¡Vivir Mi Vida!: A Pilot Study of a Lifestyle Intervention to Optimize Health Outcomes in Latino Patients
Phase: NA
Conditions: Healthy Lifestyle
Sponsor: University of Southern California

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RESEARCH PROTOCOL  
ίVivir Mi Vida! Pilot Study 
 
 
IRB Project Title:  ¡Vivir Mi Vida!: A pilot study of a lifestyle intervention to optimize health outcomes in 
Latino patients 
 
IRB ID: 
HS-14-00725 
 
Primary  
Stacey L. Schepens Niemiec 
Investigator: 
Research Assistant Professor, K12 Research Scholar  
 
USC Chan Division of Occupational Science and Occupational Therapy 
 
1540 Alcazar St., CHP-133 
 
Los Angeles, CA  90089-9003 
 
323-442-2069 
 
Co-Investigators:  
Michael Carlson 
 
Cheryl Vigen 
 
Jeanine Blanchard 
 
Jenny Martinez 
Collaborators: 
Antelope Valley Partners for Health 
 
Antelope Valley Community Clinic 
 
 
I. Specific Aims 
1. Through a mixed-methods process evaluation, assess the feasibility and acceptability of the ¡VMV! 
intervention and associated study procedures, as administered in a community-based health service system.  
2. Preliminarily examine the efficacy of the ¡VMV! intervention to improve patient-relevant outcomes 
pertaining to diabetes and CVD risk and general health promotion.  
3. Based on data collected from Aims 1 and 2, refine and optimize the lifestyle intervention to prepare for a 
large-scale RCT. 
 
II. Methods 
A. Study Design 
In the proposed study, 40 Latino adults aged 50-65 years old will be included. All participants will receive the 
intervention. Throughout the course of their study involvement, participants will continue to receive usual care at 
their regular primary care facilities or community health clinics or from community-based programs in which they 
are enrolled. 
An assessment battery, consisting of both questionnaire and clinical outcome measures, will be administered 
at baseline, a subsequent four-month post-testing session, and a 12-month follow-up testing session. Each 
assessment period will include an in-person assessment to obtain clinical values and responses to questionnaires. 
Each in-person assessment period is expected to last about 1.5 to 2 hours. In addition to study-generated 
measures, we will collect electronic data on medical service utilization and clinical assessments from our 
collaborating healthcare partners. Finally, at the conclusion of the intervention and post-testing, we will collect 
information about implementation issues, including reach, patient and staff satisfaction, identification of 
intervention facilitators and barriers, and program sustainability.  
Total length of enrollment will include one day for initial testing, four months for the intervention, one day 
for follow-up testing post-intervention, one day if the person participates in a post-intervention focus group, and 
one day if the person participates in the 12-month follow-up testing session. 
 
B. Participants, Recruitment, and Consent 

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A convenience sample of 40 late middle-aged (50-65 years old) Latino adults will be recruited from direct 
personal contacts at recruitment tables, provider referrals, and postings at the Antelope Valley Community Clinic 
and local community centers. If a potential participant responds to a flyer and calls a study team member, the 
screening form will be utilized to describe the study and ensure his/her eligibility. For those individuals who 
participated in the study as a supervisor, intervener, or tester, research staff will directly approach them to solicit 
participation in a follow-up interview.  
 
