"Kidney Health: Eat Well, Live Well": A Program to Reduce Kidney Injury and Early CKD Progression Through Nutrition & Empathetic Support From a Health Partner
Phase: NA
Conditions: Chronic Kidney Diseases
Sponsor: University of Texas at Austin

 
FORM: IRB Proposal - Standard Submission 
NUMBER 
VERSION DATE 
HRP-UT901 
07/05/2021 
 
 
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Clinicaltrials.gov cover page 
 
Official Title of the study 
Kidney Health: Eat Well, Live Well 
 
NCT number  
NCT05970341 
 
Date of the document 
September 12th, 2023 
 
Unique Protocol ID: 
STUDY00002253 
 
Principal Investigator: 
Maninder “Mini” Kahlon  
Associate Professor 
Population Health, Dell Medical School, University of Texas at Austin 
 
 
 

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GENERAL STUDY INFORMATION 
 
Use for greater than minimal risk studies and minimal risk studies that fit into one or more expedited categories (see 
Section 5.3 of our Policies & Procedures  for details regarding expedited research). 
 
Do NOT submit this form if the study will qualify for exempt review, instead submit HRP-UT902 IRB Proposal – Exempt 
Submission Form found in the document Library.  
 
If you are only using secondary data that will not be initially collected solely for this research project, use HRP-UT903 
Template IRB Proposal Secondary Use form instead. 
 
For studies following a multi-center or sponsor protocol, please use this guidance to assist in your completion of this 
form. 
 
For questions regarding definitions, policies, or terms referenced below see the policies and procedures manual. 
 
Please note, Word online does not support Word checkboxes. Please download the file and use your desktop version of 
Microsoft Word. 
 
1 
Review Type (Choose one) 
 
Click on the check box (or double click and type an “X” if using Google Docs) the one review type that in the 
investigator’s opinion applies.  
 
Please note: Expedited Review does not refer to the timeliness of the review of your protocol, but specific 
categories of research defined by ORHP. If you would like help determining which type of review is most 
appropriate for your study please contact the Office of Research Support and Compliance:  
https://research.utexas.edu/ors/about-ors/contact-us/. 
 
Investigator’s assessment of review does not preclude the IRB from alternate determinations. In cases where the 
investigator and the IRB’s determination conflict, the IRB’s determination should be considered accurate. 
 
A ☐ 
 
Full Board Review – Greater than Minimal Risk Research 
B ☒ 
 
Expedited Review – Minimal Risk Research  
 
2 
Research Hypothesis 
To input text, click in the light grey area below. 
 
Can lowering barriers to resources, providing instrumental support and empathetic 
connection improve diet and reduce kidney injury in low-income patients with CKD 2 
and 3 over 6-months/26 weeks. 
1. Can kidney injury, cardiovascular risk, diet and mental health improve by (a) 
lowering barriers to improving diet by providing resources (direct delivery of 
fruits and vegetables (F&V) and grocery store eGiftcards) (b) providing 
instrumental support  (educational materials, recipes and as-needed practical 

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food purchase and preparation help) and (c) providing empathetic connection 
over the telephone through a dedicated “Health Partner” (Intervention).  
2. Does the more easily implemented part of the program lead to improvements in 
kidney injury, cardiovascular risk, mental health and diet, with just the provision 
of grocery store eGiftcards, educational materials and recipes without the more 
operationally complex provision of customized delivery of F&V and the dedicated 
health partner(Control). 
 
3 
Study Background 
To input text, click in the light grey area below. 
 
Chronic kidney disease (CKD) is diagnosed and monitored mainly through abnormal urine albumin 
levels and a persistent reduction in the estimated glomerular filtration rate (eGFR). These markers are 
used to stage it from 1 to 5, reflecting disease progression. Detection in early stages (1-3) can greatly 
improve disease prognosis by enabling early intervention and delaying, or even avoiding, kidney 
replacement therapy, like dialysis, or kidney transplant when it progresses to CKD stages 4 and 5 (end-
stage kidney disease, ESKD). At early stages, however, CKD usually remains undetected; it is not 
systematically screened for in primary care practice and is asymptomatic, with little to no impact on 
the individual’s quality of life (National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK), 2021). ESKD, on the other hand, disrupts individuals’ lives and their families’, in addition to 
being expensive for them and the health care system. Recently, based on usage in clinical trials, urine 
Albumin:Creatinine ratio (uACR) has been included in CKD guidelines as a marker for monitoring 
kidney damage in primary care (National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK), 2021). Therefore, healthcare payers have also begun assessing the benefit of measuring and 
reducing this marker. 
 
At any CKD stage, metabolic acidosis can be a serious CKD-related complication (Raphael, 2019). For 
some individuals, an oral alkali treatment, generally sodium bicarbonate tabs, can be included as part 
of the pharmacological treatment to help regulate acid-base balance in the blood (National Kidney 
Disease Education Program, 2014). The addition of sodium can, however, increase the chances of 
cardiovascular disease (CVD) complications, especially given that CKD often presents with other 
chronic conditions, such as diabetes and hypertension, with the latter being the leading cause of CKD 
mortality (National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), 2021). Diet 
therapy has been considered a key component of disease management mostly in ESKD to support 
electrolyte and mineral balance during kidney replacement therapy. More recently, however, dietary 
intake has been studied as a means to support the reduction in renal acid load in early CKD stages and 
potentially improve kidney-related outcomes (van Westing et al., 2020). 
 
Randomized trials conducted with patients diagnosed with CKD have demonstrated that increasing the 
consumption of alkali-inducing fruits and vegetables can positively impact biomarkers of CVD, adding 
the benefit of CVD protection, on top of protecting kidney function similarly to sodium bicarbonate 
(Goraya et al., 2012, 2014, 2019, 2021). In their initial study, Goraya et al. (2012) showed that a fruits 
and vegetables intervention among patients with CKD stage 1 or 2 successfully reduced urine 
Albumin:Creatinine ratio (uACR) better than usual care and sodium bicarbonate after just one month. 
Following that study, the same team (Goraya et al., 2014) showed a reduction in uACR and 
preservation of eGFR in patients with CKD stage 3 who received a fruits and vegetables intervention 

Page 4 of 34 
 
and were followed for 3 years. These studies demonstrated that fruits and vegetables consumption 
can protect kidney function. Further studies also support the need to adopt a more comprehensive 
approach to eating patterns, such as making healthier food choices in the overall diet (Pereira et al., 
2020; Wesson et al., 2020). Together with other lifestyle changes, improved dietary patterns can have 
a compounded effect to delay or avoid dialysis (Quintela et al., 2021). Experts in the field have made 
the case for more pragmatic trials in CKD, so that such programs can be evaluated and reach people in 
the context of their lives (De Boer et al., 2016).  
 
Here, we propose a 6-month program aimed at supporting patients to change their eating habits to 
reduce the likelihood of kidney injury. We aim to reduce barriers to trying healthier, kidney-friendly 
foods through the direct provision of fruits and vegetables and grocery store eGiftcards. We will 
provide instrumental support, including education to support a better understanding of kidney disease 
and the role of healthy eating in slowing its progression, recipes customized to provided resources and 
food preparation tips. Finally, we will provide empathetic relational support through a dedicated 
“Health Partner” who will connect via telephone. The program will be assessed with a 2-arm 
randomized controlled trial, with primary outcome of Urine Albumin to Creatinine ratio (uACR), 
cardiovascular risk via Hemoglobin A1C and blood pressure, mental health and diet.  
 
This project is a partnership with the Harris Health system in Houston with co-investigators: Karen 
Tseng (Sr. VP & Chief Integration Officer), Dr. Meroë Morse (Baylor’s Integrative Internal Medicine-
Primary Care, Smith Internal Medicine Clinic), Dr. Rob Wesley (Site Director & Associate Director of 
Medicine Subspecialties-LBJ Outpatient Center UT Medicine Clinic and Associate Professor of 
Medicine, McGovern School UT Health), and Dr. Jaime Rueda (Internal Medicine and Pediatrician at 
Smith & MLK Clinics and Assistant Professor at Baylor College of Medicine). 
 
