Adaptation and Evaluation of an Online and eHealth Diet and Physical Activity Program to Improve Cardiometabolic Health in Rural Latino Adults "Mi Vida Saludable en el Valle"
Phase: NA
Conditions: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Sponsor: Fred Hutchinson Cancer Center

  
FRED HUTCHINSON CANCER RESEARCH CENTER  
Current version: 10/18/2021 
 
 Version        1 
        7/24/2019 
 Version        2 
        2/27/2020 
 Version        3 
        09/10/2020 
 Version        4 
        04/20/2021 
Version         5 
09/21/2021 
Version         6 
10/18/2021 
  
  
Title of Protocol:  
Adaptation and Evaluation of an Online and eHealth Diet and Physical Activity Program to Improve 
Cardiometabolic Health in Rural Latino Adults “Mi Vida Saludable en el Valle” 
  
 
Investigator List:  
Rachel Ceballos, PhD  
Associate Professor, Fred Hutch 
(206) 667-7806  
Co-Investigators:  
Heather Greenlee, ND, PhD 
Associate Professor, Fred Hutch 
(206) 667-4502  
Biostatistician:  
Katherine Guthrie, PhD  
Professor, Fred Hutch 
(206) 667-5595  
 
SPONSOR:  CCSG Pilot Funds (May 1, 201 9 - December 31, 2021)  
   
Additional Performance Sites:  
Site  
Investigator  
Phone Number  
Center for Community Health Promotion    Rachel Ceballos, PhD  
(206) 667-7806  
 
Emergency (24-hour) phone number: office (206) 667-7806, mobile (206) 529-7039 
  
  
 

 
2
PROTOCOL SYNOPSIS  
Protocol Title  
Adaptation and Evaluation of an In‐person and eHealth Diet and Physical Activity 
Program to Improve Cardiometabolic Health in Rural Latino Adults “Mi Vida 
Saludable en el Valle” 
Protocol Number  
 RG1005660 
Protocol Sponsor  
 CCSG 
Trial Phase  
 Phase 2 
Trial Type  
 Pilot RCT 
Clinical Indication  
 Latino adults with history of hypertension, diabetes, cardiovascular disease, 
cancer, or obesity 
Study Objectives  
Aim 1 
Assess feasibility of a remotely delivered and remotely assessed online group 
sessions and eHealth communication intervention strategies as measured by 
quantitative (accrual rate, intervention adherence, study retention, percent data 
collection processes completed, duration of staff assistance to complete data 
collection) and qualitative (exit interviews) data. Feasibility of intervention delivery 
for staff within the rural community context will be assessed and necessary 
adaptations from the urban intervention delivery process will be documented.   
 
Aim 2 
Examine changes from baseline to 3 months in nutrition and physical activity 
knowledge and preferences, and changes in physical activity patterns as assessed 
via Fitbit data.   
Study Design  
 Feasibility study  
Population  
Latino residents of the Lower Yakima Valley with a history of hypertension, 
diabetes, cardiovascular disease, cancer, and/or obesity. 
Primary Endpoints  
 Accrual rate, intervention adherence, study retention, data completion rates, 
assessability/acceptability (exit interview) and required intervention delivery 
adaptations. 
Secondary Endpoints  
Changes in nutrition and physical activity knowledge and preferences from baseline 
to 3 months. 
Changes in physical activity patterns as assessed via Fitbit data. 
Type of control  
 N/A  
Treatment Groups   
Single-arm 
Treatment Schedule  
Participants will attend six 2-hour virtual nutrition and PA education sessions that 
include cooking and physical activity (i.e., dance class, walking in place). 
Participants will then receive 12 weeks of motivational text messages 4 times per 
week and link to access the nutrition cookforyourlife.org website. eHealth 
communication messaging will focus on increasing knowledge on the benefits of 
healthy nutrition, reducing intakes of energy dense and processed foods, and 
increasing  physical activity. 
Number of trial subjects  
 N=25 
Estimated duration of trial  
 6 months 
Duration of Participation  
 3-4 months 
  
   
  
ABBREVIATIONS  
 CHE 
 Community Health Educator 

 
3
 CCHP 
 Center for Community Health Promotion 
IPAQ 
International Physical Activity Questionnaire 
  
  
Contents 
1.0 GENERAL INFORMATION ....................................................................................................................................... 5 
1.1 
Protocol Title .............................................................................................................................................. 7 
1.2 
Sponsor Information .................................................................................................................................. 7 
1.3  
Investigator Information ............................................................................................................................ 7 
2.0 INTRODUCTION TO THE PROTOCOL ...................................................................................................................... 7 
2.1 Introduction  ...................................................................................................................................................... 7 
2.2 Background ........................................................................................................................................................ 8 
2.3 Risks/Benefits .................................................................................................................................................... 8 
3.0 OVERVIEW OF CLINICAL TRIAL............................................................................................................................... 8 
3.1 Study Objectives ................................................................................................................................................ 8 
3.1.1 Primary Objectives ...................................................................................................................................... 8 
3.1.2 Secondary Objectives ................................................................................................................................. 8 
3.2 Study Population ............................................................................................................................................... 8 
3.3 Study Design ...................................................................................................................................................... 9 
3.3.1 Primary Endpoints ...................................................................................................................................... 9 
3.3.2 Secondary Endpoints .................................................................................................................................. 9 
3.3.3 Exploratory Endpoints ................................................................................................................................ 9 
3.4 Study Approach ............................................................................................................................................. 9 
3.5 Estimated Accrual ........................................................................................................................................ 10 
3.6 Name of Sponsor/Funding Source:.............................................................................................................. 10 
4.0 SUBJECT ELIGIBLITY ............................................................................................................................................. 10 
4.1 Inclusion Criteria.............................................................................................................................................. 10 
4.1.1 Demographic Data .................................................................................................................................... 10 
4.1.2 Disease Related Criteria ........................................................................................................................... 10 
4.1.3 Prior/Current Therapy Criteria ................................................................................................................. 11 
4.1.4 Accessibility Criteria ................................................................................................................................. 11 
4.1.5 Clinical/Laboratory Criteria ...................................................................................................................... 11 
4.1.6 Ability to understand and the willingness to sign an online informed consent document ..................... 12 
5.0 SUBJECT REGISTRATION ...................................................................................................................................... 12 
6.0 STUDY PROCEDURES AND INTERVENTION .......................................................................................................... 12 
6.1 Informed Consent and Baseline Data Collection ............................................................................................. 13 

 
4
6.2 Intervention Overview .................................................................................................................................... 14 
6.3 Intervention Details ......................................................................................................................................... 15 
6.4 (eHealth Communication) ............................................................................................................................... 16 
6.5 Activity Monitoring .......................................................................................................................................... 16 
6.6 Retention ......................................................................................................................................................... 16 
6.7 Follow-up 3 Months Data Collection. .............................................................................................................. 17 
7.0 SUBJECT EVALUATION ......................................................................................................................................... 17 
7.1 Evaluations ...................................................................................................................................................... 17 
7.1.2 
Retention calls and data collection .......................................................... Error! Bookmark not defined. 
8.0 SUBJECT DISCONTINUATION OF ACTIVE TREATMENT- WITHDRAWL ................................................................. 17 
9.0 CONCOMITANT MEDICATIONS ............................................................................................................................ 17 
10.0 ADVERSE EVENTS ............................................................................................................................................... 17 
10.1 Adverse Event ................................................................................................................................................ 17 
10.2 Serious Adverse Event ................................................................................................................................... 18 
11.0 DATA AND SAFETY MONITORING PLAN ............................................................................................................ 18 
12.0 DATA ENTRY AND MANAGEMENT/CONFIDENTIALITY ...................................................................................... 18 
13.0 STATISTICAL CONSIDERATIONS ......................................................................................................................... 21 
13.1 Study Design .................................................................................................................................................. 21 
13.2 Primary/Secondary Endpoints/Hypotheses and Analytical Methods ........................................................... 21 
 