Potential participants for the intervention and follow-up focus group will be included if they: 
1. Are male or female adults aged at least 50 years at the outset of the four-month intervention and will be 
no older than 65 years upon completion of the intervention 
Justification: This age group is at high risk for developing disease in older age and likely 
amenable to an intervention that may help prevent or delay chronic disease in later life 
2. 
Self-identify as Latino/Hispanic 
Justification: The intervention was culturally tailored to and designed for Latino adults. Latino 
adults are at high risk for certain chronic diseases which could potentially be prevented or 
delayed through lifestyle intervention 
3. 
Are fluent in Spanish 
Justification: Group sessions will be held in Spanish. Individual sessions may take place in either 
English or Spanish, depending on the participant’s preference 
4. 
Live in Antelope Valley and do not plan on moving within six months from the beginning of the study 
5. 
Are enrolled as a patient in the Antelope Valley Community Clinic 
6. 
Have visited his/her primary care healthcare facility within the past year 
Justification: This criterion ensures that patients are “active” in the health care system 
7. 
Will be available by telephone for the duration of the intervention 
Justification: A portion of the intervention is delivered via telephone 
8. 
Are oriented to person, place, and time as tested by asking the person’s name, date, age, and place of 
residence 
9. 
Self-report their ability to participate for the duration of the intervention  
 
Individuals who participated as supervisors, interveners, or testers will be included for a follow-up interview if 
they: 
1. 
Held the role of supervising occupational therapist or promotor, intervening promotor, or tester during 
study implementation. 
 
After screening, informed consent materials will be sent or handed to prospective participants for pre-review. 
Only key personnel who are HIPAA and CITI certified, trained in consenting procedures, and do not have a 
conflict of interest will conduct the consent process. The consenter will explain the study procedures and describe 
in detail what will be expected of participants. Participants will have ample time to ask questions about the study 
and their role in it. If the individual is interested in participating, s/he will sign the consent form. If participants 
are not comfortable with the study, they may choose not to participate. 
 
For the 12-month follow-up testing session, the project manager will mail the Consent Addendum with a cover 
letter, which will (a) invite existing participants to participate in this additional assessment session; (b) encourage 
them to read the enclosed consent document; and (c) inform them that the assessor (who is HIPAA and CITI 
certified) will contact them soon to schedule a time to go over the informed consent, enroll them in the study if 
they are willing, and complete the assessments if they are willing. The assessor and primary Spanish study contact 
will call each of the existing participants to schedule a time to go over the informed consent, enroll them in the 
study if they agree to participate, and complete the assessment battery. 
 
C. Assessment Procedures 
Following the informed consent process, participants will complete a battery of self-report questionnaires and 
clinical tests. The following data, with the exception of fixed background variables, will be assessed during each 
measurement point (baseline, four months, and 12 months). Participants may undertake assessment in Spanish or 
English, as preferred. 
 

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—Background. Information regarding participants’ background and demographics (e.g., sex, race, smoking status, 
insurance coverage) will be collected using a study-specific questionnaire. Additionally, ongoing health problems 
will be documented (i.e., a checklist will include selected health conditions such as cancer, heart attack, heart 
failure, hypertension, high cholesterol, arthritis, asthma, alcohol abuse, drug abuse, mental/psychiatric problem, 
other).  
 
—Measure Your Medical Outcome Profile 2 (MYMOP2). The MYMOP2 is a simple patient-centered 
questionnaire that asks the participant to identify one or two symptoms that are bothersome. Patients rate the 
severity of the symptoms as well as how much they interfere with their daily activities. Upon retest, participants 
are asked about the symptoms that were initially identified, but are not told what their initial ratings were. The 
questionnaire has been shown to be sensitive to change,90-92 and has demonstrated construct 90,92 and criterion 
validity.90 Most importantly, this short item questionnaire gets to the heart of what is important to the patient and 
measures the personally relevant effect of changes that have taken place over the measurement interval. 
Therefore, the mean degree of change across the set of self-reported symptoms on the MYMOP2 will be used as 
the study’s secondary outcome. 
 
—Block 2005 Food Frequency Questionnaire Spanish Version (Block FFQ).  The Block FFQ was designed to 
estimate usual and customary intake of a wide array of nutrients and food groups. It takes 30-40 minutes to 
complete and is intended for either self- or interviewer-administration (we intend to use interviewer-
administration). The bilingual format, with text in both Spanish and English will be used. This version of the FFQ 
has additional food items typical of diets among Hispanics. The food list for this questionnaire was developed 
from NHANES 1999-2002 dietary recall data;121 the nutrient database was developed from the USDA Food and 
Nutrient Database for Dietary Studies (FNDDS), version 1.0.122 A series of "adjustment" questions provide 
greater accuracy in assessing fat and carbohydrate intake. Individual portion size is asked for each food, and 
pictures are provided to enhance accuracy of quantification. 
 
