heads) 
Carrots (1 lb.) 
Snap peas (1 lb.) 
Oranges (1 lb.)  
Grapes (1 lb.) 
Chicken thighs, frozen (1 lb.)  
Eggs (1 dozen) 
Milk, 1% or skim (1/2 gal.) 
Cheddar cheese (8 oz.) 
Bread, whole grain (1 loaf) 
Tortillas, whole grain (1 pkg.) 
 
3.4 Diabetes self-management education (DSME) and support (SMS) 
A major component of the intervention is to provide study participants with diabetes self-management 
education and support that is culturally appropriate and tailored to meet their needs relative to their 
socio-economic status, literacy level, and food security challenges.  We have drawn from evidence-
based practice and adapted existing diabetes education curricula to develop a structured intervention 
that is designed to be flexible to accommodate individual, community, and site variations.   
 
The FAITH-DM educational intervention is modeled on the American Association of Diabetes 
Educators “AADE7™ Self-Care Behaviors”.  These seven self-care behaviors include: 
 Healthy Eating 
 Being Active 
 Monitoring 
 Taking Medications 
 Problem-Solving 
 Healthy Coping 
 Risk-Reduction 
 
The FAITH-DM curriculum was primarily adapted from the “Type 2 Diabetes BASICs” curriculum 
(Park Nicollet International Diabetes Center), with additional content adapted from educational 
materials used in the “Improving Diabetes Care and Outcomes on the South Side of Chicago” project 
(Peek M., Chin M., University of Chicago).  The FAITH-DM curriculum addresses the AADE7™ 
through a combination of group classes, 11 packets of written education materials to accompany the 

 
 
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food box distributions, and one-on-one interactions to reinforce those messages.  A “Train the 
Trainer” model will be used to build capacity among the health educators at each site who will be 
implementing the intervention with study participants.   
 
 
The three DSME components of the education and support intervention described below include: 
 Formal DSME Group Classes (2 sessions with monthly drop-in sessions): section 3.4.1 
 Brief one-on-one interactions to reinforce DSME messages: section 3.4.2 
 Passive education materials (11 bi-monthly packets of written educational materials to 
accompany the food box distributions): section 3.4.3 
 
 
*** Note: Intervention group and control group participants receive different elements of the study 
DSME program (see below).  Food bank education staff will need to maintain a process to ensure 
participants receive the correct educational components based on their group assignment (the study 
MS Access database will support this process).  This group difference will allow us to assess the 
effectiveness of DSME components at the study’s end. 
 
 
All outreach and communication related to diabetes programming for participants in the intervention 
group should be targeted to the individual (using project reminder cards for group classes, phone 
calls, 1-on-1 in-person meetings, etc.).  Food bank education staff should NOT use global outreach 
strategies (general announcements, flyers, posters, mass mailings, etc.) to promote any diabetes 
education components to the general food bank population. 
 
 
Overview of DSME Components by Participant Group 
DSME Component 
Intervention Group 
Wait List Control Group 
Group Classes (includes monthly 
drop-in sessions) 
Yes 
No 
1-on-1 Interactions 
Yes 
Yes, after waiting period 
ACP “Living with Diabetes” Guide 
Yes, at enrollment 
Yes, after waiting period 
Bi-monthly passive education 
materials with food packages 
Yes 
Yes, after waiting period 
 

 
 
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3.4.1 DSME Group Classes 
For the purposes of this study our assumptions are that a majority of study participants will be linked 
to a primary medical home to receive ongoing diabetes clinical care and chronic disease 
management, and a majority of study participants will (or should) be receiving basic DSME from 
existing clinic services at their primary medical home.  However, based on our experience in the 
diabetes pilot project, we know that many participants may not receive DSME as part of their primary 
care, or clinic-based DSME messages may not be appropriate or relevant for this population. 
 
Rationale behind FAITH-DM DSME Group Classes: Based on prior experience attempting to 
conduct group DSME classes with food pantry clients, we have learned that it is difficult to run formal 
class series that meet more than 3-4 times.  We have thus decided to tailor our DSME program to 
focus on elements of diabetes self-management that are particularly important and specific to low-
income populations facing food insecurity, with the understanding that existing health care clinic 
services will address traditional DSME messages and support.  While we plan on addressing 
information on all AADE7™ Self-Care Behaviors, we will conduct a 2-class series emphasizing: 
healthy eating, problem solving, healthy coping, and risk reduction (prevention of diabetes-related 
complications), with a third open monthly forum session for further group discussion, support for the 
challenges of living with diabetes, reinforcement of problem-solving skills, and troubleshooting by 
participants. 
 
Key Metrics for DSME Program Selection and Adaptation 
1. Relevance for participant population 
2. Flexibility to be tailored to heterogeneity of participant group 
3. Cost 
4. Translation into Spanish 
5. Materials for participant distribution and training of facilitators 
 
Intervention participants will be asked to sign up for a group DSME Class series at the time of their 
enrollment into the study.  Prior to a participant’s first class session, food bank staff will send out 
reminder postcards and make reminder phone calls. Template postcards will be provided and a script 
for reminder phone calls will be given to staff and volunteers making those calls. (See Appendix AD 
for a sample of the post card with text.) 
 
To help maximize attendance at Sessions 1 and 2, sites will offer supplies to participants in 
attendance to support their diabetes self-management.  Supplies will include items such as water 
bottles, measuring cups, re-usable grocery bags, cookbooks, medication pill boxes, foot mirrors, 
pedometers, and stress balls.  Grant awards include funding for these items. 
 
Group classes (including the monthly drop-in sessions) are only offered to participants randomized to 
the intervention group. 
 
 

 
 
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Group Classes 
Group classes will be offered twice each month (or as needed) at varied days, times, and locations to 
maximize attendance. Classes will be conducted in English and Spanish by trained health educators.  
Each class session lasts 2 – 2.5 hours, and a class series will include 2 sessions with follow-up drop-
in sessions for ongoing support.  Class structure will emphasize participant involvement, group 
discussion and interaction, participant teachback, use of visual aids, and repetition of clear, simple 
messaging around key self-management strategies. 
 
Class sessions will be scheduled so that all study participants can complete session 1 within 1 month 
of their enrollment date, and session 2 within 2 months of their enrollment date. 
 
Session 1: Introduction to Diabetes – provide participants with basic information needed for diabetes 
self-management including disease overview, healthy eating strategies, physical activity, blood sugar 
monitoring, and treatment plans.  Primary AADE7™ behaviors addressed: Healthy Eating, Physical 
Activity, and Monitoring. 
 
Session 2: This session will focus on living with diabetes given the challenges of food insecurity and 
other common issues for food pantry clients.  Primary AADE7™ behaviors addressed: Problem 
Solving, Healthy Coping, and Risk Reduction. 
 
Drop-in Open Forum Sessions: These sessions will be offered once monthly (in both English and 
Spanish and in as many geographic areas as needed) and facilitated by food bank nutrition education 
staff.  The goal of the drop-in classes is to create a space for participants to receive ongoing support, 
practice problem-solving skills, develop health care connections, etc.  The forum sessions are also 
opportunities for sites to respond directly to participant needs and interests.  A secondary objective in 
offering open forum sessions is to help foster a participant support structure whereby food pantry 
participants can benefit from one another’s experiences, skills, and strategies on diabetes self-
management.  Each session should last 60-90 minutes. 
 
Drop-in sessions are for study participants in the intervention arm, and participants should be 
encouraged to attend all sessions while they remain in the study.  Monthly reminder calls and flyers 
during food distributions are useful strategies for increasing attendance.  Additionally, food bank staff 
should encourage study participants to attend the sessions with a family member or a support person. 
 
These monthly sessions can focus on a variety of topics related to diabetes self-management 
education and support.  Food bank staff can draw from existing nutrition education programming and 
adapt materials to target study participants.  Example session topics include: 
 Healthy eating and MyPlate 
 Healthy eating: rethink your drink 
 Healthy eating: grocery store tour 
 Healthy eating: label reading and carbohydrate counting 
 Healthy eating on a budget 
 Physical activity: walking program 

 
 
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 Goal setting and action plans 
 
Additionally, sites are encouraged to build on existing connections with local community health care 
providers to involve clinicians as guest speakers during monthly sessions.  Clinicians and 
practitioners can be invited to participate in 1-2 sessions during a 12-month period.  Examples of 
topics and providers include: 
 Stress management (social worker, therapist) 
 Depression and healthy coping (social worker, therapist) 
 Diabetes and eye health (ophthalmologists) 
 Diabetes and dental health (dentist) 
 Diabetes and foot health (podiatrist) 
 Diabetes medications overview (RN/CDE, MD) 
 Physical activity alternatives (yoga instructor, zumba instructor, dance instructor) 
 Smoking cessation (local provider) 
 
 
More detail about the lesson plans, participant handouts, and facilitator guides can be found in 
Appendix AC.  Formal content for drop-in sessions need not last longer than 30 minutes.  Participant 
peer support is an important aspect of drop-in sessions and can last the majority of the time. 
 
Participants in the control group will not have access to the group classes or drop-in sessions 
following their six-month waiting period (but they will receive passive diabetes education materials 
along with each food package they pick up).   
 
3.4.2 Brief 1-on-1 interactions  
1-on-1 interactions are offered to participants in the intervention group (T0-T6) and to control group 
participants (T6-T12).  
 
In order to reinforce DSME messages participants receive in the group class series or through the bi-
monthly passive education materials, health educators and food pantry staff will conduct brief 1-on-1 
interactions and check-ins with participants over the course of the intervention.  These interactions 
will take place during food distributions when participants pick up their bi-monthly food boxes. 
 
These interactions will assist participants in acquiring and reinforcing diabetes self-care knowledge 
and developing and strengthening diabetes self-management skills by providing a support structure 
for participants.  The interactions are opportunities for study staff to listen to participant feedback, 
challenges, and successes, as well as to provide participants with information on other existing 
community-based resources. In order to meet this obligation, study staff should be accessible and 
open to questions and informally check in with participants during food box distributions. Being 
proactive, friendly, and enthusiastic is critical to the success of this informal intervention component. 
 

 
 
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Health educators at sites will utilize materials from the diabetes education curriculum to interact with 
participants and respond to comments and questions relative to the AADE7™ Self-Care 
Behaviors.  Sample questions and prompts to initiate interactions with participants include: 
 What have you been working on to help take care of your diabetes? 
 What challenges have you had with your diabetes? 
 How do you like the diabetes food packages included in the FAITH-DM project?  What 
changes would you like to see with the food packages? 
 What questions do you or your family have about taking care of your diabetes? 
 What challenges have you had with keeping to your plan to eat healthy? 
o Educators can utilize existing food bank nutrition education resources and expertise 
o Focus on Healthy Eating messages (MyPlate, label reading, portion control, “rethink 
your drink”, etc.) 
 Review bi-monthly passive diabetes education materials 
o Highlight any local resources that relate to current topics 
 
Because these are 1-on-1 interactions, participants may have questions or comments specific to their 
individual health status and diabetes self-management plan.  Food bank staff and volunteers should 
respond to specific questions within their own scope of knowledge and practice (as applicable per 
individual training and credentials).  Participants should always be encouraged to contact their 
primary care provider for information related to their individual care, treatment plan, and diabetes self-
management activities. 
 
3.4.3 Bi-Monthly Written Materials and Handouts 
Study participants in the intervention arm will receive at enrollment the “Living with Diabetes” guide 
published by the American College of Physicians (ACP) and specifically developed for low-literacy 
audiences.  The guide is available in both English and Spanish. 
Study participants in the control arm will receive the ACP “Living with Diabetes: guide at the 
completion of their six-month waiting period and when they begin picking up the bi-monthly diabetes 
food packages. 
 
All study participants will receive written diabetes educational materials twice monthly with each food 
box. These materials will also be available in English and Spanish, and will focus on a specific 
AADE7™ Self-Care Behavior. A distribution schedule and list of included educational resources can 
be viewed in Appendix I.  
 
Along with these “passive” diabetes education materials, participants will receive diabetes-appropriate 
recipes with each food box they pick up.  These recipes will be developed or evaluated by study staff 
(Registered Dietitians and/or Certified Diabetes Educators).  Recipe selection and distribution each 
month will likely vary at all three study sites due to community differences, food bank resources, and 

 
 
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seasonal availability and variety of fresh produce, but will be in alignment with Healthy Eating 
principles outlined in the AADE7™. 
 
3.4.4 Other diabetes education interventions 
While study staff should make every effort to ensure FAITH-DM study participants receive the correct 
diabetes education components based on their group assignment, it is likely that some study 
participants may have access to other diabetes programs outside of FAITH-DM.  In order to adhere to 
the study protocol, and to account for other clinic- or community-based diabetes programming, food 
bank and FAITH-DM staff should do the following: 
1. Communicate to the Coordinating Center (Morgan Smith, FANO) any knowledge of other 
diabetes education programs that may actively target food pantry clients 
2. If other diabetes education programs do exist and it is unethical not to allow study participants 
access to these programs, both the intervention groups and control groups must have equal 
access to the programs (e.g., FAITH-DM staff should not be referring ONLY control group 
participants only to a commuity-based DSME program) 
Food banks and FAITH-DM staff should refrain from conducting or participating in other diabetes 
education programming or other diabetes interventions (either as a lead site or a partner site) for the 
duration of their participation in the FAITH-DM study.  Any food bank participation in non-FAITH-DM 
diabetes programming needs to be communicated to the Coordinating Center (Morgan Smith, 
FANO). 
 
3.5 Tracking participation in intervention elements 
The MS Access database has several fields to track participant engagement in the study intervention 
(dates of food package pick-up, percent of food package pick-up, participation in diabetes education 
classes, etc.).  Study staff should maintain consistent processes to record participant engagement 
during study activities, and update participant records in Access in a timely manner. 
 
The MS Access database has several open “notes” fields for adding additional information, which 
may include important data and participant feedback that can be included in study analyses to help 
interpret final results.  In order to help capture this information, study staff should use the “Barriers to 
Participation in FAITH-DM Activities” form (Appendix AV) for any intervention-specific data reported 
by a participant.  The site RAs will use completed forms to enter this data into Access in the notes 
fields for study participants. 
 
Additionally, site and study staff can use results from these forms as part of a continuous quality 
improvement process at the sites.  However, any changes that may impact the study intervention, or 
how participants access the intervention, must be discussed with and approved by the Coordinating 
Center. 
 

 
 
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3.6 Length and time windows for intervention 
For participants in the intervention group, access to the food package and DSME intervention 
components is only available during their 6-month intervention window (T0-T6).  Intervention group 
participants should no longer have access to these elements after they reach their T6 time point in 
the study (they will have access to referrals for care, if needed, at T6 and T12, and have access to 
HbA1c testing and monitoring at T6 and again at T12). 
 
For participants in the control group, access to the food package and the modified DSME intervention 
components is also only available during their 6-month intervention window (T6-T12). Control group 
participants should not have access to intervention components prior to T6, nor should they continue 
receiving any intervention components after T12. Control group participants will have access to 
referrals for care, if needed, at T6 and T12, and have access to HbA1c testing and monitoring at T6, 
T9, and again at T12 per existing study protocols. 
 
Site adherence to these time windows will help achieve and maintain fidelity to the original study 
design. While sites may need to make minor, reasonable accommodations for individual participants 
(e.g., provision of a maximum of 2 food packages to be picked up within 1 month post T6 follow-up 
activities for intervention group participants), any deviation from these protocols should be logged in 
the MS Access database for the participant, and site staff should complete and submit a Protocol 
Deviation (Appendix F) form. 
 
Any food bank services (e.g., food packages, education, support, referrals) provided or conducted 
after T12 activities for any study participant will be at the discretion of the food bank as these clients 
will no longer be enrolled in the study as active study participants. 
 
 
4 Recruitment and Retention Plan   
In order to meet recruitment targets, we will: 
 Monitor recruitment and intervene quickly to change recruitment techniques that are 
proving unsuccessful; discuss on monthly calls 
 Identify barriers to recruitment 
 Use multiple recruitment strategies depending on the needs of each food bank or food 
pantry (see Appendix AJ for a sample recruitment flyer to post at pantry sites) 
 If we are not meeting recruitment goals, we can employ additional outreach strategies such 
as English and Spanish language flyers and advertisements 
 Recruitment-related team conference calls will occur weekly to start, then switch to monthly  
 Our goal is to recruit approximately 240 people per site 
4.1 Participant Retention  
We will use the following practices to ensure the highest levels of retention in our study, as this is one 
of the most important steps we can take to ensure the validity of our findings.  
At baseline: 

 
 
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 Whenever possible, recruitment into the study, informed consent, administration of the 
baseline survey, and randomization should occur during a single, face-to-face visit 
 Stress the importance of adherence to entire study protocol during the informed consent 
interview and throughout the study 
 Obtain the names and contact information for 2 individuals closely related to the participant 
(e.g., next of kin, friends, etc.). Such individuals can be contacted in the event that a 
participant does not return for follow-up visits.  This information (as with all participant 
information) will be stored in the MS Access database. 
 Establish rapport with the participants 
 Treat participants and their caregivers with respect 
 Assure a welcoming atmosphere where participants are seen 
 Be considerate of the participant’s time and confidentiality  
 Identify and resolve issues in a timely manner 
 
Throughout the study: 
 Streamline assessments and procedures that are excessively burdensome and time 
consuming, especially completing the baseline and follow-up questionnaires in the most 
convenient time and place for participants  
 Use reminder notes and calls to let the participant know you will be calling shortly for their 
follow-up assessment, or to increase adherence to intervention components such as 
education classes 
 Be persistent. Document in MS Access database all attempts to contact participants, and 
keep trying.  
 Use the contact information for a missing participant that has not withdrawn consent. The 
telephone numbers for friends and/or relatives in the MS Access Database should be 
accessed to locate the participant.  
 Use global strategies for staying in contact with all participants, such as: monthly phone 
calls; birthday and holiday cards; & reminder postcards.  FANO will provide pre-printed 
birthday, holiday, and diabetes class reminder cards to sites (see Appendix AD for 
samples). 
 Encourage pantry staff and volunteers to interact with all study participants (especially 
those in the control group during their waiting period) during distributions and other events 
to maintain high levels of excitement, enthusiasm, and awareness of the project 
 
Participant retention requires careful planning and continuous efforts and helps to ensure a 
successful study. Every effort should be made to retain study participants without coercion. 
 
4.2 Study Flow 
For a detailed, illustrated overview of the flow of participants through the study, see Appendix C.  For 
a general overview that can be used when describing the trial to staff, clinic partners, and pantry 
agencies, see Appendix AQ.  An overview of the study flow is below: 

 
 
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1. Screen for diabetes with HbA1c testing 
2. Perform informed consent, HIPAA 
3. Conduct baseline survey 
4. Randomize the participant 
5. Perform intervention, wait list intervention 
6. Perform follow-up survey and HbA1c testing 
7. Provide compensation at baseline and/or at follow-up survey (see section 9.3) 
 
Study Approach to Screening and Enrollment 
When enrolling new clients into the study, every effort should be made by study staff to complete all 
enrollment processes (HbA1c testing, consents, baseline survey, randomization, and study 
orientation) on-site and face-to-face with the new study participant. 
 
If a food bank client is identified as eligible to participate in the study but does not have time to 
complete these enrollment processes, then study staff should not consent and enroll the client at that 
time.  Instead, study staff should attempt to identify a time and food distribution location occurring 
within 2 weeks that is available to the client so that they can enroll into the study and complete all 
enrollment processes during one encounter. 
 
Additionally, for study participants completing their follow-up and /or final HbA1c testing and surveys, 
study staff should attempt to complete testing and surveys in-person during one encounter. 
 
If necessary, FANO and UCSF project staff can review challenges to this approach identified by the 
food banks and work to develop alternative screening, enrollment, and survey administration 
strategies that are responsive to issues identified at the participant / food pantry level.  Food bank 
staff should communicate any screening, enrollment, and survey administration challenges directly to 
Morgan Smith, FANO Project Manager. 
 
5 Screening and Eligibility Criteria 
To help assure that study sites accrue participants with the required characteristics, this section 
provides a detailed discussion of the screening procedures, including checking random blood sugar 
and HbA1c levels, and eligibility and exclusion criteria. 
5.1 Screening procedures 
In order to identify potentially eligible participants, we will conduct diabetes screening with adults who 
utilize services at food pantries.  We will use random blood glucose testing and Point-of-Care 
Hemoglobin A1C testing to screen adults for diabetes. 
 
Prior to initiating screening activities, we will conduct a diabetes screening training seminar with study 
staff (Research Assistants) and food bank staff and volunteers in order to ensure safety and 
consistency of screening across all sites. 
 

 
 
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The diabetes screening training of RAs and food bank personnel will include information in the 
following areas: 
 Diabetes pathophysiology, screening, evaluation, and treatment 
 Client privacy and HIPAA regulations 
 Universal precautions & sharps safety 
 Medical waste handling 
 Use of specific study equipment (e.g., GE100 glucometers, A1C+Now Testing System) 
 
To ensure screening programs at the food bank sites are in compliance with all relevant local, county, 
state, and federal regulations, sites will apply for and obtain any necessary certifications prior to 
initiating diabetes screening (e.g., CLIA waiver certifications, sharps storage and transport, medical 
waste permitting; see section 7.5). 
 
Food banks and food pantry sites are non-traditional locations for conducting diabetes screenings.  In 
acknowledgement of this, we address the following to ensure food pantry clients have a safe, 
informative, and positive experience when participating in a screening event in the food pantry 
setting: 
 Food pantries typically operate in community settings (e.g., senior centers, community centers, 
churches, etc.) with limited resources regarding space and supplies.  We will conduct 
screenings at identified pantries that do have adequate space and resources (tables and 
chairs, room dividers, etc.). 
 Screening stations will be located in food pantry areas where client privacy and confidentiality 
can be maintained (separate room or office, or on the periphery of the pantry).  
 
Screening Protocol 
Any adult (aged 18 years or older) present at a food pantry site where diabetes screening is available 
can participate in the screenings.  Food bank staff will promote the screening events at the food 
pantries through flyers, announcements, and other outreach activities targeting existing food pantry 
clients. 
 
All food pantry clients participating in diabetes screening events will be informed by staff that 
screening results are NOT diagnostic.  Staff will direct clients to contact their primary medical provider 
or a community health center to address all personal medical and health questions, and for further 
screening, evaluation, and treatment as needed.  Staff will provide food pantry clients with contact 
information for local community health care organizations as part of the screening process. 
 
Each food bank site is only expected to conduct regular screening activities until that site reaches its 
target number of enrolled participants (240 per site).  Once study recruitment and enrollment has 
ended, each site will only be required to continue testing and monitoring enrolled participants per the 
study timeline.  Sites can continue to conduct general screening activities with pantry clients if they 
have the time, resources, and capacity.   However, no new screening information should be tracked 
in ACCESS after enrollment has closed, and pantry clients screened after the enrollment has closed 
may not participate in study activities or interventions.  Sites can develop their own protocols (e.g., 

 
 
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referral processes for clients needing care, educational programming, food resources) for managing 
pantry clients and screening activities beyond what is required for this trial. 
 
When an adult food pantry client provides verbal consent and agrees to participate in a diabetes 
screening test, we will use the following flow chart to identify what screening tests and procedures are 
used: 
 
5.2 Eligibility and Exclusion Criteria 
Study eligibility is determined by a set of specific inclusion and exclusion criteria. Individuals must 
meet all eligibility criteria. This section defines the criteria, method for determination, and the specific 
forms needed to document eligibility. 
 
Our specific inclusion criteria include: 
 Type II diabetes mellitus with HbA1c ≥ 7.5% using food bank point-of-care testing 
 Food pantry client (defined as any individual engaging with a food bank or partner agency for 
food assistance, regardless if is their first visit or not, or if they are requesting direct food 
assistance, SNAP enrollment assistance, or general information on any food resources or 
programming) 
 Reliable mode of contact (either phone or address) where they can be reached 
 English or Spanish verbal fluency 
 18 years of age or older 
 Intent to remain in the study area for at least the next 12 months 
 Willingness to participate in intervention (including picking up bi-monthly food boxes and 
participating in diabetes education activities) 

 
 
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Exclusion criteria include: 
 Type 1 diabetes  
 Pregnant or less than 6 weeks post-partum* 
 Cognitively impaired: dementia, mental illness, or active substance abuse severe enough to 
make client incapable of providing informed consent and could interfere with administration of 
the survey or participation in the intervention** 
 Household member already enrolled in the study*** 
 
* Study participants who become pregnant after enrollment may remain in the study and participate in 
all study activities in their assigned group (intervention or control).  Study staff will emphasize with 
any pregnant study participant the importance of staying connected with their healthcare providers (to 
receive regular pre-natal care and any pregnancy-specific diabetes self-management education and 
support). 
 
** Refer to Appendix AS “Cognitive Impairment Assessment Tool” to assess cognitive impairment 
during participant enrollment; this form and process need only be used on clients where study staff 
suspect cognitive impairment. 
 
*** Other household members with diabetes can share the food box, participate in the education, and 
have their HbA1c checked, but should not be enrolled in the study. 
 
5.2.1  Prompts for speaking with ineligible clients 
During the screening and enrollment process, it is likely that food bank staff will interact with clients 
who want to enroll in the project, but who do not qualify based on the study eligibility requirements.  
For example: a client who has an HbA1c result of 7.4%, or is planning on moving away in 11 months, 
or does not speak English or Spanish fluently would be excluded from study participation.  The 
following prompts are to provide guidance to project staff to communicate this information to the 
client, with the goals of ensuring that the client understands and has a positive pantry experience. 
 Emphasize that because this is a research study, enrollment requirements are very clear and 
are not flexible (potentially a difference from other pantry programs); adhering to the protocol 
will allow the researchers to learn what best helps participant with diabetes 
 Provide information about other pantry or community resources for which the participant may 
be eligible 
 If the client may become eligible in the future (e.g., has an increased HbA1c, or exits out of the 
6-week post-partum period), then encourage the participant to return in the future for additional 
screening and assessment of eligibility 
o It may be important to stress that the enrollment period will have an end date, and there 
is no guarantee that enrollment will be possible at a later date 
o For clients with an elevated HbA1c level that is not high enough to qualify for the study 
(e.g., an HbA1c 6.5% - 7.4%), it is essential to provide the client with positive feedback 

 
 
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that they are doing a tremendous job in managing their diabetes well and that they 
should continue working hard to keep their HbA1c level under 7.5% (we do not want 
clients “sabotaging” their diabetes self-management in order to enter the study) 
 Remind clients that the study is helping the food bank to learn more about community based 
interventions that help people living with diabetes; it is likely that the food bank will offer 
additional diabetes programming after the study ends that will have much less strict enrollment 
requirements   
 
5.3 Informed Consent 
Informed consent is a process in which an eligible individual is informed of all aspects of the research 
that are relevant to his or her decision and is then given the chance to choose whether or not to 
participate without any consequence to usual care. 
 
US regulations 21 CFR 50 and 45 CFR 46 require that informed consent be documented by the use 
of an informed consent form approved by the responsible institutional review board (IRB) and signed 
and dated by the participant and research staff at the time of consent. Detailed instructions for 
obtaining informed consent are listed below and a quick guide to the informed consent process 
(Western Institutional Review Board, except from “A Guide for Researchers”) can be found in 
Appendix T. In addition, a copy of this study’s informed consent form can be found in Appendix AE. 
 
The informed consent form and process has been approved by the Western Institutional Review 
Board. 
5.3.1 The Informed Consent process for participants with adequate literacy 
 Review eligibility: Before initiating the informed consent process, be sure to review the 
eligibility of the potential participant and make sure this information is accurately recorded on 
the screening and enrollment checklists. 
 Verbally explain the study and research activities: Using the informed consent form as a 
guide, verbally go through each section (section headings are in bold) of the form with the 
potential participant, speaking clearly and allowing the potential participant to ask questions. 
The consent form and consent process must be completed in the potential participant’s 
preferred language (either English or Spanish). 
 Provide the written consent: When the verbal consent process is complete, provide the 
participant with the written form for them to read. The participant must be given sufficient time 
to read and consider what is required of them, the risks, benefits, and alternatives of 
participating before providing their consent. 
 Assess client comprehension: In addition to fielding questions from the potential participant, 
the person obtaining the consent must assess the food bank client’s comprehension by using 
the teach-back method whereby the person obtaining consent asks open-ended and non-
directive questions that require the potential participant to explain in his or her own words the 

 
 
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basic study procedures. Research staff should make sure the potential participant can 
describe why the research is happening, what is being asked of him or her, and the risks 
and/or benefits to taking part in the study.  Some sample questions include: 
o If someone in your family asked you what this study was about, what would you tell 
them? 
o How often might you need to pick up food boxes as part of this study? 
o Where will you be picking up your food boxes during the study? 
o If you had a question or problem during the study, who could you contact? 
o What else might you receive for participating in this study? 
o How many diabetes classes might you be expected to participate in during the study? 
 Obtain consent: Once all questions are answered by both parties and the individual has 
agreed to participate in the study, the participant should sign and date the consent form where 
indicated. The research staff member who performed the consent procedures should sign and 
date the same consent form. The participant and research staff should also sign a second 
consent form for the participant to keep as a copy for their records. 
 Store and track signed forms: Once the consent is complete, the original form should be 
stored in an informed consent binder at the individual site. This material is sensitive and 
access should be restricted to trained FAITH-DM study personnel only (see section 17.4). 
Documentation that the consent was or was not completed should be noted on the appropriate 
tracking forms in the MS Access database. 
 
5.3.2 The Informed Consent process for participants with limited literacy 
If you are enrolling participants who cannot read the consent materials due to limited literacy skills: 
 It is recommended that an impartial witness observe the consent process. 
o In the food pantry setting, impartial witnesses could include: other study staff or 
volunteers, food bank / pantry staff or volunteers, or host site staff / volunteers. 
 Consent materials should be presented orally, including the HIPAA form (see next section) 
 Sufficient time should be allowed for questions to be asked and answered, both by the 
participant and by the person obtaining consent, to ensure the subject comprehends the 
consent information. 
 
 Review eligibility: Before initiating the informed consent process, be sure to review the 
eligibility of the potential participant and make sure this information is accurately recorded on 
the screening checklist. 
 Verbally explain the study and research activities: Using the informed consent form as a 
guide, verbally go through each section (section headings are in bold) of the form with the 
potential participant, speaking clearly and allowing the potential participant to ask questions. 
The consent form and consent process must be completed in the potential participant’s 
preferred language (either English or Spanish). 

 
 
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 Assess client comprehension: In addition to fielding questions from the potential participant, 
the person obtaining the consent must assess the food bank client’s comprehension by using 
the teach-back method whereby the person obtaining consent asks open-ended and non-
directive questions that require the potential participant to explain in his or her own words the 
basic study procedures. Research staff should make sure the potential participant can 
describe why the research is happening, what is being asked of him or her, and the risks 
and/or benefits to taking part in the study.  Some sample questions include: 
o If someone in your family asked you what this study was about, what would you tell 
them? 
o How often might you need to pick up food boxes as part of this study? 
o Where will you be picking up your food boxes during the study? 
o If you had a question or problem during the study, who could you contact? 
o What else might you receive for participating in this study? 
o How many diabetes classes might you be expected to participate in during the study? 
 Obtain consent: Once all questions are answered by both parties and the individual has 
agreed to participate in the study, the participant should sign and date the consent form where 
indicated.  To document the consent process, Western Institutional Review Board’s 
recommendations are consistent with guidance endorsed by the FDA (FDA 21 CFR 50.25). If 
the participant verbally agrees to participate in the study: 
o If capable of doing so, the participant signs or marks an X to signify consent. 
o The witness signs and personally dates the consent form. By doing so the witness 
attests that the consent information was accurately explained and that the participant 
apparently understood the information, and informed consent was given freely. 
o The research staff that performed the consent procedures should sign and date the 
same consent form. The participant, witness, and research staff should also sign a 
second consent form for the participant to keep as a copy for their records. 
 
Important notes: It is the responsibility of the research staff obtaining consent to judge the 
participant’s comprehension of the consent information including the understanding that participation 
is voluntary and that the participant has the right to withdraw at any time during the study. If any study 
staff doubts the participant’s consent comprehension, he/she should not enroll the individual in the 
study. 
 
5.3.3 Participant update process at T6 
The IRB-approved consent forms include information on possible T12 activities that could occur in the 
event ancillary funding is obtained for the study.  As a result of receiving this funding (see section 
17.3) the MOP has been revised to reflect changes to study activities at T12.  Western IRB approved 
of these changes and the updated research protocol on: 3/18/2016. 
 

 
 
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While these changes did not require a revision to original and existing informed consent processes, 
study staff will need to inform current and future study participants of all study activities and timelines 
accordingly: 
 Use revised participant recruitment flyer and other materials to describe all participant activities 
and study timelines 
 Verbally communicate all participant activities and study timelines when promoting study and 
recruiting participants 
 Verify all participant activities and study timelines when completing informed consent process 
during participant enrollment (“If you are in the intervention group, we may contact you to 
perform HbA1c testing and follow-up 12 months after you enroll.”) 
 Disseminate informational sheet (“Participant FAITH-DM Study Update”, Appendix AW) to all 
study participants at their 6-month marks (in-person and/or via mailings) 
 
5.4 HIPAA Authorization 
The Health Insurance Portability and Accountability Act authorization form is a separate document 
from the informed consent, and must be reviewed and signed by the study participant at the time of 
consent.  The HIPAA authorization form is an extension of the informed consent form that pertains to 
the study purpose and procedures.  When signed, this document authorizes the release of specified 
personal identifiable health information for use in this study and allows communication with a 
participant’s health care provider.  The signed HIPAA authorization form must be faxed or securely 
sent to the health care provider before they can release any information about the patient. 
 