 
13.3 Additional Outcome Measures and Statistical Methods .............................................................................. 21 
13.4 Ethnic and Gender Distribution Chart ........................................................................................................... 22 
14.0 INVESTIGATOR OBLIGATIONS ............................................................................................................................ 22 
15.0 REFERENCES ....................................................................................................................................................... 23 
 
 
 

 
5
1.0 GENERAL INFORMATION  
  
This document is a clinical research protocol and the described study will be conducted in compliance with the 
IRB approved protocol, associated Federal regulations and all applicable IRB requirements. Pilot data collected 
from this feasibility study will support a novel R21 application to assess the efficacy of an online group sessions 
and eHealth communication intervention in a rural population of Latino adults with hypertension, diabetes, 
cardiovascular disease, cancer, and/or obesity via a  feasibility assessment. Importantly, through collaboration 
with community partners, the current and subsequent trials will build community capacity to deliver nutrition and 
PA resources to underserved rural Latino adults and to introduce innovative technology‐based intervention 
strategies not often applied in rural Latino communities.  
 
Testing scalable intervention strategies for uptake of nutrition and PA recommendations as a new treatment 
model to improve cardiometabolic health with potential for broad dissemination among Latinos living in a 
rural community. This feasibility study will generate preliminary data needed to design a novel R21 proposal for 
a larger trial with long-term outcomes in a broad population of Latino adults living in a rural setting. We will 
leverage the Fred Hutch capacity and resources to provide rural adult Latinos with tools beyond brochures and 
single visit referrals to clinicians to discuss lifestyle modifications. This work has the potential to identify a 
scalable and cost-effective intervention targeting multiple lifestyle behaviors to be disseminated in clinical and 
community settings.  
 
Building collaborations and new research opportunities. The proposed project maximizes strengths of 2 Fred 
Hutch Public Health Sciences investigators, Drs. Rachel Ceballos and Heather Greenlee, in a new collaboration 
and new research directions. Dr. Ceballos brings to the collaboration experience in community-based 
participatory research (CBPR) in rural Latino communities and Dr. Greenlee provides her expertise in behavioral 
nutrition and PA interventions among cancer survivors. This new collaborative project provides an opportunity 
for Dr. Greenlee to expand her research into rural Latino communities and Dr. Ceballos to gain experience in the 
fields of nutrition and PA intervention delivery, which sets the stage for future grant applications. Through 
current request of applications (RFAs), the National Cancer Institute (NCI)’s Division of Cancer Control and 
Population Sciences is currently highlighting and prioritizing the needs of rural communities, racial/ethnic 
populations, and obesity-related cancer prevention and control. Achieving the proposed project’s specific aims 
will provide important pilot data on intervention adaptation, feasibility assessment, and preliminary 
effectiveness data needed to support a larger R01 grant application. 
 
Community partnerships and capacity building. This project will develop new community collaborations among 
Latinos in the Lower Yakima Valley by adapting and developing the Mi Vida Saludable en el Valle intervention 
through partner feedback and interaction. Based on participant input, the intervention will be tailored to the 
unique nature and needs of this rural population with the goal of achieving a more effective intervention. 
Community partners will contribute to the delivery of the intervention by providing space and resources. 
Community partners, along with our Community Action Board (CAB), will receive information about data 
collection, research methods, and contribute to data interpretation and next steps towards an R21 application. 
These community partnerships contribute to the community’s ability to evaluate and build capacity for future 
behavioral programs. A local chef and local community health educator will receive rigorous training to deliver 
the online group class intervention, which will ensure education and skills specific to nutrition and PA for rural 
Latinos remain in the community. 
 
eHealth communication as a new strategy for nutrition and PA change in rural Latinos. The use of technology 
in behavioral interventions is proving to be a cost-effective way to deliver targeted nutrition and PA education to 
promote behavior change. Electronic (e) technology has been effective in many types of health interventions, 

 
6
including smoking cessation1 and diabetes management2, among others.3-5  Studies suggest that when possible, 
participants should be offered multiple modes of theory-based e-communication to allow flexibility.6,7 However, 
there are limited data on the use of eHealth communication to achieve and maintain behavior change among 
Latino adults. 
 
As part of the eHealth communication intervention, participants will receive weekly educational and 
motivational text messaging, and links to electronic (e) newsletters and a nutritional website. Dr. Greenlee has 
collaborated with the non‐profit Cook for Your Life for the past decade on NCI funded R21 and R01 trials. The 
study will make use of the bilingual Cookforyourlife.org website, now owned by Fred Hutch, which is tailored to 
cancer survivors and is available in English and Spanish.7, 8 The website offers free nutrition and healthy cooking 
information, recipes, and cooking videos and disseminates scientifically supported information on nutrition and 
cancer survivorship.  For the proposed trial, password-gated study specific pages will be created to provide 
resources addressing cancer, cardiovascular disease, diabetes and obesity. 
 
Note about modifications due to the COVID-19 pandemic:  On March 5, 2020, the Mi Vida Saludable en el Valle 
(My Healthy Life in the Valley) study among Latino cancer survivors was suspended due to the COVID-19 
pandemic.  Consenting for this study had not yet begun, but some recruitment activities had occurred, and 
interested individuals had provided their contact information to study staff. After consultation with IRO, these 
individuals were contacted and informed that the in-person intervention would be delayed due to public health 
related risk and that all consenting, and baseline data collection activities would be stopped immediately 
effective March 13, 2020. The intervention involved in-person group sessions with classroom education, 
cooking/eating, and exercise. Due to the foreseeable COVID-19-related risks of bringing immunosuppressed 
cancer survivors together for group activities, we have adapted our intervention and data collection activities to 
be delivered remotely. The trial has been a modified to test an intervention that is remotely delivered and 
remotely assessed so that no part of the study or data collection procedures occur in groups or onsite at the 
Fred Hutch Center for Community Health Promotion office in Sunnyside, WA.  
 
Although recruitment activities were able to resume under the modified, remote protocol and many recruitment 
methods were used, our staff were unable to enroll a significant number of Latino cancer survivors. In February 
2021, Drs Ceballos and Greenlee reviewed the study and decided to expand the eligibility criteria to include 
Latinos with other conditions and chronic illnesses for which nutrition and PA lifestyle changes are 
recommended.35-36 This expanded the eligible population to include Latinos with hypertension, diabetes, 
cardiovascular disease, obesity, as well as Latino cancer survivors. 
 
Modifications included modifications to the two arms of the study. The study was to use a high dose vs. low 
dose model for the study arms. The high dose arm would receive 6 virtual PA and nutrition classes every other 
week for 3 months. The low dose arm would receive 1 PA and nutrition class at the beginning of the intervention 
period. Both arms would have received the same set of eHealth materials including text message reminders and 
access to the Cook for Your Life website.  
 
