Latinos Combatiendo la Diabetes (Latinos Combating Diabetes)
Phase: NA
Conditions: Pre Diabetes, Obesity, Metabolic Syndrome
Sponsor: Wake Forest University Health Sciences

Study Title: Latinos Combatiendo la Diabetes (Latinos Combating Diabetes)   
Identifier: NCT01831921 
Version Date:  February 15, 2017 (uploaded July 26, 2018)  

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Mara Z. Vitolins, DrPH, MPH, RD, Professor of Public Health Sciences, Principal Investigator 
 
Jeffrey A. Katula, PhD, Assistant Professor of Health and Exercise Science, Co-Investigator 
Michael S. Lawlor, PhD, Professor of Economics, Co-Investigator 
Floyd “Ski” Chilton, PhD, Professor of Physiology and Pharmacology, Co-Investigator 
Jasmin Divers, PhD, Assistant Professor of Public Health Sciences, Co-Investigator   
 
 
 
 
Sponsored by the National Institutes of Health, 
National Institute of Minority Health and Health Disparities 
 
 
 
 

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Table of Contents 
 
 
I. 
Background, Rationale and Context_______________________________1 
 
II. 
Specific Aims__________________________________________________4 
 
III. 
Methods and Measures__________________________________________4 
A. Overview of Study Design___________________________________4 
B. 
Conceptual Framework_____________________________________5 
C. 
Setting____________________________________________________6 
D. Subject Selection Criteria____________________________________8 
E. 
Screening and Randomization________________________________9 
F. 
LaComunidad Lifestyle Weight-Loss 
Intervention______________________________________________10 
G. Comparison Condition_____________________________________13 
H. Data Collection____________________________________________13 
I. 
Documentation____________________________________________17 
 
IV. 
Analytical Plan________________________________________________18 
 
V. 
Human Subjects Protection_____________________________________19 
A. Potential Risks to Subjects___________________________________19 
B. Protection Against Risks_____________________________________19 
C. Potential Benefits/Importance of Knowledge to be Gained_______20 
 
VI. 
Subject Recruitment Methods___________________________________20 
 
VII. 
Informed Consent_____________________________________________21 
 
VIII. 
Confidentiality and Privacy_____________________________________21 
 
IX. 
Data and Safety Monitoring_____________________________________21 
A. Reporting of Unexpected Problems, Adverse Events, Deviations__22 
 
References___________________________________________________________23 
 
Appendix A.  La Comunidad Committee 
Membership_______________________________________________26 
 
Appendix B.  La Comunidad 
Questionnaires_____________________________________________27 
 

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I. 
Background, Rationale and Context 
 
Type 2 diabetes mellitus is a major health concern in the United States, accounting for 90 to 95% 
of the more than 25 million diagnosed cases of diabetes in 20101.  The estimated healthcare 
burden in the United States for persons with diabetes was more than 150 billion dollars in 2010, 
making it one of the costliest chronic diseases2. Diabetes mellitus increases the risk of mortality 
from all causes, and is a major risk factor for cardiovascular disease, renal disease, blindness, 
and lower extremity amputations3. Because current treatment does not prevent a substantial 
proportion of these related complications, and application of proven therapies is inconsistent, 
prevention of diabetes mellitus is preferable to reducing related sequelae once the disease is 
established. Racial and ethnic minorities are disproportionately affected by the diabetes 
epidemic, specifically African Americans, Hispanic Americans, and Native Americans3.  
 
In the last decade, several large clinical trials have demonstrated the potential for the 
prevention of diabetes through lifestyle change, primarily through interventions focused on 
weight loss, physical activity and nutrition4,5. In the Diabetes Prevention Program (DPP), a 
lifestyle intervention produced an average of 7% weight loss and a 0.2% drop in glycosylated 
hemoglobin (HbA1c) by year 2, and a decrease in the absolute risk of developing diabetes 
mellitus from 11.0 to 4.8 cases per 100 person-years of follow-up4.  This change was achieved 
through increased physical activity and reduced caloric intake and was effective in reducing the 
incidence of diabetes mellitus by 58% among persons with impaired glucose tolerance4.  The 
intervention was delivered through a 16-lesson core curriculum taught by case managers on an 
individual basis over a 24 week period, after which participants entered a maintenance phase 
consisting of monthly individual and/or group sessions6. Based on these and other results, the 
American Diabetes Association, the North American Association for the Study of Obesity and 
the American Society for Clinical Nutrition issued a joint statement recommending weight 
management through lifestyle modification for the prevention of diabetes in 20047.   
 
A number of recent studies have attempted to translate the DPP lifestyle intervention into 
community-based diabetes prevention programs and have demonstrated encouraging effects 
across diverse settings, including primary care settings8-10, cardiac rehabilitation programs11, 
churches12, YMCAs13, health care facilities14,15, and community-based facilities (e.g., parks and 
recreation centers)16.  Taken together, these interventions typically produce approximately 6% 
weight loss at one year of follow-up17. Although the cumulative evidence suggests that 
successful translations of the DPP can be implemented across a variety of settings with diverse 
personnel, numerous barriers to widespread dissemination of diabetes prevention programs in 
minority populations still exist.  
 
This study is designed to address these barriers by further adapting a community-based 
lifestyle intervention for Latinos and we have identified several key elements to enhance 
logistical and fiscal feasibility and long-term dissemination: 1) identifying persons at risk using 
a diabetes risk screening tool followed by measurement of HbA1c , 2) using a group-based, 
rather than an individual-based intervention that will be implemented by bilingual Latino Lay 
Health Advisors (LHAs), and 3) delivering the intervention in a community-based setting. 
Latinos Combatiendo la Diabetes (La Comunidad) is a group-based, behavioral lifestyle 
intervention delivered by LHAs and integrated within the Latino community. It will be 

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population-based, proactive and community member-centered, consistent with the chronic care 
model. 
 
II. 
Specific Aims 
 
Our central hypothesis is that a community-based lifestyle weight-loss intervention 
implemented within the accountability and structure of existing Latino communities will have a 
more beneficial and clinically meaningful impact on HbA1c, insulin metabolism, and markers of 
the metabolic syndrome when compared to an enhanced usual care condition.    
 
1. The primary outcome is change in HbAlc.  
2. The secondary outcomes consist of clinical (body weight, blood pressure) and 
biochemical (glucose, HDL, triglycerides) markers of the metabolic syndrome. 
3. The tertiary outcomes include biomarkers of insulin sensitivity and inflammation 
(fasting insulin, homeostatic model assessment [HOMA], CRP, IL-6, leptin, 
adiponectin, expression of IL-8 in circulating mononuclear cells, Omega 3 and 6 
fatty acids, free fatty acids). 
4. We also plan to evaluate the program’s effect on health-related quality of life 
(HRQL) and determine the costs and cost-effectiveness of the intervention in 
terms of the primary and major secondary outcomes.  
 
La Comunidad will provide much-needed information regarding the effectiveness of a 
community-based, behavioral intervention for the prevention of diabetes mellitus in Latinos. If 
the proposed approach is cost-effective, it will enable the rapid dissemination of this model to 
the many areas with Latino communities in the United States. Because many chronic diseases 
are influenced by activity and diet, this approach should translate into public health benefits in 
other areas (obesity, hypertension, cardiovascular disease) multiplying the potential social 
benefits and serving as a model for Latino community-based health promotion programs. Our 
overarching aim is translating evidence based, lifestyle strategies to eliminate health disparities 
in diabetes prevention. 
 
III. 
 Methods and Measures 
 
A. Overview of Study Design 
 
La Comunidad is a randomized clinical trial involving 225 Latino participants designed to 
further build upon the methods successfully implemented in the Healthy Living Partnerships to 
Prevent Diabetes (HELP PD)16,18,19. Participants in the lifestyle weight loss group will take part 
in a group-based intervention aimed at achieving modest weight loss (5-7%) through promoting 
healthy eating and increasing physical activity. The intervention sessions will take place at 
churches and other community locations and will be coordinated and facilitated by LHAs. 
Content will be delivered by the LHA using educational materials (DVDs, workbook, etc.) 
provided by the research team. The lifestyle intervention will be delivered in 2 phases: Phase 1 
will last for 6 months and consist of weekly group meetings; Phase 2 will last for 6-18 months 
(depending on date of randomization) and consist of one LHA-led group session or one 
telephone contact from the LHA per month.  Participants in this treatment arm will also receive 
individual visits with an RD during months 1, 3, and 6 of phase 1. Participants in the-enhanced 

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usual care group will receive two individual sessions with an RD and monthly newsletters that 
focus on existing community resources.  
 
Participants will be Latino community-dwelling adults with pre-diabetes as defined by HbA1c 
of 5.7-6.5% and BMI of 25-45 kg/m2. Participants will be recruited and pre-screened from a 
variety of Latino community settings.  Screening activities will be conducted at churches and 
other community settings, with baseline and follow-up visits occurring in the Clinical Research 
Unit (CRU) of Wake Forest Baptist Medical Center or other WFBH facilities, including 
Lexington Medical Center, as needed. Following baseline assessment, participants will be 
randomized to one of the treatment conditions described above. Follow-up exams will occur 
every 6 months to assess weight, laboratory parameters, and other measures of the intervention 
effect. Due to the nature of the lifestyle intervention, neither participants nor project personnel 
can be masked to the participant’s intervention status; however, personnel performing 
laboratory tests and interpreting their results will be masked. The project will operate under the 
general oversight of the Maya Angelou Center for Health Equity and will use an external safety 
officer to monitor trial progress and participant safety.  
 
B. Conceptual Framework 
 
The proposed study is guided by a conceptual model that integrates key concepts from social 
cognitive theory and the literature surrounding group dynamics20,21. Weight loss and fitness 
improvement achieved through a combination of modifying eating and physical activity 
behaviors is determined by the joint, reciprocal interaction of personal factors (e.g., beliefs and 
values), social influences (e.g., support and strain), and features of the physical environment 
(e.g., structure and access to resources). The lifestyle intervention incorporates several 
components of social cognitive theory: self-efficacy, outcome expectations, and incentives.   
 
Self-efficacy refers to the extent to which individuals believe they can successfully perform 
specific behaviors, even when confronted with barriers. Research has shown that self-efficacy 
beliefs are determined by prior behavior, physical symptoms (e.g., pain, fatigue), appetite, 
affect, and environmental/social factors. Because self-regulatory behaviors are important to 
successful behavior change, the intervention is designed to increase self-efficacy in relation to 
goal setting, self-monitoring, and other self-management skills.  
 
Outcome expectations refer to the anticipated costs and benefits of performing a specific 
behavior; people are more likely to approach a behavior if the perceived consequences of 
performing it have a favorable cost/benefit ratio. In many instances, people simply do not have 
the knowledge to understand the negative health effects of being overweight or obese and 
sedentary or are unduly optimistic about their own fate. Also, people often hold unrealistic 
expectations about how much weight they can lose through caloric restriction and increased 
energy expenditure and can become disappointed when the results from lifestyle interventions 
do not meet their expectations.  
 
Incentives refer to the value that people associate with specific behavioral outcomes. 
Understanding the role of incentives on lifestyle behavior is a three step process. In relation to 
weight loss, one must understand (a) the desire that an individual has to lose weight, (b) the 
goal discrepancy or the degree of satisfaction/dissatisfaction between where one wants to be 

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and his/her current weight, and (c) the value/commitment to competing behaviors such as 
responsibilities to families or friends.  
 
The effective use of and change in self-efficacy expectations, outcome expectations, and 
incentives in the context of lifestyle behavior change requires the acquisition and use of self-
regulatory skills in conjunction with a continuous problem-solving model of behavior change. 
Self-regulatory skills enable people to exert control over their behavior, cognitions, and 
environment and are an integral part of the lifestyle intervention.  
 
C. Setting 
 
a. Organization 
 
La Comunidad is a collaborative partnership between researchers from Wake Forest School of 
Medicine, Wake Forest University, and local Latino churches and organizations throughout the 
community.   Churches in the Forsyth County, NC area will serve as intervention sites in La 
Comunidad when possible.  A companion Manual of Procedures and Intervention Manual will 
provide specific operational details of the project for all study personnel.    
 
The study is managed through several committees with distinct roles and responsibilities. The 
Steering Committee, made up of the principal investigator, all co-investigators, and senior 
project staff, will meet monthly. The Steering Committee is responsible for the study protocol, 
definition of all study outcomes, data analysis confirmation, publications, content approval of 
the interventional materials, and data collection and management procedures. The Steering 
Committee assumes full responsibility for the scientific integrity of the study, including 
protection of human subjects and health information. This committee is responsible for 
requesting and reviewing study progress reports made by the other standing committees. 
 
The Intervention Committee, made up of investigators and with expertise in behavioral lifestyle 
interventions, including LHA training and supervision, will plan and oversee implementation 
of the intervention in La Comunidad.  The Intervention Committee will be responsible for the 
adaptation and translation of intervention materials and procedures and training and 
supervision of the LHAs.  This Committee will also be responsible for developing the 
intervention documentation procedures and for overseeing documentation of the process of 
intervention delivery.  The Intervention Committee will meet weekly early in the study and at 
least monthly throughout the course of the study.   
 
The Recruitment and Retention Committee will be responsible for planning, implementing and 
overseeing the recruitment and retention plans for La Comunidad, including advertisements, 
mailings (including procurement of mailing lists), development of telephone and in-person 
screening instruments and procedures, and screening, recruitment and retention monitoring 
reports.  This committee will also monitor all aspects of participant retention, including visit 
and procedure adherence and will develop strategies and procedures to enhance retention of 
the LHAs.   This Committee will meet weekly early in the study and at least monthly 
throughout the course of the study.  As we anticipate that our relationship with partnering 
churches and community organizations will be instrumental to the recruitment and retention of 

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participants in La Comunidad, a member of the Pastoral Care team will be included on this 
committee.  
 
The Data Management Committee, made up of investigators and staff with special expertise in 
study design and analysis, will be responsible for development of data collection instruments, 
data management procedures and data analysis plans, including quality control reports and 
reports to the study’s safety officer.  This Committee will meet weekly early in the study and at 
least monthly throughout the course of the study.   
 
The Operations Committee, made up of the principal investigator and all research staff, meets 
weekly. This committee is charged with developing the Manual of Operations, reporting study 
progress, implementing the protocol as directed by the Steering Committee, including any 
changes, and ensuring that the intervention and data collection are proceeding according to the 
study timeline. 
 
It is expected that roles and recommendations of these committees may overlap in some areas; it 
is the responsibility of the Steering Committee to coordinate activities and reconcile any 
conflicting recommendations.  A schematic of study organization is included in Figure 2 and 
committee rosters are included in Appendix A.  
 
