Osage Community Supported Agriculture
Phase: NA
Conditions: Diet, Healthy, Blood Pressure, Overweight or Obesity, Food Insecurity, Health Status
Sponsor: Oklahoma State University Center for Health Sciences

Cover Page for ClinicalTrials.gov 
 
Document:  
Study Protocol 
 
Official Study Title:  
Indigenous Supported Agriculture Study (ISA) “Go Healthy” 
 
Document Date:  
April 30, 2024 

Contact PD/PI: Jernigan, Valarie Blue Bird  
Research Protocol 
Page 1 
Research Protocol 
Revised April 30th,  2024 
Title of Project: Indigenous Supported Agriculture Study (ISA) “Go Healthy” 
Principal Investigator: Valarie Blue Bird Jernigan, DrPH, MPH, Professor of Rural Health and Director of the 
Center for Indigenous Health Research and Policy at Oklahoma State University Center for Health 
Sciences 
Co-Investigators: Ying Zhang, PhD, MD, Jessica Reese, PhD, MS,  Robert Rosenman, PhD, Tvli Jacob, PhD, 
Jann Hayman, PhD, Susan B. Sisson, PhD, RDN, CHES, FACSM,  
 
1. SPECIFIC AIMS  
The proposed study will implement an agricultural and health education program in which American Indian (AI) 
residents of Osage Nation will receive a weekly share of healthy fresh fruit and vegetables for four months, 
coupled with healthy recipes and cooking materials. These types of programs, referred to as “Community 
Supported Agriculture (CSA)” programs, have improved diet and health in non-AI populations, and are evidence-
based strategies recommended by the Centers for Disease Control and Prevention and the Institute of Medicine 
to reduce health disparities. However, no randomized controlled trial of a CSA program has been conducted in 
the AI population. Accordingly, we will test the efficacy of a CSA program- which we refer to as the Go Healthy 
Indigenous Supported Agriculture (ISA) program- combined with culturally-tailored nutrition and cooking 
education on diet and health outcomes among AI households. We will evaluate its cost-effectiveness, and 
develop a multimedia toolkit for disseminating findings. Our specific aims are to: 1) Conduct a randomized 
controlled trial to test the newly developed ISA program’s effect on diet, blood pressure, and blood lipids (primary 
outcomes) and on body mass index (BMI), hemoglobin A1c (HbA1c), food insecurity, health status, and Skin 
carotenoid measurement by Veggie Meter (secondary outcomes) among 200 AI households with an index adult 
(aged 18-75) identifying as AI with overweight/obesity; 2) Perform an economic evaluation for individual (e.g., 
health-related quality of life), organizational (e.g., healthcare utilization costs), and community-level (e.g., 
prevention of cardiometabolic diseases) outcomes; and 3) Document and disseminate study processes and 
findings using participatory video methods, and compile a web-based toolkit for other AI communities to use to 
improve tribal food systems. This study is the first to rigorously intervene across all components of the food 
system to address poor diet and health among AIs. Building upon Osage Nation assets and priorities, guided by 
a participatory research and Indigenous food sovereignty orientation, and based upon recommended strategies 
to eliminate disparities, study findings will inform research and policy efforts to create sustainable food access 
in reservations with high rates of chronic disease as well as urban AI communities where ISAs are available and 
could be tailored to AIs.  
2. RESEARCH TEAM AND SETTING 
This study will be led by an experienced research team with diverse and complementary expertise and a long 
and positive history of collaboration. 
 