In October 2021, investigation into the reason for slow recruitment (n=22 to date) revealed a high burden of 
data collection for potential participants.  In addition, preliminary analyses of data currently being collected by 
Dr. Greenlee in a similar intervention among a predominantly non-Hispanic white population of urban breast 
cancer survivors suggested a minimal effect of the low dose arm.  As such, Drs. Greenlee and Ceballos decided 
to adapt the study as follows: change the design to be a single-arm feasibility study in which all participants 
receive the full “high-dose” intervention, decrease the target recruitment goal, and decrease participant burden 
by removing intensive data collection methods.  These modifications will yield valuable information to 
determine how best to proceed with future diet and physical activity behavioral interventions in this rural 
population. 
 

 
7
Overview of Study Design. The proposed pilot study will recruit 25 Latinos who are residents of the rural Lower 
Yakima Valley (LYV) with one or more of the following diagnoses based upon self-report: hypertension, diabetes, 
cardiovascular disease, obesity, or a history of cancer. Recruitment, retention, and data collection procedures 
will be carried out by Community Health Educator (CHE) study staff. Eligible participants will undergo online 
baseline assessments over a period of 1-2 weeks. Interested and eligible participants will be sent an online 
informed consent, HIPPA and medical records release form and baseline questionnaires to complete.  
 
Following the completion of baseline data collection, participants will receive the intervention. All participants 
will receive a Fitbit device to self-monitor their PA. The intervention will include 6 biweekly 2-hour Zoom-based 
nutrition, culinary, and physical activity sessions. The sessions will be led by a local chef consultant and CHE, 
both trained by the study team. Participants will receive eHealth communication meant to motivate healthy diet 
and improved PA via educational and motivating text messages and using resources available as part of the 
study-related website over a 3-month period. Following completion of the 3-month intervention period, 
repeated baseline at-home assessments will take place and an exit intervention completed.  The exit interview 
will include questions regarding acceptability and accessibility of the intervention for participants.  
 
1.1 
Protocol Title 
Adaptation and Evaluation of an eHealth Diet and Physical Activity Program to Improve Cardiometabolic 
Health in Rural Latino Adults “Mi Vida Saludable en el Valle” 
1.2 
Sponsor Information 
CCSG Pilot Funds (May 1, 2019 – December 31, 2021)   
1.3  
Investigator Information  
 
Rachel Ceballos, PhD, office, (206) 667-7806, mobile (206) 529-7039 
Email: rceballo@fredhutch.org  
  
2.0 INTRODUCTION TO THE PROTOCOL  
  
2.1 Introduction  
The American Cancer Society and the American Institute for Cancer Research recommend cancer survivors to 
consume high‐quality diets (i.e., diets high in fruits, vegetables, and whole gains, and low in energy‐dense and 
processed foods) and to engage in ≥150 minutes per week of moderate‐to‐vigorous physical activity (MVPA).1, 2 
The American Heart Association and American Diabetes Association have similar recommendations to promote 
cardiovascular health and improve the prevention or management of diabetes.35-36  
 
The rationale for these recommendations is to reduce disease recurrence risk, improve disease survival rates, 
and reduce comorbid conditions.3 For Latinos living in rural medically underserved regions, meeting these 
recommendations is hindered due to limited resource availability and sociocultural barriers (linguistic, beliefs). 
These barriers contribute to poor diet quality, low physical activity (PA), disproportionately high risk of chronic 
diseases, and poor cancer‐related outcomes, compared to non‐Latino Whites.4, 5 To address these disparities, 
innovative approaches utilizing effective technologies, culturally appropriate education, and skill building are 
needed to lay the groundwork for scalable and sustainable interventions. 
  

 
8
2.2 Background  
Dr. Heather Greenlee has developed and demonstrated feasibility and effectiveness of theory‐based multi‐
strategy (in‐person group and electronic e-health communication) interventions to improve nutrition and PA 
among urban Latino (primarily Dominican and Puerto Rican) cancer survivors (R21CA152903; R01CA186080).6‐8 
In collaboration with Dr. Rachel Ceballos and her community partners in Yakima County, WA, the proposed pilot 
project will adapt Dr. Greenlee’s existing Mi Vida Saludable (My Healthy Life) intervention to address the 
sociocultural (cultural, infrastructural, and logistical) needs of rural‐dwelling, primarily Mexican‐American, Latino 
adults with a history of hypertension, diabetes, cardiovascular disease, cancer, or obesity and test the feasibility 
of the adapted intervention. Latino adults with hypertension, diabetes, cardiovascular disease, obesity, and/or a 
history of cancer (n=25) who live in Yakima County’s agricultural region known as the Lower Yakima Valley will 
be recruited. Participants will receive a high dose intervention delivery.  
 
2.3 Risks/Benefits  
There are few potential risks that may occur to participants. There may be some discomfort in completing 
questionnaires about cancer and other diseases, but staff are trained to be aware of such discomfort and are 
trained to be compassionate to individuals answering such questions. Research related injuries are highly 
unlikely due to the low risk nature of this study; however, there is a risk of unintentional injuries that may occur 
while cooking, dancing or participating in exercises as promoted via online sessions. Participants will be asked to 
increase their physical activity during the 3 months of the study. This increased physical activity may cause 
unintentional soreness, joint pain or exercise related injuries. Recommended dietary changes may include gas 
and bloating due to increased fiber consumption. The timing and frequency of the online sessions and data 
collection at baseline and 3 months may provide an inconvenience to participants’ schedules. 
 
Participants will receive up to $50 in compensation in the form of a gift card to a local vendor. Since the in-
person session are to be delivered via online Zoom videos, we are also providing participants randomized to 
receiving the online sessions with a grocery bags with an estimated cost of $25 or less per sessions for total of 
$150 in groceries per participant to cover all six sessions or one session. Aside from the gift card and grocery 
bags and gaining new knowledge about ways in which participants can decrease their risk of cancer 
reoccurrence by being physically active and consuming a diet high in fruits and vegetables and low in fat and 
added sugar, there are no other direct benefits of this research to a given study participant. The data from the 
study will be used to direct future intervention efforts targeting similar populations.  
  
3.0 OVERVIEW OF CLINICAL TRIAL  
  
3.1 Study Objectives  
This feasibility study aims to assess assessibility, acceptability, adherence, retention, data collection rates, and 
required adaptations of an online and eHealth intervention as well as to assess changes from baseline to 3 
months in food knowledge and health-related physical activity. 
3.1.1 Primary Objectives  
Assess feasibility of online group sessions and eHealth intervention strategies.  
3.1.2 Secondary Objectives   
Assess changes from baseline to 3 months in nutrition and physical activity knowledge and 
preferences 
Assess changes in physical activity patterns as assessed via Fitbit data 
 
