Delivering Health: An Integrated Approach to Address Diabetes in the Context of Food Insecurity
Phase: NA
Conditions: Food Insecurity, Diabetes Mellitus, Type 2
Sponsor: University of Arkansas

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Study Title: 
Delivering Health: An Integrated Approach to Address Diabetes in 
the Context of Food Insecurity 
 
Principal Investigator:  
Krista Langston 
University of Arkansas for Medical Sciences Northwest 
2708 S. 48th Street 
Springdale, AR 72762 
Telephone: 479-713-8691 
Email: KLangston@uams.edu 
 
 
Study location: 
University of Arkansas for Medical Sciences Northwest 
4301 West Markham Street 
Little Rock, AR 72205 
 
 

Title: Delivering Health: An Integrated Approach to Address Diabetes in the Context of Food 
Insecurity 
PI: Krista Langston 
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Background and Rationale 
Decades of increasing incidence of type 2 diabetes (T2D) present a multifaceted challenge to the 
health of a growing number of Americans, affecting their diets and how they live life. 
Approximately 30 million (~9%) of all people in the US have T2D,1 and this number is expected 
to continue to rise. It is estimated that the prevalence will increase to more than 54 million 
Americans by 2030.2 At the same time, 15 million (11.8%) US households experience food 
insecurity,3 which is associated with risk for T2D and other chronic diseases.4 Both T2D and 
food insecurity are even more prevalent in Arkansas, with rates of T2D and food insecurity at 
12.2%5 and 17.3%,6 respectively. T2D and food insecurity are strongly associated for U.S. 
adults: Very low food security is associated with an over 100% increase in prevalence of T2D 
compared with adults from high food-secure households.4 Even for adults in marginally food 
secure households, probability of T2D increases by 59%.4 
 
~40 million Americans are food insecure,3 and food insecurity is associated with double the 
prevalence of T2D.4 Food insecure people face many risk factors for unmanaged T2D,7 including 
poor diet quality,8-12 insufficient physical activity,13-15 and lack of access to health care.16-18 
Unmanaged T2D can lead to increased risk of serious complications, including neuropathy, 
nephropathy, retinopathy, atherosclerosis, heart attack, stroke, and death.19 
 
~46 million Americans per year turn to food pantries and related programs to help meet 
household nutritional needs.20 An estimated 33% of food pantry client households have at least 
one member with T2D.20 Among these, 46% use food pantries at least six times per year.21 
 
However, food pantries are not a long-term solution to improve health for food insecure people 
with T2D. Most food pantries do not provide food of sufficient dietary quality to support a 
healthy lifestyle, particularly for vitamins A and C and calcium.22 Current food pantry clients’ 
diet quality is insufficient for caloric intake, fruits, vegetables, and dairy.23 
 
Diabetes self-management education (DSME) is an approach with documented efficacy in 
helping people manage T2D. DSME supports informed decision-making, encourages goal setting 
and problem solving, and improves self-care behaviors.24 Across many populations, DSME 
improves glycemic control;25 lowers body mass index (BMI);26 improves diabetes knowledge,27 
diet quality,28 physical activity,29 and self-efficacy;27 reduces health care costs and 
hospitalizations;30,31 and increases use of primary care and preventive services.32 
 
Recent studies have shown promise for DSME among food pantry clients with T2D. One study 
paired DSME classes with T2D-appropriate food boxes distributed at food banks and found 
significant improvements in glycemic control.33 However, this study suffered from problems 
with attendance and retention, retaining only 42% of participants. In a follow-up trial, only 20% 
engaged fully with the DSME and food box intervention (i.e., picked up ≥9 of 11 food 
distributions, attended 2 DSME classes, etc.).34 
 
By removing barriers to attendance and retention, our research team will leverage the full 
potential of home-delivered T2D-appropriate food boxes paired with DSME. We have 

Title: Delivering Health: An Integrated Approach to Address Diabetes in the Context of Food 
Insecurity 
PI: Krista Langston 
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Date: 20230222 
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successfully adapted diabetes education for delivery in community settings, including homes, 
faith-based organizations, and community centers.35 We have adapted DSME for people from 
diverse cultural backgrounds who face economic, transportation, health care, and health literacy 
barriers.36 We are experienced at developing interventions to improve health of low-income food 
insecure people, including food pantry interventions to improve access to healthy food.37,38 
 
We propose a study to develop and evaluate the efficacy of a plain-language DSME curriculum 
to improve the nutritional health, physical activity, and health outcomes of low-income food 
insecure people with T2D. We will home-deliver this curriculum along with T2D-appropriate 
healthy food boxes to mitigate difficulties associated with access to healthy food and attendance 
at DSME sessions outside of the home. We hypothesize that this approach will lead to 
improvements in participants’ glycemic control, diet quality, and other outcomes. 
 