Betz, M., Steenes, A., Peterson, L., & Saunders, M. (2021). Knowledge Does Not Correspond to Adherence of Renal Diet 
Restrictions in Patients With Chronic Kidney Disease Stage 3-5.  Journal of Renal Nutrition, 31(4), 351–360. 
https://doi.org/10.1053/j.jrn.2020.08.007 
Cohen, S. D., Sharma, T., Acquaviva, K., Peterson, R. A., Patel, S. S., & Kimmel, P. L. (2007). Social Support and Chronic 
Kidney Disease: An Update. Advances in Chronic Kidney Disease, 14(4), 335–344. 
https://doi.org/10.1053/j.ackd.2007.04.007 
De Boer, I. H., Kovesdy, C. P., Navaneethan, S. D., Peralta, C. A., Tuot, D. S., Vazquez, M. A., & Crews, D. C. (2016). Pragmatic 
clinical trials in CKD: Opportunities and challenges. Journal of the American Society of Nephrology, 27(10), 2948–
2954. https://doi.org/10.1681/ASN.2015111264 
Evangelidis, N., Craig, J., Bauman, A., Manera, K., Saglimbene, V., & Tong, A. (2019). Lifestyle behaviour change for 
preventing the progression of chronic kidney disease: A systematic review. BMJ Open, 9(10). 
https://doi.org/10.1136/bmjopen-2019-031625 
Goraya, N., Munoz-Maldonado, Y., Simoni, J., & Wesson, D. E. (2019). Fruit and Vegetable Treatment of Chronic Kidney 
Disease-Related Metabolic Acidosis Reduces Cardiovascular Risk Better than Sodium Bicarbonate. American Journal 
of Nephrology, 49(6), 438–448. https://doi.org/10.1159/000500042 
Goraya, N., Munoz-Maldonado, Y., Simoni, J., & Wesson, D. E. (2021). Treatment of Chronic Kidney Disease-Related 
Metabolic Acidosis With Fruits and Vegetables Compared to NaHCO 3 Yields More and Better Overall Health 
Outcomes and at Comparable Five-Year Cost. Journal of Renal Nutrition, 31(3), 239–247. 
https://doi.org/10.1053/j.jrn.2020.08.001 
Goraya, N., Simoni, J., Jo, C. H., & Wesson, D. E. (2014). Treatment of metabolic acidosis in patients with stage 3 chronic 
kidney disease with fruits and vegetables or oral bicarbonate reduces urine angiotensinogen and preserves 
glomerular filtration rate. Kidney International, 86(5), 1031–1038. https://doi.org/10.1038/ki.2014.83 
Goraya, N., Simoni, J., Jo, C., & Wesson, D. E. (2012). Dietary acid reduction with fruits and vegetables or bicarbonate 
attenuates kidney injury in patients with a moderately reduced glomerular filtration rate due to hypertensive 
nephropathy. Kidney International, 81(1), 86–93. https://doi.org/10.1038/ki.2011.313 
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). (2021). Identify & Evaluate Patients with Chronic 

Page 5 of 34 
 
Kidney Disease. https://www.niddk.nih.gov/health-information/professionals/clinical-tools-patient-
management/kidney-disease/identify-manage-patients/evaluate-ckd 
Pereira, R. A., Alvarenga, M. S., Avesani, C. M., & Cuppari, L. (2020). Strategies designed to increase the motivation for and 
adherence to dietary recommendations in patients with chronic kidney disease. Nephrology Dialysis Transplantation, 
Nov 6 Epub(gfaa177). https://doi.org/10.1093/ndt/gfaa177 
Quintela, B. C. S. F., Carioca, A. A. F., de Oliveira, J. G. R., Fraser, S. D. S., & da Silva Junior, G. B. (2021). Dietary patterns and 
chronic kidney disease outcomes: A systematic review. Nephrology, 26(7), 603–612. 
https://doi.org/10.1111/nep.13883 
van Westing, A. C., Küpers, L. K., & Geleijnse, J. M. (2020). Diet and Kidney Function: a Literature Review. Current 
Hypertension Reports, 22(2), 1–9. https://doi.org/10.1007/s11906-020-1020-1 
Wesson, D. E., Kitzman, H., Montgomery, A., Mamun, A., Parnell, W., Vilayvanh, B., Tecson, K. M., & Allison, P. (2020). A 
population health dietary intervention for African American adults with chronic kidney disease: The Fruit and Veggies 
for Kidney Health randomized study. Contemporary Clinical Trials Communications, 17, 100540. 
https://doi.org/10.1016/j.conctc.2020.100540 
 
 
4 Design and Methodology 
 
Provide information regarding study design or data collection methodologies. Details regarding protocol specific 
research procedures will be discussed in a later section. 
 
To input text, click in the light grey area below. 
 Design: Two-arm randomized trial. Arm 1 is intervention (“program”) and arm 2 is control 
(usual care). Arm 2 will receive a monetary amount at the end of the 6 months to their 
preferred grocer. 
 
Randomization: 1:1 ratio, stratified by diabetes mellitus type 2 diagnosis prior to 
enrolment.  
 
Blinding: Outcome assessors, principal investigator, and biostatistician are blinded to 
participant allocation. Participant and other staff are unblinded.  
 
6-month/26 week, 2-arm Randomized Controlled Trial 
o Arm 1: Program + Usual Care 
Program contains following components provided in different combinations 
and frequencies over 26 weeks. 
1. Kick-off phone call plus a welcome package hand delivered in person by 
the RA at the baseline visit (after measurement completion) that will 
contain educational materials and resources (once after enrolment) 
2. Bags with fruits and vegetables (F&V) delivered at preferred times to 
the participant’s preferred location.  
3. SMS texts to remind of upcoming F&V deliveries, with links to access 
recipes. 
4. Electronic Gift cards (eGiftcards) to a grocery store chosen by the 
participant among available options.  

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5. A personal health partner who connects on the phone and via SMS text 
with the participant. 
o Arm 2: Materials Control + Usual Care 
1. Welcome package that includes same educational materials and 
resources: same as given to Arm 1. (Any intervention program-specific 
information will be removed.) 
2. Recipes: compiled from the same ones that Arm 1 received, but hand 
delivered at the beginning of the program by the RA at the baseline 
visit (after measurement completion (one-time). 
3. eGiftcards to a grocery store chosen by the participant among the same 
available options delivered after the 6 month measurement visit. 
 
Description of usual care: 
Patients in this study will be recruited from clinics within the Harris Health system.  In this 
system usual care for patients with CKD not requiring kidney replacement therapy 
includes having access to primary care physicians by face-to-face or virtual (TeleHealth) 
appointments and on an as-needed basis by phone or through Harris Health’s online 
portal.  
To support disease management, physicians can refer patients to Patient Educators (PtEd) 
[Registered Nurses (RN)], Registered Dietitians (RDs), and Case Managers [RNs and/or 
Social Workers (SWs)]. 
• The Outpatient Center is designed exclusively for outpatients requiring specialty and 
diagnostic and surgical care. Non-medical support at clinic site includes a Food 
Farmacy [which includes services by RDs, PtEd, and Community Health Workers 
(CHWs)] and the “Nourish Teaching Kitchen” (delivered in partnership with 
University of Texas School of Public Health). 
• The Smith Clinic and the Martin Luther King Jr. Health Center (MLK) are similar in 
their services to patients. They have an internal medicine clinic, which provides 
general primary care, along with multi-specialty clinics. It also has diagnostic 
imaging (such as Magnetic Resonance Imaging and ultrasound), full-service 
pharmacy with clinical pharmacists that provide support to patients with DM2 and 
hypertension, and laboratory services. They offer counseling, social services, and 
nutrition and health education, such as classes on diabetes and on basic nutrition.  
 
Outcomes: 
• Primary Outcome: Urine Albumin:Creatinine Ratio (uACR). 
• Secondary Outcomes: Food intake, diet quality, Hemoglobin A1C, Blood Pressure, 
and mental health (depression, anxiety) 
 
Measurements and tools: 

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The table below summarizes the tools and methods for data collection (for outcomes and 
population descriptors) and the time points during the study.  
All self-report will be conducted using a tablet with study staff available as necessary for 
help. 
 