3.2 Study Population  

 
9
Our aim is to enroll 25 adult Latinos in the Lower Yakima Valley. Participants must have one or more of the 
following: hypertension, diabetes, cardiovascular disease, past cancer diagnosis, or obesity. We will recruit 
with the assistance of our Community Health Educator (CHE) staff who work at the Fred Hutch satellite site, the 
Center for Community Health Promotion (CCHP) in Sunnyside, WA. 
3.3 Study Design  
This is a single arm feasibility study to assess a culturally tailored eHealth diet and physical activity program for 
rural Latino adults with a history of hypertension, diabetes, cardiovascular disease, cancer, and/or obesity in the 
Lower Yakima Valley. 
3.3.1 Primary Endpoints  
Accrual rate, adherence (online sessions attendance in intervention arm, text message 
responses, and use of website), retention (completion of all study assessments), and 
acceptability (exit interview).  Feasibility of intervention delivery for staff within in the 
rural community context will also be assessed and necessary adaptations from the urban 
intervention delivery process will be documented.  
3.3.2 Secondary Endpoints 
Changes from baseline to 3 months in nutrition and physical activity knowledge and 
preferences 
Changes from baseline to 3 months in physical activity patterns as assessed via Fitbit data 
3.3.3 Exploratory Endpoints 
Changes in self-reported weight, mediators of behavior change, and patient‐reported 
psychosocial/quality of life outcomes. 
3.4 Study Approach 
Behavioral Framework. Intervention educational and motivational content for the study will be based on Social 
Cognitive Theory (SCT) and Self Determination Theory (SDT), which targets specific behavioral constructs (i.e., 
knowledge, self‐efficacy, barriers and motivators).14 These behavioral theories provide a comprehensive 
framework to identify behavioral strategies to increase patients’ intrinsic motivation, confidence in their 
abilities, and expectations about improvements in their health. 8-11  This combined framework can provide 
relevant targets to build supportive environments to foster motivation, confidence, and outcome expectations 
in nutrition and PA behavioral interventions for Latino adults.10,11 
SCT explains confidence in one’s capability to change a behavior (i.e., self-efficacy) and expectations around 
engaging in a behavior.12 A limitation of using SCT alone is that it does not fully address two key constructs: 
intrinsic motivation and the environment, which are important for initiating and sustaining behaviors.10,11 Self-
Determination Theory (SDT) incorporates these two constructs into a broad motivational theory to explain why 
and how individuals behave.10,11 Intrinsic motivation is a desire to engage in an activity to achieve an internal 
sense of reward, satisfaction, or enjoyment. Individuals feel intrinsically motivated by being able to engage in 
challenging, achievable activities (i.e., competence) and being able to make their own choices about their 
behaviors (i.e., autonomy). To achieve this internal sense of satisfaction, improve confidence and achieve 
expectations, an autonomy-supportive environment provided by educators or eHealth communication can help 
an individual make better dietary and PA choices to improve health and reach their goals. 
 
Behavioral Targets. All participants will be advised on nutrition and PA goals: 1) progressively adhering to high‐
quality diets by increasing intakes of fruits, vegetables and whole grains; and decreasing intake of energy‐
dense, nutrient‐poor foods (i.e., processed foods, refined grains and added sugars), and 2) progressively 
reaching an optimal target of ≥150 minutes per week of MVPA.  
 
Setting. The study will take place in the Lower Valley of Washington State’s Yakima County. Yakima is the 
second largest county in the state by size and largely agricultural.13 The Lower Valley region of the county 
includes the highest concentration of Latinos (69%) in Washington state, the majority of which are 1st and 
2nd generation Mexican-Americans.14 The region is characterized by high poverty levels, with 21% of the 

 
10
population living below the poverty line, compared to 13% nationally.15 The Community Need Index (CNI), 
which identifies the severity of health disparities for every U.S. zip code, ranks the LYV’s zip codes from 4.2 
to 5.0 where 5.0 is the highest level of severity of health disparities.16 Our previous research shows up to 
70% of adult Latinos in the Lower Valley have less than an 8th grade education.17,18  
 
Community Health Educators (CHEs). Our CHEs (promotores) are male and female Latino bilingual and bi-
cultural community members, trained to deliver health education, in qualitative and quantitative research 
methods, and have worked in the target community for 5-15 years.19-22 For the purpose of this study, key 
functions of the CHEs include: participant recruitment, assisting during intervention activities, 
documenting implementation process, and/or coordinating and supporting data collection. As members 
of the community they serve, the CHEs are familiar and connected with their community thereby 
enhancing cultural competency of the research methods and the participants’ level of comfort and trust 
with intervention delivery. They also serve as community stakeholders empowered to advocate for 
community health interests. All CHEs are required to complete and maintain human subjects, information 
privacy, and confidentiality certification.  
 
Consultant.  One community collaborator (trained local Chef) will participate in the delivery of the intervention. 
The collaborator has undergone 16 hours of training to ensure accurate delivery of the intervention content in 
the given timeframe. The training included human subjects’ certification, orientation to the intervention 
content, and mock intervention delivery session prior to actual intervention delivery. He is known in the 
community through the creation of online recipe videos, and has the equipment and expertise needed to deliver 
nutrition content remotely.   
 
3.5 Estimated Accrual 
Based on previous studies with Latino cancer survivors in Yakima Valley, we expect target enrollment of 
up to 25 participants. The 25 participants will be recruited using methods successfully utilized by Dr. 
Ceballos to recruit Latino adults who meet the study eligibility criteria in the Lower Yakima Valley: 1) print 
and radio advertisements by bilingual/bicultural research staff at local retailers, community events, 
churches, and medical facilities, 2) through social media, and 3) mailing flyers to participants of previous 
studies that provided prior consent to contact.10 For individuals who provided prior consent to contact, if 
there is no response from the potential participant within 1-week of mailing, the CHE will follow-up with 1 
phone call to determine interest. CHEs will screen all interested participants via telephone. The eligibility 
screener is provided in Appendix A.  
 
3.6 Name of Sponsor/Funding Source: CCSG Pilot Funds 
  
4.0 SUBJECT ELIGIBLITY  
  
4.1 Inclusion Criteria   
 4.1.1 Demographic Data  
• 
Participants must self-identify as being at least 18 years of age or older. 
• 
Participants must self-identify as Latino.  
• 
Participants must be a resident of the Lower Yakima Valley (LYV) and anticipate remaining in the LYV for 
at least 1 year.  
• 
Participants must speak Spanish or English and fully understand Spanish for online group sessions. 
 
4.1.2 Disease Related Criteria 
 
Participants must meet one of the following disease-related criteria: 

 
11
 
Hypertension 
• 
Participants must self-identify as having a medical history of hypertension  
 
Diabetes 
• 
Participants must self-identify as having a medical history of diabetes  
 
 
Cardiovascular Disease 
• 
Participants must self-identify as having a medical history of cardiovascular disease  
 
Obesity 
• 
Participants must self-identify as having a medical history of obesity, as defined by a BMI of >30 kg/m2  
 
Cancer 
• 
Participants must self-identify as having a medical history of cancer (excluding non‐melanoma skin 
cancer). All other cancer types will be included provided;  
• 
there is no evidence of recurrent or metastatic disease; and 
• 
the patient has not received a bone marrow, stem cell, or cord blood transplant 
  
4.1.3 Prior/Current Therapy Criteria 
• 
For cancer survivors, participants must self-identify as being at least 60 days post final chemotherapy, 
biologic therapy, or radiation therapy treatment and/or surgery. Current use of hormonal therapy is 
permitted (e.g., tamoxifen and aromatase inhibitors). 
 
4.1.4 Accessibility Criteria  
• 
Participants must be willing and able to receive text messages via cellphone for 3-6 months. 
• 
Participants must be willing and able to attend six 120-minute online group sessions. 
• 
Participants must be willing to complete the surveys, and diet/PA assessments.  
 