Objective 
Develop, implement, and evaluate the effectiveness of an intervention to use home-delivery of 
T2D-appropriate food boxes with plain language adapted education materials, in English, 
Spanish, and Marshallese, to improve the nutritional health, physical activity, and health 
outcomes of low-income food insecure people with T2D. 
Study Design and Procedures 
Stakeholder involvement Stakeholders were involved in problem selection and project 
development. Stakeholders will participate in adapting the DSME curriculum. To ensure the 
study captures outcomes important to each stakeholder group, stakeholders helped choose study 
outcomes. Stakeholders will be invited to help interpret study results and to participate in 
dissemination as co-authors of manuscripts, reports, and presentations. 
 
Project activities 1. Adapt DSME curriculum for use by low-income food insecure 
communities. As part of the development, we will 
incorporate T2D-appropriate recipes and 
information on cooking and shopping when on a 
limited budget and with foods commonly found at 
food pantries. In addition, 12 videos will be 
created and posted on a freely accessible UAMS 
website to introduce and reinforce key DSME 
concepts.  
 
Table 1. 12-week Adapted ACP Curriculum Modules 
1. What is Diabetes? 
2. Healthy Eating Part 1Healthy 
3. Healthy Eating Part 2 
4. Physical Activity Part 1 
5. Physical Activity Part 2 
6. Monitoring Diabetes 
7. Acute Complications 
8. Chronic Complications Part 1 
9. Chronic Complications Part 2 
10. Medication Management 
11. Healthy Coping 
12. Problem Solving 

Title: Delivering Health: An Integrated Approach to Address Diabetes in the Context of Food 
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PI: Krista Langston 
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The 12 adapted modules are presented in Table 1. In the study, these modules will be delivered 
to the participants on paper in the T2D-appropriate food boxes and in easy to access online 
versions, which link to the videos summarizing the key concepts and demonstrating cooking 
techniques. All materials are translated into English, Spanish, and Marshallese. 
 
 
2. Design T2D-appropriate food boxes. The project team led by an endocrinologist, registered 
nurse, and registered dietitian designed 12 weekly food boxes to be home delivered to each 
participant. The boxes were adapted from the American Diabetes Association Create Your Plate 
method,49 which emphasizes non-starchy vegetables, proteins, and grains, consistent with the 
meal pattern promoted in the ACP DSME.48 In addition, the boxes will include food that largely 
reflects Feeding America’s Foods to Encourage framework,50 which was developed by nutrition 
experts and food bank leaders to meet USDA dietary guidelines51 and MyPlate framework.52 
 
The boxes will include ~9,000 calories of food, equivalent to the amount the average household 
would receive pro-rated per week from an average Arkansas food pantry.37 Each box will 
include fresh fruits and vegetables, as well as the ingredients necessary to prepare the recipes 
included with that week’s DSME curriculum. If a certain item is unavailable or out of stock, 
there is a list of potential substitutions that are of equal nutritional content compared to the first 
choice food item. Each 
week’s box will include an 
educational fact sheet of 
the week’s DSME module, 
including links and QR 
codes leading to the videos. 
Links to the week’s online 
materials, which present 
the same content as the 
paper materials, will be 
texted or emailed to each 
participant based on their 
preferred contact method 
on the day each box is 
delivered. Table 2 shows 
an example T2D-
appropriate food box. 
 