5.4.1 Process for obtaining HIPAA authorization 
The process for reviewing the HIPAA document and obtaining participant authorization is similar to 
the process for obtaining informed consent. It is usually easiest to append this document to the end of 
the informed consent form in order to review them in a single session with the potential participant. 
For this study, personal identifiable health information will be collected in the form of selected data 
from medical records. 
 
We will collect information on healthcare use by each participant. Because part of the intervention 
involves a referral to primary care, we will also assess if an appointment with a primary care provider 
was made and kept. Furthermore, we seek to collect information on other health care utilization, 
including emergency department visits, hospitalizations, and primary care visits. 
 
As with the informed consent, verbally discuss pages 6-7 of the HIPAA form, allow time for questions 
and review, employ the teach-back method, and if the participant agrees, obtain his/her signature. If 
the subject has limited literacy skills, refer to section 5.3.2. 
 

 
 
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Completed HIPAA documents should be kept with the associated informed consent documents in the 
secure site-specific binder. Again, documentation that HIPAA authorization was or was not provided 
should be made in the MS Access database. The HIPAA form can be found in Appendix X. 
 
5.5 Medical Records Release Form 
The Medical Records Release Form (Appendix AO) should be completed at the same time as the 
informed consent form and the HIPAA authorization form during participant enrollment.  This form 
needs to be completed and signed by the participant in order to access clinic medical records as part 
of the Health Care Utilization Analysis.  While the informed consent and HIPAA authorization forms 
are mandatory for participants, the medical records release form is optional.  If a participant refuses to 
sign this form, they can still participate in the study, but we cannot request any of the participant’s 
medical records from their provider. However, because the HCUA is an important part of this study, 
study staff should provide support and encouragement to participants to ensure they understand the 
form and request, and complete it as part of the enrollment process.  Encouragement entails not only 
explaining the benefits of the information obtained in the study, but also emphasizing that the decision 
to sign the medical release form in no way impacts a person’s participation in the study. As such, 
encouragement excludes any action or statement that can be interpreted as coercive to the 
participant. Coercive actions include, but are not limited to, putting undue pressure on the participant 
or implying that the participant will not receive FAITH-DM food boxes and/or any applicable 
intervention components, or regular food bank services if he or she does not sign the release form. 
Study staff should document in the MS Access database whether or not the medical records request 
form was completed for each participant. 
 
When filling in the dates of requested information on the bottom of the first page of the Medical 
Release Form, please fill in the following dates specified in the “From” and “To” blanks.               
 From: The date 6 months prior to the day of enrollment of the participant 
 To: The date the participant will have been in the study for 1 year from the day of enrollment 
 
Prior to asking the participant to sign the Medical Release Form, please mark all fields under 
“Specific type of information to be disclosed” with a check or X mark (with the exception of the “other” 
field, which you should leave blank).  
 
 
6   Blinding and Unblinding (Masking and Unmasking) 
This study is not blinded.  However, to reduce bias in allocation, the randomization process will be 
completed by UCSF staff prior to enrollment of the first participant.  The baseline survey should 
always be administered prior to determining the randomization status of the participant. 
 
 
7   Study Measurements and Procedures 
To ensure that assessments and measures are conducted consistently across study participants and 
sites, this section describes detailed procedures for: 

 
 
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 Universal precautions and safety 
 Random blood glucose testing (including Quality Control testing) 
 Point-of-care HbA1c testing (including Quality Control testing) 
 Regulatory requirements for testing (CLIA certificates of waiver, medical waste permits and 
plans, licenses and certifications, county and/or state specific regulations, etc.) 
 Survey administration 
 Health care utilization plan 
7.1 Universal precautions and safety 
Safety of study staff, food bank staff, volunteers, and clients are top study priorities.  While the risk of 
injury and/or infections disease transmission associated with our community screening program is 
negligible, risk still exists.  To further reduce risk and maintain a safe screening environment, all study 
staff, food bank personnel, and food bank volunteers who conduct screening and testing activities will 
complete training on universal precautions and screening safety (or demonstrate evidence that they 
successfully participated in a comparable training program) prior to screening clients.  Training will 
include information on: hand hygiene, proper use of personal protective equipment (e.g., nitrile 
gloves), surface sanitizers, single-use lancet devices, sharps containers (including use, transport, and 
storage), proper testing techniques with clients, and on developing site-specific sharps and accidental 
needle stick protocols. 
7.2 Random blood sugar testing 
We will use GE100 Blood Glucose Monitoring System (Bionime Corporation) glucometers to conduct 
all random blood glucose testing with food pantry clients and study participants.  The GE100 Blood 
Glucose Monitoring System received U.S. FDA 510K approval for use by healthcare personnel to test 
multiple patients. 
 
Random blood glucose testing can be conducted by trained study staff and food bank personnel.  
Testing will follow manufacturer guidelines for glucometer use, maintenance, cleaning, and quality 
assurance (see Glucometer User Manual in Appendix M). 
 
Materials List for Random Blood Glucose Testing 
 GE100 Blood Glucose Meter 
 GE100 Blood Glucose Test Strip (check expiration date on strips; do not use expired strips) 
 Hand sanitizer 
 Nitrile gloves 
 Alcohol prep pad (minimum 70% alcohol) 
 Single-use lancet device 
 Cotton balls 
 Bandage 
 Dental bib (disposable barrier) 
 Surface sanitizer (Sani Cloth Super Wipes) 
 Trash can with liner 

 
 
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 Sharps container 
 Dex4 Glucose Tabs 
 
7.2.1 Procedure to conduct a blood glucose test 
1. 
Have client sit at health screening table. 
2. 
Introduce yourself and provide client with background on screening. 
3. 
Ask client: “have you ever been told by a doctor that you have diabetes?” 
4. 
Always maintain client privacy.  If necessary, ask other food bank clients to stand away from 
the screening area. 
5. 
Clean hands with hand sanitizer. 
6. 
Set up testing supplies. 
7. 
Put on exam gloves. 
8. 
Ask if client has a preference for which finger to use in order to access blood sample. 
a. Do not use any site on a finger that is an open wound, has scar tissue, has evidence or 
infection, or has any other contraindication (e.g., previous diabetes-related amputation, 
scleroderma); select a different finger for testing. 
9. 
Ask client to hang hand below table and open and close their fist 3-4 times in order to 
increase blood flow to the fingers. 
10. 
Open alcohol swab and clean finger at site where sample will be obtained.  The side of the 
finger provides a blood sample with less pain than the center of the finger pad. 
11. 
Allow finger to air dry or blot with clean cotton ball to dry site. 
12. 
Take one GE100 Blood Glucose Test Strip from the vial.  Close the vial cap immediately. 
13. 
Insert the test strip into Test Strip Port of the GE100 Glucose Meter with the indication 
symbol facing up; the meter confirms the insertion of a strip with a beep (if volume is turned 
on). 
14. 
A blood drop icon will appear on the meter display window and will be accompanied by a 
beep (if the volume is turned on).  Apply the blood sample within 2 minutes. 
15. 
A minimum of 1.0μL of blood is needed for testing with the GE100 Blood Glucose 
Monitoring System. Blood sample size above 3.0μL might contaminate the test strip port and 
the meter. Blood sample size below 1.0μL might cause inaccurate test results or might not 
start the meter. In this case, repeat the test with a new test strip. 
16. 
Place lancet device against prepared site on client’s finger and push down quickly and 
firmly. 
17. 
Assess puncture site; if necessary provide light pressure around puncture site to form a drop 
of blood on the client’s skin (avoid touching blood or puncture site). 
18. 
Touch and hold the drop of blood to the edge of the sample port until you hear a “beep” (if 
volume is turned on) and the view window is filled with blood. If the view window is not 
completely filled with blood the test will not start.  If this happens, discard the test strip and 
repeat with a new GE100 Blood Glucose Test Strip. 
19. 
Countdown mode will begin on the display window. After 5 seconds, test result will appear. 
20. 
Apply cotton ball to client’s finger and ask client to apply pressure at puncture site. 
21. 
Apply bandage to client’s finger at puncture site (if necessary). 

 
 
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22. 
Discard used lancet into red sharps container.  Never reach in or try to remove any material 
from the sharps container. 
23. 
Record every blood glucose test on study screening form and on client results form.  Explain 
results to client. 
24. 
Discard all other used testing supplies (alcohol prep pad, cotton ball, bib, used test strip, 
etc.) into trash.  Never push down on trash or reach into trash to remove objects. 
25. 
Use alcohol wipes (at least 70% alcohol) to clean and disinfect the GE100 Blood Glucose 
Monitoring System.  Staff should be careful to ensure that the entire meter, including the top, 
sides, and bottom, are wiped off, while ensuring that “liquid” alcohol is not dripped directly 
into the electrical components of the meter.  The Monitoring Systems should then be 
allowed to “air dry” prior to being used on the next client. 
26. 
Remove exam gloves by pulling gloves off using the wrist section and inverting the gloves 
as they are removed from your hands.  Dispose gloves in trash. 
27. 
Use hand sanitizer to clean hands. 
28. 
At the end of each screening event and as needed during screening activities, put on a new 
set of gloves and use Sani-Cloths to sterilize table, pens, glucometers, and all other supplies 
at testing station. 
7.2.2 Performing a Quality Control Test with the GE100 Blood Glucose Monitor 
Always follow manufacturer guidelines and instructions when using the GE100 meter.  It is necessary 
to perform a Quality Control (“QC”) Test to ensure the meter is functioning properly. 
 
When to Perform a QC Test: 
 If meter is dropped or appears damaged 
 When using a new shipment or lot of test strips 
 If meter was left out in extreme heat or cold 
 If meter was exposed to any liquid (including any cleaning solutions that may have entered 
meter’s testing port) 
 After any confirmed “Hi” or “Lo” test result on a patient 
 Whenever test result seems to be an error 
 After replacing the meter battery 
 Every 2 weeks, if not already preformed for other reasons. 
 
A Quality Control Log should be kept to ensure the QC procedures have been completed at least 
every 2 weeks (see Appendix Q).  All QC logs should be saved and stored with other project 
documents. 
 
Performing a Quality Control Test with the GE100 Blood Glucose Meter 
1. 
Take one GE100 Blood Glucose Test Strip from the vial and close the vial cap immediately. 
2. 
Insert the GE100 Blood Glucose Test Strip with the indication symbol facing up, into test 
strip port. 
3. 
While the blood drop icon is flashing on the display window, press and hold the Main button 
for at least 3 seconds until the “CS” symbol appears. 

 
 
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4. 
You will see the blinking “drop” icon and “CS” icon on the screen, prompting you to apply 
GE100 Control Solution. 
5. 
Shake the bottle of GE100 Control solution well before opening cap.  Place cap on a flat 
surface. 
6. 
Place a drop of the control solution onto the top of the cap. 
7. 
Gently touch the sample entry of the strip with the GE100 Control Solution from the top of 
the cap.  The screen will display the count time starting from 5 (you will hear a beep if the 
volume is turned on). 
8. 
Tightly replace the cap on the GE100 Control Solution bottle. 
9. 
The Control Solution result will appear. Compare your Quality Control Test result to the 
Control Solution Range printed on the GE100 Blood Glucose Test Strip vial label. 
10. 
Record the QC result and any comments on the GE100 Quality Control Log (Appendix Q). 
11. 
All QC logs should be saved and stored with other project documents. 
12. 
When a meter fails a QC test, refer to the user manual for troubleshooting steps and then 
perform a second QC test.  If after troubleshooting, a meter still does not pass a QC test, 
replace the meter. 
 
QC Testing Notes 
 Control Solution Test should be conducted between 59-104°F (15-40°C). 
 Before the drop icon and “CS” appears, do not touch the GE100 Control Solution to the sample 
entry on the strip. The GE100 Blood Glucose Meter is preforming an internal check.  Touching 
the Control Solution to the sample entry before prompted will result in an error message, drop 
icon, and beeps (if volume is turned on). 
 Do not drip the GE100 Control Solution into the sample port of the strip directly. The reagent 
on the strip might leak into the bottle of GE100 Control Solution and cause degeneration of 
GE100 Control Solution. Doing this could also contaminate the meter via the test strip port. 
 Do not touch anything to the tip of the GE100 Control Solution bottle. 
 
Maintenance of the GE100 Blood Glucose Meter 
Keep the GE100 Blood Glucose Meter and Test Strip free of dust, water, and any liquids. Store the 
meter in the carrying case when not in use. If meter is dropped or damaged, perform a quality control 
test with the control solution before doing a blood glucose test. 
 
Cleaning the GE100 Blood Glucose Meter 
Clean the outside of the GE100 Blood Glucose Meter with a damp cloth and mild soap/detergent. Do 
not get the test strip port wet.  The meter should be cleaned with 70% alcohol, as described earlier, 
between client uses. 
 
Cleaning the GE100 Blood Glucose Meter Test Strip Port 
If Test Strip Port is stained with blood, control solution or any other liquid, use a dry tissue or cotton 
swab to clean it immediately. Do not use anything wet to clean it. Perform a quality control test to 
ensure that the GE100 Blood Glucose Meter is working properly. 
 

 
 
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7.3 Point-of-care HbA1c testing 
We will use the PTS Diagnostics A1CNow®+ System to conduct all point-of-care (POC) HbA1c 
testing with food pantry clients and study participants.  HbA1c testing will be conducted by trained 
study staff or food bank personnel.  Testing will follow manufacturer guidelines for device use, 
maintenance, storage, cleaning, and quality assurance (see A1CNow®+ System User Guide in 
Appendix N). 
 
Materials List for HbA1c Testing 
 A1CNow®+ System Monitor 
 A1CNow®+ System Blood Collector, Sampler Body, and Cartridge 
 Hand sanitizer 
 Nitrile gloves 
 Alcohol prep pad (minimum 70% alcohol) 
 Single-use lancet device 
 Cotton balls 
 Bandage 
 Dental bib (disposable barrier) 
 Surface sanitizer (Sani Cloth Super Wipes) 
 Trash can with liner 
 Sharps container 
7.3.1 Procedure to conduct an HbA1c test 
1. 
Prior to starting an HbA1c test, ensure you have access to a stable, level surface at room 
temperature and out of direct sunlight. 
2. 
Have client sit at health screening table. 
3. 
Introduce yourself and provide client with background on screening. 
4. 
Ask client: “have you ever been told by a doctor that you have diabetes?” 
5. 
Always maintain client privacy.  If necessary, ask other food bank clients to stand away from 
the screening area. 
6. 
Clean hands with hand sanitizer. 
7. 
Set up supplies.  Ensure that lot numbers on Monitor, pouched test Cartridge, and pouched 
Sampler all match. 
8. 
Put on exam gloves. 
9. 
Ask if client has a preference for which finger to use in order to access blood sample. 
a. Do not use any site on a finger that is an open wound, has scar tissue, has evidence or 
infection, or has any other contraindication (e.g., previous diabetes-related amputation, 
scleroderma); select a different finger for testing. 
10. Ask client to hang hand below table and open and close their fist 3-4 times in order to 
increase blood flow to the fingers. 
11. Open alcohol swab and clean finger at site where sample will be obtained. 
12. Allow finger to air dry or blot with clean cotton ball to dry site. 
13. Open pouched Sampler Body and Blood Collector. 

 
 
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14. Place lancet device against prepared site and push down quickly and firmly. The side of the 
finger provides a blood sample with less pain than the center of the finger pad. 
15. Assess puncture site; if necessary provide light pressure around puncture site to form a drop 
of blood on the client’s skin (avoid touching blood or puncture site). 
16. Gently touch tip of Blood Collector to puncture site to completely fill Collector.  Wipe away 
excess blood from Collector (if necessary).  A blood sample size of 5 microliters (µL) is 
required to run a test.  A large blood drop is approximately 5 µL. 
17. Apply cotton ball to client’s finger and ask client to apply pressure at puncture site. 
18. Fully insert Blood Collector with sample into Sampler Body. 
19. Shake Sampler Body well 6-8 times. 
20. Stand Sampler Body on table while preparing test Cartridge. 
21. Insert Cartridge into Monitor.  Ensure that codes match and Monitor is placed on a level 
surface, at room temperature, and out of direct sunlight.  Sample must be applied to 
Cartridge within 2 minutes. 
22. Wait for “SMPL” to display on Monitor. 
23. Remove base of Sampler Body and dispense sample into Cartridge. 
24. Do not handle Monitor again until test is complete (approximately 5 minutes). 
25. Once test is complete, Monitor will display quality control test result (“QCOK” indicates the 
Monitor is functioning properly with no detected errors), HbA1c result, and number of tests 
remaining for Monitor.  Refer to User Guide for list of error codes if “QCOK” is not displayed. 
26. Apply bandage to client’s finger at puncture site (if necessary). 
27. Discard used lancet into red sharps container.  Never reach in or try to remove any material 
from the sharps container. 
28. Record HbA1c result on study form (screening log and enter in MS Access database at site 
or immediately after screening event) and on client results form.  Explain results to client. 
29. Discard all other used testing supplies (used test Cartridge, used Blood Collector and 
Sampler Body, alcohol prep pad, cotton ball, bib, etc.) into trash.  Never push down on trash 
or reach into trash to remove objects. 
30. Remove exam gloves by pulling gloves off using the wrist section and inverting the gloves as 
they are removed from your hands.  Dispose gloves in trash. 
31. Use hand sanitizer to clean hands. 
32. At the end of each screening event and as needed during screening activities, put on a new 
set of gloves and use Sani-Cloths to sterilize table, pens, Monitor, and all other supplies at 
testing station. 
7.3.2 Performing a Quality Control Test with the A1C+Now Monitor 
Each A1CNow+ Monitor performs over 50 internal chemical and electronic quality control checks, 
including potential hardware and software errors (e.g. cartridge alignment, programming), and 
potential reagent strip errors (e.g. insufficient sample volume, invalid calculations). The Monitor has 
been programmed to report an error code if these quality checks are not passed. 
 
Control testing solutions are not included with testing kits.  When ordering new test kits, you must 
order and purchase both the high and low control solutions in addition to the kits. 

 
 
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Follow manufacturer instructions for properly conducting a QC test with the A1C+Now System.  
Record the QC result and any comments on the A1C+Now Quality Control Log (Appendix R).  All 
QC logs should be saved and stored with other project documents. When a monitor fails a QC test, 
refer to the user manual for troubleshooting steps and then perform a second QC test.  If after 
troubleshooting, a monitor still does not pass a QC test, replace the monitor. 
 
 
Quality control testing should be performed at the following times: 
 With each new shipment 
 With each new lot 
 With each new operator (conduct QC test before a newly trained staff begins using monitor 
with clients) 
 Whenever problems (storage, operator, instrument, or other) are identified 
 To ensure that storage conditions have not affected the product, run a control sample before 
running a patient sample if the test kit has been stored for more than a month and it has been 
at least a month since the last control testing 
 
The measured value should be within the acceptable limits stated for the control material (refer to 
specific instructions and limit information included with control testing solutions).  If the results 
obtained are outside the acceptable limit, please review the procedure and re-test the control 
material. If the measured value continues to fall outside the acceptable limit, please refrain from 
analyzing additional patient samples and contact Customer Service (1-877-870-5610). 
 
Good laboratory practices include a complete quality control program. This entails proper sample 
collection and handling practices, ongoing training of testing personnel, ongoing evaluation of control 
results, proper storage of test kits, etc.  A permanent record of control results should be retained see 
A1C+Now Quality Control Log in Appendix R). 
 
7.4 Ordering Information for testing supplies 
Sites will be responsible for ordering and purchasing all supplies required to conduct testing, and 
each site has funding that should cover screening costs for the duration of the project.  The following 
includes suggested information on where to purchase all supplies.   
 GE100 meters and strips 
o Katie Enright, Katie.Enright@bionime.com  
o http://www.gediabetes.com/ge100/  
 A1C+Now Testing System 
o System information: http://www.ptsdiagnostics.com/ 
o Vendor information: http://www.whitmiremedical.com/ 
o Vendor contact: Michael Falck, michael@whitmiremedical.com  
o Vendor pricing for Feeding America: $152.50 per box (20 tests), not including S/H 
 General Testing Supplies 

 
 
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o Allegro Medical: http://www.allegromedical.com/  
 Miscellaneous supplies (e.g., dental bibs, Dex4 glucose tablets) 
o Amazon.com  
 
7.5 Regulatory requirements for testing 
Conducting community-based screening and testing programs requires that organizations comply 
with a number of federal, state, and local regulations.  FANO FAITH-DM project staff will provide 
technical assistance to food bank sites to support the sites in applying for and maintaining all required 
certifications in order to conduct testing.  Food bank sites are ultimately responsible for ensuring that 
their organization is in compliance, and that any screening program is successfully meeting all 
regulatory requirements for the duration of the program.  Sites cannot conduct any testing, screening, 
or monitoring until all regulatory requirements are met and maintained.  
 
Regulatory requirements for conducting community-based screening and testing programs include 
the following: 
7.5.1 CLIA Certificate of Waiver 
Both of the devices we will use for testing (GE100 Blood Glucose Monitor, A1C+Now Monitor) are 
CLIA-waived devices.  The Clinical Laboratory Improvement Amendments of 1988 (CLIA) program is 
managed by Centers for Medicare and Medicaid Services (CMS), and implemented through state 
CLIA offices.  All project sites need to apply for CLIA certificates of waiver for use of these testing 
devices through their state offices, following the state-specific processes and forms.  Funding is 
included in the food bank grants to cover all state and federal fees associated with obtaining and 
maintaining a CLIA certificate of waiver. 
7.5.2 Medical Waste Permitting 
For the FAITH-DM study, the only medical waste that will be generated by the sites are sharps 
(single-use lancet devices).  We anticipate that each site will generate under 10 pounds of sharps 
medical waste each month. Regulations addressing the use, storage, transport, and treatment of 
sharps and sharps containers vary by state.  In Texas, generators who generate 50 pounds or less 
per month of medical waste are exempted from permit, registration, and notification requirements.  
Both California and Michigan require organizations apply for and maintain permits to transfer and 
store medical waste that includes sharps, regardless of the quantity generated monthly.   
 To meet state requirements for Small Quantity Medical Waste generators and for Limited 
Quantity Hauling Exemptions, sites will submit applications and associated fees to their 
appropriate state or county offices. 
 Sites will submit a “Medical Waste Management Plan” along with their application, and use a 
Medical Waste Tracking Log (Appendix S) to document waste management. 

 
 
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 All sites will utilize a USPS-approved medical waste mail back service (Sharps Compliance, 
Inc.: http://www.sharpsinc.com/) for purchase of sharps containers, shipping, tracking, and 
treatment of medical waste generated during screening activities. 
7.5.3 Additional Screening Requirements 
Sites will submit applications and program materials as required to address any additional local 
regulations relative to conducting screening and testing in the community setting. 
 Non-Diagnostic General Health Assessment (NDGHA) application 
o Sites located in California need to complete and submit a NDGHA application annually 
to their local county health department in order to meet state screening requirements 
o The application must be submitted at least 30 days prior to any screening activities 
taking place, and must include all required information and documentation relative to 
program protocols, staff credentials, and screening locations, dates, and times 
o Sites must also include with their application materials the names and credentials 
(phlebotomist, RN, MA, PA, MD, etc.) of all staff that will be conducting screening. 
 
7.6 Survey Administration 
This section of the MOP covers instructions for the administration of surveys used in the course of 
this study. Surveys are administered by trained FAITH-DM research staff to consented food bank 
clients in the participant’s preferred language. All surveys will be administered via the CASIC data 
collection software on a laptop provided by University of California San Francisco. 
 
This study includes a baseline survey and two follow-up surveys.  All participants will complete the 
same Baseline Survey (Appendix U).  Intervention group participants will complete the Follow-Up 
Survey Intervention (Appendix V1) at T6.  Control group participants will complete the Follow-Up 
Survey Control Survey (Appendix V2) at T6.  As a result of study extension funding, both groups will 
also complete surveys at T12.  The T12 INT survey (Appendix W1) is identical to the T6 INT survey, 
but does not include any satisfaction items.  The T12 CONT survey (Appendix W2) is identical to the 
T6 INT follow-up survey. 
 
The timing for completing the T6 and T12 follow-up surveys is outlined below and uses the same time 
windows for follow-up HbA1c testing. 
 
SURVEY VERSION 
GROUP 
TIMING* 
Baseline 
All Participants 
T0 
T6 Follow-up (INT) 
Intervention Group 
T6 (5 – 7 months [6±1]) 
T6 Follow-up (CONT) 
Control Group 
T6 (5 – 7 months [6±1]) 
T12 Follow-up (INT) 
Intervention Group 
T12 (11 – 13 months [±1])** 

 
 
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T12 Follow-up (CONT) 
Control Group 
T12 (11 – 13 months [12±1])** 
* 1 month = 30 DAYS ALWAYS 
** Alternatively, T12 survey windows can be manually calculated as 5-7 months after the completion 
date of a participant’s T6 follow-up activities.  This revision will accommodate participants who 
complete their T6 activities at month 5 (earliest part of the window) and maintain a 5-7 month 
separation between the T6 and T12 follow-up activities. 
 
If a participant does not complete their follow-up survey at T6 or T12, study staff can still complete it 
with the participant when they are next seen at a pantry or study activity.  Participant surveys can also 
be completed over the phone if necessary. 
 
7.6.1 Survey administration procedures 
In order to maintain confidentiality, the survey should be conducted in an area away from other 
people, where the participant will feel comfortable discussing personal information with the research 
staff. The survey should last about 30 minutes and should be completed in one sitting; make sure the 
participant is aware of the duration of the survey before beginning. It is the research staff’s 
responsibility to obtain full and accurate information from participants. 
 
Strategies for starting baseline survey with a new participant: 
 Emphasize the time commitment required to complete survey (approximately 30 minutes) 
 Get a verbal commitment from the participant that they are able and willing to stay for the 
entire survey 
 Only begin survey with participant who can commit to completing the survey now 
 
Strategies and procedures for successfully administering the survey include:  
 Read clearly and in a natural rhythm and tone; read as if you were speaking. 
 If the answer provided seems inappropriate for the question asked, kindly acknowledge the 
response and then repeat the question, clarifying where needed. 
 Each question must be asked of each participant in the same way and in the same order to 
ensure that comparable information is being obtained from all the participants in the study. 
 Transition sentences appear throughout the survey to help you introduce a new topic.  Read 
these out loud and in full as they often contain information for the participant on how to answer 
the following set of questions. 
 “Don’t read out loud” will often appear in multiple choice questions for the answers “don’t know 
or refused”. Study participants may not know the answer to a question and are allowed to 
refuse to answer any question, but don’t read this aloud as an option; let the participant tell 
you. 
 
See section 12.3.1 for instruction on using CASIC. 
 

 
 
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7.6.2 Completing surveys when participant needs to leave 
At times, a participant may need to leave before administration of a survey is complete.  If the 
participant completed approximately less than half the survey, staff should inform the participant that 
they will need to restart the survey and complete it at a future date. 
 
Instructions for when a client does not start a survey or completes less than half: 
 If possible, schedule a day and time to complete the survey within the next two weeks 
 Verify the participant’s contact information, and the information for their additional contacts 
(participant, friend, family member) in order to place reminder calls 
 Remind client of the program benefits / incentive available once survey is completed 
 Save participant ID# used to enter baseline data into ACCESS database and to start CASIC 
survey 
o Do NOT open the randomization envelope; do NOT assign client to a study group 
 In the event the participant does not start or complete the survey within the two week period: 
o The client will be considered lost to follow-up; add note to ACCESS 
o Notify Sophie Rosenmoss that client did not start/complete survey and was not 
randomized 
o Do not reuse the participant ID# and destroy the randomization envelope 
o If the participant was completing a follow-up survey, notify Sophie Rosenmoss that the 
survey was not completed within the two-week window 
 
Instructions for when a participant completes approximately half of the survey or more: 
 Site staff can save the survey and attempt to finish the remainder with the client within two 
weeks 
 If completing a baseline survey, open the randomization envelope with the participant for group 
assignment before the participant leaves the site 
o If randomized to the intervention group, provide participant with resources and first food 
package per study protocols 
o If randomized to the control group, provide participant with 1st incentive ($15 gift card) 
and have participant sign for receipt of the gift card 
 If completing a follow-up survey, provide participant with the correct incentive and have 
participant sign for receipt of the gift card 
 Verify the participant’s contact information, and the information for their additional contacts 
(participant, friend, family member) in order to place reminder calls 
 If possible, schedule a day and time to complete the survey within the next two weeks, either in 
person or over the phone 
 Conduct reminder calls to participant and contacts throughout this two week period to ensure 
they are able to complete survey at next visit (or over the phone) 
 If, after two weeks the survey has not been completed, enter a note in ACCESS that the 
survey was “incomplete” 
 Notify Sophie Rosenmoss that participant will not complete survey 
 

 
 
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7.6.3 CASIC instructions for completing surveys at a later date 
When exiting and resuming an incomplete survey perform the following: 
 
CASIC Online: 
1. Simply exit survey using upper right hand corner exit button on pop-up survey window 
2. Email Sophie to let her know of incomplete assessment and plans to complete or destroy 
3. When resuming, click “Start assessment” and enter PPT ID as usual 
4. You will be prompted to resume baseline survey, select this option 
5. Complete survey as usual 
 
CASIC Remote: 
When managing an incomplete survey on CASIC Remote, the RA can select either option outlined 
below.  
 
CASIC Remote surveys that are incomplete and uploaded to the server using the “upload data” 
button in the “synchronize subject data” tab cannot be resumed using CASIC Remote. They can only 
be resumed using CASIC Online, as the data no longer “lives” on the local drive after synchronization. 
You may resume a survey on CASIC Remote using the instructions below only if the survey data is 
not synchronized after exiting the survey. However, it is best practice to synchronize the subject data, 
incomplete and otherwise, at the end of each day. It is likely that these computers will be used for 
other survey administration during the timeframe that the incomplete survey remains outstanding. It is 
not possible to leave only the incomplete survey on the local drive and upload the other completed 
surveys, and it poses a risk of lost study data if surveys are not uploaded to the server in a timely 
manner, so it is best to upload the incomplete survey and resume using CASIC Online.  
 
This may be less convenient for on-site administration, but since the RA will be working with the 
participant to re-schedule a time, they should take into account that they will need internet access to 
resume the survey. For this reason, it may be useful to complete the surveys by phone. In situations 
in which there are no other surveys on CASIC Remote on the computer in question and there is a 
reasonably short time period between first administration and completion of the incomplete survey, it 
may be appropriate to leave the study data from the incomplete survey on the local drive and resume 
and complete the survey using CASIC Remote. 
 
Option 1: Synchronize subject data and resume survey using CASIC Online: 
1. Simply exit survey using upper right hand corner exit button on pop-up survey window 
2. Email Sophie to let her know of incomplete assessment and plans to complete or destroy 
3. Navigate to the “Synchronize subject data” tab on the left hand navigation panel, select 
“Upload only” to upload the incomplete survey to the host 
4. When resuming the survey using CASIC Online, click “Start assessment” and enter ppt ID as 
usual 
5. You will be prompted to resume baseline survey, select this option 
6. Complete survey as usual 
 

 
 
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Option 2: Leave subject data on the local drive and resume survey using CASIC Remote: 
1. Simply exit survey using upper right hand corner exit button on pop-up survey window 
2. Email Sophie to let her know of incomplete assessment and plans to complete or destroy 
3. Do not synchronize subject data 
4. When resuming the survey using CASIC Remote, click “Start assessment” and enter ppt ID as 
usual 
5. You will be prompted to resume baseline survey, select this option 
6. Complete survey as usual 
 
7.6.4 Survey piloting procedures 
Research assistants and any staff involved in survey administration should practice administering the 
surveys before completing with study participants.  Piloting surveys will allow for feedback on 
improving study forms and surveys, and facilitate streamlined administration with initial participants. 
 First, pilot survey on 1-2 colleagues to become familiar with the study format, questions, and 
response options. 
 Practice using CASIC to enter practice study data. 
 Second, pilot the study with 1-2 food pantry clients. 
o Use incentive gift cards to compensate clients for their time (1 - $15 gift card per survey) 
o Clients do NOT need to be consented for completing a pilot survey 
o Explain to clients that responses to pilot surveys will not be saved, and the client is free 
to answer survey questions with real or made-up responses 
 
CASIC is programmed with participant ID numbers that have been identified for use in piloting and 
training purposes.  Use these ID numbers when piloting surveys: 
 
Site 
Practice Participant ID Numbers 
UCSF / FANO 
10 - 29 
ACCFB 
30 - 49 
GCFB 
50 - 69 
HFB 
70 - 89 
 
 
7.7 Health Care Utilization Analysis 
This section contains information and processes specific to the Health Care Utilization (HCU) plan, 
including communicating with health care providers about the study and health care utilization data 
requests. A table at the end of this section identifies the different packets used when communicating 
with providers. 
 

 
 
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The HCUA is a critical component of the FAITH-DM study. The analysis will provide important 
information on how participating in the intervention may impact the ways in which a patient utilizes 
health care services for primary care and diabetes management. 
 
Collection of health care utilization data from providers follows this format: HCU surveys are sent to 
providers two times over the course of the study: once at T6 for the entire previous 12 month period 
for both the control and intervention groups, and once at T12 for the previous 6 month period for the 
intervention group only.   
   