Figure 1. Study Organization 
 
 
 
b. Local Latino churches 
 
As churches continue to play an important role in the social structure of the Latino community 
in which there are long standing associations between religion and health, we plan to base 
many of our recruitment efforts in local churches with large Latino populations. Local churches 
have been instrumental in establishing a system for health education in this community. We are 
also hopeful that we will be able to utilize church facilities to hold screening events and 
intervention group sessions when possible. Five local churches have initially agreed to take part 
in the recruitment efforts for this study: 
Steering 
Committee
Vitolins, Chair
Data 
Management
Recruitment 
and Retention
Lifestyle 
Intervention
Operations
Churches and 
Community 
Groups
Latino Health 
Advisors

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• 
Our Lady of Mercy Catholic Church 
• 
Calvary Baptist Church 
• 
Green Street United Methodist Church 
• 
El Buen Pastor Presbyterian Church 
• 
Iglesia Nueva Vida Pentecostal Church 
 
We will also identify other local churches and community groups that can play an integral role 
in the implementation and delivery of this intervention moving forward. 
 
D. Subjects selection criteria 
 
The principles guiding the selection of the following inclusion and exclusion criteria are to 
ensure the enrollment of participants who meet 3 major criteria: 1) high risk for developing 
diabetes, 2) no medical contraindications to participate in a lifestyle intervention including 
unsupervised physical activity and weight loss, and 3) ethical randomization, i.e., there are no 
compelling reasons that potential participants should be referred for immediate weight loss. 
Subjects will include 225 overweight or obese adults with pre-diabetes in Forsyth County, NC 
and the surrounding area.  All participants will be required to identify themselves as Hispanic 
or Latino and we hope to recruit approximately equal numbers of men and women based on 
their representation in the population of the area.  As women are more likely to seek medical 
care than men, we anticipate at least 50% of our sample to be female.  We plan to make 
concerted efforts to ensure that no less than 40% of our sample is male.  
 
a. Inclusion Criteria 
 
• 
Demographics: Men and women 18 years of age and older who reside in or near Forsyth 
County, NC. 
• 
Ethnicity: self-identified as Hispanic or Latino 
• 
Evidence of pre-diabetes: HbA1c of 5.7-6.5% 
• 
Body Mass Index (BMI):  25-45 kg/m2 
• 
Willingness to Accept Randomization:  Potential participants must be willing to accept 
randomization to either the intensive lifestyle intervention or the comparison usual care 
condition. 
 
b. Exclusion Criteria 
 
• 
Weight Loss:  Currently involved in a supervised program for weight loss. 
• 
Diabetes:  Clinical history of diabetes mellitus, or newly diagnosed diabetes mellitus at 
screening.  
• 
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, 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.  

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• 
Hypertension:  Uncontrolled high blood pressure: BP > 160/100. Potential participants 
can be re-screened after control has been achieved.  
• 
Pregnancy:  Pregnancy, breast feeding, or planning pregnancy within 2 years. 
• 
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 La Comunidad, 
major psychiatric or cognitive problems (schizophrenia, dementia, self-reported active 
illegal substance or alcohol abuse), participation in another research study that would 
interfere with La Comunidad. 
 
E. Screening and Randomization 
 
a. Tiered Screening Process 
 
A tiered screening process will be implemented to maximize the efficiency of screening. 
Interested prospective participants will be identified at the churches, community events, or by 
advertising, and will complete or be administered an initial pre-screening tool to assess medical 
history and the diabetes risk screening tool developed by the American Diabetes Association22. 
If potentially eligible, they will then be invited to take part in an interactive question and 
answer session to learn more about the study, followed by the informed consent process.  Those 
participants still interested and eligible will then have their height, weight, and blood pressure 
measured and will complete the physical activity readiness questionnaire (PAR-Q).  Those 
participants who have met all other eligibility criteria will then have a blood draw to determine 
HbA1c.  Figure 2 outlines the screening process that we plan to implement.  
 
Figure 2. Tiered Screening Process for La Comunidad 
 

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b. Randomization 
 
Potential participants who 1) satisfy the inclusion/exclusion criteria previously described, and 
2) provide a signed informed consent will be invited to the CRU or Lexington Medical Center to 
complete a baseline visit and be randomized to one of the treatment conditions. The number of 
participants recruited and randomized during a given month will vary, depending both on the 
flow of interested participants into the screening process and the needs/limitations of the 
lifestyle intervention arm of the study. We anticipate LHA-led intervention groups of 10-15 
participants and for the intervention to begin within one month of randomization. We will 
recruit participants in waves to ensure that there are sufficient numbers to fill intervention 
groups. We will adopt a permuted block design with varying block size, as this can lower the 
time randomized individuals wait for intervention groups to develop and ensure a degree of 
balance. A list of random study arm assignments will be generated and used by the web based 
randomization routine to make sequential assignments. Randomization will occur in a 2:1 
pattern; for every two participants randomized to the lifestyle intervention, one will be 
randomized to the usual care group. Table 2 illustrates that the 225 participants will be 
recruited in 11 distinct waves with 20-21 in each wave.  We anticipate the recruitment period 
lasting from the latter part of Year 1 through Year 3. Based on our 2:1 randomization, 
approximately 14 participants will be randomized to the intervention condition in each wave. 
We anticipate a total of 11 LHA-led groups.  
 
 
Table 1. Planned Recruitment for La Comunidad 
  
Year 1 
Year 2 
Year 3 
Months 
1-6 
7-12 
1-6 
7-12 
1-6 
7-12 
Waves 
  
Wave 1 
Waves 2-4 
Waves 5-6 
Waves 7-9 
Waves 10-11
Number of Participants 
  
21 
61 
41 
61 
41 
  
  
  
  
  
Total  
225
 
F. La Comunidad Lifestyle Weight Loss Intervention 
a. Goals of the Lifestyle Intervention  
 
The lifestyle intervention is designed to induce weight loss by creating an energy deficit.  This 
will be achieved by decreasing daily caloric intake and increasing daily caloric expenditure 
through moderate intensity physical activity. We will advise participants to adapt a low-calorie 
eating pattern, with a goal daily deficit of 500 to 1000 kcal, coupled with an increase in 
moderate intensity physical activity, by walking for 30 minutes on most days. The primary 
treatment objectives for the weight loss component of the intervention will be to decrease 
caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 
0.3 kg per week for the first 6-months of treatment for a total weight loss of 5-7%. After that, 
participants will be encouraged to continue weight loss as long as their BMI does not fall below 
20 kg/m2, but the primary focus will be on weight maintenance. The primary objective for the 
physical activity component of the intervention will be to promote an increase in home-based 
energy expenditure to an eventual goal of 180 minutes per week. The intervention will be 
tailored to the unique needs of each participant, with daily calorie goals ranging from 1200-1800 
calories based on weight. 

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b. Structure of the Lifestyle Intervention 
 
The lifestyle intervention will be a modified version of the DPP intervention adapted for use in 
groups, as used in both Look AHEAD and HELP PD16,19. The core content was integrated into a 
DVD video series for HELP PD to assist with standardization of intervention delivery. These 
DVDs contain information on the physiological, emotional, cognitive, and behavioral basics of 
losing weight as well as adopting and maintaining an active lifestyle. Each DVD segment also 
has a series of questions that are then addressed in the LHA-led group sessions. The 
intervention, including the DVDs, will be adapted and culturally-tailored to make it 
comfortable and relevant to Latino participants. The physical activity program will be 
progressive and will focus on walking and other large muscle activities. 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. We will also provide pedometers 
to enable participants to self-monitor their physical activity and to set goals for progressively 
increasing their activity level. Within 3 months of study onset, the goal will be to have 
participants engaging in 30 minutes or more of moderate intensity activity, for a total of 180 
minutes per week. Specific components of the lifestyle intervention are outlined in Table 2. 
 
Table 2. Overview of Lifestyle Intervention 
Phase 
Contact Schedule 
Objectives 
PHASE 1  
Initial Lifestyle 
Intervention 
(Months 1-6) 
Weekly LHA-led group meetings, 
with content delivered via DVD 
series or by community experts  
 
Individual RD sessions in months 
1, 3, and 6; Session 1 to occur 
prior to 1st group meeting  
 
Knowledge:  relation of body weight and fitness to disease 
and health; benefits of weight loss; basics of energy balance 
and nutrition; appropriate methods for weight loss and 
increasing physical activity; exercise precautions  
Diet:  reduction of intake by 500-1000 kcal per day; increase in 
fruit and vegetable consumption to 5 per day; intake of > 3 
whole grain servings per day 
Physical activity:  gradual progression to 180 minutes of 
moderate intensity exercise per week (e.g., 30 min/day of 
walking, 6 days/week)  
Behavioral skills:  self-monitoring, goal-setting, self-
reinforcement, stimulus control, social support, cognitive 
restructuring 
Material: core content delivered through DVD videos and 
community experts 
PHASE 2  
Extended Care 
Intervention 
(Month 7-24, 
depending on date 
of randomization)) 
 
1 contact per month (alternating 
each month between an LHA-led 
group meeting and a telephone 
contact with the LHA) 
Knowledge:  proper methods for weight maintenance; 
appropriate levels of activity, caloric intake and sound 
nutrition for maintenance of stable weight  
Diet:  isocaloric intake tailored to maintenance of lost weight; 
continued daily intake of 5 fruits and vegetables and > 3 
whole grain servings 
Physical activity:  maintenance of 180 min of moderate 
intensity exercise per week; coping with injuries and other 
barriers to the maintenance of exercise  
Behavioral skills:  ongoing or intermittent self-monitoring of 
weight and habit changes; anticipating/avoiding obstacles to 
maintenance; coping with setbacks/lapses; building social 
support for maintenance; developing self reliance skills for 

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c. Empowered Community Partners: Latino Health Advisors  
 
We plan to deliver the intervention using LHAs from the local community, many of whom are 
part of an established network of Latino LHAs that were identified by their churches because of 
their leadership skills and community recognition. We will supplement this core group of LHAs 
with recommendations from our investigative team and study dietitian, as we did previously in 
HELP PD. The LHAs used in La Comunidad will be adults with a history of diabetes mellitus, 
pre-diabetes, or metabolic syndrome that have been successful in achieving and maintaining 
lifestyle changes related to diet and physical activity. They must also have a desire to help 
community members who are at risk for developing diabetes by leading them through a 
weight-loss and lifestyle change program, demonstrate leadership ability, and be able to devote 
at least 10 hours per week to the program. The LHA’s that participate in the network have 
already received structured training at WFUSM (80 hours) for delivering medical education to 
their communities in topics related to diabetes, metabolic syndrome, and cardiovascular 
disease, and were tested for knowledge proficiency before and after training.  
 
In La Comunidad, all LHAs will receive 36 hours of training over 4-6 weeks. Major components 
include: (a) instruction on appropriate diabetes prevention messages, (b) basic counseling skills 
(e.g., active listening and the basics of group dynamics), (c) how to teach and reinforce self-
regulatory skills, (d) overview and use of the intervention materials, (e) a 5-step approach to 
problem solving that has been used successfully in many weight loss trials, and (f) the 
structure/goals of telephone contacts. At the end of training, there will be a formal certification 
process involving a criterion-based assessment of (a) their skills running groups and handling 
situations within the group, (b) knowledge regarding the intervention protocol and use of the 
treatment manual, and (c) competence in completing requisite forms. The training will be 
provided by registered dietitians, one of whom was responsible for training community health 
workers in HELP PD. In addition to this training, the study RD will meet monthly with the 
LHAs to discuss intervention implementation and participant progress to maintain consistency 
across LHAs. Our real-time web-based data reporting system will enable us to monitor 
intervention delivery by the LHAs, as reflected by participant attendance, adherence measures, 
and, eventually, outcomes.  
 
d. Intervention Group: LHA Sessions  
 
The peer group counseling sessions will last about 60 minutes and will include 3 segments. The 
first segment will review participants’ progress in implementing strategies recommended for 
changing their diet or physical activity in the previous session. After a private weigh-in (scales 
will be provided for each LHA), participants will describe the progress they have achieved, and 
they will identify any problems they might have encountered. Good progress will be 
highlighted with strong positive feedback. Difficulties will be dealt with through group support 
and advice. The second segment will focus on skill training related to cognitive-behavioral self-
management skills, nutrition training, or exercise science. This core content will be delivered 
and discussed via the DVD series. Additional educational materials will be made available in a 
“toolkit” to enhance the activities as appropriate. The final component 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 
long-term weight management 

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group.  We anticipate holding all LHA sessions in community settings, starting with the 
churches that have agreed to participate previously. We also plan to identify other churches and 
community settings (recreation centers, community centers, YMCAs, etc) as needed to 
accommodate additional LHA-led groups.   
 
e. Evaluation of the Lifestyle Intervention 
 
The success of this intervention will be dependent, in part, on our ability to monitor the fidelity 
of intervention delivery. The DVD series will also serve to enhance treatment fidelity by 
standardizing delivery of the intervention content.  We will monitor and track the following: a) 
adherence to LHA-led group meetings and make-up sessions, b) weight at all sessions, c) self-
monitoring data from the participants concerning dietary intake and physical activity 
behaviors, and d) phone contacts during the maintenance phase of the study. The RD will 
supervise the LHAs, collate data from individual interactions with participants, and provide 
written and verbal feedback to LHAs that can be shared with participants. Members of the 
intervention committee will provide ongoing support and monitor intervention progress, 
thereby providing ongoing access to expertise in nutrition, behavioral, and exercise science. 
 
G. Comparison Condition 
 
Our comparison intervention condition is designed to exceed the usual care provided to similar 
community members and to enhance retention. Our comparison intervention will be an 
individual education program that builds on an increased awareness of existing community 
resources. Comparison participants will receive 2 sessions with an RD during the first 6 months. 
The RD will cover basic aspects of healthy eating and activity to support weight loss, and 
discuss existing community resources.   In addition to this, participants will receive a monthly 
newsletter that includes information on nutrition, physical activity, and healthy living.  
 
H. Data Collection 
 
We plan to collect all screening data for this study in community locations (churches, recreation 
centers, etc).  Those participants that meet all eligibility criteria and provide informed consent 
will complete baseline and follow-up visits at the CRU or Lexington Medical Center.  To enable 
assessment of the process of implementation, impact and outcomes of the intervention, data 
will be collected at both the individual and program levels. At the individual level, we will 
collect information regarding demographics, anthropometry (height, weight, and waist), blood 
pressure, pulse, medical history, health behaviors (diet, physical activity), 
 health-related quality of life (HRQL), healthcare resource utilization and cost. We will also 
obtain blood samples to measure HbA1c, glucose, insulin, and lipids and to store for future 
uses. At the program level, we will collect data related to implementation and cost.  A schedule 
of data collection visits for participants is outlined in Table 3. Participants will be followed from 
the baseline/randomization visit through 24 months or June 30, 2017 (for those participants 
randomized after July 2015). Anticipated participation in the study will be at least one year for 
all randomized participants. Study questionnaires will be included in Appendix B as 
developed/purchased and approved by the Steering Committee.  
 

