Meals for Me: Drop Shipment Versus Personally Delivered Medically Tailored Meals for Patients With Unmanaged Diabetes.
Phase: NA
Conditions: Diabetes
Sponsor: University of Texas at Austin

 
FORM: IRB Proposal - Standard Submission 
NUMBER 
VERSION DATE 
HRP-UT901 
(Ignore, template date is confusing 
clinicaltrials.gov) 
 
 
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Cover page added for Clinicaltrials.gov 
Meals for Me: Managing Diabetes at Home 
IRB Proposal with Protocol & Statistical Analysis Plan. Last update: June 21, 2023  
Clinical Trials No: STUDY00002808-2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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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. 
 
1. Assess the impact of medically-tailored meals program on diabetes management 
and mental health in comparison to usual care without such program for older 
adults. 
2. Assess the differential impact of two delivery models being considered for 
payment by the health system on diabetes management and mental health: 
once-a-week frozen drop shipment model versus more frequent warm meal 

Page 3 of 34 
 
delivery model that is more complex to implement but allows for human 
connection and easier meal preparation. 
 
3 
Study Background 
To input text, click in the light grey area below. 
 
Diabetes is prevalent and often accompanied by mental health conditions.1–3 Recent 
estimates suggest 28% of adults over 65 have diabetes4, and 18% of older adults who 
had difficulty paying medical bills reported symptoms of depression.5 The magnified 
challenges of supporting diabetes when mental health conditions such as depression co-
present have been recognized.6,7 
 
Home-delivered meals have begun to be assessed for their utility in improving health of 
recipients. The U.S. health system is beginning to pay for such services, usually for up to 
a month after discharge from hospitals.8 Recently, delivery of medically tailored meals 
(MTMs) has begun to be tested to support chronic condition management at home, 
especially for older adults.9,10 One dominant model for delivering MTMs by industry 
providers (e.g., Mom’s Meals) is a box of frozen meals drop-shipped once every week or 
two weeks. Meals on Wheels (MOW) organizations also provide these services but 
usually with delivery of ready-to-eat meals 3-5 times a week. Both kinds of programs 
have been shown to reduce hospitalizations suggesting improvements in health for 
those receiving the meals.9,11 
 
The drop shipment of frozen meals is optimized for delivery logistics and doesn’t deliver 
nor require human connection. In contrast, the MOW’s model is optimized for 
participant needs, with the participant receiving frequent meals that are ready-to-eat, 
delivered by a person directly with varying degrees of interaction. Qualitative 
assessments have highlighted the benefits perceived by participants of the daily 
delivery model.12 Because of changing funding environments, MOW organizations have 
also begun to test a frozen drop-ship delivery model for its relatively easier 
implementation.13,14 Neither model has been assessed, however, for how much benefit 
they provide to the participant including how many meals are actually eaten, health 
outcomes or other benefits of the human connection during delivery. Here, we aim to 
assess the benefits of medically-tailored meals on these measures as well as compare 
the differences in benefit from the two delivery models.  
 
This project is done in partnership with Meals on Wheels Central Texas (MOWCTX). 
 
References 
1. Anderson RJ, Freedland KE, Clouse RE, Lustman PJ. The prevalence of comorbid depression in adults with diabetes: A 
meta-analysis. Diabetes Care. 2001;24(6). doi:10.2337/diacare.24.6.1069 