7.7.1 HCUA Roles and Responsibilities 
Site research assistants (RAs): 
 Track primary care provider (PCP) information for study participants (at T0, T6, and T12) and 
enter data into MS Access database 
 Communicate with PCPs regarding study activities by sending pre-drafted letters and HCU 
documents per the HCUA plan (see Appendix Y – Health Care Utilization Provider Letters 
[1-8] for all HCU Provider Letters) 
 Track PCP completion of HCU surveys and provide follow-up and support as needed 
 Compile completed surveys and ensure that documentation is de-identified before sending in 
batches to the Urban Institute 
 Submit and track quarterly payments to clinic partners for data extraction and survey 
completion fees (per food bank – clinic MOU agreements) 
 
Urban Institute: 
 Provide technical assistance to site RAs in communicating HCUA to partner clinics and 
supporting clinics to complete HCU surveys per study protocols 
 Communicate with site RAs to troubleshoot unanticipated challenges relative to completing 
provider surveys (e.g., participant uses a small, family practice for care which does not have a 
food bank MOU) 
 Work with RAs to revise HCUA processes as needed at the site or clinic level to streamline 
acquisition of utilization data 
 Develop and refine all HCU documents and surveys as needed 
 Complete all data entry from submitted provider surveys and documents 
 In the event site RAs submit de-identified copies of medical records, Urban Institute will 
complete data extraction and data entry for use in HCUA 
 Manage all HCU-related data and conduct final data analyses 
 
All RAs will be provided with contact information for the appropriate research personnel at the Urban 
Institute so that they can obtain assistance with any questions or issues that arise during the Health 
Care Utilization component of the study. 
 

 
 
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7.7.2 HCUA Activities at Baseline (T0) 
The following sections outline HCUA activities that take place when a new participant enrolls in the 
study. 
 
At enrollment, all participants will be asked to provide the name of their current primary care provider 
(individual provider and/or practice/clinic site) and to provide consent for communication with 
provider, including release of medical record information (see section 5.3 for discussion of consent 
and HIPAA procedures, and Appendix AO for the Medical Records Release Template).  The site 
personnel will request as much contact information for the provider as possible (phone number, 
address, or nearest cross streets the participant can identify).  The RA may need to research and 
complete the provider contact information if the participant is unable to provide full contact information 
at the time of enrollment.  
 
If the participant declines to provide consent for the release of medical records from the current 
provider, this should be documented and entered into the MS Access database.  No further action to 
request information from the provider can be taken regarding release of medical record information.  
However, when a participant provides informed consent to enroll in the study, study staff does receive 
participant permission to contact the participant’s care provider to inform provider of the participant’s 
entry into the study. 
7.7.2.1 Intervention group participants with an existing primary care provider 
For intervention group participants who have a PCP, study staff will assemble a baseline provider 
communication packet that will include: 
 Provider Letter (HCU Letter 1 - T0 Current Pt INT)  
 Copy of the participant’s signed HIPAA authorization form 
 
This baseline letter provides background information on FAITH-DM, informs the provider that the 
participant has enrolled in FAITH-DM, identifies the participant’s group assignment, discloses 
screening results (only for participants assigned to the intervention group), describes the HCUA 
process, and informs the provider that a care utilization survey will be sent at the participant’s 6- and 
12-month mark in the study.  No action is requested of the provider at baseline.  
 
The provider communication packet should be generated and sent (by fax or mail) within two weeks 
of the participant’s enrollment in the study.  A description of how the site can maintain a HIPAA 
compliant fax is contained in section 3.2.1. 
7.7.2.2 Intervention group participants without a primary care provider 
When the intervention participant does not have an existing source of primary care, he or she will 
receive an active referral per the process outlined in section 3.2.1. A modified baseline provider 
communication packet will be assembled and includes: 
 Provider Letter (HCU Letter 2 - T0 Newly Referred Pt INT)  
 Copy of the participant’s signed HIPAA authorization form 

 
 
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The RA will need to verify the primary care provider information at the six-month participant survey 
(and is prompted by CASIC to do so). 
 
The provider communication packet should be generated and sent (by fax or mail) within two weeks 
of the participant’s enrollment in the study.   
7.7.2.3 Waitlist control group participants with an existing primary care provider 
For participants assigned to the waitlist control group and who state they have an existing primary 
care provider, the following communication packet will be sent to the provider: 
 Provider Letter (HCU Letter 3 - T0 Current Pt CONT)  
 Copy of the participant’s signed HIPAA authorization form 
 
The provider communication packet should be generated and sent (by fax or mail) within two weeks 
of the participant’s enrollment in the study.   
7.7.2.4 Waitlist control group participants without a primary care provider 
If a waitlist control participant does not have an existing source of primary care, he or she will receive 
a provider resource handout (passive referral) per section 3.2.1.   
 
No provider communication packet is required for this group at T0. 
 
If the participant states they do not have a provider now, but they did receive primary health care 
services in the last six months, then the RA should complete the steps listed above for sending a 
communication packet (HCU Letter 3 - T0 Current Pt CONT) to their previous provider and offer a 
resource handout for the participant to establish care with a new provider.  Contact information for the 
previous provider should be stored in Access to use when sending out HCU surveys at T6. 
 
The RA will need to repeat the request for whether there is a current primary care provider at the 
point at which the participant becomes eligible to enroll in the intervention at six months (the 6-month 
participant survey includes a prompt in CASIC for this inquiry). 
 
7.7.3 HCUA Activities at Six Months (T6) 
The following sections outline the processes for how site staff communicate with providers at the six-
month mark for each participant, including completion of the health care utilization survey (HCUS).   
Site staff should still attempt to have the HCUS completed for any participant who at T6 has been 
identified as “lost to follow-up” or who dropped out of the study, unless the participant actively 
revoked their consent to participate in the study, or their consent to release medical records.  Site 
staff cannot request HCUS completion for any participant who revokes these consents, and this 
should be recorded in the study MS Access database.   

 
 
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“Lost to follow-up” is defined as not completing follow-up activities after at least three no-shows to 
appointments during the participant’s follow-up window.  For participants lost to follow-up at T6, site 
staff can again attempt to engage with them during their T12 follow-up windows. 
7.7.3.1 Study participants who had an existing provider at baseline 
Site staff will complete the same provider packet at T6 for participants in both the intervention and 
control groups who identified a provider at baseline. 
 
The T6 provider packet for these participants includes: 
 Provider Letter (HCU Letter 4 - T6 Current Pt) 
 Copy of signed HIPAA form 
 Copy of signed Medical Records Release Form 
 HCUS (Appendix Z) 
 
Site personnel will complete the first page of the HCUS prior to sending the provider communication 
packet, including the participant’s full name and date of birth so that the provider can verify that the 
participant data matches that reflected in the patient’s records. If the provider has no record of the 
patient, they will be instructed to return the face sheet to the RA. The RA will also need to write in the 
participant ID number in the designated box at the top of each remaining page of the survey. 
 
The top portion of each page will include space to specify the range of service dates the HCUS is 
requesting.  Study staff should enter the date the participant reaches T6 as the end date for the 
record request and the start date should be entered as the corresponding date 12 months earlier 
(which equates to the 6-month period that occurred just prior to the participant’s enrollment into the 
study).  For example, if the participant reaches T6 in the study on November 1, 2016, the record 
request period will be identified as “November 1, 2015 through November 1, 2016.”  
 
After filling out the relevant dates we are requesting data on the HCUS, please use a highlighter to 
highlight on the first page the text “Period of Requested Data: ___________ to ___________.”  We 
want to emphasize these dates because they will be different compared to those specified on the 
Medical Records Release Form, which encompasses the entire span of the study and does not 
distinguish between the control and intervention groups. 
 
All T6 provider packages should be faxed to or mailed to providers (based on individual processes 
outlined in each clinic’s MOU with the food bank site).  We expect providers to return completed 
surveys via fax to the RA. Please see section 7.7.7 for instructions on how to send completed 
provider surveys to the Urban Institute. 
7.7.3.2 Study participants without provider at T0 but have provider at T6 
For participants who did not have a provider at baseline (T0), but do identify having a provider at the 
six-month mark (T6), site staff will send the same T6 packet identified above to the participant’s new 
provider. 
 

 
 
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The T6 provider packet for these participants includes: 
 Provider Letter (HCU Letter 4 - T6 Current Pt) 
 Copy of signed HIPAA form 
 Copy of signed Medical Records Release Form 
 HCUS (Appendix Z) 
 
The RA should follow the process outlined above for completing portions of the HCUS and sending 
the packet to providers. 
7.7.3.3 Study participants without provider at T0 and who still do not have a provider at T6 
For participants who did not have a provider at baseline (T0), and still do not identify having a 
provider at the six-month mark (T6), site staff will generate an active referral to a partner clinic per the 
process outlined in section 3.2.1. 
 
In addition to the referral for care, site staff will send a modified T6 packet to the participant’s new 
provider. 
 
The T6 provider packet for these participants includes: 
 Newly Referred Patient T6 Letter (HCU Letter 5 - T6 Newly Referred Pt) 
 Copy of signed HIPAA form 
 Copy of signed Medical Records Release Form 
 HCUS (Appendix Z) – for use in the event the provider does have records for this participant 
 
The RA should follow the process outlined above for completing portions of the HCUS and sending 
the packet to providers. 
7.7.3.4 If a participant has switched providers between T0 and T6 
It is possible that a participant may have switched primary care providers during the study 
intervention period.  This could occur for several reasons: the participant may have moved and the 
prior provider location was no longer be convenient; the provider may have closed or changed the 
conditions under which it sees patients (e.g., the provider is no longer on the panel for the 
participant’s insurance plan); the participant may have had a change in insurance or coverage status 
that affects his or her provider options; or the participant has decided to change for other reasons.  It 
is important that the RA re-verify the primary care provider information for all participants at the six 
month survey point and note where any changes may have been made. 
 
If there is more than one provider during the six-month period, then requests for records should be 
made to all primary care providers the participant has identified.  Each provider will receive a T6 
provider packet; however, the new provider should receive a modified version of the T6 letter that 
does not assume any prior communication with that provider (see: HCU Letter 5 - T6 Newly Referred 
Pt).  The RA should make a note in the MS Access database that provider data is being requested 
from multiple providers.  This information should be recorded on all survey forms for that participant 

 
 
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once they have been returned and logged into the database so that the analysis team is aware that 
two or more surveys will be entered for that period and special attention can be paid to reconciling the 
information for that participant.  
 
7.7.4 HCUA Activities at Twelve Months (T12) 
The following sections outline the processes for how site staff communicate with providers at the 
twelve-month mark for intervention group participants, including the completion of the second health 
care utilization survey (HCUS). These activities will be very similar to those conducted at T6. 
However, it is important to note that these activities will only be carried out for the intervention group. 
No further healthcare utilization activities will be conducted for the control group.  
Site staff should still attempt to have the second HCUS completed for any INT participant who at T12 
has been identified as “lost to follow-up” or who dropped out of the study, unless the participant 
actively revoked their consent to participate in the study, or their consent to release medical records.  
Site staff cannot request HCUS completion for any participant who revokes these consents, and this 
should be recorded in the study MS Access database.   
“Lost to follow-up” is defined as not completing follow-up activities after at least three no-shows to 
appointments during the participant’s follow-up window.  For participants lost to follow-up at T6, site 
staff can again attempt to engage with them during their T12 follow-up windows. 
 
7.7.4.1 Intervention group participants that had an existing provider at T6  
Site staff will complete a provider packet very similar to the packet outlined in 7.7.3.1. 
 
The T12 provider packet for these participants includes: 
 Provider Letter (HCU Letter 7 – T12 Current Pt INT) 
 Copy of signed HIPAA form 
 Copy of signed Medical Records Release Form 
 HCUS (Appendix Z) 
 
Site personnel will complete the first page of the HCUS prior to sending the provider communication 
packet, including the participant’s full name and date of birth so that the provider can verify that the 
participant data matches that reflected in the patient’s records. If the provider has no record of the 
patient, they will be instructed to return the face sheet to the RA.  The RA will also need to write in the 
participant ID number in the designated box at the top of each remaining page of the survey. 
 
The top portion of each page will include space to specify the range of service dates the HCUS is 
requesting.  Study staff should enter the date the participant reaches T12 as the end date for the 
record request and the start date should be entered as the corresponding date 6 months earlier 
(which equates to the 6-month period after the participant completed the intervention).  For example, 

 
 
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if the participant reaches T12 in the study on April 1, 2017, the record request period will be identified 
as “November 1, 2016 through May 1, 2017.”  
 
After filling out the relevant dates we are requesting data on the HCUS, please use a highlighter to 
highlight on the first page the text “Period of Requested Data: ___________ to ___________.”  We 
want to emphasize these dates because they will be different compared to those specified on the 
Medical Records Release Form, which encompasses the entire span of the study and does not 
distinguish between the control and intervention groups. 
 
All T12 provider packages should be faxed to or mailed to providers (based on individual processes 
outlined in each clinic’s MOU with the food bank site).  We expect providers to return completed 
surveys via fax to the RA. Please see section 7.7.7 for instructions on how to send completed 
provider surveys to the Urban Institute. 
7.7.4.2 Study participants without provider at T6 but have provider at T12 
For participants who did not have a provider at six months (T6), but do identify having a provider at 
the twelve-month mark (T12), site staff will send the same T12 packet identified above to the 
participant’s new provider. 
 
The T12 provider packet for these participants includes: 
 Provider Letter (HCU Letter 7 – T12 Current Pt) 
 Copy of signed HIPAA form 
 Copy of signed Medical Records Release Form 
 HCUS (Appendix Z) 
 
The RA should follow the process outlined above for completing portions of the HCUS and sending 
the packet to providers. 
7.7.4.3 Study participants without provider at T6 and who still do not have a provider at T12 
For participants who do not have a provider at T12, site staff will generate an active referral to the 
partner clinic per the process outlined in section 3.2.1 
 
In addition to the referral for care, site staff will send a modified T12 packet to the participant’s new 
provider for intervention group participants only. 
 
The T12 provider packet for these participants includes: 
 Newly Referred Patient T12 Letter (HCU Letter 8 – T12 Newly Referred Pt) 
 Copy of signed HIPAA form 
 Copy of signed Medical Records Release Form 
 HCUS (Appendix Z) – for use if the provider does have records for this participant 
 

 
 
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The RA should follow the process outlined above for completing portions of the HCUS and sending 
the packet to providers. 
7.7.4.4 If a participant has switched providers between T6 and T12 
Follow directions as outlined in section 7.7.3.4. For new providers, staff should send providers the 
HCU Letter 8 – T12 Newly Referred Pt.  
 
7.7.5 Sending Follow-Up Prompts to Primary Care Providers Regarding Survey 
The RA should monitor the results of all provider record requests on a weekly basis.  If there has 
been no response to a record request after two weeks, a reminder letter will be generated and sent to 
the provider (HCU Letter 6 - Provider Survey Reminder).  This mailing will include a friendly reminder 
about the survey, and enclose another copy of the consent to release records and the survey.  The 
RA will log the date of the follow-up mailing in the MS Access database. If there has been no 
response after two more weeks, the RA will generate one final written reminder with a copy of the 
survey and consent. 
 
If there has been no response to the first and second written reminders after four weeks, the RA will 
implement a phone contact protocol. If the provider / clinic on file for the participant has an MOU with 
the FAITH-DM site, the RA will follow the contact procedures previously identified by the provider site.  
If there is no MOU, the RA will make up to three telephone attempts to talk to the practice manager or 
medical records department to inquire whether the survey has been received and/or if the survey was 
sent in error (e.g., the provider has no record of this patient).  If there is patient data that matches the 
participant, the RA will encourage the provider to complete the survey, offer assistance as needed, 
and review the opportunity for financial incentives upon completion.  If after three contacts that result 
in direct communication, the RA is still unsuccessful in obtaining a baseline survey, the RA will note 
the attempts and the lack of response in the MS Access database.   
 
Outstanding record requests will be reviewed quarterly with Urban Institute staff and the FAITH-DM 
project manager to determine if the FAITH-DM team can provide any additional assistance in 
securing a response or if the case should be deemed “nonresponse.” 
 
 
7.7.6 Financial Incentives for Provider Survey Completion 
The FAITH-DM sites have funds allocated to provide reimbursement to providers for each survey 
completed ($20).  This information is included in the provider communication packet.  
Reimbursements should be generated quarterly by site personnel to ease the administrative burden 
for both the site personnel and providers (e.g., to avoid providers having to generate individual 
invoices for each record extraction). 

 
 
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7.7.7 Returning / Receiving the HCU survey 
The provider communication packet will include instructions about how to return the survey to the site 
RA via fax.  The site RA is responsible for logging receipt of a completed survey in the MS Access 
database. Similarly, provider requests for clarification on the survey or any follow-up prompts sent to 
the provider by the RA should be logged in the MS Access database so there is a complete picture of 
provider communication available to the site personnel.  Once a quarter, the RA can tally the number 
of completed surveys by provider and generate the appropriate compensation from the food bank 
project funds, with a letter of thanks for their participation.   
 
When the site RA receives the provider survey or any accompanying documentation the provider may 
have sent (e.g., printout of dates of service and diagnostic codes from their electronic health record), 
the RA must ensure that all PII must be removed before forwarding surveys to the Urban Institute.  
This includes removing and shredding the provider face sheet with the personal data; making 
sure that the participant ID is included on the remaining survey pages but not associated with 
any PII (like name, date of birth, etc.) and blacking out the names or other identifying 
information from any attached records.  
 
In lieu of the shredded provider face sheet, the RA should subsequently complete an Urban Institute 
HCUS Cover Sheet for the purpose of sending the survey to the Urban Institute (see Appendix AX). 
The cover sheet will ask for the participant ID, period of requested data, and date the survey was 
received, and will additionally include a space for any special notes or considerations about the 
survey that the RA wishes to communicate to the Urban Institute. 
 
The RA should then make a copy of the survey / documentation with only the project identifier 
number displayed on each page and keep a copy for their files.  At the end of every month, beginning 
with the month that provider surveys begin start arriving, the RA should assemble all completed 
provider surveys and send these in one mailing to the Urban Institute project contact via a verifiable, 
trackable delivery method, as described below.  The UI project contact will provide the RA will email 
verification once the monthly survey package has been received and will verify the cost to the site of 
the mailing. Each quarter Urban Institute will generate a reimbursement check to the site for the costs 
of mailing the surveys. 
 
Trackable Survey Delivery Methods 
A trackable delivery method is defined as any mailing service that allows the sender to confirm the 
receipt of your package at the intended destination. Trackable delivery methods include: 
 USPS Priority Mail with Delivery Confirmation 
 USPS Priority Mail with Signature Confirmation 
 USPS Express Mail (for overnight delivery requests) trackable delivery method 
 Other trackable services such as UPS or FedEx that have delivery confirmation 
 
Survey packages should be mailed to the following address: 

 
 
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Urban Institute 
Attn: Justin Morgan 
2100 M Street NW 
Washington, DC 20037 
 
See Appendix BA for detailed instructions when sending scanned, electronic HCUA data to the 
Urban Institute using encrypted USB devices. 
 
7.7.8 Provider Packet Summary Table 
The table below summarizes the different types of provider packets to be assembled at baseline and 
follow-up based upon the participant’s enrollment in the intervention or control group and their 
reporting of a PCP:  
 
Intervention group 
Control group 
Existing PCP 
At T0: HCU Letter 1 - T0 
Current Pt INT, signed 
forms, information sheets 
At T6: HCUS, HCU Letter 4 
- T6 Current Pt, signed 
forms 
At T12: HCUS, HCU Letter 
7 – T12 Current Pt, signed 
forms 
At T0: HCU Letter 3 - T0 
Current Pt CONT, signed 
forms, information sheets 
At T6: HCUS, HCU Letter 4 
- T6 Current Pt, signed 
forms 
At T12: No provider 
communication 
No existing PCP (at 
T0) 
At T0: HCU Letter 2 - T0 
Newly Referred Pt INT, 
signed forms, information 
sheets 
At T6: HCUS, HCU Letter 4 
- T6 Current Pt, signed 
forms 
At T6: If participant still 
doesn’t have PCP: HCU 
Letter 5 - T6 Newly Referred 
Pt, HCUS, signed forms, 
information sheets 
At T0: No provider 
communication, but 
participant will be 
encouraged to see PCP 
At T6: If participant now has 
PCP: HCUS, HCU Letter 4 - 
T6 Current Pt, signed forms, 
information sheets  
At T6: If participant still 
doesn’t have PCP: HCU 
Letter 5 - T6 Newly Referred 
Pt, HCUS, signed forms, 
information sheets 

 
 
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At T12: HCUS, HCU Letter 
7 – T12 Current Pt, signed 
forms 
At T12: If participant still 
doesn’t have PCP: HCU 
Letter 8 – T12 Newly 
Referred Pt, HCUS, signed 
forms, information sheets 
At T12: If participant now 
has a PCP, no provider 
communication 
At T12: If participant still 
doesn’t have PCP, use 
“Screening and Referral 
Form” to complete active 
referral 
 
 
8 Randomization  
In randomized, controlled clinical trials, participants are assigned to a treatment group based upon a 
pre-determined randomization scheme developed by the study statistician (Courtney Lyles, UCSF).  
Randomization is used to reduce bias in assignment to treatment. In our case, clients will be 
randomized to receive the intervention immediately or after a 6-month delay.   
 Randomization Plan:  We will use a 6-block randomization scheme to ensure that the rolling 
enrollment process across multiple food bank sites will distribute participants equally into each 
study arm over time.  This scheme will be generated using the website 
www.randomization.com for each food bank site separately, which will create a list of the order 
of randomization by sequential participant ID.  
 Process Responsibilities: UCSF will be in charge of creating the randomization scheme for 
each site.  This will include generating the randomization list, preparing sealed envelopes by 
participant ID, and mailing them to each site to open as recruitment progresses.  In the event a 
participant ID is not used (e.g., a client withdraws consent upon learning what group he/she is 
randomized to), site study staff should note the participant ID number, destroy the number and 
envelope, and report the event and ID number to UCSF.  UCSF staff will determine if any 
adjustments need to be made to maintain balance between assignments to intervention and 
control groups, and will instruct study staff accordingly. 
Participant Identification Numbers by Study Site 
Site 
ID Numbers 
Houston 
101-399 
Detroit 
401-699 
Oakland 
701-999 

 
 
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 Procedure for Randomizing a Participant:  The research assistant at each food bank will 
enroll participants into the study.  No staff member will know the randomly selected allocation 
of the participant until the HbA1c screening, informed consent process, and baseline survey is 
completed.  At the conclusion of this baseline visit, the staff member will open the sealed 
envelope that corresponds to the participant ID number of the enrolled client and determine the 
arm assignment, either immediate intervention or waitlist intervention. 
 Best Practices for Using Randomization Envelopes: Study staff that participate in 
enrollment activities should use the following best practices to ensure consistency in the 
randomization process, and to foster a satisfactory client experience. 
o 
Have all of your enrollment materials available when you are meeting with a new 
participant (e.g., consent forms, education materials, survey materials, and 
randomization envelopes) 
o 
It is especially important to have the participant’s randomization envelope at your table 
(and in plain sight) during the entire enrollment process 
o 
Have only 1 randomization envelope at the table for each participant 
 
In similar studies, some clients assigned to the waitlist control group have 
argued about their assignment, especially if the study staff leaves the area to 
retrieve the envelope after the consent and survey administration is completed 
(they may think staff selected the envelope based on their survey responses) 
o 
After the survey is completed, open the randomization envelope in front of the 
participant so they can observe the process 
 
Randomization assignments must be documented in the Microsoft Access database.  
 
 
9  Participant Timeline and Visit Schedule 
A schedule of visits and evaluations that specifies what is to be done at each study phase and at 
each contact with the study participant is provided in Appendix E.   
9.1 Scope/Schema  
This section outlines all in-person visits study participants have with the study staff.  All dates listed 
below are relative to the day of enrollment for each participant (see Appendix E). 
 
Participants – Intervention Group 
 Day 1 (Month 1, Week 1) = T0 (by convention we identify the baseline visit as “T0”) 
o Food bank client participates in diabetes screening (blood glucose and/or HbA1c 
testing) event at food pantry; study staff verifies that client meets eligibility requirements 
for study inclusion 
o Client agrees to participate in study and completes written consent form with study staff 
o Participant completes baseline survey with study staff (CASIC) 
o Participant randomly assigned to study intervention group by study staff 

 
 
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o Participant receives 1st bi-monthly food box and passive education materials and 
receives information from food bank staff on group diabetes education classes 
 Month 1, Week 2 
o Participant receives bi-monthly food box, passive education materials, and 1-on-1 
education from food bank staff 
o Participant attends Session 1 of group diabetes education class around this time 
 Month 2, Week 1 
o Participant receives bi-monthly food box, passive education materials, and 1-on-1 
education from food bank staff 
o Participant attends Session 2 of group diabetes education class around this time 
 Month 2, Week 2 
o Participant receives bi-monthly food box, passive education materials, and 1-on-1 
education from food bank staff 
 Month 3, Week 1 
o Participant receives bi-monthly food box, passive education materials, and 1-on-1 
education from food bank staff 
o Participant attends monthly group drop-in diabetes education class around this time 
 Month 3, Week 2  = T3 
o Participant completes 3-month HbA1c test with study staff 
o Participant receives bi-monthly food box, passive education materials, and 1-on-1 
education from food bank staff 
 Month 4, Week 1 
o Participant receives bi-monthly food box, passive education materials, and 1-on-1 
education from food bank staff 
o Participant attends monthly group drop-in diabetes education class around this time 
 Month 4, Week 2 
o Participant receives bi-monthly food box, passive education materials, and 1-on-1 
education from food bank staff 
 Month 5, Week 1 
o Participant receives bi-monthly food box, passive education materials, and 1-on-1 
education from food bank staff 
o Participant attends monthly group drop-in diabetes education class around this time 
 Month 5, Week 2 
o Participant receives bi-monthly food box, passive education materials, and 1-on-1 
education from food bank staff 
 Month 6, Week 1 = T6 
o Participant completes 6-month HbA1c test with study staff 
o Participant completes T6 survey with study staff (CASIC) 
o Participant receives $30 gift card for completion of survey 
o Participant receives final bi-monthly food box, passive education materials, and 1-on-1 
education from food bank staff 
o Participant attends monthly group drop-in diabetes education class 
 Month 12 = T12 

 
 
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o Participant completes 12-month HbA1c test with study staff 
o Participant completes T12 INT survey with study staff (CASIC) 
o Participant receives $15 gift card for completion of survey 
o Participant formally exits research study 
 
Participants – Control Group 
 Day 1 (Month 1, Week 1) = T0 
o Food bank client participates in diabetes screening (blood glucose and/or HbA1c 
testing) event at food pantry; study staff verifies that client meets eligibility requirements 
for study inclusion 
o Client agrees to participate in study and completes written consent form with study staff 
o Participant completes baseline survey with study staff (CASIC) 
o Participant randomly assigned to study control group by study staff 
o Participant receives $15 gift card for survey completion 
 Month 1, Week 1 – Month 6, Week 2 
o Participant attends regular food pantry distributions and receives normal services per 
food pantry guidelines (does NOT receive diabetes food packages or education) 
 Month 7, Week 1 = T6 
o Participant completes HbA1c test with study staff 
o Participant completes final survey with study staff (CASIC) 
o Participant receives $15 gift card for survey completion 
o Participant receives 1st bi-monthly food box, passive education materials, and 1-on-1 
education from food bank staff 
 Month 7, Week 2 
o Participant receives bi-monthly food box, passive education materials, and 1-on-1 
education from food bank staff 
 Month 8, Week 1 
o Participant receives bi-monthly food box, passive education materials, and 1-on-1 
education from food bank staff 
 Month 8, Week 2 
o Participant receives bi-monthly food box, passive education materials, and 1-on-1 
education from food bank staff 
 Month 9, Week 1 
o Participant receives bi-monthly food box, passive education materials, and 1-on-1 
education from food bank staff 
 Month 9, Week 2 = T9 
o Participant receives bi-monthly food box, passive education materials, and 1-on-1 
education from food bank staff 
o Participant completes HbA1c test with study staff 
 Month 10, Week 1 
o Participant receives bi-monthly food box, passive education materials, and 1-on-1 
education from food bank staff 
 Month 10, Week 2 

 
 
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o Participant receives bi-monthly food box, passive education materials, and 1-on-1 
education from food bank staff 
 Month 11, Week 1 
o Participant receives bi-monthly food box, passive education materials, and 1-on-1 
education from food bank staff 
 Month 11, Week 2 
o Participant receives bi-monthly food box, passive education materials, and 1-on-1 
education from food bank staff 
 Month 12, Week 1 = T12 
o Participant receives final bi-monthly food box, passive education materials, and 1-on-1 
education 
o Participant completes T12 HbA1c test with study staff 
o Participant completes T12 CONT survey with study staff (CASIC) 
o Participant receives $15 gift card for completion of survey 
o Participant formally exits research study  
9.2 Language capacity 
Informed consent, survey administration, and diabetes education must be provided to all Spanish-
speaking participants by bilingual study staff. Other study contact may be conducted with an 
interpreter.  
 
9.3 Compensation 
In order to realistically compensate participants for the time they spend participating in this research 
study and encourage full participation, participants will be reimbursed according to the following 
schedule: 
 Intervention Group: $30 gift card on completion of T6 follow-up survey; $15 gift card on 
completion of T12 follow-up survey 
 Wait-List Control Group: $15 gift card on completion of baseline survey; $15 gift card on 
completion of T6 follow-up survey; $15 gift card on completion of T12 follow-up survey 
Compensation will be provided in the form of assorted store gift cards (e.g., Walmart, Target, etc., but 
should not include major grocery stores).  Study staff will have participants sign the “Participant 
Compensation Receipt Form” (Appendix AL) upon receipt of a gift card. 
 
9.3.1 Transportation Vouchers 
If a study participant reports transportation costs as a major barrier to completing T6 and/or T12 
follow-up activities, site staff can provide transportation vouchers (e.g., gas card, bus token, public 
transit pass, etc.) not to exceed $10 in value.  Transportation vouchers may be offered to study 
participants up to two times (at T6 and T12), and only for completing study follow-up activities.  
Transportation vouchers should not be used to assist participants in attending other study or 

 
 
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intervention activities, nor should they be used in place of existing participant compensation (see 
section 9.3 above). 
 
Site staff should enter any information (date, amount, type, and notes) for participants who do receive 
transportation vouchers in the study MS Access database. 
 
9.4 Final Study/Early Discontinuation Evaluations 
Participants should be actively followed through all study visits till the final visit, unless he or she 
withdraws informed consent.   
 
It is important to note that if a study participant discontinues any part of the intervention but does NOT 
actively withdraw informed consent, he/she should still be followed to the end of the study.  That is, 
participants in any component of the intervention (e.g. picking up food boxes, attending educational 
sessions) should still have HbA1c testing and complete follow-up survey as regularly scheduled. 
 
 
10   Adverse Events and Safety Reporting 
All adverse events should be reported to UCSF and Morgan Smith (FANO) within 24 hours.  Study 
staff should complete an “Adverse Event” report (Appendix AN) for each incident that occurs, and 
enter the data into the MS Access database (if appropriate [involves a study participant] and when 
possible). 
 
An adverse event can include study participants, or include study staff and food pantry clients that 
participate in any study activity (e.g. blood glucose screening event).  An adverse event report should 
be completed for all events, with the one exception of low blood glucose screening results for pantry 
clients who do not report a history of diabetes. Food pantry clients with a blood glucose screening 
result < 70 mg/dL who do not report a history of diabetes do not require treatment by study staff, and 
the event does not need to be reported as an adverse event. 
 
Adverse events which are reasonable to anticipate include: 
1. Low blood glucose (hypoglycemia) 
2. High blood glucose (hyperglycemia) 
3. Reports of suicidality or homicidality 
4. Reports of elder abuse or neglect 
5. Reports of poor food quality 
6. Study related injury 
 
Each of these adverse events, along with steps on how to address, are discussed below. 
 

 
 
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10.1   Blood glucose < 70 mg/dL (Hypoglycemia) 
 For the purposes of this study, hypoglycemia will only be addressed as an adverse event for 
clients who have a screening blood glucose result < 70 mg/dL, and who report a history of 
diabetes 
o Some clients with a diabetes history (especially if their diabetes is poorly controlled) 
may report hypoglycemic symptoms at a higher threshold (e.g., < 100 mg/dL); in these 
cases it is appropriate to treat the symptomatic client as if hypoglycemic and document 
as an adverse event 
o While some conditions exist that may cause hypoglycemia in people without diabetes, 
these condition are extremely rare 
o For clients who do not report a history of diabetes and have a screening blood glucose 
< 70mg/dL, it is not necessary for study staff to treat or report as an adverse event 
 In clients reporting a diabetes history, any blood glucose lower than 70 mg/dL is considered 
low (“hypoglycemia”) and requires immediate intervention to bring the glucose level up into a 
normal range. 
 The GE100 Blood Glucose Monitor displays results between 20 and 600 mg/dL (if a test result 
is under 20 mg/dL, the meter will display “Lo” – in this event repeat test to confirm correct 
glucose level). 
 A client / study participant with a blood glucose < 70 mg/dL should immediately be given an 
appropriate hypoglycemia snack (15 grams of quickly absorbing carbohydrate).  Study staff 
should stock pre-packaged glucose tabs (e.g., “Dex4 Glucose Tablets”) during all blood testing 
and DSME events to use in these cases (note: 1 Dex4 glucose tab contains approximately 4 
grams of CHO; clients experiencing hypoglycemia should thus receive 4 tablets). 
 Study staff should recheck the client’s blood glucose 15 minutes after the client consumed the 
snack.  If the client’s blood glucose level has not increased to over 70 mg/dL, repeat dosing of 
glucose tablets / hypoglycemic snack and recheck glucose levels every 15 minutes until the 
glucose returns to a normal level. 
 Caution client against eating / drinking too much fast-acting carbohydrate too quickly (e.g., 
more than 15 grams every 15 minutes) in order to prevent post-treatment hyperglycemia. 
 Once the client is experiencing normoglycemia, a longer-acting complex carbohydrate snack 
(peanut butter and crackers, cheese and crackers, nut and raisin mix, yogurt and fruit, half a 
whole grain bagel with cream cheese, etc.) should be given to help maintain normal blood 
glucose levels if the next planned meal or snack is more than 1-2 hours away.   
 Effort should also be made to identify the underlying cause of the hypoglycemia in order to 
help avoid future episodes. 
 Refer client as needed to PCP or local community health center for further evaluation and 
treatment management. 
 These events should be reported in the MS Access database for all study participants. 
 

