The Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study
Phase: NA
Conditions: Pre-diabetes, Obesity
Sponsor: Wake Forest University Health Sciences

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Healthy Living Partnerships to Prevent Diabetes in Veterans 
(HELP PD Vets) 
 
Pilot Study Protocol 
 
Mara Z. Vitolins, DrPH, MPH, RDN, Principal Investigator, Wake Forest School of Medicine 
Kimberly C, Phillips, PhD, BSN, RN, Principal Investigator, Salisbury VAMC 
 
Version Date: August 8, 2018 
 
Clinicaltrials.gov Identifier: NCT02835495 
 
 

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I. 
Background, Rationale, and Context 
a. Diabetes in the Veteran Population 
Type II Diabetes Mellitus (T2DM) is consistently identified as one of the costliest and deadliest public 
health problems facing the United States today.  T2DM accounted for more than $153 billion in medical 
costs in 2010 and an estimated $65 billion in reduced productivity1.  An estimated 11.3% of adults in the 
United States had diagnosed T2DM in 20102. In the population served by the Department of Veteran’s 
Affairs (VA), the estimated prevalence of T2DM in the male population was nearly 25% in 20103.  T2DM 
increases the risk of mortality from all causes, contributing to over 230,000 deaths each year in the US 
and is a major risk factor for various cardiovascular diseases, renal disease, blindness, neuropathy, lower 
extremity amputations and depression4.  As recent research has suggested that nearly 70% of Veterans 
accessing VA facilities are overweight and at risk for T2DM5, interventions to address this epidemic are 
not being utilized effectively within the existing healthcare systems of the VA and continue to be sorely 
needed.  Recent data reported from the MOVE! Program, a weight-management program available to 
Veterans nationwide, show that access is variable6, participation rates remain low7, and weight loss 
results have varied widely by delivery site6, 7. 
b. Lifestyle Interventions to Prevent Diabetes 
Large-scale clinical trials and subsequent translations have demonstrated the potential for the 
prevention of T2DM through lifestyle change, primarily through interventions focused on weight loss, 
physical activity and nutrition. The Diabetes Prevention Program (DPP), a behavioral lifestyle 
intervention targeting modest weight loss and increased physical activity, reduced the incidence of 
T2DM by 58% among persons with impaired glucose tolerance8.  The DPP lifestyle intervention produced 
a mean weight loss of 7% and a decrease of 4 mg/dl in fasting glucose at 2 years8. The DPP intervention 
was delivered through a 16-lesson core curriculum taught by case managers on an individual basis over 
a 24 week period9. Several recent studies have attempted to translate the DPP lifestyle intervention into 
other settings, including primary care10-12, churches13, YMCAs14, and parks and recreation centers15, 16.  
Taken together, these interventions typically produce approximately 6% weight loss at one year of 
follow up17.  
The Healthy Living Partnerships to Prevent Diabetes (HELP PD) was designed to translate the DPP 
approach for use in community settings as a cost-effective intervention led by community health 
workers (CHWs) with T2DM and administered through a local diabetes education program18.  
Approximately 300 overweight and obese (BMI 25-40 kg/m2) individuals with prediabetes (fasting blood 
glucose 95-125 mg/dl) were randomly assigned to either a lifestyle weight loss intervention or an 
enhanced usual care comparison condition19. At 6 months, HELP PD reported significant decreases in 
biological markers and adiposity comparable to those seen in DPP, including a mean weight loss of more 
than 7.5% and a mean reduction in fasting glucose of almost 4  mg/dL in intervention participants 
compared to a weight loss of 1.2% and increase in glucose of 1.1 mg/dL in usual care participants15. 
These results were largely maintained at 12 and 24 months16 and cost analysis demonstrated that the 
HELP PD intervention could be delivered for less than one-third the per capita cost of the DPP lifestyle 
intervention20. 

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c. Existing Diabetes Education and Prevention Efforts in the VA 
Current clinical practice guidelines developed by the VA include information on screening and 
therapeutic strategies for the prevention of T2DM.  Previous studies in similar care settings have 
demonstrated that even when this screening is conducted as recommended, follow-up is uncommon 
and few patients receive information about lifestyle interventions for prevention from their healthcare 
providers21. As managing T2DM is complicated and multifaceted, and requires ongoing education, 
behavioral interventions, risk factor reduction, health promotion and periodic examination for signs of 
complications, diabetes self-management education programs can reduce the burden on primary care 
providers by incorporating comprehensive care, skill training and behavioral strategies that can 
favorably affect some of the metabolic outcomes for patients with T2DM22. Diabetes education 
programs employ personnel with expertise in lifestyle interventions regarding physical activity and diet 
and have demonstrated effectiveness for improving patient quality of care23-28.  While community-based 
diabetes prevention programs are available29, they are often expensive, may not be easily accessible in 
rural areas, and often fail to bridge the divide between a medically-supervised intervention and the 
community-based resources needed to support a healthy lifestyle long-term.   
The VA has introduced a personalized, team-based system for providing diabetes education and care in 
the primary care setting known as Patient Aligned Care Teams (PACTs). This approach, based on the 
patient-centered medical home model, focuses on providing care that is patient-centered, efficient, and 
comprehensive by engaging all members of the healthcare team to provide education, preventive care, 
lifestyle coaching, and other services30.  PACTs currently provide T2DM screening and self-management 
education within the VA system, making them the logical home for prevention efforts in the clinical 
setting.  As the PACTs currently providing T2DM self-management education in VA outpatient clinics 
have the required infrastructure and expertise to provide prevention programming within their existing 
primary care framework, access to potential CHWs from within their diabetic patient populations, and 
existing provider referral mechanisms to enroll participants, the HELP PD intervention has great 
potential for dissemination and sustainability in this environment.   
Previous adaptations of the DPP, including HELP PD, have translated specific components of the 
intervention15, 16, 18, tested enrollment processes31-34, or changed the delivery setting35-none have 
attempted to combine all of these individual pieces into a fully integrated program. It is important to 
note that although HELP PD has been successful at translating the DPP lifestyle weight loss intervention 
through resources in the local community, further investigation is required to determine whether this 
model can be effective in other populations and settings. A joint effort with the Salisbury VAMC offers a 
real-world opportunity to adapt and implement the HELP PD lifestyle intervention in an existing primary 
care system.  Furthermore, current practice paradigms focusing on patient-centered care make VA 
outpatient clinics well-positioned to test screening and referral procedures and implementation of this 
lifestyle intervention30.  This pilot study will allow us to further refine and tailor efforts for use in this 
population and this setting.  
No interventions to date have attempted to use CHWs to deliver diabetes prevention in clinics 
administered by the VA or to mix lay personnel and healthcare professionals.   Ongoing efforts to 