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Date: February 15, 2017 
 
 
 
 
 
Table 3. Planned Data Collection for La Comunidad 
Measure 
Baseline 
F06 
F12 
F18 
F24 
HbA1c 
x 
x 
x 
x 
x 
Glucose 
x 
x 
x 
x 
x 
Insulin 
x 
x 
x 
  
x 
Lipids 
x 
  
x 
  
x 
Height, Weight 
x 
x 
x 
x 
x 
Blood Pressure 
x 
x 
x 
x 
x 
Waist Circumference 
x 
x 
x 
  
x 
Adverse Events 
  
x 
x 
x 
x 
Contact Information 
x 
x 
x 
x 
x 
Demographics 
x 
x 
x 
x 
x 
Medical History 
x 
x 
x 
x 
x 
Medication Review 
x 
x 
x 
x 
x 
IPAQ 
x 
x 
x 
  
x 
Food Frequency 
Questionnaire 
x 
x 
x 
  
x 
Short Form 36 
x 
x 
x 
  
x 
Behavioral Constructs 
x 
x 
x 
x 
x 
Health Utilities Index 
x 
x 
x 
  
x 
Economic Evaluation 
  
x 
x 
x 
x 
Stored Blood Samples 
x 
x 
x 
  
x 
 
 
a. Demographics and Anthropometry 
 
Age (date of birth), gender, race and ethnicity (US Census Definition), and names and contact 
information for at least 2 informants will be collected. Weight (nearest 0.1 kg), height (nearest 
0.5 cm), minimum waist (nearest 0.5 cm) will be measured using standardized methodology as 
used in HELP PD. 
 
b. Blood Pressure 
 
Blood pressure will be measured using an automated device (Omron HEM 907XL) following 
standardized procedures as outlined in current clinical practice guidelines. Use of an automated 
device reduces measurement variability and errors. The presence of hypertension at baseline 
and follow-up will be assessed using a combination of BP measurement, self-reported diagnosis 
and use of antihypertensive medication. 
 
c. Medical History 

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During screening, medical history of diabetes, cardiovascular disease and other medical 
conditions will be obtained to evaluate the inclusion and exclusion criteria. During follow-up, 
new diagnoses of diabetes, cardiovascular disease, hypertension and other chronic diseases, 
unexpected problems, serious adverse events will be tracked. Deaths will be identified by 
following up missed appointments with contacts to the participant’s residence and informants. 
 
d. Laboratory Measures 
 
Phlebotomy will be performed by trained, certified phlebotomists.  Specimen collection at 
baseline and follow-up visits will be performed following at least an 8 hour fast (typically over 
night) in accordance with American Diabetes Association guidelines. Blood samples for plasma 
glucose will be collected in vacutainers containing sodium fluoride in order to minimize post 
collection changes due to glycolysis and will be stored at room temperature until processed. 
Samples for HbA1c, glucose, insulin, and lipids will be collected and transported to the local 
LabCorp facility for analysis.  Communications with LabCorp and requisitions for these assays 
will be facilitated through the CRU’s existing contract with LabCorp.  Plasma and serum 
samples will be retained for future analysis of CRP, IL-6, leptin, adiponectin, expression of IL-8 
in circulating mononuclear cells, Omega 3 and 6 fatty acids, free fatty acids.   We will also 
collect sufficient blood samples to isolate DNA and may perform genome-wide association 
studies (GWAS). These analyses are included in the specific aims, but samples with which to 
conduct these analyses will be stored in Dr. Chilton's laboratory until additional funding can be 
obtained.  
 
e. Diet Assessment 
 
Usual dietary intake will be assessed using a widely-used food frequency questionnaire (FFQ). 
The FFQ provides estimates of macronutrients, micronutrients, and servings of particular foods 
of interest, and has been validated against food records. Although the FFQ has shortcomings, 
such as potential underestimation of energy, it is the most practical instrument for large 
intervention studies and has become the most common method for measuring usual dietary 
intake. Its low cost and ease of administration are also important considerations.  
In addition, diet will be monitored daily by the intervention participants through completion of 
their diet and physical activity logs. The precision of the FFQ is sufficient to enable us to 
evaluate intervention group differences in diet. 
 
f. Physical Activity 
 
Throughout the lifestyle intervention, physical activity will be monitored via logs that are 
collected by the LHAs and data entered by members of the research study team. These logs 
include a record of the frequency and duration of physical activity and daily steps that are self-
monitored using pedometers. In addition, at assessment visits, we will use the International 
Physical Activity Questionnaire to evaluate between group differences in physical activity, an 
internationally reliable and valid instrument for assessing physical activity.  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 activities and walking, during the seven 
days prior to the interview.   Different levels of physical activity are assigned metabolic 

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equivalent (MET) scores based on the Compendium of Physical Activity and, using MET-
minutes, can be converted to both continuous and categorical values.   
 
 
g.  
Self-Efficacy 
 
There are a series of four brief measures based on social cognitive theory that address 1) barriers 
efficacy for physical activity and weight loss, 2) task efficacy related to specific physical 
capacities and weight loss, 3) satisfaction with physical function and body appearance and 4) 
the desire to be physically competent and to lose varying percentages of weight (converted to 
pounds on an individual basis).  These measures will be collected at baseline and all follow-up 
visits for all participants and are included in Appendix B.  
 
 
h. Health-Related Quality of Life 
 
Two common HRQL instruments – the Short Form 36 items (SF-36) and Health Utilities Index - 
3 (HUI 3) will be used in La Comunidad. The SF-36 is the most widely used general health 
status measure with extensive validation and population norms available. It allows comparison 
of the planned study population with those of other studies and other chronic diseases. Eight 
scale scores will be generated in the following domains: general health, physical function, role-
physical, role-emotional, vitality, social function, mental health, and pain. It can also be scored 
in terms of physical health and mental health component scores. The Health Utilities Index 
Mark 3 (HUI3) system is a generic HRQL instrument which was developed not only for 
measuring health status but also for economic evaluation. HUI3 includes a health-status 
classification system and a preference-based scoring formula. The HUI3 has eight attributes 
(vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain) with five to six 
levels per attribute. The multiplicative multi-attribute utility function for the HUI3 system can 
be used to generate utility scores for use in economic analysis.  
 
i. 
Cost 
 
The cost of La Comunidad will be separated into research and intervention costs. Research costs 
will be excluded from the economic evaluation. The intervention costs will be classified into 
direct medical, direct nonmedical, and indirect costs. The identification and measurement of the 
cost of a health prevention program can be determined from four different perspectives: 
individual, health care provider, third party payer (including large health care systems, 
insurers, government, etc.), and society. In La Comunidad, we will adopt the perspectives of 
individuals, third party payers and society in three separate analyses, as all three perspectives 
will influence successful dissemination. From the individual’s perspective, the total cost 
estimation will include participants’ out of pocket expenses, and cost associated with travel 
time and missed working days due to illness. In the third party payer perspective, we will only 
include the direct medical costs (including the intervention) in the total cost estimation. The 
participants’ out of pocket expenses and indirect cost such as missed working days will not be 
included. In the societal perspective, the total cost will constitute all direct and indirect costs 
incurred by participants and the third-party payers. In order to assure comparability to both 
DPP and HELP PD, we will apply similar criteria for determining costs. Direct medical costs 

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include the cost of implementation and maintenance of the intervention and the cost of 
utilization of medical services by study participants. We will assess the personnel resource use 
and cost in the comparison and lifestyle intervention groups, including personnel time, 
mailings and telephone calls using standardized questionnaires administered to the staff. Unit 
cost for personnel will be calculated as the median salaries of personnel employed by the study 
team with a fringe benefit rate. Unit costs of health education materials will be based on actual 
reproduction rates. Unit costs of laboratory tests will be based on the Center for Medicare and 
Medicaid Services (CMS) reimbursement rates. Overhead costs will be estimated by multiplying 
personnel costs related to the intervention by the institutional rate negotiated with NIH. The 
proposed intervention may have an impact on the use of medical services outside La 
Comunidad, including hospital, emergency department, outpatient clinic, physician office, and 
medications. A resource utilization questionnaire will be administered to participants semi-
annually, inquiring about hospital admissions, length of stay, number of emergency department 
(ED) and physician office visits, and medications used. Unit costs of hospital admissions, 
hospital days, ED visits, and physician’s office visits will be based on CMS average 
reimbursements, respectively. Unit costs of medications will be based on average wholesale 
prices available on the internet. This questionnaire will also inquire about purchases of 
equipment -and memberships in health facilities and other related direct nonmedical costs. 
These and other direct nonmedical costs including transportation to clinic, waiting and 
participation time will be estimated using the DPP direct nonmedical cost estimation methods23. 
Indirect costs include participants’ productivity losses such as working days missed due to 
health reasons, and will be estimated based on the median hourly wage, as in DPP23. 
 
I. Documentation 
 
La Comunidad will develop a Manual of Procedures (MOP), an LHA Intervention Manual (IM), 
and participant manuals. More comprehensive than this protocol, the MOP will include the 
protocol as its first chapter and will provide the specifics of study conduct. It will be modified 
during the study if any changes in the data forms and data collection techniques are necessary. 
The MOP will contain detailed information on the study’s conduct, including comprehensive 
descriptions of recruitment, enrollment, randomization, data collection, monitoring and follow-
up procedures. It is meant to be the "how-to" manual and the source of information regarding 
the day-to-day operation of the study. A separate manual, the IM, will be developed for LHA 
training, intervention conduct, and standardization purposes. Comprehensive detailed 
guidelines for the dietary, exercise and behavioral interventions will be in the IM and serve as 
the basis for the intervention monitoring system. Participant manuals will supplement the IM. 
The MOP and IM will be developed prior to the first training session. 
 
J. Database Management System 
 
To facilitate data transfer and preserve records that can be audited, we plan to use paper forms 
for data collection and remote data entry via an internet-based web browser interface. As in 
HELP PD, electronic data will be managed centrally, with a feedback mechanism through e-
mail and web-based reporting. Data reside on the server in a Microsoft SQL Server relational 
database. Cold Fusion middleware, a web application development tool, will be used to link the 
web-based forms interface to the SQL Server database. SAS/Access is used to translate data 
from the SQL Server database to SAS datasets, which reside on a UNIX-based Sun 

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Microsystems server. Validation checks are applied during the data entry process. Insofar as 
possible, checks are programmed and made as the staff enter data from each form, so that errors 
on the forms are corrected on-site at this early stage. These include intra-form and inter-form 
checks for consistency of responses, range checking, and checks for required fields and skip 
patterns.  
 
Our internet based data entry system will protect confidentiality and data security. A very high 
level of data encryption during transmission coupled with the use of acrostics and study ID 
numbers, rather than subject names, provides adequate data security. The use of text containing 
identifying information will be avoided. We will implement standard protection against 
computer hackers. Our site will offer neither special challenges nor sensational data for hackers. 
This lack of inducements may decrease the chance that it will be targeted. 
 
 
K. Methods for Ensuring High Data Quality and Integrity 
 
Quality control (QC) is a shared responsibility among all staff. The impact of La Comunidad on 
diabetes in the Latino population depends on the integrity of its implementation: maintaining 
randomization integrity, assessing participant eligibility accurately, recording dropouts and 
adherence, measuring outcome variables without bias, preventing premature leaks of results, 
monitoring and assessing protocol adherence, and avoiding biases in the analyses. In order to 
deal effectively with these important issues, adaptations of models for QC systems currently 
utilized in many of our ongoing studies will help us establish the QC system for La Comunidad. 
QC procedures will be devised to monitor screening, data collection, follow-up, clinical and 
biochemical measurements, forms control and data entry procedures, implementation of the 
intervention and overall operations. 
 
IV. Analytical Plan 
 
All statistical analyses will be conducted by the Research Core of the Maya Angelou Center for 
Health Equity. The main hypothesis being tested involves evaluating the mean differences in 
changes in HbA1c at one year.   Secondary outcomes include changes in clinical characteristics 
and biochemical lab results and biomarkers of insulin sensitivity. Statistically, all of these 
analyses could be treated in a similar fashion after appropriate transformations are made to 
satisfy assumptions made about the distribution of residuals. We will apply a repeated 
measures analysis of variance to changes (collected across the planned visits at 6, 12, 18, and 24 
months) to address intra-individual correlations, which accommodates interim testing and 
allows participants with incomplete patterns to contribute to the analysis and evaluation24. Our 
analysis adopts the intention-to-treat approach. Inference for primary comparisons will be two-
sided, with significance level alpha = 0.05. We will use repeated measures analysis of covariance 
in which indicators for visit are included to control for systematic temporal differences that may 
occur that are common to both intervention conditions. We test differences from baseline (rather 
than using baseline levels as a covariate in analyses of post-randomization values), as it is these 
differences that are the focus of our intervention and to limit the bias associated with estimates 
from regression models that include fallible covariates. Random effects terms will be used to 
model differences as these have been shown to yield inferences of more appropriate size than 
fixed effect models. Compound symmetry models will be used to model intra-subject 

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longitudinal covariance and models will be fitted via maximum likelihood. The primary 
comparison will be based on a Wald statistic. We will not include additional covariates or 
stratification in the primary comparison, however, we will describe any chance differences 
between cohorts and, in supporting analyses, covary comparisons on any baseline factors that 
appear to be unbalanced. When we are developing the ANCOVA models, we will determine 
whether the assumptions of general linear models are satisfied. Diagnostics and residual plots 
will be reviewed to ensure that the assumptions are met. Should assumptions be violated, 
transformations of the outcome data will be considered:  the order of the priority in choosing a 
transformation will be to satisfy the (1) linearity assumption, (2) homogeneity assumption 
(homoscedasticity), and (3) normality assumption. As mentioned above, secondary (supporting) 
analyses will assess the influence of covariates on the mean differences and to explore whether 
mean differences vary over follow-up time (using interaction terms). In addition, we will 
explore the homogeneity of LHAs with respect to outcome measures using hierarchical mixed 
models in which LHAs are coded as random effects and participant data are nested within 
LHAs. Such models will allow us to place confidence bounds on the contributions of LHA 
differences to overall variability. 
 
Sample Size and Power 
 
In this section we justify our plans to recruit and follow 225 participants who will be 
randomized with equal probability to either the intensive lifestyle intervention or individual 
education arm. Our goal is to provide greater than 80% statistical power to detect an average 
difference of .25 standard deviations from baseline in HbA1c between the two groups at one 
year.  With a sample size of 225 participants, we will have 85-88% power to detect a net 
intervention effect of .25%.  These estimates include allowance for a 5% loss to follow-up rate 
every 6 months. Although the DPP has not published any data that allow us to estimate the 
standard deviation and longitudinal correlation of HbA1c, similar studies conducted for a 
longer period of time have estimated the average change in A1c to be .74% with a standard 
deviation of 1.25% for an effect size of .59.   
 