Page 4 of 34 
 
2. Darwish L, Beroncal E, Sison MV, Swardfager W. Depression in people with type 2 diabetes: Current perspectives. 
Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy. 2018;11. doi:10.2147/DMSO.S106797 
3. Holt RIG, de Groot M, Golden SH. Diabetes and Depression. Current Diabetes Reports. 2014;14(6):491. 
doi:10.1007/s11892-014-0491-3 
4. The Administration for Community Living. 2020 PROFILE OF OLDER AMERICANS.; 2021. Accessed January 9, 2022. 
https://acl.gov/sites/default/files/Profile%20of%20OA/2020ProfileOlderAmericans_RevisedFinal.pdf 
5. Cheruvu VK, Chiyaka ET. Prevalence of depressive symptoms among older adults who reported medical cost as a barrier 
to seeking health care: findings from a nationally representative sample. BMC geriatrics. 2019;19(1). doi:10.1186/s12877-
019-1203-2 
6. Rosenthal MJ, Fajardo M, Gilmore S, Morley JE, Naliboff BD. Hospitalization and mortality of diabetes in older adults: A 3-
year prospective study. Diabetes Care. 1998;21(2). doi:10.2337/diacare.21.2.231 
7. Kangethe A, Lawrence DF, Touya M, Chrones L, Polson M, Evangelatos T. Incremental burden of comorbid major 
depressive disorder in patients with type 2 diabetes or cardiovascular disease: a retrospective claims analysis. BMC Health 
Services Research. 2021;21(1). doi:10.1186/s12913-021-06802-9 
8. Thomas Kornfield et al. Medicare Advantage Plans Offering Expanded Supplemental Benefits: A Look at Availability and 
Enrollment (Commonwealth Fund, Feb. 2021). Https://Doi.Org/10.26099/345k-Kc32.; 2021. 
9. Berkowitz SA, Terranova J, Hill C, et al. Meal delivery programs reduce the use of costly health care in dually eligible 
medicare and medicaid beneficiaries. Health Affairs. 2018;37(4). doi:10.1377/hlthaff.2017.0999 
10. Morris AM, Engelberg JK, Schmitthenner B, et al. Leveraging Home-Delivered Meal Programs to Address Unmet Needs 
for At-Risk Older Adults: Preliminary Data. Journal of the American Geriatrics Society. 2019;67(9). doi:10.1111/jgs.16013 
11. Cho J, Thorud JL, Marishak-Simon S, Hammack L, Stevens AB. Frequency of Hospital Use Before and After Home-
Delivery Meal by Meals On Wheels, of Tarrant County, Texas. Journal of Nutrition, Health and Aging. 2018;22(4). 
doi:10.1007/s12603-017-0973-5 
12. Thomas KS, Akobundu U, Dosa D. More Than A Meal? A Randomized Control Trial Comparing the Effects of Home-
Delivered Meals Programs on Participants’ Feelings of Loneliness. Journals of Gerontology - Series B Psychological Sciences 
and Social Sciences. 2016;71(6). doi:10.1093/geronb/gbv111 
13. Hewitt M, Nowak M, Gala L. Consolidating home meal delivery with limited operational disruption. European Journal of 
Operational Research. 2015;243(1). doi:10.1016/j.ejor.2014.10.045 
14. Gualtieri MC, Donley AM, Wright JD, Vega SS. Home delivered meals to older adults: A critical review of the literature. 
Home Healthcare Now. 2018;36(3). doi:10.1097/NHH.0000000000000665 
 
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: We will conduct a randomized controlled trial to assess impact of medically 
tailored meal (MTM) delivery on Hemoglobin A1C and mental health. The trial has two 
phases of 6 months each, for a total of 12 months. 
 
Phase 1: Randomized controlled trial, 6 months, with 3 arms as described below, with 
measurements at baseline, 3 months, and 6 months. 
 
Arm 1: Waitlisted Control 

Page 5 of 34 
 
• Educational materials 
 
Arm 2: “Daily Warm” MTM in-person delivery 
• Educational materials 
• Meal preparation instructions 
• 10 MTM delivered in-person 3-5X a week. 
• Each delivery day, one meal is warm, the other is frozen. Depending on the 
participant’s availability (3-5 days/week), more frozen meals will be given one 
day to account for a total of 10 meals every week. 
• Meals are delivered to the participant’s home by trained volunteers and/or paid 
delivery drivers who provide human interaction. 
 
Arm 3: “Weekly Frozen” MTM drop shipment   
• Educational materials 
• Meal preparation instructions 
• 10 MTM delivered 1X a week 
• Each week all meals are frozen. 
• Meals are shipped to the participant’s home with no human interaction. 
 
Phase 2: Three parallel arms, including the waitlisted control, will receive the standard 
MOWCTX model, which includes a lower number of meals delivered daily (1 instead of 2 a 
day), case management to help with social needs, and access to helpful services (e.g., 
home repair, pet care). Measurements will be taken at 6 (the same as in Phase 1), 9 and 
12 months. 
 
Each Arm: “Daily Warm MOWCTX Standard” 
• Meals are delivered 2-4x a week, depending on participant’s availability and 
delivery route. 
• Each delivery day includes a1 warm MTM and can include 1 or more frozen meals 
to account for a total of 5 meals/week.  
• Meals are delivered to the participant’s home by trained volunteers and/or paid 
delivery drivers who provide human interaction. 
• As per MOWCTX standard approach, participants will be assigned a case manager 
for additional support, as needed. 
• Welcome packet will be provided by the case manager, menu and educational 
materials sent monthly through the mail by MOWCTX (as part of their normal 
business model). 
 
 

Page 6 of 34 
 
 
Figure 1: Trial Design. MTM = medically tailored meals 
 
Randomization: Three-way randomization of eligible MOW clients to waitlisted control 
(n=80), and the two active arms (n=120 each) in 2:3:3 ratio. Eligible participants who are 
members of the same household will have one person as the index participant who be 
randomized to one of the three arms, and the other household member(s) will be 
allocated to that same arm. 
 
Blinding/Masking: Assessments are made in participant homes or an identified central 
site such as Dell Medical School.  
1. Outcome assessors are research associates (RAs) who will take direct biomedical 
measures (A1C, Blood Pressure). Participants self-report other measures directly through 
a tablet. However, given prior experiences, we anticipate cases where the RAs will need 
to assist them in answering questions.  RAs are blinded for all measures at baseline and 3 
months. At the end of each assessment, however, a set of questions are asked that are 
different for each of the three arms on food intake and preferences, and for arm 2, for 
the experience of delivery. Thus, baseline and 3-month assessments will be blinded to 
group assignment. But at the end of the 3-month assessment RAs will no longer be 
blinded. To minimize influence of unblinding, we will actively cross-assign RAs after the 3-
month measurement. We will also setup the online self-administered surveys specific to 
certain arms in a way that will reduce the likelihood of RAs accidentally identifying 
participants in different arms.  