4.1.5 Clinical/Laboratory Criteria 
• 
Participants must not be active smokers within the past 30 days. Active smoking is defined as any 
smoking, even a puff. Participants who smoke are much less likely to engage in healthy lifestyle 
behaviors, and it is probably more important for participants to stop smoking than it is to change their 
dietary patterns. If identified as a smoker, the individual will be referred the CDC “Quit Now” phone line 
which supports smoking cessation, or the NIH quite support website “SmokeFree.gov which are both 
available in English and Spanish.  
• 
Participants who report having been told by a health professional they have diabetes or cardiovascular 
disease must provide a clearance from their physician for participation (See Appendix B for Medical 
Release Form). 
• 
Participants must consume <5 servings of fruits and vegetables per day and/or engage in <150 minutes 
per week of moderate to vigorous physical activity, as assessed by brief questionnaires.23,24 
• 
Participants must have an ECOG Scale of Performance Status Score of 0 or 1 for performance status 
(Appendix C). These scales and criteria are commonly used by doctors and trained research staff to assess 
a person’s daily living abilities. Scores of 0 and 1 corresponds to being fully active, able to carry on all pre-

 
12
disease performance without restriction; and restricted in physically strenuous activity but ambulatory 
and able to carry our work of a light or sedentary nature, respectively.  
• 
Women must not be pregnant at time of enrollment.  
 
4.1.6 Ability to understand and the willingness to sign an online informed consent document  
• 
Depending on preference, the consent will be provided in English or Spanish. 
 
 
5.0 SUBJECT REGISTRATION  
  
Eligible participants will be identified by the Center for Community Health Promotion Study Staff who will 
register the patient by contacting the Fred Hutch Study Coordinator who will enter their information into the 
secure REDCap database. A complete, electronically signed, study consent and HIPAA consent are required for 
registration. 
  
6.0 STUDY PROCEDURES AND INTERVENTION  
  
 
Figure 1. Study Flow Chart  
 
 
 
Table 1.  Data Collection Overview 
MEASURE 
Screening 
Baseline 
Follow-up 
T1 
T2 
Eligibility criteria 
X 
 
 
At-home assessments: 
 
 
 
Demographic and clinical characteristics 
 
X 
 
Self-reported weight 
 
X 
X 
Dietary Intake and PA measures: 
 
 
 
Social and Behavioral measures: 
 
 
 

 
13
Physical Activity Questionnaire 
 
X 
X 
Psychosocial/Quality of Life Outcomes 
 
X 
X 
Nutrition and physical activity knowledge and 
preferences 
 
X 
X 
Exit Interviews on intervention acceptability 
 
 
X 
 
6.1 Informed Consent and Baseline Data Collection 
Informed Consent. Prior to any baseline data collection, CHEs will orient participants to the study activities, 
rights and responsibilities and will provide electronic informed consent via a HIPPA-complaint and secured 
REDCap electronic form (eConsenting) for participation in the intervention program and data collection 
procedures, including the release of medical records regarding diagnosis and treatment for condition identified 
for study eligibility. Research staff will review the study in detail and outline participant involvement during the 
screening process over the phone. Research staff will discuss the consent process with the potential participant 
prior to providing consent online. All items in the informed consent will be discussed, including why the study is 
being conducted, the number of people participating, what is involved in the study, how long the participant will 
be in the study, the risks and benefits of the study, alternatives to participation, confidentiality, rights as a 
participant, and who to call with questions or concerns. Participants will be encouraged to contact research staff 
any time they have concerns or questions about the study. Each consent is implemented in REDCap using the 
survey functionality. The survey functionality presents the pages of the traditional paper consent, including the 
IRB stamp, to a potential research subject, then uses REDCap to present the questions and signature fields that 
appear on the paper consent. Once an individual agrees to participate, electronically signs the informed 
consent, then hits submit, a PDF of the completed consent can be automatically generated and saved to a 
REDCap form to preserve the exact consent text along with the research subject’s responses. Informed consents 
will be provided in Spanish and English, depending on participant’s preference. To make this less burdensome, 
we will collect their doctor/medical institution information as part of the medical release form and our staff can 
directly contact their doctors to acquire their clearance, when needed. See Appendix B for the consent and 
medical release form in English—provided in English for initial IRB approval and will be subsequently translated 
in Spanish.  
Baseline Data Collection. Eligible participants will undergo remote baseline assessments that will include at-
home, over the phone and web-based data collection and a “run-in” within an 8-week period prior to the start 
of the intervention (see Figure 1). Reasons for the run-in period include opportunities to: 1) assess participant’s 
ability to complete trial assessments, 2) facilitate building of a rapport between the CHE and participant, and 3) 
ensure CHEs have the time needed to provide participants with proper orientation to the project and 
assistance completing surveys and study assessments. Because this pilot project will assess feasibility, this 
information is essential to determine acceptability of the project protocol.  
All data collection materials will be provided to participants in Spanish or English based on the participants 
preferred language. For participants with low literacy, the CHEs are trained to assist in completing surveys 
without leading responses. Demographic, clinical characteristics, mediators of behavior change within domains 
framed within SCT and SDT, psychosocial and quality of life outcomes, stress, and acculturation will be assessed 
at T1.  Details regarding data collection methods for these outcomes can be found in Table 4. Measurement 
Tools, Data Collection Timing, and Timing of Intervention Activities (Appendix D). Baseline survey materials are 
found in Appendix E.  
The baseline data collection will include completion of an electronic (e) eConsent form via a secure HIPPA-
complaint REDCap interphase and the following assessments: 1) online self-administered questionnaires 

 
14
assessing demographics, medical history, clinical characteristics and self-reported height and weight; mediators 
of behavior change; and patient-reported psychosocial and quality of life (QOL) outcomes.  
Intervention. The intervention includes six 120-minute online sessions. The participants will have access to text 
messages, electronic newsletters and access to interactive nutrition website. Participants will be notified of 
intervention start date via a phone call from the project coordinator. This will be followed by a mailed start-up 
study package that will include: 1) Fitbit device with detailed instructions on how to pair smartphone and sync 
data, 2) study activities schedule, 3) detailed instruction on how to set-up Zoom in their computers and access 
online sessions, and 4) study binder with written materials to be used during the online sessions. Study staff will 
call participants one week after receiving the start-up study package to review the materials together and 
answer any questions. 
 
6.2 Intervention Overview  
All participants will be assigned the goal of improving diet quality and engaging in ≥150 minutes per week of 
moderate-to-vigorous physical activity. The intervention will be based on an integrated social cognitive theory 
(SCT) and self-determination theory (SDT) theoretical framework to promote uptake of recommendations and 
target specific behavioral constructs (i.e., awareness, knowledge, self-efficacy, motivation, taste preferences, 
goal action planning, outcome expectations, autonomy-supportive environments).25-27  
 
Remotely delivered online group sessions via Zoom video calls (Intervention Group). All online sessions will be 
held in Spanish. Resource materials and survey data will be available in both English and Spanish. The 
intervention will be delivered according to an intervention-specific curriculum that have been adapted to be 
delivered online28, as we have done previously. 
 
At least two days prior to each session CHEs will make reminder calls and send email or text messages to each 
study participant, depending on their preference, in order to keep attendance at sessions high and attrition low. 
Participants will also have the ability to contact the study coordinator via text, cell phone, office phone or email, 
whichever participants prefer, for any issues related to the study.  
 
Class content: Each 120-minute session will include the following components: 1) classroom education on 
nutrition and PA, 2) exercise training/PA classes; 3) hands-on skills-building cooking; and 4) sharing a meal 
prepared by the group. Behavioral framework: Each activity will target specific behavioral constructs based on 
SCT and SDT theoretical framework: 1) classroom education (awareness, knowledge, autonomy-supportive 
environment); and 2) hands-on skills-building cooking and PA classes (self-efficacy, motivation, autonomy 
supportive environment); and 3) sharing a meal (taste preferences, goal action planning, and outcome 
expectations).  
 
