Healthy Eating and Active Living to Reverse Diabetes Pilot Study
Phase: NA
Conditions: Diabete Type 2, Diabetes, Overweight , Obesity
Sponsor: University of Tennessee

Title: Healthy Eating and Active Living to Reverse Diabetes Pilot Study 
Principal Investigator: Bailey, James E 
CO-Is: Frankie Stentz, Satya Surbhi, Asos Mahmood, Tracy Bruen, Susan Butterworth, Umar Kabir, Rick 
Bloomer, Alexandria Boykins 
Additional Research Personnel: Melissa Petersen, Susie Suttle, Colbie Andrews, Deborah Ogunsanmi 
 
Abstract: 
The HEAL Diabetes Program is a multicomponent intensive plant-forward healthy eating program 
designed to reverse diabetes. Several recent studies, most notably the Diabetes UK-funded Diabetes 
Remission Clinical Trial (DiRECT) in England and Scotland, have demonstrated that intensive programs for 
weight loss and weight loss maintenance can lead to long-term remission of diabetes for as many as half of 
patients with early Type 2 (adult-onset) diabetes. Furthermore, the U.S. Preventive Services Task Force has 
recommended that all patients with obesity and at highest risk for diabetes be referred to such intensive 
multicomponent behavioral weight loss interventions, but no such programs are available for people living in 
the low-income and underserved areas of Memphis. This effort will pilot an innovative, culturally tailored, and 
intensive healthy eating program designed to reverse diabetes based in the UTHSC Neighborhood Health Hub 
located in low-income neighborhoods to demonstrate that this approach will work in Memphis to improve and 
extend people’s lives. The HEAL Diabetes Pilot Program will: a) engage and retain a minimum of 30 patients 
with Type 2 diabetes and obesity to participate in the program as well as 30 additional “control” patients who 
will receive routine care, and b) assess patient outcomes including weight loss and rates of diabetes remission 
using average blood sugar (hemoglobin A1c) over a six-month period.  
BACKGROUND AND SIGNIFICANCE  
A.  Significance.   
A1. Type 2 diabetes is epidemic among the medically underserved. The growing worldwide epidemic of 
Type 2 diabetes (T2D) and other obesity-associated chronic conditions (OCC) disproportionately affects 
minority and medically underserved subpopulations, impacting over 10 million people residing in medically 
underserved areas in the U.S.1-3 Researchers have long known that weight gain and obesity are the main 
drivers of T2D,1,4 but little progress has been made addressing obesity in primary and specialty care settings. 
Low income and African American patients are less likely to get recommended care for T2D and other OCC,5 
and as a result are much more likely to experience diabetes-related amputations, kidney failure, and premature 
death.6,7 Yet despite low-income and minority populations facing special barriers to effective T2D self-care 
related to food insecurity and other social determinants of health (SDOH),8,9 most T2D behavioral interventions 
are tailored for the majority, higher-income, patient populations. Thus, low-income and minority groups need 
specific culturally-tailored solutions that address any particular SDOH they face.8,9 Life expectancy is markedly 
reduced in patients with T2D, largely through the impact of the multiple OCC that commonly accompany T2D, 
including cardiovascular disease, cancer, and chronic kidney disease.10 Intensive medication therapy to lower 
blood sugar, cholesterol, and blood pressure in patients with T2D has led to modest improvements in real-
world major clinical outcomes at best,11 in part because of the challenges of adherence to multiple medications 
particularly among vulnerable and medically underserved populations.7 Although weight management is 
considered essential therapy for people with T2D and other obesity-associated chronic conditions, lack of 
pragmatic approaches for implementing effective weight loss programs for this population has served as a 
critical barrier to achieving better outcomes for vulnerable patients with T2D.12 
A2. Evidence on best diet composition supporting food as medicine hypothesis. Numerous studies have 
thus far clearly established the benefits of plant-forward diets (i.e. diets emphasizing plant-based foods).13 
Large observational studies have demonstrated substantial survival benefits for a plant-forward Mediterranean 
diet related to cardiovascular disease and multiple other chronic conditions.14-16 A large randomized controlled 
trial (N=322) confirmed that both Mediterranean and low-carbohydrate diets have similar sustained impacts on 
weight and cardiometabolic health.17,18 Studies of pre-diabetes and diabetes remission support a relatively 
high-protein diet (26-30% protein vs. 15%) for effective and sustained weight loss while maintaining lean body 
mass.19-21 New evidence from an inpatient randomized controlled trial of ad libitum food intake shows that ultra-
processed diets cause excess calorie intake and weight gain,22 providing evidence that processed foods are 
primary vectors of obesity that must be eliminated from diets to achieve and sustain weight loss.23  
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A3. New powerful evidence demonstrating effectiveness of primary care-based multicomponent 
interventions for rapid weight loss, weight loss maintenance, and diabetes remission. The Diabetes 
Remission Clinical Trial (DiRECT), an open-label, cluster-randomized pragmatic trial in 49 primary care 
practices in low-income areas of Scotland and England, recently demonstrated that such interventions can 
achieve and sustain similar results to bariatric surgery.21,24 DiRECT used health coaching by nutritionists in 
primary care practices, intensive preparation for change, total diet replacement (TDR), and physician-
supervised medication discontinuation (PSMD), to achieve an average weight loss of 10.0 kg, diabetes 
remission in 46% of those in the treatment group at 1 year,24,25 sustained remission in 36% at 2 years,26 and 
substantial improvements in other biological health outcomes,27,28 at low cost.29 Best evidence from DiRECT 
and other studies suggests that these intervention components have the most potential to achieve similar 
outcomes in at-risk populations. 
A4. Intensive multicomponent behavioral weight loss interventions most effective. The U.S. Preventive 
Services Task Force (USPSTF) concluded that adults with obesity benefit most from behavioral weight loss 
interventions that are intensive and multicomponent.12,30,31 A systematic review of the Community Preventive 
Services Task Force found sufficient evidence to particularly recommend technology-supported 
multicomponent coaching or counseling interventions to help adults achieve and maintain weight loss.32 
Pragmatic trials of these multicomponent interventions in obesity-associated T2D are desperately needed. The 
USPSTF has called for well-designed pragmatic comparative effectiveness trials to test and disseminate 
multicomponent interventions in primary care settings and to provide evidence regarding most effective 
intervention components.12,31 The USPSTF has identified subpopulations such as high-risk racial and ethnic 
groups as important targets for further outcomes research.12 Communities that are predominantly African 
American, low-income, and in medically underserved areas of the South are among those in greatest 
need.2,3,33,34 Over 40% of African American men and over 50% of African American women suffer from 
obesity.34 Diabetes prevalence exceeds 18%.35 Most patients with obesity-associated diabetes also experience 
additional OCC such as hypertension, hyperlipidemia, and arthritis that contribute to adverse outcomes.36-39  
The USPSTF and other critical appraisals of the literature have identified the following component 
interventions as the most evidence-based and promising for achieving substantial weight loss and diabetes 
remission in medically underserved populations. 
A4a.  Motivational Interviewing-based Health Coaching (MI-based HC). Motivational interviewing (MI) has 
demonstrated efficacy and effectiveness across a range of behavior change outcomes.40 Meta-analyses 
confirm that MI is more effective than traditional diabetes education and weight management programs in 
achieving weight loss.41-48 Health coaching by non-clinical staff has been identified as among the lowest cost 
strategies for expanding primary care capacity to support diabetes self-care, with strong evidence of 
effectiveness from numerous clinical trials.49,50  Moreover, recent systematic reviews have identified health 
coaching as among the most efficacious strategies for engaging patients in behavior change to help adults 
achieve and maintain weight loss,12,31,32,51 and improve diabetes outcomes in disadvantaged populations.51 
A4b.  Tailored Motivational Text Messaging (TM). TM has been observed to be an effective, low cost 
approach for engaging patients in diabetes self-care.52-56 Numerous studies employing TM have demonstrated 
improved glycemic control, healthy eating, and physical activity in patients with T2D.52,54-56 Our prior research 
and those of others have also demonstrated that patients with diabetes are appreciative of TM from their 
doctor’s office.36,55-57 Further, systematic reviews have identified TM as among the most efficacious and low-
cost strategies for engaging patients in behavior change47,58,59 and have highlighted the importance of such 
technology-supported interventions to help adults achieve and maintain weight loss.12,31,32 
A4c.  Total Diet Replacement. Numerous studies have demonstrated the efficacy of TDR for supporting 
major changes in eating habits and weight loss for patients with obesity and T2D,19,60-63 and TDR was a core 
intervention for the DiRECT study.21,24,25,64 Although some of these studies used liquid meal replacements for 
initial weight loss, several others have used whole foods throughout.19,60 Diet replacement with low glycemic 
whole food diets is associated with increased satiety and weight loss.65,66 TDR requires complete substitution 
of the individual’s habitual diet, giving a period of about 12 weeks to plan a new normal diet for life. Numerous 
recent studies have also demonstrated effectiveness for healthful food pharmacies, food banks, and food 
delivery in changing key obesity-related eating behaviors and addressing food access issues for low-income 
populations.67-72 
A4d.  Support Groups. Although conclusive evidence cannot be drawn regarding the relative effectiveness of 
group- vs. individual-based interventions, group counseling has served as a fundamental component of most 
successful multicomponent healthy eating, physical activity, and weight loss interventions.12,73-75 Most notable 
among these are Look AHEAD (Action for Health in Diabetes),76-80 the Activity Counseling Trial (ACT),81,82 and 
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the Diabetes Prevention Program (DPP).83-86 Consistent with the Social Cognitive Theory that undergirds the 
proposed study, evidence suggests that the most successful group counseling programs employ peer social 
support.87-95 Recent systematic reviews have identified peer support groups as a promising strategy that can 
mitigate the effects of SDOH,51,91,96 and improve T2D outcomes for African Americans51,89 and the general 
population.90 
A4e.  Cooking Classes. Many successful multicomponent healthy eating and weight loss interventions such 
as the DPP83-86 have employed cooking classes, and culinary medicine is emerging as a popular intervention 
among patients and providers.97 Hands-on cooking classes can improve nutrient intake in people with obesity-
associated T2D from diverse ethnic and socioeconomic backgrounds.98 Further, cooking classes encourage 
home cooking and increase “food literacy” and self-efficacy or confidence in both basic technical culinary skills 
and competency to plan, choose, prepare, and consume nutritious food.99-101 Consumption of meals at home 
has been associated with a decreased risk for T2D and less weight gain over time.102 
A4f.   Physician-Supervised Medication Discontinuation (PSMD). Numerous studies have highlighted the 
importance of PSMD for T2D and hypertension patients participating in intensive weight loss to avoid serious 
hypoglycemia and/or hypotension.103,104 Most notably, PSMD was a core intervention for DiRECT.21,24,25,64  
A5. Scientific Foundation. Our objective is to assess the effectiveness of a pragmatic intensive 
multicomponent weight loss intervention that leverages existing staff and resources in primary care settings 
with potential to achieve simultaneous improvements in multiple chronic conditions associated with obesity. 
The Healthy Eating and Active Living to treat Diabetes (HEAL Diabetes) pilot study seeks to reproduce the 
results of the DiRECT study using a similar multicomponent intervention culturally tailored for a U.S. medically 
underserved population. Data from surgical weight loss trials have shown that bariatric surgery can lead to 
simultaneous improvements in multiple metabolic parameters and chronic disease states, resulting in frequent 
diabetes remission and improved health outcomes.105-112 Yet, until the recent DiRECT study,21,24-26 little 
progress had been made in identifying practical behavioral weight loss approaches with similar outcomes. 
Now, multiple lines of recent evidence reviewed above are converging to demonstrate the component 
interventions most likely to succeed in achieving the substantial and sustained weight loss necessary to 
improve T2D outcomes. Based on small studies challenged to deliver culturally appropriate behavioral 
interventions, many researchers suggest that substantial weight loss and T2D remission are not obtainable or 
sustainable in low-income and minority populations.113,114 The current study seeks to clearly demonstrate that 
this presumption is wrong. 
A6. Summary. Although it is premature to conclude that the above intervention components are definitively the 
most efficacious, our review indicates they are among the most important for multicomponent interventions 
emphasizing whole foods. This demonstration project will use the above key evidence-based, community-
engaged, and culturally-tailored components115 in a “full-court press” clinic-based intervention based on the 
Chronic Care Model116-118 to substantially impact major biological, metabolic, and patient-reported outcomes. 
The HEAL Diabetes study will test a primary and specialty care delivered multicomponent healthy eating and 
weight loss program designed to address and ameliorate the SDOH root causes of the T2D epidemic.8,9 
B.  Innovation. 
The current study is innovative because it has potential to reframe the culture and paradigm of T2D treatment 
by demonstrating an effective, low-cost, and sustainable multicomponent behavioral intervention in real-world 
clinical settings. The literature has been biased through comparisons of high-cost surgical interventions with 
nutritional interventions too under-resourced to achieve similar efficacy. This research will allow us to identify 
and refine a behavioral treatment protocol that can reverse T2D in routine clinical practice. Further, the 
proposed study’s focus on improvements in self-efficacy as a fundamental mechanism of action is innovative. 
Our approach draws on the strong evidence for effectiveness of motivational interviewing in multiple disease 
states42,44,119-126 and all its component interventions are designed to enhance patient self-efficacy for healthy 
eating, physical activity, and weight loss.127-134 The proposed study’s selection and cultural tailoring of 
international best practices in T2D behavioral interventions for maximal impact based on extensive input from 
patients in a medically underserved U.S. population is also highly innovative.115 Our study seeks to reproduce 
the results of the United Kingdom DiRECT study24 by adapting its interventions in a culturally appropriate and 
sustainable way for a predominantly African American population in the U.S. As Gamburzew et al. note, 
developing multicomponent interventions that offer understandable nutritional guidance to medically 
underserved patients in real-world settings, requires specific targeting of ethnic minority populations.135-140 
 
C.  Approach 
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C1. Study Overview -Overall Goal, Aims, Design. The proposed pilot study replicates the inclusion criteria 
and outcome measures of the DiRECT study21,24-26 and tests a multicomponent intervention similar to 
DiRECT’s that is culturally tailored and informed by the preliminary results of our own Management of Diabetes 
in Everyday Life (MODEL) study.142,143 The design is a randomized controlled pilot study in a sample of 72 
patients with obesity-associated T2D. Eligible patients will be enrolled and randomized to one of the following 
two arms: 1) Multicomponent intervention (treatment) group (n=36), or 2) Usual Care (control) group (n=36) as 
detailed in Table 1 below. 
C1a. Study Overview. Research demonstrates that diabetes remission is achievable through weight loss, but 
pragmatic approaches that leverage existing staff and resources in the healthcare setting to deliver intensive 
behavioral lifestyle modification interventions are underdeveloped and underutilized. Our goal is to assess the 
effectiveness of an intensive multi-component plant-forward healthy eating intervention for patients with 
obesity-associated T2D. Our approach builds on the results of the Diabetes Remission Clinical Trial (DiRECT) 
study,21,24-26 and the preliminary results of the Management of Diabetes in Everyday Life (MODEL) study,142,143 
to test a culturally tailored multicomponent intervention designed for a U.S. medically underserved population. 
This research design is an individually randomized controlled trial in 72 patients with obesity-associated T2D. 
The Healthy Eating and Active Living to Treat Diabetes (HEAL Diabetes) Study will assess a “full-court press,” 
clinic-based intervention with these evidence-based components: 1) Intensive preparation for change to a 
plant-forward healthy eating program for weight loss, 2) Motivational interviewing-based health coaching 
(MI-based HC) support for healthy eating and physical activity, 3) Tailored motivational text messaging  
from the health coach, 4) Total diet replacement (TDR) with healthy food boxes for 3 months, 5) Health 
coach-led support groups, 6) Cooking classes, and 7) Physician-supervised medication 
discontinuation (PSMD). All components will be individually and culturally tailored to address social 
determinants of health serving as key barriers to healthy eating and physical activity. The U.S. Preventive 
Services Task Force concluded that adults with obesity benefit most from behavioral weight loss interventions 
that are intensive and multicomponent.12,30,31 MI-based HC has been demonstrated to be among the most 
effective component interventions for weight loss.41-48 Our team has extensive expertise implementing these 
interventions in the settings where low-income individuals with T2D and other obesity-associated chronic 
conditions receive routine care through the DiRECT,21,24-26 our MODEL,142,143 SafeMed,157-161 and other19,77-
82,84,162-165 studies. DiRECT used health coaching in primary care practices, intensive preparation for change, 
TDR, and PSMD to achieve an average weight loss of 10.0 kg, diabetes remission in 46% at 1 year,24,25 
sustained remission in 36% at 2 years,26 and improvements in key biological health outcomes27,28 at low 
cost.29,155 Best evidence suggests that these are among the components with the most potential to achieve 
similar outcomes in other at-risk populations. Preliminary results from the MODEL study indicate that primary 
care-integrated MI-based HC is well received, with highest self-reported levels of improvements in health 
behaviors, confidence, and health outcomes in the MI-based HC group, and overall retention of over 90% in 
672 program participants. By directly supporting patients in achieving their health goals, MI-based HC is more 
effective at engaging patients in self-care than traditional diabetes education or weight loss classes.41-48 
Furthermore, health coaches integrated into practices are increasingly sustainable due to the growth of value-
based payment initiatives.141 
C1b. Specific Aims. In light of the recent evidence indicating that multicomponent behavioral interventions 
can achieve levels of weight loss and diabetes remission comparable to bariatric surgery, we seek to assess 
the effectiveness of the most evidence-based of these component interventions delivered in combination. 
Aim 1:  Provide preliminary demonstration of the feasibility, effectiveness, and operational and financial 
sustainability of a health coach-supported intensive weight loss and weight maintenance program designed for 
people in Memphis. Specifically, we will: 
A. Assess our recruitment capability and resulting sample characteristics 
B. Evaluate resources and ability to manage and implement the study and study interventions 
C. Evaluate acceptability and suitability of intervention and study procedures (e.g. operational 
sustainability assessed through participant 3-, 6-, and 12-month program retention and attendance 
rates) 
D. Preliminary evaluation of participant responses to intervention (see Aim 2 below) 
E. Assess cost effectiveness of the multicomponent intervention (financial sustainability). 
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Aim 2: Quantify and compare the treatment and control groups on the following measures: 
A. Primary biological outcomes of body weight, blood pressure (number of prescribed blood pressure 
medications), average blood sugar (hemoglobin A1c [A1c]), and diabetes remission (A1c ³ < 6.5%) 
after at least 2 months off all diabetes medications except for GLP-1 agonist and/or SGLT-2 inhibitor 
medications which patients will be allowed to continue or start if desired by patient and recommended 
by their physician. 
B. Secondary patient-reported outcomes of self-efficacy and self-care activities related to general diet 
and exercise. 
C1c. Goal. The HEAL Diabetes study addresses a critical need to identify effective, scalable, and sustainable 
behavioral weight-loss approaches to help medically underserved patients in the U.S. achieve substantial weight 
loss and diabetes remission. We will compare primary biological outcomes (body weight, number of prescribed 
blood pressure medications, A1c, and diabetes remission), secondary metabolic outcomes (fasting glucose, 
insulin, insulin resistance, lipid profile, and CRP levels), and secondary patient-reported outcomes (self-efficacy, 
self-care activities related to general diet and exercise, health-related quality of life, and average pain rating) at 
baseline and 12-months. Based on DiRECT and MODEL study experience and evidence from other key studies 
and systematic reviews, we hypothesize that the HEAL Diabetes intervention will result in weight loss ≥ 10 kg 
and diabetes remission in over 40%,21,24-26 self-efficacy in plant-forward healthy eating will mediate its effects on 
primary biological outcomes, and it will be operationally and financially sustainable.2,29,142,143,155 
Table 1:  Program Interventions by Group* 
Intervention Components 
Multicomponent Intervention Group 
(Treatment) 
Core Intervention Group 
(Control) 
1) Intensive Preparation 
for Change and 
Education on plant 
forward healthy eating 
for weight loss 
Guidebook, handouts 
Guidebook, handouts 
Two (introductory and kickoff) health coach and 
nutritionist/registered dietician co-led sessions with 
intensive preparation for dietary change & weight loss 
One traditional diabetes education session 
led by a pharmacist or 
nutritionist/registered dietician 
2) Health Coaching -
Motivational and 
educational support for 
healthy eating, physical 
activity, and weight loss 
Individual HC sessions bi-monthly for first 3-4 months 
(Intensive Phase) and monthly for remaining 7-8 months 
(minimum of 14 sessions total) 
– 
Health coach-led individual or group grocery store tours 
with individual patient reminders  
– 
3) Tailored motivational 
text messaging (TM) 
Scheduled Registry-based TM and occasional individual 
TM from their health coach 
– 
4) Diet Replacement  
Total diet replacement for months 2-4 using tailored 
healthy food boxes with recipes delivered weekly 
Partial diet replacement for months 2-4 
using grocery store produce vouchers 
5) Support Groups 
 