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implement DPP programming in the VA to-date have been professionally led36, 37 and, as such, would be 
expensive to scale up and place a significant burden on the nurses and dietitians already struggling to 
meet demand. Previous studies have demonstrated the effectiveness of using both non-clinical 
personnel to deliver weight loss interventions38, 39 and peer coaches to provide diabetes management 
assistance40, but none have used a peer-led model to deliver a behavioral lifestyle intervention.  As 
current legislative and policy initiatives examine potential reimbursement mechanisms for lay-led 
diabetes prevention programs29, translating the HELP PD intervention into the VA healthcare system will 
provide valuable information on potential barriers to delivery and allow us to develop organizational, 
financial, and attitudinal support for a CHW-led intervention at the program and patient level. 
II. 
Objectives 
We have identified three aims to enable us to take the first steps to translate the evidence-based HELP 
PD intervention to reduce risk for diabetes in the Veteran population served by VA clinics.  We will: 
1. Adapt the HELP PD intervention specifically for Veterans in collaboration with Salisbury VAMC 
health care providers and Veterans who have been diagnosed with T2DM; 
2. Assess the feasibility of modifying healthcare delivery at an outpatient clinic associated with the 
Salisbury VAMC to implement the adapted HELP PD Vets program in Veterans with prediabetes; 
a. Aim 2A. Assess our ability to train providers and staff who are currently providing diabetes 
education to recruit and train veterans with T2DM to serve as CHWs who will administer, 
implement, and monitor the 6-month HELP PD Vets intervention program.  
b. Aim 2B. Conduct a randomized controlled pilot feasibility study in 50 Veterans with 
prediabetes. 
c. Aim 2C: Assess our ability to recruit and retain Veterans in the randomized controlled pilot 
study of HELP PD Vets. 
d. Aim 2D. Obtain preliminary data to estimate variances (means, SD) of measures to be 
utilized in the larger study.  Measures include anthropometrics, blood biomarkers, dietary 
intake, HRQL and behavioral constructs. 
 
3. Conduct a cost evaluation of the HELP PD Vets program to estimate the relative cost of intervention 
implementation in the clinical setting.  
Upon addressing these aims, we will be prepared to develop a larger grant proposal to implement a full-
scale evaluation of the efficacy and practicality of delivering the HELP PD Vets lifestyle intervention 
within the existing structure of outpatient VA clinics to reduce the risk for T2DM and its complications. 
III. 
Methods and Measures 
a. Design  
The Healthy Living Partnerships to Prevent Diabetes in Veterans (HELP PD Vets) is a two-armed 
randomized controlled feasibility pilot study. One arm will consist of the HELP PD Vets intensive lifestyle 
intervention aimed at promoting healthy eating, increasing physical activity and attaining modest, yet 
achievable (5-7%) weight loss and the comparison intervention will be an education program consisting 

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of 2 visits with an RD, health education materials and monthly newsletters. The HELP PD Vets 
intervention will be implemented and monitored by staff members at the Kernersville Health Care 
Center, who will recruit, train, and supervise community health workers (CHWs), to facilitate the 
delivery of the lifestyle intervention.   
Participants will be community dwelling Veterans with prediabetes who are overweight or obese seen at 
a local facility for primary care.  Following baseline assessments, participants will be randomized to the 
intervention or control arm with 1:1 allocation (see Figure 1).  Study measures will be collected at 
baseline and 6 months to assess feasibility and to provide data to inform the larger R18 application (i.e., 
anthropometric measures, blood biomarkers, psychosocial measures).  
b. 
Setting 
The VA operates 23 distinct Veterans Integrated Service 
Networks (VISNs) across the United States, providing a wide 
array of healthcare services including inpatient facilities, 
outpatient and primary care, and allied health services. The 
Salisbury VAMC is one of 8 medical centers housed within 
VISN 6: the VA Mid-Atlantic Health Care Network and 
provides service to the central and Piedmont portions of 
North Carolina. In addition to the Medical Center, there are 
3 community clinics affiliated with Salisbury VAMC located in 
Kernersville and Charlotte.  In this pilot feasibility study, we 
intend to target Veterans seen in the Kernersville Health 
Care Center because of the large number of visits conducted 
each year (145,653 in the previous fiscal year at the 2 
previous Winston-Salem locations) and the population 
served and services offered are representative of clinics 
throughout the VA system. In a future, full-scale pragmatic 
trial we anticipate including all clinics affiliated with 
Salisbury VAMC to deliver the HELP PD Vets intervention. 
The screening activities, data collection, and individual sessions will take place in the Kernersville Health 
Care Center.  The CHW led intervention meetings and contacts will take place in designated community 
facilities (e.g., recreation facilities, libraries, churches or schools).  We will enroll 50 adult (21 and older) 
Veteran participants in the greater Winston-Salem, Forsyth County, NC area to participate in this study.  
Based on recent data from the National Center for Veterans Analysis and Statistics, there are more than 
775,000 living Veterans in NC of which 73.0% are non-Hispanic white, 21.7% black/African-American, 
and 2.7% Latino. Roughly 10% of the total Veteran population in NC is female. There are approximately 
25,000 living Veterans in Forsyth County alone.  As the demographics of the Veteran population in NC 
closely resemble national averages, we anticipate recruiting a study population that closely resembles 
the larger population of Veterans seen at VA facilities across the country. 