Page 7 of 34 
 
2. Participant and program staff who are not part of the research assessment process are 
unblinded.  
3. Principal investigator and biostatistician are blinded to participant allocation. 
 
Outcomes & Data collection:  
Research assistants will collect data through direct measure and through surveys for self-
reported data either at the participant’s home or at a central location such as Dell 
Medical School or other identified location Section 11 describes research and data 
collection procedures. 
 
• Primary Outcome: glycated hemoglobin (HbA1c) 
• Secondary Outcomes: Blood Pressure, general physical and mental health, quality 
of life, diabetes distress, loneliness, depression, anxiety 
• Exploratory: Health care utilization (such as, hospitalizations, ED and doctor visits, 
food/medication trade-off, care delay), food consumption 
 
The table below provides an overview of the outcome measurements to be assessed and 
the population descriptors.  
 
Table 1. Outcome measurements to be assessed and population descriptors 
Outcome 
Indicator or Measure 
Tool 
Type 
Time points 
Diabetes 
management 
Hemoglobin A1c 
Fingerstick POC 
Direct measure 
B, 3m, 6m, 9m, 
12m 
Physical health 
Blood pressure 
Digital automatic BP 
monitor 
Direct measure 
B, 3m, 6m, 9m, 
12m 
Physical health & quality of 
life 
SF12-Physical health 
questions 
Self-reported 
B, 3m, 6m, 9m, 
12m 
Mental health 
Diabetes-related distress 
Diabetes Distress 
Screening 2-items (DDS2) 
Self-reported 
B, 3m, 6m, 9m, 
12m 
Mental health & quality of 
life 
SF12-Mental health 
questions 
Self-reported 
B, 3m, 6m, 9m, 
12m 
Loneliness 
3-item UCLA Loneliness 
Self-reported 
B, 3m, 6m, 9m, 
12m 
Depression 
PHQ-8 
Self-reported 
B, 3m, 6m, 9m, 
12m 
Anxiety 
GAD-7 
Self-reported 
B, 3m, 6m, 9m, 
12m 
Health care utilization 
& access 
DM medications 
Customized 
Self-reported 
B, 3m, 6m, 9m, 
12m 
Hospitalizations 
Customized 
Self-reported 
B, 3m, 6m, 9m, 
12m 
Emergency room visits 
Customized 
Self-reported 
B, 3m, 6m, 9m, 
12m 
Hypoglycemia episodes 
Customized 
Self-reported 
B, 3m, 6m, 9m, 
12m 

Page 8 of 34 
 
Visits to the doctor, 
behavioral health, social 
services 
Customized 
Self-reported 
B, 3m, 6m, 9m, 
12m 
Care delay due to cost 
Customized 
Self-reported 
B, 3m, 6m, 9m, 
12m 
Food/basic needs trade-offs 
Customized 
Self-reported 
B, 3m, 6m, 9m, 
12m 
Medication underuse due 
to cost 
Customized 
Self-reported 
B, 3m, 6m, 9m, 
12m 
Food security 
Food security scores 
USDA 6-item Food security 
questionnaire 
Self-reported 
B, 3m, 6m, 9m, 
12m 
Food consumption 
and satisfaction 
Dietary assessment 
Diet Screener (DSQ) 
Self-reported 
B, 3m, 6m, 9m, 
12m 
Non-program meal 
consumption 
Customized - Non-
program meals 
Self-reported 
B, 3m, 6m, 9m, 
12m 
Program hot meal 
consumption (Phase 1 Arm 
2 only; Phase 2 all arms) 
Customized 
Self-reported 
3m, 6m, 9m, 12m 
Program frozen meal 
consumption (Arms 2, 3) 
Customized 
Self-reported 
3m, 6m 
Program snack 
consumption, Overall 
program food consumption, 
Satisfaction, Comments 
(Phase 1 Arms 2 and 3; 
Phase 2 all arms) 
Customized 
Self-reported 
3m, 6m, 9m, 12m 
Value of human 
connection 
Perceived positiveness from 
having MOW 
volunteer/driver checking in 
on them. (Phase 1: Arm 2 
only. Phase 2: All arms.) 
Customized 
Self-reported 
3m, 6m, 9m, 12m 
Descriptors 
Measures 
Tool 
Type 
Time points 
Demographic data & 
social needs 
E.g., Age, time of DM 
diagnosis, household 
information, Housing 
Insecurity; Transportation 
Barriers; Financial Strain 
Customized 
Self-reported 
Baseline 
Usual healthcare & 
health status 
Usual healthcare received, 
insurance, health status and 
comorbidities 
Customized 
Self-reported 
Baseline 
Isolation and social 
connection 
Isolation and social 
connection 
Lubben Social Network 
Scale (LSNS-6) 
Self-reported 
Baseline 
 
Self-reported questionnaires on health care resource utilization (such as doctor visits, ER 
visits, hospitalizations, and medication use) have been shown to be acceptable proxies 
when medical claims and administrative data are unavailable, particularly for shorter 
recall periods than yearly (Allin et al., 2013; Leggett et al., 2016; Moura et al., 2021; Short 
et al., 2009).  
 