3. Recruit and enroll up to 
110 participants. Study 
participants may be 
recruited from waiting areas of food pantries located in Benton and Washington Counties in 
northwest Arkansas. (See Letters of Support from local food pantries.) Due to social distancing 
and public health guidelines related to COVID-19 each of the food pantries have established 
drive-thru clinics where participants can remain isolated in their vehicles while completing data 
collection. Participants may use these drive-thru clinics for consent and all biometric collection. 
Table 2. Example of T2DM-appropriate Food Box 
Fruit 
• 
1- 20 oz. Canned Pineapple Tidbits in Natural 
Juice 
• 
1- 15 oz. Canned Lite Sliced Peaches 
• 
3 Fresh Apples 
Vegetables 
• 
1- 15 oz. Canned Mixed Vegetables 
• 
1- 14.5 oz. Canned No Salt Added Green 
Beans 
• 
2 Fresh Sweet Potatoes 
• 
1 Fresh Onion 
• 
1- 10 oz. bag Frozen Spinach 
Meat/Protein 
• 
1- 15 oz. can No Salt Added Black Beans 
• 
1- 10 oz. Canned Chicken 
• 
1- 12 oz. Canned Tuna 
• 
1- Dozen Large Eggs 
Whole 
Grains 
• 
1- 10 count Whole Wheat Tortillas 
• 
1- 14 oz. box Instant Brown Rice 
Dairy 
• 
1- Gallon 1% Milk 
• 
1- 10 oz. bag Part Skim Mozzarella String 
Cheese 
Other 
• 
1- 8 fl oz. bottle Extra Virgin Olive Oil (this is 
included in the calorie count) 

Title: Delivering Health: An Integrated Approach to Address Diabetes in the Context of Food 
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If COVID-19 regulations are lifted and food pantries are welcoming clients inside, consent and 
biometrics will be collected in a private area of the facility. In our preliminary data from 247 
food pantry clients, 95% of clients in this region screen positive for food insecurity, and ~30% 
report at least one household member diagnosed with T2D. Participant inclusion criteria include: 
report food insecurity (confirmed by adapted 10-item screener53); 18 years of age or older; report 
T2D (confirmed by having an HbA1c equal to or greater than 7 at initial data collection 
immediately following consent. Participant exclusion criteria include conditions making it 
unlikely the participant will be able to follow the protocol, such as terminal illness, non-
ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder, pregnant, 
or plans to move out of the geographic region. Only one adult per household will be enrolled. 
Individuals under 18 years old are not included in the proposed study because the intervention is 
designed for adults with T2D.  
 
Consent materials will be available in English, Spanish, or Marshallese and will use plain 
language. Eligible participants will be provided a copy of the consent to review, and participants 
will have the opportunity to ask questions, consent, and enroll in the study. The consent process 
will include providing information to the potential participants and the opportunity to have 
bilingual Marshallese or Spanish speaking staff answer questions regarding study participation. 
The consent document will be given to the participant, and the informed consent process will be 
documented in the participant’s research record. Consent with the participant’s signature will 
serve as documentation. An opportunity will be provided to all potential participants for 
individual, private discussion of the study and the consent document before they sign the 
consent. All members of the research team will be trained and certified in participant consent 
procedures, the study protocol, human subjects protection, and HIPAA regulations.  
 
 
Enrollment is expected to begin in Year 2 Quarter 3, and will remain open until recruitment 
goals are met, which is expected to be Year 4 Quarter 2. 
 
4. Collect data. For each participant, participation will take place over 22 weeks (Weeks 1-4: 
Pre-intervention data collection; Weeks 5-16: Intervention; Weeks 17-22: Post-intervention data 
collection). Table 3 describes the study measures and outcomes. Data collection will take place 
at pre-intervention and post-intervention for each participant. At enrollment (i.e., pre-
intervention) and one week after the 12th food box delivery (i.e. post-intervention), participants 
will provide data on glycemic control (measured by HbA1c), physical activity, body mass index 
(BMI), T2D self-management behaviors, T2D knowledge, T2D self-efficacy, and food security. 
To enhance the study’s significance in characterizing the diet patterns and fruit and vegetable 
consumption of low-income food insecure people with T2D, we are collecting extensive diet 
quality data measures pre-intervention and post-intervention. Specifically, we will collect 24-
hour dietary recalls. Participants will be asked to document their dietary intake over a 24-hour 
period three times within four weeks. Two of the dietary recalls must be collected from a 
weekday and one of the recalls must be collected from a weekend day. Also, Skin carotenoid 
level will be measured using a Veggie Meter® optical skin scanner, which uses Raman 
Spectroscopy. The Veggie Meter assesses frequency changes in reflected light to calculate 
carotenoid presence. Skin carotenoid levels are a biomarker of fruit and vegetable dietary 