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c. Subject Selection Criteria 
The principles guiding the selection of the following inclusion and exclusion criteria are to ensure the 
enrollment of participants who meet 4 major criteria: 1) high risk for developing Type 2 Diabetes 
Mellitus (T2DM), 2) no medical contraindications to participate in a lifestyle intervention including 
unsupervised physical activity and weight loss, 3) ethical randomization, i.e., there are no compelling 
reasons that potential participants should be referred for immediate weight loss, and 4) willingness to 
accept the randomized arm.  
i. Inclusion Criteria 
Demographics:  Men and women (21 years of age and older) of all races/ethnicities seen as patients at 
the Kernersville Health Care Center.  
BMI:  25 kg/m2 < BMI < 40 kg/m2. We plan to use the widely accepted BMI cut point for overweight (25 
kg/m2) as the threshold for eligibility. The maximum BMI will be 40 kg/m2, as current recommendations 
indicate that intensive weight loss management is appropriate for persons with BMI values greater than 
that, even including consideration of surgery. Hence, randomization might raise ethical concerns in this 
group.  
Evidence of Pre-Diabetes:  As we plan to identify participants in a clinical setting, all participants will be 
required to qualify based on evidence of prediabetes from fasting plasma glucose, oral glucose tolerance 
test, or HbA1c taken in the three months. The appropriate ranges for each test are 1) HbAlc: 5.7 to 6.4%; 
2) Fasting Plasma Glucose: 95-125 mg/dL; 3) Oral Glucose Tolerance Test: 140-200 mg/dL.  Blood 
measures will be collected from the medical record.   
Willingness to Accept Randomization:  Prospective participants must be willing to accept randomization 
to either the intensive lifestyle intervention or the comparison intervention condition. 
ii. Exclusion Criteria 
Weight Loss:  Currently involved in a supervised program for weight loss. 
Diabetes:  Clinical history of diabetes.  
Recent History of Cardiovascular Disease:  Clinical history of cardiovascular disease (CVD) occurring 
within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, 
TIA, carotid revascularization, peripheral arterial disease, and congestive heart failure. All persons with 
recent CVD should be participating in cardiac rehabilitation (with appropriate supervision as indicated) 
to reduce their risk of recurrence; hence, randomization might raise ethical concerns.  
Hypertension:  Uncontrolled high blood pressure: BP > 160/100 mmHg. Potential participants can be re-
screened after controlled. 
Pregnancy, planning pregnancy and breast feeding (self-report) during screening:  Pregnancy, breast 
feeding, or planning pregnancy within the next year. 

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Other Chronic Conditions:  Other chronic disease likely to limit lifespan to less than 2-3 years, including 
any cancer requiring treatment in past 5 years except non-melanoma skin cancer. 
Medication:  Chronic use of medicine known to significantly affect glucose metabolism (e.g., 
corticosteroids, protease inhibitors).  
Other:  Conditions/criteria likely to interfere with participation and acceptance of randomized 
assignment, including the following: inability/unwillingness to give informed consent, another 
household member already randomized to HELP PD Vets, major psychiatric or cognitive problems 
(schizophrenia, dementia, self-reported active illegal substance or alcohol abuse), participation in 
another research study that would interfere with HELP PD Vets. 
d. Sample Size 
This is a pilot study and is not powered to test the effect of the HELP PD Vets intervention on any 
outcome. The sample size of 50 for this pilot study was selected to provide reasonably tight estimates of 
the treatment effect, allowing us to estimate treatment differences in continuous outcomes to within ± 
0.6 SD with 95% confidence (assuming a dropout of 16%). Retention can be estimated to within ± 14% 
and successful adherence within the intervention to within ± 20%. The estimates obtained in this study 
will be used to design a fully powered randomized controlled trial assessing the effect of the HELP PD 
Vets intervention on blood glucose. Estimates of the variability of the outcome measures obtained in 
this study will be used to determine the required sample size in the subsequent trial. Effect estimates 
will inform us if desired effects are feasible. Estimates of retention and adherence will be used to modify 
the sample size to account for dropouts and poor adherence. Estimates of the participation and accrual 
rates will be used to judge the feasibility of the subsequent trial given the required sample size relative 
to patient availability and our ability to recruit them into our trial. 
IV. 
Interventions and Interactions 
a. Intensive Lifestyle Intervention 
The intensive lifestyle intervention used in HELP PD was a modification of the DPP core curriculum 
adapted for use in groups. The 16-session core curriculum used in DPP, covering key concepts related to 
energy balance, nutrition, and physical activity, was expanded to include regular sessions focused on 
group problem-solving of barriers and issues specific to the members and to incorporate presentations 
from local community groups on topics relevant to weight-loss and healthy living (exercise resources, 
food shopping, etc.) The same intervention will be used in HELP PD Vets and will target decreased 
caloric intake (reduction of 500-1000 kcal/day) and increased caloric expenditure through moderate 
intensity physical activity (goal ≥180 min/wk). The primary objective will be to produce a total weight 
loss of 5-7% from baseline during the 6-month intervention. A DVD series was developed in HELP PD to 
standardize this core content, improve fidelity of intervention delivery, and to allow the CHWs to focus 
on group facilitation and problem-solving.  This DVD series will also be used in HELP PD Vets.   
There will be 24 sessions delivered over the course of 6 months; materials consist of CHW lesson plans, 
participant workbooks, and the DVD series. These materials will be adapted for use in HELP PD Vets and 