—International Physical Activity Questionnaire (IPAQ). Exercise will be measured using the long version of the 
IPAQ.96 This assessment includes 12 to 27 items, depending on the number of non-applicable questions that the 
respondent is allowed to skip. The questionnaire contains job-, transportation-, household-, and recreational-
related physical activity, and time spent sitting. This questionnaire has been used extensively in varying cultures 
and has been validated with accelerometer data.97-99  
 
—Satisfaction with Participation in Discretionary Social Activities and Satisfaction with Participation in Social 
Roles short forms. These two scales, contained on the Patient Reported Outcomes Measurement Information 
System (PROMIS), will be used to measure satisfaction with participation. Each covers the past seven days and 
contains 7 questions answered on a 5-point scale. These short forms, as well as the full Satisfaction with 
Participation bank, have been extensively tested and validated.100 
 
— PROMIS: Emotional Distress – Depression - Short Form 8a. This instrument uses 8 items to assess depression 
over the past seven days. These 8 items have been calibrated and validated in both English and Spanish using 
Item Response Theory.100-102 The short form has the advantage of providing almost as much precision as the full 
item bank (r=.977),103 while substantially reducing the testing burden on the participant.  
 
—Pittsburgh Sleep Quality Index (PSQI). Sleep quality within a one-month period will be measured using the l9-
item PSQI. This assessment produces a global sleep quality score and seven subscores: sleep quality, sleep 
latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medications, and daytime 
dysfunction. This measure has been validated in adult and older adult populations.123, 126 
 
 
—Clinical Measures. Non-fasting blood samples will be drawn using finger pricks and the Afinion (HBA1C) and 
Cholestech (Lipid Test) meters will be used to assess HbAlc and lipid profiles (total, HDL, and LDL cholesterol, 
and triglycerides). We have chosen to not require participants to fast at the time of blood draw. This will increase 
patient participation and decrease patient inconvenience. Recent studies have shown minimal difference between 
fasting and non-fasting values for total, HDL, and LDL cholesterol.111 Blood pressure will be measured using an 
average of two readings taken from a digital blood pressure monitor. BMI (weight in kilograms divided by height 
in meters squared) will be obtained using a standard weight scale and stadiometer. Waist circumference will be 
measured via tape at the midpoint between the iliac crest and the lower rib. Hip circumference will be measured 

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via tape at the level of the trochanter and used in the calculation of waist to hip ratio. Elo et al.’s Single Item 
Stress Index will be used to assess level of stress using a 5-point Likert scale that captures general level of stress 
“these days.”104 It correlates well (r=0.20-0.75) with other validated measures of mental well-being.104 Self-
reported healthcare utilization will be collected including ER visits, hospitalizations, and clinic visits. 
 
—Disease Risk Scores. In response to strong interest in the study population for overall risk scores for CHD and 
diabetes, we will use the Framingham Risk Score LDL Points Total115 to measure CHD risk and the EPIC 
Diabetes Risk Score116 to measure diabetes risk. Both risk scores are modifiable by lifestyle behaviors and 
calculable from data that are already being collected during the background and clinical assessment, and thus will 
not add to the participants' testing burden. 
 
—Healthcare Service Utilization. We will extract data from each participant’s electronic medical record for 
routine and preventive healthcare utilization (e.g., number of clinic, lab, and other preventive, diagnostic, or 
screening visits) and non-routine healthcare utilization (e.g., number of emergency department visits and 
hospitalizations) during the six months prior to baseline and at the end of the intervention. This extraction process 
will be conducted by the assessors on the study team.  
 