Timing and location: Classes will be held every other week via Zoom video calls. Participants will be provided 
with instructions on how to install Zoom and join Zoom video calls. Zoom video links will be sent to participants 
at least 24 hours prior each class via email or text, depending on participants preference. Zoom video calls will 
be recorded. Participants will receive a link to the recorded sessions. This will allow participants to watch it the 
session at a later and more convenient time. 
 
Resources for cooking component of online sessions: All participants (n=25) will be provided with a grocery bag 
with the ingredients needed to participate in the hands-on cooking portion of the online sessions. Study staff 
will arrange the purchasing of the ingredients and will offer participants with the option to pick up the grocery 
bag at a convenient local grocery store or to have it delivery to participants homes either via Instacart or similar 
delivery service and/or by study staff, if needed. The total cost of each grocery bag is estimated at $25 or less 
per session for a recipe to serve 4 or more. The ingredients provided will be based on each menu to be 
demonstrated by the trained Chef so participants can prepare the meals themselves at home. Once the grocery 

 
15
bags are ready for pick-up or delivery, depending on participants preference, study staff will send a friendly 
reminder to participants and will help coordinate as needed.  
 
Fidelity of the online group-based intervention will be assessed by an objective process evaluator, who will 
attend all sessions and observe and take detailed notes on the timing of the activities and delivery according to 
protocol. This person will not have any interaction with study participants and will not participate in data 
collection or study activities implementation. 
 
6.3 Intervention Details 
• 
Arm A (High Dose): Online Sessions 1 to 6: The nutrition and physical activity educator leads the classroom 
education part of the session (refer to table 2 for detail on topics). Participants first receive nutrition 
education related to increasing intakes of fruits, vegetables and whole grains; and decreasing intake of 
energy‐dense, nutrient‐poor foods (i.e., processed foods, refined grains and added sugars) via PowerPoint 
slides. Physical Activity. Participants then discuss being physically active in the home, review the importance 
of using their Fitbit device as a self-monitoring tool (technical Fitbit issues are directed to study staff after 
class time), and are encouraged to engage in the exercises (stretching, Zumba dance class, aerobic exercises) 
during the presentation tracking steps. Cooking. Participants then receive hands-on cooking classes led by 
the Chef and get to participate in the preparation of a meal. Finally, all participants virtually share the meal 
they themselves prepared at their homes with the nutrition educator and other study participants while 
discussing lessons learned and setting goals for the next week as prompted by the nutrition and physical 
activity educator. 
Table 2: Online group intervention schedule and topics for high dose  
Class 
Classroom Education Topic 
Hands‐on Skills‐building Cooking and Physical 
Activity Classes & related activities 
Sharing a Meal 
1 
Nutrition and Activity Guidelines, 
Increasing Fruits and Vegetables; 
Introduction to aerobic exercise, 
using the Fitbit 
Cooking: Intro to a Healthy Kitchen 
Physical Activity: Intro to Aerobic Exercise + Using 
the Fitbit to Track Exercise  
 
Share meal, 
discuss barriers 
and facilitators, 
goal setting 
activity 
2 
Reading Labels, Reducing Sugar 
and Finding Hidden Sugar; How to 
plan for Success 
Cooking: Using Whole Ingredients and No Added 
Sugars 
Physical Activity: Planning exercise  
3 
Healthy Fats & Proteins; Using the 
environment as your gym 
Cooking: Cooking with Healthy Fats, Plant and 
Animal Protein 
Physical Activity: Outdoor physical activity  
4 
Grocery Shopping; Learning When 
and How to Properly Stretch with 
Stretching Activity at End of 
Session  
Cooking: Adapting Flavor to Preference  
Physical Activity: Optimal Stretching  
5 
Carbohydrates, serving sizes, meal 
preparation and planning; ASCM 
New Guidelines, Tips and Tricks 
for exercising at home, injury 
prevention 
Cooking: Healthy Carbohydrates Choices 
Physical Activity: Exercise for Injury Prevention  
6 
Eating, Moving and Cooking for a 
Healthy Future; How to maintain 
physical activity as a lifestyle and 
community and online resources.  
Cooking:  
Physical Activity: Community and Online Resources  
  

 
16
 
 
6.4 eHealth Communication  
Electronic (e) Health (eHealth) communication materials are found in Appendix G, including sample text 
messages and sample newsletters content. Seattle-based study staff oversee the eHealth component. 
Participants in both arms will receive 12 weeks of motivational text messages 2-3 times per week and link to 
access the nutrition cookforyourlife.org website. eHealth communication messaging will focus on increasing 
fruits/vegetables intake and reducing intakes of energy dense and processed foods and increasing PA using 
constructs of the SCT and SDT. Participants will be prompted to respond on average to one of the weekly text 
messages (i.e., Think about yesterday. Did you eat 5 or more servings of fruits and vegetables?) Study staff will 
respond to participants as needed if any specific questions arise. The eHealth text topics and schedule are 
presented in Table 3. 
 
Table 3: eHealth text topics and schedule (16 texts per month) 
Target behavioral construct 
Nutrition texts (50%) 
Physical activity texts (50%) 
Skill‐building 
2/month 
2/month 
Goal‐setting 
2/month 
2/month 
Motivation 
1/month 
1/month 
Knowledge 
1/month 
1/month 
 
6.5 Activity Monitoring  
All participants will use both devices: participants will wear Fitbit Inspire on the wrist. Participants do not have 
to wear Fitbit during sleep. The wearing time of each device is outlined below. 
Device 
Duration  
Fitbit Inspire 
Baseline to 3 months follow-up data collection, on wrist 
 
Participants will be trained to monitor their step count on smartphone and Fitbit. Participants should perform 
activity monitoring by checking the step counts by looking at the screen of their Fitbit Inspire and the Apple 
Health/Google Fit app. The purpose is to make participants aware of their activity level throughout the day. 
Participants are not required to change their usual activities according to the step count but are encouraged to 
progressively achieve ≥150 minutes per week of MVPA as displayed by the Fitbit physical activity tracker. 
Participants will receive monthly check-in calls, texts and/or emails to inquire about device usage and 
troubleshooting.  
 
6.6 Retention 
To improve retention CHEs will conduct a brief monthly follow-up telephone calls during month 2 of the 3 
months intervention to all study participants. Staff will thank participants for their continued participation in the 
study, and will ask questions about (1) COVID-19 incidence, exposure, testing, related-symptoms and whether 
they have felt isolated during the pandemic, (2) Fitbit use, and (3) will help troubleshoot any issues associated 
with Fitbit devices. In month 3, participants will be encouraged to complete data assessments, as needed and 
even if participants do not completely adhere to the intervention. 
In the event that a study participant’s phone is disconnected, or if a participant stops responding to our calls or 
text messages after 4-6 attempts, study staff will mail a letter to study participants’ home address and will send 
an email message indicating that we have had trouble reaching them. We will encourage study participants to 
get in touch with us and to provide us with a new phone number so that they can be contacted to answer study 
questions by phone, and if able, complete the in-person clinic visits.    

 
17
6.7 Follow-up 3 Months Data Collection.  
At 3 months, participants will repeat baseline measures (see Table 1) and complete a short exit interview to 
assess intervention acceptability. 
 