Monthly clinic-based, health coach-led or co-led sessions 
focused on MI-based group problem solving (added 
individual patient text and/or phone reminders) 
– 
6) Cooking Classes 
 
Free monthly cooking classes with individual patient text 
and/or phone reminders 
– 
7) Physician-Supervised 
Medication 
Discontinuation 
Baseline and follow-up physician visit (month 1 and month 
2-4) with standardized instructions and protocol for partial 
medication discontinuation 
Physician made aware of program 
participation and patients informed of need 
to discuss medications with physician 
* See Sustainability Plan and Facilities for details on sustaining organizations and sustainability plans for each intervention. 
C2. Justification, feasibility and preliminary data. The Center for Health System Improvement (CHSI) that 
Dr. Bailey directs has a longstanding close partnership with the participating health systems and our 
investigative team has deep experience with pragmatic clinical trials of lifestyle interventions in diabetes. Thus, 
our team has the capability to demonstrate the effectiveness of a promising multicomponent intervention 
strategy to achieve substantial weight loss and high rates of diabetes remission in underserved population. 
C2a. Preliminary Data. 
1.  Health coaching. Health coaches are increasingly being integrated into clinical care and are increasingly 
sustainable due to the growth of value-based payment initiatives.141 We have been refining a promising 
strategy to promote behavior change in patients with T2D, named Motivational Interviewing-based Health 
Coaching (MI-based HC) through our Patient-Centered Outcomes Research Institute (PCORI) funded 
Management of Diabetes in Everyday Life (MODEL) study.142,143 Our qualitative results to date from nine focus 
groups of participants indicate that primary care integrated MI-based HC is particularly well received compared 
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to patients enrolled in TM and enhanced care arms, with health coaching arm participants reporting highest 
levels of overall program satisfaction and empowerment in taking charge of critical self-care activities. 
2.  Tailored motivational text messaging (TM). Our previous survey (N=60) of 60 diabetes patients in medically 
underserved areas demonstrated high interest in receiving TM from the physician’s office.57 Our mixed-
methods study (N=36) showed preferred TM characteristics.143 We developed, refined, and are testing a 
registry-based TM system in MODEL.142 Although MODEL program main outcomes data are not yet available, 
MODEL TM group participants report higher levels of satisfaction to date144,145 and have a retention rate of over 
90%. 
3.  “Daniel Fast” diet. Plant-based and plant-forward dietary plans offer multiple health benefits. The Daniel 
Fast is a biblically inspired dietary approach that is nutritionally equivalent to the Mediterranean diet and has 
received considerable recent attention. Bloomer et al. were the first to conduct a controlled experiment using 
the Daniel Fast146 and have conducted both human and animal studies specific to this eating plan since 2009. 
The dietary approach is simple: individuals can consume ad libitum intake of plant-based foods with no 
processed foods, caffeine, or alcohol. A modified plant-forward version of the plan (i.e., allowing caffeine and 
one daily serving of meat and dairy) has been used with similar success.147 Adherence to the Daniel Fast plan 
results in improvements in a variety of health related outcomes,146-151 including reduced weight, reduced total 
and LDL cholesterol, blood pressure, insulin and HOMA-IR (Homeostatic Model Assessment for Insulin 
Resistance), C-Reactive Protein (CRP), and oxidative stress. Furthermore, Bloomer et al. have observed 
excellent compliance with this plan—nearly 80% over a six-month period in human subjects.152 Animal studies 
have yielded similar findings.153,154 Focus groups (detailed in C2b4 below) demonstrate that most participants 
(82%) deem the biblically-based “Daniel Fast” diet is socially and culturally acceptable. Patients felt 
comfortable with their providers offering prayer (94%) and religious TM (82%) as part of a clinic-based healthy 
eating and weight loss intervention. Key informant interviews revealed that patients from Memphis’ medically 
underserved areas are highly interested in this diet and many have used it. 
4.  Focus groups. Over the last six years, we have conducted over 24 focus groups and six surveys before and 
after the initiation of the MODEL study to assess the target population’s preferences regarding clinic-based 
interventions to support diabetes self-care through healthy eating, physical activity, and weight loss.36,57,142-145 
These studies consistently demonstrate high interest in MI-based HC, TM, support groups, and plant-forward 
healthy eating for T2D. We recently conducted four focus groups of medically underserved patients with OCC 
to assess preferences regarding best ways for doctors’ offices to support plant-forward healthy eating and 
weight loss, and components considered most effective, feasible, and culturally appropriate from the patient 
perspective (IRB# 19-06698-XP). Patients expressed high levels of interest in intensive plant-forward healthy 
eating and weight loss programs overseen by their doctors, particularly if it would help treat a chronic condition 
or reduce medication requirements. Concurrent surveys confirmed highest levels of patient interest in health 
coaching (100%), healthy food boxes with recipes (100%), TM from the doctor’s office (82%), support groups 
(82%), and cooking classes (77%). Patients reported strong preferences for plant-forward diets that 
incorporated both lean meat and familiar traditional foods, rather than commercial liquid formula diets. 
5.  DiRECT Study. Dr. Lean and his team demonstrated that primary care-led weight management is both 
feasible and effective.24,25 Using a 3-month low-calorie liquid diet, a 2–8 weeks structured food reintroduction, 
and monthly visits with a nurse or dietician for long-term weight loss maintenance, DiRECT achieved 
substantial weight loss and full remission of diabetes in nearly half of the participants. While the entire program 
has proved highly cost-effective and other healthcare costs fell,29,155 providing a commercial liquid formula diet 
for 3 months is relatively expensive and is both culturally unacceptable and unsustainable due to expenses for 
long-term maintenance in low-income areas of the South. The challenges of eating a healthful diet for long-
term maintenance are so high in these areas that we believe a whole food plant-forward diet is most likely to 
be successful if it is initiated from the outset of major dietary changes. 
6.  Diet Composition, Diet Replacement and Prediabetes Remission. Dr. Stentz, a member of our investigative 
team, has conducted a randomized clinical trial demonstrating remission of pre-diabetes to normal glucose 
tolerance in obese adults with high protein versus high carbohydrate diet.19 She is currently completing a 
similar randomized clinical trial (IRB# 15-03832-FB) assessing the effects of a high protein diet on diabetes 
remission in T2D. She has extensive experience implementing TDR in clinical trials. She has also 
demonstrated a novel insulin resistance index to monitor changes in insulin sensitivity and glucose 
tolerance.156 Further, the Mid-South Food Bank and Methodist Le Bonheur Healthcare (MLH, Memphis’ largest 
health system) have shown that providing healthy food boxes to high-risk patients at hospital discharge 
reduced rehospitalizations by 34% 
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7.  Peer support groups. Support group meetings were found to be very popular in our previous Centers for 
Medicare and Medicaid Services-funded SafeMed157-161 and MODEL142,143 studies in the target population for 
the current study. Our ongoing study of T2D remission and trajectories of glycemic change (IRB# 18-06224-
XP) has shown that T2D patients in our target population achieve and maintain partial (A1c < 6.5 and ³ 5.7) 
and complete remission (A1c < 5.7) by 12.1% and 1.5%, respectively, at one year, and remission is highly 
associated with weight loss (p-value < .0001). Key informant interviews with “Healthy Living Heroes” in our 
target population who have achieved remission and Diabetes Wellness & Prevention Coalition (DWPC) Patient 
Advisory Council members indicate high levels of interest and willingness to serve as clinic volunteer peer 
mentors for support groups. 
8.  Prevalence of obesity-associated chronic conditions. Dr. Bailey has conducted a retrospective cohort 
analysis of adult patients with obesity-associated T2D seen in practice-based research networks participating 
in the Delta Clinical and Translational Science Consortium and the Southern Obesity and Diabetes Coalition 
(IRB# 18-06394-XP). This university-funded study demonstrated that of the 229,646 adult patients in the Mid-
South’s DWPC Registry and Practice-based Research Network (PBRN) from January 2016-December 2017, 
about 110,577 adults (48.2%) were obese (BMI>30), and 34.2% of obese patients were diagnosed with >1 
obesity-associated chronic condition (OCC). Of these patients, 10,707 (28.3%) had T2D. This study had a high 
representation of African Americans (55.8%) residing in low-income areas (69.4%). 
C3. Conceptual Model.  The theory of change underlying the current study is Social Cognitive Theory (SCT) 
developed by Albert Bandura and utilized in the DPP,84,162 ACT,81,82 and Look AHEAD weight loss 
interventions.77-80 Bandura’s theory postulates that behavior results from triadic influences between: 1) 
behavioral and cognitive processes influenced by the social/environmental context, 2) an individual’s 
motivation and belief about the consequences of a behavior, and 3) an individual’s self-efficacy concerning 
their ability to achieve a certain outcome.166-168 Modeling healthy thoughts and behavioral goal-specific plans 
are key to the SCT approach. The proposed multicomponent interventions provide supportive role modeling for 
goal setting, reinforcement of physician advice, review of patient progress in self-care behaviors, timely review 
of feedback, and assisting patients in learning healthy behaviors and problem-solving skills. We chose this 
conceptual model because, in addition to guiding and informing the behavioral HC intervention at the individual 
level, it provides the necessary framework to test a multi-level intervention. 
C4. Setting. The city of Memphis is majority African American (63.9%) and low income (average income 
$37,199 with 27.8% below the federal poverty level) ranking it as 2nd highest in poverty among the 36 U.S. 
cities with a population greater than 500,000).169,170 The majority of people in Memphis live in HRSA-
designated medically underserved and primary care health professional shortage areas (HPSA).171 Memphis 
has a very high age-adjusted prevalence of adult obesity at 41.0% and diagnosed diabetes at 15.1% as of 
2016.172  Obesity and diagnosed diabetes rates are even higher among African Americans in Memphis.34,35 
Thus, this research targets the most vulnerable adult patients with obesity-associated T2D in the U.S. 
C4a. Participant Recruitment Sites. Potential participants will be recruited with prominently displayed 
recruitment materials including flyers at the UTHSC Health Hub, the ShelbyCares on 3rd facility, and affiliated 
clinics. Health hub supervisors will be available to provide study information to potentially eligible patients. 
Final eligibility will be confirmed following intake completion and subsequent ability to contact patients by 
phone following intake (Run-in period). All data will be entered into the Research Electronic Data Capture 
(REDCap) application. 
C4b. Study Population. Our inclusion and exclusion criteria closely mirror those of the DiRECT study, 
recruiting adult patients within 6 years of diagnosis of T2D and without serious complications (i.e. recent eGFR 
<30 mls/min/1.73 m2) or requiring insulin.21,24,64 All eligible individuals seen in participating locations will be 
offered participation. 
Inclusion Criteria: Replicating the inclusion criteria of the DiRECT study,21,24-26 this study includes all persons 
who meet the following criteria: 1) ≥18 years of age, 2) T2D of duration 0–6 years (diagnosis based on 2 
recorded A1c tests, self-reported duration of diabetes confirmed by chart review), 3) A1c ≥ 6.5% at the 
screening visit, 4) Body Mass Index (BMI) ≥ 30 kg/m2, 5) receiving care in a clinic the majority of whose adult 
patients reside in an HPSA, and 6) has a cell phone or smartphone with texting and voicemail capabilities.  
Exclusion Criteria: 1) Current use of insulin or more than two hypoglycemic medications (either oral or 
injectable), 2) Recent routine A1c ≥ 12%, 3) Weight loss of >5 kg within the last 6 months, 4) Inability to 
understand consent procedures, 5) Inability to communicate using the English language, 6) Pregnancy or 
considering pregnancy, 7) Diagnosis of an unstable psychiatric condition, dementia, neurological disorder, or 
history of severe head trauma or brain tumor, 8) Diagnosis and/or hospitalization for severe depression in the 
last six months, 9) Evidence of cognitive impairment exhibited by difficulty either understanding, following 
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directions, or communicating clearly with program staff, 10) Exhibiting uncontrolled psychiatric symptoms 
and/or behaviors that may present a danger to program staff or to the study participants themselves, 11) 
Perceived unwillingness or inability to participate, 12) Plans to move from the area and change primary care 
physicians in the next year, and 13) People currently participating in another clinical research trial. 
Incidental Inclusion of Vulnerable Subjects (Inclusion of Decisionally Impaired): This study will not incidentally 
include decisionally impaired persons, as an individual may have undiagnosed psychiatric, cognitive, or 
developmental disorders, or may have had previous substance abuse problems. If individuals meet the 
inclusion criteria, but are deemed unable to provide informed consent, they will not be accepted into the study. 
However, they will be informed of and offered all health hub services that are available outside of study.  
Withdrawal Criteria If female participants become pregnant during the study, they will be removed from the 
study. Any participant who becomes seriously ill, injured, hospitalized, or incapacitated, will be suspended from 
participation until they return to normal health. If they do not return to normal health, they will be withdrawn. If I 
participant withdraws informed consent or no longer wants to participate, they will be withdrawn from the study. 
C4c.  Participant Identification and Recruitment.  
Recruitment. Study participants will be recruited from UTHSC Health Hubs in Uptown and ShelbyCares on 3rd 
in South Memphis. The UTHSC Health Hub, located on 534 North Second Street, will serve as our primary 
recruitment and intervention site. Currently, the UTHSC Health Hub offers health coaches to provide a system 
of support in weight loss, blood pressure control, healthy eating strategies, physical activity, medication 
adherence, and thus providing access to a range of potential participants. 
Recruitment Strategy.  
• 
Press Release: A press release describing the study will be approved and distributed through the 
UTHSC Communications and Marketing department. The press release will be delivered via radio, 
local television, local newspapers, and local newsletters, as appropriate. The press release will 
occur at the beginning of recruitment. 
• 
Social Media Promotion:  Recruitment flyers will be posted on social media sites (i.e., Facebook, 
Twitter, Instagram) 
• 
Flyer: Campaign Flyers will be displayed in various locations interested in participating. The flyers 
will include the study name, logo, brief description of the study, eligibility bullet points, and contact 
information including study phone number and website. Community locations are planned to 
include, but not limited to, the UTHSC Health Hub, churches, community centers, and local 
businesses. Flyers will be handed out at community events, such as health fairs and church 
gatherings in catchment areas. Additionally, flyers will be emailed as a PDF attachment interested 
parties and community organizations’ listservs. 
• 
“Word-of-Mouth”: Members of the study team will distribute promotional items and make contact 
with community members and potential participants. Team members will be responsible for 
informing all interested persons about the study and as appropriate, provide marketing materials 
and/or study contact information. Study team members, particularly the RAs, HCs, and Research 
Coordinator are expected to maintain good relationships with those involved in recruitment. 
• 
Refer-a-Friend: To encourage enrolled participants to inform other interested persons with diabetes 
about the study, the study team will encourage ‘refer-a-friend.’ 
• 
Study Website: The health hub’s website [https://uthsc.edu/healthhub/] will have a public page that 
is devoted to the HEAL Diabetes program and recruitment information. The webpage will include 
study name, logo, brief description of the study, eligibility inclusion criteria, and directions for 
interested individuals to contact the study staff. 
Non-responders. Data including age, gender, body weight and height, and duration of diabetes will be recorded 
for all patients found to satisfy recruitment criteria upon screening who decline to participate. We will record 
reasons for non-participation. Characteristics of non-responders will be compared with those of participants to 
identify any recruitment bias, assess the representativeness of study participants, and help establish 
generalizability of the trial findings. 
C4d. Randomization Strategy. Eligible participants will be randomized in a 1:1 ratio using a block design with 
blocks of size 8. We will select the block sequence at random and fill blocks of 8 before selecting a new block. 
This will guarantee approximately the same number of participants in each group throughout the trial. The SAS 
program will be used for implementing the randomization scheme. Randomization logs will be created by Dr. 
Mahmood and uploaded to the REDCap system. The study staff will use the REDCap system to randomize 
patients to either the Intensive Care (Treatment) group or Enhanced Care (Control) group. Study personnel 
who collect and manage data will be blinded to participants’ treatment assignments. 
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C4e. Sample Size, Power, and Attrition. This trial aims to recruit a sample of 72 (36 in each group), which is 
a pragmatic decision based on the patient pool, budget, and two-year study period. We will recruit patients 
from the Health Hub and Tennessee Population Health Data Network (TN- POPnet). Given the study has 
broad eligibility criteria, we anticipate an estimated 20 adult patients with diabetes and obesity being eligible 
each month. This will provide a sufficient pool to enroll 8 patients/month and 72 patients over 9 months. We 
expect that after accounting for 15% attrition at 12-month follow-up, about 61 study participants will complete 
the study. The attrition rate is based on the evidence from our MODEL study and from Lean et al. This pilot 
study will help us to estimate the following: 1) Effect size for the study intervention, 2) Total number patients 
recruited, 3) Number of patients recruited each month, 4) Total time required to recruit patients, 5) Number of 
patients retained, and 6) Barriers and facilitators to recruitment and implementation of the interventions. The 
research will employ intensive scientific rigor in every stage of design and conduct to ensure robust and 
unbiased experimental design, methodology, analysis, interpretation, and reporting of results and the ability to 
reproduce the research findings.   
C5.  Multicomponent Motivational Interventions. All component interventions received by both the 
treatment and control groups will be delivered in phases as shown in Table 2 below. 
C5a. Intensive Preparation for Change and Core Educational Interventions. All patients will receive 
introductory education on plant-forward healthy eating for weight loss. Health coaches will lead two sessions 
(introductory and kickoff) for the treatment group; pharmacists or nutritionists will lead one traditional diabetes 
education session for the control group. All patients will receive evidence-based self-care tools included in the 
MODEL program toolkit142,143 adapted from DPP,84,162 ACT,81,82 Look AHEAD,77-80 and TARGIT,163 and 
supplemental recipe and diet information adapted from DiRECT21 and the Daniel Diet174 program. Treatment 
group participants will also receive training in cognitive behavioral strategies employing these tools. 
Treatment group sessions will begin with an icebreaker to foster authentic relationships and trust,115 
and will focus on goal setting, group problem solving, and preparation for intensive weight loss, and will include 
interactive education regarding the recommended intensive plant-forward diet including a small cooking 
demonstration. Treatment group participants will also participate in two individual health coaching sessions and 
TM in preparation for their “quit date” on which they initiate TDR with whole plant-based foods. All of these 
sessions will seek to engage both the patient and the person who does the shopping and cooking in the 
household to obtain buy-in from all family members regarding food replacement plans. 
 