—Patient Activation Measure (PAM) 13. The PAM 13 is a 13-item short form tool that assesses a patient’s 
knowledge of, skills in, and confidence in health self-management.127 Following assessment, a patient is classified 
in one of four progressively higher activation categories. This 13-item short form has been validated as a measure 
of a patient’s level of engagement in his/her own healthcare.127  
 
—Brief Pain Inventory (BPI; short form) subscales: Pain Severity and Pain Interference. The BPI Severity 
subscale measures the amount of pain a person experiences at its “worst,” “least,” and “average” severity as well 
as the pain he/she is in “now.” The BPI Interference subscale assesses how much a person’s pain interferes with 
everyday life including general activity, walking, work, mood, life enjoyment, relationships, and sleep. The BPI 
short-form and its subscales are considered valid and reliable.128-130 The Spanish-translated tool has been validated 
in a Spanish-speaking population.129 
 
—Dietary Habits Questionnaire. The My Habits questionnaire measures participants’ heart-healthy behaviors, 
consisting of 3 subscales: salt intake, cholesterol and fat consumption, and weight control behaviors. The 
questionnaire has been shown to be reliable131-132 in previous studies with Hispanic adults. 
 
D. Intervention Procedures 
—Background. The intervention is informed by Lifestyle Redesign (LR), a health promotion program which has 
produced beneficial effects in underserved, ethnically diverse, older minority populations.60,68 LR enables patients 
to design, practice, and ultimately enact a personalized, sustainable health-promoting daily routine that is tailored 
to address CD risk factors as well as promote health and well-being more generally. Promotores – health workers 
in the Latino community who have completed specialized training to provide basic health education programs – 
will serve as the front line ¡VMV! interveners. Typically well-respected in their communities, they are perceived 
as sharing commonly held values and predisposed to deliver interventions in a culturally sensitive manner.75  
The American Occupational Therapy Association published the original LR manual in 1999.76 A second 
edition was released in April 2015.124 An investigative team from the United Kingdom has been studying the 
effectiveness of a LR spinoff adapted to the needs of British elders when implemented in the UK National Health 
Service system.77 ¡VMV! is the first version of the LR program that has been tailored for late middle-aged Latinos 
with or at risk for CDs.  
 
—Structural Overview. The ¡VMV! intervention is divided into five units representing different content areas and 
follows the general activity-based, culturally sensitive treatment strategies of other LR interventions.60,61,68 The 
treatment protocol includes eight 1-hour individual sessions, three 1-hour group sessions, and two 15-minute 
telephone calls— all delivered over four consecutive months in a tapered design, as outlined in Table 1. 
Individual sessions, which will occur in patients’ homes or in a public location of the patient’s choosing, will 
allow patients to pursue their self-identified goals and to receive personalized health information. Group sessions, 
which will take place at the Antelope Valley Community Clinic, will be devoted to synthesizing individual 
session instruction, sharing experiences related to embracing a healthy lifestyle, and problem-solving as a means 

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of fostering peer support and advisement from other patients. Phone calls will be utilized to maintain contact with 
patients and to monitor their experience with lifestyle change.  
 
Table 1: Intervention sequence for one participant 
 
Month 1 
Month 2 
Month 3 
Month 4 
Total 
# Individual (in-home) Sessions (1 hour) 
3 
3 
2 
0 
8 
# Group Sessions (1 hour) 
1 
1 
0 
1 
3 
# Telephone Sessions (15 minutes) 
0 
0 
1 
1 
2 
Total contacts 
4 
4 
3 
2 
13 
 
—Content. The five educational units contained in the ¡VMV! manual will be used to organize the presentation of 
principles and strategies to achieve a healthy and active lifestyle. These units are summarized in Table 2 and 
include: Healthy Eating and Physical Activity; Healthcare Navigation; Chronic Disease Management; Mental 
Well-being; and Wrap-up. To promote patient-centeredness, flexibility, and customization, the treatment plan 
includes standard content for all patients and discretionary content which will be presented to a given patient only 
when relevant. For example, as a part of the Healthy Eating and Physical Activity unit, all patients will be taught 
how to incorporate a balance of protein, fruits, vegetables, grains, and oils into meals. However, this unit will also 
contain discretionary content that pertains to specific diseases (e.g., self-care for diabetes) which will only be 
presented if appropriate.  
 