V. 
Human Subjects Protection 
 
A. Potential Risks to Subjects 
 
The risk to participants is modest, consisting primarily of the risk of increased moderate 
physical activity. Adoption of a vigorous activity regimen can increase the risk of 
cardiovascular events in sedentary individuals. The other minor risks include risks associated 
with phlebotomy and confidentiality concerns. Phlebotomy carries a small risk of vasovagal 
syncope (fainting), hematoma formation and phlebotomy site infection.  
 
B. Protection against Risks  
 
Approval to proceed with this project will be sought from the WFUHS Institutional Review 
Board (IRB). We will submit an informed consent document, including HIPAA authorization, as 
part of our application for approval. The risks inherent in the project consist mainly of the small 
risk of a cardiovascular event associated with adopting a moderate intensity physical activity 
regimen, the risk of phlebotomy and confidentiality concerns. The risk of the physical activity 

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program will be minimized by focusing on moderate, as opposed to vigorous, activity and by 
stressing a start slow and increase slowly approach. We will be encouraging participants to 
adopt brisk walking as the foundation of their activity program and we will educate 
participants about the potential risks of increased activity. Potential participants will also be 
screened using the Physical Activity Readiness Questionnaire. Persons who screen positive will 
be required to obtain medical clearance from a primary care provider prior to participation. All 
potential participants will be encouraged to discuss participation with their usual physician 
prior to enrolling in La Comunidad. An informational brochure will be developed so that 
potential participants can review and discuss the program with their physician, and if he/she 
does not have a physician, he/she will be referred to a source of care in the community.  This 
brochure will be provided to the IRB for approval prior to use. The risk of phlebotomy will be 
minimized through the use of trained professional phlebotomists. The blood volume obtained 
at any phlebotomy will be no more than 20 mL. 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. The linking report and personal identifying data will be destroyed after 
completion of the study. No identifying information will be released in any published reports.   
 
C. Potential Benefits and Importance of Knowledge to be Gained 
 
The potential direct benefits to participants include the decreased risk of developing diabetes 
and cardiovascular disease. In the DPP, the risk of developing diabetes was 11% per year in the 
“usual care” group. This risk was decreased by over 50% in the intensive lifestyle intervention 
group. In the HELP PD study, the group-based intervention showed significant weight loss and 
improvements in glucose. La Comunidad is designed to move the intervention tested in HELP 
PD into the Latino community, improving diabetes prevention efforts. The development of 
diabetes carries with it significant morbidity and mortality risk. Persons with diabetes are at an 
increased risk of cardiovascular diseases, in addition to increased risk of blindness, kidney 
failure and lower extremity amputation. The small risks of an acute cardiovascular event 
triggered by moderate physical activity should be far offset by the substantial potential benefit 
of diabetes prevention. Other potential benefits to subjects may include improved quality of life 
and satisfaction with self-image. Little direct benefit is expected to others; however, as persons 
with diabetes may impose some care-giver burden on others due to their need for frequent 
medical attention, it is possible that there will be some benefit related to decreased care-giver 
burden. 
 
The knowledge to be gained in the proposed trial relates to our ability to implement evidence-
based lifestyle interventions in different populations. As discussed above, the risks of diabetes 
are substantial and the potential benefits for preventing diabetes are great at the societal level; 
hence, the risk that participants will assume by participating in this program should be offset by 
the potential for public health benefit that would occur following dissemination of a successful 
diabetes prevention program. Furthermore, this approach could also serve as a model for other 

Protocol version: 8 
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Date: February 15, 2017 
community-based health promotion programs in the Latino community, further enhancing the 
potential societal benefit of the proposed project. 
 
 
VI. Subject Recruitment Methods 
 
Participants will be recruited to La Comunidad using a mixture of advertising, community 
recruitment events, and provider referrals from healthcare sites. Given the unique role that 
churches play in the Latino community, we plan to initiate our recruitment efforts there.  
Currently, 5 local churches have agreed to serve as partners for this effort and we plan to 
identify additional churches in the future.  We will also request a list of adult patients seen in 
outpatient primary care clinics at Wake Forest Baptist Medical Center who have no diagnosis of 
diabetes and for whom ethnicity is recorded as “Hispanic or Latino”.  This list will be requested 
from the Enterprise Data Warehouse through the Translational Science Institute and will be 
used to generate mailings to potential participants. As a part of this data request, we will also 
request a limited waiver of HIPAA authorization from the IRB and the list generated will only 
be used under this waiver.  We will also plan to post flyers and posters in the Downtown 
Health Plaza space to supplement these efforts. All flyers, brochures, letters, and other 
recruitment materials will be submitted to the IRB of Wake Forest University Health Sciences 
for approval prior to use.  Signed informed consent will be obtained from all participants prior 
to conducting any screening activities. Copies of the signed consent forms will be provided to 
all participants. The original signed forms will be kept in study files. 
 
We plan to identify local adults who identify themselves as Latino who are at high risk for 
developing type 2 diabetes.  Primary inclusion criteria include BMI of 25-45 kg/m2 and 
evidence of pre-diabetes (based on HbA1c).  Candidates will also be screened for co-morbid 
conditions that would make physical activity unsafe or limit participation in the study, 
including recent history of an acute cardiovascular disease event, clinical history of diabetes 
mellitus, cancer or other conditions limiting life expectancy, and major psychiatric or cognitive 
problems, including depression. For safety purposes, potential participants will also be 
screened using the Physical Activity Readiness Questionnaire (PAR-Q). Persons who screen 
positive on the PAR-Q will be required to obtain medical clearance from a physician prior to 
participation.  
 
 
 
VII. Informed Consent 
 
Signed informed consent will be obtained from each subject after pre-screening but prior to the 
collection of any blood samples or other physical measurements.  Participants who speak 
Spanish as their primary language will be provided with Spanish-language consent forms and 
will be consented by a study data collector who is fluent in Spanish. All potential participants 
will be informed 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 be required to sign an informed consent document prior to screening and 
enrollment. HIPAA authorization to collect and share personal health information within the 
investigative group is included in the consent form and will be fully explained as part of the 

Protocol version: 8 
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Date: February 15, 2017 
consent process.  For those participants who choose to allow us to store blood samples for 
future analysis of inflammatory markers, a separate sub-study consent will be administered 
during the baseline visit.  
 
 
VIII. 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.  To help 
ensure subject privacy and confidentiality, two unique study identifiers will appear on the data 
collection forms.  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.  The linking report 
and personal identifying data will be destroyed within 3 years of completion of the study. This 
is consistent with accepted practices for data validation and study design, and will enable us to 
produce 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. 
 
 
 
IX. 
Data and Safety Monitoring 
 
The principal investigator will be responsible for the overall monitoring of the data and safety 
of study participants.  The principal investigator will be assisted by other members of the study 
staff and an independent safety officer (Kristen Hairston, MD) will be used to adjudicate 
adverse events and monitor study progress. As weight loss and weight fluctuation have been 
associated with increased morbidity and mortality, all hospitalizations will be monitored. In 
addition, potential adverse effects of the intervention specific to physical exercise, primarily 
injuries and orthopedic conditions, will be monitored. All serious adverse events and 
unexpected problems will be recorded on adverse event reporting forms, including action 
taken. A semi-annual report will be compiled and will include a list and summarization of any 
adverse events. In addition, these reports will address (1) whether adverse event rates are 
consistent with pre-study assumptions; (2) reason for dropouts from the study; (3) whether all 
participants met entry criteria; (4) whether continuation of the study is justified on the basis that 
additional data are needed to accomplish the stated aims of the study; and (5) conditions 
whereby the study might be terminated prematurely. These reports will be provided to both the 
study safety officer and the IRB.   
 
A. Reporting of Unanticipated Problems, Adverse Events or Deviations 
 
Any unanticipated problems, serious and/or unexpected adverse events, deviations or protocol 
changes will be promptly reported by the principal investigator or designated member of the 
research team to the safety officer, IRB and NIH if appropriate. 
 
 

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Date: February 15, 2017 
 (22)  Bang H, Edwards AM, Bomback AS et al. Development and validation of a patient self-
assessment score for diabetes risk. Ann Intern Med. 2009;151:775-783. 
 (23)  Hernan WH, Brandle M, Zhang P et al. Costs associated with the primary prevention of 
type 2 diabetes mellitus in the diabetes prevention program. Diabetes Care. 2003;26:36-47. 
 (24)  The Diabetes Prevention Program: baseline characteristics of the randomized cohort. The 
Diabetes Prevention Program Research Group. Diabetes Care. 2000;23:1619-1629. 
 
 
 
 

Protocol version: 8 
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Date: February 15, 2017 
Appendix A.  La Comunidad Committee Membership 
 
 
 
 
Lifestyle Intervention
•Pulgar (C)
•RD (TBN)
•Vitolins
•Katula
•LHAs
Data Management
•Divers (C)
•Vitolins
•Pulgar
•Chilton
•Davis
•Brown
•Ospino-Sanchez
Recruitment and Retention
•Pulgar (C)
•Vitolins
•Ospino-Sanchez
•Arias
•Del Valle-Fagan
Operations
•Blackwell (C)
•Vitolins
•Pulgar
•Ospino-Sanchez
•Arias
•Davis
•Brown
•Del Valle-Fagan
Steering
•Vitolins (C)
•Chilton
•Divers
•Katula
•Blackwell
•Pulgar

Protocol version: 8 
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Date: February 15, 2017 
Appendix B.  La Comunidad  Baseline and Follow-Up Questionnaires 
 
Physical Activity Readiness Questionnaire (PAR-Q) 
 
Becoming more active is very safe for most people, but just to be certain, please complete the 
questionnaire below.  Some people should check with their doctor before they start becoming 
much more physically active.  Start by answering the seven questions below.   
 
 
 
1. Has your doctor ever said that you have a heart condition and that you should only do 
physical activity recommended by a doctor? 
 YES  
 NO 
 
2. Do you feel pain in your chest when you do physical activity? 
 YES  
 NO 
 
3. In the past month, have you had chest pain when you were not doing physical activity? 
 YES  
 NO 
 
4. Do you lose your balance because of dizziness or do you ever lose consciousness? 
 YES  
 NO 
 
5. Do you have a bone or joint problem that could be made worse by a change in your 
physical activity? 
 YES  
 NO 
 
6. Is your doctor currently prescribing drugs (for example, water pills) for your blood 
pressure or heart condition? 
YES  
 NO 
 
7. Do you know of any other reason why you should not do physical activity? 
 YES  
 NO 
 
 
If you answered YES to one or more questions, talk with your doctor before you start 
becoming much more physically active. 
 
If you answered NO to all questions, you can be reasonably sure that you can start 
becoming more physically active right now.  Be sure to start slowly and progress gradually- 
this is the safest and easiest way to go.   
 
 
 
 
 Referred to primary care physician for medical clearance prior to participation 
 
 
 
 

Protocol version: 8 
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Date: February 15, 2017 
CURRENT PHYSICAL ACTIVITY LEVEL 
VIGOROUS PHYSICAL ACTIVITY 
First we are going to ask you some questions about your participation in vigorous or 
“hard” activities.  These are activities that take hard physical effort, make you breathe 
much harder than normal, and cause heavy sweating. 
 
1.  In general how many days per week do you do vigorous activities like running, heavy lifting, 
aerobics, or fast bicycling for at least 10 minutes in a row? Do not count any vigorous activities 
you did for less than 10 minutes in a row.  Assume that one week is seven (7) days.   
CHECK ONLY ONE ANSWER 
 
 
 0 Days per week   
 
 4 Days per week 
 
 1 Day per week 
 
 
 5 Days per week 
 
 2 Days per week 
 
 
 6 Days per week 
 
 3 Days per week 
 
 
 7 Days per week 
 
2.  On the days that you do vigorous activities, how much time do you usually spend doing 
them?  Only count the time that you spend doing vigorous activity for at least 10 minutes in a 
row.  CHECK ONLY ONE ANSWER 
 
  I do not do vigorous activity for more than 10 minutes in a row 
  10-15 minutes per day 
  15-30 minutes per day 
  30-45 minutes per day 
  45-60 minutes per day 
  Over 60 minutes per day 
 
 
 

Protocol version: 8 
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Date: February 15, 2017 
DAILY WALKING 
 
Next we are going to ask you about your daily walking. 
 
3.  In general, how many days per week do you walk for at least 10 minutes in a row?    
Think about all the walking you do during the day, including walking for exercise, walking to get 
to places (transportation), walking at work or home, or any other walking that you do during the 
day.  Do not count any walking that you do for less than 10 minutes in a row.  CHECK ONLY 
ONE ANSWER 
  
 
 0 Days per week   
 
 4 Days per week 
 
 1 Day per week 
 
 
 5 Days per week 
 
 2 Days per week 
 
 
 6 Days per week 
 
 3 Days per week 
 
 
 7 Days per week 
 
4.  On the days that you walk, how much time do you usually spend walking? Only count the 
time that you spend walking for at least 10 minutes in a row.  CHECK ONLY ONE ANSWER 
 
  I do not walk for more than 10 minutes in a row 
  10-15 minutes per day 
  15-30 minutes per day 
  30-45 minutes per day 
  45-60 minutes per day 
  Over 60 minutes per day 
 
5.  Of the time you spend walking for at least 10 minutes in a row, how much of that time is 
spent in brisk walking that increases your heart rate and breathing faster than normal?  
CHECK ONLY ONE ANSWER 
 
  I do not do walk briskly for more than 10 minutes in a row 
  10-15 minutes per day 
  15-30 minutes per day 
  30-45 minutes per day 
  45-60 minutes per day 
  Over 60 minutes per day 

Protocol version: 8 
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Date: February 15, 2017 
OTHER MODERATE PHYSICAL ACTIVITY 
 
Last, we are going to ask you about your participation in moderate activities other than 
walking.  These are activities that take some physical effort, and increase your heart 
rate and breathing above resting levels, but is not as hard as vigorous activity.  Please 
do not include walking in any of your answers about moderate activity. 
 