Valarie Blue Bird Jernigan, DrPH, MPH (Choctaw), Principal Investigator (PI), Professor of Rural Health 
and Director of the Center for Indigenous Health Research and Policy (CIHRP) at Oklahoma State University 
Center for Health Sciences (OSU-CHS), is an Indigenous researcher trained in intervention science. Dr. Jernigan 
uses participatory research to address diet-related health disparities among AIs. She is the PI of several NIH-
funded studies and currently co-leads three NIH trials.  
Ying Zhang, PhD, MD, Co-I, Associate Professor in the Department of Biostatistics and Epidemiology at 
OUHSC, will serve as the methods lead of the study. Dr. Zhang has two decades of experience using CBPR in 

Contact PD/PI: Jernigan, Valarie Blue Bird  
Research Protocol 
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Native communities across the United States and currently serves as the PI of the Strong Heart Study 
Coordinating Center. Dr. Zhang will provide methodological oversight and oversee statistical analysis for the ISA 
study. Dr. Zhang will attend virtual or in-person monthly research team methods meetings with OSU-CHS.  
Jessica Reese, PhD, MS, Co-I, Assistant Professor of Research in the Department of Biostatistics and 
Epidemiology at OUHSC, will serve as the lead analyst for the heath outcomes of study. Dr. Reese has expertise 
in clinical research, epidemiologic methods, and data analysis and currently conducts research with the Strong 
Heart Study, which is an NIH-funded, multi-centered cohort study of CVD in AIs. Dr. Reese will attend virtual or 
in-person monthly research team methods meetings with OSU-CHS. 
Robert Rosenman, PhD, Co-I, Professor Emeritus of Economic Sciences at WSU, will lead the health 
economics analyses. Dr. Rosenman is performing economic analyses on seven behavioral intervention studies 
involving AIs led by Dr. Jernigan. Dr. Rosenman will develop customized instruments for measuring direct and 
indirect costs and benefits associated with the intervention at individual, organizational, and community levels 
and across domains (e.g., health-related quality of life and clinical outcomes).  
Susan B. Sisson, PhD, RDN, CHES, FACSM, Co-I Behavioral Scientist, Research Dietician, and Professor 
at the University of Oklahoma Health Sciences Center (OUHSC), will oversee all dietary components of the 
study. Dr. Sisson will determine appropriate dosage for each ISA box and calculate associated nutritional 
content. Dr. Sisson will also provide dietary and nutritional guidance for curriculum development, study 
implementation, and evaluation. Dr. Sisson will attend virtual or in-person monthly research team meetings with 
OSU-CHS and Osage Nation research partners. 
Tvli Jacob, PhD (Choctaw), Assistant Professor in the Department of Psychiatry at OSU-CHS, is an 
Indigenous qualitative researcher and filmmaker who uses video and other media to effect social change. He 
has been a Co-I on several NIH-funded studies led by Dr. Jernigan, including the THRIVE and FRESH studies. 
Dr. Jacob will use participatory videography techniques to teach AI community members how to use video to tell 
their stories and lead the development of the web-based multimedia manual and “how-to” toolkit for 
dissemination to AI communities locally and nationally. 
Jann Hayman, PhD (Osage), Tribal PI, Director of Natural Resources for the Osage  
Nation, and Director of Harvest Land, has over a decade of experience leading tribal agricultural initiatives that 
include sustainable agriculture program development and implementation, agricultural marketing and 
communications, and agriculture education programs for youth and adults. Dr. Hayman will oversee all aspects 
of the ISA program, with extensive support from Harvest Land staff. 
 
This research will take place in two locations – the Osage Nation and OSU-CHS. Located in northeastern 
Oklahoma, Osage Nation occupies the state’s only federally recognized reservation, which is coterminous with 
Osage County. Osage Nation has a healthcare system that includes a main healthcare center providing 
comprehensive primary and specialty care. Recruitment will be conducted at community locations (e.g. health 
fairs, powwows, and community dances) and within the healthcare center. Data will be collected via REDCap 
and stored and analyzed at both OSU-CHS and WSU.  
 
3. RESEARCH METHODS 
 
This study will be overseen by the OSU-CHS IRB, which will serve as the official IRB of record for the study. It 
will also be reviewed and approved by the Osage Nation Historic Preservation Department prior to 
implementation. This Department serves as a research review body for the Osage Nation. No research will take 
place without both the OSU-CHS IRB review and approval and the Osage Nation Preservation Department 
review and approval. This study will be registered in ClinicalTrials.gov no later than 21 calendar days after 
enrollment of the first participant and primary summary results reported in ClinicalTrials.gov, no later than one 
year after the completion date.  
 