Title: Delivering Health: An Integrated Approach to Address Diabetes in the Context of Food 
Insecurity 
PI: Krista Langston 
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Date: 20230222 
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intake. Participants will be asked to complete a survey via (email, text or in person) asking about 
their preference for the food provided in the food boxes. 
Initial data collection will take place in a private space immediately following enrollment. The 
remaining pre-intervention data collection and post-intervention data collections will take place 
via telephone and at locations of each participant’s choosing (e.g., HbA1c will be collected at 
home or at a community-based location such as a food pantry). Our team has necessary expertise 
and equipment to complete data collection in homes or community-based locations, having 
successfully completed thousands of such data collection events.37,43,54-61 
The study has a single-arm, pre-post study design. All participants will receive the intervention 
(i.e., 12 weekly food boxes including the adapted DSME materials). Our target sample size for 
recruitment is 100. Assuming a repeated measures t-test, two-sided α=.05, and a Pearson 
correlation between repeated measures of r=.5, we will have 80% power to detect a Cohen’s d 
effect size of 0.28. For context, Chrvala, Sherr, & Lipman’s (2016) meta-analysis found that on 
average DSME led to a 0.6% improvement in HbA1c.25 Assuming a standard deviation of 1.5%, 
this translates to Cohen’s d of 0.4 (i.e., 0.6/1.5=0.4). Thus, the proposed intervention with a 
sample size of 100 is powered to detect a small-to-medium effect consistent with the expected 
effect size for standard DSME interventions in the context of research trials, and smaller than the 
effect found in previous food pantry-based DSME interventions.33,34 
Table 3. Delivering Health study measures and outcomes 
Variables 
Instrument(s) or Measure(s) 
COVARIATES 
Demographic 
& 
Socioeconomic 
Demographic (age, gender, marital status, race, number of adults and 
children in the household) and socioeconomic (education, employment 
status, insurance coverage, WIC and SNAP benefits) variables will be 
captured using validated questions from the Behavior Risk Factor 
Surveillance System (BRFSS)62 and National Health Interview Study 
(NHIS).120 
EFFECTIVENESS OUTCOMES 
HbA1c 
Finger stick blood collection will be used to test HbA1c using a Siemens 
DCA Vantage analyzer that can be taken into the field.63 
Diet Quality 
and Fruit and 
Vegetable 
Consumption 
Skin carotenoid level will be measured using a Veggie Meter® optical skin 
scanner, which uses Raman Spectroscopy. The Veggie Meter assesses 
frequency changes in reflected light to calculate carotenoid presence.  
 
24-hour dietary recalls will be collected using the widely-used Nutrition 
Data System for Research (NDSR) software, which includes over 18,000 
foods.64 NDSR will be used to calculate Healthy Eating Index-2015 (HEI) 
scores and fruit and vegetable consumption. HEI-2015 scores comprise nine 

Title: Delivering Health: An Integrated Approach to Address Diabetes in the Context of Food 
Insecurity 
PI: Krista Langston 
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Date: 20230222 
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5. Implement intervention. Table 4 summarizes the intervention.  
 
component scores (e.g., vegetables, dairy) and are recommended by National 
Cancer Institute to assess impact of diet quality interventions.65,66 
BMI 
Weight and height will be used to compute a continuous measure of BMI 
using the Quetelet Index (kg/m2). Weight will be measured in light clothing 
to the nearest 0.5 lb. (0.2 kg) using a calibrated digital scale. Height (without 
shoes) will be measured to the nearest 0.5 in. using a stadiometer.  
Medical 
Conditions 
BRFFS self-report items will assess lifetime prevalence of medical 
conditions.62 
T2D Self-
Management 
Behaviors 
The Summary of Diabetes Self-Care Activities (SDSCA) will be used to 
measure self-care activities. The SDSCA consists of 12 items to assess the 
frequency of performing diabetes self-care tasks.67 SDSCA was validated in 
minority populations, including the Marshallese.68  
Oral Health 
Oral health will be assessed by a single-item taken from the BRFFS 
survey.62 
T2D Self-
Efficacy 
Self-efficacy for health behaviors will be assessed through the Diabetes 
Management Self-Efficacy Scale (DMSES), which assesses the extent to 
which respondents are confident in managing their blood sugar, diet, and 
exercise.69 DMSES was validated in several studies of minority populations, 
including the Marshallese.68 
T2D-related 
Distress 
Psychological distress related to type-2 diabetes will be assessed through 
PAID-5 scale of the Diabetes Attitudes, Wishes, and Needs second study 
questionnaire (DAWN2)122 
Food Security 
Food security will be assessed using the adapted 10-item USDA screener.121  
Food Pantry 
Utilization 
Food pantry utilization will be assessed through modified items from Feeding America’s 
Hunger in America Client Survey123 
Medication 
Adherence 
Measures of diabetes medication adherence will be collected with measures from BRFFS62, 
NHIS120, and ARMS-D.124 
Cooking Skills 
and 
Knowledge 
Assessment of participants confidence in following a simple recipe and 
cooking from basic ingredients will be assessed using items developed for 
use in low socioeconomic populations.125 
PROCESS EVALUATION MEASURES 
Process 
Indicators 
Process evaluation will include tracking indicators of retention (e.g., 
numbers of participants enrolled, data collection events completed) and 
dosage (e.g., food boxes successfully received). Post-intervention data 
collection will include open-ended questions about satisfaction with food 
boxes and suggestions to improve intervention. 