Table 2: Intervention units and associated sessions 
Unit 
Month  
Week 
Type 
Title 
 
1 
(3/1/0)* 
1 
I 
Session 1: Introduction 
Healthy 
Eating &  
Physical 
Activity 
2 
I 
Session 2: Transform Your Eating Habits Today 
3 
I 
Session 3: Making Healthy Food Choices in Real-Life 
Situations (Outing) 
4 
G 
Session 4: Healthy Eating in Social Situations 
2 
(3/1/0) 
5 
I 
Session 5: Healthy Physical Activity and You  
Healthcare 
Navigation 
6 
I 
Session 6: Getting the Most out of Your Healthcare  
Chronic 
Disease 
Mgmt. 
7 
I  
Session 7: Disease Specific Health Management (Flexible) 
Mental 
Well-Being 
8 
G 
Session 8: Gratitude and a Positive Outlook 
3 
(2/0/1) 
9 
I 
Session 9: Mental Well-Being  
10 
I 
Session 10: Stressors (Flexible Sessions) 
 
Session 10a: Finances and Your Health  
 
Session 10b Sleep 
 
Session 10c: Effective Communication 
 
Session 10d: Coping with Loss 
 
Session 10e: Safety 
11 
T 
Session 11: Follow-Up  
Wrap-Up 
4 
(0/1/1)* 
12 
G  
Session 12: Graduation 
 
T  
Session 13: Follow-Up 
Notes: I=Individual; G=Group; T=Telephone 
 
Although at the outset of the intervention patients will be assigned to groups of ten, the first session will be 
individualized and, in most cases, home-based. In this session, led by both the promotor assigned to the patient’s 
group and an occupational therapist who will be present via teleconference using HIPAA compliant VSee 
software, the patient will be able to review a personalized Health Status Report, which contains a summary of the 
most recent information extracted from his or her health records, including health markers such as weight and 
blood pressure levels. After discussing this report, the patient, occupational therapist, and promotor will develop a 
Health Action Plan (HAP). The HAP will include three health-related goals that the patient wishes to achieve 
through the intervention and a list of four to five strategies or activities that can be implemented to achieve these 
goals. Additionally, each participant will be given a wrist-worn activity monitor to keep permanently even after 
the intervention concludes. Participants will be instructed in the features of the monitor and guided in how they 

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could use it to help achieve the goals delineated in the HAP, as appropriate. Through ongoing individual and 
group supervisory meetings, the occupational therapist will use the information from the HAP to guide the 
promotor in tailoring the intervention to meet individual patient’s needs.  
During the course of individual, group, and phone sessions, the HAP will be updated with topic-specific unit 
content. At the beginning of month three, the promotor will take note of the progress that the patient has made 
toward his or her goals and reassess various health indicators such as weight or blood pressure. These results will 
be forwarded to the patient’s physician. Concurrently, patients will be encouraged to review these results to self-
monitor any change in their health status. By the conclusion of the intervention, each patient will be helped to 
adopt his or her HAP to maximize the likelihood of lifelong implementation of health-enhancing activity and 
habits. 
 