 
 
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10.2 Blood glucose > 240 mg/dL, or HbA1c > 9% (Hyperglycemia) 
 The GE100 Blood Glucose Monitor displays results between 20 and 600 mg/dL (if a test result 
is over 600 mg/dL, the meter will display “Hi” – in this event, repeat test to confirm glucose 
level; perform QC check on meter as necessary). 
 The A1C+Now system displays test results up to 12.9% (for results greater than 12.9%, the 
device will display > 13%). 
 If a participant (or client not yet enrolled in the study) has a blood glucose result between 240 – 
399 md/dL, or a HbA1c result between 9% - 12.9%, study staff should refer the client back to 
their primary care provider for evaluation.  If the client or participant does not have a primary 
care provider, study staff should make a new patient referral to a partner clinic following study 
protocols.  Partner clinic agreements contain recommended timeframes for contacting referred 
patients with these results (within 1 week) to schedule a patient appointment to occur within 1 
month from receiving the referral. 
o Hyperglycemia in the absence of symptoms does not require action by study staff or 
reporting as an adverse event; all testing results should be recorded and saved in the 
MS Access database. 
 If a participant (or client not yet enrolled in the study) has a blood sugar greater than 400 
mg/dL (or confirmed “Hi” reading on the glucometer), or a HbA1c result > 13%, study staff 
should refer the client back to their primary care provider and/or facilitate an appointment being 
made.  If the client or participant does not have a primary care provider, study staff should 
make a new patient referral to a partner clinic following study protocols. 
o Food bank – clinic partnership agreements outline that clinics will attempt to contact 
referred clients with these results within 24 hours, and will schedule appointments for 
clients experiencing severe hyperglycemia within 72 hours of receiving a referral from 
the food bank. 
o All clients with severely elevated blood glucose results should also be encouraged by 
study staff to initiate contact with their PCP or nearest community clinic. 
o Hyperglycemia in the absence of symptoms of study staff action does not require 
reporting as an adverse event; all testing results should be recorded and saved in the 
MS Access database. 
 If necessary, clients can also be provided with information about local emergency medical care 
(local Emergency Rooms and hospitals) if the client prefers or needs immediate medical 
attention. 
 If necessary and/or at the client’s request, study staff can also call “911” to initiate the local 
emergency response system (EMS) to have the client evaluated by health care professionals 
onsite.  Severe hyperglycemia accompanied by any of the following symptoms potentially 
constitutes a medical emergency and warrants activation of the EMS: nausea and/or vomiting, 
chest pain, abdominal pain, or altered mental status. 
 Only hyperglycemia events where clients report symptoms and study staff respond/act (e.g. 
activating local EMS) are required to be reported as an adverse event. 
o Complete an Adverse Event Report and contact Morgan Smith within 24 hours of event. 
o These events should be reported in the MS Access database for all study participants. 
 

 
 
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10.3   Reports of severe depression, suicidality, or homicidality 
The participant surveys contain multiple items asking about participant activity, behavior, and health 
(including a standard 8-question section used to monitor the severity of depression).  It is possible 
that during survey administration (or during other project-related activities [e.g., DSME group classes, 
1-on-1 encounters, etc.)], participants will reveal symptoms of major depression that could include 
disclosure of suicidal / homicidal thoughts, plans, and risks.  While food bank and project staff may 
not have expertise in the treatment of mental health emergencies, it is critical that project staff is 
skilled in identifying potential risks and responding appropriately to protect participants’ and others’ 
well-being.  This section describes how to handle possible mental health emergencies identified 
during study activities. 
 
All food bank sites and partner pantries should maintain a list of local mental health resources for staff 
reference and to be provided to any participant who suggests severe depression and/or depression 
with suicidal or homicidal thoughts. 
 
Suicidal Ideation Protocol 
Suicidal ideation (SI) refers to a person’s thoughts about or a preoccupation with suicide.  The range 
of suicidal ideation varies greatly from fleeting thoughts, to extensive thoughts, to detailed planning, 
role playing (e.g., standing on a chair with a noose), and incomplete attempts.  Study staff should be 
attentive to study participants who may exhibit any variation of SI. 
 
If during a study activity a participant reports suicide ideation, study staff should immediately ask this 
question to ascertain intent: 
 “I am so sorry you feel this way.  For your safety, I have to ask a difficult question: do you have 
a plan to act on these thoughts to harm yourself?” 
 
 If a participant answers “no” (no intent) 
o Staff should respond: “I am so sorry you feel this way, but I am glad you do not have 
plans to harm yourself.  If you remember from the consent form, having thoughts of 
harming yourself, even if you won’t act on them, is a reason that I need to contact Dr. 
Seligman (the doctor in charge of this study), your doctor or your doctor’s team.  We do 
this to make sure you are safe.  Before we continue with the survey / activity, please 
give me a minute to speak with a doctor who may be able to help you.” 
o Staff should contact participant’s primary care provider or provider’s clinic to have PCP 
assess participant over the phone. 
o If participant does not have a PCP (or does not know the name of the provider or of 
their health care clinic), study staff should contact Dr. Hilary Seligman at 415-443-4171 
(pager) or on her cell at 415-336-4460 to report incident and have her assess the 
participant over the phone. 
 If participant’s PCP, other clinic provider, or Dr. Seligman is able to speak with 
the client and confirms the client has no intent, proceed with survey.  Document 
event in MS Access database. 

 
 
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 If participant’s provider, clinic, or Dr. Seligman is unable to speak with client, staff 
should contact local community health clinic or local mental health resource to 
have other trained professional assess participant.  If medical/mental health 
professional is able to speak with the client and confirms the client has no intent, 
proceed with survey.  Document event in MS Access database. 
o If the contacted medical professional identifies intent to harm, follow any physician 
instructions, stop study activity, do not leave participant alone, and call 911 to activate 
the local emergency response system (see below). 
o Page Dr. Hilary Seligman at 415-443-4171 or on her cell at 415-336-4460 to report 
incident. 
o Document event in detail; include report in MS Access database for study participants. 
 
 If a participant answers “yes” (has intent) 
o Staff should respond: “I am so sorry you are feeling this way, and I am very concerned 
you might harm yourself.  If you remember from the consent form, if you report you may 
harm yourself I will need to contact your doctor or other medical professional.  We want 
to make sure you get the help you need to keep you safe.  I apologize, but I need to 
stop this survey/activity now.  Please give me a moment to speak with a doctor who can 
help you.” 
o Stop survey administration or study activity immediately. 
o Do NOT leave participant alone; ask participant if another study staff person or food 
bank staff person can sit with them for a few minutes. 
o Call 911 to report a mental health emergency; inform operator of situation, your location, 
and the participant’s disclosure of SI with intent. 
o Stay with client until emergency medical response arrives to evaluate participant 
o Page Dr. Hilary Seligman at 415-443-4171 or on her cell at 415-336-4460 to report 
incident. 
o Document event in detail; include report in MS Access database for study participants. 
 
The primary investigator must be made aware of any emergencies involving study participants as 
soon as possible. 
 
10.4   Reports of Elder Abuse or Neglect 
 Employ standard site-specific protocols or page Dr. Hilary Seligman at 415-443-4171, or call 
on her cell at 415-336-4460. 
 If unable to reach Dr. Seligman, study staff should call “911” to report situation and activate the 
emergency response system. 
 Document event in detail; include report in MS Access database for study participants. 
 
The primary investigator must be made aware of any emergencies involving study participants as 
soon as possible. 
 

 
 
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10.5   Reports of Poor Food Quality 
All food banks participating in the FAITH-DM study are members of the Feeding America network and 
as such, must meet certain minimal compliance standards with respect to food safety and food 
distribution.  Food banks are audited periodically by the Feeding America National Office and may 
also undergo periodic auditing by external entities. Food banks are required, in turn, to periodically 
monitor practices of their agencies. 
 
Feeding America maintains a timely distribution of food recall information to all food sourcing 
personnel in the network.  In addition, Feeding America provides education to all food banks on 
current guidance with respect to food industry use of dates for use by dates, best by dates and other 
practices.  These practices will be reviewed with the study sites and the quality of food distributed will 
also be observed during project site visits.   
 
Key information to be reviewed includes: 
 Packing or manufacturing date 
o Used by manufacturers for tracking and recalls          
o Not an expiration date 
 Sell-by date 
o This is a quality date 
o It tells the store how long to display the product for sale 
o The product is still safe to eat past this date 
 Best-by or best if used by date 
o This is a quality date 
o It tells clients the date by which the product should be eaten for best flavor or quality 
 Use-by or expiration date 
o This is the last date recommended for the product while at peak quality. 
o Most products (if not temperature controlled for safety - TCS) are still safe to eat past 
this date 
o Cut product (TCS foods) must be kept 41˚F or below to control potential bacterial 
growth 
o Any other type of produce can be kept at room temperature or refrigerated; refrigeration 
provides extended shelf life but may affect the quality of the produce 
o Mold on produce is a spoilage indicator; mold will not give someone a food borne illness 
but product should be disposed of if mold is observed 
 
In the event that any participant expresses a concern about the quality of food received, the site 
coordinator should determine if the concern is related to any potential food safety issues and if so, 
notify the food bank food sourcing management immediately so that appropriate follow-up measures 
can be taken.  If a participant reports that he or she believes that food received through the program 
may have made them ill, food bank management should be notified immediately, so that they can 
implement appropriate procedures, and an adverse event form must be completed. Morgan Smith, 
FANO project manager, must be notified within 24 hours to determine appropriate follow-up with the 
participant. 

 
 
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10.6 Study Related Injuries 
Any study related injury is considered an adverse event and must be reported.  Study related injuries 
may include: 
 Sharps / needle stick injury and/or blood exposure 
 Fainting and related injuries (e.g., falls) 
 Excessive bleeding 
 
In the event of a study related injury, staff should immediately respond to address the incident. 
 
10.6.1  Sharps Injuries and Blood Exposures 
(Adapted from CDC Emergency Needlestick Information, 
http://www.cdc.gov/niosh/topics/bbp/emergnedl.html): 
 
For sharps / needle stick injuries, and/or blood exposure, study staff should immediately: 
1. Wash needlesticks and cuts with soap and water 
2. Flush splashes to the nose, mouth, or skin with water 
3. Irrigate eyes with clean water, saline, or sterile irrigants 
4. Report the incident to site supervisor 
5. Seek medical treatment 
a. Injured staff and/or client may need to seek medical care with local urgent or emergency 
care for treatment and evaluation for post-exposure prophylaxis 
b. Contact Clinician Consultation Center (UCSF, http://nccc.ucsf.edu/) at 1-888-448-4911 
(9 a.m. – 2 a.m. EST,  seven days a week) for clinical guidance on obtaining Post-
Exposure Prophylaxis 
6. Complete Adverse Event Reporting Form (Appendix AN), enter event details into MS Access 
database (if event includes a study participant), and notify Morgan Smith (FANO) within 24 
hours of event.  
10.6.2  Fainting and Related Injuries 
While unlikely, it is possible that a client or staff could faint during a screening activity.  A person 
experiencing fainting episodes can be triggered by factors or situations such as hypoglycemia, low 
blood pressure, excessive pain, dehydration, standing for long periods of time, emotional distress and 
anxiety.  
 
In the event a client or staff faints or is injured during a study activity, study staff should: 
1. If possible, assist the client to sit down or lie down on the floor before fainting in order to 
prevent a fall and related injuries. 
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a. If client is not breathing, or not breathing normally, call 911 and initiate CPR (if 
appropriate and staff is trained to do so) 
3. If necessary (e.g., client has no history of fainting, client was injured during fall, and/or client 
does not recover consciousness after 2-3 minutes), call 911 to activate local emergency 
medical system 
4. Complete Adverse Event Reporting Form (Appendix AN), enter event details into MS Access 
database (if event includes a study participant), and notify Morgan Smith (FANO) within 24 
hours of event 
 
10.6.3  Excessive Bleeding 
Some clients who participate in a blood screening activity may have a reduced capacity for normal 
blood clotting (which can be caused by some medications, an underlying health condition, etc.).  
While excessive bleeding is unlikely to occur as a result of a screening activity, it is important that 
screening staff are aware of how to identify and respond to a case of excessive bleeding with a client. 
1. Apply direct pressure at puncture site (site staff should follow universal precautions, wear 
gloves, and utilize barrier protections) using available supplies (gauze pads, cotton balls, etc.) 
2. Elevate puncture site 
3. If bleeding is significant, does not stop, or gets worse, call 911 to activate the emergency 
response system 
4. Complete Adverse Event Reporting Form (Appendix AN), enter event details into MS Access 
database (if event includes a study participant), and notify Morgan Smith (FANO) within 24 
hours of event 
 
10.6.4  Infection 
If a food pantry client or study participant reports an infection that resulted from their participation in a 
study related screening event, staff should complete an Adverse Event Reporting Form (Appendix 
AN), enter event details into MS Access database (if event includes a study participant), and notify 
Morgan Smith (FANO) within 24 hours of report. 
  
 
11   Study Compliance 
Clinical trials are expensive endeavors and every effort should be made to maximize adherence to 
the protocol and minimize non-compliance. Comprehensive training on the study protocol, early 
review of the data, and routine communications with the sites help to minimize protocol deviations. 
However, protocol deviations do occur, especially in trials such as this one conducted n community 
settings.  There is therefore a mechanism in place to track protocol deviations and procedures and to 
notify appropriate parties about their occurrence. 
 
Protocol deviations include, but are not limited to the following: 
 Randomization of an ineligible participant 

 
 
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 Failure to obtain Informed Consent 
 Enrollment of a participant into another diabetes study occurring at the same time 
 Wrong treatment administered to participant, such as a participant who is randomized to the 
waitlist control group and instead receives the intervention 
 Outcome measurement not performed, such as follow-up HbA1c or follow-up survey 
 
All protocol deviations should be reported to Morgan Smith (FANO) within 48 hours and officially 
recorded on the Protocol Deviation Log (Appendix F).  Morgan Smith will discuss these deviations 
with UCSF within 48 hours so that corrective actions may be taken if necessary.  While there are 
rational and expected reasons for occasional deviations, a site with continuous problems is at risk of 
losing its funding.  
 
 
12   Data Collection and Study Forms 
All survey data collection will be done within the CASIC system, and all study tracking will take place 
within Microsoft Access databases. Copies of all study forms will be maintained in the MOP for 
reference.  See Appendix D for Electronic Forms completed at each study visit. 
 
FAITH-DM is a complex study requiring multiple points of data collection with study participants.  
Ensuring that all data are collected and properly recorded is critical to study staff being able to 
accurately analyze results. Research assistants and site staff can use the document “Data Collection 
Best Practices” (Appendix AT) as a guide to consistently maintain quality data collection.  
12.1   Source Documentation   
A source document is any document on which study data are initially recorded.  
 
Source documents for this study include: 
 Screening Log 
 CASIC forms 
 Healthcare utilization abstraction forms 
 Informed consent, HIPAA, and medical records release forms 
 Participant compensation receipts 
 MS Access database 
 
12.2   Participant Binder 
This section describes how participant data are maintained in the study. All essential study 
documents must be retained at each food bank in a Participant Binder(s) and include the following:  
 Signed consent forms 
 Paper tracking forms (if any) 
 Data correction forms (if any) 
 

 
 
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12.3   General Instructions for Completing Forms  
All data recorded on study forms must be verifiable in the source documents maintained by the food 
banks.  In addition to the Informed Consent, HIPAA, and medical records release forms, additional 
formats include: 
1. CASIC (for survey administration) 
2. MS Access database 
 
 
12.3.1  Best practices for completing paper forms 
 Header:  Complete the header information on EVERY page, including pages for which no 
study data are recorded.  
 Participant ID:  The participant ID must be recorded on EVERY page, including pages for 
which no study data are recorded.  Participants must NOT be identified by name on any study 
document. Use only the participant ID number. 
 Abbreviations:  Use of abbreviations not specifically noted in the instructions for completing 
the forms can be problematic and should be held to a minimum. 
 Correcting errors:  If an error has been made on the study forms, place a single line through 
the erroneous entry and record the date and your initials. Indicate the correct response. 
 Skipping items: Do not skip any items. Some items may carry "Unknown" or "Not Applicable" 
response choices which should be selected when necessary. 
 Incomplete data: Data may not be available to complete the form for various reasons.  Circle 
the item for which information is not available and indicate the reason near the appropriate 
field: 
o If an evaluation was not done, write ND and provide a reason. 
o If the information is not available, but the evaluation was done, write NAV.  
o Note:  Only in rare circumstances, as in the case of lost documentation, should 
NAV be recorded on the form.  Every effort should be made to obtain the information 
requested. 
o If an evaluation is not applicable, write NA. 
o Incomplete or Illegible forms: Incomplete forms that do not have adequate 
explanation (as described above) compromise the integrity of the entire study. Errors, 
such as incomplete or illegible forms, are problems that require time and energy to 
resolve.  The use of CASIC helps to prevent these problems. 
  
Incomplete or illegible paper forms: 
 If an entire page of the form cannot be completed (e.g., no parts have any responses), and it is 
unlikely that it will be completed, draw a diagonal line through the form and write NOT DONE, 
NOT AVAILABLE or NOT APPLICABLE, as appropriate 
 The header information must be completed even though no data are recorded on the form  
 Do not leave forms incomplete or unused without explanation. Include the explanation on the 
form itself 

 
 
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12.3.2 CASIC Instructions 
CASIC data collection software will be used to record all data from participant baseline and follow-up 
surveys. CASIC is a secure web-based data collection software hosted on servers at UCSF. To 
access CASIC via the internet, go to https://faithdm.ucsf.edu/CASIC/ and sign in using your secure 
log-in credentials. When internet access is not reliably available, site laptops will be equipped with 
CASIC Remote. Instructions on how to use CASIC and CASIC Remote follow. 
 
Note: because CASIC is accessible in both online and offline formats for use in completing 
participant surveys, we will never use paper versions of the participant surveys.  Using CASIC 
exclusively for survey completion will help to maintain consistent, quality data collection, and reduce 
potential survey administration problems inherent with the use of paper surveys (e.g., correct 
implementation of the complex skip patterns used throughout the surveys). 
 
Instructions for using CASIC 
1. Go to https://faithdm.ucsf.edu/CASIC/ and log-in 
2. Select “FAITH-DM” study 
3. From the drop-down menu, select the assessment you wish to administer, the food bank from 
which the participant was recruited, and the participant ID (from randomization envelop) 
4. Begin assessment, being sure to double check accuracy of all information entered 
5. Whenever possible, complete survey in single session 
Instructions for using CASIC Remote 
1. Open CASIC remote from the desktop while internet connection is still available and select 
“sync” in order to ensure use of the most up-to-date survey (see section 12.3.2) 
2. In the field, open CASIC remote, log in, and select “Start Assessment” 
3. From the drop-down menu, select the assessment you wish to administer, the food bank from 
which the participant was recruited, and the participant ID 
4. Begin assessment, being sure to double check accuracy of all information entered 
5. Whenever possible, complete survey in single session 
6. When internet connection is reestablished at the end of each day during which data collection 
took place, click “sync” again to upload all data to the server 
For more detailed information regarding CASIC, visit www.westportal.com.  
 
All survey data should be correctly entered into CASIC within 14 days from survey initiation.  Contact 
UCSF Project Coordinator (Sophie Rosenmoss) with any CASIC-related questions or issues. 
 

 
 
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12.3.3 CASIC Remote Syncing Process 
Before and after data collection at a field site that may not have reliable internet access, it is best to 
sync the data on CASIC Remote with the host. Doing so will reconcile all patient survey information 
so that anything that has been collected using either CASIC online or CASIC Remote will be reflected 
on both platforms. To sync the data, do the following: 
 
1. Make sure you have adequate internet connection 
2. Log onto CASIC Remote using Mozilla Firefox at localhost/CASICRemote/Default.aspx 
3. Make sure that the URL in the CASIC Host box is 
https://faithdm.ucsf.edu/CASICHost/Services.asmx  
4. Click “Test” 
5. Click “Save” or “Continue” 
6. Under “Host services” on the left navigation panel, click on “Host URL” 
7. Click “Synchronize subject data” in the navigation panel 
8. Click “download” to download information from CASIC online and “upload” if you have 
collected data offline on CASIC Remote in the field and would like to upload to CASIC online 
 
12.3.4  Downloading Updated Instruments in CASIC Remote 
Below are the step-by-step instructions for downloading updated instruments in CASIC remote. Note: 
If you wanted to just updated a single or a few instruments you do not have to do the first part of step 
3 (deleting the study). You would want to keep the study and only delete the instruments in question.  
Contact Sophie Rosenmoss if you have any questions while trying to do this. 
1. Download the updated survey to CASIC Remote 
a. Step one: log onto CASIC Remote using Mozilla Firefox at 
localhost/CASICRemote/Default.aspx 
b. Step two: Under “Host services” on the left navigation panel, click on “Host URL” 
i. Make sure that the URL in the CASIC Host box is 
https://faithdm.ucsf.edu/CASICHost/Services.asmx 
ii. Click test 
iii. Click save (or continue) 
iv. You must be connected to the internet to do this 
c. Step three: Click “Study setup” under Host Services. 
i. Scroll down to Available instruments, delete list of instruments (attached here) 
from computer 
d. Step four: On the same page under “Study setup” next to FAITH DM, click “Setup on 
this computer” 
e. Step five: Synchronize subject data by clicking “Synchronize subject data” in the 
navigation panel then clicking “download” to download information from CASIC online 
and “upload” if you have collected data offline on CASIC Remote in the field and would 
like to upload to CASIC online. You will do this regularly before and after going to the 
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12.3.5  Paper survey instructions 
All participant surveys will be completed electronically using either CASIC online or CASIC remote.  
Paper surveys will not be used with participants in this study. 
 
12.3.6  MS Access database instructions 
This study uses Microsoft Access databases to store tracking information. Specifically, the Microsoft 
Access database will have the following forms and sub-forms: 
 Screening form (for all individuals screened): Screening will be completed on paper forms; 
study staff is responsible for entering data on each individual screened from paper forms into 
Access databases at the end of each day. 
 Baseline data and participant status form (for all individuals enrolled): This form is completed 
after initial enrollment of a study participant and is the only form in which study staff can edit 
participant status. 
 Contacts Form: This form will contain all contact information for the participant 
 PCP Contact Form: This form will contain all the contact information for a participant’s PCP 
 Study Data Forms 
o HbA1c form: Record all HbA1c values here 
o Food boxes form: Record all data on participant food box pick-up here 
o Education sessions form: Record all data on participant class attendance here 
o Primary care contact form: Record all data on contact study staff has with primary care 
here 
 Study Data – Browse Only: When study staff need to retrieve, but not edit, data, use this form 
 Reports: Study staff use this form to run reports on collected data 
 Utilities: This option is used to make changes to the database, such as adding a new 
interviewer 
 Close database: This form safely closes the database 
Microsoft Access tracking forms can be used offline and uploaded to the FAITH-DM folder using VPN 
at the end of each day. It is important that all data is entered each day and securely saved and 
uploaded to the FATIH-DM folder using the instructions outlines in section 13.1.1. 
 
 
13   Data Management  
It is the food banks’ responsibility to ensure that all forms are complete, intact, and transmitted to the 
Coordinating Center, as appropriate: 

 
 
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13.1 Storage and Transmission of Electronic Files 
This section addresses use of the MS Access and CASIC programs for storage and transmission of 
study data. The UCSF Project Manager will monitor uploads weekly and will contact sites as needed 
for troubleshooting and quality control / process improvement. 
13.1.1 Backing up Microsoft Access Databases to UCSF server 
All tracking forms are housed on site-specific Microsoft Access (MA) databases. Each site will have 
one computer that has the MA database. To prevent data loss, sites will employ the following back-up 
instructions daily and/or weekly. Though the MA database stored locally on the laptop hard drive will 
be the “original copy”, study staff must upload a copy of the MA database to the UCSF servers 
(weekly, at a minimum). Upload the latest version of the MA database to UCSF’s servers using the 
following process: 
Uploading Access information to UCSF server 
After you are finished collecting data for the day in Access following these steps: 
1. Close the Access database 
2. Log in to UCSF Pulse client using your UCSF credentials (the “Pulse” client uses Secure File 
Transfer Protocol [SFTP] for secure file transfer capabilities between networked hosts) 
3. Open your “Public Documents” folder in one window (this is found under Documents  My 
Documents  Public Documents) 
a. In this folder you will see the access database you created today. To confirm it’s the 
correct one, the date modified field to the right of the title should read with today’s date 
(or whenever you last entered info into it) 
4.  In a separate window, open the FAITH DM Site Data folder, then open your specific site folder 
(Houston, Detroit, or Oakland) 
a. You can do this by right clicking on the FAITH DM Site Data folder and selecting “open 
in new window” 
5. Drag the most recent back end file from the Public Docs folder to the FAITH DM Site Data/Site 
specific folder 
6. Right click on the new file in UCSF’s Site Data folder and rename with today’s date 
Alternatively, you can do all of steps 1-3 and instead right click on the most recent Access file in your 
public documents folder, select “copy” and then open the FAITHDM Site Data/site folder, right click in 
the folder, and select “paste”. Then rename the file with today’s date. 
 
13.1.2 CASIC Online 
1. Go to https://faithdm.ucsf.edu/CASIC/ 
2. Enter User ID and password 
3. Select FAITH-DM Study 
4. Select study location (food bank name) 
5. Select assessment 
6. Start survey 
7. Questions save every time you click “next” 

 
 
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8. Be sure to click “close window” when done 
13.1.3 CASIC Remote 
1. Before leaving for field site that may not have internet access, open CASIC Remote and click 
“sync” to ensure you have the most up-to-date survey and participant list (see section 12.3.2) 
2. Open CASIC Remote from desktop 
3. Log in using User ID and password 
4. Select FAITH-DM Study 
5. Select study location (food bank name) 
6. Select assessment 
7. Start survey 
8. be sure to click “close window” when done 
9. When internet connection is reestablished, upload study data by clicking “sync” 
 
13.2 Administrative Forms 
Administrative forms provide documentation of study processes and assist with study operations.  
Administrative forms for this study include: 
 Facsimile Transmittal Sheet - serves as a cover page for all faxes, and must include HIPAA 
confidentiality language (Appendix AB) 
 Screening Log - a record of all individuals screened for participation in the study. It should be 
arranged chronologically and be kept up-to-date at all times (Appendix B).  
 Participant Identification Code List – a record of the participant's name, ID number, 
randomization arm, and study entry and exit dates.  Due to the confidential nature of this 
information, it should be maintained only on the encrypted computer, kept in the MS Access 
Database, apart from other forms and data files at the food bank. The information contained in 
the list must be maintained by the food bank until 3 years after completion of the study and/or 
return of the study computer to UCSF. 
 Protocol Deviation Log – used to document deviations from the protocol as they are identified 
by participant, or study staff. This log (Appendix F) will be kept and maintained centrally by 
FANO (Morgan Smith). 
 
13.3 Retention of Study Documentation 
All study documents should be retained and securely stored for 3 years following study completion 
(study completion ends after the end of last data analysis).  All study related electronic documents 
and data sets will be securely stored for 5 years following study completion, and then deleted. 
 
Best practices for secure document storage: 
 Study documents with participant identifying information should be stored separately from 
documents containing general information or de-identified participant data 

 
 
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o For example, study consent forms and participant baseline forms contain identifying 
information and should be stored separately from screening logs 
 When possible, use permanent markers to black out participant identifying information (e.g., 
name, DOB) on forms that also contain a participant ID # 
 Keep documents organized in 3-ring binders with appropriate tabs 
o Consent forms and baseline forms can be stored by participant last name 
o Forms with de-identified data should be filed in numerical order by participant ID # 
 Binders and documents with participant data should be stored in drawers or cabinets that can 
be secured with a locking mechanism 
o Only FAITH-DM study staff and approved site staff should have access to these storage 
areas 
 
Once the documentation retention period has passed, all study documents should be destroyed via: 
 Document shredding 
 Release of documents to secure document disposal service 
 
13.3.1 HCUA Data Stored at Food Bank Sites 
As outlined in section 7.7, the research assistants (RA) at each site are responsible for requesting, 
obtaining, storing, and transmitting all HCUA data to the Urban Institute (UI).  Transmission of HCUA 
data (either via mailings of photocopied surveys and records, or via electronic file transfer using 
secure flash drives) will ultimately result in the existence of two sets of HCUA data (local copies 
stored at each food bank, and a master copy located at the Urban Institute). 
In order to maintain data security, the research assistants at each food bank will destroy all local 
HCUA data at the conclusion of data collection (projected to be early October, 2017).  Prior to 
destruction of HCUA data, each RA will confirm with Urban Institute project staff that local data 
collection is complete, and that UI has received all mailings and packages sent by the site RA that 
include any HCUA data (e.g., completed HCU provider surveys, de-identified medical records, etc.).  
Once UI confirms receipt of all HCUA data from a site, the RA will commence with destruction of local 
HCUA data copies via: 
 Document shredding 
 Release of documents to secure document disposal service 
 Permanent deletion of all electronic files and electronic folders containing any HCUA data 
 
 
13.4  Data Analysis Plan 
13.4.1 Sample size estimation 
We used the sampsi program in Stata to calculate the necessary sample size to detect a 0.4% 
decrease in HbA1c with 90% power. Using our preliminary data from the pilot phase of this project, 
we projected that the average A1c would decrease from 9.5% to 9.1% with a correlation between the 

 
 
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2 observations per individual at 0.51. Given these parameters, we determined that 300 individuals 
were needed in both the intervention and waitlist arms of this RCT. In order to allow for 20% attrition 
from baseline to follow-up, we increased the final recruitment goal to 720 individuals total (240 per 
site). 
 
sampsi 9.5  9.1, sd1(1.6) sd2(1.9) method(ancova) pre(1) post(1) r1(.51) power(0.9) 
 
Estimated sample size for two samples with repeated measures 
Assumptions: 
                                      alpha =   0.0500  (two-sided) 
                                      power =   0.9000 
                                         m1 =      9.5 
                                         m2 =      9.1 
                                        sd1 =      1.6 
                                        sd2 =      1.9 
                                      n2/n1 =     1.00 
           number of follow-up measurements =        1 
            number of baseline measurements =        1 
   correlation between baseline & follow-up =    0.510 
 
Method: ANCOVA 
relative efficiency =    1.352 
    adjustment to sd =    0.860 
        adjusted sd1 =    1.376 
        adjusted sd2 =    1.634 
 
Estimated required sample sizes: 
                  n1 =      300 
                  n2 =      300 
 
13.4.2 Data sources 
The primary sources of data for this analysis will be from the point-of-care HbA1c testing done on site 
at the food pantries and the participant survey data, both at baseline and follow-up.  In our 
assumptions, rolling enrollment lasted for approximately 6 months, and the length of follow-up 
between baseline and follow-up was also approximately 6 months (4-9 months overall).  
 
13.4.3 Hypotheses 
We are testing several hypotheses in this study.  

 
 
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1. The primary hypotheses which we are powered to examine is a significant improvement in 
HbA1c over a 6-month timeframe.   
a. For all of these outcomes, we also hypothesize that the effect sizes will be largest 
among those who completed a minimum amount of exposure to all intervention 
components.  A priori, we defined engagement in the intervention components as:  
picking up 80% of diabetes-appropriate food boxes, attending the 2 required diabetes 
education classes, and having at least 1 primary care visit over the 6-month follow-up 
period.   
b. We also hypothesized that the intervention would have the largest effect on those in the 
poorest A1c control (>9%) and those with very low food security status at baseline. 
 
2. Secondary hypotheses:  The secondary outcomes of interest are improvements in 
fruit/vegetable intake, diabetes distress, self-reports of severe hypoglycemic events, 
depressive symptoms, medication adherence, tradeoffs between affording food vs 
medication/supplies, food security status, and food stability.   
 
3. Healthcare utilization hypotheses/analyses will be covered in a separate analysis plan 
 
13.4.4 Statistical analyses 
For all the outcomes specified above, we will determine significant improvements using an ANCOVA 
specification: 
𝑌𝑖,𝑡=1 = 𝛽0 + 𝛽1𝑇𝑖+  𝜋𝑌𝑖,𝑡=0 +  𝜀𝑖 
 
Where 𝑌𝑖,𝑡=1 is the given outcome variable measured post-treatment, 𝑌𝑖,𝑡=0 is its baseline value, 𝑇𝑖 is 
an indicator for being assigned to treatment, and 𝜀 is the error term. Since randomization is at the 
individual-level, HuberWhite standard errors will be used. 𝛽1 will provide the intent-to-treat effect. 
 
Loss to follow-up 
We intend to collect follow-up data on at least 80% of participants.  We will conduct a formal 
missingness investigation to determine if the attrition rate differed between intervention and waitlist 
groups.  If treatment status is found not to significantly affect attrition at the 5 percent significance 
level, then all estimation will proceed without any adjustment for attrition. If attrition is found to be 
related to treatment status, we postulate that attrition will be higher for the control group, and will 
employ Lee bounds to obtain bounds on our treatment estimates which are robust to this attrition 
(https://ideas.repec.org/c/boc/bocode/s457477.html).  Multiple imputation for missing outcome data 
will also be explored as sensitivity analyses (http://aje.oxfordjournals.org/content/175/3/210.full).  
 