 
 
7.0 SUBJECT EVALUATION  
  
7.1 Evaluations  
7.1.1 
Home-based Data Collection 
1) Anthropometrics will include self-reported height and weight.  
2) Nutrition and physical activity knowledge and preferences will be measured using questions adapted 
from a battery of questions developed and validated by our team (The Preferences and Self-Efficay of 
Diet and Physical Activity Behaviors Questionnaires for Latinas) (preparing manuscript for submission).  
3) Patient-reported psychosocial/Quality of Life outcomes will be measured via questionnaires assessing 
self‐ efficacy and motivation to make dietary and physical activity changes 16‐19, stress (Hispanic Stress 
Inventory)20, and quality of life (PROMIS 10).21 
 
  
7.1.2 
Retention calls and data collection 
1) During monthly retention call participants will be asked about use of and technical issues with their study 
Fitbits. These data will be recorded to understand Fitbit usage patterns. 
2) During monthly retention call, participants will be asked about COVID-19 symptoms, testing and isolation. 
These data will be used to examine the effects of the COVID-19 pandemic on intervention adherence 
patterns. 
 
 
8.0 SUBJECT DISCONTINUATION OF ACTIVE TREATMENT- WITHDRAWL 
 
Participants can discontinue participating at any time and for any reason.  
 
9.0 CONCOMITANT MEDICATIONS  
 
Participants will be asked during the Baseline 1 questionnaire about comorbidities and medication use. 
  
10.0 ADVERSE EVENTS  
  
10.1 Adverse Event   
This is a low risk study with no intervention agent.  We do encourage participants to be physically active to be 
able to capture, and compare, physical activity levels across devices.  Any adverse events will be recorded in the 
Adverse Event Summary From (Appendix I) and reported as follows. 

 
18
10.2 Serious Adverse Event   
Adverse event grading scale:  
0= No Adverse Event or within normal limits 
1= Mild Severity: Transient laboratory test alterations; discomforts noted but no disruption of daily 
activities; no therapy, or only symptomatic therapy required 
2= Moderate Severity: Laboratory test alterations indicating injury without long-term risk; discomfort 
sufficient to modify normal daily activity; specific therapy required (i.e., more than symptomatic) 
3= Serious Severity: Laboratory test indicating a serious health threat or permanent injury; incapacity, 
inability to work, inability to perform normal daily activity; hospitalization required or prolonged; emergency 
treatment required; life-threatening events; death. 
Plan for unanticipated AE reporting: All unanticipated AEs related to the study procedures that are severe or 
serious will be reported by Dr. Rachel Ceballos to the IRB within 7 days of notification of the investigator.  
Plan for anticipated AE reporting: All serious anticipated AEs related to the study procedures will be reported by 
Dr. Rachel Ceballos to the IRB within 7 days of notification of the investigator.  
Plan for ongoing review of results: The PIs will be notified within 24 hours by the research manager of any early 
terminations due to an adverse event.  
Plan for safety review: The PI will perform a cumulative review of all adverse events and premature 
terminations review every 6 months after study initiation or after completion of 50% of participant visits, 
whichever occurs first.  
Plan for annual reporting: A summary of the investigation including all adverse events and how they were 
handled, enrollment, drop-outs and reason for discontinuation and any protocol modifications will be provided 
to the IRB on an annual basis.  
Annual Reports will contain:  
a. The number of adverse events and an explanation of how each event was handled  
b. The number of complaints and how each complaint was handled  
c. The number of subject withdrawals and an explanation of why the subject withdrew or was withdrawn  
d. The number of protocol deviations and how each was handled  
The occurrence of any serious and unexpected event may prompt changes in study protocol. Any such change 
will be approved by the IRB before implementation.   
  
11.0 DATA AND SAFETY MONITORING PLAN  
 
A data safety and monitoring committee is not needed as this is not a Phase 3 clinical trial. Drs. Greenlee and 
Ceballos will oversee the data safety and monitoring for this project. They will meet with the study staff to 
discuss protocols and procedures to ensure participant safety and the validity and integrity of the study data.  All 
staff members will attend trainings on these procedures and will be given information on the importance of 
reporting any adverse event immediately. Drs. Greenlee, Ceballos and the Institutional Review Office (IRO) will 
be alerted about any adverse events immediately. Drs. Greenlee and Ceballos will discuss any adverse effects 
and examine available data to assess whether safety is compromised. Action to resolve the adverse event will be 
discussed with IRO prior to implementation. The team will enact any actions recommended by the IRO. 
 
12.0 DATA ENTRY AND MANAGEMENT/CONFIDENTIALITY  
  
Collaborative Data Services (CDS) Shared Resource. CDS will use REDCap (Research Electronic Data Capture) to 
track, collect and maintain study data. REDCap is a web-based research-centric electronic data capture system 
supported through a federally-funded consortium led by Vanderbilt University. The system is fully supported by 
CDS, which maintains the REDCap installation and provides a secure system with high reliability and availability. 
CDS will design, build, and maintain the REDCap data forms that will be used for data capture, including 

 
19
screening, participant questionnaires, and staff forms for participant tracking. CDS will provide programming 
extensions to REDCap when necessary to improve efficiency.  
 
Specific to this study, CDS will build an automated bi-directional text message interface where participants will 
report their nutrition and physical activity goals and accomplishments, and the REDCap system will send 
automated motivational responses as provided by the study team. However, CDS will not monitor participant 
responses. All bidirectional communication with participants will take place with designated Spanish-speaking 
research staff only overseen by Dr. Greenlee. CDS will also build an integrated messaging system to send 
appointment reminders via email or text messaging (based on the participant’s choice) that will be used to 
improve participant retention rates. CDS will also generate study tracking reports for staff to monitor day-to-day 
study activities. All staff have received Human Subject Research and HIPAA training. All data will be stored in a 
secure password protected computer folder, which only authorized research staff will have access to.    
 
Fitbit Data 
Fitbit PA data will be downloaded from Fitbit.com in weekly intervals up until their final follow-up visit. The data 
will reside on a server managed by the Fred Hutch IT group. Fred Hutch shared resource will develop a program 
to fetch and monitor PA data collected by Fitbit. Fitbit syncs user data through its smart phone application 
periodically and stores these data on their server. Fitbit Inc. offers an application-programming interface (API) 
for batch data access (https://dev.Fitbit .com/docs). The application is registered with Fitbit Inc., which grants a 
license to fetch data with the participants’ consent. The program will collect the following data via the Fitbit API: 
steps, distance, calories and active times. The license allows the retrieval of both interday and intraday data (at 
one-minute level) on these activities. Participant data will be combined into a single data file for analyses. To 
monitor participant activity and Fitbit use, embedded within the program there are several visualizations of 
time-series activity history, and summary statistics for each participant. The program is written in R 
programming language and can run on a personal computer or a server. It is only on Fred Hutch's secure 
computing and networking environment where data collected by Fitbit, Inc. will be linked to the participants' 
questionnaire data responses. Neither questionnaire data will not be shared with Fitbit, Inc. nor will the link 
between the Fitbit.com username and subject name be shared anyone not authorized to work on this research 
study. Dr. Greenlee research team has successfully implemented this methodology in previous studies. 
 
 
Text message management: The REDCap platform is a web-based software application that allows scientists 
to easily integrate and manage integration of SMS/text messaging into their research projects. Seattle-based 
study staff will manage and implement the REDCap platform. No personal health information will be transferred 
via the text-management system.  
 
Participant ID’s and personal telephone numbers are entered into a password protected web-based application 
(REDCap). REDCap requires strong passwords and will be accessed an encrypted (SSL) network connection only 
which is granted only to study personnel and software engineering staff that are trained in HIPAA compliance. 
Once participants are entered into the system, study personnel assign a start date and message suite to deliver 
to study participants. Participants then receive SMS messages according to the schedule defined for the 
message suite that they are assigned to (English or Spanish). 
 