Outcome 
Indicator or Measure 
Time points 
Tool 
Approach 
Demographics & Behavioral Patterns 
Demographics 
Includes  
-Gender, age, ethnicity, race, household size, 
income, age at CKD diagnosis, other conditions 
-Relationships: other food programs (e.g., 
Harris Health’s Food Farmacy, SNAP, WIC), 
where shop, social/wellbeing institutions & 
Harris Health. 
- Diabetes diagnosis (for stratification) 
Baseline 
Customized 
Self-report  
Social Needs 
Housing, transportation, paying for household 
necessities 
Baseline 
PRAPARE 
(within 
demographics 
survey) 
Self-report  
Biomedical Measures 
Kidney Injury 
Urine albumin:creatinine ratio (UACR) 
Baseline, 3, 6 mos 
Single urine 
sample  
Sample 
collection 
sent to Lab 
for analysis 
From 18 mo prior 
to 15 mo post 
enrollment, as 
available 
Electronic 
Health 
Records 
Data 
exchange 
Estimated Glomerular Filtration Rate (eGFR) 
From 18 mo prior 
to 15 mo post 
enrollment, as 
available 
Electronic 
Health 
Records 
Data 
exchange 
CVD risk & Diabetes 
Hemoglobin A1C 
Baseline, 3, 6 mos 
Finger stick on 
portable 
device 
Direct 
measureme
nt 
From 18 mo prior 
to 15 mo post 
enrollment, as 
available 
Electronic 
Health 
Records 
Data 
exchange 
CVD risk & 
Hypertension 
Blood Pressure 
Baseline, 3, 6 mos 
Automatic 
blood 
pressure cuff 
Direct 
measureme
nt 
From 18 mo prior 
to 15 mo post 
enrollment, as 
available 
Electronic 
Health 
Records 
Data 
exchange 
Anthropometric 
measures 
Measured Weight 
Baseline, 6 mos 
Weight Scale 
Direct 
measureme
nt 
Height 
Baseline 
Customized or 
Electronic 
Health 
Records 
Self-report 
or data 
exchange 

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BMI 
Baseline, 6 mos 
---- 
Derived 
From 18 mo prior 
to 15 mo post 
enrollment, as 
available 
Electronic 
Health 
Records 
Data 
exchange 
Eating Habits & Diet 
Food intake 
30-day food frequency questionnaire 
(screener) 
Baseline, 3, 6 mos 
Dietary 
Screener 
Questionnaire 
in the 
NHANES 
2009-10 
Self-report 
Self-
administere
d 
Diet quality 
Estimates of individual mean dietary intake  
Baseline, 3, 6 mos 
Calculated 
(from DSQ) 
Derived  
Food security 
Access to food 
Baseline, 6 mos 
USDA Food 
Security 
Questionnaire 
Self-report 
Food Preparation, 
Diet & Health self-
assessment 
Who shops, who prepares food, self and 
household assessment of diet and health. 
Baseline, 3, 6 mos 
Customized 
Self-report   
Mental Health, Social Support & Quality of Life 
Depression 
Depression symptoms 
Baseline, 3, 6 mos 
Patient Health 
Questionnaire 
8 items (PHQ-
8) 
Self-report  
Anxiety 
Anxiety symptoms 
Baseline, 3, 6mos 
General 
Anxiety 
Disorder 
(GAD-7) 
Self-report 
Perception of 
aloneness/ 
Loneliness 
Loneliness 
Baseline, 3, 6mos 
3-item UCLA 
loneliness 
scale 
Self-report 
Social support 
network & Isolation 
Frequency of connection with friends and 
family who can be relied on. 
Baseline, 6 mos 
Lubben Social 
Network scale 
Self-report 
Quality of Life 
Perceived Quality of life (general) Mental & 
Physical 
Baseline, 6 mos 
Short Form-12 
(SF-12) 
Self-report 
Healthcare Utilization 
Health care 
utilization 
Prescribed meds, Medical visits, 
hospitalization, ER, care delay due to cost, 
med-food tradeoff, medication underuse due 
to cost 
Baseline, 3, 6 mos 
Customized 
survey 
Self-report 
History of visits to clinic (both primary care 
and specialty care), visits to the ER, and 
hospitalizations 
From 18 mo prior 
to 15 mo post 
enrollment, as 
available  
Electronic 
Health 
Records 
Data 
exchange 
Kidney Disease & Role of Diet Perceptions 
Perception of kidney 
disease, role of diet, 
actionability. 
Understanding of having kidney disease; 
having some control over trajectory; 
perception of role of medical treatment & diet 
in improving disease. 
Baseline, 6 mos 
Modified 
“Brief Illness 
Perception 
Questionnaire
” 
Self-report 
Program Components 

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Interactions with 
dedicated health 
partner & program 
evaluation  
Perception of utility of partner overall and 
specific aspects; program satisfaction; 
community organization interaction. 
6 mo 
(intervention arm 
only) 
Customized 
survey 
Self-report 
         
 
5 
Data Analysis 
Describe the data analysis plan, including any statistical procedures or power analysis. 
 
To input text, click in the light grey area below. 
 
Our primary outcome of interest is Urine Albumin:Creatinine ratio (uACR) and 
secondary outcomes are Food intake through Dietary Screener Questionnaire, 
Hemoglobin A1C, Blood Pressure, self-efficacy, and mental health (depression, anxiety). 
Because comorbidity of diabetes mellitus (DM), particularly type 2, can affect 
responsiveness to the intervention, we will rely on stratified randomization of patients 
from the clinics by DM type 2 diagnoses.  
 
We will test differences in the trajectory of uACR over the course of six-months with 
three assessments (baseline, 3- and 6-months) for those who participate in the program 
versus those who do not. We will rely on linear mixed effect regressions with random 
terms to model individual differences in both the intercept and change terms, 
accounting for the clustering effect of the clinic sites. We will predict these trajectories 
using the following person-level covariates: grouping indicator, terms to capture DM 
comorbidity, and age. The cross-level interaction of grouping indicator with time will 
constitute the effect of interest. 
 
To explore if program’s impact on uACR varies for those with DM comorbidity, we will 
test three terms: the DM indicator, its interaction of time, and intervention X DM X time 
term. Given their exploratory nature, alpha for these terms will be lowered to 0.025. In 
order to assess the dose-response relationships, we will examine Pearson correlations 
among uptake of program elements with primary and secondary outcomes from 
baseline to 6-month assessments.  
STUDY ELEMENT IDENTIFICATION 
6 
Study Elements 
 
Click on the check box (or double click and type an “X” if using Google Docs) each procedure included in your 
study. 
 

Page 10 of 34 
 
A full description of all study procedures should be provided in the Procedures (Details) section below and/or the 
applicable supplement form. 
 
 
 
☒ 
 
Bio-specimens 
☐ 
 
Biometrics 
☒ 
 
Registry or Repository 
 
☐ 
 
Focus Group 
☐ 
 
Genetic Analysis 
☐ 
 
Genomic Data Sharing 
 
☐ 
 
International 
Research 
☒ 
 
Interview/Survey 
☐ 
 
MRI 
 
☒ 
 
Protected Health 
Information 
☐ 
 
Observation 
☐ 
 
Radioactive Material/PET/Nuc. 
Med 
 
☒ 
 
Record Review 
☒ 
 
Sensors  
(Externally Placed) 
☐ 
 
Sensors  
(Inserted) 
 
☐ Video/Audio 
Recording 
☐ 
X-Ray/CT 
 
 
 
7 
Study Intervention 
 
Click on the check box (or double click and type an “X” if using Google Docs) if you will implement any of the 
following interventions. 
 
A full description of all study interventions should be provided in the Procedures (Details) section below and/or 
the applicable supplement form. 
 
 
 
☒ Behavioral 
☐ Device 
☐ Drug/Biologic 
 
 
8 
Clinical Trial  
 
Click on the following check box (or double click and type an “X” if using Google Docs) if the research meets the 
below definition of a clinical trial.  
 