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may include information on mental health resources available to Veterans for common illnesses like 
depression and post-traumatic stress disorder and modifying physical activity recommendations for 
Veterans with limited mobility. We will conduct an initial round of modifications to the materials prior to 
training community health workers and will modify the materials again based on feedback received 
during that training. Final adaptations to the materials will be made (for the subsequent larger trial) 
based on feedback collected from the participants at their 6-month close out visit. 
The training programs for staff and lay personnel will be adapted from HELP PD and designed with the 
understanding that staff delivering diabetes education services as part of a PACT in the Kernersville 
Health Care Center will be trained by investigators and staff from Wake Forest School of Medicine to 
screen and enroll participants, recruit and train community health workers, and administer, implement, 
and monitor the HELP PD Vets 6-month weight-loss program.  The training program will focus on study 
specific material and consist of a) study protocol; b) program philosophy, goals, and procedures; c) 
weight loss (energy balance); d) physical activity basics; e) group facilitation; f) cognitive-behavioral 
principles; g) participant monitoring; and h) use of the study website for data entry.  
Staff from the Kernersville Health Care Center 
will then recruit and train 3 CHWs. These 
CHWs will be recruited from the existing 
patient population seen for diabetes care at 
the Kernersville Health Care Center. All 
potential CHWs will be required to be 
members of the local Veteran community 
and will be expected to maintain good 
control of their diabetes, have the ability to 
devote ten hours per week to the study, and 
to maintain a regular exercise program. The 
CHWs will be responsible for facilitating 
participant group meetings, conducting calls 
to remind study participants of the group 
meetings, completing make-up sessions for 
missed group meetings, providing regular 
updates to the CBOC staff, and attending 
required training sessions.  At the end of the 
training program, each CHW will undergo a 
formal certification process adapted from 
HELP PD for this pilot study.   
Participants will meet weekly for CHW-led 
group sessions for 6 months. The core 
content will be delivered via DVD series to 
allow the CHW to focus on facilitating the 
group.  The physical activity program will 
Table 1.  Weekly Session Topics from HELP PD
Session # 
Session Title 
1 
Welcome to HELP PD 
2 
Nutrition 101 
3 
Physical Activity 101 
4 
Footwear 
5 
Troubleshooting 
6 
Calorie Balance  
7 
Mindfulness  
8 
Portion Sizes  
9 
Troubleshooting 
10 
Community Exercise/Nutrition Resources 
11 
Problem Solving  
12 
Physical Activity Hands On 
13 
Troubleshooting 
14 
Emotions and You  
15 
Healthy Eating  
16 
Stretching/Injury Prevention/Strength Training  
17 
Troubleshooting 
18 
More about Healthy Eating 
19 
Food shopping/eating out  
20 
Creating an Environment for Success  
21 
Troubleshooting 
22 
Wt. loss maintenance  
23 
Preparation for Independence  
24 
Transition 