Table 2. Study Timeline, Intervention Phases and Components, and Study Procedures 
Month(s) 
Study Procedures 
Treatment Group 
(Intervention Phases and Components) 
Control Group 
(Intervention Phases and Components) 
 
Screening 
 
 
1 
Baseline Visit 
(Randomization) 
Phase 1 -Intensive Preparation for Change: 1) 
Two (introductory and kickoff) health coach 
and nutritionist or dietician co-led support 
group sessions, 2) Health coaching, 3) Tailored 
motivational text messaging 
Phase 1 -Education: One traditional diabetes 
education session led by a pharmacist or 
nutritionist/registered dietician 
2-4 
Follow-up Visit 1 (Month 
3) 
Phase 2 -Total Diet Replacement: 1) Total diet 
replacement for months 2-4 using tailored 
healthy food boxes with recipes, 2) Health 
coaching, 3) Tailored motivational text 
messaging, 4) Coach-led support groups, 5) 
Monthly cooking classes, 6) Physician-
supervised medication discontinuation 
Phase 2 -Partial Diet Replacement: Partial diet 
replacement for 3 months using grocery store 
produce vouchers 
 
4-6 
Follow-up Visit 2 (Month 
6) 
Phase 3 -Food Reintroduction: 1) Health 
coach-led individual or group grocery store 
tours with individual patient reminders, 2) 
Health coaching, 3) Tailored motivational text 
messaging, 4) Coach-led support groups, 5) 
Monthly cooking classes 
Phase 3 -Food Reintroduction: No additional 
activities 
6-12 
Follow-up Visit 3 (Month 
12) 
Phase 4 -Weight Loss Maintenance: 1) Health 
coaching, 2) Tailored motivational text 
Phase 4 -Weight Loss Maintenance: No 
additional activities 
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messaging, 3) Coach-led support groups, 4) 
Monthly cooking classes 
 
 
 
Phase 1 (preparation phase) educational sessions for both groups will focus on introduction to and 
preparation for initiating plant-forward healthy eating. But in the treatment group, participants will be supported 
in preparing to strictly follow a low-calorie plant-forward weight loss diet (approximately 800 to 1200 kcal/d). 
Recommended diet characteristics are detailed below (C5d. Diet Replacement). Treatment group participants 
will be encouraged to track their adherence to prescribed low-glycemic diets with < 30% of calories from fat (< 
10% from saturated fat) via easy-to-use logs. For the treatment group health coaches will help participants 
tailor their meals to their goals and preferences and TM will recommend similar meals. For both groups, 
emphasis will be placed on eating more fruits, vegetables, and other high-volume, low-energy-density foods. 
Continuous 30-minute moderate physical activity on over five days per week will be recommended. 
C5b. Health Coaching. Participants in the treatment group will have their first individual session with their 
assigned health coach immediately after the baseline (randomization) visit. Health coaches will prioritize 
establishing rapport with the participant and identifying their motivations and initial goals using MI. HC program 
goals, plans for future individual sessions, and a written copy of their personal health goals will be given to 
them at the end of the session. Participation in the treatment arm will be monitored and supported by the 
assigned coach. The MI-based HC intervention will use MODEL toolkit content as described above.77-82 HC will 
aim to meet with participants for individual HC sessions bi-monthly the first month (Preparation Phase–2 
sessions following randomization) and throughout Phase 2 (TDR) for 3 months (6 sessions total). 
 
Components of HC will be personalized to each patient based on: patient preferences for frequency of 
contact and setting (in-clinic, telephone, home visit, or community); stage of disease (regimen complexity, 
complications, etc.); and patient-identified health goals, needs, motivations, and barriers to change.   
HC Training. Health coaches have been trained using the Health Sciences Institute all-inclusive Chronic Care 
Professional (CCP) and Registered Health Coach (RHC) Certification Program, a nationally recognized 
curriculum developed and vetted by credentialed, trained experts that encompasses evidence-based chronic 
care, wellness, disease management and MI-based HC.175-180 This model is SCT-based and fits well within our 
conceptual framework. The training will be supported and supplemented by content-specific training related to 
the intervention protocol by behavioral health/HC expert trainer (Dr. Butterworth). In the event of staff changes, 
Dr. Butterworth will oversee the training of new coaches. 
C5c. Tailored Motivational Text Messaging (TM). All treatment group participants will receive scheduled 
Registry-based TM, occasional individual TM, and assistance participating in the TM program from their health 
coach. TM will be tailored using patient’s personal health goals and preferences using the MODEL study TM 
protocol142 modified to allow occasional individual messages from their health coach; eliminate scheduled TM 
related to medication adherence; and incorporate additional scheduled TM related to benefits of and 
approaches to plant-forward healthy eating, potential for diabetes remission or cure, and optional religious 
health-related messages. The MODEL TM library includes over 5000 text message stems that have been 
extensively culturally tailored for low-income and African American individuals in our target population.57,142,143 
The dietary, physical activity, and weight loss messages are derived primarily from American Diabetes 
Association content.181,182 The TM library uses Registry and study data (see Facilities) to personalize and 
tailor messages based on participant demographics, preferences (e.g. regarding frequency, preferred 
behavioral focus, and desire for religious health-related messages), potential barriers to self-care,52 and 
responses to four instruments:  the Revised Summary of Diabetes Self-Care Activities Questionnaire,183-185 the 
Treatment Self-Regulation Questionnaire,186 the Diabetes-39 quality of life instrument,186-190 and the Perceived 
Competency Scale,191 as has been previously described.142 TM will be intensive during the first two Study 
phases. At any time, participants can change the frequency and behavioral focus of the messages by 
responding to monthly text-based questionnaires or by calling or texting their coach. 
C5d. Total Diet Replacement. Our dietary intervention is based on the successful DiRECT model for TDR 
adapted to the cultural preferences of our patient population to focus on a whole food plant forward diet 
consistent with a modified “Daniel Fast” diet. The dietary intervention will be delivered in 3 phases (Table 2). In 
Phase 1 (preparation, 0-1 month) treatment group participants will prepare for TDR as described above. In 
Phase 2 (TDR, 2-4 months) treatment group participants will receive nutritionally and calorically complete food 
boxes tailored to participant food preferences sufficient to feed their whole family. Recipes and instructions for 
serving sizes to provide 800–1200 kcal/d low-glycemic whole food plant forward diet with relatively high protein 
(25-30%) and < 30% of calories from fat (< 10% from saturated fat) to replace usual foods, with ample fluids 
(2.25 L) will be included. The total diet replacement (TDR) phase is mostly plant-based, focusing on vegetables 
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and fruits, but will also include lean meat/protein, eggs, and non-fat or low-fat milk products. Intervention group 
participants will receive healthy food boxes for 3 months during this time. Grocery supplies will include some 
foods that can be eaten as snacks and some beverages (i.e. low-fat milk). The nutrition team will estimate 
energy requirements (within the low calorie diet range) and macronutrients including kilocalories and protein for 
each individual participant adjusted per equations such as the Institute of Medicines Estimated Energy 
Requirement ( IOM EER) Equations for adults. Nutrition requirements will be adjusted for age, height, weight, 
level of exercise and presence of any co-morbid conditions. Macronutrients will be distributed accordingly per 
individual assessment so that despite daily total energy requirement needed to meet the Dietary Reference 
Intakes for individuals, the meal plans will fall in the lower carbohydrate diet range and higher percentage of 
total energy requirement from protein and healthy monounsaturated fats to ensure light ketosis. The nutrition 
team will use a spread sheet to help shoppers then determine total amounts of food needed per box per 
individual based on individual needs. Participants will be medically monitored by study personnel, including 
health coaches, nutrition specialists, and the medical director to ensure safe weight loss patterns and 
behaviors. 
 
During Phase 2 healthy food boxes (i.e. grocery supplies with recipes) will be delivered to the home on a 
weekly basis for three months. Preference and special diets will be taken into consideration when putting 
healthy food boxes together. We will survey participants at baseline with questions about the whole families’ 
food preferences, allergies, and special dietary concerns, like vegan, halal, kosher, etc. Nutritionist Dr. Tracy 
Bruen will train study personnel to use FARE, an app that will enable us to shop for individuals with identified 
food allergies as well as specific dietary preferences. Study personnel will be trained to use the app to verify 
that none of the food box contents include known allergies. Participants will be surveyed at baseline to collect a 
record of known food allergies/preferences a month before the diet replacement phase. Personnel will also be 
trained to find an appropriate replacement item without the known allergen. It is free and allows you to pick diet 
type and then scan an item in the grocery store to ensure it fits a participant’s dietary needs. A food delivery 
service hired by the study who has undergone a background check through the university will deliver food 
boxes to the participant’s home address scheduled at their convenience for 3 months (months 2 through 4). If 
participants are not at home or are unavailable, it is the assigned study personnel’s responsibility to work with 
the participant to reschedule a delivery and accommodate the participant’s schedule to ensure study 
participants have their weekly food provisions so that they are able to complete all study procedures. While the 
food boxes contain enough food to feed the whole family, family members should not be treated as study 
participants. They are not enrolled in the study and have not undergone consent or screening. Study personnel 
will not perform any study procedures on family. Food boxes are intended to help aid and support the study 
participant in completing study components.  
 
Participants may elect to continue the TDR phase for up to 5 months if their commitments, or life events, 
prevent achievement of 15 kg weight loss at 3 months, or if they wish to achieve more weight loss. If BMI falls 
below 23 kg/m2 during the TDR phase, participants will be moved forward to the weight loss maintenance 
phase. Near the end of TDR phase and in the first 3 months of the weight loss maintenance (WLM) phase, 
health coaches will encourage participation in individual or group grocery store tours and will assist patients 
with shopping and meal planning. In Phase 3 (WLM, 5-12 months) treatment group participants will be advised 
to follow a whole food plant forward diet and will be provided with an individually tailored energy prescription, to 
support weight stabilization and prevent weight regain. Patients will be advised to increase daily physical 
activity. If weight regain occurs, or if diabetes is found to have returned (A1c ≥ 6.5%) at any time during the 7-
month WLM phase, health coaches will work with patients to develop personalized ‘rescue plans’ to reverse 
weight gain. Phase 3 (Food Reintroduction) and Phase 4 (Weight Loss Management) will again follow the 
same mostly plant-based (produce and lean protein, eggs, nuts, and seeds, and non-fat or low-fat milk 
products) guidelines.  
C5e. Support Groups. Participants in the treatment group will be encouraged by their health coach and TM to 
participate in monthly health coach-led support groups focused on reporting progress and problems, and group 
problem solving using the framework proposed by Daaleman and Fisher for implementing peer support in 
diabetes self-management support groups.87-95 Peer mentor “Healthy Living Heroes” who have achieved 
weight loss, diabetes remission, or improved control will frequently attend and share personal experience. 
C5f. Cooking Classes. Treatment group participants will be encouraged by their coach and through TM 
reminders to attend free community cooking classes, occurring at least once a month at the central, north, and 
south Memphis locations (Facilities). Topics include whole food, plant-forward diet, macronutrients, meal 
planning and shopping, reading nutrition and ingredient labels, healthful meal choices for breakfast, lunch, 
dinner, and snacks, and healthy cooking skills. Classes will be led by either culinary medicine trained medical 
students, physicians, registered dietitians, and/or chefs; will be culturally tailored to meet the needs of the 
study population;192,193 will encourage home cooking and increase “food literacy” and self-efficacy in basic 
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technical culinary skills and competency to plan, choose, prepare, and consume nutritious food;99-101and each 
class will conclude with nutrition discussion while sharing the food prepared during the class. 
C5g.  Physician-Supervised Medication Discontinuation. Oral hypoglycemic agents (OHA) will be stopped 
on commencement of TDR, and antihypertensive and diuretic drugs will be stopped or reduced by half (based 
on physician judgement) on commencement of TDR. OHA, antihypertensive, and diuretic drugs will be 
reintroduced (as per study protocols) if T2D or hypertension returns. Aspirin will be continued if prescribed 
because of a previous heart attack or stroke but will be discontinued if prescribed solely because of T2D. Beta-
blockers prescribed for the management of angina will be continued. During the PSMD phase, participants will 
have their blood glucose monitored once a week at the health hub during the Total Diet Replacement and 
PSMD phase. Participants will also be encouraged to continue recommended monitoring by their primary care 
providers. For participants in the intensive care group, participants will only have some of their diabetes 
medications and/or antihypertensive medications discontinued or decreased according to the medication 
discontinuation protocol. The Medication Discontinuation Protocol gives discretion to the UTHSC Health Hub 
Medical Director, thus  participants in this group will be allowed to continue medications if needed in the 
estimation of the Medical Director in consultation with their primary care physician. Although PSMD is one of 
the study procedures, if the Medical Director (in consultation with the primary care provider) decides that a 
participant needs to continue diabetes and/or antihypertensive medications, they will be allowed to continue 
them and will not be withdrawn from the study. 
 
PSMD Guidelines. In general, antihypertensive, diuretic, and diabetes medications will be stopped by the 
Health Hub Medical Director on the day the total diet replacement and intensive weight loss phase begins. As 
a procedure, primary care providers’ contact information is collected at baseline before other study procedures 
are implemented.  Medical Director informs the patient’s primary care doctor of any changes in regimen. This is 
a safety measure, because blood pressure is likely to fall on the very calorie-restricted diet. This protocol lays 
out the standard approach to be followed to allow clear description of the research findings. Individual clinical 
decisions may be necessary for a person’s best interest. For all HEAL Diabetes intervention participants, in 
Week 4 of the Intensive Preparation for Change period participants, they are required to meet with the Health 
Hub medical director/covering physician for an online consultation to discuss their medication discontinuation 
plan. This session will allow them to make plans for medication reduction/discontinuation on day 1 of intensive 
weight loss diet following this protocol. The Health Hub Medical Director will seek to consult with the patient’s 
primary care MD if possible, to discuss and get their approval on the plan. The Medical Director will also 
encourage the patient to arrange a primary care follow-up visit in 1-4 weeks to assess for hypo/hyperglycemia 
and low/high BP and provide patient with copy of their Medication Reduction/Discontinuation Instructions to 
share with primary care MD. When antihypertensive drugs are stopped, the Medical Director will emphasize 
the importance of avoiding sodium (salt). 
 
Blood glucose will be monitored weekly at the UTHSC Health Hub months 2 through 4 (e.g., during the 
Total Diet Replacement phase) and periodically thereafter. Health Coaches and the UTHSC Health Hub 
medical director should encourage participants to continue any glucose monitoring recommended by their 
primary care physician or diabetes doctor and to contact their doctor and/or the UTHSC Health Hub Medical 
Director for blood glucose levels below 70 or above 300. Blood pressure will be monitored weekly at the 
UTHSC Health Hub for the 2nd – 4th months of the study (e.g., during the Total Diet Replacement phase) and 
periodically thereafter. Health Coaches and the UTHSC Health Hub medical director should encourage any 
self-monitoring recommended by their primary care physician. Advise participants to notify their healthcare 
provider and the Health Hub Medical Director for systolic blood pressure greater than 160 or diastolic BP 
greater than 100 with symptoms (acute vision changes, headache, chest pain, etc.) or systolic blood pressure 
greater than 180 or diastolic greater than 110 (regardless of symptoms). Advise participants to immediately call 
emergency medical services and seek emergent medical care for blood pressure readings 180/110 or higher 
AND symptoms of chest pain, shortness of breath, numbness, weakness, change in vision, difficulty speaking, 
or severe headache. In the three months of total diet replacement, participants should be seen at least once a 
week and should be offered blood glucose and blood pressure checks to assess for hyperglycemia, 
hypoglycemia, and/or hypertensive episodes. HEAL Diabetes Program Participant Medication 
Reduction/Discontinuation Instructions will be included in the intervention group’s toolkits. Study personnel, 
including health coaches and the medical director will emphasize instructions for monitoring for adverse events 
related to blood pressure or blood glucose. Procedures for monitoring blood glucose and blood pressure will be 
included and further detailed in the Manual of Procedures (MOP). 
 