Title: Delivering Health: An Integrated Approach to Address Diabetes in the Context of Food 
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PI: Krista Langston 
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Given the study’s longitudinal design, participant retention will be crucial. We engaged 
stakeholders to develop a retention plan. The plan specifies that study staff responsible for 
recruitment and retention will be bilingual (Spanish/English or Marshallese/English). Study staff 
will obtain each participant’s contact information and preferred method of contact. Before each 
follow-up data collection visit or call, research staff will contact participants about the upcoming 
data collection.  
"Participants will be offered a $40 gift card for participation in each of the two data collection 
events for a total of $80. Those participants who only participate in the survey or biometric data 
collection will receive $20 for their time. Participants will also be offered $10 gift cards at each 
of the dietary recall phone interviews for a total of $60. Participants will only receive gift cards 
for the data collection events they complete. If a participant drops out, the study team will 
document who dropped out and why the drop out occurred. Participants will be able to choose a 
Tango electronic gift card at each of the data collection events.  
 
Study Population 
Up to 110 study participants will be recruited from food pantries located in Benton and 
Washington Counties in northwest Arkansas. 
 
Inclusion Criteria 
• 18 years of age or older 
• Food insecure (confirmed with adapted 10-item screener) 
• HbA1c levels of ≥7 
Table 4. DSME and T2D-appropriate Food Boxes Intervention 
Evidence-
based 
DSME 
Curriculum 
■ Consistent with the American Association of Diabetes Educators, the adapted 
ACP DSME will cover the topics of understanding diabetes, eating right, being 
active, checking blood sugar, taking medicines, keeping feet healthy, and 
insulin. The adapted curriculum consists of 12 modules, which will include 
recipes and information on cooking and shopping when on a limited income and 
with foods commonly found at food pantries. 
T2D-
appropriate 
food boxes 
■ Each weekly food box will include ~9,000 calories of food, equivalent to the 
amount the average household receives prorated per week from an average 
Arkansas food pantry.37 The boxes will follow the American Diabetes 
Association Create Your Plate method, consistent with the ACP DSME. Food 
will be purchased from a local grocery store. 
Intervention 
Delivery 
■ Food boxes will be delivered to participants’ homes once per week. Each 
week’s box will include a two-page educational fact sheet version of the week’s 
DSME module, including links and QR codes leading to videos supporting the 
week’s curriculum module. Links to the week’s online materials, which present 
the same content as the paper materials, will be texted or emailed to each 
participant the day their box is delivered. 
Dosage 
■ 12 food boxes (including curriculum) delivered once per week over 12 weeks 

Title: Delivering Health: An Integrated Approach to Address Diabetes in the Context of Food 
Insecurity 
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Date: 20230222 
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Exclusion Criteria 
• Conditions making it unlikely the participant will be able to follow the protocol, such as 
terminal illness, non-ambulatory, severe mental illness, severely impaired vision or 
hearing, eating disorder, or plans to move out of the geographic region 
• Pregnant 
• Only one adult per household will be enrolled 
 