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focus on walking and other large muscle activities. Within 3 months of study onset, the goal will be to 
have participants engaging in 30 minutes or more of moderate intensity activity for most, if not all, days 
of the week for a total weekly accumulation of 180 minutes. Physical activity bouts of ten minutes and 
longer will be counted toward the physical activity goal, but occupational activity will not be counted 
towards the physical activity goal. The physical activity goals and methods of HELP PD and this pilot are 
consistent with the recommendations of the Surgeon General and the American College of Sports 
Medicine41. We will use pedometers to enable participants to self-monitor their physical activity and to 
set goals for progressively increasing their activity level. As a component of the community-based 
design, some sessions may be presented by community representatives, including sessions on selecting 
appropriate footwear for walking or running, community exercise resources, safe exercise practices, and 
food shopping.  An outline of the sessions used in HELP PD is included in Table 1.  
As the intervention is based on social cognitive theory, each group session will begin with a review of 
the participants’ progress in implementing the strategies recommended for changing their eating or 
physical activity in the previous session. After a private weigh-in with the CHW, participants will describe 
the progress they have achieved and they will identify any problems they might have encountered. 
Difficulties encountered by participants will be dealt with through group support and advice. The session 
will then focus on skill training related to self-management skills (e.g., goal setting, self-monitoring), 
nutrition training (e.g., recognizing the caloric and fat contents of food), or exercise science (e.g., 
minimizing the risk of injuries). The final component of each session will consist of a discussion of the 
next week’s goals. Each participant will be asked to identify specific behavioral goals for the next period 
and will receive feedback and encouragement from the group. Each participant will also receive 
individual counseling sessions with a study nutritionist during months 1 and 3.   
b. Enhanced Usual Care (EUC) 
Our comparison intervention is designed to exceed the usual care provided to Veterans diagnosed with 
prediabetes. The EUC will consist of an individual education program that builds on an increased 
awareness of existing community resources.  Comparison participants will receive two individual 
nutrition counseling sessions with a study nutritionist during the first 3 months.  In these sessions, she 
will cover basic aspects of healthy eating and activity to support weight loss, and discuss existing 
resources (e.g., fitness facilities, weight loss programs, parks, walking trails, etc.) that may fit the 
individual needs of comparison participants as they pursue dietary change, increased physical activity 
and weight loss.  In addition, comparison participants will receive monthly newsletters with topics 
related to healthy lifestyle. In order to maximize retention of participants in this group, participants will 
be allowed to enroll in any existing wellness programs provided by the VA including MOVE!  and other 
diabetes prevention programs and we will track their participation via documentation in the electronic 
medical record and participant self-report. 
V. 
Study Measures 
We will collect information regarding demographics, anthropometry (height, weight, and waist 
circumference), blood pressure, medical history, health behaviors and behavioral constructs and health- 

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related quality of life (HRQL). The frequency with which study measures will be collected is outlined in 
Table 2.  
a. Demographics  
Age (date of birth), gender, race and ethnicity (US Census Definition), and names and contact 
information will be collected.  
b. Blood pressure and anthropometry 
Blood pressure, height, and weight will be collected from the most recent clinical encounter in the 
participant’s existing medical record within the VA.  This data will be used to both confirm eligibility for 
the trial and to serve as baseline and follow-up data.  
c. Medical history and current medications 
During screening, medical history of T2DM, cardiovascular disease and other medical conditions 
described above will be obtained to implement the inclusion and exclusion criteria. Medications that 
have the potential to impact blood glucose, lipid levels and body weight will be collected.  This 
information will be obtained from the electronic medical record.  Throughout the study, adverse and 
serious adverse events will be tracked.  
d. Laboratory measures 
Based on the current standard of care provided to patients in VA CBOCs, participants who are diagnosed 
with prediabetes are seen every 6 months and fasting blood is collected at those visits.  Staff at the 
Kernersville Health Care Center will be able to obtain laboratory values to verify eligibility for 
participation and to serve as baseline and follow-up data from the participant’s existing electronic 
medical record including hemoglobin A1c, fasting glucose, lipids and lipoproteins. 
e. Physical activity  
We will use the 
International Physical 
Activity Questionnaire 
(IPAQ), a reliable and valid 
instrument for assessing 
physical activity42.  The 
IPAQ short form is a 7-
item index that asks 
respondents the number 
of days per week and the 
amount of time per day 
spent in vigorous- and 
moderate-intensity 
Table 2. Pilot Study Data Collection:  Measures and Frequency 
 
Screening 
Baseline 
6-months  
Informed Consent and HIPAA Authorization 
X 
 
Demographics 
X 
 
 
*Medical History 
X 
 
X 
*Blood Pressure 
X 
 
X 
*Height, Weight 
X 
 
X 
*Current Medication Use 
X 
X 
*HbA1c, *Fasting Glucose, *Lipids 
X 
X 
3-day food records 
X 
X 
International Physical Activity Questionnaire (IPAQ) 
X 
X 
Veterans RAND36 (VR-36) 
X 
X 
*Measure obtained from medical record 
 
 

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activities and walking, during the seven days prior to the interview.  Different levels of physical activity 
are assigned metabolic equivalent (MET) scores based on the Compendium of Physical Activity and, 
using MET-minutes, can be converted to both continuous and categorical values.  Using the IPAQ in 
HELP PD Vets will enable us to compare changes in physical activity with other trials, including the 
original HELP PD study.  
f. 
Health-related quality of life (HRQL)  
The Veterans RAND 36 (VR-36) Item Health Survey will be collected43, 44. The VR-36 differs from the 
RAND 36 in the use of 5-point response choices for two of the eight scales, role limitations due to 
physical and emotional problems. The eight domains of the VR-36 include physical functioning, role 
limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, 
role limitations due to emotional problems and mental health. The eight scales are summarized into 
physical and mental summary scores.  The summaries are standardized using a t-score transformation 
and are normed to a U.S. population at a score of 50 and a standard deviation of 1045. 
g. Diet records  
During screening, potential participants will be instructed to write down all foods and beverages 
consumed during the day prior to their baseline visit. A reminder call will be made to candidates two 
days prior to their visit to remind them of the visit and to remind them to start documenting their intake 
the next day.   These diet records will serve two purposes: 1) to provide the study dietitian with baseline 
diet information to allow for tailored nutrition counseling, and 2) to assess changes in dietary intake pre- 
and post- intervention and compare dietary intake between intervention and EUC group participants. 
These food records will be analyzed using the Nutrition Data System for Research (Minneapolis, MN). 
h. Cost estimation 
We will conduct a preliminary cost estimation of HELP PD Vets. Direct medical cost is a close proxy for 
what the intervention delivery would cost a large healthcare provider, such as the Veteran’s 
Administration, a hospital, or insurance company.  These direct costs will include the implementation of 
the lifestyle intervention and side effects of the intervention.  We will estimate cost by relying on 
records of personnel and material costs and records of the number of participants attending 
intervention sessions; this information will be jointly collected by Wake Forest and staff from the 
Kernersville Health Care Center.  Since this is a feasibility pilot study, we will not attempt the expensive 
and labor-intensive process of collecting and analyzing all data on cost, outcomes and efficacy 
associated with this trial from all possible standpoints, as would be required in a full-scale cost-
effectiveness analysis.  We will propose such an analysis in the full-scale R18 study. 
i. 
Intervention evaluation 
Participants randomized to the lifestyle intervention will be asked to complete a brief, anonymous 
evaluation at the conclusion of the 6-month close-out visit. This evaluation will capture qualitative data 
on the conduct of the intervention, participants’ interaction with members of the study team, and each 