Allin, S., Bayoumi, A. M., Law, M. R., & Laporte, A. (2013). Comparability of self-reported medication use and pharmacy claims 
data. Health Reports, 24(1), 3–9. https://doi.org/10.1177/1742395320985913 
 

Page 9 of 34 
 
Leggett, L. E., Khadaroo, R. G., Holroyd-Leduc, J., Lorenzetti, D. L., Hanson, H., Wagg, A., Padwal, R., & Clement, F. (2016). 
Measuring resource utilization: A systematic review of validated self-reported questionnaires. Medicine, 95(10), 1–8. 
https://doi.org/10.1097/MD.0000000000002759 
 
Moura, C. S., Payette, Y., Boileau, C., Abrahamowicz, M., Pilote, L., & Bernatsky, S. (2021). Agreement in the CARTaGENE 
cohort between self-reported medication use and claim data. Chronic Illness. https://doi.org/10.1177/1742395320985913 
 
Short, M. E., Goetzel, R. Z., Pei, X., Tabrizi, M. J., Ozminkowski, R., Gibson, T. B., Dejoy, D. M., & Wilson, M. G. (2009). How 
accurate are self-reports? An analysis of self-reported healthcare utilization and absence when compared to adminstrative 
data. Journal of Occupational and Environmental Medicine, 51(7), 786–796. https://pubmed.ncbi.nlm.nih.gov/19528832/ 
 
 
 
 
 
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. 
 
The analytic plan is described for the primary outcome measures HbA1c (an objective 
indicator for diabetes management) and for PHQ-8 (a patient-reported measure of 
depression symptoms, part of mental health-related outcomes). Each of the remaining 
self-reported secondary outcome measure will be examined relying on similar model 
testing procedures. Only the index participant’s data will be included in the primary 
analyses.  
 
The two types of outcomes measures (objective and patient reported on mental health) 
inform questions around potential ‘losses’ and ‘gains’ in each phase and across phases. 
 
We will rely on linear mixed effect regressions with random person intercepts to 
analyze the outcome that are continuously distributed and measured repeatedly within 
each phase. These methods readily accommodate drop-out, variations in schedule of 
assessments that produce uneven spacing.  
 
In Phase 1, time will be modeled as days elapsed from baseline. Group assignments 
(arms) and person-level variables such as gender and age will be modeled in the second 
level to address questions of interest.  
 
Figure 1: A1 versus C1 
• We expect “weekly frozen” (C1) to make negligible, if any, difference in mental 
health relative to the waitlisted control group (A1), especially in the case of PHQ-
9 (depression symptoms), GAD-7 (anxiety symptoms) and SF-12 Mental Health 
subscale. 
 

Page 10 of 34 
 
Figure 1: B1 versus C1 
• Phase 1 models will also elucidate the health benefits of “daily warm” (B1) versus 
“weekly frozen” (C1) related to both the objective (HbA1C and blood pressure) 
and patient-reported mental health. 
 
In phase 2, all groups will be switching to the MOWCTX standard delivery (1 hot meal, 
3-4x/week, plus 1-2 frozen meals for a total of 5 meals/week), informing estimates for 
potential ‘losses’ and ‘gains’ that are observable from the switch. Hence, group 
assignments will still be modeled as the original Phase1 group assignments, but 
inferences will be distinct. The effect of primary interest to study questions is the fixed 
cross-level interaction of time with the grouping indicator (dummy indicators will be 
reserved for the active arms). 
 
Phase 2 models will be fitted to data twice: once starting with 6-month assessments 
and once starting with baseline assessments. If the maximal effects of phase 1 are 
evident at 6-months for majority of outcome measures, which we expect will be the 
case, modeling data from the maximal gains at 6-months to assess changes at 9- and 12-
months in the phase 2 of the program will be sufficient to inform targeted estimates. 
 
Figure 1: Arm 2, B1 → B2 
• We expect that Arm 2 shows some ‘loss’ in objective measures (HbA1c and blood 
pressure) moving from B1 to B2, but do not expect this group to show changes in 
mental health outcomes  
 
Figure 1: Arm 3, C1 → C2 
• We expect to observe ‘gains’ on mental health outcomes in Phase 2 (6-12 
months) in Arm 3 switching from “weekly frozen” shipment to standard 
MOWCTX’s meals delivery. 
•  The ‘gains’ on objective outcomes (HbA1c and blood pressure) for Arm 3 
(“weekly frozen”) may be limited. 
 