Risks and Benefits 
A risk to study participants is the potential for loss of confidentiality of study data. Measures to 
protect the confidentiality of study data will be implemented as described in the Data Handling 
and Recordkeeping section below. 
A finger stick is required to collect a small amount of blood for testing, this may cause some 
discomfort. 
The food box deliveries will be packaged to hold the correct temperature of perishable foods for  
three hours. After that time, or if the box is in any way damaged there is a risk of potentially 
eating spoiled foods from the food box delivery. There is also a risk of consuming a food item 
that the participant is unknowingly allergic to. We will do our best to ensure the integrity of the 
food box deliveries and are always available to contact with any questions regarding the food 
items in the deliveries. 
Potential benefits include provision of nutritionally balanced food to participant’s home for the 
12 week period of the study. Participants may experience improved health status, specifically 
related to type 2 diabetes. 
In addition to the potential of benefits to the participants, knowledge gained from the study could 
potentially benefit patients in the future. 
Data Handling and Recordkeeping 
The Principal Investigator will carefully monitor study procedures to protect the safety of 
research subjects, the quality of the data and the integrity of the study.  
All study subject material will be assigned a unique identifying code or number. The key to the 
code will be stored in a secure location in the Office of Community Health and Research. Only 
the principal investigator and the study coordinator will have access to the code and information 
that identifies the subject in this study. During data collection events survey data will be 
collected on a UAMS iPad or laptop using REDCap mobile app (with built in encryption 
technology). As soon as the data collectors return to UAMS, they will upload the data to the 
REDCap instance housed on a secure UAMS server and delete the data from the iPad or laptop. 
Blood specimens collected for HbA1c testing are only used for point of care testing, they will be 
discarded immediately after the test is performed. At the conclusion of the study the key to the 
code will be shredded, the data will be permanently de-identified. 

Title: Delivering Health: An Integrated Approach to Address Diabetes in the Context of Food 
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The study will comply with UAMS Admin Guide Policy 3.2.01 – research data, reports and 
analyses be retained for seven years after final reporting or publication of a project, or longer if 
required by a sponsor or regulation. 
 
Data Analysis 
Analyses will be performed with SAS 9.4. Data will be examined for distributional normality 
and outliers prior to analyses. Descriptive statistics will be generated for all variables of interest. 
We will examine patterns and predictors of missing values. If the percentage of missing values is 
larger than approximately 10%, we will compare models using multiple imputation with those 
using complete case analysis to examine the potential impact of missing values on the results. 
To examine the intervention’s effect on the primary outcomes of glycemic control as measured 
by HbA1c and diet quality as measured by Healthy Eating Index-2015 (HEI) scores, we will use 
mixed effects regression models for repeated measures. These analyses will focus on testing for a 
statistically significant difference between pre-intervention versus post-intervention measures. 
Additional analyses will include relevant covariates such as sex or age. We will also explore 
models that include process indicators of dosage of intervention received (e.g., number of food 
boxes received) to examine whether dosage predicts change in primary outcomes. 
 
Ethical Considerations 
This study will be conducted in accordance with all applicable government regulations and 
University of Arkansas for Medical Sciences research policies and procedures. This protocol and 
any amendments will be submitted and approved by the UAMS Institutional Review Board 
(IRB) to conduct the study. 
The formal consent of each subject, using the IRB-approved consent form, will be obtained 
before that subject is submitted to any study procedure. All subjects for this study will be 
provided a consent form describing this study and providing sufficient information in language 
suitable for subjects to make an informed decision about their participation in this study. The 
person obtaining consent will thoroughly explain each element of the document and outline the 
risks and benefits, alternate treatment(s), and requirements of the study. The consent process will 
take place in a quiet and private room, and subjects may take as much time as needed to make a 
decision about their participation. Participation privacy will be maintained and questions 
regarding participation will be answered. No coercion or undue influence will be used in the 
consent process. This consent form must be signed by the subject and the person obtaining the 
consent. A copy of the consent will be given to the participant, and the informed consent process 
will be documented in the research record. 
A $40 Walmart gift card will be provided to the participant each time they complete a data 
collection event. If they complete both data collection events, they will receive a total of $80 in 
Walmart gift cards. 
 
Dissemination of Data 

Title: Delivering Health: An Integrated Approach to Address Diabetes in the Context of Food 
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Results of this study may be used for presentations, posters, or publications. The publications 
will not contain any identifiable information that could be linked to a participant. The study will 
be listed on clinicaltrials.gov in accordance with funder requirements. A summary of results will 
be returned to participants in an infographic that is provided to them in person and/or mailed to 
the participants. After publication of the major findings in peer-reviewed journals, we will make 
the dataset available to other researchers for further analyses. 
 
 

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