All surveys and data collection protocols are included within this document.  
 
We summarize the study aims, methods, and measures, as follows.  

Contact PD/PI: Jernigan, Valarie Blue Bird  
Research Protocol 
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Aim 1. Conduct a randomized controlled trial to test the Go Healthy ISA program’s effect on diet, blood 
pressure, and blood lipids (primary outcomes) and on body mass index (BMI), hemoglobin A1c (HbA1c), 
food insecurity, and health status (secondary outcomes) among AI households.  
 
This is a five-year study. During years one and two of the study we will finalize research protocol and survey 
measures. In years two and three of the study, we will recruit and follow a cohort of 200 AI households over a 
four-month period (400 adults and up to 400 children). 
 
Specifically, one AI adult will be recruited as an “index” participant. This individual must be aged 18-75 years, 
identify as AI, reside within Osage Nation, and be overweight or obese (BMI ≥ 25 kg/m2) based on height and 
weight information collected onsite by a research staff member. The individual should also have no plans of 
moving within the next year and must not be pregnant or plan to become pregnant within the next year.  
 
We will also enroll up to two additional adults living within the index participant’s household and up to four children 
(aged 3-17 years) living within the index participant’s household. These individuals are not required to be AI or 
overweight/obese but must reside within the index participant’s household.  
 
Households will be randomized to either immediately receive four months of weekly ISA produce plus culturally-
tailored nutrition education, website links to Indigenous cooking demonstration videos, and basic kitchen supplies 
(intervention group), or to receive equally valued gift cards to use at Harvest Land (gift cards loaded in small 
increments over four months) and education after completing the study (wait-list control group).  
 
The primary outcomes assessed for adult participants are diet, systolic and diastolic blood pressure, and blood 
lipids. Secondary outcomes are BMI, HbA1c, food insecurity, health status, and skin carotenoid measurement 
by Veggie Meter. For children, only BMI and dietary intake.  
 
Data collection for all measures will be conducted at baseline and four months and for adults will comprise self-
report questionnaires, blood panels, 24-hour dietary recalls, and biometrics measured by the research staff.  
 
For children, only BMI and dietary intake will be assessed. BMI will be assessed by measuring height and weight. 
Dietary intake will be assessed using a Pediatric-Adapted Liking Survey and a “Veggie Meter”, which is a 
noninvasive research-grade instrument that detects and quantifies carotenoids in the skin, a class of 
phytochemical compounds found in fruits and vegetables and therefore commonly used as a biomarker for 
fruit/vegetable intake. The Veggie Meter will also be used with adults. 
 
The study uses a wait-list control group, and all participants assigned to the control group will have the 
opportunity to receive an Osage Nation Harvest Land Farm gift card of equal monetary value during the 
completion of the trial. An overview of the randomized control trial study design is shown in Figure 1.   
 
Staff Training, Recruitment, Screening, and Enrollment  
 

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Recruitment, screening, and enrollment of study participants will be 
conducted by a research team that comprises both university and 
tribal staff. All research team members will be trained in one 
standard screening and data collection protocol developed for and 
implemented in our previous studies. The protocol includes the use of 
standard study equipment, regularly monitored and calibrated, and a 
standardized protocol for the collection of blood pressure, height and 
weight, and the administration of dietary recalls and survey questions. The 
blood panel and HbA1c data will be collected and analyzed using Point of 
Care Testing (POCT) at the Osage Health System, which uses a standard 
protocol. 
 
The research team will recruit, screen, and enroll study participants in 
both community and clinic settings. In the community setting, the team 
will advertise the study through the media (e.g., Osage television, Osage 
newspaper, and Osage websites) and attend town hall meetings and 
community events, such as powwows, gatherings, community dinners, 
and health fairs. The team will also set up recruitment tables in the waiting 
rooms at the Osage Health System main clinic.  
 