Adverse events related to medication discontinuation are unlikely but may include hyperglycemia and 
hypertension. We will monitor those in the intervention group regularly for adverse events related to medication 
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discontinuation. Adverse event reports related to medication discontinuation may also come from self-reports 
from at home readings (blood pressure and blood glucose monitoring). Blood pressure and blood glucose 
screenings should be offered to participants at their weekly health hub visits, as well as through consultation 
with participants’ primary care providers. Regular care providers and participants can call the medical director 
to report any abnormal or extreme readings that occur outside of health hub’s regular monitoring. The health 
hub medical director and participant will work together to adjust medications based on individual needs and 
best interests. There is an existing medication reintroduction protocol.  However, if a participant does not follow 
the diet plan which then causes irregular blood pressure or blood sugar, the participant will not be removed 
from the study. Health hub staff will monitor blood pressure and blood sugar weekly. If a participant needs to 
increase or reintroduce their medication, the medical director will do that using best judgment and available 
information.  
C6.  Cultural Tailoring. Because culture plays an integral role in forming individuals’ health behaviors and 
many underserved populations have dietary preferences born from cultural influences and necessity,192,193 all 
component interventions will be extensively culturally tailored. This tailoring will occur during the initial planning 
phase (see section D and Milestones) and on an ongoing basis to ensure that they are culturally congruent 
and appropriate based on the cultural values of the population served.193,194 Interventions will be tailored to 
reflect the subjective culture (i.e., norms and attitudes), behavioral preferences, and expectations of the target 
population193,194 using preliminary focus group data (see section C2b4), patient focus groups (three planned in 
Y1, and two each year in Y2-4), and DWPC Patient and Community Advisory Council focus groups (two total in 
Y1). We will also employ ongoing interview input from early drop-out, ongoing, and completed participants. 
C7.  Intervention Fidelity and Quality Control. We will focus on design, training, delivery, receipt, and 
enactment (see analysis section below). To ensure consistency of intervention content and delivery, we will 
use standardized treatment manuals and procedures. All staff will be thoroughly trained in interventions, and 
protocol knowledge will be tested among staff. Training will be standardized, tested, and repeated. Even 
among highly trained staff, slight deviations (intervention drift) from treatment protocol may occur over time. To 
protect against this, regular “booster” training sessions will be conducted with all members of the study team. 
The behavioral and HC investigator (Dr. Butterworth) will oversee the fidelity, quality control planning, and 
implementation of the HC and TM interventions respectively and will conduct intervention meetings bi-monthly 
and then monthly with staff to discuss difficult cases and help problem solve implementation and participant 
adherence issues. Fidelity of health coaching to best motivational interviewing practices195 will be assessed 
regularly by a member of the Motivational Interviewing Network of Trainers (MINT) using a validated and 
standardized tool, based on the Motivational Interviewing Treatment Integrity coding system.196 Health coaches 
will submit recorded patient sessions (with patient written permission) for coding and assessment bimonthly for 
their first 6 months of the employment, monthly for two years, and periodically as needed thereafter. 
C8.  Study Visits. 
Screening Visit. Eligibility will be assessed. A1c will be obtained from through a blood draw (less than 1 
teaspoon of blood) through a finger stick. Dr. Frankie Stentz will assay the patient’s sample for HbA1c using 
the analyzer in the UT Endocrinology Lab to assess potential eligibility. In addition, patient’s weight, height, 
BMI, and blood pressure will be measured using the scales the appropriates scales and validated protocols. 
Participants will also be required to provide a list of their current medications and name and contact information 
of the primary care provider in event that they are randomized into the intervention arm at the baseline visit. 
Participants will be informed of their rights to determine who has access to their personal health information 
(PHI) in compliance with HIPPA regulations. As part of informed consent patients will be extensively counseled 
regarding all components of the treatment and control interventions to confirm their interest and willingness to 
participate in all component interventions prior to enrollment. After informed consent, contact and demographic 
information will be obtained. If a study participant has difficulty reading the informed consent or other study 
data collection forms, project personnel will assist. At this visit, all baseline study measures will be obtained. 
 
Baseline Visit. Following confirmation of eligibility at the screening visit, potential participants will be 
scheduled for a baseline visit at the health hub. Eligible participants will be randomly assigned to one of the 
two arms and informed of their group assignment.  Participants will be randomized to the HEAL Diabetes arm 
or the usual care condition. We will randomize 20-24 participants for each recruitment wave, for a goal of 
approximately 12 per condition. Participants will be randomized 1:1 to the two study conditions in randomly 
permuted blocks of size 8 using SAS random allocation. The randomization list was generated through SAS at 
the start of the study before randomization. The list is managed by one of the PIs. Once a participant has been 
determined to be eligible, the PI will assign each participant to the next open assignment on the list. We will tell 
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them at the Baseline visit which group they were assigned. Additionally, participants will have their first 
introduction to the health coaches. 
 
Follow-up visits 1–3. Outcomes will be assessed at the end of three months (Follow-up 1), 6 months 
(Follow-up 2) and at one-year (Follow-up 3).  All survey measures described below will be conducted at the 
health hubs. 
 
Additional In-Person Visits for intervention group:  
• 
Individual health coaching over 6 months (14 sessions total) (1 hour) 
• 
Group support sessions (6 sessions total) (1.5 hours) 
• 
Cooking/Nutrition classes (6 sessions total) (2 hours) 
C9.  Participant Retention. Our procedures will include the following strategies to track and retain 
participants: 1) collecting names, addresses, and phone numbers of relatives and friends who will usually know 
the participant’s whereabouts; 2) contacting participants with personalized letters and cards and remembering 
them at special times such as birthdays and holidays; 3) maintaining phone contact with participants 
throughout the study; 4) setting up a tracking database with names, addresses, phone numbers, email 
addresses, social media page information, and projected time windows; 5) taking a case management 
approach for handling difficult retention cases.  
Participant withdrawal. If participants withdraw from the protocol or fail to return for follow-up visits, we 
will continue to collect utilization and clinical data unless they withdraw consent. Data analysis will use best 
available follow-up weights and A1c values (closest within a window of ±3 months from routine attendances) 
and end of study diabetes status for participants who discontinue the protocol. Drug intolerance, diet 
intolerance or poor compliance will be recorded; these patients will be included in intention-to-treat analyses. 
Procedures for Involuntary or Voluntary Study Discontinuation 
Phase 1-Intensive Preparation for Change. If participants are removed from the study or voluntarily stop 
participation, nothing will occur since they have only received educational instruction and no other study 
procedures. Data collected from their participation will be analyzed using the “intention to treat” principle.  
Phase 2-Total Diet Replacement. If participants are removed from the study or choose not to continue, 
participants will be advised to follow up with their primary care provider and resume their diabetes and 
antihypertensive medication, as well as continue healthier diet and lifestyle changes. Participants will be 
informed that they can continue to receive Neighborhood Health Hub (NHH) services, including health 
coaching and group activities and education. Participants can also speak with the medical director and/or the 
PI if they have any questions about their ongoing care. In addition, participants may elect to have their glucose, 
blood pressure, and weight checked. Data collected from their participation will be analyzed using the 
“intention to treat” principle. 
Phase 3-Food Reintroduction. If participants are removed from the study or choose not to continue, 
participants will be advised to follow up with their primary care provider and resume their diabetes and 
antihypertensive medication, as well as continue healthier diet and lifestyle changes. Participants will be 
informed that they can continue to receive Neighborhood Health Hub (NHH) services, including health 
coaching and group activities and education. Participants can also speak with the medical director and/or the 
PI if they have any questions about their ongoing care. If participants proceed with their 6-month assessment, 
data collected will be analyzed using the “intention to treat” principle. 
Phase-4- Weight Loss Management. If participants are removed from the study or choose not to continue, 
participants will be advised to follow up with their primary care provider and resume their diabetes and 
antihypertensive medication, as well as continue healthier diet and lifestyle changes. Participants will be 
informed that they can continue to receive Neighborhood Health Hub (NHH) services, including health 
coaching and group activities and education. Participants can also speak with the medical director and/or the 
PI if they have any questions about their ongoing care. Data collected from their participation will be analyzed 
using the “intention to treat” principle. If participants proceed with their 12-month assessment, data collected 
will be analyzed using the “intention to treat” principle. 
 
C10.  Outcome Measures. Outcome Measures. As shown in Table 3, our primary biological outcomes 
assessing effectiveness (Aim 2) replicate the main outcome measures of the DiRECT study.21,24-26 Table 3 also 
details our secondary metabolic, patient-reported, and sustainability outcomes. To assess cost-effectiveness 
for Aim 1, we will calculate incremental cost of delivering the intervention to the study group compared to the 
control group by tracking all the program implementation costs, net of one-time costs associated with 
developing study materials or other costs that would not be expected to be incurred if the intervention were 
repeated or scaled up. 
Table 3:  Outcome Measures 
IRB NUMBER: 23-09351-FB UM
IRB APPROVAL DATE: 08/11/2023

Outcome Measures    
Measurement    
Schedule 
Primary biological outcomes (Aim 2) 
Body weight (kg) 
Body weight will be measured without shoes in regular clothes 
using calibrated scales (Befour Model: WH1061)  
Baseline, 3-, 6-, and 
12-month visits 
 
Weekly 
Blood pressure (mm Hg) 
Systolic and diastolic blood pressure using automated cuffs 
(Omron Model: HEM-907) using a validated protocol197 and 
number of blood pressure medications by patient report 
supplemented by medical record review  
Baseline, 3-, 6-, and 
12-month visits 
A1c (%)198 and diabetes 
remission21,24 
Metabolic assessments obtained using standard protocols with 
diabetes remission defined as A1c < 6.5% after at least 2 months 
off all antidiabetic medications except GLP-1 agonists and SGLT-
2 agonist medications, from baseline, months 6 & 12 
Baseline, 6-, and 
12-month visits 
Secondary metabolic and patient-reported outcomes (Aims 1 and 2) 
Self-efficacy 
129,130 Stanford Diabetes Self-Efficacy Scale  
Baseline, 6-, and 
12-month visits 
Diabetes self-management 
Two (out of six total) subscales of the revised Summary of 
Diabetes Self-Care Activities questionnaire for general diet and 
exercise 
Baseline, 6-, and 
12-month visits 
Secondary sustainability outcomes (Aim 1) 
Program retention (operational 
sustainability)  
Proportion of patients retained in study at each follow-up visit 
calculated by dividing the number who completed follow-up at 
each interval by the number expected. 
3-, 6-, and 12-
month visits 
Cost effectiveness of the 
multicomponent intervention 
(financial sustainability) 
Cost-effectiveness may be calculated using method employed by 
DiRECT29,155 and recommended by Centers for Disease Control 
and Prevention.199 Incremental total costs per patient related to 
primary outcomes of body weight (cost per additional kg weight 
loss), A1c (cost per additional unit A1c reduction), and diabetes 
remission (cost per additional diabetes remission) at one year 
calculated using an intention to treat analysis. Effectiveness 
measured as quality adjusted life years (QALYs) using EQ-
5D.200,201 
Following 
completion of data 
collection 
 
Other Factors. Covariates will be measured at baseline. These will include demographic characteristics, 
marital status, education level, insurance, chronic conditions, and SDOH (using electronic health record data 
collected on all Health Hub clients), and health literacy.206,207 At baseline, 6-, and 12-month visits, we will 
assess prescribed medications. Exposure to each component intervention will be assessed using health coach 
attendance logs. 
C11.  Analysis. We will evaluate the extent to which the program was implemented according to the protocol, 
examine if all components of the intervention were delivered in a standardized and reproducible format, and 
summarize the trial as a flow diagram following Consolidated Standards of Reporting Trials (CONSORT) 
guidelines.214 Patient characteristics will be compared between study groups to assess integrity of the random 
assignment process. Data will be presented as means and standard deviations for continuous variables and as 
frequencies and percentages for categorical variables. Results will be analyzed based on intention-to-treat. 
For Aim 2, we will use baseline, 6-, and 12-month follow-up data to compare differences between treatment 
and control group means in continuous primary biological outcomes (body weight, blood pressure, and A1c) 
and secondary patient-reported outcomes (self-care activities related to general diet and exercise). We will use 
the MIXED procedure of SAS because this is a parallel groups trial with repeated measures assessed over 
time. In the context of repeated measures ANOVA, we will use t-tests within group to detect change from 
baseline to 12-months (Follow-up 3) and t-tests between groups to detect the effect of the treatment on the 
various outcome variables at 12-months.  While the preceding hypothesis tests are a priori and not adjusted, 
other comparisons at the intermediary assessments will be adjusted using the Bonferroni method. To examine 
a difference in the proportion of patients who achieved diabetes remission at 12-month, we will use a chi-
square test.  
 For Aim 1, we will assess intervention operational sustainability as detailed above and in Table 3. Based 
on MODEL study experience providing MI-based HC and TM interventions, we hypothesize that operational 
sustainability will be high with 12-month program retention rates of approximately 85-90%. 
We will assess financial sustainability using cost-effectiveness analysis to estimate the incremental cost of 
providing the intervention compared with the control group as detailed in Table 3 above. Our analysis will be 
IRB NUMBER: 23-09351-FB UM
IRB APPROVAL DATE: 08/11/2023

conducted from the payer perspective. Based on DiRECT study experience,29,155 we hypothesize that the 
HEAL Diabetes intervention will be cost-effective when compared with control.217 
C12.  Study Limitations (Potential Problems and Alternative Approaches) 
1. Poor intervention fidelity. Every effort will be made to ensure key intervention fidelity in all arms. For 
example, if a health coach resigns, their patient panel will be distributed among the other health coaches within 
or across health systems as has been done the MODEL study to avoid any interruptions in care. 
2. Low participant recruitment or retention. It is possible that we will experience difficulties recruiting interested 
patients or that more than 20% of the participants will fail to complete the study, but we think this is unlikely 
given our MODEL study experience. In MODEL, we have recruited 672 similar T2D patients from the same 
clinics with 90% retention overall thus far. To prevent difficulties, we will closely monitor participants, discuss 
recruitment and retention at regular meetings, identify reasons for problems, and implement changes 
accordingly. If all retention strategies fail, we will increase number of participants to maintain adequate power.  
D.  Study Timeline and Future Directions 
We expect that this study will provide preliminary evidence regarding the effectiveness of the HEAL Diabetes 
multicomponent intervention in improving weight and blood pressure and achieving diabetes remission. These 
results will provide pilot data for larger studies demonstrating the effectiveness of nutrition-based multi-
component interventions as an alternative to pharmaceutical treatment alone for obese patients with early T2D. 
Our future research will focus on assessing: 1) long-term success in weight maintenance and diabetes 
remission, 2) comparative cost-effectiveness of bariatric surgery vs. a multicomponent behavioral intervention, 
3) relative effectiveness of component interventions in supporting behavior change and sustained weight loss, 
4) refinements of the multicomponent intervention model to strengthen most powerful intervention components, 
5) impact of payment policy changes for multicomponent obesity interventions on Medicaid and other 
vulnerable populations, and 6) effectiveness of multicomponent interventions for additional high-risk 
populations including the broader population with obesity, those with prediabetes, and those with multiple 
chronic conditions associated with obesity. 
E.  Data Collection.  
Collection Method. Data will be collected from a combination of EHR records accessed through REDCap or 
EPIC sourced from UTHSC Health Hub activities, blood samples, blood pressure readings, and weigh-ins, as 
well as from surveys and questionnaires conducted at baseline, 6-, and 12-months.   
Viewing and Collecting. We will collect: a) Name, contact information, primary care contact information, 
medications, demographic data, comorbidity information, income, b) HbA1c levels, blood pressure readings, 
and weight data, c) scores on standardized tools (diabetes management and self-efficacy). 
Deidentifying Data. Key personnel will deidentify data and participants will have unique participant ID numbers 
stored in REDCap. Access to the files will require permission from the program director, a UTHSC password, 
and IRB personnel approval. For each user, REDCap will require a REDCap profile, username, and password 
to enter the program. Study personnel will only have access to the database if the data manager has given 
them access. Any PHI fields will be stored in a separate form from other data collection forms. Data will be 
completely de-identified once the last assessment phase is complete. At this time the link between ID number 
and study data will be destroyed. Study data in the form of hard copies will be stored in a locked file cabinet 
managed by the program director and will be destroyed 3 years after completion of the study. 
 