Figure 1: C1 → C2 versus B1 ‘gains’ 
• Arm 3 ‘gains’ on objective outcomes (HbA1c and blood pressure) may be more 
variable relative to the gains observed for participants in Arm 2 (“daily warm”) in 
phase 1. 
 
Figure 1: A2 versus B1 
• Finally, we will estimate whether the ‘gains’ in both mental health and objective 
measures observed in the waitlisted control during Phase 2 is inferior to the 
maximal gains we expect to observe in Arm 2 in phase 1. 

Page 11 of 34 
 
 
At 12-months, we have the opportunity to compare these groups on overall objective 
and mental health outcomes. This particular comparison informs whether there is an 
advantage of being exposed to ‘frequent’ contact over the prior year versus only half 
the year. If mental health support available in the “daily warm” delivery model 
maximizes the reductions in HbA1c and blood pressure (‘gains’) from delivered meals, 
we would expect such effects to be evident at 12-months.  
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. 
 
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 

Page 12 of 34 
 
 
 
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  
 
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. 
 
For those not eligible to the regular MOWCTX program, there are no other alternatives 
to participation. While the alternative to participation in this study for some individuals 
would be the usual Meals on Wheels Central Texas program, eligibility to the regular 
MOWCTX program is, however, different from the eligibility to this present study 
 
 

Page 13 of 34 
 
 
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. 
 
 
After eligibility is confirmed and consent is obtained, participants will be randomized 
to one of the three arms (as described in Section #4 of the protocol). 
 
Phase 1 (6 months) 
• Arm 1: Waitlisted control 
o Receives educational materials on such topics as healthy eating for 
diabetes. 
 
 
• Arm 2: “Daily Warm” MTM in-person delivery 
o Receives the same educational materials as Arm 1, in addition to materials 
on meal planning and instructions. 
o All participants randomized to this arm will receive a total of 5 hot, 5 
frozen, and 5-10 snacks per week. Meals and snacks offer approx. 1200 
kcal per day. 
o The frequency and type of meals change as the following, depending on 
the participant’s availability:  
▪ 5x/week delivery: Receives daily 1 hot, 1 frozen, and 1-2 healthy 
snacks Mon-Fri. 
▪ 4x/week delivery: Receives 1 hot + 1 frozen meal each delivery day, 
plus 2 extra frozen meals on one day. 
▪ 3x/week delivery: Receives 1 hot + 1 frozen meal each delivery day, 
plus 4 extra frozen meals on one day.  
o MOWCTX’s trained volunteers and/or paid delivery drivers delivering the 
meals will have a brief social interaction (“check-in”) with the participant. 

Page 14 of 34 
 
o Time required: approx. 5-15min. for participant to receive food and 
interact.   
 
• Arm 3: “Weekly Frozen” MTM drop shipment  
o Receives the same educational materials as Arm 1, in addition to materials 
on meal planning and instructions 
o Receives once a week 10 frozen medically tailored meals and 5-10 healthy 
snacks (with the goal of providing 2 meals and 1-2 snacks for 5 days of the 
week). Meals and snacks offer approx. 1200 kcal per day.  
o Meals are shipped to the participant’s home.  
o No human interaction. 
o Time required: approx. 3 min. for participant to collect the box once a 
week. 
 
Phase 2 (6 months) 
• All arms receive standard MOWCTX home meal delivery: 
o Everyone receives 5 meals/week, delivered 2-4x a week, depending on 
participant’s availability and delivery route. Planned to offer approx. 600 
kcal per day. 
o Each delivery day includes one hot MTM plus one or more cold bags (with 
healthy snacks), plus enough frozen meals to account for a total of 5 
meals:  
o Meals are delivered Monday to Friday at the participant’s home during a 
delivery window set by MOWCTX. 
o MOWCTX’s trained volunteers and/or paid delivery drivers delivering the 
meals will have a brief social interaction (“check-in”) with the participant. 
o Participants will have access to a case manager to assist with additional 
resources within the community and for additional support if needed 
(e.g., grocery shopping assistance, home repairs, and pet care).  
o Time required: approx. 5-15 mins. for the participant to receive food and 
interact.  
 
All meals are planned and approved by MOWCTX’s Registered Dietitian Nutritionists.  
 
As a standard of practice, MOWCTX screens (runs background checks) and trains their 
volunteers and paid drivers delivering the meals. These volunteers and drivers will not 
be engaged in research (i.e., will not do consent, collect data, or data analysis). We will 
not collect data on them as part of the research.  
 
Data collection procedure during visits: 

Page 15 of 34 
 
Baseline (0) and subsequent measurement collection (3, 6, 9, and 12 months) will 
occur at a central site or at participant’s home. The initial baseline visit will take 
approximately 45 minutes, while subsequent measurements will be shorter (20-30 
minutes each). The research team members will follow the steps and procedures 
below for data collection: 
 
1. Enrollment/Baseline (5-10 mins) 
a. Research team member will obtain written consent if consent has not 
already been received electronically. 
b. HbA1c will be measured by trained research staff to ascertain eligibility. 
Once confirmed, the research staff will proceed with collecting other data 
measures. If participant does not meet A1c inclusion criterion, research 
staff will not collect any further data and will provide compensation for 
the visit. This information will be recorded in HIPAA-secure REDCap 
database. 
 