In addition, Osage Health System clinical staff will conduct chart reviews 
to identify individuals who may be eligible for the study and refer them to 
the research team to learn more information and, if interested and eligible, 
to enroll (see Letter of Support from Osage Health System). Research team members will explain the study 
goals, study design, and requirements of participation to potential participants. Individuals who are screened as 
eligible and choose to enroll will provide written informed consent and complete baseline data collection prior to 
being randomized to a treatment group. All baseline data will be collected by research team members. Based 
on retention rates in our previous studies with AIs, we expect at least 80% of potential families to participate. We 
are highly confident that we can successfully achieve a final sample size of 160 households after accounting for 
attrition.  
 
Baseline Data Collection  
 
After completing all baseline data collection, participants will be told whether they have been selected to receive 
the ISA program in the first round (intervention group) or a Harvest Land gift card of equal value in the second 
round (wait-list control group). Intervention group participants will be provided with an informational folder about 
the ISA program, including pick-up times and dates and in-person meetings. Data will be collected on all 200 
index participants and participating household members, up to two additional adults and up to four 
children per household (intervention and wait-list control) at the two time points. 
 
Randomization. Households will be randomized using variable-size block randomization in a 1:1 ratio with a 
computer-generated randomization sequence. Treatment group assignment will be concealed from field staff 
until the moment when a household is ready for randomization. Dr. Muller, lead biostatistician, will work with 
study staff to conduct regular audits to ensure that randomization is being accurately implemented.   
 
Immediate Intervention. Households in the intervention group will receive the ISA program during a four-month 
growing period (January-May 2024). The ISA program consists of both didactical education as well as practice-
based learning, informed by an ecological model to influence multiple levels of eating behavior and designed by 
our research group in partnership with Osage community health planners. The program consists of five 
components: 1) ISA produce boxes from Osage’s Harvest Land Farm and a local food supply company available 
weekly for pick-up at one of the three Osage Nation Districts; 2) a healthy eating and traditional foods curriculum 
Figure 1: Randomized control trial study design 

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that will be available inside the box with the history and preparation options for the foods in the weekly box; 3) a 
monthly in-person healthy eating and traditional Indigenous foods cooking workshop during which Osage staff 
and Osage cooks (a position of leadership and prominence within Osage culture and held exclusively by women) 
will prepare and feature a healthy, traditional meal with ISA foods and then facilitate a discussion guided by the 
Indigenous food sovereignty principles; 4) Indigenous cooking demonstration video website links (provided 
through QR codes) to accompany suggested recipes; and 5) a kitchen starter kit that includes kitchen cooking 
supplies.    
 
ISA Produce Boxes. The study will purchase a Harvest Land ISA membership for intervention group 
households. The ISA will provide each household with 12 servings of vegetables and eight servings of fruits per 
day, which is the recommended daily serving for four adults, for the duration of the four-month intervention.  The 
average household size in Osage Nation is 2.5, according to the most recent US Census data. In a given week, 
each ISA will contain at least 6–12 types of produce. Example foods include carrots, scallions, cucumbers, 
squash, tomatoes, pumpkins, kale, spinach, celery, salad greens, beets, sweet peppers, hot peppers, tomatillos, 
and melons. The produce will be picked up by a household participant at one of three pickup locations closest 
to the participant’s residence each week.   
 
Healthy Eating and Traditional Foods Curriculum. Each ISA box will include healthy recipes, incorporating 
as many traditional Osage foods and recipes as possible, due to the high nutrient content. As part of the FRESH 
study with Osage Nation and in preparation for the proposed study, our research team compiled a list of recipes 
incorporating Osage traditional foods and preparation processes. We worked with the Osage Nation Language 
Department to translate all recipes into Osage language. We will incorporate these recipes and their nutritional 
profiles into a finalized curriculum to be reviewed and approved by the Osage Nation Congress and the Osage 
Historic Preservation Department. The recipes will be available in the ISA box and on our study website, to which 
participants will receive a link.   
 