Per protocol/exposure to treatment 
Among those with complete baseline and follow-up A1c ascertainment, we will also examine the 
influence of the amount of exposure to the program.  Specifically, we will determine whether the 

 
 
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participants who met our criteria for being “engaged” in the program (overall and by specific 
intervention component) had larger effects than those who were less engaged.   
 
In this analysis, because the randomization benefits will be lost, we will adjust for other covariates in 
our model that we hypothesize to influence A1c and self-management improvements:  age, gender, 
race/ethnicity, educational attainment, language, and site/location.  
 
Subgroup analyses 
While we are randomizing within sites, we also plan to conduct subgroup sensitivity analyses by both 
adjusting for site and examining changes within site to determine differential effectiveness by location.  
Site-specific differences will be shared with the food banks, but only reported publicly in manuscripts 
if found to be significantly different.  
 
Other planned subgroup analyses (as specified in our hypotheses) are by baseline glycemic control 
(>9%) and food security status. 
 
13.5 Health Care Utilization Data Analysis Plan 
Overview of analysis 
The health care utilization analysis is designed to explore the effects of the intervention on the use of 
health care services by the study participant, specifically primary care visits, emergency 
room/department visits and inpatient utilization. The pilot project that preceded the development of 
this randomized controlled trial did not collect health care utilization data; therefore, this aspect of the 
analysis will provide new information on whether the intervention affects health care utilization.  There 
is an opportunity to collect both self-reported health care utilization data from study participants 
before (T0) and at the conclusion of the six-month intervention or waitlist period (T6), as well as six 
months following completion of the intervention or waitlist period (T12).  A survey will also be sent to 
primary care providers for records of selected services for both the intervention and waitlist groups 
after the initial six month enrollment period (T6).  This survey will request data for the six month 
period prior to enrollment, as well as the six months the study participant was enrolled in either the 
intervention or waitlist group. At T12, the same survey will be sent to providers caring for original 
intervention study participants and will request data for the period between T6 and T12. Providers 
caring for individuals in the original waitlist group will not be surveyed at T12. 
 
The participant and provider data can provide insight on whether the intervention has an effect on the 
utilization of selected health care services, and by using geographically adjusted cost averages for 
the associated services, can provide some general information on potential cost implications for those 
utilization patterns. Other data that can inform the analysis, such as participant self-reported health 
status, health care coverage status and reports of missed time at school or work will also be included 
in the analysis. 

 
 
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13.5.1 Participant and provider data collection process 
Self-reported data on the use of selected health care services will be collected from all participants in 
the survey administered at enrollment (T0), after six months in the study (T6), and again six months 
after completion of the initial intervention or waitlist period (T12) (see section 7.6 for a general 
description). In each survey, the study participant will be asked to report on health care utilization in 
the prior six months. At enrollment (T0), the participant will also be asked to provide consent for the 
release of medical record information from their current primary care provider during the enrollment 
process. 
 
If the participant reports he or she does not currently have a primary care provider, the participant will 
be given an active referral if part of the treatment group and offered a provider resource sheet if part 
of the waitlist control group.  
 
After the participant has been in the study for six months, the site RA will send a health care 
utilization survey to the primary care provider the participant identifies at enrollment. The site RA will 
also ask if there has been any change in primary care provider during the prior six months and will 
send additional surveys as appropriate. The provider survey will be accompanied by (see Appendix 
Y) a brief explanation of the survey and contact information for any questions or assistance needed in 
completing the request, as well as a copy of the signed HIPAA and medical records release 
authorization.  
 
The T6 provider survey will query dates of service for primary care visits made in the past 12 months 
for each participant (the six month period prior to enrollment, and the following six month period 
during the intervention or waitlist window), as well as the primary associated CPT codes and up to 
four ICD-9/ICD-10 diagnosis codes.  The provider survey is not restricted to services provided for 
diabetes or diabetes complications since it may be difficult to discern whether a particular condition is 
associated with or affected by diabetes.  The provider survey will also ask for dates of any scheduled 
but missed appointments. Providers will be asked to list the dates of service, primary procedure 
codes and diagnosis codes for any emergency department visits or inpatient hospital admissions for 
which they have records. Although the records of these services may be less complete than those 
delivered directly by the provider practice/clinic, it is standard practice for hospitals to forward 
discharge summaries if a provider is identified at the time of admission and we will obtain this 
information whenever possible. 
 
At T12, provider surveys will be sent only to those providers who have cared for a study participant 
originally enrolled in the intervention group.  The information collected will be identical to that 
requested at T6, but will focus on utilization during the intervening six-month period.  Providers who 
cared for a study participant originally enrolled in the waitlist group will not receive a survey for that 
participant. 
 
See section 7.7 for additional details on the processes for communicating with providers and 
obtaining completed health care utilization surveys.  

 
 
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13.5.2 Health care utilization indicators and hypotheses 
One of the four arms of the intervention is the active referral to a primary care provider if the 
participant does not have one at the time of enrollment.  In addition, the self-management support 
(SMS) activities in the intervention are designed to reinforce engagement of the participant with the 
primary care provider as a component of their diabetes management. Thus, our primary indicator will 
be change in the reported utilization of primary care services, as assessed by self-reported data and 
provider reports where available. 
Our hypothesis is that the intervention participants will have increased engagement with their primary 
care provider when compared to the control group, and when compared to their level of engagement 
prior to the intervention.  Because this particular model is unique in its use of food pantries as a point 
of outreach and support and its incorporation of a diabetes-focused food security intervention, there is 
no prior literature that directly informs our hypothesis development.  However, we can draw some 
insight for hypothesis development from other studies of the impact of self-management support 
models on health care utilization. For example, Hamid et al. (2014) reported on a cluster-randomized 
design used to assign 268 diabetes patients to a nurse-community health worker intervention or usual 
care. Hospitalizations, emergency department, and primary care physician visits were collected 
retrospectively for one year prior to, and during, the intervention to assess changes in health care 
utilization. Adjusted incidence rate ratios for primary care physician visits were significantly higher in 
the community health worker intervention relative to the usual care. The authors found no main 
intervention effect on emergency department utilization, but visits in the prior year modified the 
intervention effect on emergency department visits. Increased primary care physician utilization was 
associated with greater decreases in HbA1c. 
In a review of studies implementing at least some features of chronic disease management models 
(including SMS), Bodenheimer, Wagner and Grumbach (2002) reported mixed evidence on the 
impact of diabetes interventions on health care utilization.  However, the authors were surprised to 
note that while they expected shorter-term interventions would not affect diabetes health care 
utilization or costs because of the relatively long horizon for the evolution of disease complications, 
some studies suggested that even shorter-term interventions reduced utilization in some services, 
including the length of hospital stays, fewer hospital stays and reduced utilization of emergency 
department visits. Some studies failed to show a reduction in overall health care costs; at least one 
did show a reduction in emergency department and specialty visits but not overall costs. 
It is not clear whether this intervention can be expected to have a significant impact on reducing the 
use of more intensive services, especially since neither diversion of  patients from more intensive 
services nor intensive chronic disease management are specific aims of the study, and there is no 
change in payment incentives related to utilization.  However, based on some evidence of reduced 
utilization associated with SMS and community-oriented models in the literature, our secondary 
indicators will include changes in inpatient hospital stays, inpatient hospital length and number of 
emergency department visits. We hypothesize that there may be some trend toward reduction in 
more intensive services, at least for those with sufficient uptake of the intervention.  

 
 
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In some cases, however, it is possible that increased utilization might be observed and even 
desirable; for example, if patients learn to identify high-risk health situations more effectively and seek 
treatment as a result of the intervention. An analysis of primary diagnostic codes associated with 
utilization will be conducted to assess the extent to which utilization appears to be associated with 
diabetes-related conditions, especially more acute events such as severe hypoglycemia. We will also 
examine whether there is an association between changes in health care utilization and improvement 
in the primary study indicator of improved HbA1c. 
13.5.3 Sample size estimation 
The health care utilization analysis will utilize the sample generated by the FAITH-DM study.  The 
estimated recruitment goal for the project is 720, with a projected sample size of 600 (300 each in 
intervention and waitlist arms) after estimated loss to follow-up of 20%. This sample provides the 
basis for the analysis of the self-reported utilization data and the pool of participants from which 
provider surveys will be requested.  It is our goal to collect provider data from at least 80% of the 
intervention participants and 70% of the waitlist control participants (it is anticipated that this group 
will yield fewer primary care provider relationships, since they are not receiving the intervention that 
supports these).  The pilot project upon which this study was based suggested that most individuals 
who participated in food pantry screening reported that they had a primary care provider at the time of 
their enrollment in the pilot project.  However, prior health records were not requested from those 
providers in the pilot so it is difficult to know prospectively how many provider contacts will actually 
yield records, given that individuals struggling with food insecurity may also have been disconnected 
from health care access in the months prior to their recruitment at the food pantry. 
 
13.5.4 Statistical analyses 
For each of the outcomes from the utilization analysis we would assess the impact of the intervention 
using the following specification:  
 
𝑌𝑖= 𝛽0 + 𝛽1,𝑖𝑇+ 𝛽2,𝑖𝑃𝑜𝑠𝑡+ 𝛽3,𝑖𝑇∗𝑃𝑜𝑠𝑡+ 𝜖𝑖 
 
Where 𝑌𝑖 is the given outcome variable, 𝑇𝑖 is an indicator for being assigned to treatment, Post is an 
indicator that the observation is from the post intervention time period, and 𝜖𝑖 is the error term.  The 
impact of the intervention is measured by 𝛽3 which measures the intent to treat effect – or the change 
in the outcome of interest for the treatment group compared to the change in the outcome of interest 
for the wait-list group. Since randomization is at the individual-level, HuberWhite standard errors will 
be used. 
 
Loss to follow-up 
We intend to follow the same procedures for loss to follow-up as specified in the analysis of the 
primary study outcome (HbA1c). We will conduct a formal missingness investigation to determine if 
the attrition rate differed between intervention and waitlist groups.  If treatment status is found not to 
significantly affect attrition at the 5 percent significance level, then all estimation will proceed without 

 
 
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any adjustment for attrition. If attrition is found to be related to treatment status, we postulate that 
attrition will be higher for the control group, and will employ Lee bounds to obtain bounds on our 
treatment estimates which are robust to this attrition.  Multiple imputation for missing outcome data 
will also be explored as sensitivity analyses.  
 
Subgroup analyses 
While the study is randomizing within sites, we also plan to conduct subgroup sensitivity analyses by 
both adjusting for site and examining changes within site to determine differential effectiveness by 
location.  Site-specific differences will be shared with the food pantries, but only reported publicly in 
manuscripts if found to be significantly different.  
 
Other planned subgroup analyses (as specified in our hypotheses) are by baseline glycemic control 
(>9%) and food security status. 
 
 
14  Quality Control Procedures 
Data integrity and study credibility depend on factors such as:  
 Ensuring adherence to the protocol 
 Obtaining complete follow-up information on all participants enrolled  
 Using quality control measures to establish and maintain high standards for data quality 
 
Quality control procedures for point-of-care testing is described in section 7. 
 
Data entry directly into CASIC or MS Access allows for immediate range checks.  Data questions will 
be posed by the study statistician (Courtney Lyles) to sites as needed.  Data quality will be reviewed 
by the study statistician at least every six months. 
 
Site visits will be conducted annually (or as needed).  Protocol deviations will be reviewed within 48 
hours to determine if corrective actions need to be taken.  This procedure is not intended to be 
punitive, but to assist with avoiding similar problems across sites in the future. 
 
Ongoing quality control and iterative improvement helps to ensure the highest quality study possible. 
 
14.1 Standard Operating Procedures 
One aspect of site quality control is a set of standard operating procedures (SOPs). SOPs describe 
generic procedures that are specific to the site, and should be drafted and maintained by study staff 
at each site.  The SOPs should be located in a central location and made easily available to staff for 
reference. 
 
For FAITH-DM, SOPs should include: 

 
 
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1. Storage of study materials (outlines where participant binders, quality control logs, screening 
forms, blood testing materials, etc.) are stored 
2. Secure storage of study documents with participant data (signed consent forms, paper 
enrollment forms, signed HIPAA forms, etc.) 
3. Copies of all handouts with site-specific information 
a. Diabetes education handouts used during screenings (pre-diabetes range; diabetes, 
controlled; diabetes, uncontrolled) 
b. Primary care provider referral forms 
c. Mental health referral handouts 
d. Reminder materials (diabetes class postcards)  
e. Retention materials (birthday / holiday cards) 
 
14.2 Site Monitoring 
FANO and UCSF will conduct site monitoring visits during the course of the study. These will be 
arranged in advance with each food bank. 
 
FANO and/or UCSF project staff will conduct initial site visits at all three food bank sites between 
October 1, 2015, and February 28, 2016.  Site visits will be planned with input and availability of 
project staff at each food bank.  Additional goals of site visits are: ensure FAITH-DM activities are 
being conducted as designed; provide feedback and technical assistance to food bank FAITH-DM 
project staff; problem-solve any unanticipated issues that arise during implementation of FAITH-DM 
protocols at the food bank sites; and provide an opportunity for food bank staff to provide feedback 
regarding implementation of study procedures. 
 
Once the site visit is complete, a site monitoring report is drafted to provide feedback regarding any 
problems or issues that may have been uncovered during the visit. The report will state the problems 
uncovered during the visit and describe recommendations to correct them. A timeline will be agreed 
upon and included in the report to ensure that follow-up of the issues is completed and implemented 
into the study’s procedures.   
 
Any additional site visits will be scheduled as/if needed during the remainder of the FAITH-DM study 
period.  FANO and UCSF project staff will communicate closely with food bank staff in the event 
additional site visits are required and need to be scheduled.  In the pilot study these site visits 
occurred approximately annually. 
 
The purposes of monitoring visits are to: 
 Ensure the rights and safety of participants 
 Confirm that the study is conducted in accordance with Good Clinical Practice guidelines 
 Ensure maintenance of required documents 
 
 Verify adherence to the protocol 
 Monitor the quality of data collected 

 
 
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 Ensure accurate reporting and documentation of all adverse events and unanticipated 
problems 
 
During monitoring visits, data recorded are reviewed and verified against source documents to 
ensure: 
 Informed consent has been obtained and documented in accordance with IRB regulations 
 The information recorded on forms is complete and accurate, where applicable 
 There are no omissions in the reports of specific data elements or protocol deviations 
 Missing study components 
 
Food bank staff must ensure that FANO/UCSF has access to all study documents, including informed 
consent forms, intervention accountability records, and source documents.  This is a requirement of 
the IRB. 
 
14.3  Acceptable Roles for Volunteers 
Food banks may choose to use volunteers to participate in aspects of study implementation, provided 
that they have the appropriate training and credentials for the role and are able to implement the 
study protocol as outlined in this document and per direction of the project team.  Acceptable roles for 
volunteers may include:  
 Packing of food boxes 
 Signing in participants during food distributions 
 Distribution of food boxes 
 Blood sugar and HbA1c screening: RN, RD, CHW, or other volunteers who are properly 
trained and credentialed as per local and state guidelines and who are willing to commit to 
ongoing volunteer participation to assure quality control  
 Survey administration: please make sure volunteers have practiced survey administration prior 
to their first administration  
 Diabetes education: RD, RN, CDE, CHW volunteers with expertise in diabetes education who 
are trained and able to implement the diabetes education component of the study as directed 
may participate in the education through:  
o Leading group class sessions 1 and/or 2 
o Participating as an expert guest speaker for the Open Forum/Support Group  
o Providing one-on-one education 
 
Any volunteer who interacts with a study participant in any way must complete their CITI training and 
forward the certificate to Morgan Smith for filing with the Western Institutional Review Board.   
 
 
15  Reports 
Once a study begins, routine reports compiled by the Coordinating Center are an important quality 
control tool.  

 
 
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15.1 Reporting Schedule 
 Food bank informal monthly reports will describe target and actual enrollment by site and in 
aggregate, individuals screened, and participant disposition (enrolled, active, completed, 
discontinued, and lost to follow-up); sites will also report all staff and volunteers that have 
completed CITI training and are eligible to work directly with study participants and study data 
o Morgan Smith (FANO) will be responsible for assembling these reports and 
communicating to UCSF. 
o During initial enrollment period (September – December, 2015), these reports will be bi-
monthly 
 Participant Overview Report (compilation of data from all sites and includes: numbers 
screened, enrolled, randomized group totals, participants completed, and participants lost-to-
follow up); monthly report during enrollment period compiled by UCSF 
 Food bank site progress and budget reporting: annually by each site and submitted to FANO 
(Morgan Smith and/or FANO Grants Team) 
o Year 1 report covers study period July 1, 2015 – April 30, 2016: due May 26, 2016 
o Year 2 / FINAL report covers study period May 1, 2016 – October 31, 2017: due 
October 5, 2017; final report will request information on project activities, and both year 
2 and extension funding awards 
 HCUA Reporting (Urban Institute) 
o Quarterly report to Morgan Smith (FANO) with updates 
 FANO will be responsible for all official reporting to project funder (LJAF)  
 
 
16  Data and Safety Monitoring Board 
At this time we have no plans to convene a Data Safety and Monitoring Board due to the low-risk 
nature of the research we are conducting. 
 
However, in order to track data quality, enrollment numbers, and other study events, UCSF study 
staff (study statistician, principle investigator, and project coordinator) will conduct an internal review 
of study data every 6 months, and report general results to coordinating center team members.  In 
order to maintain research best practices and study rigor, this review will not include any analyses, 
audits, or interpretations of raw study data.  The primary purpose of these reviews are for quality 
control. 
 
Internal reviews should be conducted on or around the following dates: 
 March 1, 2016 
 September 1, 2016 
 March 1, 2017 
 September 1, 2017 
 
 

 
 
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17  Study Completion and Closeout Procedures 
Study closeout activities are performed to confirm that the food banks’ study obligations have been 
met and post-study obligations are understood. Closeout activities include: 
 Verification that study procedures have been completed and data have been collected. 
 Final uploads of all food bank site MS ACCESS Database data due by 9/30/17. 
 Final uploads of all food bank site CASIC survey data due by 9/30/2017. 
 Final submission by food bank sites of HCU-surveys shipped to Urban Institute by 9/30/17. 
 Comparison of the food banks’ study files against the Coordinating Center's records for 
completeness.  
 Assurance that all data queries have been completed. 
 Assurance that correspondence and study files are accessible for external audits. 
 Reminder to food banks of their ongoing responsibility to maintain study records for 3 years 
and to report any relevant study information to the Coordinating Center.  
 Participant notification of the study completion. 
17.1 Participant Notification 
The Coordinating Center will develop a sample letter to notify participants that the study is completed, 
ask whether they would like to be informed of the results, and thank them for their participation. Food 
banks may modify this letter to personalize it and add their own branding. 
17.2 Site Procedures Post-Study 
The Feeding America National Office will likely want to highlight the trial results both internally and 
externally. This may include messages of appreciation. Staff from participating food banks may be 
asked to assist with the dissemination of trial results and best practices, for example at national 
workshops. Feedback will be provided to participating clinics. 
17.3 Ancillary funding 
If additional money is secured, it will be put towards 12-month follow-up HbA1c screening and survey 
administration.  Procedures for these activities will be discussed in detail with each food bank and 
described in detail in the MOP prior to initiation of any activities. 
 
17.3.1 Extension plan 
In late 2015, the Urban Institute was awarded a grant from the Robert Wood Johnson Foundation 
(RWJF).  Under the grant, Urban will serve as a transdisciplinary research hub in support of RWJF’s 
Policies for Action: Policy and Law Research to Build a Culture of Health.  Urban has dedicated a part 
of this award is towards ancillary, or “extension”, funding for FAITH-DM. 
 
As initially outlined in section 17.3 (Ancillary Funding), this extension funding will be dedicated 
towards additional HbA1c testing, survey administration, and HCU activities for participants at the 12-
month (T12) mark.  An overview of these activities is provided here: 

 
 
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T12 Activity 
Intervention Group 
Control Group 
HbA1C Testing 
Yes – new extension activity 
Yes – original protocol 
Participant T12 Post-
Survey 
Yes – new extension activity 
Yes – revised from original 
protocol 
HCUS Provider 
Survey 
Yes – new extension activity 
No 
 
Primary rationale for extension activities: 
 The T12 follow-up activities with the intervention group will provide important data on how well 
participants maintain any benefits that they may have experienced at the immediate end (T6) 
of the intervention.  Identifying health promotion interventions that positively impact outcomes 
for the long term has important implications for public health programming and policy 
development. 
 The extension plan will also allow us to compare, to a degree, the efficacy of the primary study 
intervention to the “modified” intervention that the control group receives.  This comparison 
may provide important information on how well specific intervention components work (e.g., 
the formal vs. modified DSME program).  
17.3.2 IRB Approval 
Because these extension activities include significant changes to the existing study protocol, the 
Coordinating Center re-submitted the revised protocol to the study IRB for approval. The revised 
protocol, along with associated participant materials, were approved by the Western IRB on 3/18/16. 
17.3.3 Revised Project Budgets 
The study extension plan includes additional funding for the Coordinating Center and the food bank 
sites to adequately cover the costs associated with the new activities.  The Feeding America grants 
team will issue revised grant awards to the food bank sites in summer 2016.  These award letters will 
detail the increased grant amounts dedicated to food bank staffing, medical and testing supplies, 
outreach materials, participant and provider incentives, and other extension-related items. 
17.3.4 Description of New and Revised Study Activities 
This section describes in detail the study activities that are new, or that are revisions to the original 
study protocol, related to the implementation of this extension plan.  Note: the entire MOP has also 
been updated and reflects these revisions. 
 
 Participant Recruitment and Enrollment 
o Site staff will use a revised recruitment flyer (Appendix AJ) and communicate the 12-
month timeframe and activities when informing food pantry clients, prospective study 
participants, and new participants about the study 

 
 
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o Staff will use an IRB-approved form (“FAITH-DM Updates for Study Participants”, 
(Appendix AW) to update all participants at T6 of T12 study activities 
 Intervention Group Activities 
o Under the original study protocol, intervention group activities ended at T6. With the 
extension plan, site staff will work to engage with all intervention group participants to 
conduct a final visit at T12. 
o Participant outreach: at or near the T11 mark, site staff will attempt to contact 
participants (phone and by mailing T12 engagement materials) to provide information 
about T12 testing and surveys, and to attempt to schedule a study visit 
o Site staff will conduct a final HbA1c test with participants at T12 (testing window: 
months 11-13) at a project site following normal study protocols 
o Site staff will complete a final post-survey (INT-12) with each participant as part of this 
final visit.  This survey is identical to the T6 post-survey, but does not include the final 
section with items on satisfaction.  Intervention group participants who complete the 
final T12 survey will receive a final incentive ($15 gift card) according to normal study 
protocols. 
o Site staff will complete an active referral per existing study protocols for any participant 
identified at T12 as not having a source of primary medical care 
o Site staff will use the ACCESS database and CASIC system to record all data per 
normal study protocols. 
 Control Group Activities 
o Per the original study protocol, control group participants are scheduled to receive a 
T12 HbA1c test; the extension plan keeps this process unchanged 
o The T12 “satisfaction” survey will be replaced with the T12 CONT Post Survey (identical 
to the T6 Post Survey administered to intervention group participants) on CASIC for all 
control group participants at T12, and administered per normal study protocols 
o Site staff will complete an active referral per existing study protocols for any participant 
identified at T12 as not having a source of primary medical care 
o The extension grant includes new funding for control group participants to receive a $15 
gift card upon completion of their T12 surveys; site staff will distribute gift cards per 
normal study protocols 
 HCUA Activities 
o The extension plan includes a final round of HCU surveys (HCUS) for the intervention 
group only at T12 
o Site staff will use revised HCU provider letters to send to PCPs for participants assigned 
to the intervention group 
o Staff will follow original protocols for provider communication to obtain HCUS surveys at 
the T6 time frame for all study participants 
o At T12, site staff will send intervention group providers additional communication and a 
second survey (HCUS) that requests care utilization data for the T6 – T12 timeframe 
o Site staff will follow normal HCUA protocols for sending provider communication 
materials and surveys, conducting provider follow-up to encourage HCUS survey 

 
 
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completion, and survey collection, packaging, and mailing to Urban Institute project staff 
(see section 7.7.4 HCUA Activities at Twelve Months [T12] for details) 
o Extension funding is included to submit payments ($20 per HCUS survey completed) to 
providers, following established study protocols for payments 
 
17.3.5 List of Revised Forms and Study Materials 
The following study documents were revised or developed to reflect study changes connected to the 
extension plan: 
 Sample Recruitment Flyer 
 Participant Flow – Overview  
 FAITH-DM Updates for Study Participants [new] 
 Intervention Group T12 Post Survey 
 Control Group T12 Post Survey 
 Participant Compensation Receipt Form 
 HCUA Provider Letters (1-6) 
 HCUA Provider Letter (HCU Letter 7 – T12 Current Pt INT) [new] 
 HCUA Provider Letter (HCU Letter 8 – T12 Newly Referred Pt INT) [new] 
 HCUS Provider Survey (T6 & T12) 
 T6 & T12 Engagement Materials for Intervention & Control Groups [new] 
 
17.3.6 Reporting 
Site staff will follow original study protocols for reporting all study related information, data, events, 
and materials to the Coordinating Center. 
 
Site staff will follow any new grant-related reporting requirements (narrative and budget reporting) per 
instructions detailed in grant award letters.  Sites will submit a final project report by October 5, 2017 
as part of the final project report (via the FA Member Grants reporting portal).  
 
17.3.7 Study Closeout 
Study completion and closeout procedures will remain in place as originally outlined in study MOP. 
 
17.4 Confidentiality Procedures 
It is the responsibility of UCSF to outline and enforce participant and study data confidentiality 
policies. Study staff has responsibilities regarding data safeguards. Data must not be released to any 
unauthorized individuals, unless such a release is approved by the Coordinating Center and is not in 
violation of applicable Federal and state laws.    
 

 
 
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This section of the MOP will discuss the safeguards which have been put in place by the Steering 
Committee to ensure participant confidentiality and data security.  
 
The following is a list of study participant confidentiality safeguards: 
 Fax transmissions – all faxes sent to health care partners should include a HIPAA compliant 
cover page (Appendix AB).  Participant data should only be sent from / to HIPAA-compliant 
fax machines. 
 Data flow procedures – data identifying participants should not be transmitted from study 
sites to the Coordinating Center. Use the participant ID only on all study forms. 
 Electronic files – data identifying participants that are stored electronically should be 
maintained in an encrypted form or in a separate file. Only allow study data to reside on 
computers and equipment purchased by UCSF specifically for the FAITH-DM trial. These 
computers have been pre-loaded with virus protection and encryption software. 
 Forms - forms or pages containing personal identifying information, including name and date 
of birth, should be separated from other pages of the data forms.  All computer systems and 
paper back-up forms have been designed to separate all study information from personal 
identifying information. 
 Access - participant records should not be accessible to any persons outside the study 
without the express written consent of the participant.  No staff member or volunteer without 
CITI certification should be able to access any study documentation. 
 Storage – all study forms and related documents should be stored in a secure location. The 
Coordinating Center and the food banks should use the following computer security best 
practices to ensure that the data remain confidential: 
o 
Passwords: Passwords provide limitations on general access to computer 
systems and to the functions that individuals can use. Passwords should be 
changed on a regular basis. 
o 
User Training: Study staff with access to clinical computer systems will be 
trained in their use and in related security measures. Training will include 
explanations of how to access the system and a discussion of the need for, and 
importance of, system security. This will be done at the Study Training meeting. 
o 
System Testing: Prior to the use of a new computer system, and subsequent to 
any modifications, the system should be tested to verify that it performs as 
expected. Testing should verify that the password-activated access system 
performs as intended.  
o 
System Backups: Two copies of all data are kept.  The primary copy is on the 
hard drive of the computer.  The backup is electronically transmitted to the UCSF 
secure server daily. 
 

 
 
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17.5 Publications and data release 
Investigators have a responsibility to the public to make study results available as soon as possible. 
Data should not be released inappropriately or without the approval of UCSF. 
 
UCSF has responsibility for data analysis, manuscript development, and manuscript submission. A 
publication plan and author list will be created at the conclusion of the study. Main study results will 
be disseminated as soon as possible in both abstract form and peer reviewed manuscript form. Dr. 
Seligman will take primary responsibility for this process and will be listed as either first or senior 
author. 
 
As required by law, UCSF will report basic results to ClinicalTrials.gov within 12 months of trial 
completion.  The funder has also requested that we report basic results to them prior to publication.  
We will adhere, within reason, and as defined by our contract, to all funder requests. 
 
17.6 MOP Maintenance 
The MOP is maintained and updated throughout a study. The MOP will be available to study staff in 
loose-leaf and electronic form. Each page of the MOP is numbered, dated, and contains a version 
number to facilitate any changes and/or additions. The MOP may serve as a history of the project, 
documenting the time and nature of any changes in procedures and policies.   
 
The MOP will be continuously reviewed by the Coordinating Center to ensure that the operating 
procedures described are accurate. If any procedures have been changed or modified, the MOP 
should be updated and the appropriately modified pages distributed, with instructions, for 
replacement in the MOP. A MOP template for changes is included in Appendix G.  It is the 
responsibility of the Coordinating Center to maintain the MOP and document all MOP changes, and 
communicate MOP changes to the food banks. 
 
 

 
 
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Hyde AW.  The Changing Face Of Electronic Data Capture: From Remote Data Entry To Direct Data 
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Appendix A – Logic Model 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Appendix B – Screening Log 
 
 
1. Fasting is more than 8 hours from last intake. 
2. Perform HbA1c if: history of diabetes or gestational diabetes, fasting blood sugar 140 or higher, or non-fasting blood sugar 160 or higher. 
3. Do not check blood sugar or HbA1c on any person younger than 18 years of age. 
 
 
Blood 
Sugar 
Fasting1? 
HbA1c2 
Repeat 
Age3 
Gender 
Race/ 
Ethnicity 
ONLY if HbA1c 7.5 or higher 
 
      Fasting 
      Non-
fasting 
 
      YES 
       18-40 
       41-60 
       61+ 
      Female 
      Male 
      White     
      Black 
      Latino 
      Other 
        ENROLLED 
NOT ENROLLED DUE TO: 
□ Doesn’t speak Eng or Sp        □ HH member enrolled     □ Type I diabetes 
□ Pregnant/<6 wks postpartum □ Not pantry client       □ Cognit. impaired 
□ Not in area for next 12 mos.    □ Declined:_______________________    
□ No reliable contact info 
 
      Fasting 
      Non-
fasting 
 
      YES 
       18-40 
       41-60 
       61+ 
      Female 
      Male 
      White     
      Black 
      Latino 
      Other 
        ENROLLED 
NOT ENROLLED DUE TO: 
□ Doesn’t speak Eng or Sp        □ HH member enrolled     □ Type I diabetes 
□ Pregnant/<6 wks postpartum □ Not pantry client       □ Cognit. impaired 
□ Not in area for next 12 mos.    □ Declined:_______________________    
□ No reliable contact info  
 
      Fasting 
      Non-
fasting 
 
      YES 
       18-40 
       41-60 
       61+ 
      Female 
      Male 
      White     
      Black 
      Latino 
      Other 
        ENROLLED 
NOT ENROLLED DUE TO: 
□ Doesn’t speak Eng or Sp        □ HH member enrolled     □ Type I diabetes 
□ Pregnant/<6 wks postpartum □ Not pantry client       □ Cognit. impaired 
□ Not in area for next 12 mos.    □ Declined:_______________________    
□ No reliable contact info 
 
      Fasting 
      Non-
fasting 
 
      YES 
       18-40 
       41-60 
       61+ 
      Female 
      Male 
      White     
      Black 
      Latino 
      Other 
        ENROLLED 
NOT ENROLLED DUE TO: 
□ Doesn’t speak Eng or Sp        □ HH member enrolled     □ Type I diabetes 
□ Pregnant/<6 wks postpartum □ Not pantry client       □ Cognit. impaired 
□ Not in area for next 12 mos.    □ Declined:_______________________    
□ No reliable contact info 

 
 
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Appendix C – FAITH-DM Flow Chart 
The Screening Log and the MS Access database should allow us, at study end, to track every potential participant screened for the 
study.  This chart will be used to describe participant flow through the study. 
 
 
 
 
 
 
 
 
 
 

 
 
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Appendix D – Electronic Forms Completed at Each Study Visit 
 
 
MA = MS Access Database.  The MS Access database contains many forms (outlined here). 
 