E. Feasibility and Acceptability Data Collection Procedures 
Feasibility and acceptability data will be collected throughout the study. We will track (a) rates of recruitment, 
protocol adherence and engagement, and retention; (b) adverse events; (c) participants’, interventionists’, and 
testers’ perceptions of the intervention and/or study procedures (e.g., perceived benefits, burden, satisfaction); and 
(d) facilitators and barriers to successful completion of study procedures.  
A number of methods will be employed to collect these data. Detailed records will be kept throughout the 
duration of the study. Planned documentation ranges from specifics of the screening and intake process to 
promotor notes summarizing each intervention session. We will hold fidelity checks periodically which will 
require the promotor audio/video record selected patient sessions with permission of the participant or for the 
supervisory OT or promotor to sit in on patient sessions. Additionally, a brief exit interview at the end of the four-
month and 12-month assessment sessions will be administered to all participants. After the close of the four-
month data collection, semi-structured focus groups and interviews will be held with participants and research 
staff, respectively. We will conduct two 1.5 to 2-hour participant focus groups (approximately eight people per 
group) that will be video recorded to allow for verbatim transcription and analysis. Participants who join a focus 
group will have completed the intervention, as well as all other study requirements, within the past month, and 
will be selected so as to achieve variation in sex, ethnicity, education level, and number of chronic diseases. 
Furthermore, one-hour exit interviews will be conducted with the treating promotores, supervising occupational 
therapist and promotor, and assessment battery deliverers. Interviews will be audio recorded to allow for verbatim 
transcription and analysis by one of our bilingual research team members authorized to interact with participants. 
Due to the semi-structured nature of the focus groups and interviews, the focus group facilitator or interviewer 
may depart from facilitation guides in order to probe for pertinent details and follow up on information disclosed 
by the participants.  
 
F. Data Management and Storage and Communication 
Data collection during assessment sessions will primarily occur within REDCap—a secure, web-based application 
designed to support data collection for research—using a study-specific laptop. In rare circumstances (e.g., upon 
loss of internet access, participant request), assessment data will be captured through use of hardcopy 
questionnaires. REDCap will also serve as a secure, password protected storage database for data collected during 
assessment sessions (not including interview/focus group data). Data that are captured in hard copy form, will be 
transferred to REDCap by authorized, trained study personnel. Any hard copies of study documents when not in 
use will be maintained and stored in locked files at the Antelope Valley study office during the recruitment and 
intervention implementation phases of the study. Documents containing participants’ names (e.g., informed 
consent documents) will be stored and locked separately from documents with participant codes. All hardcopy 
files will be permanently transferred to the USC study office (CHP-101) upon completion of the post-intervention 
assessments and focus groups. Data that are neither captured within REDCap nor in hardcopy format (i.e., 
audio/video recordings), will be stored on a secure, password protected data server of USC. 
 
Research investigators and staff located at USC and Antelope Valley will remain in regular communication 
throughout the study. At the outset of the study and at subsequent one-month intervals, a project staff meeting will 
be held. We will discuss items such as the safety and proper treatment of the research participants. These meetings 
will be mandatory for all project personnel who have contact with participants or with data that result from the 
study. Additionally, an internal committee comprised of the principal investigator, Antelope Valley collaborator 
Ms. Michelle Kiefer, the co-investigator responsible for training and supervising the occupational therapist, and 
the project coordinator will meet monthly to assess participant recruitment; accrual and retention; data quality and 
timeliness; participant risk versus benefit; and the development of external conditions that could potentially affect 

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the study. Additionally, the primary investigator and collaborator Ms. Kiefer will remain in regular weekly 
contact via telephone or email to discuss any study-related issues that arise. 
 
III. Statistical Considerations   
A. Sample Size 
We will enroll 40 participants in this pilot study.  With this sample size we will have 80% power to detect a 
statistically significant change score effect size of 0.454 in any of our continuous outcome variables (two-sided 
alpha=0.05, paired sample t-test).  This is considered a medium effect size.  In the Well Elderly 2 study, effect 
sizes were generally small.  Therefore, we expect this pilot study to have minimal statistical power.  Nevertheless, 
this sample size is adequate for assessing the feasibility and acceptability of this intervention and to identify any 
obstacles that need to be addressed before a large-scale version of this study can be undertaken. 
 