6.  In general, how many days per week do you do moderate activities like carrying light loads, 
playing doubles tennis, or regular bicycling, for at least 10 minutes in a row.  Assume that one 
week is seven (7) days.  CHECK ONLY ONE ANSWER 
 
 
 0 Days per week   
 
 4 Days per week 
 
 1 Day per week 
 
 
 5 Days per week 
 
 2 Days per week 
 
 
 6 Days per week 
 
 3 Days per week 
 
 
 7 Days per week 
 
7.  On the days that you do other moderate activities, how much time do you usually spend 
doing them? Only count the time that you spend doing moderate activity for at least 10 minutes 
in a row.  CHECK ONLY ONE ANSWER 
 
  I do not do moderate activity for more than 10 minutes in a row 
  10-15 minutes per day 
  15-30 minutes per day 
  30-45 minutes per day 
  45-60 minutes per day 
  Over 60 minutes per day 
 

Protocol version: 8 
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Date: February 15, 2017 
 
 

Protocol version: 8 
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Date: February 15, 2017 
Barriers to Physical Activity 
 
 
 

Protocol version: 8 
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Date: February 15, 2017 
 
 
 

Protocol version: 8 
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Date: February 15, 2017 
How confident are you that you could lose… 
 
1. 5% of your body weight (XX pounds) and keep it off 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1  
2  
3  
4
5
 
6
 
7
 
8
 
9
 
10 
No 
 
 
 
Moderate 
 
 
 
Complete 
Confidence 
 
Confidence 
 
 
 
Confidence
 
2. 7½% of your body weight (XX pounds) and keep it off 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1  
2  
3  
4
 
5
 
6
 
7
 
8
 
9
 
10 
No 
 
 
 
Moderate 
 
 
 
Complete 
Confidence 
 
Confidence 
 
 
 
Confidence
 
3. 10% of your body weight (XX pounds) and keep it off 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1  
2  
3  
4
 
5
 
6
 
7
 
8
 
9
 
10 
No 
 
 
 
Moderate 
 
 
 
Complete 
Confidence 
 
Confidence 
 
 
 
Confidence
 
4. 12½% of your body weight (XX pounds) and keep it off 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 
 
2  
3  
4
5
 
6
 
7
 
8
 
9
 
10 
No 
 
 
 
Moderate 
 
 
 
Complete 
Confidence 
 
Confidence 
 
 
 
Confidence
 
5. 15% of your body weight (XX pounds) and keep it off 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1  
2  
3  
4
5
 
6
 
7
 
8
 
9
 
10 
No 
 
 
 
Moderate 
 
 
 
Complete 
Confidence 
 
Confidence 
 
 
 
Confidence
 
 
 
 
 

Protocol version: 8 
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Date: February 15, 2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol version: 8 
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Date: February 15, 2017 
 
 
 
 
 

Protocol version: 8 
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Date: February 15, 2017 
This questionnaire relates to eating. Please respond to each statement by indicating 
how confident you are that you can resist or control your eating in the following 
situations by placing a check mark in the appropriate box.  
 
1.  I can resist eating when I am anxious (nervous).    
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
 
 
 
 
 
 
 
 
 
 
 NOT AT ALL 
MODERATELY 
VERY 
 CONFIDENT 
CONFIDENT 
CONFIDENT 
 
 
 
2.  I can control my eating on the weekends.    
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
 
 
 
 
 
 
 
 
 
 
 NOT AT ALL 
MODERATELY 
VERY 
 CONFIDENT 
CONFIDENT 
CONFIDENT 
 
 
 
3.  I can resist eating even when I have to say “no” to others.    
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
 
 
 
 
 
 
 
 
 
 
 NOT AT ALL 
MODERATELY 
VERY 
 CONFIDENT 
CONFIDENT 
CONFIDENT 
 
 
 
4.  I can resist eating when I feel physically run down.   
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
 
 
 
 
 
 
 
 
 
 
 NOT AT ALL 
MODERATELY 
VERY 
 CONFIDENT 
CONFIDENT 
CONFIDENT 
 
 
 
 
 
 
 

Protocol version: 8 
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Date: February 15, 2017 
5.  I can resist eating when I am watching TV.    
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
 
 
 
 
 
 
 
 
 
 
 NOT AT ALL 
MODERATELY 
VERY 
 CONFIDENT 
CONFIDENT 
CONFIDENT 
 
6.  I can resist eating when I am depressed (or down).   
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
 
 
 
 
 
 
 
 
 
 
 NOT AT ALL 
MODERATELY 
VERY 
 CONFIDENT 
CONFIDENT 
CONFIDENT 
 
7.  I can resist eating when there are many different kinds of food available.  
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
 
 
 
 
 
 
 
 
 
 
 NOT AT ALL 
MODERATELY 
VERY 
 CONFIDENT 
CONFIDENT 
CONFIDENT 
 
8.  I can resist eating even when I feel it’s impolite to refuse a second helping.  
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
 
 
 
 
 
 
 
 
 
 
 NOT AT ALL 
MODERATELY 
VERY 
 CONFIDENT 
CONFIDENT 
CONFIDENT 
 
9.  I can resist eating even when I have a headache.    
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
 
 
 
 
 
 
 
 
 
 
 NOT AT ALL 
MODERATELY 
VERY 
 CONFIDENT 
CONFIDENT 
CONFIDENT 
 
 
 
 
 

Protocol version: 8 
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Date: February 15, 2017 
10.  I can resist eating when I am reading.    
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
 
 
 
 
 
 
 
 
 
 
 NOT AT ALL 
MODERATELY 
VERY 
 CONFIDENT 
CONFIDENT 
CONFIDENT 
 
 
 
 
11.  I can resist eating when I am angry (or irritable).    
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
 
 
 
 
 
 
 
 
 
 
 NOT AT ALL 
MODERATELY 
VERY 
 CONFIDENT 
CONFIDENT 
CONFIDENT 
 
 
 
12.  I can resist eating even when I am at a party.   
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
 
 
 
 
 
 
 
 
 
 
 NOT AT ALL 
MODERATELY 
VERY 
 CONFIDENT 
CONFIDENT 
CONFIDENT 
 
 
 
 13.  I can resist eating even when others are pressuring me to eat.    
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
 
 
 
 
 
 
 
 
 
 
 NOT AT ALL 
MODERATELY 
VERY 
 CONFIDENT 
CONFIDENT 
CONFIDENT 
 
 
 
 
 
 
 
 
 

Protocol version: 8 
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Date: February 15, 2017 
14.  I can resist eating when I am in pain.   
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
 
 
 
 
 
 
 
 
 
 
 NOT AT ALL 
MODERATELY 
VERY 
 CONFIDENT 
CONFIDENT 
CONFIDENT 
 
 
15.  I can resist eating just before going to bed.  
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
 
 
 
 
 
 
 
 
 
 
 NOT AT ALL 
MODERATELY 
VERY 
 CONFIDENT 
CONFIDENT 
CONFIDENT 
 
 
16.  I can resist eating when I have experienced failure.  
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
 
 
 
 
 
 
 
 
 
 
 NOT AT ALL 
MODERATELY 
VERY 
 CONFIDENT 
CONFIDENT 
CONFIDENT 
 
 
17.  I can resist eating even when high-calorie foods are available.    
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
 
 
 
 
 
 
 
 
 
 
 NOT AT ALL 
MODERATELY 
VERY 
 CONFIDENT 
CONFIDENT 
CONFIDENT 
 
 
 
18.  I can resist eating even when I think others will be upset if I don’t eat.    
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
 
 
 
 
 
 
 
 
 
 
 NOT AT ALL 
MODERATELY 
VERY 
 CONFIDENT 
CONFIDENT 
CONFIDENT 

Protocol version: 8 
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Date: February 15, 2017 
 
19.  I can resist eating when I feel uncomfortable.    
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
 
 
 
 
 
 
 
 
 
 
 NOT AT ALL 
MODERATELY 
VERY 
 CONFIDENT 
CONFIDENT 
CONFIDENT 
 
 
 
20.  I can resist eating when I am happy.   
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
 
 
 
 
 
 
 
 
 
 
 NOT AT ALL 
MODERATELY 
VERY 
 CONFIDENT 
CONFIDENT 
CONFIDENT 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol version: 8 
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Date: February 15, 2017 
MY HEALTH BEHAVIORS 
Tobacco Use 
1. Have you smoked at least 100 cigarettes during your entire life? 
 
1
 Yes  
 
  
 
 
2
 No  
go to Question 9, next page 
 
 
2.  Do you smoke cigarettes now? 
1
 Yes 
About how old were you when you first started 
smoking cigarettes (fairly regularly)? 
              
Age 
 
 
2
 No   
go to Question 7, below 
 
3.  Do you now smoke cigarettes every day or some days? 
1
 Every Day  
 
  
 
2
 Some 
 
4. On how many of the past 30 days did you smoke cigarettes? 
 
 
 
 
 
 
 
Number of days 
 
5.  On the days that you smoke, about how many cigarettes do you usually smoke per day? 
 
 
 
 
 
 
 
Number of cigarettes per day 
 
6. For approximately how many years have you smoked this amount?  
 
 
 
 
 
 
 
Number of years 
go to Question  9, next page 
 
7. About how old were you when you quit smoking cigarettes (fairly regularly)? 
            
Age  
 

Protocol version: 8 
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Date: February 15, 2017 
 
a.  About how old were you when you first started smoking cigarettes (fairly regularly)?  
     
Age 
 
8. About how many cigarettes per day did you usually smoke at that time?  
 
 
 
 
 
 
 
Number of cigarettes per day 
 
9. Does anyone living with you now smoke cigarettes regularly inside your home? 
1
 Yes  
 
  
 
2
 No  
go to Section B, “Alcohol Use," below 
 
a. 
Please mark all the people who live with you who now smoke cigarettes regularly inside 
your home: Mark all that apply. 
 
1
 Spouse or partner 
2
 Son(s) or daughter(s) 
3
 Other person/people 
Alcohol Use 
1. Did you drink any alcoholic beverages in the past year? 
1
 Yes  
Go to Question 2, below 
  
2
 No  
go to Section C, "Eating Patterns," next page 
 
2. How many drinks of wine do you usually have per week? By drink, we mean about a 5-ounce 
glass.   
 
 
 
 
 
Drinks per week 
 
3. How many drinks of beer do you usually have per week? One beer is a 12-ounce glass, can, or 
bottle.   
 
 
 
 
 
Drinks per week 
 
4. How many drinks of liquor do you usually have per week? Count each shot (1 ½ ounces) as one 
drink.  
 
 
 
 
 
Drinks per week 
 

Protocol version: 8 
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Date: February 15, 2017 
5. During the past 24 hours, how many drinks have you had? 
Drinks 
 
6. In the past month, what is the largest number of drinks you had in one day?  
Drinks 
 
7. Have you made any attempts to stop drinking in the past five years?  
1
 Yes  
 
  
2
 No  
 
 
8. During the past 30 days, on how many days did you have five or more drinks on the same 
occasion?  
By "occasion," we mean at the same time or within a couple of hours of each other.  
Days 
 
Eating Patterns 
1. 
How many days out of the 7-day week do you eat breakfast?  
Days per week 
 
2. 
How many days out of the 7-day week do you eat lunch/brunch? 
 
Days per week 
 
3. 
How many days out of the 7-day week do you eat dinner? 
 
Days per week 
 
4. 
Counting all meals and any snacks you may have, how many times a day do you usually eat:  
Times per day 
 
 

Protocol version: 8 
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Date: February 15, 2017 
5. 
How many days a week do you eat out at...   
Breakfast  
Brunch/Lunch         
Dinner 
a. Fast food restaurants for: 
 
 
     days/wk 
         days/wk 
            days/wk
 
  
b. Other types of restaurants for:  
 
              
    days/wk 
         days/wk 
            days/wk
 
 
6. 
In the past 6 months, have you experienced any food cravings (i.e., intense desires to eat a 
specific food)?  
1
 Yes 
 
 
  
2
 No 
 
 
Weight Control Practices 
 
1. How often do you weigh yourself? (check one answer only) 
1
 Never  
 
  
2
 About once a year or less 
3
 Every couple of months  
 
  
4
 Every month 
5
 Every week 
6
 Every day 
 
 
  
7
 More than once per day 
 
 
 
 

Protocol version: 8 
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Date: February 15, 2017 
Myself and My Family 
MYSELF 
 
1. 
Marital Status: (Choose one that is most appropriate) 
 
1
 Never married 
 
4
 Widowed 
 
2
 Married 
 
 
5
 Separated 
 
3
 Divorced  
 
 
6
 Living in a marriage-like relationship 
 
 
2. 
What is the most education you have completed?   
 
CHECK ONLY ONE BOX FOR THE HIGHEST LEVEL OF SCHOOLING YOU RECEIVED. 
 
1
 Less than high school  
  
 
2
 High-school diploma or equivalency (GED) 
 
3
 Some vocation school  
 
4
 Some college 
 
5
 Associate degree (junior college) 
 
6
 Bachelor’s degree 
 
7
 Some graduate school 
 
8
 Master’s degree 
 
9
 Doctorate 
 
10
 Professional (MD, JD, DDS, etc.) 
 
11
 Other, specify: 
 
 
 
3. 
How many years of formal school did you attend? 
 
 
 
 
 
 
 
Years 
 
 
 
 

Protocol version: 8 
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Date: February 15, 2017 
4. 
Are you working full time for pay? 
 
 
1
 Yes 
 
Which of the following best represent your full-time occupation?  
 
 
  
 
(choose only one) 
 
2
 No 
 
1  Office/Professional 
 
 
4  Office/Clerical 
 
  
 
2  Technician  
 
 
5  Skilled/Craftsman 
 
  
 
3  Sales 
 
 
 
6  Unskilled/semi-skilled 
 
 
 
 
5. 
Are you working part-time for pay? 
 
1
 Yes  
 
Which of the following best represent your full-time occupation?  
 
 
 
 
(choose only one) 
2
 No  
 
1  Office/Professional 
 
 
4  Office/Clerical 
 
 
 
2  Technician  
 
 
5  Skilled/Craftsman 
 
 
 
3  Sales 
 
 
 
6  Unskilled/semi-skilled 
 
 
6. 
Are you unemployed or laid off? 
 
1
 Yes  
 
 
2
 No 
 
7. 
Are you looking for work? 
 
1
 Yes  
 
 
2
 No 
 
 
8. 
 Are you keeping house or raising children full-time? 
 
 
1
 Yes  
 
 
2
 No 
 
9. 
Are you a full or part-time student? 
 
1
 Yes  
 
 
2
 No 
 
10. 
How many people are currently living in your household, including yourself? 
 
 
number of people 
 
 
 
 
 
 
 

Protocol version: 8 
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Date: February 15, 2017 
11. 
Do you have any children or stepchildren living with you now? 
 
 
1
 Yes  
 
 
a. How many are 18 years of age or older?  
 
2
 No 
 
 
 
b. How many are 18 years of age or younger? 
 
12. 
In the past twelve months, how much did you and others currently living in your household earn 
from all sources?  
  
 Preferred not to answer 
 
1
 Under $10,000 
 
4
 $30,000-$39,999 
 
7
 $60,000-$69,999 
 
 
2
 $10,000-$19,999 
 
5
 $40,000-$49,999 
 
8
 $70,000-$79,999 
 
3
 $20,000-$29,999 
 
6
 $50,000-$59,999 
 
9
 $80,000 or more 
 
13. 
How much money would you and others currently living in your household have if you cashed in 
all your checking and savings accounts, stocks and bonds, real estate, sold your home, your 
vehicles, and all your valuable possessions?  
 