 
 
☒ This study meets the definition of a clinical trial according to clinical trials.gov in 
that it involves one or more human subjects who are prospectively assigned to 
one or more interventions (which may include placebo or other control) to 
evaluate the effects of those interventions on health-related biomedical or 
behavioral outcomes. 
 
 
9 
Additional Oversight  

Page 11 of 34 
 
 
Click on the check box (or double click and type an “X” if using Google Docs) each activity that requires oversight 
from additional UT committees.  
 
 
 
☐ Energy introduced 
to the subject 
(electrical, 
magnetic, light) 
☐ Human embryonic, 
human induced 
pluripotent, or human 
totipotent stem cells; 
or human gametes or 
embryos 
☐ Radiation exposure without 
direct clinical benefit 
 
☒ Biological Samples, Biohazards, Recombinant DNA, or Gene Transfer  
 
 
If biological samples are used and stored on UT campus IBC approval is needed. 
 
a 
☒ 
Biological samples collected will not be stored on UT sites and another 
agency has responsibility for biospecimen safety. 
 
b 
IBC Protocol Number 
To input text, click in the light grey area below. 
 
 
10 Alternatives to Participation in This Study 
To input text, click in the light grey area below. 
 
The alternative to participation is usual care at Harris Health clinics, the clinic system 
where we will be recruiting participants for this study. Participation in the study is 
voluntary; if the individual chooses not to participate in the research study, it will not 
affect the care they receive from Harris Health. 
 
STUDY PROCEDURE DESCRIPTION  
11 Procedure Description 
 
Describe all study procedures, including a step-by-step outline of what participants will be asked to do or how 
data will be used. Be sure to describe all of the following in detail, as applicable: 
 
- Provide a description of all research procedures being performed and when they are performed, in sequential 
order. 
- All research measures/tests that will be used and state if questions or measures are standardized or published 
(upload copies of all surveys, scripts and data collection forms) 
- Secondary data or specimens that will be obtained, how they will be collected, and how they will be used 
- Where each activity will take place, the duration of each, and who will perform each activity 
- Include time commitment of participants 
 
To input text, click in the light grey area below. 
 
 
This randomized trial study will have a total duration of 6 months. 

Page 12 of 34 
 
 
The procedures will take place at the following site: Harris Health System clinics (for 
example, LBJ Hospital Outpatient Center, Martin Luther King Jr. Medical Center, and 
Smith Clinic) in Houston, TX. 
 
This project is a partnership with the Harris Health system in Houston with co-Principal 
Investigators Esperanza “Hope” Galvan (Senior Vice President and Chief Health Officer, 
Harris Health System), and co-Investigators Dr. Rob Wesley (Site Director & Associate 
Director of Medicine Subspecialties- Harris Health’s LBJ Outpatient Center UT Medicine 
Clinic and Associate Professor of Medicine, McGovern School UT Health Houston), and 
Dr. Jaime Rueda (Internal Medicine and Pediatrician at Harris Health’s Smith & MLK 
Clinics and Assistant Professor at Baylor College of Medicine). 
 
 
1. Arm 1 (Intervention): 
 
Intervention components: 
F&V Bag Delivery with associated recipes.  
• F&V bags will be delivered to each participant’s preferred delivery 
location (e.g. home or work) and time (morning, after-work, etc.), within 
limits of grocery deliverer. 
• SMS texts (sent through a secure, HIPAA-compliant platform) will be used 
to inform participants of upcoming F&V bag deliveries and its content, as 
well as provide links to recipes customized to the items in the bag.  
• F&V bag content will be predetermined every week to include 2 kidney-
friendly vegetables sufficient for 2 meals for 4 people (family meals), fruit, 
and 1 kidney-friendly snack (e.g. dried fruit). The total cost is estimated at 
$20.00, excluding delivery, for prices in June 2022. 
eGiftcards for a grocery store (named “Healthy Eating Card” for the participant) 
• Sent via SMS text (or email if SMS text is not possible for the participant).   
• The choice of grocery store will be obtained at the beginning of the study 
from a list of options (e.g., Walmart, H-E-B, Kroger). 
Dedicated health partner: 
• A consistent program staff (“health partner”) will call the participant on a 
preferred phone number to build a relationship based on empathy, 
support the participant’s journey, answer specific questions about the 
program and help the participant get answers for practical shopping and 
food preparation questions.  
• Health partners will answer basic health-related questions that are 
available in the educational materials provided.  No medical guidance or 

Page 13 of 34 
 
advice will be provided – as these arise, health partners will recommend 
the participant call their clinic or physician. Questions will be answered on 
the phone or via SMS texts using a secure, HIPAA-compliant tool. A 
curated list of resources will be available for the Partner to share with the 
participant as needed—some examples appended. 
• Participants will receive phone calls from the dedicated health partner 2 
times a week for 4 weeks, then every other week for 8 weeks with the 
option to increase or decrease how frequent these phone calls are during 
the program. The schedule for calling is outlined in more detail in the next 
section below (under “Intervention Protocol”). 
• Based on our experience with such telephonic ‘lay’ support, we expect the 
average duration of calls to be less than 15 minutes.  
Share learnings with groups (Optional activity):  
• During the program, the Health Partner will encourage participants to 
identify an institution, group, or community of interest to them (e.g., ask 
to speak at a religious gathering, or at an association, a club, a community 
center or other) where they could share with others their own learned 
expertise on navigating their kidney disease. This will be optional and 
choosing not to do this activity will not affect their ability to participate in 
the overall study.  
 
Intervention Protocol 
o Week 1-2 (2 weeks): 
▪ Welcome Packet: During the baseline visit after measurement 
collection, the Research Staff will hand the participant a welcome 
packet including educational and motivational written materials, as 
well as a recipe book. 
▪ Welcome Call: Participants will be contacted by the Program Staff to 
introduce them to the program and ensure understanding. This call is 
expected to last 10-20 minutes. 
o Weeks 3-10 (8 weeks): 
▪ Weekly F&V Bags with recipes: Participants will receive one produce 
bag delivered every week for 8 weeks, for a total of 8 bags.  
▪ eGift cards for Grocery Store: At the start of week 7, participants will 
receive one eGift card for a grocery store of $30.00 value.  
▪ Phone calls with a Dedicated Partner: Participants will receive 2 calls a 
week from their dedicated partner in weeks 3-6. At the end of week 6, 
calls will shift to once every 2 weeks by default, but participants will be 
asked if they prefer increasing the frequency to once a week or 
decreasing to once every 4 weeks.  

Page 14 of 34 
 
o Weeks 11-18 (8 weeks): 
▪ Bi-weekly F&V Bags with recipes: Participants will receive one produce 
bag delivered once every 2 weeks for 8 weeks, for a total of 4 bags. 
▪ eGift cards for Grocery Store: during weeks 11-18, participants will 
receive two eGift cards of $40.00 each, sent 4 weeks apart, for a total 
of $80.00. 
▪ Phone calls with a Dedicated Partner: once every 2 weeks by default, 
but participants will be asked if they prefer increasing the frequency to 
once a week or decreasing to once every 4 weeks.   
o Weeks 19-26 (8 weeks): 
▪ eGift cards for Grocery Store: during weeks 19-26, participants will 
receive two eGift cards of $60.00 each, sent 4 weeks apart, for a total 
of $120.00. 
▪ Phone calls with the Dedicated Partner: once every 2 weeks by default, 
but participants will be asked if they’d prefer increasing frequency to 
once a week or decreasing to once every 4 weeks.   
 
2. Arm 2 (Control): Participants randomized to this arm will receive usual care, which 
was described in section #4 in the protocol. 
o Welcome Packet: During the baseline visit after measurement collection, the 
Research Staff will hand the participant a welcome packet including 
educational written materials, as well as a recipe book. 
o Welcome text: Soon after randomization, Program Staff will contact 
participants allocated to this arm to inform them of their allocation and share 
expectations for the next 6 months.  
o eGiftCards for Grocery Store: A $250 eGiftCard to the participant’s preferred 
grocer will be provided after the 6 month measurement visit. 
 