2. Baseline and subsequent measurements: 
a. Biomedical measures (~10 mins): BP and HbA1c will be measured by 
trained research staff and will be recorded in HIPAA-secure REDCap 
database. 
 
Participants will self-report other measures through self-administered online surveys 
in REDCap using a tablet. Given prior experience, we expect that RAs may need to help 
some individuals answer questions. If needed, research staff may give hard copies of 
the surveys for the participant to look at in the event they have a limitation where this 
may be needed or they may need to read the questions aloud to the participant if they 
have a limitation that does not allow for them to read it themselves. 
 
 
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 

Page 16 of 34 
 
 
 
 
☐ 
 
Emancipated 
minors 
☐ 
 
Fetuses 
☐ 
 
Individuals with limited 
English proficiency 
 
☐ 
 
Neonates 
☐ 
 
Pregnant Woman 
☐ 
 
Prisoners 
 
☐ 
 
UT Students 
☐ 
 
UT or Seton 
Staff/Employees 
 
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. 
Older adults, 55 and over, living in the Austin city limits with poorly controlled diabetes. 
 
Minimum Age 
To input text, click in the light grey area below. 
55 
 
c Maximum Age 
To input text, click in the light grey area below. 
90 
 
d Inclusion Criteria 
To input text, click in the light grey area below. 
• Adult 55-90 
• Hemoglobin A1c ≥7.5  
• Living in Austin city limits and within a MOWCTX daily delivery route 
• Interested and available to receive meals during delivery window time 
• Has access to a freezer and a microwave 
• Pass a MOWCTX background check 
 
e Exclusion Criteria 
To input text, click in the light grey area below. 
• Participated in MOW program in previous 3 months. 
• Has any of the following: dementia or cognitive impairment, diagnosis of heart 
failure, cirrhosis, or active cancer 
• Is receiving hospice care 

Page 17 of 34 
 
 
 
SCREENING AND RECRUITMENT 
• Does not pass a MOWCTX background check 
 
 
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. 
We aim to recruit a total of 400 people who will be randomized to account for an 
estimated attrition of 20%. This would optimize the ability to retain the number of 
participants in each arm, shown below, that supports the statistical analysis with 
adequate power. 
Total N = 320 
Arm 1: Waitlisted Control, n=80  
Arm 2: Daily warm, n=120 
Arm 3: Weekly frozen, n=120 
15 
Sample size rationale 
To input text, click in the light grey area below. 
Our target sample sizes (after attrition) in the active arms (2 and 3), each 120, and 80 in 
the waitlist (for a total of N=320) permits us to test both targeted effects supporting 
causal inference in phase 1. The potential loss/gain estimates we will inform from the 
switch to daily warm delivery of a single meal in phase 2. As described in the data 
analysis section, the study is powered to detect meaningful cross-level interactions of 
time with dummy variables capturing group assignments in phase 1. We have 80% 
power to detect at alpha =.05 fixed interaction effects of f = .08 with minimal attrition. 
Even with 20% attrition we can still detect fixed interaction effects of size f= .09. These 
are meaningful small to moderate size effects. 
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: 

Page 18 of 34 
 
 
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. Interest: Potentially eligible participants will be identified through various 
recruitment venues and sites (as described in Section 19) where older adults 
who are low income can be reached and where those with unmanaged diabetes 
can be easily identified. Those who express their interest in the study will be put 
on an interest list. 
2. Screening #1 + reading consent: Research staff contacts via text and phone call 
those on the interest list to give more information on the study, confirm interest, 
conduct initial screening and proceed to reading the consent form. 
a. Screening #1: Once RA confirms interest, they will obtain their 1) name, 2) 
age, 3) address (which will be shared with MOWCTX post-call to confirm 
they live within the delivery route zones), 4) availability during the week 
and the meal delivery window, 5) confirmation that they are the 
household participant who will receive and eat the meals, 6) willingness to 
undergo a MOWCTX background check (noting that they have to pass to 
be eligible), and 7) access to a freezer and a microwave. The RA will also 
review the exclusion criteria, such as any prior MOWCTX program 
participation and disease diagnoses. 
b. Once the participant has shown interest and confirms they can receive the 
meal during the delivery time window (after #4 and #5 above), the RA will 
let them know that for the study, it is important to make sure they are the 
ones that will receive and eat the meals.   If at this time, the individual 
shares that it is a household member who should receive the meal, the RA 
will schedule a follow up phone call with the household member who will 
then be screened to see if they are eligible for the program. Reading the 
consent form: If the individual is deemed eligible after Screening #1 (with 
the exception of the background check, which will be screened for after 
the initial assessment of interest call takes place), the RA will proceed to 
reading the consent form and scheduling an enrollment visit (contingent 
on a passed background check). The RA will also inform the individual of 
the three criteria that still need to be confirmed for full eligibility and 
enrollment into the study: 1) living in a MOWCTX daily delivery route (via 
the address, to be checked by the RA using the delivery map provided by 
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 
 