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participants' experience in the weight-loss components of the study. The data collected on this 
evaluation will not be linked to study-related process or outcome data as no ID number, acrostic, or 
other identifier will be collected. Prior to completing the survey, participants will be provided with a 
cover letter explaining the purpose of the evaluation and explaining that completion is voluntary. 
Participants will be provided the opportunity to ask questions about the evaluation and can refuse to 
complete it at their discretion. The data collected from this evaluation will inform intervention conduct 
and design in a larger trial.  
VI. 
Analytical Plan 
This feasibility study is designed to provide useful pilot information that can be used subsequently to 
develop a grant application to translate the HELP PD intervention into the VA healthcare system. 
Specifically, we will assess our ability to recruit Veterans, obtain estimates of adherence to the 
intervention and retention to the study, and obtain estimates of the means and standard deviations of 
outcome measures such as weight loss, waist circumference, BMI, self-reported levels of physical 
activity, and caloric intake.  For recruitment, we will estimate the proportion of referred patients who 
are eligible for the study and the proportion of eligible patients who agree to participate.  For 
adherence, we will estimate the proportion of intervention sessions attended.  For retention, we will 
estimate the proportion of participants who complete the study. For the continuous outcome measures, 
we will estimate the means and standard deviations at each measurement time and the correlation over 
time.  These data are necessary for developing larger scale VA translational efforts. Participants will be 
assigned to HELP PD Vets or EUC with equal probability using variable length permuted block 
randomization through a web-based data entry system. Estimates of intervention efficacy will be 
obtained using the ‘intent to treat’ approach, in which all randomized participants will be used in the 
analyses, regardless of protocol adherence. Data will be collected at baseline and 6-months at visits 
conducted by appropriate medical staff at the VA.  
Missing Data 
In longitudinal trials, it is likely that some data will be missing due to missed forms, missed visits, or 
patient drop-out. We will minimize missingness by: 1) using incentives and sending multiple reminders, 
2) providing multiple methods for data collection (paper, phone), and 3) attempting to contact 
participants with missing items. Additionally, multiple imputation methods will be used to assess the 
sensitivity of our conclusions to assumptions regarding the missingness. 
Descriptive statistics (means, standard deviations, frequencies, etc.) will be presented for pretreatment 
participant characteristics and the outcome measures mentioned above.  Each of the outcomes will be 
analyzed and reported separately.  Exact confidence intervals will be provided for the estimated 
proportions. Analysis of covariance will be used to obtain estimates of the intervention effect for each 
outcome and to obtain adjusted estimates of the variability of these outcomes. Least squares means 
and 95% confidence intervals will be provided for each outcome, stratified by intervention, and for the 
difference between the treatment arms. Subsequent models will include additional covariates such as 
age and gender. Regression diagnostics and residual plots will be used to find appropriate 

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transformations for the variables in the models to satisfy the linearity, homogeneity of variances, and 
normality assumptions. Limited (because of our small sample size) exploratory analyses will be done to 
determine if the treatment effect differs for different levels of the covariates (e.g., by including 
intervention by covariate interactions in the model) to see if the subsequent fully-powered trial should 
be conducted in particular subsets (e.g. specific age ranges) of participants.  Logistic regression will be 
used to determine which participant characteristics are associated with the binomial outcomes such as 
retention and successful adherence (in the intervention arm). 
Data Management and Quality Control 
In HELP PD, we implemented an electronic data management system using a secure web-based data 
entry system for randomization, data collection and participant tracking. For this study, we will leverage 
the forms and processes already in existence, along with our existing web infrastructure. As in other 
trials coordinated by Wake Forest School of Medicine in which the VA has participated and in order to 
comply with IRB and institutional regulations, only de-identified data will be entered in this website. This 
system has substantial functionality in major areas such as security and authentication, user access 
management, calendar functionality, directory, document, and committee management and dynamic 
reporting.  Electronic data being entered by staff and CHWs are immediately transmitted to a secure 
server at the Data Center, where data will reside throughout the study. The web-based system allows 
great flexibility in processing data management tasks, including the ability to register participants and 
verify eligibility criteria before randomization; provide the randomization assignment; allow real-time 
monitoring and reporting of accrual, retention, and intervention adherence; and track participant phone 
calls and follow-ups. If needed, data can be securely downloaded directly by study team members for 
use in analyses. There will also be public areas of the website for posting of non-secured information 
available to the general public, if needed.  
Website activity will be monitored and audited for security purposes. Restricted areas of the website 
will be protected by user login. Prior to gaining access to the restricted area, the user will be required to 
enter a username and password that will be checked against a database. If the combination is correct, a 
"flag" will be set to allow the user to enter certain areas of the website. This system allows precise 
assignments for access based on the person’s role in the study. Once a user has successfully logged into 
the system, inactivity for a period of 30 minutes will automatically force the user to re-authenticate 
prior to using the system again. 
Users may view detailed tracking and management information for each participant and/or by 
intervention session or follow-up visit. When study team members access the website, a list of 
upcoming participant assessments is presented for them to view so that participant management is 
easily accessible: they may run reports, enter data into forms, review and edit data, and access trial-
specific documents. As data are entered, validation rules are applied before data are saved. 
Inconsistencies are noted for staff to resolve. To integrate database content within the website we use a 
secure Windows server running Internet Information Server, with a middleware product (ColdFusion). 
Data will be stored in a secure SQL server relational database. With this web infrastructure, data entered 