 

 
 
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Appendix E – Schedule of Events 
INTERVENTION GROUP 
TIMELINE 
ACTIVITY / STUDY VISIT 
T0: Day 1 (Month 1, 
Week 1) 
 
Food bank client participates in diabetes screening (blood glucose and/or HbA1c testing) event at food pantry; study staff verifies that 
client meets eligibility requirements for study inclusion 
 
Client agrees to participate in study and completes written consent form with study staff (informed consent, HIPAA authorization, and 
medical records release form) 
 
Participant completes baseline survey with study staff 
 
Participant randomly assigned to study intervention group by study staff 
 
Participant receives 1st bi-monthly food box and passive education materials and receives information from food bank staff on group 
diabetes education classes 
 
RA sends participant’s PCP the baseline provider communication packet 
Month 1, Week 2 
 
Participant receives bi-monthly food box, passive education materials, and 1-on-1 education from food bank staff 
 
Participant attends Session 1 of group diabetes education class around this time 
Month 2, Week 1 
 
Participant receives bi-monthly food box, passive education materials, and 1-on-1 education from food bank staff 
 
Participant attends Session 2 of group diabetes education class around this time 
Month 2, Week 2 
 
Participant receives bi-monthly food box, passive education materials, and 1-on-1 education from food bank staff 
Month 3, Week 1 
 
Participant receives bi-monthly food box, passive education materials, and 1-on-1 education from food bank staff 
 
Participant attends monthly group drop-in diabetes education class around this time 
T3: Month 3, Week 2 
 
Participant completes 3-month HbA1c test with study staff 
 
Participant receives bi-monthly food box, passive education materials, and 1-on-1 education from food bank staff 
Month 4, Week 1 
 
Participant receives bi-monthly food box, passive education materials, and 1-on-1 education from food bank staff 
 
Participant attends monthly group drop-in diabetes education class around this time 
Month 4, Week 2 
 
Participant receives bi-monthly food box, passive education materials, and 1-on-1 education from food bank staff 
Month 5, Week 1 
 
Participant receives bi-monthly food box, passive education materials, and 1-on-1 education from food bank staff 
 
Participant attends monthly group drop-in diabetes education class around this time 
Month 5, Week 2 
 
Participant receives bi-monthly food box, passive education materials, and 1-on-1 education from food bank staff 
T6: Month 6, Week 1 
 
Participant completes 6-month HbA1c test with study staff 
 
Participant completes final survey with study staff 
 
Participant receives $30 gift card for completion of survey 
 
Participant receives final bi-monthly food box, passive education materials, and 1-on-1 education from food bank staff 
 
Participant attends monthly group drop-in diabetes education class 
 
RA sends participant’s PCP the T6 provider communication packet and HCUS 
T12: Month 12 
 
Participant completes 12-month HbA1c test with study staff 

 
 
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WAIT LIST CONTROL GROUP 
TIMELINE 
ACTIVITY / STUDY VISIT 
T0: Day 1 (Month 1, 
Week 1) 
 
Food bank client participates in diabetes screening (blood glucose and HbA1c testing) event at food pantry; study staff verifies that client 
meets eligibility requirements for study inclusion 
 
Client agrees to participate in study and completes written consent form with study staff (informed consent, HIPAA authorization, and 
medical records release form) 
 
Participant completes baseline survey with study staff 
 
Participant randomly assigned to study control group by study staff 
 
Participant receives $15 gift card for survey completion 
 
RA sends participant’s PCP the baseline provider communication packet (control) 
Month 1, Week 1 – 
Month 6 , Week 2 
 
Participant attends regular food pantry distributions and receives normal services per food pantry guidelines (does NOT receive diabetes 
food packages or education) 
T6: Month 7, Week 1 
 
Participant completes HbA1c test with study staff 
 
Participant completes final survey with study staff 
 
Participant receives $15 gift card for survey completion 
 
Participant receives 1st bi-monthly food box, passive education materials, and 1-on-1 education from food bank staff from food bank staff 
 
RA sends participant’s PCP the T6 provider communication packet and HCUS 
Month 7, Week 2 
 
Participant receives bi-monthly food box, passive education materials, and 1-on-1 education from food bank staff 
Month 8, Week 1 
 
Participant receives bi-monthly food box, passive education materials, and 1-on-1 education from food bank staff 
Month 8, Week 2 
 
Participant receives bi-monthly food box, passive education materials, and 1-on-1 education from food bank staff 
Month 9, Week 1 
 
Participant receives bi-monthly food box, passive education materials, and 1-on-1 education from food bank staff 
T9: Month 9, Week 2 
 
Participant receives bi-monthly food box, passive education materials, and 1-on-1 education from food bank staff  
 
Participant completes HbA1c test with study staff 
Month 10, Week 1 
 
Participant receives bi-monthly food box, passive education materials, and 1-on-1 education from food bank staff 
Month 10, Week 2 
 
Participant receives bi-monthly food box, passive education materials, and 1-on-1 education from food bank staff 
 
Participant completes T12 INT survey with study staff (CASIC) 
 
Participant receives $15 gift card for completion of survey 
 
RA sends participant’s PCP the T12 provider communication packet and HCUS 
 
Participant formally exits research study 

 
 
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Month 11, Week 1 
 
Participant receives bi-monthly food box, passive education materials, and 1-on-1 education from food bank staff 
Month 11, Week 2 
 
Participant receives bi-monthly food box, passive education materials, and 1-on-1 education from food bank staff 
T12: Month 12 
 
Participant receives final bi-monthly food box, passive education materials, and 1-on-1 education from food bank staff  
 
Participant completes T12 HbA1c test with study staff 
 
Participant completes T12 CONT survey with study staff (CASIC) 
 
Participant receives $15 gift card for completion of survey 
 
Participant formally exits research study  
 
 
 

 
 
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Appendix F – Protocol Deviation Log 
Site ____________________________________  
Protocol deviations must be reported to Morgan Smith (FANO) within 48 hours of discovery.  Morgan Smith is responsible for keeping 
the Protocol Deviation Log. 
 
Protocol 
Deviation Code: 
Participant 
Initials 
Participant 
ID# 
Date Deviation 
Occurred: 
mm/dd/yyyy 
Date Protocol 
Deviation 
Documented: 
mm/dd/yyyy 
Contact Person 
(if applicable) 
Notes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PROTOCOL DEVIATION CODES 
 
Consent Form: 
1. Missing or not obtained 
2. Not signed and dated by participant 
3. Does not contain all required signatures 
4. Outdated; current IRB-approved version not used   
 
 
Randomization: 
5. Ineligible participant enrolled and/or randomized 
6. Participant is randomized prior to determining whether eligible for 
study.  
7. Participant randomized prior to completing baseline survey 
 
IRB: 
8. Not reporting a serious complication within 24 hours; 
9. Approvals not kept up to date 
10. Enrollment and/or treatment occurs prior to IRB approval or 
during period when on “on hold.”  
11. Reportable serious adverse events not reported to IRB 
Participant 
12. Receives wrong intervention (immediate vs waitlist) 
13. Visits occur outside expected follow-up window  
14. Entered into another diabetes study 
 
Study Data and/or Forms 
15. Missing HbA1c 
16. Missing surveys 
17. Forms or data not sent from clinical site to coordinating center 
 

 
 
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Appendix G – MOP Modification Log 
 
 
MOP Modification Log 
Protocol Name: Feeding America Intervention Trial for Health – Diabetes Mellitus 
 
MOP MODIFICATION LOG 
VERSION # 
SECTION # 
PAGE # 
DATE 
MODIFIED 
A / D / R ** 
BRIEF MODIFICATION SUMMARY 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
** A = Addition, D = Deletion, R = Revision 
 
 
 
 
 
This log is the responsibility of the Coordinating Center. 

 
 
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PAGE __________ 
 
Appendix H – CONSORT 2010 Checklist 
CONSORT 2010 checklist of information to include when reporting a randomised trial* 
 
Section/Topic 
Item 
No 
Checklist item 
Reported 
on page No 
Title and abstract 
 
1a 
Identification as a randomised trial in the title 
 
1b 
Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for 
abstracts) 
 
Introduction 
Background and 
objectives 
2a 
Scientific background and explanation of rationale 
 
2b 
Specific objectives or hypotheses 
 
Methods 
Trial design 
3a 
Description of trial design (such as parallel, factorial) including allocation ratio 
 
3b 
Important changes to methods after trial commencement (such as eligibility criteria), with reasons 
 
Participants 
4a 
Eligibility criteria for participants 
 
4b 
Settings and locations where the data were collected 
 
Interventions 
5 
The interventions for each group with sufficient details to allow replication, including how and when they 
were actually administered 
 
Outcomes 
6a 
Completely defined pre-specified primary and secondary outcome measures, including how and when 
they were assessed 
 
6b 
Any changes to trial outcomes after the trial commenced, with reasons 
 
Sample size 
7a 
How sample size was determined 
 
7b 
When applicable, explanation of any interim analyses and stopping guidelines 
 
Randomisation: 
 
 
 
 Sequence 
generation 
8a 
Method used to generate the random allocation sequence 
 
8b 
Type of randomisation; details of any restriction (such as blocking and block size) 
 

 
 
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 Allocation 
concealment 
mechanism 
9 
Mechanism used to implement the random allocation sequence (such as sequentially numbered 
containers), describing any steps taken to conceal the sequence until interventions were assigned 
 
 Implementation 
10 
Who generated the random allocation sequence, who enrolled participants, and who assigned 
participants to interventions 
 
Blinding 
11a 
If done, who was blinded after assignment to interventions (for example, participants, care providers, 
those assessing outcomes) and how 
 
11b 
If relevant, description of the similarity of interventions 
 
Statistical methods 
12a 
Statistical methods used to compare groups for primary and secondary outcomes 
 
12b 
Methods for additional analyses, such as subgroup analyses and adjusted analyses 
 
Results 
Participant flow (a 
diagram is strongly 
recommended) 
13a 
For each group, the numbers of participants who were randomly assigned, received intended treatment, 
and were analysed for the primary outcome 
 
13b 
For each group, losses and exclusions after randomisation, together with reasons 
 
Recruitment 
14a 
Dates defining the periods of recruitment and follow-up 
 
14b 
Why the trial ended or was stopped 
 
Baseline data 
15 
A table showing baseline demographic and clinical characteristics for each group 
 
Numbers analysed 
16 
For each group, number of participants (denominator) included in each analysis and whether the 
analysis was by original assigned groups 
 
Outcomes and 
estimation 
17a 
For each primary and secondary outcome, results for each group, and the estimated effect size and its 
precision (such as 95% confidence interval) 
 
17b 
For binary outcomes, presentation of both absolute and relative effect sizes is recommended 
 
Ancillary analyses 
18 
Results of any other analyses performed, including subgroup analyses and adjusted analyses, 
distinguishing pre-specified from exploratory 
 
Harms 
19 
All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) 
 
Discussion 
Limitations 
20 
Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of 
analyses 
 
Generalisability 
21 
Generalisability (external validity, applicability) of the trial findings 
 

 
 
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Interpretation 
22 
Interpretation consistent with results, balancing benefits and harms, and considering other relevant 
evidence 
 
Other information 
 
Registration 
23 
Registration number and name of trial registry 
 
Protocol 
24 
Where the full trial protocol can be accessed, if available 
 
Funding 
25 
Sources of funding and other support (such as supply of drugs), role of funders 
 
 
*We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. If relevant, we 
also recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and 
pragmatic trials. Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see www.consort-statement.org. 
 
 
 
 

 
 
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Appendix I – Passive Diabetes Self-Management Education Materials 
AADE7 Self-Care Behaviors 
1. Healthy Eating 
2. Being Active 
3. Monitoring 
4. Taking Medication 
5. Problem Solving 
6. Reducing Risks 
7. Healthy Coping 
 
Study participants will receive 11 sets of passive education materials over a six-month period.  Each 
set will be included with one of the bi-monthly food box distributions.  This schedule was designed so 
that all participants, regardless of what week during the year they enroll and enter the study, will 
receive nearly identical sets of education materials over the course of their participation. 
 
Time Frame 
Subject Area 
Resources 
Recipes 
Notes 
Enrollment 
Introduction to 
FAITH-DM; Basic 
Diabetes 
Information 
FAITH-DM Welcome 
Letter and Resources; 
ACP Guide 
(intervention arm 
only); LAD – What’s My 
A1C? 
** Project staff at 
food bank sites will 
develop diabetes-
appropriate recipes 
based on current 
food inventory, 
participant 
preferences, etc. 
Participant also receives 
weekly materials with 
1st box at time of 
enrollment; participants 
in control group receive 
ACP guide and first set 
of weekly materials with 
first food package pick-
up after 6-month 
waiting period 
 
January – 
week 1  
Healthy Eating 1 
LZ – Diabetes MyPlate, 
Portion Distortion 
 
 
January – 
week 2  
Being Active 1 
IDC – Activity Pyramid 
LAD – My Weekly 
Exercise Plan 
 
 
February – 
week 1  
Healthy Coping 1 
IDC – Life Balance 
Pyramid; LAD – 
Diabetes and 
Depression 
 
 
February – 
week 2 
Problem Solving 
LAD – Saving Money on 
Medicines, Diabetes 
Supplies, Sick Days 
with Diabetes 
 
 
March – week 
1 
Reducing Risks 1 
LAD – Tips for Good 
Foot Care, Diabetes 
and Your Eyes; State-
 
 

 
 
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Time Frame 
Subject Area 
Resources 
Recipes 
Notes 
specific smoking 
cessation info 
March – week 
2 
Monitoring 
LAD – Blood Sugar 
Meters, Blood Sugar 
Diary, Low Blood 
Sugar, High Blood 
Sugar 
 
 
April – week 1 
Taking 
Medication 
LAD – Your Diabetes 
Pills, Diabetes Pills - 
Actions, Medicines You 
Inject - Actions 
 
 
April – week 2 
Healthy Eating 2 
LZ – MyPlate on a 
Budget, Sugar Shockers 
 
 
May – week 1 
Being Active 2 
LAD – Let’s Get 
Moving, Walking 
Works 
 
 
May – week 2 
Reducing Risks 2 
LAD – High Blood 
Pressure and Diabetes, 
Cholesterol and 
Diabetes, Diabetes 
Care Schedule 
 
 
June – week 1 
Healthy Eating 3 
LAD – The Nutrition 
Facts Label; Healthy 
Cooking Tips 
 
 
June – week 2 
Healthy Coping 2 
LAD – Diabetes and 
Stress; My Goal This 
Month 
 
 
July – week 1 
Healthy Eating 1 
LZ – Diabetes MyPlate, 
Portion Distortion 
 
 
July – week 2 
Being Active 1 
IDC – Activity Pyramid 
LAD – My Weekly 
Exercise Plan 
 
 
August – week 
1 
Healthy Coping 1 
IDC – Life Balance 
Pyramid; LAD – 
Diabetes and 
Depression 
 
 
August – week 
2 
Problem Solving 
LAD – Saving Money on 
Medicines, Diabetes 
Supplies, Sick Days 
with Diabetes 
 
 
September – 
week 1 
Reducing Risks 1 
LAD – Tips for Good 
Foot Care, Diabetes 
 
(Begin participant 
enrollment, 2015) 

 
 
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Time Frame 
Subject Area 
Resources 
Recipes 
Notes 
and Your Eyes; State-
specific smoking 
cessation info 
September – 
week 2 
Monitoring 
LAD – Blood Sugar 
Meters, Blood Sugar 
Diary, Low Blood 
Sugar, High Blood 
Sugar,  
 
 
October – 
week 1 
Taking 
Medication 
LAD – Your Diabetes 
Pills, Diabetes Pills - 
Actions, Medicines You 
Inject – Actions 
 
 
October – 
week 2 
Healthy Eating 2 
LZ – MyPlate on a 
Budget, Sugar Shockers 
 
 
November – 
week 1 
Being Active 2 
LAD – Let’s Get 
Moving, Walking 
Works 
 
 
November – 
week 2 
Reducing Risks 2 
LAD – High Blood 
Pressure and Diabetes, 
Cholesterol and 
Diabetes 
 
 
December – 
week 1 
Healthy Eating 3 
LAD – The Nutrition 
Facts Label; Healthy 
Cooking Tips 
 
 
December – 
week 2 
Healthy Coping 2 
LAD – Diabetes and 
Stress; My Goal This 
Month 
 
 

 
 
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LZ = Learning Zone Express 
 
Diabetes MyPlate 
 
Portion Distortion 
 
MyPlate on a Budget 
 
Sugar Shockers 
 
USDA MyPlate (screening resource only for clients with A1C result < 5.7%) 
 
 
LAD = Learning About Diabetes 
 
What’s My A1C 
 
My Weekly Exercise Plan 
 
Diabetes and Depression 
 
Saving Money on Medicines 
 
Diabetes Supplies 
 
Sick Days with Diabetes 
 
Tips for Good Foot Care 
 
Diabetes and Your Eyes 
 
Blood Sugar Meters 
 
Blood Sugar Diary 
 
Low Blood Sugar 
 
High Blood Sugar 
 
Your Diabetes Pills 
 
Diabetes Pills – Actions 
 
Medicines You Inject – Actions 
 
Let’s Get Moving 
 
Walking Works 
 
High Blood Pressure and Diabetes 
 
Cholesterol and Diabetes 
 
Diabetes Care Schedule 
 
The Nutrition Facts Label 
 
Healthy Cooking Tips 
 
Diabetes and Stress 
 
My Goal This Month 
 
ACP = American College of Physicians 
 
Diabetes Guides 
 
IDC = International Diabetes Center 
 
The Activity Pyramid 
 
The Life Balance Pyramid 
 
 
State Smoking Cessation Resources 
 
CA: http://www.nobutts.org/ 
 
MI: http://www.michigan.gov/healthymichigan/0,4675,7-216-33084_33091_33302---,00.html 
 
TX: http://www.yesquit.org 
 
 
 
 

 
 
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Appendix J – Screening Results Form [English] 
 
 
 
 
Thank you for having your blood sugar and/or hemoglobin A1c (A1C) checked here today.  Your A1C tells you 
what your average blood sugar was for the last three months.  If your A1C is high, you may have diabetes.  For 
people who already have diabetes, a common goal is to have an A1C close to 7%. 
 
Your blood sugar is: _____________ mg/dL  (normal is 70 – 160) 
Your A1C is: ________________ %   
 
 
[   ] This is normal (A1C 5.6% or less). 
[   ] This is a little high (A1C 5.7% - 6.4%).  You may have pre-diabetes.  We suggest you see your doctor 
to find out for sure whether you have pre-diabetes. 
[   ] This is high (A1C 6.5% or higher).  You may have diabetes.  We suggest you see your doctor to find 
out for sure whether you have diabetes. 
 
Your A1C test result is not a diagnosis of pre-diabetes or diabetes.  Only a doctor can tell you whether you 
have pre-diabetes or diabetes, or if your diabetes is well-controlled.  Please see the back of this form for 
information about community health care centers and additional food resources. 
 
 
 
 
(Site Specific Information) 
 
Food Resources 
 
Food Bank: 
 
SNAP: 
 
Special Nutrition Program for Women, Infants, and Children (WIC): 
 
Community Health Centers & Programs 
 
Clinic 1 
 
Clinic 2 
 
Clinic 3 
 
Clinic 4 
 
Local DPP 
 
Local DSME Program 
 
 

 
 
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Appendix K – Screening Results Form [Spanish] 
 
 
 
 
Gracias por haberse verificado los niveles de azúcar en la sangre y de hemoglobina A1c (A1C) hoy. Su A1C le 
dice su promedio del nivel de azúcar durante los últimos tres meses. Si su A1C es alto, es posible que usted 
tenga diabetes.  Para las personas que ya tienen diabetes, un objetivo común es tener un A1C cerca de 7%. 
 
El nivel de azúcar en su sangre es: ____________ mg/dL  (normal es 70 – 160)  
 
Su A1C es: ________________ % 
[   ]  Esto es normal (A1C 5.6% o menos). 
[   ]  Esto es un poco alto (A1C 5.7% - 6.4%).  Es posible que usted tenga pre-diabetes.  Le sugerimos 
que visite su doctor para averiguar si usted tiene pre-diabetes. 
[   ]  Esto es alto (A1C 6.5% o más alto). Usted puede tener diabetes.  Le sugerimos que visite su doctor 
para averiguar si usted tiene diabetes. 
Su A1C resultado de la prueba no es un diagnóstico de pre-diabetes o diabetes.  Solo un doctor le puede 
decir si tiene pre-diabetes o diabetes, o si su diabetes está bien controlada.  Por favor consulte la parte atrás 
de esta forma para información sobre centros comunitarios de salud y más recursos para comida.  
 
 
 
 (Site Specific Information) 
 
Recursos de Comida 
 
Banco de alimentos o despensa: Food Bank: 
 
SNAP (estampillas para comida):  
 
Programa de Nutrición Suplementar para Mujeres, Bebes, y Niños (WIC): 
 
Centros y Programas de Salud en la Comunidad 
 
Clinic 1 
 
Clinic 2 
 
Clinic 3 
 
Clinic 4 
 
Local DPP 
 
Local DSME Program 
 
 
 

 
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Appendix L – GE100 Blood Glucose Monitor User Manual 
 
(Refer to User Manual.) 
 
 
 
Appendix M – GE100 Getting Started Guide 
 
(Refer to Guide.) 
 
 
 
Appendix N – A1CNow+ Professional Procedure Guide 
 
(Refer to Procedure Guide.) 
 
 
 

 
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Appendix O – DRAFT Food Bank – Clinic MOU 
 
 
(Food Bank Logo) 
 
 
MEMORANDUM OF UNDERSTANDING 
 
THE XXX FOOD BANK 
Street Address 
City, State, Zip Code 
Phone, Fax 
and 
COMMUNITY HEALTH CENTER 
Street Address 
City, State, Zip Code 
Phone, Fax 
 
EFFECTIVE DATES: January 1, 2016 to December 31, 2017 
 
 
Part I: Introduction 
This Memorandum of Understanding between the XXX Food Bank, hereinafter referred to as the FOOD 
BANK, and the XXX Community Health Center, hereinafter referred to as The Organization, outlines 
policies and procedures related to the Feeding America Intervention Trial For Health - Diabetes 
Mellitus (FAITH-DM), an IRB-approved randomized controlled trial with an intervention that includes 
the distribution of healthy food boxes, fresh produce, and diabetes education to low-income, food 
insecure individuals ages 18 or older, and maintains a referral system with community health care 
organizations for clients diagnosed with or at risk for type 2 diabetes. 
 
Part II: Term and Termination 
This agreement shall be effective for the period from January 1, 2016 to December 31, 2017, and may 
be extended thereafter upon mutual consent of the parties in writing.  Either party may terminate this 
agreement by giving at least thirty (30) days written notice. This written notice will include closeout 
responsibilities, procedures, and timelines.  
 
The Food Bank and the Organization and its designated representative(s) agree to the guidelines and 
procedures set forth here: 
 
Part III: Description of Work: The Organization 
 

 
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Patient Referrals 
1. If the Organization accepts direct referrals, the FOOD BANK will refer clients directly to the 
Organization for a new patient appointment, or (if the client has already established care with the 
Organization) for a follow-up appointment using the following process: 
a. For food bank clients needing primary care who are referred from FOOD BANK to The 
Organization, The Organization agrees to attempt to contact clients within 2 weeks of 
receiving the referral from FOOD BANK in order to schedule a new patient appointment for 
the referred clients to be seen at The Organization. 
i. The Organization agrees to attempt to schedule new patient appointments for 
referred clients to take place within 3 months from date of referral. 
ii. For clients referred from the FOOD BANK with blood glucose results between 240 
mg/dL – 399 mg/dL, or HbA1c results 9.0% - 12.9%, The Organization agrees to 
attempt contacting the clients within 1 week of referral to schedule a new 
appointment that will take place within 1 month from the date of referral. 
iii. For clients referred from the FOOD BANK with a blood glucose result > 400 mg/dL, 
or with an HbA1c result > 13%, The Organization agrees to attempt contacting the 
client within 24-48 hours of referral to schedule a new appointment that will take 
place within 1 week from the date of referral. 
b. The Organization will identify a staff person(s) that can be contacted by FOOD BANK staff so 
that study staff can verify The Organization attempted to contact and schedule 
appointments with clients referred for care from the FOOD BANK. 
2. If the Organization does NOT accept direct referrals from any agency, then the FOOD BANK will 
provide clients needing care with written information, verbal instructions, and encouragement for 
the client to make a new appointment with their existing PCP or a new patient appointment at the 
Organization by using the Organization’s existing patient appointment scheduling process. 
3. The Organization can implement a process to identify any existing clinic patients who may be food-
insecure or at risk for food-insecurity, and who may benefit from resources organized and/or 
managed by the FOOD BANK. 
a. See attached document: FAITH-DM FI Clinical Training Brief for detailed information on how 
to screen patients for food insecurity and refer patients into the local hunger safety net. 
4. The Organization will refer clinic patients to the FOOD BANK via existing food bank protocols for 
referrals. 
5. NOTE: The Organization can NOT refer clinic patients directly into the FAITH-DM trial. 
a. For Organization patients with diagnosed type 2 diabetes referred from the clinic to the 
FOOD BANK, FAITH-DM staff will use existing study protocols to recruit and enroll clients 
into the FAITH-DM trial. 
6. When requested (but no more than quarterly), The Organization will provide FOOD BANK with data 
on referral processes and on FOOD BANK-referred clients that establish care with The Organization. 
 
 
Health Care Utilization Analysis 
7. The FAITH-DM study includes a Health Care Utilization (HCU) Analysis to examine health care 
utilization patterns for both treatment and control group participants.  Study participants will be 
asked to provide HIPAA Authorization and a Medical Records Release for their primary care 
providers (PCP) to release information from their medical records to FAITH-DM study staff. 

 
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8. The Organization will receive surveys to complete for their patients who are participating in the 
FAITH-DM study: 
a. HCUS: survey requesting patient visit information for a continuous twelve-month period (six 
months of visit information prior to the participant’s enrollment, and six months of visit 
information during the patient’s participation in the study) 
b. HCUS: follow-up survey requesting patient visit information for a six-month period after the 
patient’s participation in the intervention (if study is extended) 
9. The HCU surveys will have similar information requests that include: CPT and diagnostic codes for 
primary care visits, hospital admissions and discharges, Emergency Room admissions and 
discharges, missed primary care appointments, and other medical record information. 
10. The Organization agrees to complete all Health Care Utilization surveys for FAITH-DM study 
participants per project guidelines. 
a. Surveys are designed so that Medical Records and/or administrative staff can complete all 
surveys (no PCP time is required to complete surveys) 
b. For each study participant who is also a patient at the Organization, the FOOD BANK will 
send a survey packet to the Organization that includes: informational letter, provider 
survey, and instructions on how to complete the survey 
c. The Organization agrees to complete and return completed surveys to the FOOD BANK 
within 1 month of receiving the original request 
i. Specific instructions on how to return each survey (fax information, email 
information, etc.) will be included with each survey request sent by the FOOD BANK 
11. The Organization will track all surveys completed and returned to the FAITH-DM staff, and submit a 
quarterly invoice to the FOOD BANK for payment related to medical record data extraction requests. 
a. The Organization will receive $20 per completed survey / medical record extraction request 
 
 
Project Administration 
12. The Organization agrees to be listed in future publications as a participating partner site in the 
FAITH-DM study. 
 
 
Part IV: Description of Work: FOOD BANK 
Patient Referrals 
1. If the FOOD BANK accepts direct referrals from organizations: 
a. Upon receiving a patient referral from The Organization, the FOOD BANK will be responsible 
for contacting the patient per existing food bank protocols to assess eligibility for 
participation in any food bank or partner agency food program. 
b. The FOOD BANK will make at least three (3) attempts to contact the referred patient.  If the 
FOOD BANK is unable to contact the patient, or if the patient declines to participate in any 
food distribution / pantry program, then the referral will be closed and the FOOD BANK will 
notify The Organization that the referral was closed. 
2. FOOD BANK FAITH-DM staff will screen food bank clients for type 2 diabetes risk and control at 
existing food distribution sites using Point-of-Care blood glucose and HbA1c testing.  
3. If the Organization accepts direct referrals, the FOOD BANK will refer clients to The Organization 
who are assessed as being at risk (HbA1c result ≥ 5.7%) and who state they are without a primary 
medical provider. By identifying and referring these clients, the FOOD BANK aims to facilitate a 

 
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process for clients to establish medical care and receive follow-up evaluation regarding diabetes risk 
and/or health status. 
a. For food bank clients with an HbA1c result ≥ 9.0%, The FOOD BANK will refer clients to The 
Organization if they state they are without a primary medical provider (and live within The 
Organization’s service area), or if they state that they already receive care at The 
Organization. 
b. The FOOD BANK will complete a “Screening and Referral Form” indicating the dates of 
screenings, HbA1c and other screening results, and additional client information for food 
pantry clients not enrolled in the FAITH-DM trial (see attached document: FAITH-DM 
Screening and Referral Form) 
c. The FOOD BANK shall obtain client consent to share Protected Health Information (PHI) with 
The Organization. 
d. The FOOD BANK will fax completed referral forms to The Organization. 
4. If the Organization does NOT accept direct referrals from any agency, then the FOOD BANK will 
provide clients needing care with written information, verbal instructions, and encouragement for 
the client to make a new appointment with their existing PCP or a new patient appointment at the 
Organization by using the Organization’s existing patient appointment scheduling process. 
5. The FOOD BANK will implement an Emergency Action Plan if during a screening event, food 
distribution, or education activity, a client is identified as needing medical attention. In the event of 
a client emergency, FOOD BANK staff will implement study procedures, and/or contact 911 to 
activate the local emergency response system. 
6. In order to evaluate project effectiveness, the FOOD BANK will be tracking client data for the 
duration of the FAITH-DM study.  The FOOD BANK will comply with the Health Insurance Portability 
and Accountability Act (HIPAA) and existing laws and regulations regarding client privacy and 
Protected Health Information (PHI).  The FOOD BANK will maintain appropriate safeguards to secure 
PHI. 
 
Health Care Utilization Analysis 
7. FAITH-DM staff will obtain participant consent, HIPAA authorization, and a Medical Records release 
to receive patient medical record information from The Organization. 
8. FAITH-DM staff will send (via fax, mail, or hand delivery) The Organization patient-specific packets 
that include: background information on the project’s Health Care Utilization (HCU) Analysis, copy of 
patient’s HIPAA authorization and Medical Records release forms, and provider survey to be 
completed by The Organization’s staff. 
9. The FOOD BANK agrees to pay The Organization $20 for each medical record request fulfilled 
(completed survey). 
a. The FOOD BANK will submit payments to The Organization quarterly. 
 
Project Administration 
10. The FOOD BANK agrees to share any data and study results with The Organization, as long as the 
data and results are shared in formats and at times that adhere to FAITH-DM study guidelines. 
11. This memorandum supersedes all previous agreements, including scopes of works and timeframes 
included therein, between FOOD BANK and The Organization regarding participation in the FAITH-
DM study. 
 

 
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Part V: Signatures 
 
 
 
 
_______________________________________________________________________  
Name, Title 
 
 
 
 
 
 
 
Date 
Community Health Center 
 
 
 
 
 
_______________________________________________________________________ 
Name, Executive Director 
 
 
 
 
 
Date 
XXXXX Food Bank  
 
 
 
Documents: 
FAITH-DM Food Insecurity Training Brief 
FAITH-DM Screening and Referral Form  
 

 
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Appendix P – Food Insecurity Training Brief (for Clinic Partners) 
 
 
 
Clinical Training: Food Insecurity Screening 
Background 
The USDA defines food insecurity (FI) as a household-level economic and social condition of limited or 
uncertain access to adequate food. “Adequate” refers to the quantity or quality of food for all 
household members to maintain an active lifestyle at all times.  In contrast, hunger is an individual-level 
physiological condition (a physical discomfort from lack of food) that may result from food insecurity.1 
The USDA recognizes two levels of food insecurity, which they refer to as “low” and “very low” food 
security. Households reporting more severe difficulty accessing food—such as missing meals, losing 
weight, or going an entire day without eating—are considered very low food secure. 
 
Feeding America reports2: 
 
In 2013, 14.3% of U.S. households (17.5 million households) were food insecure 
 
In 2013, 49.1 million Americans lived in food insecure households (33.3 million adults and 15.8 million 
children) 
 
In 2013, 5.6% of households (6.9 million households) experienced very low food security 
 
In 2013, households with children reported food insecurity at a significantly higher rate than those 
without children, 19.5% compared to 11.9%  
 
In 2013, households that had higher rates of food insecurity than the national average included 
households with children (19.5%), especially households with children headed by single women (34.4%) or 
single men (23.1%), Black non-Hispanic households (26.1%) and Hispanic households (23.7%) 
 
In 2013, 5.4 million seniors (over age 60), or 9.0% of all seniors were food insecure 
 
(LOCAL DATA) According to the (NAME) Food Bank, 1 out of 6 (NAME) County residents are food 
insecure.  This translates to more than (NUMBER) residents in need of food assistance each month. 
 
Impact of Food Insecurity – Why Screen? 
Food insecurity is a major public health problem. Family members in food insecure households are more 
likely to report poorer health and depressive symptoms, and have higher risks for chronic diseases like 
obesity, hypertension, and diabetes.  Food insecure patients managing chronic diseases like diabetes are 
also more likely to have worse control (e.g., elevated HbA1c levels) potentially leading to poorer health 
outcomes.3  FI also negatively impacts children’s health and development status and increases risk for 
iron-deficiency anemia, acute infection, chronic illness,  hospitalization, and developmental and mental 
health problems.4,5  Identification of FI and referral to appropriate nutrition and support services can 
help to prevent illness, support patients in chronic disease management, and promote wellness. 
                                            
1 USDA Economic Research Service. 2013. Definitions of Food Security. Accessed at: 
http://www.ers.usda.gov/topics/food-nutrition-assistance/food-security-in-the-us/definitions-of-food-
security.aspx#.Uz8lwPldXTo 
2 Feeding America. 2014. Hunger and Poverty Statistics. Accessed at: http://feedingamerica.org/hunger-in-
america/hunger-facts/hunger-and-poverty-statistics.aspx  
3 Seligman et al. 2012. Food insecurity and glycemic control among low-income patients with type 2 diabetes. 
Diabetes Care,35,233-238. 
4 Seligman et al. 2010. Food insecurity is associated with chronic disease among low-income NHANES participants. 
J Nutr,140,304-310. 
5 Hager et al. 2010. Development and validity of a 2-item screen to identify families at risk for food insecurity. 
Pediatrics, 126, e26-e32. 