F. Data and Safety Monitoring Plan. Monitoring of the study is important for both assessment of safety of the 
intervention and interpretation of study results. We have a system for monitoring, scheduling, and tracking 
participants. Staff roles will clearly be delineated and there will be ongoing monitoring of the health education, 
nutrition support, and the health coaching provided. Participants will be followed for approximately one year. 
For any serious adverse event reported during the study, the nature, date of onset, duration, and resolution will 
be recorded. A co-investigator will monitor each participant for serious adverse events. If the serious adverse 
event is thought to be related to study participation by either the primary care provider and/or the physician 
investigators (Dr. Bailey), the investigator may request the participant to undergo a physical examination, 
psychiatric evaluation, and/or laboratory testing whenever appropriate local to the participant. All staff 
members are trained on the FDA and IRB criteria and policies for a Serious Adverse Event. Study staff will be 
trained in assessing and reporting serious adverse events for all study populations. 
F1.  Medical Monitoring.   
F1a. Investigator and study team only. Monitoring of the study is important for both assessment of safety of 
the intervention and interpretation of study results. We have a system for monitoring, scheduling, and tracking 
participants. Staff roles will clearly be delineated and there will be ongoing monitoring of the health education 
IRB NUMBER: 23-09351-FB UM
IRB APPROVAL DATE: 08/11/2023

and the HC provided. Participants will be followed for approximately one year. For any serious adverse event 
reported during the study, the nature, and date of onset and resolution (duration), intensity will be recorded. A 
co-investigator will monitor each participant for serious adverse events. If the serious adverse event is thought 
to be related to study participation by either the primary care provider and the physician investigators (Dr. 
Bailey), the investigator may request the participant to undergo a physical examination, psychiatric evaluation, 
and/or laboratory testing whenever appropriate local to the participant. All staff members are trained on the 
FDA and IRB criteria and policies for a Serious Adverse Event. Study staff will be trained in assessing and 
reporting potential serious adverse events for all study populations. 
F1b. Monitoring the Progress of Trials and the Safety of Participants. This study will be overseen by the 
Principal Investigator (PI) who is an MD, a Co-Investigator MD, a study statistician, program manager, and the 
research coordinator. The study will be monitored by the study team on an on-going basis for protocol 
compliance and adequate study progress. Every month after recruitment commences, the team will review the 
following information in detail: Subject accrual rate; Subject drop-out and the reasons for drop-out; Gender 
recruitment rate; Major and minor problems related to interventions; Subject compliance with the protocol; and 
Program Manager and/or Research Coordinator questions or concerns. Researchers are directly involved with 
this review so decisions about changes, modifications, or adaptations are decided and acted upon 
immediately. 
It is anticipated that medical problems will occur during the study. The following is a summary of the 
plan of action based on the level of acuity of the problem. We do not expect major issues, emergencies, or 
urgent problems related to our intervention; however, in the case of these events, we will address these issues 
as outlined in the following paragraph. Emergent problems or those problems that are life threatening or 
require life-saving attention should be dealt with using the Emergency Medical System (EMS) by calling 911. 
For any events occurring at the intervention site (UTHSC Health Hub), health hub staff will provide basic life 
support as an interim measure when appropriate until EMS personnel arrive. The health hub staff will be 
responsible for notifying the participant’s family or designated contacts and the participant’s primary care 
physician. For events occurring outside of the health hub setting, participants will be instructed to call 911, and 
go to the nearest emergency room. Urgent medical problems or those problems that require the immediate 
attention but that do not require life-saving attention should be dealt with by taking measures to ensure the 
participants comfort and offering first aid as appropriate under the direction of the primary care physician at the 
respective site. Disposition plans should be made with the involvement of the participant, health hub staff, 
investigators, primary care physician and the participant’s family or designated contacts should always be 
notified. 
General medical problems or those problems that require attention should be dealt with by the primary 
care physician. The health hub staff should follow the primary care provider’s directions regarding treatment, 
disposition, and follow-up. Documentation of the problem and actions taken should be placed in the 
participant’s record. See Adverse Events for additional information. 
F1c. Serious Intercurrent Illness Unrelated to the Study. If the participant has a major illness, is 
hospitalized, or has other physical issues that interfere with the assigned study intervention, participation in the 
study will be suspended until routine health is resumed by the participant. The study physician will determine 
whether or not it is medically safe to continue the study. If the participant has a major illness (i.e., broken bone, 
etc.) that does not interfere with the assigned study intervention, the study physician will determine whether it 
is safe for the participant to continue participation in the study. 
F2.  Data Safety and Monitoring. This study will be conducted in accordance with all applicable federal 
requirements for subject privacy and safety. 
F2a. Informed Consent. Written consent will be obtained from each participant by study staff at the screening 
visit (SV) and reviewed with the participant prior to each of the subsequent visits for data collection purposes 
(i.e., surveys, blood draws). It will become part of the permanent study record. Each participant will be assured 
that study participation is voluntary and that they may withdraw at any time for any reason without jeopardizing 
their future care at this institution. At the time of obtaining written consent, the study staff/investigators will 
advise participants of the experimental nature of the study, the duration of the trial, alternate modes of 
treatment, and prevalent adverse events that might occur. Each participant will be questioned to ascertain 
whether they have understood the information. An opportunity for questions and discussion will be provided for 
each participant. The participant's signature on the consent form is required prior to the collection of any study 
measures and, if applicable, randomization. Each participant will receive a copy of the informed consent 
statement. The informed consent statement will be reviewed and approved by the Institutional Review Board 
(IRB) of the University of Tennessee prior to recruitment of participants. 
IRB NUMBER: 23-09351-FB UM
IRB APPROVAL DATE: 08/11/2023

F2b. Education on the Protection of Human Subjects. All key individuals responsible for the design and 
conduct of this research project have received education on the protection of human research participants. The 
curricula consisted of Internet computer-based training for researchers at the University of Tennessee. Study 
staff that will be hired for this project at a future date will also receive appropriate education on the protection of 
human research participants prior to interacting with the study participants. 
F2c. Education on HIPAA. All key individuals responsible for the design and conduct of this research project 
have received education on protection and confidentiality of protected health information (PHI). We do not 
envision the risks to participants to be above that of a diabetic receiving health education from their primary 
physician or health educator. However, implementation of this intervention may increase a participant’s risk for 
developing hypoglycemic episodes or hyperglycemic episodes. Although this study is associated with minimal 
risk, an independent, institutional data and safety monitoring will be appointed before enrollment of participants 
into the study. 
F2d. An independent Data and Safety Monitoring Board (DSMB). DSMB will be formed prior to the 
enrollment of the participants. We plan to have this committee review the final protocol for the study and to 
periodically review study data for the occurrence of outcomes of interest. We will specifically ask the committee 
to address serious adverse events and the risk to benefit profile for all study participants. The DSMB will meet 
a minimum of once each year and be composed of five persons, who are not involved in the study in another 
capacity, with expertise in any one of the following fields: medicine, endocrinology, clinical trials, epidemiology, 
psychology, and biostatistics. Guidelines for recommendations for changes in the study protocol will be refined 
for use by the DSMB. The committee will review these guidelines and make recommendations for changing 
any component of the trial based on regular review of all pertinent study data. 
• 
Dr. Surbhi, who is a co-investigator on this project, will have responsibility for analyzing interim data 
and preparing data and safety monitoring reports that the committee will review. These reports will 
include data on all adverse events and study outcomes for all study participants. Dr. Surbhi will be an 
ex-officio member of the committee and will not be blinded to participant group assignment. After the 
start of participant enrollment, we plan to conduct data and safety monitoring meetings in-person or via 
conference call twice a year. Data and safety monitoring reports will be sent to all committee members 
prior to the conference call. 
• 
A Manual of Procedures will be developed for the study and the procedures will be strictly followed. All 
controlled trials personnel are trained in sessions that will cover all study procedures, including 
recruitment, informed consent, measurements, randomization, participant follow-up, and adverse 
events. Adherence to the procedures in the operations manual will be assured by periodic assessment 
and retraining. A co-investigator will monitor each participant for adverse events throughout the study 
using participant report and reports by primary care physician. All participants will be asked at each 
study visit about emergency visits, hospital visits, or other serious adverse events in the intervening 
period, and these reported events will be recorded in the study database. If significant differences in 
adverse events noted above are found, additional interviews of the participant experiencing these 
adverse events may be conducted at the discretion of the DSMB and any necessary remedial action 
taken will be recorded. At any point a participant may be withdrawn from the study for health-related 
reasons. Medical side effects of improvements in healthy eating, physical activity, and medication 
adherence will be explained as part of the informed consent process to each participant by trained 
study personnel and participants will be provided a copy of the informed consent statement that will 
include a written list of potential side effects prior to randomization. An attempt will be made to quantify 
the severity of each side effect by asking the participant to grade its importance or impact on quality of 
life. 
• 
All participants will be encouraged to contact the study site if any episodes of severe hypoglycemia, 
hyperglycemia, or hospitalizations of any nature occur. In addition, physicians will be asked to notify the 
study site of any hospitalizations or severe episodes of hypoglycemia or hyperglycemia. Conversely, if 
the UTHSC Health Hub personnel uncover a morbid event in a study participant, the study staff will 
contact the participant's personal health care provider. The participants will have access to study 
personnel or to one of the physician investigators by telephone 24 hours each day through the on-call 
system in the event of medical problems related to the study. Our health systems have on-call systems 
that give the participants access to a physician investigator 24 hours a day. To further ensure 
participant safety, during the follow-up period we plan to assess wellbeing by physical assessment 
including blood pressure.  
IRB NUMBER: 23-09351-FB UM
IRB APPROVAL DATE: 08/11/2023

F3a. Adverse Events. We define serious adverse events as any adverse event or adverse reaction that 
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in 
persistent or significant disability or incapacity, or congenital anomaly or birth defect. We define adverse events 
as any untoward medical occurrence in a participant or experimental investigation subject administered a study 
treatment and which does not necessarily have a causal relationship with this treatment. Because this is a 
pragmatic trial with minimal risks we will only be recording and reporting serious adverse events such as 
severe hypoglycemia, or less serious, hyperglycemia. 
F3b. Classification of Events. In this study, the likelihood of serious adverse events associated with the 
planned interventions is very low, and mostly consists of a small possibility of serious hypoglycemic or 
hyperglycemic reactions associated with improvements in health habits as detailed below. All adverse events 
will be classified as to whether they are serious or not serious. An adverse event is considered serious if it is 
life threatening, prolonged or permanently disabling, requires or prolongs hospitalization for any cause other 
than routine delivery, is a congenital anomaly, or a major cardiovascular event. An event may also be 
considered serious if an investigator judges it to be a significant hazard or contraindication to continued study 
intervention or use of study medication. In addition, we will classify all adverse events regarding the 
relationship, severity, and expectedness as described below. 
Relationship The following are expected adverse events that may occur during the trial: 
Related to Intervention. Potential adverse events (AE) known to be associated with caloric restriction, weight 
loss, or improved medication adherence in patients with diabetes: hypoglycemia, hyperglycemia, malnutrition, 
bone loss, gall bladder disease. The DiRECT trial which employed a similar intervention found that severe 
hypoglycemia occurred between 0.2 to 0.57 times per 100 patient years in the treatment arm over the first 4 
years of the study. 194 Potential AE’s known to be associated with exercise in patients with diabetes: 
hypoglycemia, fracture or other injury, cardiac arrhythmia, cardiovascular event.  
Related to condition under study. Potential AE’s known to be associated with overweight or obesity include: 
diabetes, hypertension, dyslipidemia, cardiovascular disease (CVD), gall bladder disease, liver disease. All 
patients will be monitored at every data collection visit through the 12-month visit for the occurrence of these 
adverse events. 
Severity During the trial participants will be queried to determine if a serious adverse event has occurred as 
described above and all adverse events will be identified through patient and provider report. All serious 
adverse events will be recorded. A serious adverse event is considered serious if it is life threatening, 
prolonged or permanently disabling, requires or prolongs hospitalization for any cause other than routine 
delivery, is a congenital anomaly, a major cardiovascular event, or cancer other than non-melanoma skin 
cancer. An event may also be considered serious if an investigator judges it to be a significant hazard or 
contraindication to continued study intervention or use of study medication. 
Expectedness Adverse events will also be classified as to whether they are expected or unexpected. An 
unexpected adverse event is one for which the nature or severity is not consistent with information about the 
condition under study or intervention in the protocol, consent form, or program brochure. An expected event is 
one known to be associated with the intervention or condition under study. Thus, expectedness is related both 
to the intervention and to the condition under study. All serious or unexpected adverse events related to the 
intervention will be reported to the IRB and to the sponsor in a timely manner. 
F3c. Data Collection Procedures for Adverse Events. As described above, a co-investigator will monitor 
each participant for serious adverse events throughout the study using participant and provider reports. All 
patients will be asked at each study visit about emergency visits, hospital visits, or other serious adverse 
events in the intervening period, and these reported events will be recorded in the study database and 
concordance with the registry assessed as described above. Participants will be asked at each study visit 
about any serious adverse events that may have occurred between study visits. All participants will be 
encouraged to contact the study site if untoward symptoms, illnesses, or hospitalizations of any nature occur. 
In addition, their relatives and their personal physicians will be asked to notify the study site of any 
hospitalizations or major illnesses. Conversely, if the health hub personnel uncover a morbid event in a study 
participant, the study staff will contact the participant's personal health care provider. 
Reporting Procedures 
• 
Data and safety monitoring reports will be sent to the IRB every 6 months during the adverse event 
reporting period. 
Adverse Event Reporting Period 
• 
Initiation of enrollment (May 1, 2023) through March 30, 2024. 
Post-study Adverse Event 
IRB NUMBER: 23-09351-FB UM
IRB APPROVAL DATE: 08/11/2023

• 
Not expected 
 
G. Ethical Considerations. 
G1.  Informed Consent. The consent process will take place at the beginning of the baseline appointment. We 
will allow time for discussion or questions about the study. Consent will be obtained by study personnel trained 
in the consent process. To be able to participate in the study, participants must be adults without impaired 
decision-making ability that are able to speak, read, and understand English. The consent process will include 
a discussion of the participant’s understanding of what their participation in the study means, which will include, 
discussion of their rights, the protocol, all potential risks and benefits, and their options and contacts to express 
any concerns or complaints. A copy of the consent form has been provided with this application. 
G2.  Risks and Side Effects. Possible risks for being in this study include hypoglycemia, gallstones, 
temporary discomfort, or mental anguish adapting to the behavioral changes (i.e., new diet, increased 
movement and activity), and possibly breach of confidentiality and privacy by other participants during nutrition 
education classes. We will have procedures in place to minimize the potential for risks and side effects for 
participants. 
• 
A possible side effect, Hypoglycemia, is a condition in which an individual’s blood sugar (glucose) level 
is lower than the standard range. Participants will be carefully monitored and counseled on ways to 
decrease the risk of hypoglycemia. Staff and patients will be trained to recognize the signs and 
symptoms of hypoglycemia, in addition, a physician is available to provide supervised medication 
discontinuation for every participant. 
• 
Gallstones are expected to be very rare (Less than 1% risk). However, this discomfort usually resolves 
or greatly diminishes within one week as long as participants stick with their healthy diet. This potential 
risk is not serious and is completely reversible. Participants will be carefully monitored and counseled 
on ways to decrease the risk of gallstones. 
• 
Regarding discomfort and mental anguish, participants will be advised of the risks and benefits of 
participation and informed of their right to withdraw from the study at any time if they should choose to 
discontinue. Finally, participants will be advised on informed consent and their role in protecting the 
confidentiality and privacy of other participants and their own. 
• 
Randomization: Although it is expected that both study treatments will be either beneficial or neutral 
(with no effect at all), it is possible that the treatment that a participant is assigned to, may later be 
shown to be less effective than other therapies. 
G3.  Benefits. Participants may or may not benefit from participating in the study. Benefits that may occur 
include weight loss and/or diabetes remission. Another tangible benefit for the experimental group is receipt of 
food subsidies during the study timeframe, while the control group will receive food vouchers. Societal benefits 
include providing evidence to support the use of multi-component behavioral change interventions to treat 
obesity and diabetes. Additionally, this research will contribute to a growing body of research on treating 
diabetes and other chronic illnesses using the ‘food as medicine’ hypothesis or medically-tailored meals as an 
alternative to traditional treatment. 
G4.  Alternatives to Participation. Should individuals choose not to participate, they have the option of 
standard care through options already available to them. Another alternative to participation is the health hub, 
where health coaches provide support in weight loss, blood pressure control, healthy eating strategies, 
physical activity, and medication adherence. 
G5. Costs to Subjects. Costs to subjects include time investment and transportation expenses, but 
participants can be helped with free medical transportation. Economic burden to subjects includes the time 
needed for screening and study participation. Regarding the time commitment, we will do our best to work with 
subjects’ schedules, so that any possibly resource-vulnerable individuals are not required to miss work or other 
important obligations in exchange for their participation. While there is no cost to participation in the study, if 
participants elect to receive motivational text messages, standard texting rates will apply.  
G6. Compensation to Subjects. Although there are many potential benefits to participation, subjects will not 
receive monetary compensation outside of the food subsidies, food vouchers, and transportation expenses (as 
needed). 
G7. Provisions for Vulnerable Subjects. The patient sample for this study is likely to include economically 
disadvantaged persons, as well as racial/ethnic minorities. Additionally, this study may unintentionally or 
unknowingly include participants who are considered decisionally-impaired due to psychiatric, cognitive or 
developmental disorders, substance abuse problems or individuals in chronic pain. The study team will take all 
necessary steps to assure that participants in this study are fully informed about and understand the study, as 
IRB NUMBER: 23-09351-FB UM
IRB APPROVAL DATE: 08/11/2023

well as their rights and protections. We will thoroughly explain the risks, benefits, costs, privacy, confidentiality, 
and ability to withdraw or refuse participation. Participants will undergo the consent process at baseline and will 
know that their participation in this study is voluntary and they have a right to refuse or withdraw participation at 
any point in the study. Individuals who are decisionally-impaired may still be capable of providing consent. If 
evidence is present that they are incapable of providing informed consent due to the incapacity to understand, 
an individual who is legally authorized to consent for them must sign and date the consent document in order 
for them to be included in the study. 
G8. Subject Privacy and Data Confidentiality. REDCap will be used for data entry and management. Digital 
recorders will be used for recording audio from the group nutrition classes/support group sessions. The 
database and recordings will be maintained on UTHSC servers where security will be maintained through 
access controls. Once recordings are saved on the server they are deleted from the recorder. Recordings are 
used only for quality control and will not be transcribed. Access to the files will require permission from the 
program director, a UTHSC password, and IRB personnel approval. For each user, REDCap will require a 
REDCap profile, username and password to enter the program. Study personnel will only have access to the 
database if the data manager has given them access. UTHSC IRBs and their representatives, and study 
personnel will have access to the research data, as will the study sponsor if requested. All participants will be 
assigned an ID number, which will link them to their study data. PHI fields will be stored in a separate form 
from other data collection forms. Data will be completely de-identified once the last assessment phase is 
complete. At this time the link between ID number and study data will be destroyed. Study data in the form of 
hard copies will be stored in a locked file cabinet managed by the program director and will be destroyed 3 
years after completion of the study. 
H. Conflicts of Interest. There are no conflicts of interest for the PI or any member of the study team. 
I. Plans for Dissemination of Findings. We will disseminate study findings through regional and national 
scientific meetings in the form of presentations and reports. 
J. References  
1. 
Lazar MA. How Obesity Causes Diabetes: Not a Tall Tale. Science. 2005;307(5708):373-375. 
doi:10.1126/science.1104342 
2. 
Conway BN, Han X, Munro HM, et al. The obesity epidemic and rising diabetes incidence in a low-
income racially diverse southern US cohort. PLOS ONE. 2018;13(1):e0190993. 
doi:10.1371/journal.pone.0190993 
3. 
Division of Nutrition PA, and Obesity, National Center for Chronic Disease Prevention and Health 
Promotion. Adult Obesity Prevalence Maps, 2018. Centers for Disease Control and Prevention. Updated 
September 12, 2019. Accessed October 6, 2019.  
4. 
Colditz GA. Weight Gain as a Risk Factor for Clinical Diabetes Mellitus in Women. 1995;122(7):481. 
doi:10.7326/0003-4819-122-7-199504010-00001 
5. 
Medicine Io. Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care (with CD). 
The National Academies Press; 2003:432. 
6. 
Spanakis EK, Golden SH. Race/Ethnic Difference in Diabetes and Diabetic Complications. Curr Diab 
Rep. 2013;13(6):814-823. doi:10.1007/s11892-013-0421-9 
7. 
Miech RA, Kim J, McConnell C, Hamman RF. A Growing Disparity in Diabetes-Related Mortality. 
American Journal of Preventive Medicine. 2009;36(2):126-132. doi:10.1016/j.amepre.2008.09.041 
8. 
Walker RJ, Gebregziabher M, Martin-Harris B, Egede LE. Relationship between social determinants of 
health and processes and outcomes in adults with type 2 diabetes: validation of a conceptual framework. BMC 
Endocr Disord. Oct 9 2014;14:82. doi:10.1186/1472-6823-14-82 
9. 
Krishnaswami J, Sardana J, Daxini A. Community-Engaged Lifestyle Medicine as a Framework for 
Health Equity: Principles for Lifestyle Medicine in Low-Resource Settings. Am J Lifestyle Med. Sep-Oct 
2019;13(5):443-450. doi:10.1177/1559827619838469 
10. 
Diabetes Mellitus, Fasting Glucose, and Risk of Cause-Specific Death. New England Journal of 
Medicine. 2011;364(9):829-841. doi:10.1056/nejmoa1008862 
11. 
Gregg EW, Gu Q, Cheng YJ, Venkat Narayan KM, Cowie CC. Mortality Trends in Men and Women 
with Diabetes, 1971 to 2000. Annals of Internal Medicine. 2007;147(3):149. doi:10.7326/0003-4819-147-3-
200708070-00167 
12. 
Force. USPST, Curry SJ, Krist AH, et al. Behavioral Weight Loss Interventions to Prevent Obesity-
Related Morbidity and Mortality in Adults: US Preventive Services Task Force Recommendation Statement. 
JAMA. Sep 18 2018;320(11):1163-1171. doi:10.1001/jama.2018.13022 
IRB NUMBER: 23-09351-FB UM
IRB APPROVAL DATE: 08/11/2023