 
Research Measures Procedures (both arms) 
All study data will be collected during an in-person visit to a clinic within the Harris 
Health network, or other nearby convenient location, at 0 (baseline), 3, and 6 months 
of the study. Baseline visit may last a maximum of one hour, with subsequent visits 
being shorter. Data collection visits will follow the steps and procedures below:  
 
1. Consenting (max. 30 min) 
a. This process is detailed later. It happens over the phone and outside of 
the data collection visit. 
2. Enrolment (at baseline) or check-in (during subsequent visits) (max. 5 min) 

Page 15 of 34 
 
a. At enrolment, research staff will check in advance whether consent was 
received electronically (DocuSign), if not, will obtain it in writing, and ask 
questions to verify identity and register in the study. Research staff will 
also answer any questions the participant may have and make sure the 
participant still agrees to participate in the study since the time of initial 
consent. 
3. Biomedical measures (max. 10 min): 
a. A single urine sample will be collected on site in a sterile container 
following Labcorp and Harris Health standardized protocols and collected 
by a Labcorp courier for analysis within 24 hours of collection. 
b. Height, weight, blood pressure and Hemoglobin A1C will be measured by 
trained research staff, who will record them through the REDCap 
platform.  
4. Questionnaires (surveys) (max. 20 min) 
a. Other self-reported measures will be collected from participants through 
online, surveys using the REDCap platform on a mobile device (tablets) 
that will be provided to them at the time (self-administered) or read aloud 
(structure interview) by trained research staff and recorded onto the 
tablet in REDCap.  
 
Data collection tools are described in Item #4 of this protocol. 
 
 
 
SUBJECT POPULATION 
12 
Protected Subject Populations 
Click on the check box (or double click and type an “X” if using Google Docs) each population, if they are 
specifically studied for this research. 
 
 
☐ 
 
Active military 
personnel 
☐ 
 
Children 
☐ 
 
Decisionally impaired adults 
 
☐ 
 
Emancipated 
minors 
☐ 
 
Fetuses 
☐ 
 
Individuals with limited 
English proficiency 
 
☐ 
 
Neonates 
☐ 
 
Pregnant Woman 
☐ 
 
Prisoners 
 
☐ 
 
UT Students 
☐ 
 
UT or Seton 
Staff/Employees 

Page 16 of 34 
 
 
 
 
13* Research Participant Information 
Describe the research population. 
 
*For multiple research populations (e.g., teachers, students, and parents), copy this section as necessary to 
describe your population. 
 
a Participant Group Name 
To input text, click in the light grey area below. 
The research population is individuals at risk for progressing to late stage kidney 
disease.  1) Those diagnosed with chronic kidney disease (CKD) stages 2, 3a, and 3b, as 
defined by eGFR ≥ 30 and <90 mL/min/1.73 m2. 2) Those with Albuminaria as defined 
by ACR > 30 mg/g even if they are at CKD stage 1 or undiagnosed, but not if they have 
already advanced kidney disease (stage 4 or greater). 
 
b Minimum Age 
To input text, click in the light grey area below. 
18 years old 
 
c Maximum Age 
To input text, click in the light grey area below. 
None 
 
d Inclusion Criteria 
To input text, click in the light grey area below. 
• Adult (18 years of age or older) 
• Primary care visit at either one of the three partner clinics from Harris Health 
[Smith Clinic, Harris Health Outpatient Center (located on the LBJ campus), or 
Martin Luther King Jr. Health Center (MLK)] and a primary care patient within 
Harris Health System 
• Have had at least 1 visit in the past 18 months with prior history in the clinic (i.e., 
not first visit) 
• Diagnosis of CKD (Stage 2, 3a, and 3b) as defined by estimated Glomerular 
Filtration Rate (eGFR) ≥ 30 and <90 mL/min/1.73 m2     OR CDK 1 or undiagnosed 
with urine Albumin Creatinine Ratio ≥ 30 mg/g  
• Within the past 12 months, the most current serum K+ ≤ 4.6 mEq/L 
• English or Spanish speaking 
• Ability to participate in the program at least 6 months 
• Ability to clean, prepare, refrigerate/freeze food products that are given to them 
• Have access to receive SMS text messages 

Page 17 of 34 
 
 
 
• Location of preferred produce bag delivery within an available delivery zone 
 
e Exclusion Criteria 
To input text, click in the light grey area below. 
• CKD 4, ESRD or on dialysis. 
• Taking certain medications chronically (more than twice a week for 90 days) that 
may interfere with K+ metabolism (such as non-steroidal anti-inflammatory drugs 
(NSAIDs), as self-reported during enrollment screening 
• Taking mineralocorticoid receptor antagonists 
• Taking Warfarin 
• Diagnosis of any specific kidney conditions (such as polycystic kidney disease, 
glomerulonephritis, Lupus associated with Nephritis, Antineutrophil cytoplasmic 
antibody (ANCA)-associated vasculitis (AAV)) that would contraindicate study 
participation as determined by physician 
• Medical history of organ transplant that would contraindicate study participation 
as determined by physician 
• Received immunotherapy for primary or secondary kidney disease within 6 
months prior to enrolment 
• Diagnostic of heart failure conditions Class IV in the New York Heart Association 
(NYHA) functional classification 
• Had myocardial infarction, unstable angina, stroke, or transient ischemic attack 
(TIA) within 12 weeks prior to enrolment  
• Had coronary revascularization (PCI, CABG) or valvular repair within 12 weeks 
prior to enrolment 
• On active hospice care as self-reported during enrollment screening 
• Diagnosis of active malignancy requiring treatment that would contraindicate 
study participation as determined by physician 
• Has decompensated cirrhosis as determined by physician 
• Cognitive impairment that would contraindicate study participation as self-
reported during enrollment screening 
f Additional Population Information 
To input text, click in the light grey area below. 
 
14 Total Sample Size 
To input text, click in the light grey area below. 
332 recruited for 150 retained in each arm. 
15 
Sample size rationale 
To input text, click in the light grey area below. 

Page 18 of 34 
 
SCREENING AND RECRUITMENT 
 
17 
Identification and/or Screening Procedures 
Describe the identification and/or screening procedures below. 
To input text, click in the light grey area below. 
1. Screening #1 – Electronic Health Records (by Harris Health - HH): During the 
period of recruitment, Harris Health will produce an EHR report for HH 
credentialed research staff to identify, on a recurring basis, potentially eligible 
patients at each participating clinic using the inclusion and exclusion criteria 
within their electronic health records. Patients that clearly meet the inclusion 
criteria without “flags” from the exclusion criteria will be added to a pool of 
potentially eligible study participants. Patients whose medical history appointed 
to potential “flags” from the exclusion criteria will be streamed into step 2 
below.  
To detect a small to moderate sized standardized effect (f = .09) for the intervention by 
time term at the end of phase 1, we assumed a moderate correlation for rank-order 
stability in uACR over time of r= .30. To have 80% power at alpha = .05, we need to 
retain 150 individuals in each arm if we configure an attrition rate of 10%. Hence, we 
plan to recruit 166x2 = 332 total individuals. This sample size permits us to capture 
moderate effect sizes previously reported for dietary interventions in this population. 
Aggregate numbers from the clinics indicate that these numbers are feasible to recruit. 
Regarding correlations, we have 90% power to detect correlations as small as r = .26 
and 80% power to detect correlations as small as r = .23 within each group (N = 150) at 
alpha = .05. These are fair to moderate effect sizes that bear on the power of any 
follow-up mediation analyses or dose-response relationships. 
16 
Identification and Screening 
 
Click on the check box (or double click and type an “X” if using Google Docs) if true. 
 
 
☒ This study involves obtaining information or biospecimens for the purpose of 
screening, recruiting or determining eligibility of prospective subjects prior to 
informed consent by either: 
1. 
Oral or written communication with the prospective subject or LAR 
2. 
By accessing records containing identifiable private information or stored 
identifiable biospecimens. 