 
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Clinical Setting 
Screening for FI is appropriate and warranted in the clinical setting, especially in environments where a 
significant percentage of the patient population has been identified as low-income.  FI screening can be 
fast and incorporated as a standardized protocol into existing patient intake procedures.  Because food 
insecurity is often cyclical in nature with alternating periods of food access and food scarcity, screening 
should be included as a standard part of care during each patient visit.  Medical assistants, nursing 
assistants, nurses, and other clinical staff are all well-positioned to implement FI screening. 
 
Two-Item Food Insecurity Screener 
This 2-item FI screen is based on Questions 1 & 2 of the U.S. Household Food Security Survey and is 
sensitive (97%), specific (83%), and valid among low-income families with children.6  The FI screen 
quickly identifies households at risk for FI, enabling providers to target services that address the health 
and developmental consequences of FI. 
 
 
 
 
 
 
 
 
 
 
 
Implementation 
 
Utilize and train clinical staff (MA, CNA, RN) to conduct FI screening 
 
Screen every patient at every visit 
 
Include positive screen note for review and discussion by patient’s PCP, social worker, or other 
health care provider as part of visit 
 
Consider clinical assessment of health-related consequences of FI during patient visit 
 
Provide nutrition resources (for example, referrals to food banks and their partner food pantries 
or meal programs, the Supplemental Nutrition Assistance Program (SNAP, formerly known as 
food stamps), the Special Supplemental Nutrition Program for Women, Infant and (WIC) and 
senior feeding programs Assess for referrals and clinical action (dietitian, social worker, psych, 
vitamin supplementation) 
 
Use existing documentation processes and Electronic Health Records systems to track referrals 
and  individual and aggregate clinic data 
 
Resources 
Food Bank Referral Line: ###-###-#### & website:  
SNAP: (number, website, etc.) 
WIC: (number, website, etc.)  
USDA Food Insecurity: http://www.ers.usda.gov/topics/food-nutrition-assistance/food-security-in-the-
us.aspx#.U0gZGPldXTo 
                                            
6 Hager et al. 2010. Development and validity of a 2-item screen to identify families at risk for food insecurity. 
Pediatrics, 126, e26-e32. 
I’m going to read you two statements that people have made about their food situation. For each 
statement, please tell me whether the statement was often true, sometimes true, or never true for 
your household in the last 12 months. 
1. “We worried whether our food would run out before we got money to buy more.”  Was that 
often true, sometimes true, or never true for your household in the last 12 months? 
 
2. “The food that we bought just didn’t last and we didn’t have money to get more.”  Was that 
often, sometimes, or never true for your household in the last 12 months? 
 
A response of “often true” or “sometimes true” to either question = positive screen for FI. 

 
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Appendix Q – GE100 Quality Control Log 
GE100 Quality Control Log 
Site: 
 
Project Lead: 
 
STAFF 
INITIALS 
DATE 
TEST 
NAME 
TEST LOT NUMBER 
/ EXPIRATION DATE 
NORMAL LEVEL CONTROL 
COMMENTS 
 
 
GE100 
(Blood 
Glucose) 
 
Range: 
Result: 
 
 
 
GE100 
(Blood 
Glucose) 
 
Range: 
Result: 
 
 
 
GE100 
(Blood 
Glucose) 
 
Range: 
Result: 
 
 
 
GE100 
(Blood 
Glucose) 
 
Range: 
Result: 
 
 
 
GE100 
(Blood 
Glucose) 
 
Range: 
Result: 
 
 
 
GE100 
(Blood 
Glucose) 
 
Range: 
Result: 
 
 
 
GE100 
(Blood 
Glucose) 
 
Range: 
Result: 
 
 
 
GE100 
(Blood 
Glucose) 
 
Range: 
Result: 
 
 
 
GE100 
(Blood 
Glucose) 
 
Range: 
Result: 
 
 
 
GE100 
(Blood 
Glucose) 
 
Range: 
Result: 
 
 
 
GE100 
(Blood 
Glucose) 
 
Range: 
Result: 
 
 
 
GE100 
(Blood 
Glucose) 
 
Range: 
Result: 
 
 
 
GE100 
(Blood 
Glucose) 
 
Range: 
Result: 
 
**Form adapted from: http://wwwn.cdc.gov/clia/Resources/WaivedTests/pdf/14_248840-
A_Stang_RST_Booklet_508.pdf  
NOTES: 
 

 
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Appendix R – A1C+Now Quality Control Log 
 
Site: 
Project Lead: 
 
Staff 
Initials 
Date 
Test Name 
Test Lot Number / 
Test Expiration Date 
Level 1 Control 
Level 2 Control 
Comments 
 
 
A1C+Now 
(HbA1c) 
 
Lot #: 
Range: 
Result: 
Lot #: 
Range: 
Result: 
 
 
 
A1C+Now 
(HbA1c) 
 
Lot #: 
Range: 
Result: 
Lot #: 
Range: 
Result: 
 
 
 
A1C+Now 
(HbA1c) 
 
Lot #: 
Range: 
Result: 
Lot #: 
Range: 
Result: 
 
 
 
A1C+Now 
(HbA1c) 
 
Lot #: 
Range: 
Result: 
Lot #: 
Range: 
Result: 
 
 
 
A1C+Now 
(HbA1c) 
 
Lot #: 
Range: 
Result: 
Lot #: 
Range: 
Result: 
 
 
 
A1C+Now 
(HbA1c) 
 
Lot #: 
Range: 
Result: 
Lot #: 
Range: 
Result: 
 
 
 
A1C+Now 
(HbA1c) 
 
Lot #: 
Range: 
Result: 
Lot #: 
Range: 
Result: 
 
 
 
A1C+Now 
(HbA1c) 
 
Lot #: 
Range: 
Result: 
Lot #: 
Range: 
Result: 
 
 
 
A1C+Now 
(HbA1c) 
 
Lot #: 
Range: 
Result: 
Lot #: 
Range: 
Result: 
 
 
 
A1C+Now 
(HbA1c) 
 
Lot #: 
Range: 
Result: 
Lot #: 
Range: 
Result: 
 
 
 
A1C+Now 
(HbA1c) 
 
Lot #: 
Range: 
Result: 
Lot #: 
Range: 
Result: 
 
 
 
A1C+Now 
(HbA1c) 
 
Lot #: 
Range: 
Result: 
Lot #: 
Range: 
Result: 
 
 
 
A1C+Now 
(HbA1c) 
 
Lot #: 
Range: 
Result: 
Lot #: 
Range: 
Result: 
 
 
 
A1C+Now 
(HbA1c) 
 
Lot #: 
Range: 
Result: 
Lot #: 
Range: 
Result: 
 
 
 
A1C+Now 
(HbA1c) 
 
Lot #: 
Range: 
Result: 
Lot #: 
Range: 
Result: 
 
 

 
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Appendix S – Medical Waste Tracking Log 
 
 
 
Medical Waste Tracking Log 
OFF-SITE TREATMENT 
 
Facility Name: 
Facility Address: 
Program Contact: 
 
START DATE 
CONTAINER 
DATE FULL 
DATE 
SHIPPED 
MEDICAL 
WASTE CO. 
DATE 
TREATED 
STAFF 
INITIALS 
(Example) 
09/12/15 
1-gallon 
sharps 
10/21/15 
10/25/15 
SHARPS 
Compliance, Inc. 
11/09/15 
JD 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NOTES: 

 
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Appendix T – The Informed Consent Process  
(Adapted from Western Institutional Review Board, “Guide for Researchers 3/9/2015”) 
  
The informed consent process is central to the ethical conduct of research.  It is an 
ongoing conversation between the human research subject and the researchers that 
begins before consent is given and continues until the end of the subject’s involvement 
in the research (see consent process diagram, below).  There are various tools for the 
investigator to use to optimize this conversation, but the most important feature of 
informed consent is the investigator commitment to the process.  
  
A. Goals of the informed consent process: 
• 
Give the subject information about the research  
• 
Make sure the subject has time to consider all options  
• 
Answer all of the subject’s questions before the decision is made  
• 
Make sure that all information is understood by the subject  
• 
Obtain the subject’s voluntary informed consent to participate  
• 
Continue to inform the subject throughout the research study  
• 
Continue to re-affirm subject consent to participate throughout the 
research study  
  
B. Consent Process Diagram  
  
 
Market 
  Ongoing discussion interaction during study 
visits 
 
  
 C. Tools an investigator might use to assist the informed consent process  
• 
Consent Form -- also called Informed Consent Form (ICF), Informed Consent 
Document (ICD) or Patient Consent Form (PCF)*  
Initial Consent 
Recruitment 
Process 
New Risk 
Information 
Loss or Gain of 
Subject Capacity to 
Consent 
Consent Form 
Change in 
Research 
e.g., Procedures, 
Visits 
Change in Drug 
Status 
e.g. Approval, 
Withdrawn from 
Study 
Extension 
End of Study 
Follow-up 
e.g., Lifetime for 
Gene Transfer or 
Cancer Studies 
Long Term 
? 

 
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• 
Pamphlets or other reading materials*  
• 
Internet information*  
• 
Instruction sheets*  
• 
Audio-visual presentations*  
• 
Charts or diagrams*  
• 
Discussions  
• 
Consultation with others  
  
* These items require IRB review before use.  
  
D. Investigator responsibilities in regard to informed consent 
• 
Obtain consent before initiating study-specific procedures.   
• 
Provide a quiet, comfortable, and private setting for the informed consent 
process whenever possible.  
• 
Explain the consent process to the subject.  
• 
Make sure the subject has time to consider all options; allow subject to take 
the form home before signing (whenever possible).  
• 
Consider the subject’s reading abilities.  Check to make sure the protocol 
does not exclude subjects unable to read.  If enrollment of limited or 
nonreaders is allowed, involve an impartial witness in the informed consent 
process.  WIRB has posted a standard generic form you can use to document 
the involvement of an impartial witness if your approved consent form lacks 
the necessary signature block for that; see the Download Forms page of 
www.wirb.com for the document titled “Impartial Witness form for Limited and 
Non-Readers.”  
• 
Answer all questions.  
• 
To the extent possible, make sure the subject understands enough 
information about the research study to give informed consent.  
• 
To the extent possible, make sure the subject can consent free from 
coercion or other undue influence.  
• 
Since the informed consent process continues throughout the subject’s 
participation in the study, consent should be informally verified on a 
continuing basis.  
• 
Significant new information must be given to the subject, and continuing 
consent documented in some way; for example, new risk information 
presented to the subjected in an addendum to be signed by subjects who 
agree to continue to participate.   
  
E. Issues to consider during the consent process 
• 
Was the subject alert and, in your opinion, able to read and understand the 
language in the consent form?  
• 
If the subject was unable to read the consent form, and limited or non-readers 
were allowed to participate, did you have an impartial witness present for the 

 
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entire process?  (An impartial witness is someone with adequate reading 
ability who is independent of the trial, who cannot be unfairly influenced by 
people involved in the trial, who attends the informed consent process while 
the consent form is being read to the subject, who reads the informed 
consent form and any other written information supplied to the subject, and 
who is  
willing to attest to this by signing the consent form.)  
• 
If the subject is not fluent in English, was an approved translation of the 
consent form provided in the primary language of the subject?  Was there 
also a bilingual translator present to assist with the informed consent 
process?  Note: a translator alone is not considered adequate.   
• 
Was the subject under any pressure (for example, family pressure, lack of 
medical insurance) to participate in the research?  Was this discussed?  
• 
Did the subject take time to carefully read the consent form, or read it along 
with you?  
• 
Were the risks as set forth in the consent form carefully explained to the 
subject?  
• 
Are there any other risks or concerns not stated in the consent form and were 
these explained to the subject?  
• 
Was the subject asked if he or she had any questions about the study?  
 Did the subject have any questions or concerns?  
 Were the subject’s questions answered?  
 Was the subject satisfied with the answer(s) they were provided?  
• 
Did the person conducting the consent discussion check for subject 
understanding by asking some basic questions about the research?  Did the 
responses reflect adequate understanding?  
• 
Did the subject express a clear decision to proceed with the study?  
• 
Was the consent form signed by the person who conducted the informed 
consent discussion?  
• 
Was the consent form signed by a witness (if required)?  
• 
Was the consent form signed by the Principal Investigator (if required)?  
• 
If a Legally Authorized Representative is allowed to sign for the subject, were 
additional concerns about the subject’s understanding and assent considered 
and addressed?  
  
F. Consent by Legally Authorized Representatives  
The laws regulating who can consent for adults who lack the capacity to consent for 
themselves are defined at the state level and vary from state to state.  Persons who can 
consent for adults who lack the capacity to personally provide informed consent are 
known as Legally Authorized Representatives (LARs).  See 45 CFR 46.102(c) and 21 
CFR 50.3(l).  Such trials, unless an exception is justified, should be conducted in 
individuals having a disease or condition for which the investigational product is 
intended.  
  

 
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WIRB’s initial review submission forms solicit information about plans for use of LARs 
from investigators who plan to enroll adults who lack the capacity to consent for 
themselves.  Sites should be able to explain how they determine which individuals meet 
the criteria for being a Legally Authorized Representative (LAR) under their 
state/provincial and local law.  WIRB can provide a copy of the relevant statutes for 
your state upon request; however, advice from your legal counsel is strongly 
recommended.  Sites should also be able to explain the process they use for verifying 
that an individual is qualified to serve as an LAR.  
 
 
 
 

 
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Appendix U – Participant Baseline Survey 
 
(See attached survey.) 
 
 
 
Appendix V1 – Participant T6 Follow-Up Survey, Intervention Group 
 
(See attached survey.) 
 
 
 
Appendix V2 – Participant T6 Follow-Up Survey, Control Group 
 
(See attached survey.) 
 
 
 
Appendix W1 – Participant T12 Follow-up Survey, Intervention Group 
 
(See attached survey.) 
 
 
Appendix W2 – Participant T12 Follow-up Survey, Control Group 
 
(See attached survey.) 
 
 
 
 
 

 
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Appendix X – HIPAA Authorization Form 
 
(See attached form.) 
 
 
 
Appendix Y – Health Care Utilization Provider Letters (1-8) 
 
(See attached documents.) 
 
 
 
Appendix Z – Health Care Utilization Survey (HCUS) 
 
(See attached survey.) 
 
 
 
 
 
 
 
 
 

 
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Appendix AB – HIPAA Fax Cover Sheet 
 
 
 
 
 
HEALTH INFORMATION 
FAX COVER SHEET 
 
Date: _________________________ 
 
 
From: _____________________________________________________________ 
 
Fax #: _________________________  
Phone#: _______________________ 
 
Cover Sheet plus ________ pages 
 
Comments: 
 
 
TO: _______________________________________________________________ 
 
 
Fax #: _________________________  
 
 
IMPORTANT: This facsimile transmission contains confidential information, some or all of which may be 
protected health information as defined by the federal Health Insurance Portability & Accountability Act 
(HIPAA) Privacy Rule. This transmission is intended for the exclusive use of the individual or entity to 
whom it is addressed and may contain information that is proprietary, privileged, confidential and/or 
exempt from disclosure under applicable law. If you are not the intended recipient (or an employee or 
agent responsible for delivering this facsimile transmission to the intended recipient), you are hereby 
notified that any disclosure, dissemination, distribution or copying of this information is strictly 
prohibited and may be subject to legal restriction or sanction. 
 
If you have received this transmission in error, please notify the sender by telephone (number listed 
above) to arrange the return or destruction of the information and all copies. 
 
 
 
 

 
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Appendix AC – FAITH-DM DSME Program Curriculum 
 
 
(See attached materials.) 
 
 
 
 

 
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Appendix AD – Education Class Reminder Postcard 
 
 
 
 

 
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Appendix AE – FAITH-DM Informed Consent Form 
 
(See attached form.) 
 
 
 

 
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Appendix AI – FAITH-DM Screening and Referral Form 
 
 
Screening and Referral Form 
 
Date: ___________________________ Client Name: _________________________________________ 
Date of Birth: _____________________ Client Phone: _________________________________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
A. Health Screening 
 
Blood Glucose: ____________ mg/dL      Fasting     Random 
 
HbA1c: _____________ %    (Finger-stick sample A1CNow+ 
System) 
 
 
Client-Reported Health History:    
 Pre-DM   
 GDM  T1DM   
 T2DM                          
 No known history of diabetes 
 
 
 
Has healthcare source or PCP? 
 Yes 
 No 
 
Clinic / Practice Name: __________________________________ 
 
PCP Name: __________________________________________ 
 
 
 
 
Food Bank  
Referring Staff Name: __________________________________ 
 
Referring Staff Phone: __________________________________ 
 
 
 
 
NOTES: 
B. Referral 
  Referral from Food Bank to clinic / provider: 
 _______________________________________ 
 
  Other (e.g., Emergency Room referral): 
_______________________________________ 
 
Preferred Language 
  English        Spanish        Other: 
 
Client Consent to Release Information: 
I give my consent to the (NAME) Food Bank to share 
information about my screening results and the 
other information on this form with my doctor or a 
health care center.  
 
Doy mi consentimiento para el (NAME) Food Bank 
para compartir información sobre los resultados de 
mis pruebas y el otro información en esta forma con 
mi médico o un centro de salud. 
 
 
________________________________________ 
Client Signature / Firma  
 
 
________________________________________ 
Date / Fecha 
Food Bank 
FAITH-DM Manager:  
Street, City, State, Zip 
T: ###-###-####; Fax: ###-###-#### 
Email:

 
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Appendix AJ – Sample Recruitment Flyer 
 
 
 
 
 
RESEARCH STUDY 
 
The [Food Bank] has partnered with Feeding America, the University of California San 
Francisco, and the Urban Institute to conduct a 2-year research study looking at how food bank 
programs may be able to help adults living with type 2 diabetes.  We are now recruiting people 
to participate in the study. 
 
Who is eligible? 
Adults (18 years old and up) 
Have type 2 diabetes 
Food pantry client 
Speak English or Spanish 
Will stay in the study area for at least the next year 
 
What will you be asked to do? 
Complete 3 surveys over the next 12 months (each survey takes about 30 minutes) 
Do blood sugar and A1c tests 4 times over 12 months (using a drop of blood from your finger) 
Pick up 2 free healthy food boxes a month for 6 months 
You may be asked to attend 2 group diabetes classes (2 hours each) 
 
Compensation 
You will receive $45 in gift cards for participating in this study. 
 
If you have any questions or are interested in participating, please contact: 
Food Bank FAITH-DM staff at (###) ###-#### 
 
FAITH-DM Research Study 
Phone: (###) ###-#### 
FAITH-DM Research Study 
Phone: (###) ###-#### 
FAITH-DM Research Study 
Phone: (###) ###-#### 
FAITH-DM Research Study 
Phone: (###) ###-#### 
FAITH-DM Research Study 
Phone: (###) ###-#### 
FAITH-DM Research Study 
Phone: (###) ###-#### 
FAITH-DM Research Study 
Phone: (###) ###-#### 
FAITH-DM Research Study 
Phone: (###) ###-#### 
FAITH-DM Research Study 
Phone: (###) ###-#### 
FAITH-DM Research Study 
Phone: (###) ###-#### 
FAITH-DM Research Study 
Phone: (###) ###-#### 
FAITH-DM Research Study 
Phone: (###) ###-#### 
FAITH-DM Research Study 
Phone: (###) ###-#### 
Food Bank 
Logo 

 
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Appendix AK – Education Handouts for Screening 
 
 
 
 
Education Handouts for Screening 
 
Notes: 
 
Every food bank client who participates in blood glucose and/or A1C screening will receive a 
“Screening Results Form” that includes testing results, local health care information, and local 
food resource information 
 
For clients who enroll in study, see FAITH-DM Passive Education Materials Schedule for 
education materials that participants receive 
 
SCREENING CATEGORY 
RESOURCE 
NOTES 
Food bank clients with no diabetes 
history and normal blood glucose 
results 
 
No additional educational resources  
 
Clients with elevated BG results 
(≥140 mg/dL fasting or ≥160 mg/dL 
random), but with an A1C result 
that is < 5.7% 
USDA MyPlate Handout (Learning Zone 
Express) 
https://www.learningzonexpress.com/p-
1386-usda-myplate-handouts.aspx 
 
English, Spanish 
2-sided tear pad (8.5 x 11) 
$11.95 per 50 sheets 
($0.24/ea.) 
 
Clients with an A1C result in pre-
diabetes range (5.7% - 6.4%) 
“All About Your Risk for Pre-diabetes, 
Type 2 Diabetes, and Heart Disease” 
(ADA resource) 
 
-AND- 
 
Diabetes MyPlate Handouts (Learning 
Zone Express) 
https://www.learningzonexpress.com/p-
1708-diabetes-myplate-handouts.aspx  
 
English, Spanish 
2-sided 8.5 x 11; requires FB 
sites to print 
 
 
 
English, Spanish 
2-sided tear pad (8.5 x 11) 
$11.95 per 50 sheets 
($0.24/ea.) 
 
Clients with an A1C result of 6.5% - 
7.4% (diabetes, controlled) 
“Taking Care of Type 2 Diabetes” (ADA 
resource) 
 
-AND- 
 
Diabetes MyPlate Handouts (Learning 
Zone Express) 
https://www.learningzonexpress.com/p-
1708-diabetes-myplate-handouts.aspx  
 
English, Spanish 
2-sided 8.5 x 11; requires FB 
sites to print 
 
 
English, Spanish 
2-sided tear pad (8.5 x 11) 
$11.95 per 50 sheets 
($0.24/ea.) 
 
Clients with an A1C result ≥ 7.5% 
(but who do not enroll in study for 
whatever reason) 
ACP Living With Diabetes Guides 
English, Spanish 
60-page printed booklet 
$64 per box of 40 ($1.60/ea.) 
 

 
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Appendix AL – Participant Compensation Receipt Form 
 
 
Participant Compensation Receipt Form 
 
Date / Fecha: _________________________ 
 
Participant Name / Nombre de Participante: _____________________________________________ 
Activity / Actividad:  survey / encuesta 
 
I CERTIFY THAT I HAVE RECEIVED A GIFT CARD FROM THE XXXX FOOD BANK IN THE AMOUNT OF $ 
______ FOR MY PARTICIPATION IN THE FAITH-DM PROJECT.  THE GIFT CARD HAS BEEN GIVEN TO ME IN 
PERSON DURING OR AFTER THE RESEARCH ACTIVITIES IN WHICH I PARTICIPATED. 
CERTIFICO QUE HE RECIBIDO UNA TARJETA DE REGALO DE LA XXXX BANCO DE ALIMENTOS POR LA 
CANTIDAD DE $ _______ POR MI PARTICIPACIÓN EN EL PROYECTO FAITH-DM. LA TARJETA REGALO HA 
DADO A MÍ EN PERSONA DURANTE O DESPUÉS DE LAS ACTIVIDADES DE INVESTIGACIÓN EN LA QUE 
PARTICIPÉ. 
 
SIGNATURE OF PARTICIPANT /  
FIRMA DE PARTICIPANTE 
 ______________________________________________________________________ 
 
 
ALTERNATE CERTIFICATION  
TO BE USED WHEN OBTAINING PARTICIPANT SIGNATURE IS NOT POSSIBLE: I CERTIFY THAT THE ABOVE NAMED STUDY 
PARTICIPANT COMPLETED THE STUDY ACTIVITY AND IS DUE PAYMENT OF $ __________________.  A GIFT CARD WILL BE 
ISSUED AND MAILED TO THE PARTICIPANT’S HOME ADDRESS OR GIVEN IN PERSON TO THE PARTICIPANT. 
 
 
Signature of FAITH-DM study staff person ________________________________________________________ 
 
 
Date gift card mailed: _______________________________________ 
 
INSTRUCTIONS 
Study participants should be asked to sign this form for each study survey they complete.  Per FAITH-DM study protocols, Control Group 
participants will receive a $15 gift card after completing the baseline survey, and a second $15 gift card after completing the T6 follow-up 
survey.  Intervention Group participants will receive $30 in gift cards after completing the T6 follow-up survey.  Participants in both groups will 
receive a final $15 gift card upon completion of the T12 follow-up survey. 
 

 
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Appendix AM – Participant Baseline Enrollment Form 
Participant Baseline Enrollment Form 
Item 
Data 
Notes 
Interviewer’s initials 
 
 
Participant ID 
 
 
Date Enrolled 
 
 
Enrollment site / pantry name 
 
 
Baseline HbA1c result (%) 
 
 
Household size 
 1 – 2            3 – 4          5+ 
 
Age Category 
 18 – 40            41 – 60          61+ 
 
Date of Birth 
 
 
Preferred Language 
 English              Spanish 
 
Consent signed   
 Yes 
 
Participant given copy of consent 
 Yes 
 
HIPPA release signed  
 Yes 
 
Medical Records release signed 
 Yes 
 
Baseline survey complete 
 Yes 
Timing: 
Randomization assignment given 
 Intervention              Waitlist control 
 
Gift card given and receipt signed 
 (Waitlist control only) 
 
Referral given 
 Active (Int.)           Passive (Control) 
 
Participant name (First, Middle, Last) 
 
 
Mailing Address 
 
 
OK to send mail?  
Cellphone 
 Yes:  
OK to text?  
OK to leave VM?  
      Any     Non-confid. 
Email 
 Yes: 
OK to send email?  
      Any     Non-confid. 
Name of friend / spouse we can contact: 
 
Relation: 
Phone number of friend or spouse: 
 
OK to call & lv. msg?  
      Any     Non-confid. 
Is there another person we can contact: 
 
Relation: 
Phone number of 2nd contact: 
 
OK to call & lv. msg?  
      Any     Non-confid. 
Primary care provider name 
 
Or No PCP  
PCP Clinic name 
 
 
Clinic address 
 
 
Clinic phone 
 
 

 
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Appendix AN – Adverse Event Reporting Form 
 
ADVERSE EVENT REPORTING FORM 
Date: ________________________________ 
 
Site: 
 ACCFB  
 GCFB  
 HFB 
 
Pantry Site / Location: 
 
Person completing form: 
 
List of people involved in incident: 
 
 
If incident involves a pantry client, does the client report a history of diabetes?  
 Yes 
 No 
If incident involves a pantry client, is the client a participant in the study? 
 
 Yes 
 No 
 
 
If “Yes”, Participant ID#: ___________________________________ 
 
Adverse Event: 
 Low blood glucose (hypoglycemia: report and treat clients reporting a diabetes history) 
 High blood glucose (hyperglycemia: report only when action is required for symptomatic clients) 
 Reports of suicidality or homicidality 
 Reports of elder abuse or neglect 
 Reports of poor food quality 
 Study related injury 
 Other: 
 
Description of Incident: 
 
 
 
 
Action Taken: 
 
 
 
 
Follow-up Action Required: 
 
 
 
 
Date Reported to Study Coordinating Center (Morgan Smith, FANO): ___________________________________________ 
 
Date Entered in MS Access (if event involved study participant): _______________________________________________ 
 
 

 
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Appendix AO – Medical Records Release Form 
 
AUTHORIZATION TO RELEASE/REQUEST MEDICAL INFORMATION  
Name of Patient: ______________________________________________________________ 
Maiden/Other Name: ___________________________________________________________ 
Date of Birth: _______________________  Phone Number: ____________________________ 
Patient Address:_______________________________________________________________ 
City, State, Zip: _______________________________________________________________ 
I authorize the following person/organization to release the health information described 
on this form:______________________________________________________________ 
Address: ____________________________________________________________________ 
City, State, Zip: _______________________________________________________________ 
Phone_______________________________________ Fax ____________________________ 
Who can receive and use this information?: 
<Insert Food Bank Name, Address, Fax #, Phone # and Contact Person> and 
the FAITH-DM study 
Specific type of information to be disclosed:
___Office Visit dates and summary 
___History & Physical 
___Inpatient hospitalization summary 
___Emergency Room Discharge Summary  
___Diabetes Care summary 
___Insurance/Payor Information 
___Other _________________
 
Dates of requested information: From ___________________ To  _____________________  
The purpose and need for disclosure: This individual is enrolled in a diabetes research study 
with <insert name of food bank>, Feeding America, University of California San Francisco, and 
Urban Institute.  Medical information will be used as part of the study’s health care utilization 
analysis. 

 
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Your initials are required to release the following information: 
______Mental Health Records (excluding psychotherapy)  
______Drug, Alcohol, or Substance Abuse Records  
______Genetic Information (including Genetic Test Results)  
______ HIV/AIDS Test Results/Treatment 
 
Right to Revoke: I understand that I have a right to revoke this authorization at any time. I understand that if I revoke 
this authorization, I must do so in writing and present my written revocation to the person/organization listed as authorized 
to release my records. They may have already released the information based on your original authorization. The 
releasing organization cannot release any additional information after receiving your revocation. Neither the releasing 
organization nor <insert name of food bank> will condition treatment or payment based on this authorization or 
revocation of authorization unless otherwise allowed by law.  
Effective Time Period: Your protected health information will be disclosed as specified in this authorization. This 
authorization will expire after 36 months from the date of signature, or until we have completed the disclosure(s) you have 
requested, whichever is shorter. Research institutions that receive federal funds, such as the research institutions 
associated with the FAITH DM project (The Urban Institute and The University of California San Francisco) are prohibited 
from re-disclosing your information to others without your permission.  If you have given permission for release of 
information to others not covered by federal or state privacy laws, the information could be subject to re-disclosure by the 
recipient and may then no longer be protected. 
 
_______________________________________________________________ 
Name of Patient/Personal Representative (please print) 
_______________________________________________________________ 
Signature of Patient/Personal Representative  
 
 
 
 
Date  
 
 
 
 
 
 
 
 
 
 
 

 
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Appendix AP – HCUA Flowcharts 
 
 
 
 
 
 
 
 
 

 
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Appendix AQ – Study Flow Handout 
 
 
 
 
 
How a Participant Moves through the FAITH-DM Study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Food Pantry Client Screened 
 
Does client have uncontrolled type 2 diabetes (HbA1c ≥ 7.5%)? 
 
Does client meet study entry criteria? 
 
Does client want to participate in the study? 
If “Yes” to all, client: 
 
Completes consents to participate 
 
Completes baseline survey 
 
Randomly assigned to either: 
o Intervention Group or Waitlist Control Group 
Intervention Group 
 
Participant begins receiving diabetes food 
packages immediately 
o 2 times a month for six months 
 
Participant receives diabetes education 
o Handouts with each food package 
o Monthly group classes 
o Check-ins with staff at the pantry 
 
Participant referred to a doctor (if needed) 
 
Participant receives monitoring of HbA1c 
Intervention Group 
 
After six months, participant completes 
blood test (HbA1c) and second survey 
 
At 12 months, participant completes final 
HbA1c test and last survey 
 
Participant exits study 
Waitlist Control Group 
 
Participant receives normal pantry services 
for six months 
Waitlist Control Group 
 
After six months, participant completes 
blood test (HbA1c) and second survey 
 
Waitlist period over; participant begins 
program (modified intervention) 
Waitlist Control Group 
 
Participant begins receiving diabetes food 
packages 
o 2 times a month for six months 
 
Participant receives diabetes education 
o Handouts with each food package 
 
Participant referred to a doctor (if needed) 
 
Participant receives monitoring of HbA1c 
Waitlist Control Group 
 
At 12 months from enrollment participant 
completes final HbA1c test and last survey 
 
Participant exits study 

 
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Appendix AR – Screening Supplies 
 
 
 
 
 
Screening Supplies 
 
Document Box  
 
 
 
 
 
Quantity (2 screeners) 
1. Screening Log  
 
 
 
 
20 
2. Screening Results (E/S)  
 
 
 
100 each 
3. Screening and Referral Form (for non-participants) 
20 
4. Education handouts 
a. Matrix (for study staff)  
 
 
2 
b. MyPlate (E/S)  
 
 
 
25 each 
c. ADA Risk handout and DM MyPlate (E/S) 
10 each 
d. ADA T2DM handout and DM MyPlate (E/S) 
10 each 
e. ACP Guides (E/S) 
 
 
 
10 each 
5. Participant Enrollment Form (paper) 
 
 
20 each 
6. Study Informed Consent Forms (E/S) 
 
 
20 each 
7. Medical Record Release Form 
 
 
 
20 
8. Randomization envelopes 
 
 
 
20 
9. Participant Compensation Receipt Form  
 
20 
10. MISC Forms 
a. Recruitment Flyers (E/S) 
 
 
5 each 
b. Protocol Deviation Form 
 
 
5 
c. Adverse Event Reporting Form  
 
5 
d. Passive Education Schedule 
 
 
2 
e. GE100 QC Log  
 
 
 
1 
f. A1C+Now QC Log 
 
 
 
1 
g. Medical Waste Tracking Log 
 
 
1 
h. Copy of CLIA certificate of waiver 
i. 
Copy of medical waste certificate (if applicable) 
 
 
 
 

 
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Testing Supplies Boxes  
Quantity (2 screeners)  
 
Vendor 
A1C+Now Kits  
 
4 boxes (20 tests/box)  
 
WM 
GE100 Meters  
 
4 meters 
 
 
 
GE 
Testing strips 
 
 
4 boxes (50/box) 
 
 
GE 
Sharps containers 
 
3 each (1 gallon) 
 
 
SC 
Hand Sanitizer  
 
3 each  
 
 
 
AM 
Nitrile Gloves 
 
 
3 boxes  
 
 
 
AM 
Alcohol prep pads 
 
2 boxes  
 
 
 
AM 
Cotton balls 
 
 
3 qt. zip lock bag (50 each) 
 
AM 
Lancets, 28G 
 
 
1 box (200) 
 
 
 
AM 
Lancets, 21G 
 
 
1 box (200) 
 
 
 
AM 
Band-Aids 
 
 
1 box (50) 
 
 
 
AM 
Sani-wipes 
 
 
1 each  
 
 
 
AM 
Dental Bibs 
 
 
100 each 
 
 
 
Amazon 
Dex4 Glucose Tabs 
 
10 each (10 count tubes) 
 
Amazon 
Boxes (e.g., wine) 
 
2 
 
 
 
 
misc. (for trash) 
Trash bags 
 
 
4 
 
 
 
 
misc. 
 