13. 
The Culinary Institute of America (CIA) and Harvard T.H. Chan School of Public Health DoN. Menus of 
Change: 2018 Annual Report. The Culinary Institute of America and President and Fellows of Harvard College; 
2018. February 2, 2020, 
http://www.menusofchange.org/images/uploads/pages/2018_Menus_of_Change_Annual_Report_FINAL.pdf 
14. 
The Diet and 15-Year Death Rate in the Seven Countries Study. American Journal of Epidemiology. 
2017;185(11):1130-1142. doi:10.1093/aje/kwx101 
15. 
Keys A, Menotti A, Karvonen MJ, et al. The diet and 15-year death rate in the seven countries study. 
Am J Epidemiol. Dec 1986;124(6):903-15. doi:10.1093/oxfordjournals.aje.a114480 
16. 
Trichopoulou A, Costacou T, Bamia C, Trichopoulos D. Adherence to a Mediterranean diet and survival 
in a Greek population. The New England journal of medicine. Jun 26 2003;348(26):2599-608. 
doi:10.1056/NEJMoa025039 
17. 
Shai I, Schwarzfuchs D, Henkin Y, et al. Weight loss with a low-carbohydrate, Mediterranean, or low-fat 
diet. The New England journal of medicine. Jul 17 2008;359(3):229-41. doi:10.1056/NEJMoa0708681 
18. 
Shai I, Spence JD, Schwarzfuchs D, et al. Dietary intervention to reverse carotid atherosclerosis. 
Circulation. Mar 16 2010;121(10):1200-8. doi:10.1161/CIRCULATIONAHA.109.879254 
19. 
Stentz FB, Brewer A, Wan J, et al. Remission of pre-diabetes to normal glucose tolerance in obese 
adults with high protein versus high carbohydrate diet: Randomized control trial. BMJ Open Diabetes Res 
Care. 2016;4(1):e000258. doi:10.1136/bmjdrc-2016-000258 
20. 
Lean M, Brosnahan N, McLoone P, et al. Feasibility and indicative results from a 12-month low-energy 
liquid diet treatment and maintenance programme for severe obesity. British Journal of General Practice. 
2013;63(607):e115-e124. doi:10.3399/bjgp13x663073 
21. 
Leslie WS, Ford I, Sattar N, et al. The Diabetes Remission Clinical Trial (DiRECT): Protocol for a 
cluster randomised trial. BMC Fam Pract. Feb 16 2016;17:20. doi:10.1186/s12875-016-0406-2 
22. 
Hall KD, Ayuketah A, Brychta R, et al. Ultra-Processed Diets Cause Excess Calorie Intake and Weight 
Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake. Cell Metab. Jul 2 2019;30(1):67-77 
e3. doi:10.1016/j.cmet.2019.05.008 
23. 
Monteiro CA, Cannon G, Moubarac JC, Levy RB, Louzada MLC, Jaime PC. The UN Decade of 
Nutrition, the NOVA food classification and the trouble with ultra-processing. Public Health Nutr. Jan 
2018;21(1):5-17. doi:10.1017/S1368980017000234 
24. 
Lean ME, Leslie WS, Barnes AC, et al. Primary care-led weight management for remission of type 2 
diabetes (DiRECT): An open-label, cluster-randomised trial. Lancet. Feb 10 2018;391(10120):541-551. 
doi:10.1016/S0140-6736(17)33102-1 
25. 
McCombie L, Leslie W, Taylor R, Kennon B, Sattar N, Lean MEJ. Beating type 2 diabetes into 
remission. BMJ. Sep 13 2017;358:j4030. doi:10.1136/bmj.j4030 
26. 
Lean MEJ, Leslie WS, Barnes AC, et al. Durability of a primary care-led weight-management 
intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial. 
Lancet Diabetes Endocrinol. May 2019;7(5):344-355. doi:10.1016/S2213-8587(19)30068-3 
27. 
Taylor R, Al-Mrabeh A, Zhyzhneuskaya S, et al. Remission of Human Type 2 Diabetes Requires 
Decrease in Liver and Pancreas Fat Content but Is Dependent upon Capacity for beta Cell Recovery. Cell 
Metab. Oct 2 2018;28(4):547-556 e3. doi:10.1016/j.cmet.2018.07.003 
28. 
Taylor R, Leslie WS, Barnes AC, et al. Clinical and metabolic features of the randomised controlled 
Diabetes Remission Clinical Trial (DiRECT) cohort. Diabetologia. Mar 2018;61(3):589-598. 
doi:10.1007/s00125-017-4503-0 
29. 
Xin Y, Davies A, McCombie L, et al. Type 2 diabetes remission: Economic evaluation of the 
DiRECT/Counterweight-Plus weight management programme within a primary care randomized controlled 
trial. Diabet Med. Aug 2019;36(8):1003-1012. doi:10.1111/dme.13981 
30. 
LeBlanc ES, Patnode CD, Webber EM, Redmond N, Rushkin M, O'Connor EA. Behavioral and 
Pharmacotherapy Weight Loss Interventions to Prevent Obesity-Related Morbidity and Mortality in Adults: 
Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. Sep 18 
2018;320(11):1172-1191. doi:10.1001/jama.2018.7777 
31. 
Yanovski SZ. Weight Management in Adults With Obesity: What Is a Primary Care Clinician to Do? 
JAMA. Sep 18 2018;320(11):1111-1113. doi:10.1001/jama.2018.11031 
32. 
Force CPST. CPSTF findings for obesity. The Community Guide. Accessed September 22, 2019. 
https://www.thecommunityguide.org/content/task-force-findings-obesity 
IRB NUMBER: 23-09351-FB UM
IRB APPROVAL DATE: 08/11/2023

33. 
Ogden CL FT, Carroll MD, et al. Prevalence of Obesity Among Adults, by Household Income and 
Education — United States, 2011–2014. MMWR Morb Mortal Wkly Rep. 2017;66:1369–1373. 
doi:http://dx.doi.org/10.15585/mmwr.mm6650a1 
34. 
Hales CM CM, Fryar CD, Ogden CL. Prevalence of obesity among adults and youth: United States, 
2015–2016. NCHS data brief. National Center for Health Statistics; 2017(no 288). 
https://www.cdc.gov/nchs/data/databriefs/db288.pdf 
35. 
Prevention. CfDCa. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the 
United States, 2014. 2014. Accessed December 17, 2015. 
http://www.cdc.gov/diabetes/data/statistics/2014StatisticsReport.html 
36. 
Jackson BM, Gutierrez ML, Relyea GE, et al. Unmet Primary Care Needs in Diabetic Patients with 
Multimorbidity in a Medically Underserved Area. Health Serv Res Manag Epidemiol. Jan-Dec 
2017;4:2333392817702760. doi:10.1177/2333392817702760 
37. 
Agborsangaya CB, Ngwakongnwi E, Lahtinen M, Cooke T, Johnson JA. Multimorbidity prevalence in 
the general population: the role of obesity in chronic disease clustering. BMC Public Health. Dec 10 
2013;13:1161. doi:10.1186/1471-2458-13-1161 
38. 
Ezzati M. Excess weight and multimorbidity: putting people's health experience in risk factor 
epidemiology. Lancet Public Health. Jun 2017;2(6):e252-e253. doi:10.1016/S2468-2667(17)30093-2 
39. 
Kivimaki M, Kuosma E, Ferrie JE, et al. Overweight, obesity, and risk of cardiometabolic multimorbidity: 
pooled analysis of individual-level data for 120 813 adults from 16 cohort studies from the USA and Europe. 
Lancet Public Health. Jun 2017;2(6):e277-e285. doi:10.1016/S2468-2667(17)30074-9 
40. 
Magill M, Apodaca TR, Borsari B, et al. A meta-analysis of motivational interviewing process: Technical, 
relational, and conditional process models of change. J Consult Clin Psychol. Feb 2018;86(2):140-157. 
doi:10.1037/ccp0000250 
41. 
Armstrong MJ, Mottershead TA, Ronksley PE, Sigal RJ, Campbell TS, Hemmelgarn BR. Motivational 
interviewing to improve weight loss in overweight and/or obese patients: A systematic review and meta-
analysis of randomized controlled trials. Obes Rev. Sep 2011;12(9):709-23. doi:10.1111/j.1467-
789X.2011.00892.x 
42. 
Lundahl B, Burke BL. The effectiveness and applicability of motivational interviewing: A practice-friendly 
review of four meta-analyses. J Clin Psychol. Nov 2009;65(11):1232-45. doi:10.1002/jclp.20638 
43. 
Lundahl B, Moleni T, Burke BL, et al. Motivational interviewing in medical care settings: A systematic 
review and meta-analysis of randomized controlled trials. Patient Educ Couns. Nov 2013;93(2):157-68. 
doi:10.1016/j.pec.2013.07.012 
44. 
VanBuskirk KA, Wetherell JL. Motivational interviewing with primary care populations: A systematic 
review and meta-analysis. J Behav Med. Aug 2014;37(4):768-80. doi:10.1007/s10865-013-9527-4 
45. 
Knight KM, McGowan L, Dickens C, Bundy C. A systematic review of motivational interviewing in 
physical health care settings. Br J Health Psychol. May 2006;11(Pt 2):319-32. doi:10.1348/135910705X52516 
46. 
Christie D, Channon S. The potential for motivational interviewing to improve outcomes in the 
management of diabetes and obesity in paediatric and adult populations: A clinical review. Diabetes Obes 
Metab. May 2014;16(5):381-7. doi:10.1111/dom.12195 
47. 
Walker RJ, Smalls BL, Bonilha HS, Campbell JA, Egede LE. Behavioral interventions to improve 
glycemic control in African Americans with type 2 diabetes: A systematic review. Ethnicity & Disease. 
2013;23:401.  
48. 
Dan Song T-ZX, Qiu-Hua Sun. Effect of motivational interviewing on self-management in patients with 
type 2 diabetes mellitus: A meta-analysis. International Journal of Nursing Sciences. September 2014 
2014;1(3):291-7.  
49. 
West DS, DiLillo V, Bursac Z, Gore SA, Greene PG. Motivational interviewing improves weight loss in 
women with type 2 diabetes. Diabetes Care. May 2007;30(5):1081-7. doi:10.2337/dc06-1966 
50. 
Resnicow K, Jackson A, Wang T, et al. A motivational interviewing intervention to increase fruit and 
vegetable intake through Black churches: Results of the Eat for Life trial. Am J Public Health. Oct 
2001;91(10):1686-93.  
51. 
Ruddock JS, Poindexter M, Gary-Webb TL, Walker EA, Davis NJ. Innovative strategies to improve 
diabetes outcomes in disadvantaged populations. Diabet Med. Jun 2016;33(6):723-33. doi:10.1111/dme.13088 
52. 
Mulvaney SA, Anders S, Smith AK, Pittel EJ, Johnson KB. A pilot test of a tailored mobile and web-
based diabetes messaging system for adolescents. J Telemed Telecare. Mar 2012;18(2):115-8. 
doi:10.1258/jtt.2011.111006 
IRB NUMBER: 23-09351-FB UM
IRB APPROVAL DATE: 08/11/2023

53. 
van Olmen J, Ku GM, van Pelt M, et al. The effectiveness of text messages support for diabetes self-
management: Protocol of the TEXT4DSM study in the democratic Republic of Congo, Cambodia and the 
Philippines. BMC Public Health. 2013;13:423. doi:10.1186/1471-2458-13-423 
54. 
Franklin VL, Waller A, Pagliari C, Greene SA. A randomized controlled trial of Sweet Talk, a text-
messaging system to support young people with diabetes. Diabet Med. Dec 2006;23(12):1332-8. 
doi:10.1111/j.1464-5491.2006.01989.x 
55. 
Arora S, Peters AL, Agy C, Menchine M. A mobile health intervention for inner city patients with poorly 
controlled diabetes: Proof-of-concept of the TExT-MED program. Diabetes Technol Ther. Jun 2012;14(6):492-
6. doi:10.1089/dia.2011.0252 
56. 
Arora S, Peters AL, Burner E, Lam CN, Menchine M. Trial to examine text message-based mHealth in 
emergency department patients with diabetes (TExT-MED): a randomized controlled trial. Ann Emerg Med. 
Jun 2014;63(6):745-54.e6. doi:10.1016/j.annemergmed.2013.10.012 
57. 
Humble JR TE, Krukowski, RA, Womack CR, Motley TS, Bailey JE. Use of and Interest in Mobile 
Health for Diabetes Self-Care in Vulnerable Populations. J Telemed and Telecare. Accepted for publication, 
April 21 2015;0(0):1-7. doi:10.1177/1357633X15586641 
58. 
Head KJ, Noar SM, Iannarino NT, Grant Harrington N. Efficacy of text messaging-based interventions 
for health promotion: A meta-analysis. Soc Sci Med. Nov 2013;97:41-8. doi:10.1016/j.socscimed.2013.08.003 
59. 
Sieverdes JC, Treiber F, Jenkins C, Hermayer K. Improving diabetes management with mobile health 
technology. Am J Med Sci. Apr 2013;345(4):289-295. doi:10.1097/MAJ.0b013e3182896cee 
60. 
Raynor HA, Anderson AM, Miller GD, et al. Partial Meal Replacement Plan and Quality of the Diet at 1 
Year: Action for Health in Diabetes (Look AHEAD) Trial. Journal of the Academy of Nutrition and Dietetics. 
2015;115(5):731-742. doi:10.1016/j.jand.2014.11.003 
61. 
Cheskin LJ, Mitchell AM, Jhaveri AD, et al. Efficacy of Meal Replacements Versus a Standard Food-
Based Diet for Weight Loss in Type 2 Diabetes: A Controlled Clinical Trial. 2008;34(1):118-127. 
doi:10.1177/0145721707312463 
62. 
Hamdy O, Zwiefelhofer D. Weight Management Using a Meal Replacement Strategy in Type 2 
Diabetes. Current Diabetes Reports. 2010;10(2):159-164. doi:10.1007/s11892-010-0103-9 
63. 
Heymsfield SB, Van Mierlo CAJ, Van Der Knaap HCM, Heo M, Frier HI. Weight management using a 
meal replacement strategy: Meta and pooling analysis from six studies. International Journal of Obesity. 
2003;27(5):537-549. doi:10.1038/sj.ijo.0802258 
64. 
Hopkins MD, Taylor R, Lean MEJ. The DiRECT principles: Giving Type 2 diabetes remission 
programmes the best chance of success. Diabet Med. Sep 4 2019;doi:10.1111/dme.14126 
65. 
Ball SD, Keller KR, Moyer-Mileur LJ, Ding YW, Donaldson D, Jackson WD. Prolongation of Satiety 
After Low Versus Moderately High Glycemic Index Meals in Obese Adolescents. PEDIATRICS. 
2003;111(3):488-494. doi:10.1542/peds.111.3.488 
66. 
Kim JY, Kim JH, Lee DH, Kim SH, Lee SS. Meal replacement with mixed rice is more effective than 
white rice in weight control, while improving antioxidant enzyme activity in obese women. Nutr Res. Feb 
2008;28(2):66-71. doi:10.1016/j.nutres.2007.12.006 
67. 
Seligman HK, Lyles C, Marshall MB, et al. A Pilot Food Bank Intervention Featuring Diabetes-
Appropriate Food Improved Glycemic Control Among Clients In Three States. Health Aff (Millwood). Nov 
2015;34(11):1956-63. doi:10.1377/hlthaff.2015.0641 
68. 
Seligman HK, Smith M, Rosenmoss S, Marshall MB, Waxman E. Comprehensive Diabetes Self-
Management Support From Food Banks: A Randomized Controlled Trial. Am J Public Health. Sep 
2018;108(9):1227-1234. doi:10.2105/AJPH.2018.304528 
69. 
Wetherill MS, White KC, Seligman H. Charitable food as prevention: Food bank leadership 
perspectives on food banks as agents in population health. Community Dev (Columb). 2019;50(1):92-107. 
doi:10.1080/15575330.2019.1570961 
70. 
Wetherill MS, White KC, Seligman HK. Nutrition-Focused Food Banking in the United States: A 
Qualitative Study of Healthy Food Distribution Initiatives. J Acad Nutr Diet. Jun 28 
2019;doi:10.1016/j.jand.2019.04.023 
71. 
Freedman DA, Bell BA, Collins LV. The Veggie Project: A case study of a multi-component farmers' 
market intervention. J Prim Prev. Aug 2011;32(3-4):213-24. doi:10.1007/s10935-011-0245-9 
72. 
Gittelsohn J, Trude AC, Poirier L, et al. The Impact of a Multi-Level Multi-Component Childhood Obesity 
Prevention Intervention on Healthy Food Availability, Sales, and Purchasing in a Low-Income Urban Area. Int J 
Environ Res Public Health. Nov 10 2017;14(11)doi:10.3390/ijerph14111371 
IRB NUMBER: 23-09351-FB UM
IRB APPROVAL DATE: 08/11/2023