 
 Preferred not to answer 
 
1
 0-$500 
 
5
 $10,001-$25,000 
 
 9
 $250,001-$500,000 
 
2
 $501-$1,000  
6
 $25,001-$50,000 
 
10
 $500,001-$1,000,000 
 
3
 $1,001-$5,000 
7
 $50,001-$100,000  
11
 $1,000,001 or more 
 
4
 $5,001-$10,000 
8
 $100,001-$250,000  
 
 
14. 
Which of the following categories describe your health insurance status?   
Check all that apply. 
 
1
 Uninsured    
2
 Insurance from your or your partner’s employer/ former employer/union 
3
 Individual Insurance 
4
 Medicare 
5
 Medicaid 
6
 Tricare/ VA/ other military insurance 
7
 Indian Health Service 
8
 Other 
 
 
 

Protocol version: 8 
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Date: February 15, 2017 
 
15. 
What type of health insurance do you have? Check all that apply. 
 
1
 Have to pay a co-payment for doctor's visits or emergency room visits.  
 
2
 Have to get a referral to see a specialist. 
 
3
 Neither. No co-payments or referral for specialist required. 
 
4
 Don’t know.  
 
16. 
Which one of the following health care facilities best describe your usual source of care? Check 
one. 
 
1
 Private doctor’s office 
 
2
 Hospital clinic or outpatient department 
 
3
 Community health center 
 
4
 Other kind of health care facility 
 
5
 No usual source of care 
  
 
 
 

Protocol version: 8 
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Date: February 15, 2017 
MY FAMILY 
 
1. 
Is your natural mother living? Check one box only: Yes, No, or I don't know. 
 
1
 Yes  
 
How old is she now? 
 
 
 
 
 
 
Years 
 
 
 
 Don’t know 
 
 
 
 
Has your natural mother ever had any of the following? 
 
 
 
Diabetes 
 
1
 Yes 2
 No 9
I don’t know 
 
 
 
High blood pressure 
1
 Yes 2
 No 9
I don’t know 
 
 
 
Stroke  
 
1
 Yes 2
 No 9
I don’t know 
 
 
 
Heart Attack 
 
1
 Yes 2
 No 9
I don’t know 
 
 
2
 No  
 
Approximately how old was she when she died? 
 
 
 
 
 
 
Years 
 
 
 
 Don’t know 
 
 
 
 
What was the cause of your natural mother’s death? 
 
 
 
1
 Cancer 
 
 
 
2
 Heart Attack 
 
 
 
3
 Stroke 
 
 
 
4
 Diabetes 
 
 
 
5
 Other 
 
 
 
9
 Don’t know 
 
 
 
 
 
Did your natural mother ever have any of the following? 
 
 
 
Diabetes 
 
1
 Yes 2
 No 3
I don’t know 
 
 
 
High blood pressure 
1
 Yes 2
 No 3
I don’t know 
 
 
 
Stroke  
 
1
 Yes 2
 No 3
I don’t know 
 
 
 
Heart Attack 
 
1
 Yes 2
 No 3
I don’t know 
 
 
 
3
 I don't know if my natural mother is living. 
 
 
 
 

Protocol version: 8 
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Date: February 15, 2017 
 
2. 
Is your natural father living? Check one box only: Yes, No, or I don't know.  
 
1
 Yes  
 
How old is he now? 
 
 
 
 
 
 
Years 
 
 
 
 Don’t know 
 
 
 
 
Has your natural father ever had any of the following? 
 
 
 
Diabetes 
 
1
 Yes 2
 No 9
I don’t know 
 
 
 
High blood pressure 
1
 Yes 2
 No 9
I don’t know 
 
 
 
Stroke  
 
1
 Yes 2
 No 9
I don’t know 
 
 
 
Heart Attack 
 
1
 Yes 2
 No 9
I don’t know 
 
 
2
 No  
 
Approximately how old was he when he died? 
 
 
 
 
 
 
Years 
 
 
 
 Don’t know 
 
 
 
 
What was the cause of your natural father’s death? 
 
 
 
1
 Cancer 
 
 
 
2
 Heart Attack 
 
 
 
3
 Stroke 
 
 
 
4
 Diabetes 
 
 
 
5
 Other 
 
 
 
9
 Don’t know 
 
 
 
 
 
Did your natural father ever have any of the following? 
 
 
 
Diabetes 
 
1
 Yes 2
 No 3
I don’t know 
 
 
 
High blood pressure 
1
 Yes 2
 No 3
I don’t know 
 
 
 
Stroke  
 
1
 Yes 2
 No 3
I don’t know 
 
 
 
Heart Attack 
 
1
 Yes 2
 No 3
I don’t know 
 
 
 
3
 I don't know if my natural father is living. 
 
 
 
 
 

Protocol version: 8 
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Date: February 15, 2017 
 
3. 
How many full brothers and sisters do you have? Include any brothers or sisters who may have 
died, but do not include any half or step brothers or sisters. Check the "don't know" box if you 
don't know. 
 
 
 
Number of brothers 
 
 
 
Number of sisters 
 
 
 I don’t know 
 
 
              
 I don’t know  
 
 
4. 
 How many of them have had: 
 
 
(Check the "don't know" box if you don't know how many have had these conditions.) 
 
 
 
 
 
 
       Number of brothers 
Number of sisters 
 
Diabetes 
 
 
 
 
Number  
 
Number 
 
 
 
 
 
 Don’t know  
 Don’t know 
 
High blood pressure 
 
 
 
Number  
 
Number 
 
 
 
 
 
 Don’t know  
 Don’t know 
 
Heart attack 
 
 
 
 
Number  
 
Number 
 
 
 
 
 
 Don’t know  
 Don’t know 
 
Stroke  
 
 
 
 
Number  
 
Number 
 
 
 
 
 
 Don’t know  
 Don’t know 
 
 
 
 
 
 
 

Protocol version: 8 
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Date: February 15, 2017 
HEALTH UTILITIES INDEX III (HUI-3) 
 
This questionnaire contains a set of questions which ask about various aspects of your health.  When 
answering these questions please think about your health and your ability to do things on a day-to-day 
basis, during the past 4 weeks.  To define the 4 week period, please think about what the date was 4 weeks 
ago and recall the major events that you have experienced during this period.  Please focus your answers on 
your abilities, disabilities and how you have felt during the past 4 weeks. 
 
You may feel that some of these questions do not apply to you, but it is important that we ask the same 
questions of everyone.  Also, a few questions are similar; please excuse the apparent overlap and answer 
each question independently. 
 
Please read each question and consider your answers carefully.  For each question, please select one 
answer that best describes your level of ability or disability during the past 4 weeks. Please indicate the 
selected answer by circling the letter (a, b, c, …) beside the answer. 
 
All information you provide is confidential.  There are no right or wrong answers; what we want is your 
opinion about your abilities and feelings. 
 
 
1. 
Which one of the following best describes your ability, during the past 4 weeks, to see well 
enough to read ordinary newsprint? 
 
a. 
Able to see well enough without glasses or contact lenses. 
b. 
Able to see well enough with glasses or contact lenses. 
c. 
Unable to see well enough even with glasses or contact lenses. 
d. 
Unable to see at all. 
 
 
2. 
Which one of the following best describes your ability, during the past 4 weeks, to see well 
enough to recognize a friend on the other side of the street? 
 
a. 
Able to see well enough without glasses or contact lenses. 
b. 
Able to see well enough with glasses or contact lenses. 
c. 
Unable to see well enough even with glasses or contact lenses. 
d. 
Unable to see at all. 

Protocol version: 8 
54 
Date: February 15, 2017 
3. 
Which one of the following best describes your ability, during the past 4 weeks, to hear what was 
said in a group conversation with at least three other people? 
 
a. 
Able to hear what was said without a hearing aid. 
b. 
Able to hear what was said with a hearing aid. 
c. 
Unable to hear what was said even with a hearing aid. 
d. 
Unable to hear what was said, but did not wear a hearing aid. 
e. 
Unable to hear at all. 
 
 
4. 
Which one of the following best describes your ability, during the past 4 weeks, to hear what was 
said in a conversation with one other person in a quiet room? 
 
 
a. 
Able to hear what was said without a hearing aid. 
 
b. 
Able to hear what was said with a hearing aid. 
 
c. 
Unable to hear what was said even with a hearing aid. 
 
d. 
Unable to hear what was said, but did not wear a hearing aid. 
 
e. 
Unable to hear at all. 
 
 
5. 
Which one of the following best describes your ability, during the past 4 weeks, to be understood 
when speaking your own language with people who do not know you? 
 
 
a. 
Able to be understood completely. 
 
b. 
Able to be understood partially. 
 
c. 
Unable to be understood. 
 
d. 
Unable to speak at all. 
 
 
6. 
Which one of the following best describes your ability, during the past 4 weeks, to be understood 
when speaking with people who know you well? 
 
 
a. 
Able to be understood completely. 
 
b. 
Able to be understood partially. 
 
c. 
Unable to be understood. 
 
d. 
Unable to speak at all. 

Protocol version: 8 
55 
Date: February 15, 2017 
7. 
Which one of the following best describes how you have been feeling during the past 4 weeks? 
 
 
a. 
Happy and interested in life. 
 
b. 
Somewhat happy. 
 
c. 
Somewhat unhappy. 
 
d. 
Very unhappy. 
 
e. 
So unhappy that life was not worthwhile. 
 
 
8. 
Which one of the following best describes the pain and discomfort you have experienced during 
the past 4 weeks? 
 
 
a. 
Free of pain and discomfort. 
 
b. 
Mild to moderate pain or discomfort that prevented no activities. 
 
c. 
Moderate pain or discomfort that prevented some activities. 
 
d. 
Moderate to severe pain or discomfort that prevented some activities. 
 
e. 
Severe pain or discomfort that prevented most activities. 
 
 
9. 
Which one of the following best describes your ability, during the past 4 weeks, to walk? 
 
Note:  Walking equipment refers to mechanical supports such as braces, a cane, crutches or a 
walker. 
 
 
a. 
Able to walk around the neighborhood without difficulty, and without       walking 
equipment. 
 
b. 
Able to walk around the neighborhood with difficulty; but did not require walking 
equipment or the help of another person. 
 
c. 
Able to walk around the neighborhood with walking equipment, but without the help of 
another person. 
 
d. 
Able to walk only short distances with walking equipment, and required a wheelchair to get 
around the neighborhood. 
 
e. 
Unable to walk alone, even with walking equipment.  Able to walk short distances with the 
help of another person, and required a wheelchair to get around the neighborhood. 
 
f. 
Unable to walk at all. 
 
 

Protocol version: 8 
56 
Date: February 15, 2017 
10. 
Which one of the following best describes your ability, during the past 4 weeks, to use your hands 
and fingers? 
 
Note:  Special tools refers to hooks for buttoning clothes, gripping devices for opening jars or lifting 
small items, and other devices to compensate for limitations of hands or fingers. 
 
 
a. 
Full use of two hands and ten fingers. 
 
b. 
Limitations in the use of hands or fingers, but did not require special tools or the help of 
another person. 
 
c. 
Limitations in the use of hands or fingers, independent with use of special tools (did not 
require the help of another person). 
 
d. 
Limitations in the use of hands or fingers,  required the help of another person for some 
tasks (not independent even with use of special tools). 
 
e. 
Limitations in the use of hands or fingers, required the help of another person for most tasks 
(not independent even with use of special tools). 
 
f. 
Limitations in the use of hands or fingers, required the help of another person for all tasks 
(not independent even with use of special tools). 
 
11. 
Which one of the following best describes your ability, during the past 4 weeks, to remember 
things? 
 
 
a. 
Able to remember most things. 
 
b. 
Somewhat forgetful. 
 
c. 
Very forgetful. 
 
d. 
Unable to remember anything at all. 
 
 
12. 
Which one of the following best describes your ability, during the past 4 weeks, to think and solve 
day to day problems? 
 
 
a. 
Able to think clearly and solve day to day problems. 
 
b. 
Had a little difficulty when trying to think and solve day to day problems. 
 
c. 
Had some difficulty when trying to think and solve day to day problems. 
 
d. 
Had great difficulty when trying to think and solve day to day problems. 
 
e. 
Unable to think or solve day to day problems. 

Protocol version: 8 
57 
Date: February 15, 2017 
13. 
Which one of the following best describes your ability, during the past 4 weeks, to perform basic 
activities? 
 
 
a. 
Eat, bathe, dress and use the toilet normally. 
 
b. 
Eat, bathe, dress or use the toilet independently with difficulty. 
 
c. 
Required mechanical equipment to eat, bathe, dress or use the toilet 
 
 
independently. 
 
d. 
 Required the help of another person to eat, bathe, dress or use the toilet. 
 
 
14. 
Which one of the following best describes how you have been feeling during the past 4 weeks? 
 
 
a. 
Generally happy and free from worry. 
 
b. 
Occasionally fretful, angry, irritable, anxious or depressed. 
 
c. 
Often fretful, angry, irritable, anxious or depressed. 
 
d. 
Almost always fretful, angry, irritable, anxious or depressed. 
 
e. 
Extremely fretful, angry, irritable, anxious or depressed; to the point of 
 
 needing professional help. 
 
 
15. 
Which one of the following best describes the pain or discomfort you have 
 
experienced during the past 4 weeks? 
 
 a. 
Free of pain and discomfort. 
b.        Occasional pain or discomfort.  Discomfort relieved by non-prescription drugs or self-control 
activity without disruption of normal activities. 
c. 
Frequent pain or discomfort.  Discomfort relieved by oral medicines with occasional 
disruption of normal activities. 
 d. 
Frequent pain or discomfort; frequent disruption of normal activities. 
  
Discomfort required prescription narcotics for relief. 
 e. 
Severe pain or discomfort.  Pain not relieved by drugs and constantly 
  
disrupted normal activities. 
 
 

Protocol version: 8 
58 
Date: February 15, 2017 
16. 
Overall, how would you rate your health during the past 4 weeks? 
 
 
a. 
Excellent. 
 
b. 
Very good. 
 
c. 
Good. 
 
d. 
Fair. 
 
e. 
Poor. 
 
 
17. 
How did you complete the questionnaire?  Please select the one answer that best describes your 
situation. 
 
 
a. 
By myself, without any help from anyone else. 
 
b. 
By myself, except someone else circled the answers on the questionnaire form for me. 
 
c. 
With the help of someone else. 
 
d. 
This questionnaire was completed by a family member, without help from the subject or 
patient. 
e. 
This questionnaire was completed by a nurse or other health professional, without help 
from the subject or patient. 
 
 Please specify type of health professional:   ______________________________ 
f. 
This questionnaire was completed by another person, without help from the subject or 
patient. 
 
Please specify relationship to subject or patient: ________________________ 
 
 

Protocol version: 8 
59 
Date: February 15, 2017 
INDIRECT COST OF MEDICAL CARE 
 
Date of last cost ascertainment:  
 
 
 
Refer to this date when inquiring below about events that have occurred or procedures that were 
performed since the last time cost data were collected. 
 
Treatments or Procedures 
 
1. Have there been any major changes in your health since (date above)? 
 
1
 Yes (complete AE forms as needed) 
 
2
 No (go to question 2) 
 
2. Have you been admitted to the hospital since (date above)? 
 
1
 Yes (complete AE form for each) 
 
  
 
 
 
 
 
2
 No (go to question 3) 
 
3. How many times did you visit your physician or receive outpatient treatment (including 
emergency room visits) since (date above)? 
 