MOWCTX – edge cases will need to be checked after the phone call and RA 
to call the person back), 2) the HbA1c level criterion, which will be checked 
during the first data collection visit, and 3) passing the background check 
conducted by MOWCTX. The consent form will be sent to the participant, 
via DocuSign, if they are willing to share an active email address. If they 
wish to sign in-person at the first enrollment visit, that will be an option 
for them.  
NOTE: If the participant does not live within MOWCTX daily delivery zones, 
the participant will be notified during the phone call using the delivery 
map provided by MOWCTX, if it is an edge case, the person will be notified 
via a subsequent text and/or phone call that they do not meet this 
eligibility criterion prior to coming in for an enrollment visit. 
3. Screening #2 (pass background check completed by MOWCTX) The background 
check will be conducted prior to a baseline visit that takes place in the potential 
participant’s home. This is a standard Meals on Wheels practice to ensure the 
safety of research staff. Once MOWCTX confirms whether they have passed or 
not with the research team, the person will be contacted again to confirm 
enrollment visit (next step).  
4. Screening #3 (Written consent + HbA1c): At the time of the enrollment visit, the 
research team member will obtain written consent, if person has not completed 
e-signature of consent form via Docusign. Once written consent has been 
confirmed or obtained, research staff member will collect HbA1c measure to 
confirm that eligibility criterion.  
5. Complete and confirm enrollment: The research team member will call and/or 
text and let the individual know whether they have been successfully enrolled 
into the study (if deemed fully eligible) or that they could not be enrolled due to 
not meeting all eligibility criteria 
 
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 
 
☒ Web-post 
☐ Word of Mouth 

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. 
 
Our lab team and MOWCTX will generate an interest of potentially eligible participants 
by engaging and outreaching to groups, sites, and organizations who serve low income 
individuals. Our recruitment efforts will focus on adding low income individuals onto 
our interest list. The table below provides examples of potential recruitment sites and 
strategies. 
 
Strategy 
Potential sites 
Referrals onto program interest list via 
clinic system 
CommUnity Care Health Centers 
WellMed medical group – dual eligibles 
People’s Community Clinics 
Direct member outreach 
United Health Care (UHC)’s Medicaid 
member list 
Outreach via older adult housing and 
centers 
Housing Authority of the City of Austin 
(HACA) senior housing, other housing sites 
and centers who serve older adults 
MOWCTX wait list 
MOWCTX 
 
Posters, flyers, emails, phone calls and/or texts with an invitation to participate will be 
posted at these locations or sent to listservs. In addition, some organizations may 
outreach to the member/patient base to assess general interest through a script 
provided by the research team (see script attachment). Once someone has indicated 
interest and provided permission, the organization will provide their contact 
information to the research team to schedule a time to obtain consent and screen the 
individual for enrollment. 
 
If multiple people from the same household indicate interest, both individuals will be 
screened as normal. If only one meets eligibility criteria, only one will be enrolled into 
the study as a unique case. The first person from that household that meets all 
eligibility criteria and completes their baseline measurement will serve as the index 
participant. The index participant will be the participant that is randomized to one of 

Page 21 of 34 
 
the three arms. The other member(s) of the household will be household participants, 
and they will be allocated to the same arm the index participant was randomized into.  
 
 
 
OBTAINING INFORMED CONSENT 
 
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 
 
☐ 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. 
 
1. Research team members will contact by phone and/or text the individuals who 
indicated interest in the study via recruitment strategies and will further explain 
the study to confirm interest.  
2. When interest is confirmed, the research team member will read through the 
consent form over the phone. They will allow as much time as the person needs 
to ask any questions they may have. They will also explain that the research is 
voluntary and they are not required to participate and may withdraw at any time 
for any reason. If the potential participant agrees to participate, they will be sent 
the consent form via DocuSign to obtain an e-signature. If the person does not 
have email, or wishes to sign in-person, they will do so at the in-person 
enrollment visit that will be scheduled with the research team member. A copy 
of the unsigned consent form will also be provided at the time of the enrollment 

Page 22 of 34 
 
 
 
visit for everyone (regardless if they signed via DocuSign or sign in-person) as 
making a copy of the signed copy at home visits or central sites may be difficult. 
If the participant would like a copy of the signed consent form, a copy will be 
mailed or provided at the next in-person visit. 
 
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. 
Multiple English fluent and native Spanish speakers within research personnel. 
One will translate and the other will confirm translation. 
 
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 

Page 23 of 34 
 
 
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. 
 
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. 

Page 24 of 34 
 
 
 
 
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 
 
 
 
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. 
 