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into the system are immediately available for review and reporting.  All systems are backed up nightly to 
disk or tape and tapes are rotated off-site several times a month.  
In addition to our electronic quality control procedures, data quality will be assured through 
standardized procedures and forms, training and supervision of data collection personnel, and attention 
to detail in data entry, management and analysis. We will monitor data quality throughout the study.  A 
random sample of the data will be double-entered and compared using SAS PROC COMPARE. 
Discrepancies between databases will be resolved by reviewing the original paper form, correcting them 
in the original database.  If deemed necessary, all data will be double-entered. 
All original data and study documents will be maintained within the VAMC system.  Only fully de-
identified data will be transcribed from the existing electronic medical record system maintained by the 
VA or collected on case report forms. Only de-identified data will be entered into the web-based data 
management system developed and maintained by WFUHS. Access to the data management system will 
require password authentication and WFUHS will take full measures to minimize the risk of breaching 
the confidentiality of data including electronic firewalls, audit trails, and systems certification. WFUHS 
has coordinated a number of trials previously in which the VA participated including ACCORD, SPRINT, 
and ACCORDION and established systems to ensure that all data is managed to be compliant with VA 
policy and to meet the requirements for approval from the VA’s Institutional Review Board.  The WFUHS 
research team will complete research training and complete the verification and credentialing processes 
required of “Without Compensation” (WOC) employees through the VAMC system. Risks related to 
inadvertent release of confidential information will be minimized through adherence to best practices 
for data collection and management. All research staff will be trained in methods for assuring 
participant confidentiality and safety. The information we are collecting is not of a particularly sensitive 
nature and we will follow exacting procedures to maintain confidentiality of the participant level data. 
Identifying information will be kept separate from research data and will be linked only by a participant 
ID, generated so as to be independent of any identifying information. All original records will be 
maintained within the VAMC system.  Only de-identified data will be released outside of the VAMC. No 
identifying information will be released in any published reports. Research study materials and 
documents will be maintained at the end of the study as required by VAMC directives under double lock. 
VII. 
Human Subjects Protection 
Approval to proceed with this project will be sought from the Institutional Review Boards (IRBs) of the 
Department of Veterans Affairs, Salisbury VAMC Medical Center and Wake Forest University Health 
Sciences and the Research and Development Committee of Salisbury VAMC.  We will submit an 
informed consent document, including HIPAA authorization, to both IRBs as part of our application for 
approval. In dealing with human subjects, Both IRBs comply with all rules and regulations of the 
Department of Health and Human Services (DHHS) regarding the protection of human subjects (Title 45 
CFR Part 46).  The principal investigator and research team routinely complete formal education on the 
protection of human research participants and all new staff, including those participants in research-
activities at the Kernersville Health Care Center, will be required to do so as well. The principal 
investigators and research team will complete and maintain all required VAMC research training and 

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NIH Information Security and Privacy Awareness Training.  Investigators will participate in additional 
formal and informal training in research ethics and scientific integrity throughout the study provided 
from time to time by ethics educators affiliated with Wake Forest School of Medicine. A Manual of 
Procedures (MOP) will be developed for all aspects of the study, and the procedures will be strictly 
followed. All study personnel will receive formalized training that will cover all recruitment, informed 
consent, measurements, specimen handling, participant follow-up, adverse events, side effects, and 
reporting issues. Adherence to the procedures in the MOP will be assured by periodic assessment and 
retraining.  
a. Subject Recruitment Methods 
We plan to identify patients seen at the Kernersville Health Care Center who are at high risk for 
developing T2DM by engaging primary care providers in identifying potential participants and referring 
them to the program for participation.  In this pilot study, we plan to identify opportunities to integrate 
the recruitment process into the existing healthcare delivery system by educating providers at all levels 
about the study, providing materials that they can share with patients at risk for developing diabetes, 
and developing support from clinic leadership to support our recruitment efforts.  We hope to use the 
strategies identified in this pilot study to inform our recruitment efforts in a larger trial testing 
implementation in the VA system.  
In order to reduce the need to collect additional information, screening and eligibility data will be 
collected from the existing medical record.    
b. Informed Consent 
Any patients interested and eligible for the study will be referred by clinic providers or staff to the nurse 
or diabetes educator affiliated with the project for eligibility verification and administration of informed 
consent. At that time, the nurse or diabetes educator will inform potential participants of the study 
design and interventions, the risks and benefits of participation, their rights and responsibilities as 
research participants, and alternatives to participation. Participants will also be informed that 
participation is voluntary and that they can withdraw from the study if their initial or on-going 
experience makes it oppressive, burdensome, or otherwise uncomfortable. All participants will be 
required to sign informed consent and HIPAA documents prior to randomization. The informed consent 
and HIPAA documents will include a required text as defined by the Salisbury VAMC IRB. 
c. Confidentiality and Privacy 
Confidentiality will be protected by collecting only information needed to assess study outcomes, 
minimizing to the fullest extent possible the collection of any information that could directly identify 
subjects, and maintaining all study information in a secure manner. As stated previously, original data 
and study documents will be maintained within the VAMC system.  Only fully de-identified data will be 
transcribed from the existing electronic medical record system maintained by the VA or collected on 
case report forms. Only de-identified data will be entered into the web-based data management system 
developed and maintained by WFUHS. To help ensure subject privacy and confidentiality, only a unique 