73. 
Birnie K, Thomas L, Fleming C, et al. An evaluation of a multi-component adult weight management on 
referral intervention in a community setting. BMC Res Notes. Feb 17 2016;9:104. doi:10.1186/s13104-016-
1901-1 
74. 
Leblanc ES, Patnode CD, Webber EM, Redmond N, Rushkin M, O’Connor EA. Behavioral and 
Pharmacotherapy Weight Loss Interventions to Prevent Obesity-Related Morbidity and Mortality in Adults. 
JAMA. 2018;320(11):1172. doi:10.1001/jama.2018.7777 
75. 
Lynch EB, Mack L, Avery E, et al. Randomized Trial of a Lifestyle Intervention for Urban Low-Income 
African Americans with Type 2 Diabetes. J Gen Intern Med. Jul 2019;34(7):1174-1183. doi:10.1007/s11606-
019-04894-y 
76. 
Ryan DH, Espeland MA, Foster GD, et al. Look AHEAD (Action for Health in Diabetes): Design and 
methods for a clinical trial of weight loss for the prevention of cardiovascular disease in type 2 diabetes. 
Control Clin Trials. Oct 2003;24(5):610-28.  
77. 
Wadden TA, West DS, Delahanty L, et al. The Look AHEAD study: a description of the lifestyle 
intervention and the evidence supporting it. Obesity (Silver Spring). May 2006;14(5):737-52. 
doi:10.1038/oby.2006.84 
78. 
Wing RR. Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in 
individuals with type 2 diabetes mellitus: Four-year results of the Look AHEAD trial. Arch Intern Med. Sep 27 
2010;170(17):1566-75. doi:10.1001/archinternmed.2010.334 
79. 
Wadden TA, West DS, Neiberg RH, et al. One-year weight losses in the Look AHEAD study: Factors 
associated with success. Obesity (Silver Spring). Apr 2009;17(4):713-22. doi:10.1038/oby.2008.637 
80. 
Wadden TA, Neiberg RH, Wing RR, et al. Four-year weight losses in the Look AHEAD study: Factors 
associated with long-term success. Obesity (Silver Spring). Oct 2011;19(10):1987-98. 
doi:10.1038/oby.2011.230 
81. 
King AC, Sallis JF, Dunn AL, et al. Overview of the Activity Counseling Trial (ACT) intervention for 
promoting physical activity in primary health care settings. Activity Counseling Trial Research Group. Med Sci 
Sports Exerc. Jul 1998;30(7):1086-96.  
82. 
Writing Group for the Activity Counseling Trial Research G. Effects of physical activity counseling in 
primary care: The Activity Counseling Trial: A randomized controlled trial. JAMA. Aug 8 2001;286(6):677-87.  
83. 
Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 diabetes with 
lifestyle intervention or metformin. N Engl J Med. Feb 7 2002;346(6):393-403. doi:10.1056/NEJMoa012512 
84. 
The Diabetes Prevention Program. Design and methods for a clinical trial in the prevention of type 2 
diabetes. Diabetes Care. Apr 1999;22(4):623-34. doi:10.2337/diacare.22.4.623 
85. 
10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes 
Study. The Lancet. 2009;374(9702):1677-1686. doi:10.1016/s0140-6736(09)61457-4 
86. 
Ma J, Yank V, Xiao L, et al. Translating the Diabetes Prevention Program Lifestyle Intervention for 
Weight Loss Into Primary Care. JAMA Internal Medicine. 2013;173(2):113. 
doi:10.1001/2013.jamainternmed.987 
87. 
Daaleman TP, Fisher EB. Enriching Patient-Centered Medical Homes Through Peer Support. The 
Annals of Family Medicine. 2015;13(Suppl_1):S73-S78. doi:10.1370/afm.1761 
88. 
van Dam HA, van der Horst FG, Knoops L, Ryckman RM, Crebolder HF, van den Borne BH. Social 
support in diabetes: A systematic review of controlled intervention studies. Patient Educ Couns. Oct 
2005;59(1):1-12. doi:10.1016/j.pec.2004.11.001 
89. 
Dale JR, Williams SM, Bowyer V. What is the effect of peer support on diabetes outcomes in adults? A 
systematic review. Diabet Med. Nov 2012;29(11):1361-77. doi:10.1111/j.1464-5491.2012.03749.x 
90. 
Deakin T, McShane CE, Cade JE, Williams RD. Group based training for self-management strategies 
in people with type 2 diabetes mellitus. Cochrane Database Syst Rev. Apr 18 2005;(2):CD003417. 
doi:10.1002/14651858.CD003417.pub2 
91. 
Qi L, Liu Q, Qi X, Wu N, Tang W, Xiong H. Effectiveness of peer support for improving glycaemic 
control in patients with type 2 diabetes: a meta-analysis of randomized controlled trials. BMC Public Health. 
May 6 2015;15:471. doi:10.1186/s12889-015-1798-y 
92. 
Heisler M. Overview of Peer Support Models to Improve Diabetes Self-Management and Clinical 
Outcomes. Diabetes Spectrum. 2007;20(4):214-221. doi:10.2337/diaspect.20.4.214 
93. 
Heisler M, Vijan S, Makki F, Piette JD. Diabetes Control With Reciprocal Peer Support Versus Nurse 
Care Management. Annals of Internal Medicine. 2010;153(8):507. doi:10.7326/0003-4819-153-8-201010190-
00007 
IRB NUMBER: 23-09351-FB UM
IRB APPROVAL DATE: 08/11/2023

94. 
Wilson W, Pratt C. The impact of diabetes education and peer support upon weight and glycemic 
control of elderly persons with noninsulin dependent diabetes mellitus (NIDDM). American Journal of Public 
Health. 1987;77(5):634-635. doi:10.2105/ajph.77.5.634 
95. 
Fisher EB, Boothroyd RI, Coufal MM, et al. Peer support for self-management of diabetes improved 
outcomes in international settings. Health Aff (Millwood). Jan 2012;31(1):130-9. doi:10.1377/hlthaff.2011.0914 
96. 
Newby OJ GD. Culturally Tailored Group Medical Appointments for Diabetic Black Americans. Journal 
for Nurse Practitioners. May 2016;12(5):317-323.  
97. 
Polak R, Phillips EM, Nordgren J, et al. Health-related Culinary Education: A Summary of 
Representative Emerging Programs for Health Professionals and Patients. Global Advances in Health and 
Medicine. 2016;5(1):61-68. doi:10.7453/gahmj.2015.128 
98. 
Archuleta M, Vanleeuwen D, Halderson K, et al. Cooking schools improve nutrient intake patterns of 
people with type 2 diabetes. J Nutr Educ Behav. Jul-Aug 2012;44(4):319-25. doi:10.1016/j.jneb.2011.10.006 
99. 
Garcia AL, Reardon R, McDonald M, Vargas-Garcia EJ. Community Interventions to Improve Cooking 
Skills and Their Effects on Confidence and Eating Behaviour. Curr Nutr Rep. 2016;5(4):315-322. 
doi:10.1007/s13668-016-0185-3 
100. 
Reicks M, Kocher M, Reeder J. Impact of Cooking and Home Food Preparation Interventions Among 
Adults: A Systematic Review (2011-2016). J Nutr Educ Behav. Feb 2018;50(2):148-172 e1. 
doi:10.1016/j.jneb.2017.08.004 
101. 
Reicks M, Trofholz AC, Stang JS, Laska MN. Impact of cooking and home food preparation 
interventions among adults: outcomes and implications for future programs. J Nutr Educ Behav. Jul-Aug 
2014;46(4):259-76. doi:10.1016/j.jneb.2014.02.001 
102. 
Zong G, Eisenberg DM, Hu FB, Sun Q. Consumption of Meals Prepared at Home and Risk of Type 2 
Diabetes: An Analysis of Two Prospective Cohort Studies. PLOS Medicine. 2016;13(7):e1002052. 
doi:10.1371/journal.pmed.1002052 
103. 
Kumar AA, Palamaner Subash Shantha G, Kahan S, Samson RJ, Boddu ND, Cheskin LJ. Intentional 
Weight Loss and Dose Reductions of Anti-Diabetic Medications – A Retrospective Cohort Study. PLoS ONE. 
2012;7(2):e32395. doi:10.1371/journal.pone.0032395 
104. 
Dutton GR, Lewis CE. The Look AHEAD Trial: Implications for Lifestyle Intervention in Type 2 Diabetes 
Mellitus. Progress in Cardiovascular Diseases. 2015;58(1):69-75. doi:10.1016/j.pcad.2015.04.002 
105. 
Buchwald H, Estok R, Fahrbach K, et al. Weight and Type 2 Diabetes after Bariatric Surgery: 
Systematic Review and Meta-analysis. The American Journal of Medicine. 2009;122(3):248-256.e5. 
doi:10.1016/j.amjmed.2008.09.041 
106. 
Frigg A, Peterli R, Peters T, Ackermann C, Tondelli P. Reduction in co-morbidities 4 years after 
laparoscopic adjustable gastric banding. Obes Surg. Feb 2004;14(2):216-23. 
doi:10.1381/096089204322857591 
107. 
Dixon JB, O’Brien PE, Playfair J, et al. Adjustable Gastric Banding and Conventional Therapy for Type 
2 Diabetes. JAMA. 2008;299(3)doi:10.1001/jama.299.3.316 
108. 
Courcoulas AP, Goodpaster BH, Eagleton JK, et al. Surgical vs Medical Treatments for Type 2 
Diabetes Mellitus. JAMA Surgery. 2014;149(7):707. doi:10.1001/jamasurg.2014.467 
109. 
Chang S-H, Stoll CRT, Song J, Varela JE, Eagon CJ, Colditz GA. The Effectiveness and Risks of 
Bariatric Surgery. JAMA Surgery. 2014;149(3):275. doi:10.1001/jamasurg.2013.3654 
110. 
Sarwer DB, Wadden TA, Moore RH, Eisenberg MH, Raper SE, Williams NN. Changes in quality of life 
and body image after gastric bypass surgery. Surg Obes Relat Dis. Nov-Dec 2010;6(6):608-14. 
doi:10.1016/j.soard.2010.07.015 
111. 
Dawes AJ, Maggard-Gibbons M, Maher AR, et al. Mental Health Conditions Among Patients Seeking 
and Undergoing Bariatric Surgery. JAMA. 2016;315(2):150. doi:10.1001/jama.2015.18118 
112. 
King WC, Chen J-Y, Belle SH, et al. Change in Pain and Physical Function Following Bariatric Surgery 
for Severe Obesity. JAMA. 2016;315(13):1362. doi:10.1001/jama.2016.3010 
113. 
Martin PD, Dutton GR, Rhode PC, Horswell RL, Ryan DH, Brantley PJ. Weight Loss Maintenance 
Following a Primary Care Intervention for Low-income Minority Women. Obesity. 2008;16(11):2462-2467. 
doi:10.1038/oby.2008.399 
114. 
Dodgen L, Spence-Almaguer E. Beyond Body Mass Index: Are Weight-loss Programs the Best Way to 
Improve the Health of African American Women? Preventing Chronic Disease. 
2017;14doi:10.5888/pcd14.160573 
115. 
Culturally Responsive Interventions: Innovative Approaches to Working with Diverse Populations. 
Routledge; 2004. 
IRB NUMBER: 23-09351-FB UM
IRB APPROVAL DATE: 08/11/2023

116. 
Wagner EH, Austin BT, Davis C, Hindmarsh M, Schaefer J, Bonomi A. Improving chronic illness care: 
Translating evidence into action. Health Aff (Millwood). Nov-Dec 2001;20(6):64-78.  
117. 
Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness. 
JAMA. Oct 9 2002;288(14):1775-9.  
118. 
Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness: The 
chronic care model, Part 2. JAMA. Oct 16 2002;288(15):1909-14.  
119. 
Martins RK, McNeil DW. Review of Motivational Interviewing in promoting health behaviors. Clin 
Psychol Rev. Jun 2009;29(4):283-93. doi:10.1016/j.cpr.2009.02.001 
120. 
Ismail K, Winkley K, Rabe-Hesketh S. Systematic review and meta-analysis of randomised controlled 
trials of psychological interventions to improve glycaemic control in patients with type 2 diabetes. Lancet. May 
15 2004;363(9421):1589-97. doi:10.1016/S0140-6736(04)16202-8 
121. 
O'Halloran PD, Blackstock F, Shields N, et al. Motivational interviewing to increase physical activity in 
people with chronic health conditions: A systematic review and meta-analysis. Clin Rehabil. Dec 
2014;28(12):1159-71. doi:10.1177/0269215514536210 
122. 
Gayes LA, Steele RG. A meta-analysis of motivational interviewing interventions for pediatric health 
behavior change. J Consult Clin Psychol. Jun 2014;82(3):521-35. doi:10.1037/a0035917 
123. 
Ananthakrishnan AN, Schellhase KG, Sparapani RA, Laud PW, Neuner JM. Disparities in colon cancer 
screening in the Medicare population. Arch Intern Med. Feb 12 2007;167(3):258-64.  
124. 
Channon SJ, Huws-Thomas MV, Rollnick S, et al. A multicenter randomized controlled trial of 
motivational interviewing in teenagers with diabetes. Diabetes Care. Jun 2007;30(6):1390-5. doi:10.2337/dc06-
2260 
125. 
Aaij R, Collaboration LH, Abellan Beteta C, et al. First evidence of direct CP violation in charmless two-
body decays of Bs0 mesons. Phys Rev Lett. May 18 2012;108(20):201601. 
doi:10.1103/PhysRevLett.108.201601 
126. 
Greaves CJ, Middlebrooke A, O'Loughlin L, et al. Motivational interviewing for modifying diabetes risk: 
A randomised controlled trial. Br J Gen Pract. Aug 2008;58(553):535-40. doi:10.3399/bjgp08X319648 
127. 
Ames GE, Heckman MG, Grothe KB, Clark MM. Eating self-efficacy: development of a short-form WEL. 
Eat Behav. Dec 2012;13(4):375-8. doi:10.1016/j.eatbeh.2012.03.013 
128. 
Ames GE, Heckman MG, Diehl NN, Grothe KB, Clark MM. Further statistical and clinical validity for the 
Weight Efficacy Lifestyle Questionnaire-Short Form. Eat Behav. Aug 2015;18:115-9. 
doi:10.1016/j.eatbeh.2015.05.003 
129. 
Delahanty LM, Peyrot M, Shrader PJ, et al. Pretreatment, psychological, and behavioral predictors of 
weight outcomes among lifestyle intervention participants in the Diabetes Prevention Program (DPP). Diabetes 
Care. Jan 2013;36(1):34-40. doi:10.2337/dc12-0733 
130. 
Hickey ML, Owen SV, Froman RD. Instrument development: cardiac diet and exercise self-efficacy. 
Nurs Res. Nov-Dec 1992;41(6):347-51.  
131. 
Harrington C C-TH. Diabetes Self-Management Education and Self-Efficacy Among African American 
Women Living With Type 2 Diabetes in Rural Primary Care. Journal of Doctoral Nursing Practice. 
2017;10(1):11-16. doi:http://dx.doi.org/10.1891/2380-9418.10.1.11 
132. 
Lorig K, Ritter PL, Villa FJ, Armas J. Community-Based Peer-Led Diabetes Self-management. The 
Diabetes Educator. 2009;35(4):641-651. doi:10.1177/0145721709335006 
133. 
Tol A, Shojaeezadeh D, Eslami A, et al. Evaluation of self-care practices and relative components 
among type 2 diabetic patients. J Educ Health Promot. 2012;1:19. doi:10.4103/2277-9531.99219 
134. 
Wilson-Barlow L, Hollins TR, Clopton JR. Construction and validation of the healthy eating and weight 
self-efficacy (HEWSE) scale. Eat Behav. Aug 2014;15(3):490-2. doi:10.1016/j.eatbeh.2014.06.004 
135. 
Gamburzew A, Darcel N, Gazan R, et al. In-store marketing of inexpensive foods with good nutritional 
quality in disadvantaged neighborhoods: increased awareness, understanding, and purchasing. Int J Behav 
Nutr Phys Act. Sep 27 2016;13(1):104. doi:10.1186/s12966-016-0427-1 
136. 
Kotler P, Zaltman G. Social marketing: An approach to planned social change. J Mark. Jul 
1971;35(3):3-12.  
137. 
Lefebvre RC, Flora JA. Social marketing and public health intervention. Health Educ Q. Fall 
1988;15(3):299-315.  
138. 
Walsh DC, Rudd RE, Moeykens BA, Moloney TW. Social marketing for public health. Health Aff 
(Millwood). Summer 1993;12(2):104-19. doi:10.1377/hlthaff.12.2.104 
139. 
Grier S, Bryant CA. Social marketing in public health. Annu Rev Public Health. 2005;26:319-39. 
doi:10.1146/annurev.publhealth.26.021304.144610 
IRB NUMBER: 23-09351-FB UM
IRB APPROVAL DATE: 08/11/2023