 

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. 
Addressing nutrition through delivery of medically-tailored meals could improve 
chronic illness and potentially result in savings to the healthcare system. The study is 
done in partnership with Meals on Wheels Central Texas (MOWCTX), one of the largest 
meal-delivery organizations in the State, who plans to expand its program 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 impact of medically-tailored meals for health care 
systems to pay for interventions that support people’s health in the community where 
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 26 of 34 
 
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. 
Individuals may or may not benefit from this study. Individuals participating in this 
study may see the anticipated direct benefit of improved glucose control, access to 
food and diabetes healthy diet, reduction of social isolation and loneliness, as well as 
improved anxiety and depressive symptoms. 
 
 
RISKS 
40 
Describe the risks associated with each activity in this research 
To input text, click in the light grey area below. 
• Accidental loss of confidentiality: Questionnaires and sample collection at an in-
person visits can pose the risk of accidental breach of confidentiality.  
• 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. 

Page 27 of 34 
 
• Accidental loss of confidentiality: Study visits will be conducted in a private space 
to ensure confidentiality and privacy are maintained. 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 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 the research team. Any hard copy documents with data 
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 
REDCap, the database linking the study subjects to their identifiers and data that 
has been collected as part of this study. Databases will be kept on secure, HIPAA-
compliant servers.  
 
• 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 Austin, 
Travis 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).  
 

Page 28 of 34 
 
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. 
 
 
 
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. 

Page 29 of 34 
 
 
 
 
52 
State any conditions that would trigger an immediate suspension of the research. 
To input text, click in the light grey area below. 
 
 
 
 
 
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. 
Participants may be withdrawn from the study if they are verbally abusive or 
inappropriate with research staff or if it is determined by a healthcare provider or the 
research team that it is unsafe for them to continue.  
 
They may be also be asked to leave the study if conditions for delivery are not deemed 
safe by staff or delivery drivers, including but not limited to, mistreatment, 
harassment or other inappropriate behavior towards staff or delivery drivers either by 
the participant or by someone else at the participant’s residence; repeated violation 
of the dog policy; dangerous structural conditions; or if illegal activities are carried in 
or around the residence. 
 
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. 
There are no procedures in place to ensure the safety of a participant that is 
withdrawn for inappropriate behavior or because it was determined by a healthcare 
provider or research staff. This is a minimal risk study and being withdrawn poses no 
risk to the participant.  
 
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. 

Page 30 of 34 
 
None  
 
 
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. 
Given the population of interest is older adults, it is reasonable that researchers could 
discover or suspect elder abuse. If we learn during the study about elder abuse or 
neglect, we will report the information to the appropriate authorities, including the 
police and the Texas Department of Family and Protective Services. 
 
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 31 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, UT Box. 
 
Participant privacy will be maintained by conducting research visits in a private room or 
if in a large space, by providing adequate distance to ensure privacy. If participant 
chooses to complete surveys with a hard copy, it will be stored in a locked cabinet 
before and after measurement collection. In addition, paper copies of signed consent 
will be stored in locked cabinet and electronic copies will be stored on secure UT Box 
platform. 
 
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. After the 
study ends, the University of Texas at Austin might contact participant/s to determine interest in 
media opportunities, which would be completely optional for them to do so. All data will be 
stored in the Dell Med REDCap database and/or on UT Box.  These secure, HIPAA compliant 
databases can only be accessed with password and dual authentication. Hard copies of the 
measurements will be available to participants upon request. Any paper copies with identifiable 
information (such as written consent forms) will be stored in a locked cabinet until it is destroyed 
with the other data (two years after the end of the study).  
 
 
63 
☐ Identifiable data will not be destroyed. 
 

Page 32 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. 
 
63a If true, provide rationale for retaining identifiable data indefinitely. 
To input text, click in the light grey area below. 
 
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. 
Due to the nature of the study, identifiable data will be shared with MOWCTX during 
the study. This is critical and necessary to be able to conduct the research study as 
MOWCTX needs to know demographic data in order to deliver the intervention. We 
will not record the addresses of ineligible participants and we will destroy the 
addresses on a monthly basis from our database if they are deemed ineligible. Non-
aggregated and de-identified study data will be shared with MOWCTX after analysis for 
the purpose of improving care to the client population. Aggregated and de-identified 
data will be shared with MOWCTX and presented in public forums. 
 
We may share data with other researchers for future research studies that may be 
similar to this study or may be different. The data shared with other researchers will 
not include information that can directly identify the participant. 
 
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. 
 

Page 33 of 34 
 
COMPENSATION AND COSTS 
 
☐ 
Cash 
☐ Check 
☒ Gift Card 
 
☐ 
Course Credit 
☐ ClinCard 
☒ Tango Card 
 
☐ 
Other 
Describe, To input text, click in the light grey area below. 
 
 
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 
To input text, click in the light grey area below. 
Participants will be paid $50.00 for each measurement visit for a maximum of $250.00 
for 5 visits. 
 
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. 
Participants will be paid $50.00 for each measurement visit for a maximum of $250.00 
for 5 visits. 
 

Page 34 of 34 
 
 
 
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 
 
☐ 
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 small cost to travel to the study visit sites.  This will vary from one participant 
to the next, but will be negligible for most.