Page 19 of 34 
 
2. Screening #2 – Physician assessment, if needed (by HH clinicians who are on 
study personnel): For patients that had “flags” in their medical history 
(especially pertaining to the exclusion criteria), research staff credentialled and 
trained by HH will share those patients’ charts with a physician in the patient’s 
circle of care so that a physician assessment of eligibility can be completed—
particularly related to life expectancy, relevance of the program to the patient, 
and any concerns related to medication use and past medical history. Based on 
the physician’s assessment, patients will then be moved to the pool of 
potentially eligible study participants (and into step #3 below) or excluded. 
3. Contacting potentially eligible study participants: Study staff credentialed at HH 
will then contact those individuals in the final pool by phone, SMS texting, letter 
or email to inform about the study and to ask whether they would be interested 
in participating. 
4. Screening #3 and consenting, if eligibility is confirmed (by study staff): Study 
staff will check for eligibility related to having access to receive SMS text 
messages, preferred produce delivery location residing within a delivery zone, 
being able to clean, prepare, refrigerate/freeze food products adequately at 
home, and to participate in the program for at least 6 months (screening #3). If 
eligibility is confirmed, the study staff will invite them to join, initiate the consent 
process, and answer any questions they may have. Those who are interested and 
eligible will be asked to read and sign the consent form via DocuSign (if they 
have access and are able to do so), and will be informed of the next steps, 
including scheduling the first visit to the clinic for baseline data collection. If a 
signature for the consent form cannot be obtained virtually through DocuSign, it 
will be obtained physically, in person, during the first visit to a clinic for baseline 
data collection. Research staff will also answer any questions the participant may 
have and make sure the participant still agrees to participate in the study since 
the time of initial consent. 
 
 
18 
Recruitment Overview 
 
Click on the check box (or double click and type an “X” if using Google Docs) all recruitment methods utilized for 
this research. 
 
 
☒ E-mail 
☒ Flyer 
 
☒ In-Person 
☒ Letter 
 
☐ Social Media 
☐ Research Pool 
 
☒ Telephone/Text 
☐ Snowball Sampling 

Page 20 of 34 
 
 
19 
Describe the recruitment process, including where recruitment will take 
place. 
Describe the recruitment procedures below. 
To input text, click in the light grey area below. 
1. Forming and contacting a pool of potentially eligible participants at the 
partnering Harris Health clinics: After review of the Electronic Health Records 
(Screening #1) and a physician assessment (Screening #2, if applicable), patients 
will be added to a pool of potentially eligible participants. 
2. The study team will contact potentially eligible patients by phone, email, mail, 
and/or text, to determine their interest in participating and for further screening 
for eligibility on an ongoing basis until planned recruitment numbers are 
reached.  
3. Those individuals will then be asked questions related to Screening #3, as 
explained earlier, as the last step in confirming their eligibility. If the patient is 
interested and eligible, the research staff will read through the consent form 
with the patient and answer any questions. The patient will then sign the 
consent form electronically via DocuSign, if able to do so, and be informed of the 
next steps. Those who are interested and deemed eligible will then be scheduled 
for a baseline visit at one of the Harris Health clinics, where consent will be 
checked (or obtained in writing if electronic signature was not received) and data 
collection procedures will be performed.  
 
 
OBTAINING INFORMED CONSENT 
 
☐ Web-post 
☐ Word of Mouth 
20 
Consent Overview 
 
Click on the check box (or double click and type an “X” if using Google Docs) all applicable items. 
 
 
☒ Obtaining Written Informed 
Consent 
☐ Requesting a Waiver of Documentation of 
Informed Consent 
 
☐ Requesting a Waiver of 
Informed Consent 
☐ Requesting an Alteration of the Required 
Elements of Informed Consent 

Page 21 of 34 
 
 
 
 
☐ Obtaining Child Assent 
☐ Obtain Consent Using a Short Form with a 
Witness 
21 
Consent and Assent Processes 
 
Provide a detailed description of the consent process including who will obtain consent, where, and when 
consent will occur in such a manner that participants have sufficient time for adequate consideration. 
 
To input text, click in the light grey area below. 
Those who demonstrated interest in the study will receive a call to invite them to join 
the study. After final eligibility is confirmed (Screening #3), the research staff will read 
the consent form and answer any questions the individual may have. They will follow-
up with an email to the participant to ask them to sign the form electronically (via 
DocuSign), if they are able to do so. If an electronic signature is not possible or not 
received by the time of the first visit to the clinic, it will be obtained physically (in 
person) during the participant’s in-person enrollment and prior to start of baseline data 
collection. At both points, all study procedures will be discussed in detail with the 
participant and all questions will be answered. Patients will be made aware that 
participation is fully voluntary, and that they may change their mind at any time if they 
no longer choose to participate, without any negative consequence to their care by 
Harris Health system. These procedures will be the same at all sites. 
22 
Consent and Translation 
 
Click on the check box (or double click and type an “X” if using Google Docs) to indicate that consent will be 
translated. 
 
 
☒ 
The study population will likely include participants whose limited English 
speaking status requires translation of the consent form. 
 
 
Translation Process 
Click on the check box (or double click and type an “X” if using Google Docs) that best describes the translation 
process, either 21 or 22. 
 
23 
☐ 
The consent documents will be translated by a certified translator. 
 
24 
☒ 
A non-certified translator will translate the consent documents. 
If selected, complete the next two questions below. 
 
i Describe the translator’s qualifications 
To input text, click in the light grey area below. 
Two English-fluent and native-Spanish speakers within Factor Health research 
personnel. One will translate and the other will review and confirm translation. 

Page 22 of 34 
 
 
 
ii ☒ 
Another individual will confirm that the translation is accurate and 
appropriate. 
 
Waiver of Documentation of Informed Consent  
 
To approve a waiver of documentation of informed consent, one of the following options below must be 
justified by the researcher. 
 
Only complete the sections below if requesting a waiver of documentation of informed consent. If not 
requesting a waiver of documentation of consent, skip to 27. 
 
Please choose one waiver option and provide additional information as prompted. The Office of Research 
Support and Compliance recommends using Waiver Option 2 in most cases. 
 
25 
Waiver Option 1 
 
Provide confirmation for the following criteria and follow the additional instructions. 
 
Additional Instructions: 
1. Include this choice in the informed consent form.  
2. Articulate the destruction process for signed consent forms in the privacy and confidentiality section. 
 
Click on the check box (or double click and type an “X” if using Google Docs). 
  
a ☐ 
 
The only record linking the subject and the research would be the consent 
document. 
b ☐ 
 
The principal risk would be potential harm resulting from a breach of 
confidentiality. 
c ☐ 
 
Each subject will be asked whether the subject wants documentation linking the 
subject with the research, and the subject’s wishes will govern. 
26 
Waiver Option 2 
Provide confirmation for the following criteria and follow the additional instructions. 
 
Click on the check box (or double click and type an “X” if using Google Docs).  
 
a ☐ 
 
The study is minimal risk. 
b ☐ 
 
Written consent would not be required outside the research context. 
27 
Waiver Option 3 
Provide confirmation for the following criteria and provide additional information as requested. 

Page 23 of 34 
 
 
 
Click on the check box (or double click and type an “X” if using Google Docs).  
 
a ☐ 
 
The subjects or legally authorized representatives are members of a distinct 
cultural group or community in which signing forms is not the norm 
b Describe the cultural group or community. 
To input text, click in the light grey area below 
 
 
c ☐ 
 
The research presents no more than minimal risk of harm to subjects. 
d ☐ 
 
There is an appropriate alternative mechanism for documenting that informed 
consent was obtained. 
e Describe mechanism for documenting that informed consent was obtained 
To input text, click in the light grey area below 
 
 
 
Waiver or Alteration of Informed Consent  
 
To approve a waiver or alteration of informed consent all of the following criteria below must be justified by the 
researcher. 
 
Only complete the sections below if requesting a waiver of informed consent.  If not requesting a waiver or 
alteration of consent, skip to 31. 
 
28 
The research involves no more than minimal risk to the subjects. 
To input text, click in the light grey area below 
 
 
 
29 
The waiver or alteration will not adversely affect the rights and welfare of the 
subjects. 
To input text, click in the light grey area below 
 
 
 

Page 24 of 34 
 
 
30 
The research could not practicably be carried out without the waiver or alteration (it 
is impracticable to perform the research if obtaining informed consent is required and 
not just impracticable to obtain consent). 
To input text, click in the light grey area below 
 
 
 
31 
If the research involves using identifiable private information or identifiable 
biospecimens, the research could not practicably be carried out without using such 
information or biospecimens in an identifiable format. 
To input text, click in the light grey area below. 
 