140. 
Frohlich KL, Potvin L. Transcending the known in public health practice: The inequality paradox: The 
population approach and vulnerable populations. Am J Public Health. Feb 2008;98(2):216-21. 
doi:10.2105/AJPH.2007.114777 
141. 
Bodenheimer T, Ghorob A, Willard-Grace R, Grumbach K. The 10 Building Blocks of High-Performing 
Primary Care. The Annals of Family Medicine. 2014;12(2):166-171. doi:10.1370/afm.1616 
142. 
Gatwood J, Shuvo S, Ross A, et al. The Management of Diabetes in Everyday Life (MODEL) program: 
Development of a tailored text message intervention to improve diabetes self-care activities among 
underserved African-American adults. Transl Behav Med. Feb 22 2019;doi:10.1093/tbm/ibz024 
143. 
Udoko AN GJ, Ransone S, Coday M, Gatwood J, Bailey JE. Characteristics of Health-related Text 
Messages Preferred by Medically Underserved African American Patients with Diabetes. Cureus. 
2019;11(9)doi:10.7759/cureus.5743 
144. 
Scott M GM, Maceri S, Riordan CJ, Bailey JE. Effectiveness of health coaching, text messaging, and 
patient education interventions in improving diabetes self-care: the patient perspective. presented at: Southern 
Meeting of the Society of General Internal Medicine; February 16, 2019 2019; Houston, TX. Session Plenary 
session, Oral presentation.  
145. 
Pope Z BJ, Gutierrez ML, Graff C. Lived Experience of Medically Underserved African-American 
Patients with Uncontrolled Diabetes with Promising Patient-Centered Self-care Interventions. presented at: 
Southern Meeting of the Society of General Internal Medicine; February 23, 2018 2018; New Orleans, LA. 
Session Plenary session, Oral presentation.  
146. 
Bloomer RJ, Kabir MM, Canale RE, et al. Effect of a 21 day Daniel Fast on metabolic and 
cardiovascular disease risk factors in men and women. Lipids Health Dis. Sep 3 2010;9:94. doi:10.1186/1476-
511X-9-94 
147. 
Alleman RJ, Jr., Harvey IC, Farney TM, Bloomer RJ. Both a traditional and modified Daniel Fast 
improve the cardio-metabolic profile in men and women. Lipids Health Dis. Jul 27 2013;12:114. 
doi:10.1186/1476-511X-12-114 
148. 
Butawan M BR. Favorable cardio-metabolic outcomes following high carbohydrate intake in accordance 
with the Daniel Fast. Journal of Fasting and Health. 2017;5(1):38-48.  
149. 
RJ B. Influence of a 6-month modified or traditional Daniel Fast on measures of health in men and 
women. Journal of Nutritional Biology. 2015;1(1):22-32.  
150. 
Trepanowski JF, Kabir MM, Alleman RJ, Jr., Bloomer RJ. A 21-day Daniel fast with or without krill oil 
supplementation improves anthropometric parameters and the cardiometabolic profile in men and women. Nutr 
Metab (Lond). Sep 13 2012;9(1):82. doi:10.1186/1743-7075-9-82 
151. 
Bloomer RJ, Kabir MM, Trepanowski JF, Canale RE, Farney TM. A 21 day Daniel Fast improves 
selected biomarkers of antioxidant status and oxidative stress in men and women. Nutr Metab (Lond). Mar 18 
2011;8:17. doi:10.1186/1743-7075-8-17 
152. 
Bloomer RJ TA. Participant compliance to a 6-month traditional and modified Daniel Fast. Journal of 
Fasting and Health. 2014;2(3):1-6.  
153. 
Smith NJ, Caldwell JL, van der Merwe M, et al. A Comparison of Dietary and Caloric Restriction Models 
on Body Composition, Physical Performance, and Metabolic Health in Young Mice. Nutrients. Feb 7 
2019;11(2)doi:10.3390/nu11020350 
154. 
Bloomer RJ, Schriefer JHM, Gunnels TA, et al. Nutrient Intake and Physical Exercise Significantly 
Impact Physical Performance, Body Composition, Blood Lipids, Oxidative Stress, and Inflammation in Male 
Rats. Nutrients. Aug 17 2018;10(8)doi:10.3390/nu10081109 
155. 
Xin Y, Davies A, McCombie L, et al. Within-trial cost and 1-year cost-effectiveness of the 
DiRECT/Counterweight-Plus weight-management programme to achieve remission of type 2 diabetes. Lancet 
Diabetes Endocrinol. Mar 2019;7(3):169-172. doi:10.1016/S2213-8587(18)30346-2 
156. 
Tripathy D, Cobb JE, Gall W, et al. A novel insulin resistance index to monitor changes in insulin 
sensitivity and glucose tolerance: The ACT NOW study. J Clin Endocrinol Metab. May 2015;100(5):1855-62. 
doi:10.1210/jc.2014-3824 
157. 
Bailey JE, Surbhi S, Wan JY, et al. Effect of Intensive Interdisciplinary Transitional Care for High-Need, 
High-Cost Patients on Quality, Outcomes, and Costs: A Quasi-Experimental Study. J Gen Intern Med. Sep 
2019;34(9):1815-1824. doi:10.1007/s11606-019-05082-8 
158. 
Bailey JE, Surbhi S, Bell PC, Jones AM, Rashed S, Ugwueke MO. SafeMed: Using pharmacy 
technicians in a novel role as community health workers to improve transitions of care. J Am Pharm Assoc 
(2003). Jan 2016;56(1):73-81. doi:10.1016/j.japh.2015.11.011 
IRB NUMBER: 23-09351-FB UM
IRB APPROVAL DATE: 08/11/2023

159. 
Nault Connors JD, Binkley BL, Graff JC, Surbhi S, Bailey JE. How patient experience informed the 
SafeMed Program: Lessons learned during a Health Care Innovation Award to improve care for super-utilizers. 
Healthc (Amst). Mar 2019;7(1):13-21. doi:10.1016/j.hjdsi.2018.02.002 
160. 
Surbhi S, Graetz I, Wan JY, Gatwood J, Bailey JE. The Effect of Opioid Use and Mental Illness on 
Chronic Disease Medication Adherence in Superutilizers. J Manag Care Spec Pharm. Mar 2018;24(3):198-
207. doi:10.18553/jmcp.2018.24.3.198 
161. 
Surbhi S, Munshi KD, Bell PC, Bailey JE. Drug therapy problems and medication discrepancies during 
care transitions in super-utilizers. J Am Pharm Assoc (2003). 2016 Nov - Dec 2016;56(6):633-642.e1. 
doi:10.1016/j.japh.2016.07.004 
162. 
Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 diabetes with 
lifestyle intervention or metformin. The New England journal of medicine. Feb 7 2002;346(6):393-403. 
doi:10.1056/NEJMoa012512 
163. 
Tennessee Uo. Treating Adults at Risk for Weight Gain With Interactive Technology (TARGIT). 
ClinicalTrials.gov. Accessed April 28, 2015. https://clinicaltrials.gov/ct2/show/study/NCT01199185 
164. 
Coday M, Richey P, Thomas F, et al. The Recruitment Experience of a Randomized Clinical Trial to Aid 
Young Adult Smokers to Stop Smoking without Weight Gain with Interactive Technology. Contemp Clin Trials 
Commun. Apr 15 2016;2:61-68. doi:10.1016/j.conctc.2015.12.010 
165. 
Johnson KC, Thomas F, Richey P, et al. The Primary Results of the Treating Adult Smokers at Risk for 
Weight Gain with Interactive Technology (TARGIT) Study. Obesity (Silver Spring). Oct 2017;25(10):1691-1698. 
doi:10.1002/oby.21968 
166. 
Bandura A, Adams NE, Beyer J. Cognitive processes mediating behavioral change. J Pers Soc 
Psychol. Mar 1977;35(3):125-39. doi:10.1037//0022-3514.35.3.125 
167. 
Bandura A. Social foundations of thought and action: A social cognitive theory. Prentice Hall; 1986. 
168. 
Bandura A. Self-efficacy: The exercise of control. Freeman; 1997. 
169. 
Delavega E BG. 2019 Memphis Poverty Fact Sheet. 2019:15. Accessed October 20, 2019. 
https://www.memphis.edu/socialwork/research/2019povertyfactsheet.pdf 
170. 
Bureau. USC. U.S. Census Bureau, American Fact Finder. Accessed October 20, 2019. 
https://www.census.gov/quickfacts/memphiscitytennessee 
171. 
Administration HRS. Find Shortage Areas. HRSA Data Warehouse. Accessed October 20, 2019. 
https://data.hrsa.gov/tools/shortage-area 
172. 
Centers for Disease Control and Prevention NCfCDPaHP, Division of Population Health. 500 Cities 
Project: Local Data for Better Health. 2019. Accessed October 20, 2019. https://www.cdc.gov/500cities/ 
173. 
Bray GA. Baseline characteristics of the randomised cohort from the Look AHEAD (Action for Health in 
Diabetes) study. Diabetes and Vascular Disease Research. 2006;3(3):202-215. doi:10.3132/dvdr.2006.031 
174. 
Gregory S BR. The Daniel Cure: The Daniel Fast Way to Vibrant Health. Zondervan; 2013. 
175. 
Institute HS. Registered Health Coach. Health Sciences Institute. Accessed April 28, 2015. 
http://www.healthsciences.org/registered-health-coach 
176. 
Health Sciences Institute. Chronic Care Professional (CCP) Certification. Health Sciences Institute. 
Accessed April 28, 2015. http://www.healthsciences.org/Chronic-Care-Professional-Certification 
177. 
Institute H. Chronic Care Professional (CCP) Certification Program Manual. 5th ed. HealthSciences 
Institute; 2014. http://www.healthsciences.org/CCP-Health-Coaching-Manual 
178. 
Linden A, Butterworth SW, Prochaska JO. Motivational interviewing-based health coaching as a chronic 
care intervention. J Eval Clin Pract. Feb 2010;16(1):166-74. doi:10.1111/j.1365-2753.2009.01300.x 
179. 
Butterworth SW, Linden A, McClay W. Health coaching as an intervention in health management 
programs. Disease Management & Health Outcomes. 2007;15(5):299-307.  
180. 
Butterworth S, Moore M, Stolzfus J, Walkup RB. Coaching experts discuss the relationships between 
coaching, culture, and health outcomes and for what coaches should be held accountable. Am J Health 
Promot. Jul-Aug 2014;28(6):TAHP3-7.  
181. 
Eating doesn’t have to be boring. American Diabetes Association. Accessed October 9, 2019. 
https://www.diabetes.org/nutrition 
182. 
Exercise for diabetes and get a leg up. American Diabetes Association. Accessed October 9, 2019. 
https://www.diabetes.org/fitness 
183. 
Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: Results 
from 7 studies and a revised scale. Diabetes Care. Jul 2000;23(7):943-50.  
IRB NUMBER: 23-09351-FB UM
IRB APPROVAL DATE: 08/11/2023

184. 
Gonzalez JS, Safren SA, Cagliero E, et al. Depression, self-care, and medication adherence in type 2 
diabetes: Relationships across the full range of symptom severity. Diabetes Care. Sep 2007;30(9):2222-7. 
doi:10.2337/dc07-0158 
185. 
Toobert DJ, Glasgow RE. Assessing diabetes self-management: The summary of diabetes self-care 
activities questionnaire. In: Bradley C, ed. Handbook of psychology and diabetes. Harwood Academic 
Publishers; 1994:351-375. 
186. 
Boyer JG, Earp JA. The development of an instrument for assessing the quality of life of people with 
diabetes. Diabetes-39. Med Care. May 1997;35(5):440-53.  
187. 
Khanna A, Bush AL, Swint JM, Peskin MF, Street RL, Jr., Naik AD. Hemoglobin A1c improvements and 
better diabetes-specific quality of life among participants completing diabetes self-management programs: A 
nested cohort study. Health Qual Life Outcomes. 2012;10:48. doi:10.1186/1477-7525-10-48 
188. 
Bott U, Muhlhauser I, Overmann H, Berger M. Validation of a diabetes-specific quality-of-life scale for 
patients with type 1 diabetes. Diabetes Care. May 1998;21(5):757-69.  
189. 
Mannucci E, Ricca V, Bardini G, Rotella C. Well-being enquiry for diabetics: A new measure of 
diabetes-related quality of life. Diabetes, nutrition & metabolism. 1996;9(2):89-102.  
190. 
Hammond GS, Aoki TT. Measurement of health status in diabetic patients. Diabetes impact 
measurement scales. Diabetes Care. Apr 1992;15(4):469-77.  
191. 
Given GW, Given BA, Gallin RS, Condon JW. Development of scales to measure beliefs of diabetic 
patients. Res Nurs Health. Sep 1983;6(3):127-41.  
192. 
G B. Can the African-American Diet be Made Healthier Without Giving up Culture. 2009. Accessed 
October 25, 2019. https://www.york.cuny.edu/academics/writing-program/the-york-scholar-1/volume-5.2-
spring-2009/can-the-african-american-diet-be-made-healthier-without-giving-up-culture 
193. 
Hines-Martin V, Starks S, Hermann C, Smith M, Chatman JM. Understanding Culture in Context: An 
Important Next Step for Patient Emotional Well-Being and Nursing. Nursing Clinics. 
doi:10.1016/j.cnur.2019.08.005 
194. 
Villarruel AM, Jemmott LS, Jemmott JB, 3rd. Designing a culturally based intervention to reduce HIV 
sexual risk for Latino adolescents. J Assoc Nurses AIDS Care. Mar-Apr 2005;16(2):23-31. 
doi:10.1016/j.jana.2005.01.001 
195. 
Miller WR RS. Motivational Interviewing: Helping People Change. Third ed. Guilford Press; 2013. 
196. 
Moyers TB, Martin T, Manuel JK, Hendrickson SM, Miller WR. Assessing competence in the use of 
motivational interviewing. J Subst Abuse Treat. Jan 2005;28(1):19-26. doi:10.1016/j.jsat.2004.11.001 
197. 
Ambrosius WT, Sink KM, Foy CG, et al. The design and rationale of a multicenter clinical trial 
comparing two strategies for control of systolic blood pressure: The Systolic Blood Pressure Intervention Trial 
(SPRINT). Clinical Trials: Journal of the Society for Clinical Trials. 2014;11(5):532-546. 
doi:10.1177/1740774514537404 
198. 
Sacks DB. Measurement of Hemoglobin A1c: A new twist on the path to harmony. Diabetes Care. 
2012;35(12):2674-2680. doi:10.2337/dc12-1348 
199. 
Centers for Disease Control and Prevention OotADfPaS. Cost-Effectiveness Analysis (CEA): What is 
cost-effectiveness analysis? Centers for Disease Control and Prevention. October 25, 2019. Accessed October 
25, 2019. https://www.cdc.gov/policy/polaris/economics/cost-effectiveness.html 
200. 
Devlin NJ, Brooks R. EQ-5D and the EuroQol Group: Past, Present and Future. Appl Health Econ 
Health Policy. Apr 2017;15(2):127-137. doi:10.1007/s40258-017-0310-5 
201. 
Brooks R. EuroQol: the current state of play. Health Policy. 1996;37(1):53-72. doi:10.1016/0168-
8510(96)00822-6 
202. 
National Association of Community Health Centers I, Association of Asian Pacific Community Health 
Organizations, Oregon Primary Care Association PRAPARE Implementation and Action Toolkit. National 
Association of Community Health Centers, Inc. Accessed October 25, 2019. http://www.nachc.org/research-
and-data/prapare/toolkit/ 
203. 
O'Gurek DT, Henke C. A Practical Approach to Screening for Social Determinants of Health. Fam Pract 
Manag. May/Jun 2018;25(3):7-12.  
204. 
Gottlieb L, Tobey R, Cantor J, Hessler D, Adler NE. Integrating Social And Medical Data To Improve 
Population Health: Opportunities And Barriers. Health Aff (Millwood). Nov 1 2016;35(11):2116-2123. 
doi:10.1377/hlthaff.2016.0723 
205. 
Pierannunzi C, Hu SS, Balluz L. A systematic review of publications assessing reliability and validity of 
the Behavioral Risk Factor Surveillance System (BRFSS), 2004–2011. BMC Medical Research Methodology. 
2013;13(1):49. doi:10.1186/1471-2288-13-49 
IRB NUMBER: 23-09351-FB UM
IRB APPROVAL DATE: 08/11/2023

206. 
Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. 
Fam Med. Sep 2004;36(8):588-94.  
207. 
Wallace LS, Rogers ES, Roskos SE, Holiday DB, Weiss BD. Brief report: Screening items to identify 
patients with limited health literacy skills. J Gen Intern Med. Aug 2006;21(8):874-7. doi:10.1111/j.1525-
1497.2006.00532.x 
208. 
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: Validity of a brief depression severity measure. J Gen 
Intern Med. Sep 2001;16(9):606-13.  
209. 
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety 
disorder: The GAD-7. Arch Intern Med. May 22 2006;166(10):1092-7. doi:10.1001/archinte.166.10.1092 
210. 
Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: 
Prevalence, impairment, comorbidity, and detection. Ann Intern Med. Mar 6 2007;146(5):317-25.  
211. 
Blewett LA, Johnson PJ, Lee B, Scal PB. When a usual source of care and usual provider matter: Adult 
prevention and screening services. Research Support, N.I.H., Extramural. J Gen Intern Med. Sep 
2008;23(9):1354-60. doi:10.1007/s11606-008-0659-0 
212. 
Li C, Balluz LS, Ford ES, Okoro CA, Zhao G, Pierannunzi C. A comparison of prevalence estimates for 
selected health indicators and chronic diseases or conditions from the Behavioral Risk Factor Surveillance 
System, the National Health Interview Survey, and the National Health and Nutrition Examination Survey, 
2007-2008. Prev Med. Jun 2012;54(6):381-7. doi:10.1016/j.ypmed.2012.04.003 
213. 
(CDC) CfDCaP. National Health Interview Survey. CDC.gov. Accessed OCtober 25, 2019, 2019. 
https://www.cdc.gov/nchs/nhis/nhis_questionnaires.htm 
214. 
Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel 
group randomised trials. BMC Medicine. 2010;8(1):18. doi:10.1186/1741-7015-8-18 
215. 
Preacher KJ, Hayes AF. SPSS and SAS procedures for estimating indirect effects in simple mediation 
models. Behav Res Methods Instrum Comput. Nov 2004;36(4):717-31.  
216. 
Williams J, Mackinnon DP. Resampling and Distribution of the Product Methods for Testing Indirect 
Effects in Complex Models. Struct Equ Modeling. 2008;15(1):23-51. doi:10.1080/10705510701758166 
217. 
Lee Y, Mozaffarian D, Sy S, et al. Cost-effectiveness of financial incentives for improving diet and 
health through Medicare and Medicaid: A microsimulation study. PLOS Medicine. 2019;16(3):e1002761. 
doi:10.1371/journal.pmed.1002761 
K. Appendices 
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