 
 
 
 Times 
 
4. Have you had any diagnostic tests as an outpatient since (date above)? 
 
1
 Yes  
 
Heart test 
 
X-ray 
CT/MRI 
 
(ECG, echo, stress test) 
 
 
 
   
 Other (specify) 
 
 
 
2
 No (go to question 5) 
 
 
REASON
REASON

Protocol version: 8 
60 
Date: February 15, 2017 
 
Insurance Status  
 
5. Which of the following best describes your current type of insurance coverage? 
 
1
 Medicare 
2
 Medicaid 
3
 Tricare/CHAMP VA 
4
 Private/Commercial 
5
 HMO 
6
 Don’t Know 
7
 Uninsured 
 
6. Do you have full or partial drug benefits under your insurance? 
 
1
 Yes 
2
 No 
3
 Don’t Know 
4
 Uninsured 
 
 
 
 

Protocol version: 8 
61 
Date: February 15, 2017 
INFORMANT CONTACT INFORMATION 
When you come in for your clinic visit, we will ask you for the names and addresses of three people outside your 
immediate household and one person within your household.  These will help us to reach you, only in the case of 
an emergency, in the future.  We will also ask you for the name of a physician whom you consider to be your usual 
source of medical care.  Please complete this worksheet and bring it with you to your clinic visit. 
 
Contact Information 
 
A. Please list the names and addresses of three people outside your immediate household who will always 
know how to contact you. 
 
1.  
 
 
First Name 
 
          MI  
 
           Last Name  
 
 
 
 
 
 
 
 
 
Street Address 
 
 
City  
 
 
 
    State   
 
Zip Code 
 
 
 
Phone Number 
 
 
 
 
 
Relationship  
 
 
2.  
 
 
First Name 
 
          MI  
 
           Last Name  
 
 
 
 
 
 
 
 
Street Address 
 
 
 
City  
 
 
 
    State   
 
Zip Code 
 
 
 
Phone Number 
 
 
 
 
 
Relationship  
 
 
3.   
 
 
First Name 
 
          MI  
 
           Last Name  
 
 
 
 
 
 
 
 
Street Address 
 
 
 
City  
 
 
 
    State   
 
Zip Code 
 
 
 
Phone Number 
 
 
 
 
 
Relationship 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol version: 8 
62 
Date: February 15, 2017 
 
 
B. Please list the name and telephone number of a person within your household.  
 
 
 
First Name 
MI 
 
 Last Name  
 
 
 
Phone Number 
 
 
 
 
 
Relationship 
 
 
 
 
 
 
 
 
 
 
Cell Phone Number 
 
 
 
 
 
 
 
 
 
  Lives Alone 
 
 
 
C. What is the name and address of a physician whom you consider to be your regular source of medical 
care? 
 
 
 
First Name 
 
 
          MI  
 
           Last Name  
 
  
 
 
 
 
Name of Practice or Office 
 
 
 
 
 
 
 
 
Street Address 
 
 
 
 
City  
 
 
 
 
 
    State   
Zip Code 
 
 
 
Phone Number 
 
 
 
 
 
 
 
 

Protocol version: 8 
63 
Date: February 15, 2017 
MEDICATIONS 
We are interested in the prescription medications you are using. We are particularly interested in 
medications your doctor prescribed for you and were filled by a pharmacist.  These include pills, skin 
patches, eye drops, creams, salves, inhalers, and injections.  The letter you received about this 
appointment asked you to bring them to the clinic.  Have you brought them with you?  Are these all 
medications that you took in the last two weeks? 
 
 Yes   
 
 
 
May I see them? 
 No   
 
 
 
Make arrangement to obtain.  
 Took no meds 
 
 
 
 Refused 
 
1. 
2. 
3. 
4. 
5. 
6. 
7. 
8. 
9. 
10. 
11. 
12. 
13. 
14. 
15.  
 
 

Protocol version: 8 
64 
Date: February 15, 2017 
SHORT FORM 36 
The followings items ask you about your health. 
 
INSTRUCTIONS:  Please read each question carefully and mark the box next to the appropriate answer. 
 
1.  In general, would you say your health is: 
 
 

 

Excellent 
Very good 
Good 
Fair 
Poor 
 
2.  Compared to one year ago, how would you rate your health in general now? 
 
 

 

Much better 
now than one 
year ago 
Somewhat 
better now than 
one year ago 
About the 
same as one year 
ago 
Somewhat worse 
now than one year 
ago 
Much worse 
now than one year 
ago 
3.  THE FOLLOWING ITEMS ARE ABOUT ACTIVITIES YOU MIGHT DO DURING A TYPICAL DAY.  DOES YOUR 
HEALTH NOW LIMIT YOU IN THESE ACTIVITIES?  IF SO, HOW MUCH? 
 
 
a) Vigorous activities, such as running, lifting heavy objects, participating in 
     strenuous sports 
 
 


 
 
Yes, limited 
a lot 
Yes, limited 
a little 
No, not limited 
at all 
 
 
 
b) Moderate activities, such as moving a table, pushing a vacuum cleaner, 
    bowling, or playing golf 
 
 


 
 
Yes, limited 
a lot 
Yes, limited 
a little 
No, not limited 
at all 
 
 
 
c) Lifting or carrying groceries 
 
 


 
 
Yes, limited 
a lot 
Yes, limited 
a little 
No, not limited 
at all 
 
 
 
d) Climbing several flights of stairs 
 
 


 
 
Yes, limited 
a lot 
Yes, limited 
a little 
No, not limited 
at all 
 
 
 
 
 
 
 
 
 
 

Protocol version: 8 
65 
Date: February 15, 2017 
 
 
DOES YOUR HEALTH NOW LIMIT YOU IN THESE ACTIVITIES?  IF SO, HOW MUCH? 
 
 
f) Bending, kneeling or stooping 
 


 
 
 
Yes, limited 
a lot 
Yes, limited 
a little 
No, not limited 
at all 
 
 
 
g) Walking more than a mile 
 


 
 
 
Yes, limited 
a lot 
Yes, limited 
a little 
No, not limited 
at all 
 
 
 
h) Walking several blocks 
 


 
 
 
Yes, limited 
a lot 
Yes, limited 
a little 
No, not limited 
at all 
 
 
 
i) Walking one block 
 


 
 
 
Yes, limited 
a lot 
Yes, limited 
a little 
No, not limited 
at all 
 
 
 
j) Bathing or dressing yourself 
 


 
 
 
Yes, limited 
a lot 
Yes, limited 
a little 
No, not limited 
at all 
 
 
 
 
 
 
 
 
 
 
 
 
e) Climbing one flight of stairs 
 


 
 
 
Yes, limited 
a lot 
Yes, limited 
a little 
No, not limited 
at all 
 
 

Protocol version: 8 
66 
Date: February 15, 2017 
4.  DURING THE PAST 4 WEEKS, HAVE YOU HAD ANY OF THE FOLLOWING PROBLEMS WITH YOUR 
WORK OR OTHER REGULAR DAILY ACTIVITIES AS A  RESULT OF YOUR PHYSICAL HEALTH? 
 
 
a) Cut down on the amount of time you spent on work or other activities? 
 
 
 
YES 
 
 
 
 
NO 
 
 
 
b) Accomplished less than you would like 
 
 
 
YES 
 
 
 
 
NO 
 
 
 
 
c) Were limited in the kind of work or other activities? 
 
 
 
YES 
 
 
 
 
NO 
 
 
 
d) Had difficulty performing the work or other activities (for example, it took extra 
     time/effort) 
 
 
 
YES 
 
 
 
 
NO 
 
 
 
5.  DURING THE PAST 4 WEEKS, HAVE YOU HAD ANY OF THE FOLLOWING PROBLEMS WITH YOUR 
WORK OR OTHER REGULAR DAILY ACTIVITIES AS A RESULT OF ANY EMOTIONAL PROBLEMS (SUCH 
AS FEELING DEPRESSED OR ANXIOUS? 
 
 
a) Cut down on the amount of time you spent on work or other activities 
 
 
 
YES 
 
 
 
 
NO 
 
 
 
b) Accomplished less than you would like 
 
 
 
YES 
 
 
 
 
NO 
 
 
 
c) Didn't do work or other activities as carefully as usual 
 
 
 
YES 
 
 
 
 
NO 
 
 
 
 
 
 
 
 
 
 

Protocol version: 8 
67 
Date: February 15, 2017 
6.  DURING THE PAST 4 WEEKS, TO WHAT EXTENT HAS YOUR PHYSICAL HEALTH OR EMOTIONAL 
PROBLEMS INTERFERED WITH YOUR NORMAL SOCIAL ACTIVITIES WITH FAMILY, FRIENDS 
NEIGHBORS, OR GROUPS? 
 
 



Not at all 
 
Slightly 
Moderately 
Quite a bit 
Extremely 
 
9.  The following questions ask you about how you have felt during the past 4 weeks. Please choose 
the one answer that comes closest to the way you have been feeling. 
 
 HOW MUCH OF THE TIME DURING THE PAST 4 WEEKS... 
 
 
a) did you feel full of pep? 
 
 
 


 

 
All of 
the time 
Most of 
the time 
A good bit 
  of the time 
 
Some of 
the time 
A little of 
the time 
None of 
the time 
 
b) have you been a very nervous person? 
 
 
 


 

 
All of 
the time 
Most of 
the time 
A good bit 
  of the time 
 
Some of 
the time 
A little of 
the time 
None of 
the time 
 
 
 
 
 
 
 
 
c) have you felt so down in the dumps nothing could cheer you up? 
 
 
 


 

 
All of 
the time 
Most of 
the time 
A good bit 
  of the time 
 
Some of 
the time 
A little of 
the time 
None of 
the time 
 
d) have you felt calm and peaceful? 
 
 
 


 

 
All of 
the time 
Most of 
the time 
A good bit 
  of the time 
 
 
Some of 
the time 
A little of 
the time 
None of 
the time 
7.  How much bodily pain have you had during the past 4 weeks? 
 
 




None 
Very Mild 
 
Mild 
Moderate 
Severe 
Very Severe 
8.  During the past 4 weeks, how much did pain interfere with your normal work 
     (including both work outside the home and housework)? 
 
 



Not at all 
 
Slightly 
Moderately 
Quite a bit 
Extremely 

Protocol version: 8 
68 
Date: February 15, 2017 
 
 
e) did you have a lot of energy? 
 
 
 


 

 
All of 
the time 
Most of 
the time 
A good bit 
  of the time 
 
Some of 
the time 
A little of 
the time 
None of 
the time 
 
f) have you felt downhearted and blue? 
 
 
 


 

 
All of 
the time 
Most of 
the time 
A good bit 
  of the time 
 
Some of 
the time 
A little of 
the time 
None of 
the time 
 
g) did you feel worn out? 
 
 
 


 

 
All of 
the time 
Most of 
the time 
A good bit 
  of the time 
 
Some of 
the time 
A little of 
the time 
None of 
the time 
 
h) have you been a happy person? 
 
 
 


 

 
All of 
the time 
Most of 
the time 
A good bit 
  of the time 
 
Some of 
the time 
A little of 
the time 
None of 
the time 
 
i) did you feel tired? 
 
 
 


 

 
All of 
the time 
Most of 
the time 
A good bit 
  of the time 
 
Some of 
the time 
A little of 
the time 
None of 
the time 
 
 
 
 
 
 
 
 
10.  During the past 4 weeks, how much of the time has your physical health or 
       emotional problems interfered with your social activities (like visiting friends, 
       relatives, etc.)? 
 
 
 



 
All of 
the time 
Most of 
the time 
Some of 
the time 
A little of 
the time 
None of 
the time 
 
 
 
 
 
 
11. HOW TRUE OR FALSE IS EACH OF THE FOLLOWING STATEMENTS FOR YOU? 
 
 
a) I seem to get sick a little easier than other people 
 
 
 



 
Definitely 
true 
Mostly 
true 
 
Don't 
know 
Mostly 
false 
Definitely 
false 

Protocol version: 8 
69 
Date: February 15, 2017 
 
 
 
 
 
 
 
 
 
b) I am as healthy as anybody I know 
 
 
 



 
Definitely 
true 
Mostly 
true 
 
Don't 
know 
Mostly 
false 
Definitely 
false 
 
c) I expect my health to get worse 
 
 
 



 
Definitely 
true 
Mostly 
true 
 
Don't 
know 
Mostly 
false 
Definitely 
false 
 
d) My health is excellent 
 
 
 



 
Definitely 
true 
Mostly 
true 
  
Don't 
know 
Mostly 
false 
Definitely 
false 
 
 
 
 
 
 

Protocol version: 8 
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Date: February 15, 2017 
SOCIAL SUPPORT 
Instructions: This questionnaire requires you to think about current relationships with other participants 
and/or group leaders in this study.  Please read each item and then indicate the extent to which you 
agree with it by checking one box next to each item with an X.  
 
Some items may seem similar to others, but it is very important that you provide an answer for each 
item. 
 
1. There are people in this program I can 
depend on to help me if I really need it. 
 
 
 
 
 
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree 
 
2. I feel that I do not have close personal 
relationships with other people in this 
program. 
 
 
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree 
3. There is no one in this program I can turn 
to for guidance in times of stress. 
 
 
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree  
4. There are people in this program who 
depend on me for help. 
 
 
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree 
5. There are people in this program who 
enjoy the same social activities that I do. 
 
 
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree 
6. Other people in this program do not view 
me as competent. 
 
 
 
       
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree 
7. I feel personally responsible for the well-
being of other people in this program. 
 
 
        
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree 
8. I feel part of a group of people in this 
program who share my attitudes and 
beliefs. 
 
 
       
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree 
9. I do not think other people in this program 
respect my skills and abilities. 
 
 
        
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree 
10. If something went wrong, no one in this 
program would come to my assistance. 
 
 
        
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree 
11. I have close relationships in this program 
that provide me with a sense of emotional 
security and well-being. 
 
 
         
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree 

Protocol version: 8 
71 
Date: February 15, 2017 
12. There is someone in this program I could 
talk to about important decisions in my 
life. 
          
        
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree 
13. In this program, people recognize my 
competencies and skills. 
          
        
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree 
14. There is no one in this program who 
shares my interests and concerns. 
          
        
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree 
15. There is no one in this program who really 
relies on me for their well-being.  
          
        
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree 
16. There is a trustworthy person in this 
program I could turn to for advice if I were 
having problems. 
          
        
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree 
17. I feel a strong emotional bond with at 
least one other person in this program. 
          
        
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree 
18. There is no one in this program I can 
depend on for aid if I really need it. 
          
        
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree 
19. There is no one in this program I feel 
comfortable talking about problems with. 
          
        
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree 
20. There are people in this program who 
admire my talents and abilities. 
          
        
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree 
21. I lack a feeling of intimacy with another 
person in this program. 
          