 
Deception and Debriefing 
Only complete the sections below if requesting an alteration of informed consent that involves deceiving 
research participants. If this study does not involve deception, skip to 35. 
 
See IRB Policies and Procedures Section 15 for a description of deception. 
 
 Click on the check box (or double click and type an “X” if using Google Docs).  
32 
☐ It is appropriate to provide additional pertinent information to the subject after 
research activities are complete (e.g., the researcher needed to deceive to subject 
to the nature of the study). 
33 
☐ Research participants will have the opportunity to withdrawal their data during 
the debriefing. 
34 
Describe the nature of deception and why it is necessary to conduct the research. 
To input text, click in the light grey area below. 
 
 
35 
Describe debriefing procedures. 
To input text, click in the light grey area below. 
 
 

Page 25 of 34 
 
BENEFITS 
36 
Benefits to Society 
Describe the scientific and societal benefit(s) below. 
 
To input text, click in the light grey area below. 
This study will test the effectiveness of a multicomponent intervention aimed at 
increasing kidney-friendly food (including fruit and vegetable) consumption among 
individuals diagnosed with early stages (non-dialysis) chronic kidney disease as one 
strategy to delay disease progression and improve biomarkers of CVD. The study is 
done in close partnership with Harris Health, the major health system in Houston 
providing for the under and uninsured, who plans to continue to deliver the program to 
their patients in the long term if results are positive. By sustaining the program, 
families who receive their services will continue to benefit, positively impacting them in 
the long term. In addition, it will also add to the growing body of evidence on the need 
for health care systems to pay for interventions that support people’s health and delay 
disease progression in the community where they live, play, and work (instead of solely 
focusing on occasional clinical or pharmacological services).   
 
 
Benefits to Participants 
Click on the applicable check box (or double click and type an “X” if using Google Docs). 
 
37 
☒ 
There is no anticipated direct benefit to participants. 
 
38 
☐ 
There are anticipated benefits to participants. 
 
39 
If applicable, describe the potential direct benefits to participants. 
To input text, click in the light grey area below. 
 
RISKS 
40 
Describe the risks associated with each activity in this research 
To input text, click in the light grey area below. 
To study participants: 
• Accidental loss of confidentiality: Questionnaires and sample collection at an in-
person clinic can pose the risk of accidental breach of confidentiality.  
• Urine sample: There are no known risks from providing a urine sample. 

Page 26 of 34 
 
• Fingerstick blood sample for HbA1c testing: The blood sample for this point-of-
care test is only a very small drop from a lancet, posing minimal risks to the 
participant. Nonetheless, some potential risks include pain at the location, 
bleeding, bruising, infection, and skin irritations from cleaning agents used to 
sterilize the skin or bandages.  
• Blood Pressure with a pressure cuff: Participants may experience mild 
discomfort in their arm when the cuff is inflated. 
• COVID-19 transmission: There is a risk of transmission of coronavirus disease 
(COVID-19).  
 
41 
Describe how each risk is mitigated/minimized. 
To input text, click in the light grey area below. 
• Accidental loss of confidentiality: Study visits will be conducted in a private space 
to ensure privacy. Participants will be flowing through data collection points at 
the clinic in a way that reduces people (other than research staff) unwillingly 
seeing others’ information, such as booking time slots and directing people to 
separate spaces/rooms in the clinic. Samples and data will be handled and 
stored to protect privacy and confidentiality. All forms and samples will be 
labeled with a unique identifier for each subject and research staff will follow 
ethics training in assuring privacy and confidentiality, such as not discussing 
participants’ information or results in public areas. All data will be kept in a 
secure, locked environment only accessible to people who are on our research 
team. Any paper study documents will be stored in a secure lock bag or cabinet, 
with access granted only to the research study staff. Only the investigators and 
study staff will have access to the databases linking the study subjects to their 
identifiers. Databases, the texting tool and the web learning platform will be 
kept on secure, HIPAA-compliant servers.  
 
 
If participants choose to take part in the optional activity where they share their 
learnings and insights gained during this health journey (by speaking at a 
neighborhood meeting, to a congregation, at their children’s school or 
community center, for example) there may be a risk of breach in confidentiality, 
in their identity or privacy. Participants will be informed about this risk, and a 
reminder that this activity is completely optional, and that choosing not to take 
part in this portion of the study will not affect their participation in the overall 
study.  
 
The dissemination of data will not contain any patient identifiers and will only be 
shared as aggregated results. 

Page 27 of 34 
 
 
• Fingerstick blood sample for HbA1c testing and Blood Pressure equipment: To 
minimize risks of biohazard and contamination for HbA1c, only staff trained on 
the proper technique in doing this collection will be obtaining this measurement 
to maintain safety and minimize discomfort. Only trained staff will obtain blood 
pressure readings to minimize discomfort for the individual during 
measurement.  
 
• COVID-19 transmission: The study activities will only occur when this type of 
human research is allowed by the University of Texas at Austin and by Houston, 
Harris County, and Texas regulations related to COVID-19 and in-person 
interactions. All UT Austin and local and state regulations regarding personal 
protective equipment (such as masks) and other measures to reduce risk will be 
followed. 
 
 
 
Data Safety Monitoring 
For additional information regarding data safety monitoring boards and data safety monitoring plans, please 
see Section 21 of our Policies and Procedures. 
 
Click on the check box (or double click and type an “X” if using Google Docs). 
 
42 
☒ 
In the investigator’s opinion, this study is minimal risk and does not require a 
Data Safety Monitoring Plan (DSMP) or a Data Safety Monitoring Board 
(DMSB). 
PLEASE NOTE: The IRB may determine minimal risk studies do require data safety monitoring under 
certain circumstances (e.g., if there is a known risk with an expected frequency).  
 
43 
☐ 
This study does not have a Data Safety Monitoring Board, but researchers have 
an internal plan/policy to monitor for safety. 
Complete Data Safety Monitoring Details (44-51). 
 
44 
☐ 
This study has a Data Safety Monitoring Board (DSMB). 
Complete Data Safety Monitoring Details (44-51) or upload this study’s Data Safety Monitoring Board’s 
charter. 
 
 
Data Safety Monitoring (Details) 
 
45 
How is safety information collected? 
To input text, click in the light grey area below. 
 
 

Page 28 of 34 
 
46 
When will safety data collection start (for each participant or for the whole study, as 
applicable)? 
To input text, click in the light grey area below. 
 
47 
How frequently will safety data be collected? 
To input text, click in the light grey area below. 
 
48 
Who will review the data for safety? 
To input text, click in the light grey area below. 
 
 
49 
How frequently will data be monitored for safety concerns? 
To input text, click in the light grey area below. 
 
 
50 
What data will be reviewed? 
To input text, click in the light grey area below. 
 
51 
State the frequency or periodicity of the review of cumulative data? 
To input text, click in the light grey area below. 
 
 
52 
State any conditions that would trigger an immediate suspension of the research. 
To input text, click in the light grey area below. 
As this is a minimal risk study that provides food, eGift cards, and phone calls we do 
not expect any conditions that would trigger an immediate suspension of the 
research.  
 
 
 
Early Withdrawal 
Only complete this section if there are planned conditions under which a participant will be withdrawn from 
the study. If not applicable, skip to 56. 
 
Include this information in your consent form. 
 
 
 
53 
List the criteria for withdrawing individual participants from the study (e.g., safety 
or toxicity concerns, emotional distress, inability to comply with the protocol, or 
requirements from study sponsor). 
To input text, click in the light grey area below. 
 
 

Page 29 of 34 
 
54 
Describe any necessary procedures for ensuring the safety of a participant who has 
withdrawn early. 
To input text, click in the light grey area below. 
 
 
55 
Describe any pre-specified criteria for stopping or changing the study protocol due 
to safety concerns. 
To input text, click in the light grey area below. 
 
REQUIRED DISCLOSURES 
PRIVACY AND CONFIDENTIALITY 
Required Consent Disclosures  
Identify each element below that may require additional information to be disclosed in the consent form. 
 