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study identifier will appear on the data collection form.  Any collected patient identifying information 
corresponding to the unique study identifier will be maintained on a linkage file, store separately from 
the data.  The linkage file will be kept secure, with access limited to designated study personnel.  Subject 
identifying information will be destroyed three years after closure of the study, consistent with data 
validation and study design, producing an anonymous analytical data set.  Data access will be limited to 
study staff.  Data and records will be kept locked and secured, with any computer data password 
protected.  No reference to any individual participant will appear in reports, presentations, or 
publications that may arise from the study. 
d. Data and Safety Monitoring 
Personally identifiable information (name, address, date of birth, etc.) will be stored in an electronic 
database, on a local hard drive physically separate from the database storing research data, on a 
password protected computer within the VAMC system following all stipulations as required by VAMC 
Directives. This information will be kept completely separate from de-identified study data entered into 
the web-based data management system.  Permission to view subject information will be available only 
to the Principal Investigator at the Salisbury VAMC or designee, as regulated by password 
authentication.  Data obtained from this study are strictly for research purposes and will be stored in a 
de-identified manner in a web-based data management system maintained by WFUHS, as described 
above. During the sessions, each participant will report any discomfort and difficulties with the study 
protocol to the research staff as they occur. The PI on an individual basis will carefully and immediately 
review these reports. Furthermore, a monthly meeting of the research team will review the safety data 
and modify or stop the study protocol if necessary. No adverse effects are expected.  In the event of an 
adverse event, a VAMC Adverse Event Report form will be completed and returned to the IRBs at both 
facilities within 5 working days.  
As this pilot study is considered only a minor increase over minimal risk, we will utilize a Safety Officer, 
Alain Bertoni, MD, MPH, to monitor participant safety and any reported events.  Working with Dr. 
Bertoni, we will also develop interim boundaries for monitoring the effect of the intervention on the 
primary outcome over time.  All data reported to Dr. Bertoni will be fully de-identified.  

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e. Medical Alerts 
All laboratory values used as outcome measures in this study are being collected from the existing 
medical record of each participant- no additional laboratory tests are being performed which could 
result in the need for alert values.  Abnormal blood pressure measurements during the baseline and 
follow-up visits will be provided to the participant and his or her primary care provider (PCP) as 
described in Table 3 below.  Dr. Bertoni, the Safety Officer, and Dr. Vitolins, the Principal Investigator 
will review medical eligibility criteria as needed, as well as measures collected during baseline and 
follow-up visits. These individuals also will serve as the primary contacts for staff, participants, and their 
PCPs regarding medical issues.  Dr. Bertoni will review summaries of blood pressure alert values on a 
periodic basis along with any safety events.   
f. 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol changes 
will be promptly reported by the principal investigator or designated member of the research team to 
the IRB if appropriate.  During participant group meetings, each participant will report any discomfort 
and difficulties with the study protocol to the research staff as they occur. The PI on an individual basis 
will carefully and immediately review these reports. Furthermore, a monthly meeting of the research 
team will review the safety data and modify or stop the study protocol if necessary. No adverse effects 
are expected.  In the event of an adverse event, a VAMC Adverse Event Report form will be completed 
and returned to the IRBs at both facilities within 5 working days.  
 
Table 3. Blood Pressure Alert Values 
Measure 
Alert Value 
Notify Participant 
Notify PCP/Safety Officer 
Blood Pressure (Avg.) 
Level 1 
SBP ≥180 mm/Hg  OR 
DBP ≥110 mm/Hg 
In clinic. Advise to follow-
up with PCP within 1 
week. 
Within 1 week. 
IF symptomatic (e.g. chest pain, headache, 
short of breath), notify safety officer 
and/or PCP immediately. 
Level 2 
SBP ≥160 mm/Hg  OR 
DBP ≥100 mm/Hg 
(and not Level 1 BP) 
In clinic. Advise to follow-
up with PCP within 1 
month. 
Within 1 week.   
IF symptomatic (e.g. chest pain, headache, 
short of breath), notify safety officer 
and/or PCP immediately. 
Level 3 
SBP ≥140 mm/Hg  OR 
DBP ≥90 mm/Hg 
(and not Levels 1 or 2) 
In clinic. Advise to follow-
up with PCP within 2 
months. 
Per routine reporting. 
IF symptomatic (e.g. chest pain, headache, 
short of breath), notify safety officer 
and/or PCP immediately. 
SBP ≤90 mm/Hg  OR 
DBP ≤50 mm/Hg 
In clinic. Advise to follow-
up with PCP within 1 
week. 
Within 1 week.   
IF symptomatic (lightheaded, feels faint), 
notify safety officer and/or PCP 
immediately. 

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