 
Vendor Key & Ordering Information 
1. WM: Whitmire Medical, http://www.whitmiremedical.com/, Michael R. Falck, michael@whitmiremedical.com, 
206.898.7444,  
2. GE: GE Diabetes (Bionime Corporation), www.gediabetes.com, Katie Enright, Sales Representative, 
919.451.0865, katie.enright@bionime.com 
3. SC: Sharps Compliance, Inc., http://www.sharpsinc.com/, http://www.sharpsinc.com/store/medical-waste-
recovery 
a. Three 1-gallon sharps recovery system: http://www.sharpsinc.com/store/three-1-gallon-sharps-
recovery-system-94  
4. AM: Allegro Medical, http://www.allegromedical.com/  
 
 
 
 
 
 
 

 
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Appendix AS – Cognitive Impairment Assessment Tool 
 
 
 
 
 
Cognitive Impairment: Decision-Making Capacity Assessment Tool 
 
 
 
 
 
 
 
 
Potential Participant Name: __________________________________________ 
 
ASSESSMENT QUESTIONS: 
1. Does the individual understand he/she would be participating in research and that research is voluntary? 
  Yes          No 
2. Does the individual understand what will happen to him/her if he/she decides to participate? 
  Yes          No 
3. Does the individual know how long he/she will be in the research study? 
  Yes          No 
4. Can the individual explain one or two risks associated with the research study? 
  Yes          No 
5. Can the individual explain what he/she should do to stop being in this research study? 
  Yes          No 
6. Does the individual know who to contact if he/she experiences problems or has questions about the study? 
  Yes          No 
7. Can the individual explain what alternatives there are if he/she chooses not to participate? 
  Yes          No 
 
STUDY STAFF EVALUATION: 
8. Does the individual express a choice about whether or not to participate? 
  Yes          No* (Not eligible for study) 
9. Does the individual have the decision-making capacity to give informed consent for this study? 
  Yes          No* (Not eligible for study) 
 
_____________________________________________________________________________________ 
Printed Name of Study Staff 
 
Signature of Study Staff  
 
 
Date 
 
* NOTE: Potential participants who are found to have diminished capacity must be excluded from the study; document “ineligible 
due to cognitive impairment” in MS Access database and file this form in study binder. 
 
 
 
Instructions: This form may be used to assess the decision-making capacity of potential participants who may 
have or may be experiencing cognitive impairments. 
Who should assess capacity? In general, the consent assessor should be a member of the research team or 
consultant familiar with dementias and/or cognitive impairment, and qualified to assess and monitor capacity 
to consent on an ongoing basis. 

 
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Appendix AT – Data Collection Best Practices 
 
Data Collection Best Practices 
Compiled by Shavonnea Brown, MA, in November 2015 
FAITH-DM Research Assistant at the Gleaners Community Food Bank (Detroit, MI) 
1. Keep all forms organized  
a. Each form that has to be entered into Access should have its own folder  
b. Once each form has been completed put it into its respective folder—this reduces the risk of losing 
information  
c. As data is entered from each form keep a checklist of what has been entered  
2. Familiarity with forms  
a. Give a brief demonstration to staff and volunteers about the purpose of each form  
b. Ensure that all staff and volunteers are familiar with each form and know where to find extra forms 
when needed  
3. Collecting data 
a. When using the screening log form write the result(s) down immediately  
i. Be sure that the demographic information is filled in for each result that is recorded  
ii. Be sure that enrollment status is also filled in for eligible participants  
iii. If an eligible participant decides not to enroll, indicate why he or she declined 
b. Make sure there are enough copies of each form  
c. Each volunteer or staff person participating in the screening should have his or her own screening log  
d. Collect screening logs and any other forms from each screener at the end of the day  
e. Before beginning the enrollment process have all forms that you will need assembled (i.e. consent 
forms, medical records release form, enrollment form, compensation form and randomization envelope)  
i. Before completing the survey have the participant sign the consent form and complete the 
medical records release form 
ii. After completing the survey have the participant complete the enrollment form—be sure to go 
through each section of the form with the participant to ensure that it is completed accurately  
1. On the enrollment form make sure to complete the checklist portion (the portion that 
indicates that all forms and the survey have been completed)  
f. Collect all forms used at box distributions and education sessions (i.e. box distribution pickup lists and 
education session class sign in)  
g. Before a participant leaves make sure that all necessary enrollment forms have been completed  
4. Entering data  
a. If possible block off at least an hour each day where you can enter data  
b. If possible limit the number of people that enter data—for example the RA and one or two volunteers 
enter all study data 
c. Group  forms together so that each form can be entered into its respective window at one time—for 
example put all the screening logs together so that while the screening log window is open all of this 
data can be entered  
d. TRIPLE check the data once it has been entered. Go back at least two times to make sure that all data 
has been accurately entered.  
e. Store all papers forms in a locked drawer in case you have to go back to check the accuracy of the data 
once it has been entered  
 
 
 
 
 

 
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Appendix AU – Participant Follow-Up Testing Results Form 
 
 
Participant Follow-up Testing Results 
 
Date: ____________________________ 
 
Participant ID #: ________________________  
 
 
 
Blood glucose result: ______________ mg/dL 
 
HbA1c result: ______________ % 
 
Notes:  
 
 
 
 
 
Participant Follow-up Testing Results 
 
Date: ____________________________ 
 
Participant ID #: ________________________ 
 
Blood glucose result: ______________ mg/dL 
 
HbA1c result: ______________ % 
 
Notes:  
 
 
 
 
 
Participant Follow-up Testing Results 
 
Date: ____________________________ 
 
Participant ID #: ________________________ 
 
Blood glucose result: ______________ mg/dL 
 
HbA1c result: ______________ % 
 
Notes:  
 
 
 
 
Staff note: shred this form after entering 
data into ACCESS 
Staff note: shred this form after entering 
data into ACCESS 
Staff note: shred this form after entering 
data into ACCESS 

 
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Appendix AV – Barriers to Participation in FAITH-DM Activities Form 
 
Barriers to Participation in FAITH-DM Activities 
Instructions:  Complete this form to document information participants provide about challenges / barriers to taking 
part in study activities.  Return completed forms to the Research Assistant. 
 
Date: 
 
Participant ID#: ___________________  
 
 
 
 
 
 
 
 
 
 
FAITH-DM Service Discussed by Participant: (Check any and all that apply) 
____ A1C / Blood Glucose Screening and Monitoring 
____ Food Packages 
____ Diabetes Education 
____ Primary Care Provider Referral or Appointments / Visits 
____ Other (please specify):  
 
Type of Concern(s) or Barrier(s) that Participant Identified: 
____ Transportation (e.g., availability, cost) 
____ Time Conflicts (e.g., can’t make the times when food distribution, education classes or clinic appointments are 
available) 
____ Food Package Concerns (e.g., doesn’t like foods provided, volume is more than household can use)  
____ Costs of Primary Care Visits (e.g., can’t afford copay, or paying out of pocket if no insurance) 
____ Hospitalization / illness / homebound:  
____ Other (please specify):  
 
Additional Notes (use this space to provide details you think are helpful to understand the participant’s concerns): 
 
 
For Use by Research Assistant: 
Date entered into ACCESS: _________________________ 
Date reported* to site manager and/or FA Project Manager (Morgan Smith): ______________________ 
 
*Report if issue(s) may require revision to study elements and/or processes. 
 
 
NOTE: This form may contain protected health information – staff must keep this data secure.  Once data is entered into 
Access database, securely store and/or destroy form according to study protocols. 
 
 
 

 
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Appendix AW – FAITH-DM Updates for Study Participants 
 
 
 
 
 
FAITH-DM Updates for Study Participants 
 
 
What is the purpose of this form? 
This form is for participants enrolled in the research study: Feeding America Intervention Trial for 
Health – Diabetes Mellitus (FAITH-DM).  The form includes important updates on study activities for 
participants. 
 
 
What are the updates? 
 Participants assigned to the intervention group will now be asked to complete a fourth HbA1c 
test that will take place 12-months from the day the participant enrolled into the study 
 All participants will be asked to complete a third survey that will take place 12-months from the 
day they originally enrolled (survey will take about 30 minutes to complete) 
 All participants will receive a $15 gift card upon completion of the 12-month follow-up survey 
 For participants in the intervention group who originally agreed to share their medical 
information, we will ask your doctor / clinic to complete a second survey about the care you 
received during the 6-month period after you completed the intervention 
 
 
What do I need to do now? 
No action is required now.  Study staff will contact you at your 12-month mark to schedule a time to 
complete the HbA1c test and survey.  Participants will exit the study after completing the 12-month 
HbA1c test and survey.  There will be no additional study activities after these 12-month items, but 
participants can continue receiving normal (non-study) food bank and pantry services for which they 
qualify. 
 
 
What if I don’t want to participate? 
As with all study activities, you are not required to complete any additional HbA1c testing or surveys.  
If you choose to decline these items at month 12, inform the study staff that you do not want to take 
part. At this point your participation in the research study will end. You can continue receiving normal 
(non-study) food bank and pantry services for which you qualify. 
 
 
 

 
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Who do I call if I have questions? 
If you have any questions, concerns or complaints about this research study or these changes, you 
may call the study site. If you think you have an injury or illness from the study activities, contact the 
Principal Investigator, Hilary Seligman, MD, MAS at (415) 206-4448. 
 
Study Contact Name:   
 
Morgan Smith, RN, PHN, CNS, CDE 
Project Director, Feeding America 
Daytime telephone number(s): 312-629-7247 
 
You should contact the food bank study staff first if you have questions, complaints or concerns about 
the study. If they cannot be of assistance, you may contact Morgan Smith or Dr. Hilary Seligman. 
 
 
Please contact Western IRB if: 
 You want to talk to someone other than the PI or study staff 
 You have a hard time reaching the PI or study staff 
 You have questions about your rights as a research subject or concerns or complaints about 
the research. 
 
 
Western Institutional Review Board® (WIRB®) 
 
1019 39th Avenue SE Suite 120 
 
Puyallup, Washington  98374-2115 
 
Telephone:  1-800-562-4789 or 360-252-2500 
 
E-mail: Help@wirb.com 
 
WIRB is a group of people who perform independent review of research. 
 
WIRB will not be able to answer some study-specific questions, such as questions about appointment 
times.  However, you may contact WIRB if the research staff cannot be reached or if you wish to talk 
to someone other than the research staff.  
 
Please visit the Western IRB website, www.wirb.com for more information about research studies and 
the role of a research subject. 
 
 
 
 

 
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Appendix AX – HCU Survey Cover Sheet 
 
 
 
Health Care Utilization Survey - Cover Sheet 
FAITH-DM Research Site:  Please complete this cover sheet and attach it to the completed provider 
survey before submitting it to Urban. Thanks! 
 
Participant ID: ______________________ 
 
Period of Requested Data: ______________________ to ______________________  
(Copy this from the date range you gave the provider when you sent out the survey.  For T6 surveys, the 
range should be 12 months; for T12 surveys, it will be 6 months). 
 
 
Date Survey Received at Your Site: ______________________ 
 
Notes about Survey or Attached Patient Records (optional): 
________________________________________________________________________________________ 
________________________________________________________________________________________ 
________________________________________________________________________________________ 
________________________________________________________________________________________ 
________________________________________________________________________________________ 
________________________________________________________________________________________ 
________________________________________________________________________________________ 
________________________________________________________________________________________ 
________________________________________________________________________________________ 
 
 
 

 
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Appendix AY – Data Security and Overview of Study Data Procedures 
 
 
Data Security: Overview of How Study Data are Obtained, Transmitted, Received, and Stored 
 
Introduction 
FAITH-DM is a large, complex, multi-site research trial that involves numerous staff and multiple points of contact with study participants for data collection.  
There are instructions delineated throughout the study MOP on how staff at the research sites and coordinating center must collect, transmit, receive, and store 
study data (especially data containing participant PII and PHI).  This overview reflects MOP content and provides a comprehensive, centralized overview on all 
study data processes. 
 
Staff Access to Study Data 
All staff engaged in the collection, storage, transmission, or analysis of study data are required to complete and maintain CITI certification.  At each institution, 
the following staff have access to study data as indicated below. 
 
Research Sites (Food Banks) 
o Research Assistants: access to all site-specific data and forms; responsible for adhering to MOP protocols for data collection, storage, security, 
transfer / upload, etc.; maintain laptops; maintain physical document storage and security; maintain logon information and passwords for study 
laptops, CASIC, ACCESS and UCSF VPN client 
o Project Managers: back-up for Research Assistants; access to all site-specific data; responsible for hard copy final document destruction (to take 
place three years after study completion) 
o Other Study Staff (screeners, educators, HCUA assistants, etc.): access only to the minimum amount of data / forms / study documentation 
necessary to complete function (e.g., an educator may only need access to participants’ names, contact information [phone, email], and study 
group assignment); staff overseen by RA and/or Project Manager 
 
Feeding America 
o Project Manager: Morgan Smith; access to all de-identified study data; access to any site-specific reports that may include client or participant 
PII/PHI data as required per study protocols for reporting purposes (e.g., adverse events, barriers, etc.) 
o Director, CHN: Michelle Berger Marshall; access to all de-identified study data 
 
University of California, San Francisco – Center for Vulnerable Populations 
o Principle Investigator (PI): Dr. Hilary Seligman; access to all study data electronically stored on UCSF servers; access to all site-specific data, 
forms, and study documentation (hard copy and electronic versions) 
o Project Manager: access to all study data electronically stored on UCSF servers; access to and responsibility for maintenance of ACCESS and 
CASIC databases (in collaboration with other UCSF staff); as part of quality control and data management, ensures each research site uploads all 
study data (ACCESS and CASIC remote surveys) at least weekly 

 
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o Study Statistician: access to all study data electronically stored on UCSF servers 
o Technology and Support / Admin Staff: access only to the minimum amount of data electronically stored on UCSF servers necessary to complete 
functions (server maintenance, database maintenance, etc.); activities and access overseen by UCSF PI and/or UCSF Project Manager 
 
Urban Institute 
o HCUA Lead: Elaine Waxman; access to all de-identified study data transmitted by UCSF; access to all de-identified HCUA provider survey data 
submitted by research sites 
o HCUA Project Staff: access to all de-identified study data transmitted by UCSF; access to all de-identified HCUA provider survey data submitted 
by research sites (must ensure survey data does not include any PII and, in the event of finding PII, is responsible for blacking-out and/or 
removing PII from survey data); activities and access overseen by Urban Institute HCUA Lead 
 
Notes 
 
Research Assistants at each Research Site maintain two laptops that were provided, configured, and encrypted by UCSF 
o Both laptops are: 
 
Encrypted and password protected (at the levels of the laptop, CASIC remote, ACCESS database, and UCSF VPN) 
 
Loaded with CASIC remote survey software 
o Only 1 laptop per site is loaded with the site-specific study ACCESS database 
o RAs follow best practices when using, transporting, charging, and storing laptops to maintain device security (including storing laptops in locked 
cabinets, using laptop cables at sites, maintaining password protocols set by UCSF, etc.) 
o All study laptops will be returned to UCSF upon study end and completion of FAITH-DM data collection and uploading processes 
 
Table Key 
o PII = Personal Identifying Information 
o PHI = Protected Health Information 
o PPT = participant 
 
 
 

 
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Data 
Storage 
Transmission 
Notes 
Research Sites (Food Banks) 
Client screening logs 
Data electronically entered into 
study ACCESS database; hard 
copies destroyed (shredded) once 
data entry complete 
Site-specific ACCESS database 
securely uploaded to UCSF servers 
daily (whenever new data are 
entered), or as soon as possible 
thereafter (weekly, at a minimum) 
via a secure UCSF VPM client 
process 
Forms contain PHI and, potentially 
PII; site-specific ACCESS data are 
stored locally on study laptop (1 per 
site); all study ACCESS data are, once 
uploaded, securely stored on UCSF 
servers 
Participant Consent and 
HIPAA Authorization 
forms 
Hard copies stored in the site Study 
Consent Binder  
Copies faxed to PCPs along with 
HCUS via a HIPAA-compliant fax 
Binders securely stored at each site in 
lockable cabinet / drawer separate 
from other study binders; do not 
include PPT #s; stored for 3 years 
after study completion and then 
destroyed (shredded on site or 
released to secure document disposal 
service) 
Medical Records Release 
form 
Hard copies stored in the site Study 
Consent Binder 
Copies faxed to PCPs along with 
HCUS via a HIPAA-compliant fax 
Binders securely stored at each site in 
lockable cabinet / drawer separate 
from other study binders; do not 
include PPT #s; stored for 3 years 
after study completion and then 
destroyed (shredded on site or 
released to secure document disposal 
service) 
Baseline Enrollment Data 
form 
Data electronically entered into 
study ACCESS database; hard 
copies destroyed (shredded) once 
data entry complete 
Site-specific ACCESS database 
securely uploaded to UCSF servers 
daily (whenever new data are 
entered), or as soon as possible 
thereafter (weekly, at a minimum) 
via a secure UCSF VPM client 
process 
 

 
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Data 
Storage 
Transmission 
Notes 
Screening and monitoring 
results 
Data electronically entered into 
study ACCESS database; hard 
copies destroyed (shredded) once 
data entry complete 
Site-specific ACCESS database 
securely uploaded to UCSF servers 
daily (whenever new data are 
entered), or as soon as possible 
thereafter (weekly, at a minimum) 
via a secure UCSF VPM client 
process 
 
Participant Surveys (T0, 
T6, T12) 
All PPT surveys completed using 
CASIC; surveys completed using 
remote CASIC stored on study 
laptops and automatically deleted 
with each upload 
PPT surveys completed on CASIC 
remote securely uploaded to UCSF 
servers daily (whenever new data 
are entered), or as soon as 
possible thereafter (weekly, at a 
minimum) via a secure UCSF VPM 
client process 
PPT surveys entered via CASIC live 
are automatically saved on secure 
UCSF servers; no local copy is saved 
on study laptops at sites 
Compensation Form 
Hard copies stored in Study 
Participant Binders; form 
completion checkbox entered in 
ACCESS database 
Site-specific ACCESS database 
securely uploaded to UCSF servers 
daily (whenever new data are 
entered), or as soon as possible 
thereafter (weekly, at a minimum) 
via a secure UCSF VPM client 
process 
Binders securely stored at each site in 
lockable cabinet / drawer separate 
from Consent Binders; any PII needs 
to be removed or blacked out (use 
PPT #s only); stored for 3 years after 
study completion and then destroyed 
(shredded on site or released to 
secure document disposal service) 
Completed HCUS Surveys 
(T6, T12)  
Hard copies stored in Study HCUA 
Binders; dates and details of HCUA 
letters and other provider 
communication entered into and 
stored in study ACCESS database 
Site-specific ACCESS database 
securely uploaded to UCSF servers 
daily (whenever new data are 
entered), or as soon as possible 
thereafter (weekly, at a minimum) 
via a secure UCSF VPM client 
process; per MOP protocols RAs 
are to compile copies of HCUSs 
each month, confirm surveys are 
de-identified (or black out PII if 
necessary), and mail in batches to 
Binders securely stored at each site in 
lockable cabinet / drawer separate 
from Consent Binders; stored for 3 
years after study completion and 
then destroyed (shredded on site or 
released to secure document disposal 
service); any PII needs to be removed 
or blacked out (use PPT #s only); 
provider face sheet (with PPT name 
and DOB) should be shredded by RA 
if PCP returned it along with survey; 

 
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Data 
Storage 
Transmission 
Notes 
Urban Institute via traceable 
shipping method 
no need to store hard copies of any 
PCP letters sent 
MISC Forms with 
Participant Information 
(Adverse Event, Barriers, 
etc.) 
Hard copies stored in Study 
Participant Binder 
Completed forms sent by site RAs 
to FA Project Manager and/or 
UCSF PI per MOP reporting 
guidelines 
Binders securely stored at each site in 
lockable cabinet / drawer separate 
from Consent Binders; any PII needs 
to be removed or blacked out (use 
PPT #s only); stored for 3 years after 
study completion and then destroyed 
(shredded on site or released to 
secure document disposal service) 
UCSF-CVP 
ACCESS Database Data 
Data received from sites weekly via 
secure UCSF VPN upload process; 
all data stored securely on UCSF 
servers 
Data de-identified prior to secure 
transmission to UI and/or FA 
Electronic data will remain securely 
stored for a period of 5 years from 
the end of study activities (data 
analysis and reporting), and then 
permanently deleted from UCSF 
servers and computers 
CASIC Database Data 
Data uploaded from CASIC remote 
when sites access an internet 
connection, and (with CASIC live) in 
real time as PPT surveys are 
completed at sites; all data stored 
securely on UCSF servers 
Data de-identified prior to secure 
transmission to UI and/or FA 
Electronic data will remain securely 
stored for a period of 5 years from 
the end of study activities (data 
analysis and reporting), and then 
permanently deleted from UCSF 
servers and computers 
Site-specific reports and 
communication (that may 
contain PPT info, PHI, 
and/or PII) 
Electronic forms and submissions 
from sites stored securely on UCSF 
servers; hard copies securely stored 
in study binder and lockable 
drawer/cabinet by PI and/or 
Project Manager 
N/A 
Hard copies of study data to be 
securely stored for a period of three 
years from the end of study activities, 
and then destroyed (shredded on site 
or released to secure document 
disposal service) 
Urban Institute 

 
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Data 
Storage 
Transmission 
Notes 
De-identified ACCESS 
database data 
Study data will be stored on secure 
UI servers and equipment, with 
access restricted to personnel 
involved in the study HCUA analysis 
Data set will be transmitted to UI 
by UCSF at the end of data 
collection (projected to be 
September, 2017); transmission 
will occur either through secure 
electronic transfer or in-person 
(e.g., by using encrypted flash 
drives, laptops, and/or other 
secure devices) 
Hard copies of study data to be 
securely stored for a period of three 
years from the end of study activities, 
and then destroyed (shredded on site 
or released to secure document 
disposal service); electronic data will 
remain securely stored for a period of 
5 years from the end of study 
activities (data analysis and 
reporting), and then permanently 
deleted from UI servers and 
computers 
De-identified CASIC 
database data 
Study data will be stored on secure 
UI servers and equipment, with 
access restricted to personnel 
involved in the study HCUA analysis 
Data set will be transmitted to UI 
by UCSF at the end of data 
collection (projected to be 
September, 2017); transmission 
will occur either through secure 
electronic transfer or in-person 
(e.g., by using encrypted flash 
drives, laptops, and/or other 
secure devices) 
Hard copies of study data to be 
securely stored for a period of three 
years from the end of study activities, 
and then destroyed (shredded on site 
or released to secure document 
disposal service); electronic data will 
remain securely stored for a period of 
5 years from the end of study 
activities (data analysis and 
reporting), and then permanently 
deleted from UI servers and 
computers 
De-identified HCUA 
provider surveys 
HCUS surveys received from 
research sites will be reviewed for 
any PII (PII will be removed or 
blacked out); once survey data are 
inputted into electronic UI 
database, hard copy surveys will be 
securely stored by UI HCUA Lead; 
electronic data sets will be stored 
securely on UI servers 
N/A  
Hard copies of study data to be 
securely stored for a period of three 
years from the end of study activities, 
and then destroyed; any electronic 
data sets made from HCUA survey 
data will remain securely stored for a 
period of 5 years from the end of 
study activities (data analysis and 
reporting), and then permanently 

 
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Data 
Storage 
Transmission 
Notes 
deleted from UI servers and 
computers 
Feeding America 
De-identified study data 
(ACCESS, CASIC, and HCUA 
Survey data) 
Any electronic files received from 
UCSF and UI will be stored on 
secure FA servers 
N/A 
Study data may be used for quality 
assurance and internal reporting 
purposes (departmental activities, 
grant reports, donor reporting, etc.); 
any electronic study data sets will 
remain securely stored for a period of 
5 years from the end of study 
activities (data analysis and 
reporting), and then permanently 
deleted from FA servers and 
computers 
Site-specific reports and 
communication (that may 
contain PPT info, PHI, 
and/or PII) 
Reports and communication to be 
accessed on a PW-protected laptop 
maintained by FA Project Manager 
and then saved and backed-up on 
secure FA servers 
N/A 
Hard copies of study data to be 
securely stored for a period of three 
years from the end of study activities, 
and then destroyed; electronic study 
data will remain securely stored for a 
period of 5 years from the end of 
study activities (data analysis and 
reporting), and then permanently 
deleted from FA servers and 
computers 
 
 
 
 
 
 
 
 

 
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Appendix AZ – HCUA Script for reminding provider site to fill out survey 
 
FAITH-DM Health Care Utilization Analysis:  Script for reminding provider site to fill out survey 
 
Introduction 
 
Hello, my name is [your name]. I’m working with [name of food bank] on a research study in which one of your patients 
is enrolled. Could I speak with the person who handles medical records for your practice? 
 
Information about study and survey 
 
[Repeat introduction above if different person] The study is called the Feeding America Intervention Trial for Health – 
Diabetes Mellitus (or FAITH-DM for short) and we are looking to gain an understanding of the trends in healthcare 
utilization and the potential impact on health care costs associated with diabetes care management provided in food 
pantry settings. As such, we are requesting healthcare information for a patient in your care that is enrolled in our study. 
About [# of weeks since survey was sent] weeks ago we sent you a survey for [name of patient]. Your patient has given 
permission to share their information with our study, and included with the survey was a HIPAA Authorization and 
consent to release medical records form signed by your patient. The survey asked for information on office visits, 
emergency department and urgent care visits, and inpatient hospital admissions for a [12 month or 6 month] period. 
Additionally, the survey inquired about missed appointments, the patient’s source of payment, and what type of clinic 
you have. Have you received this survey?  
 
If yes 
 
In order to make this process as easy as possible for you, we have provided your clinic the option to either fax us a 
completed survey (with the first page removed) or a copy of your patient’s actual medical record. We prefer that you 
complete the survey. However, if you choose to provide a copy of your patient’s medical record, we want to emphasize 
that you to black out any personal identifiable information (name, date of birth, SSN, etc.) before sending it to us. [See 
Q&A if there is pushback on this] When do you anticipate you will be able to send us back the survey or copy of your 
patient’s medical records? [If they have questions/hesitation about completing the request, see troubleshooting section] 
 
If no 
 
In that case, we will be resending you an information packet that contains the survey and a letter explaining our study in 
greater detail. How can we best address this package to ensure that it arrives to you? 
 
In order to make this process as easy as possible for you, we have provided your clinic the option to either fax us a 
completed survey (with the first page removed) or just a copy of your patient’s actual medical record. We prefer that 
you complete the survey. If you choose to fax us a copy of your patient’s medical record, we want to emphasize that you 
black out any personal identifiable information (name, date of birth, SSN, etc.) before sending it to us. [If they have 
questions/hesitation about completing the request, see Q&A section] 
 
Closing, assuming no questions/issues 
 
Thank you for your time in completing this survey for us! Do you have any questions about the survey or study more 
generally?  
 

 
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Please do not hesitate to contact us with any questions you may have. Our contact information is [phone number and 
email]. The fax number to send us the survey is [fax number]. [Food Bank RA] is the Research Assistant managing this 
project at the food bank. 
 
Common Questions and Answers 
 
Our clinic does not have time to complete this request 
 
We understand that it takes time for you (or your medical records staff) to fulfill this request. To compensate for this 
time, we will provide a $20 payment to your clinic for each survey completed or record copied. Obtaining this healthcare 
information will be critical in determining how to better help patients with uncontrolled diabetes.  
 
We would need to charge a higher price in order to fulfill your request. 
 
Unfortunately, $20 is what our research budget allows for these survey requests. Would it be at all possible to still send 
us records? [If no] How much do you envision each record will cost? I will need to check with my study director and get 
back to you. [If they say no, report the cost they quote to the study director; he or she will make a determination on 
whether the food bank will make an exception].  
 
Could you tell me more about the study? 
 
[Food bank name], in collaboration with Feeding America, the University of California San Francisco, and the Urban 
Institute, is conducting a randomized controlled trial study of a diabetes intervention focused on food pantry clients. The 
FAITH-DM study is designed to assess the effectiveness of a multi-component intervention for improving diabetes 
management among a population of food pantry clients in three cities, including [your city], using a treatment and 
waitlist control group design. The project also includes an analysis of health care utilization, both self-reported by 
participants and through selected medical record data reported by clinics like yours.  
 
The FAITH-DM intervention components include: 
 
Screening and monitoring (blood glucose and HbA1c) 4 times over a 12-month period; at baseline, 3 months, 6 
months and 12 months 
 
Twice-monthly diabetes-appropriate food boxes (including fresh produce) for 6 months 
 
Referral to a primary care provider, if participant does not currently have one 
 
Diabetes self-management support and education (handouts, classes, and 1-on-1 support). 
 
For adults with type 2 diabetes, diabetes self-management education (DSME) is critical to achieving long-term control of 
blood sugar levels (glycemic control) and preventing diabetes-associated complications. This education is often difficult 
to access for highly vulnerable and marginalized adults in the United States. Furthermore, we know that nutritious, 
diabetes-appropriate foods are often out of reach for food insecure households. The purpose of this study is to 
determine the extent to which food banks and food pantries can help reach this population with effective diabetes 
education, food, and access to primary health care, with the ultimate goal of improving diabetes outcomes. 
 
Consent/Confidentiality/IRB concerns 
 
We have obtained informed consent from all participants enrolled in our study. In addition, all participants have signed a 
HIPAA Authorization and consent to release medical records forms. As we have instructed you to black out any 
personally identifying information, all data obtained in this study will remain confidential, and no personally attributed 
information will be released. Our study has been approved by the Western Institutional Review Board, the UCSF IRB, and 

 
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the Urban Institute IRB. [To the volunteer: An Institutional Review Board (IRB) is a committee established to review and 
approve research involving human subjects, ensuring that all research is conducted in accordance with federal, 
institutional, and ethical guidelines. Because our study is being conducted by 3 organizations, we had 3 separate IRB’s 
review and approve FAITH-DM]. 
 
What if I can’t black out all of the identifying information? 
 
The Institutional Review Board that approved this study has required us to minimize the identifiable information 
exposed when data is being transferred. We would greatly appreciate it if you were able to black out identifying 
information. However if this is not feasible, we understand and appreciate your help in sending the record in a secure 
fashion, either by fax or mail. 
 
 
 
 

 
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Appendix BA – Guide on Use of Encrypted USB Devices for HCUA Data 
 
FAITH-DM Health Care Utilization Analysis:  Guide for use of IronKey Encrypted USB Devices 
 
In order to save resources and further secure the health care utilization data being sent and received between FAITH-
DM research sites and the Urban Institute, research assistants at the food banks have the option to scan health care 
utilization surveys and documents and upload them onto secure USB drives for the purposes of shipping these to Urban. 
These devices, IronKey D250 Basic Secure Drives, are password protected and hardware encrypted. Each food bank will 
receive two devices so that one is always available when the other is in transit to/from Urban. 
 
Food Bank Research Assistants 
When the site receives the USB devices the first time, the site research assistant (RA) should email the Urban Institute 
research assistant to acquire the password to unlock the device. The password is specific to each site; both USB devices 
at the site have the same password, but each site has a different password. Once the RA receives the password, the RA 
can plug the device into the computer from which records and surveys will be uploaded. If the Unlocker does not open 
immediately, open Windows Explorer; the IronKey Unlocker should now be listed as one of the drives on the computer. 
Open that drive, and run IronKey. Type the password provided by the Urban Institute. Once the device is unlocked, click 
the folder icon to open the Secure Files Drive. Add all of the documents to be sent to the Urban Institute to this folder, 
and lock the device. It is now safe to remove and mail back to the Urban Institute. 
 
Important safety procedures include: 
 
If you need to step away from your computer while using the device, lock the device. 
 
DO NOT change a device password. Passwords should be kept separate from the devices and the study 
computers and stored in a secure place. 
 
If the password does not work, do not re-attempt more than a few times and contact the Urban Institute for 
assistance if needed. If an incorrect password is entered 10 times, the device will become permanently 
unusable. 
 
When mailing a USB device to the Urban Institute research assistant, use the existing trackable shipping method 
outlined in the MOP, and check to ensure the device arrives at its intended destination by the expected delivery 
date. If a package is delayed significantly and/or lost, notify and request assistance from the shipping provider 
and alert the Urban Institute research assistant handling the HCUA data. Any instances of lost packages that 
cannot be recovered must be reported to the Urban Institute IRB.  
 
Files uploaded electronically to a computer at the site must be kept under a password-protected file. Only study-
provided computers should be used for scanning sensitive participant information.  
 
Urban Institute 
When Urban receives a USB device from a site, the Urban research assistant will send an email to the site to confirm 
receipt of the device.  The Urban research assistant will then access the device by running the IronKey Unlocker, using 
the password corresponding to the device assigned to the appropriate site.  (Passwords are maintained in a separate file 
on the Urban secure drive.) Once the device is unlocked, the files will be transferred directly into the FAITH-DM folder 
on the secure drive, and deleted from the USB device. The device will be locked in order to safely remove it. It can then 
be returned to the food bank for further use. The Urban RA will notify the site when a package is in transit. 
 
Important safety procedures include: 
 
If you need to step away from your computer while using the device, lock the device. 
 
When mailing the USB devices, check to be sure all data has been removed before shipping to the site. Use a 
trackable shipping method, and check to ensure the device arrives at its intended destination within the 
expected timeframe. 
 

 
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