B. Data Analysis 
Specific Aim 1: Through a mixed-methods process evaluation, assess the feasibility and acceptability of the 
¡VMV! intervention and associated study procedures, as administered in a community-based health service 
system.  
 
Feasibility and acceptability will be determined by (a) analyzing rates of recruitment, protocol adherence and 
engagement, and retention; (b) monitoring adverse events; (c) examining participants’ and interventionists’ 
perceptions of the intervention and study procedures (e.g., perceived benefits, burden, satisfaction) as collected 
during focus groups and interviews; and (d) identifying facilitators and barriers to successful completion of study 
procedures. Focus group and interview transcripts will be analyzed using a qualitative descriptive approach.125 
Two researchers will independently code translated transcripts. During this data analysis phase, they will meet bi-
weekly for three months to review codes and discuss emerging themes. Each researcher will highlight significant 
transcript passages and their codes at analytic meetings, during which codes will be refined and preliminary 
themes identified. The review of relevant interview passages and thematic organization of findings will be an 
iterative process that will continue until consensus is achieved among the research team. Once the team agrees 
upon the primary themes expressed during the interviews and focus groups, one researcher will extract excerpts 
that support each theme. Data from the focus groups and interviews will be compared and contrasted to other data 
tracked throughout the study by the research team and interveners (e.g., adherence, participant engagement). 
 
Specific Aim 2: Preliminarily examine the efficacy of the ¡VMV! intervention to improve patient-relevant 
outcomes pertaining to diabetes and CVD risk and general health promotion.  
 
Efficacy of the intervention will be preliminarily evaluated based on comparison of baseline and post-intervention 
data collected on the following outcomes: perceived clinical outcomes related to symptoms, activity, and well-
being (MYMOP2), pain (BPI Pain Severity and Pain Interference subscales), dietary intake (Block Food 
Frequency Questionnaire), dietary habits (My Habits Scale), self-reported exercise (IPAQ), sleep quality (PSQI), 
satisfaction with participation (PROMIS Satisfaction with Participation in Discretionary Social Activities and 
Satisfaction with Participation in Social Roles short forms), depression (PROMIS Emotional Distress - 
Depression – Short Form 8a), stress (Elo et al.’s Single Item Stress Index), patient activation (PAM-13), clinical 
outcomes (HbAlc, lipid profiles, waist and hip circumference, waist to hip ratio), CHD risk (Framingham Risk 
Score LDL Points Total), diabetes risk (EPIC Diabetes Risk Score), and healthcare service utilization.  
 
Data will be directly entered into the Research Electronic Data Capture (REDCap) system.  Data will be checked 
for completeness and reasonableness.  Descriptive statistics will be presented and analyses will inform the 
appropriateness of our intended statistical plan.  Changes in outcome variables will be assessed using paired-
sample t-tests.  Baseline covariates (e.g., age, gender), will be assessed for effect modification.  Results will be 
stratified by any effect modifiers, and repeated measures ANOVA will be used to adjust for confounders.  These 
preliminary estimations will inform refinement of the outcomes assessment battery and sample size calculations 
for a subsequent large-scale trial. 
 
Specific Aim 3: Based on data collected from Aims 1 and 2, refine and optimize the lifestyle intervention to 
prepare for a large-scale randomized controlled trial. 
 

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Our multidisciplinary team will use the triangulated quantitative and qualitative data resultant from specific aims 
1 and 2 to make important refinements necessary to improve the overall feasibility, acceptability, and efficacy of 
the intervention. We will fine tune data collection procedures as needed to ensure that participants can complete 
the assessment battery thoroughly and comfortably. Questions with excessive missing data will be re-evaluated.  
Questionnaires will be checked for internal consistency and ceiling and floor effects and will be revised 
accordingly. Aim 3 will be complete when: (a) there are no remaining questions/concerns from the investigative 
team about the ¡VMV! intervention or study procedures; (b) modifications to the intervention and study 
procedures deemed necessary have been successfully integrated; and (c) a finalized research protocol has been 
produced. 
 
 
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