Click on the check box (or double click and type an “X” if using Google Docs).  
 
56 
☐ 
It is reasonable that researchers could discover or suspect child or elder abuse. 
57 
☐ 
It is reasonable that researchers could learn of an incident that could require 
reporting under Title IX. 
58 
☐ 
It is reasonable that researchers could discover incidental findings or other 
information of medical interest about a participant's previously unknown 
condition. 
59 
Articulate methods for addressing and reporting incidental findings, if applicable. 
To input text, click in the light grey area below. 
 
60 
Privacy 
Describe how you will protect the identity and privacy of study participants during each phase of research. 
Privacy focuses on the individual participants rather than data. In this section, researchers should focus on 
issues such as where research activities take place and how participant involvement is protected from non-
participants. 
 

Page 30 of 34 
 
Describe methods to ensure participants’ privacy during identification, recruitment, screening, the consent 
process, the conduct of the study, and dissemination of data. 
 
To input text, click in the light grey area below. 
All data will be kept in a secure, locked environment only accessible to people who are 
on our research team. Electronic survey data will be stored in secure databases 
managed by the research team, such as REDCap and UT Box, approved by UT Austin for 
research purposes.  
 
Some health status data of study participants will also be requested from Harris 
Health’s electronic health record system based on participant consent and a data-
sharing agreement with Harris Health. Data will be transmitted using secured UT Box 
folder accessible only to research staff and contain identifiers for appropriate data 
linkages (first and last name and date of birth) and information on the following, as 
available: uACR, eGFR, Hemoglobin A1c, Body Mass Index, blood pressure, history of 
visits to clinic (both primary care and specialty care), visits to the ER, and 
hospitalizations. Historical health data will be obtained for the 18 months before 
enrollment into the study and 15 months post-enrollment. 
 
Data will be uploaded from the secure, password-protected Labcorp results portal into 
a secured UT Box folder accessible only to research staff and contain only two 
identifiers for appropriate data linkages (first and last name and date of birth) and the 
measured uACR results. 
 
Any paper study documents will be stored in a secure lock bag or cabinet, with access 
granted only to the research study staff.  
 
Study visits will be conducted in a private space to ensure privacy. Participant privacy 
will be maintained by conducting research visits in a private room for biomedical 
measures and dietary intake or, if in a large space due to the unavailability of private 
spaces, by providing adequate distance between participants in that same space. All 
self-administered surveys will be completed by participants using a mobile device 
(tablets) that can further ensure privacy while responding. 
 
If participants choose to take part in the optional activity where they share their 
learnings and insights gained during this health journey (by speaking at a neighborhood 
meeting, to a congregation, at their children’s school or community center, for 
example) there may be a risk of breach in confidentiality, in their identity or privacy. 
Participants will be informed about this risk, and a reminder that this activity is 
completely optional, and that choosing not to take part in this portion of the study will 
not affect their participation in the overall study. The dissemination of findings in 

Page 31 of 34 
 
 
 
64 Data Access 
 
Click on the check box (or double click and type an “X” if using Google Docs) for each group of individuals that 
will have access to study data. 
 
If you plan on creating a repository, complete the repository form as well. 
 
 
☒ Study Team 
Members 
☒ External Collaborators 
☐ Data coordinating center 
 
☐ Sponsor 
☒ Future Sharing with 
other researchers 
 
☐ Others 
Describe below. To input text, click in the light grey area below. 
reports and publications will not contain any patient identifiers and will only be shared 
as aggregated results. 
Confidentiality and Data Security Plan 
Click on the check box (or double click and type an “X” if using Google Docs) that best describes the 
confidentiality and data security plan and provide additional details regarding how you will protect the 
confidentiality of data or address confidentiality concerns.  
 
61 
☐ Identifiers will be coded to protect confidentiality. 
 
61a If true, state how data is coded and where identifiers are stored. 
To input text, click in the light grey area below. 
 
62 
☒ Identifiable data will be destroyed. 
 
62a If true, describe destruction plan and timeline 
To input text, click in the light grey area below. 
Identifiers will be destroyed at the end of the study after all data has been 
analyzed.  All data for analysis will be kept in a dedicated and restricted UT Box 
folder, accessible only by research staff associated with the project. This secure, 
HIPAA compliant platform can only be accessed with password and dual 
authentication.  
 
63 
☐ Identifiable data will not be destroyed. 
 
63a If true, provide rationale for retaining identifiable data indefinitely. 
To input text, click in the light grey area below. 
 

Page 32 of 34 
 
 
COMPENSATION AND COSTS 
65 
Describe data sharing plan for each group checked above and state whether 
researchers plan on sharing identifiable, coded, or de-identified data 
To input text, click in the light grey area below. 
No identifiable research data will be shared outside of the research team. Only de-
identified data or aggregated results will be shared with external collaborators (Harris 
Health) and when presented in public channels of communications (journals, news, 
magazines, conferences, etc.). This includes collaborating sites Harris Health, Baylor 
College of Medicine and UTHealth Houston. 
 
We may share de-identified data with other researchers for future studies to support 
advancement and comparison of evidence in the field. The data will be shared upon 
request. Information shared will only contain a study ID, selected demographic 
variables necessary for population comparison, and outcome variables—all potential 
personal identifiers will be removed.  
 
Certificate of Confidentiality  
Click on the check box (or double click and type an “X” if using Google Docs) to identify each element below that 
may require additional information to be disclosed in the consent form. 
 
If a Certificate of Confidentiality is not applicable for this study, skip to 68. 
 
66 
☐ The study requires a Certificate of Confidentiality. 
67 
☐ NIH has issued a Certificate of Confidentiality for this study. 
68 
☐ A Certificate of Confidentiality has not been obtained, but there are plans to 
apply for one. 
Compensation  
Click on the check box (or double click and type an “X” if using Google Docs). 
 
69 
☒ Subjects receive compensation. 
70 
☐ Subject will not receive compensation. 
Skip to question 74 if subjects will not receive compensation. 
71 
Total Amount of Compensation 

Page 33 of 34 
 
 
☐ 
Cash 
☐ Check 
☒ Gift Card 
 
☐ 
Course Credit 
☒ ClinCard 
☐ Tango Card 
 
☐ 
Other 
Describe, To input text, click in the light grey area below. 
 
 
 
To input text, click in the light grey area below. 
Research Compensation: Participants will receive up to US $150 total in compensation 
for the three data collection time points ($50.00 for each visit) being planned 
throughout the duration of the study. 
 
Program Payments: Participants in the intervention group will also receive $230 in 
program payments, and participants in the control group will receive $250 in program 
payments. 
 
72 
Type of Compensation 
Click on the check box (or double click and type an “X” if using Google Docs) for each form of compensation that 
will be provided. 
 
73 
Proration Schedule 
To input text, click in the light grey area below. 
Research Compensation: Participants will be paid $50.00 for each visit to the clinic at 
data collection points, for a maximum of $150.00 for 3 visits. 
 
Program Payments: Participants in the intervention group will be paid $230 at the 
following timepoints- the start of week 7- $30; weeks 11-18- 2 payments of $40 sent 4 
weeks apart, for a total of $80; weeks 19-26- 2 payments of $60 each, sent 4 weeks 
apart, for a total of $120. 
 
Participants in the control group will be given their program payment of $250 after 
their 6 month measurement visit. 
74 
☒ Amount of compensation and its form is reasonable for this population for the 
activities requested of them. 
75 
Costs 
 
Click on the check box (or double click and type an “X” if using Google Docs) each applicable item regarding 
costs. 
 
 
☐ 
Participants will have no costs associated with this study 

Page 34 of 34 
 
 
 
 
☐ 
Standard of care procedures 
contributing to study data 
 
☐ Research procedures not associated with 
standard of care 
 
☐ 
Administration of drugs / 
devices  
☐ Study drugs or devices 
 
☒ 
Transportation and parking  
76 
Describe all costs below. 
To input text, click in the light grey area below. 
 
There is a cost to the participant that will be related to travel to the sites where data 
collection for the study will happen. The amount of costs will vary from their location in 
relation to the clinic, but only a small cost is anticipated and the study visits will take 
place at their regular clinic site.