        
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree 
22. There is no one in this program who likes 
to do the things I do. 
          
        
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree 
23. There are people in this program I can 
count on in an emergency. 
          
        
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree 
24. No one in the program needs for me to 
care for them. 
          
        
 
 
 
 
Strongly Disagree        Disagree                Agree             Strongly Agree 
 

Protocol version: 8 
72 
Date: February 15, 2017 
CLINIC ASSESSMENT FORM 
 
1. Is the participant fasting? 
1
 Yes  
 
 
 
 
2
 No 
 
 
2. Was the fasting blood sample drawn? 
1
 Yes  
 
 
 
 
2
 No 
 
 
3.     Was blood collected for storage and future analysis? 
 
1
 Yes  
 
 
 
 
2
 No 
 
 
Blood Pressure 
 
4.  Blood Pressure 
(after sitting 5 minutes) 
 
   
 
1    
 
 
            mm/Hg  
  
  
  
systolic 
diastolic 
 
  
 
 
 
 
  
 
2                                             
mm/Hg   
  
systolic 
         diastolic 
 
AVG                                        
mm/Hg   
  
systolic 
         diastolic 
Body Size  
 
 
 
 
5.  Weight 
  
        .           kg 
  
 
 
 
 
6.  Height  
 
        .              cm  
 
 
  
 
 
 
 
 
7. BMI 
 
 
        .           kg/m2 
 
8.  Waist Circumference   
 
      
. 
      cm 
 
 
 

Protocol version: 8 
73 
Date: February 15, 2017 
ENCOUNTER AND DISPOSITION 
 
1.  Was information collected during this visit for a previously missed visit? 
 
 Yes 
 
 
Code for Missed Visit:  
 
 No  
 
 
2.  Was this visit completed in the clinic as described in the protocol/MOP? 
 
 Yes (stop here) 
 
 No (complete question 3) 
 
 
3. Was partial information collected? 
 
 
 
Indicate below the items that were scheduled to be collected but are 
 
missing: 
 
 
 
Blood draw  
 
HUI-3 
FFQ 
 Yes  
 
Physical Exam 
 
SF-36 
Self-Efficacy Qs 
 
 
 
Blood Pressure 
 
Medications 
Events Assessment 
 
 
 
Economic Evaluations 
IPAQ 
Health Behaviors 
 
 
 
 
 
 
 
Why were these not completed as planned? 
 
 
 
 
 Phone Contact 
 
 
 
 
Other (specify) 
 
 
 
 
 
Why was this visit missed? 
 No 
 
 Participant cannot be located 
 
 
 
 Participant located but refused clinic visit 
 
 
 
 Participant is hospitalized 
 
 
 
 Participant died 
 
 
 
 Scheduling conflict 
 
 
 
 Visit scheduled, but participant did not show 
 
 
 
 
 Other (specify) 
 
 
 
 
 
 
 

Protocol version: 8 
74 
Date: February 15, 2017 
PRE-SCREENING INTERVIEW 
 
First I would like to collect some general information from you.  
 
What is your name?  
 
Prefix or title preffered: 
Mr. 
Mrs. 
Ms. 
Dr. 
Other:____________ 
 
 
         First Name 
 
 
     Middle Initial  
 
 
   Last Name 
 
               Suffix 
 
 
 
 
 
 
Prefered Languague:                 English1                         Spanish2 
 
Preferred Name  
 
How did you hear about this study? (check all that apply) 
 
Church  Event 
    
1
Newspaper or Magazine Article  
7 
Community Event 
    
2
Newspaper or Magazine Ad 
 
8 
Flyer or Poster 
3
Radio Ad 
 
9 
Doctor/Doctor’s office 
4
Television Ad 
 
10
Letter in Mail 
5
Don’t Know 
 
11
Referral 
6
Refused 
 
12
Other (please specify): 
 
13
 
 
1.  Has anyone interviewed you or given you information about this study before? 
 
1
Yes     
 
 
 
When?  
 
 
 
What was the outcome?   
2
 No 
__________________________  
 
 
3
 Don’t Know 
 
 
 
 
 
 
2.  What is your date of birth?     
 
 
 
 
 
 
 
 
               
 
 
 
3.  What is your sex? 
 
1
 male 
 
2
 female 
 
 
 
 

Protocol version: 8 
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Date: February 15, 2017 
4.  Which of the following best describes your race? 
 
1
 African American/ Black  
 
2
 American Indian/ Native American/ Alaskan Native 
 
3
 Asian/ Pacific Islander 
 
4
 White  
5
 Other  
specify:__________________ 
 
5.  Are you Latino, Hispanic, or of Spanish origin?   
 
PARTICIPANT EXCLUDED 
 
1
 Yes  
 
 
 
 
 
Not Latino, Hispanic, or of  
 
 
2
 No  
 
 
 
 
 
Spanish Origin 
 
 
6.  Do you have diabetes?       
Are you taking any oral medications or insulin to  
 
control your diabetes? 
 
1
Yes  
 
 
 
1
Yes  
 PARTICIPANT EXCLUDED 
 
2
No 
 
2
No  
 
 
 
3
Don’t Know 
 
 
 
 
 
 
 
 
Are you following a special diet or exercise  
 
 
 
 
 
 
 
 
program to manage your diabetes? 
 
 
 
 
 
 
1
Yes       
 PARTICIPANT EXCLUDED   
 
2
No 
 
 
 
 
       
 
                       4
Borderline 
 
 Are you taking any oral medications? 
 
                                                                                       1
Yes  
 PARTICIPANT EXCLUDED 
 2 
No 
   3
Don’t Know 
   4
Don’t Know  
 
 
 
7.  What is your height? 
 
 
 
 
***BMI _____________kg/m2 
   Feet      Inches 
 
 
 
 
 
 
 
 
 
PARTICIPANT EXCLUDED 
8.  What is your weight?   
BMI is not between 23 and 50 kg/m2 
 
 
 
 
 
 
 
 
 
 
 
 
lbs. 

Protocol version: 8 
76 
Date: February 15, 2017 
9.  Have you been diagnosed with or treated for any cancer except (non-melanoma) skin cancer in the 
last 5 years? 
 
      
1
Yes                                                          
PARTICIPANT EXCLUDED 
      
                                                            
 Recent diagnosis and/or treatment of  
      
2
No 
 cancer 
 
 
  
3
Don’t Know 
 
 
 
10.  Have you ever had any of the following? 
 
your heart stopped and doctors had to  
 
1
Yes       2
No    
3
Don’t Know   
restart it with an electric shock or defibrillator  
 
 
 
 
 
 
 
 
 
 
 
kidney dialysis  
 
 
 
 
1
Yes       2
No    
3
Don’t Know  
 
  
implanted defibrillator       
 
 
 
1
Yes       2
No    
3
Don’t Know  
 
major organ transplant  
 
 
 
 
1
Yes       2
No    
3
Don’t Know  
  
If participant answered yes to any of the above: 
 PARTICIPANT EXCLUDED 
 
History of major condition/chronic disease  
 
 
11.  Can you walk two blocks (about ¼ mile) without stopping without the aid of a cane, crutches, walker 
or other such device? 
 
     1
Yes   
 
PARTICIPANT EXCLUDED 
 
  
Unable to perform moderate intensity 
     2
No 
 
exercise 
 
  3
Don’t Know 
 
 
   
12.  (If female) Are you currently pregnant or nursing or planning to become pregnant? 
 
     1
Yes     
 
PARTICIPANT EXCLUDED 
 
  
 
Pregnant 
     2
No 
 
 
Nursing 
 
 
 
Planning pregnancy 
     3
Male, not applicable  
 
 
 
13.  Have you had any of the following? 
 
Heart Attack    
 
 
1
Yes 
   2
No     3
Don’t Know 
 
Stroke, mini stroke, or TIA  
1
Yes         2
No     3
Don’t Know 
 

Protocol version: 8 
77 
Date: February 15, 2017 
Heart bypass surgery  
  
 
1
Yes         2
No     3
Don’t Know 
 
Heart angioplasty, balloon surgery  
 
1
Yes          2
No     3
Don’t Know 
of the heart, or a stent 
Participated in cardiac rehabilitation   
 
1
Yes         2
No     3
Don’t Know 
 
If participant answered yes to any of the above, did it occur in the past six months? 
 
 
1
Yes 
PARTICIPANT EXCLUDED 
 
 
Recent history of cardiovascular disease 
 
2
No   
 
 
 
 
When was your most recent event? 
 
 
 
 
 
 
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Re-screen 6 months from above date 
 
14.  Are you currently taking medications for weight loss or participating in a weight loss program? 
 
 
 
 
 
Are you willing to stop taking these medications or 
     1
Yes                                                  
participating in the other weight loss program for the time 
that you are participating in HELP?   
      
                                                    
1
Yes 
 
     2
No 
2
 No 
 
PARTICIPANT EXCLUDED 
 
 
 
 
15.  Are you currently taking steroid pills or shots such as prednisone or cortisone?  (This does not 
include hormone replacement) 
 
    1
Yes 
                                                     
    2
No 
 
   3
Don’t Know 
 
 
16.  Are you currently being treated for drug or alcohol abuse? 
 
1
Yes  
PARTICIPANT EXCLUDED 
 
2
No  
Self-Reported substance abuse 
 
 
17.  Have you ever been hospitalized for a major mental disorder or psychiatric problem?   
 
     1
Yes   
      
     2
No 
 
 
If “yes”, contact study doctor for consult before 
participant can continue screening process.   
Which ones?  
______________________________________ 
Contact study doctor for consult before participant can 
continue screening process.  

Protocol version: 8 
78 
Date: February 15, 2017 
 
18.  Are you or any members of your household currently participating in any other medical research 
trials? 
 
 
     1
Yes   
 
      
     2
No 
 
 
19.  Are you planning to move from the area in the next 2 years? 
 
     1
Yes   
PARTICIPANT EXCLUDED 
 
Unable to make time commitment for length  
     2
No 
of the study 
 
  3
Don’t Know 
 
 
20.  Are there times when you might be away for more than 2 weeks at a time that might limit 
participation in the intervention? 
 
     1
Yes   
PARTICIPANT EXCLUDED 
 
 Travel may limit participation in intervention 
     2
No 
 
 
 
21.  Do you know of any reasons, health related or otherwise, that you would not be able to participate 
completely in a 2 year research study? 
 
     1
Yes   
      
     2
No 
 
 
 
 
If eligible: 
 
Based on these questions, you may be eligible to participate in La Comunidad.  We would like to 
invite you to watch a brief video to learn more about the study. Are you interested in continuing 
the screening process? 
Yes  
No 
 
If ineligible: 
 
Based on these questions, it looks like you are not eligible to participate in La Comunidad.  We 
really appreciate your interest in the study and hope that we can contact you in the future for 
other studies related to diabetes or weight loss.  Would it be okay for us to keep your 
information on file for future studies? 
Yes  
No 
 
 
 
Reason: 
_________________________________________
_________________________________________
_________________________________________
Evaluate ability to participate before continuing  
Study: 
_____________________________________ 
Contact study coordinator for more information 
before participant can continue screening process.  
 

Protocol version: 8 
79 
Date: February 15, 2017 
 
For staff use only 
 
 
Eligibility status: 
 
     
Eligible  
      
     
Ineligible  
 
     
Refused  
 
     
Pending:  Explain  
 
 
 
 
Call back: 
 
 
      
 
 
 
 
    
 
 
 

Protocol version: 8 
80 
Date: February 15, 2017 
ELIGIBILITY SCREENING FORM  
 
1. Informed Consent  
Was informed consent obtained? 
 
 Yes   
 
 
 
Date signed: 
 
 
 
 No  
 
2. Confirmation of Prediabetes 
 
 Diabetes Risk Test completed 
 
 
  
 
 
 
 
 
 
 
 
 
 
Score:  
 
 
      
 
 
 
 
 
 
 
 
 
 
 
  
3. Blood Pressure 
   
 
            
              
  
1.   
 
 
   
 mm/Hg  
 
Is average SBP >160 or average 
 
 
 
Systolic 
diastolic 
 
 
 
DBP>100? 
 
 
 
 
 
 
 
 Yes  
 
 
 
 
 
 
 
 No   
2.  
  
 mm/Hg  
 
 
 
systolic 
         diastolic 
 
 
 
 PARTICIPANT EXCLUDED  
 
  
 
 
 
Average BP > 160/100 mm/Hg; 
 
 
 
 
 
 
 
referred to PCP   
 
 
AVG  
 
 
 
  mm/Hg 
 
systolic 
         diastolic 
 
4. Body Size  
 
 
 
 
 
 Weight 
• 
lb 
 
Is BMI < 25 kg/m2 or >45 kg/m2? 
 
 
 
 
 
 
 
 Yes  
 
 
 
 
 
 
 
 No   
 
 
 Height  
•           in  
 
  
 
 
 
 
 
 
 PARTICIPANT EXCLUDED 
**BMI  
 
 •  
    kg/m2 
 
BMI < 25 kg/m2 or >45 kg/m2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol version: 8 
81 
Date: February 15, 2017 
5. Was the PAR-Q completed? 
 
 Yes   
 
 
 
 No 
 
 Check here if medical clearance is required prior to participation. 
 
 
6. Measurement of HbA1c 
 
 Blood sample collected  
Was the HbA1c less than 5.7% or more than 6.5%? 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 Yes  
 
 
 
 
 
 
 
 No 
 
 . 
  %  
 
 
 
 PARTICIPANT EXCLUDED 
 
 
 
 
 
 
 
HbA1c < 5.7% or >6.5% 
 
 
If ineligible: 
Based on the blood that we collected at the screening event, you are not eligible to participate in La Comunidad.  
This is because your blood sugar was above/below the range to qualify for the study.  If you would like, please feel 
free to contact us in the future if you would like to be screened again.  We really appreciate your interest in the 
study and hope that we hear from you again.  
 
 
Yes  
No 
 
Date Participant is scheduled to return:   
 
 
 
 
 
 
 
 
 
 
 
 
 
Time:  
   :   
 
AM  
 
 
 
 
 
PM 
 Nature of Next Visit: 
 Additional Screening 
 Randomization  
 
Current Status: 
 Eligible 
 Ineligible 
 Refused 
 
 

Protocol version: 8 
82 
Date: February 15, 2017 
Contact Information 
 
Complete Legal Name 
 
First 
Middle 
 
 
Last 
Suffix  
 
Mother’s Name 
 
 
Address 
 
Address 1 
 
 
Address 2 
 
 
City 
State 
Zip 
 
 
Telephone 
 
Home 
Work 
 
 
Cell 
Other 
 
 
Email 
 
I do not have access to email 
 
What is your preferred contact number? 
 
Home 
Work 
 
 
Cell 
 
 
Other 
 
What is the best time of day to reach you? 
 
Morning (8 AM-12 PM) 
Afternoon (12-5 PM) 
 
Evening (5-8 PM)