Participants can respond via SMS message to received messages. All SMS messages to participants will come 
from a single study phone number. This number is rented from Twilio, Inc. (see twilio.com).  SMS messages 
originate from REDCap, which contacts Twilio’s secure servers over an encrypted connection and then Twilio 
provides the gateway service to actually send the text messages. If participants reply to messages, they go to 

 
20
Twilio and then Twilio’s servers contact our servers to deliver the message back to our web application. Twilio 
does not store any of these text messages beyond the time it takes to pass them off to our web application. 
Twilio has access only to the phone number and the message. 
 
REDCap includes functionality to notify study personnel of incoming SMS messages so that study personnel can 
then monitor and respond back to study participants via SMS message from within the web application. REDCap 
displays a conversation view of all messages per participant, both incoming and sent to the study team in a 
reverse time-based sorted order. 
 
Using the Fitbit: The Fitbit device can be worn continuously for about 6 months before requiring a new battery. 
The Fitbit can be safely worn at all times, except when bathing or swimming. Participants will be required to 
sync data with the Fitbit web-based data repository at least once a week during the study period by simply 
opening the Fitbit app on their smartphone or signing onto their computer that has the program installed. 
Adherence to this requirement will be assessed each week by the study staff by logging into an online platform 
that tracks all Fitbit activity. The platform is described more thoroughly in the Data Management plan and 
Statistical Analysis. 
 
Each participant will be assigned a de-identified anonymous user profile for Fitbit data collection. User profile 
emails will be an anonymous Gmail account that will be created for each participant by using the “+” tag in 
Gmail, in order to create multiple email accounts linked to one study account. User profile names will be 
participant’s study IDs. Note that the personal emails required for this study are only for emailing newsletters 
and not for the Fitbit user profiles. The only personal information used to create the Fitbit accounts is a 
participant’s height, weight, gender, and age. These data are essential in determining user-specific activity 
calculations, such as calories burned. Anyone who purchases the Fitbit for personal use, whether or not for 
research, would need to input this information to properly use the device. 
 
During the course of the study participants will be instructed to wear the device while awake on their wrist and 
go about their normal daily routines and to remove when sleeping. Participants will be trained to sync their 
Fitbits using a computer or smartphone. The following types of data-points, in minute and per day units, will be 
collected daily and provided at the conclusion of the study by Fitbit:  
• Number of steps walked  
• Calories burned  
• Distance walked  
• Active minutes 
 
Website: Text messages will direct study participants to the Spanish-language version of the Cook for Your Life 
website (www.cookforyourlife.org) (also available in English). Text messages will contain a unique de-identified 
URL tracking identifier and Google analytics will be used to track click through rates for each participant. The 
website will include study-specific web pages that participants will access via a unique login using their personal 
email address and a unique password. The study-specific web pages will include archived Zoom sessions, 
intervention materials, and community resources. These pages will be updated as the study progresses. 
Participants will have access to the study-specific web pages for 12 months following completion of the study. 
Participants randomized to the low dose study group will receive access to an archive of previously recorded 
sessions after completing 3-month follow-up.  
In addition, Google analytics will be used to track overall usage of the website by study participants as a group 
by directing participants to enter the site with a private homepage that is available only to participants. Using 

 
21
this method, it is not possible to track participants at an individual level, thus identifying information will not be 
collected, including IP addresses. The only extrapolation that can be made is whether or not a website user is a 
study participant based on their entry point to the site. 
 
Google analytics provides the following information that can be used as measures of: 
• 
Behavior (pages looked at, time on site, user pathways) 
• 
Acquisition (where the audience is coming from social media, Google search, newsletters or otherwise) 
• 
Conversions (goals to see if our users complete them, i.e., playing a video, downloading recipes or reading 
an article). 
• 
Note:  A HIPAA compliant server is not needed for the Cook for Your Life website because only participant 
IDs, and not PHI, will be used to track participants. 
 
Post Intervention Data Collection. At 3 months, baseline data assessments will be repeated, including 
assessments at-home, web- and telephone-based. Participants Fitbit accounts will also be changed to 
participants own personal accounts and we will not maintain record of this account information and no longer 
have access to track Fitbit activity. 
 
 
13.0 STATISTICAL CONSIDERATIONS  
  
13.1 Study Design 
This is a single-arm feasibility assessment.   
 
13.2 Primary/Secondary Endpoints/Hypotheses and Analytical Methods 
The endpoints for Aim 1, feasibility of intervention strategies, include accrual rate, adherence, retention, and 
acceptability (exit interview). Adherence will be measured by attendance to online sessions, text message 
responses, and use of the website. Retention will be measured by completion of all study assessments. 
Acceptability will be measured on a Likert scale in each of a series of questions regarding various aspects of the 
trial during the exit interview. All endpoints will be summarized using descriptive statistics. Statistical differences 
in retention rates for each study assessment between study arms will be assessed by Chi-square tests, and 
acceptability by t-test of median per-patient scores.  
Exploratory endpoints include changes in anthropometrics, mediators of behavior change, and patient‐reported 
psychosocial/quality of life outcomes. Descriptive analyses will be conducted to summarize exploratory 
outcomes.  
 
 
 
13.3 Additional Outcome Measures and Statistical Methods  
Demographic and clinical characteristics will be measured via an online questionnaire on demographics, 
comorbid conditions, medical history, and medication use (baseline only).  
Intervention feasibility will be measured by accrual, adherence (attendance to online group sessions, response 
to text messages, and use of website), acceptability of the interventions (exit interview and motivation 
interviewing educator interaction, MIMSI), quantitative data collection processes (percent completed and 
duration of staff assistance to complete surveys), and qualitative (exit interviews) data, and retention at 3 
months. MIMSI will be administered prior to the exit interview. Exit interviews will be conducted by promotoras 
and audio‐ recorded and later transcribed for analyses.  Feasibility of intervention delivery for staff within in the 

 
22
rural community context will also be assessed and necessary adaptations from the urban intervention delivery 
process will be documented.   
13.4 Ethnic and Gender Distribution Chart  
 
 
Projected Target Accrual  
ETHNIC AND GENDER DISTRIBUTION CHART  
  
TARGETED / PLANNED ENROLLMENT: Number of Subjects  
 
Ethnic Category  
 
  
Sex / Gender  
  
Females  
Males  
Total  
Hispanic or Latino  
15 
10 
 25 
Not Hispanic or Latino  
 0 
 0 
 0 
Ethnic Category Total of All Subjects*  
 15 
 10 
 25 
  
Racial Categories  
  
  
American Indian / Alaska Native  
  
  
  
Asian  
  
  
  
Native Hawaiian or Other Pacific Islander  
  
  
  
Black or African American  
  
  
  
White  
 13 
 8 
 21 
More Than One Race  
 2 
 2 
 4 
Racial Categories: Total of All Subjects*  
 15 
 10 
 25 
  
  
14.0 INVESTIGATOR OBLIGATIONS  
 
The PI is responsible for the conduct of the clinical trial at the site and is responsible for personally overseeing 
the treatment of all study subjects. The PI must assure that all study site personnel, including sub-Investigators 
and other study staff members, adhere to the study protocol and to all applicable regulations and guidelines 
regarding clinical trials both during and after study completion.  
  
All subjects are informed of the nature of the program, it’s possible hazards, and their right to withdraw at any 
time, and each subject signs a form indicating their consent to participate prior to receiving any study-related 
procedures (see Appendix B).  
  
 
 
 
 

 
23
 
 
 
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