Healthy Eating and Traditional Indigenous Foods Cooking Workshops. Interactive workshops will be offered 
monthly to intervention households during the course of the four-month intervention period. Osage Nation staff 
and cooks will teach healthy eating and traditional Indigenous foods cooking workshops that integrate traditional 
and locally grown foods with Osage language and culture. One recipe will be demonstrated each month. Along 
with the recipes, basic information about the featured foods will be provided, including the Osage name of the 
food and history of the food in relation to Osage Nation (e.g., when the food was first used by Osage people and 
how it was prepared). The monthly workshops will be held at Harvest Land and will include basic nutritional 
information, a cooking demonstration, and sharing of the meal with the participant and his/her family.  They will 
be filmed and put online for viewing for intervention participants (initially) and then for the community once the 
intervention is complete. 
 
Indigenous Cooking Demonstration Videos. Indigenous cooking demonstration videos will be made 
available through a QR code and will accompany weekly ISA boxes.  The videos will highlight healthy, Indigenous 
recipes. 
 
Kitchen Starter Kit. A kitchen starter kit will be provided to households in the intervention group at the first 
pickup of their ISA box. Each kitchen starter kit will include kitchen utensils and small appliances to promote the 
use of the ISA box produce and reduce barriers to using the produce in the provided recipes. Some of the 
suggested recipes require the use of a knife, blender, or crock pot, items a family might not have readily available 
for their use. These items will increase household capacity to utilize the produce and to try the suggested recipes. 
Each kitchen starter kit is valued at about $75.  
 
The ISA boxes, healthy eating and traditional foods curriculum, and kitchen starter kits are designed to 
strengthen and reconnect participants with the principles of Indigenous food sovereignty and increase self-
efficacy and daily participation in healthy eating. The monthly cooking workshops and Indigenous cooking 

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demonstration videos aim to increase community-efficacy and cultural connectedness and improve diet and 
health outcomes. 
 
Pilot intervention. In order to test the feasibility of the intervention and reduce potential food waste, a pilot 
intervention will be conducted in July 2023, before household randomization. A small sample of individuals 
enrolled in the ISA study (N = 5) will be invited via email to participate in the pilot intervention. Participants will 
receive 2 weeks of the ISA program, which will include, as described above, 1) a weekly ISA produce box for 2 
weeks, 2) the healthy eating and traditional foods curriculum, and 3) Indigenous cooking demonstration videos. 
After receiving the 2-week pilot intervention, participants will be invited to an in-person focus group, where 
researchers will solicit verbal feedback from participants regarding their experiences of the intervention, what 
improvements could be made to the intervention, and any necessary adjustments to the number of servings per 
box. Participants will receive a $40 gift card for attending the focus group. Focus group feedback will be 
incorporated to the ISA program before the full intervention begins in January 2024. 
 
Wait-list Control Group. At the time of their initial randomization assignment, households in the waitlist control 
group will be told that they will receive compensation equal in value to the intervention after completion of the 
trial, after data collection is complete, in approximately 10 months. They will be contacted periodically during the 
study period to update contact information and to remind them about the four-month follow-up data collection 
visits. After completing the four-month data collection visit, wait-list control group participants will be offered the 
option to receive compensation equal in value to the intervention uploaded to their ClinCard.   
 
Follow-up Data Collection. The four-month follow-up visit will take place directly after the intervention group 
receives the ISA (May-July 2024). Staff will contact participants to schedule the visit beginning in April. Staff will 
contact individuals by telephone and text up to 10 times (five phone calls and five text messages). They will also 
send up to two letters as well as two emails. Appointments will be made at a time of convenience to the participant 
including weekends and evenings.  
 
Process Evaluations. We will administer 16 weekly process evaluation surveys via REDCap to index adults in 
the intervention group to assess the fidelity of the intervention. Questions will ask about the produce 
(consumption, quality, etc.), recipes, curriculum, and costs and expenses. The survey will take no more than five 
minutes to complete. 
 
Retention and Compensation. Our participatory research approach will be essential for maintaining 
participation during the intervention. We will employ strategies that have been successful in retaining 
participation in our previous research. For example, research staff will work with the same participants for the 
duration of the study. The relationships that they establish with these participants will be critical for retention. In 
addition to each participating household receiving the ISA program, valued at approximately $800, individual 
adult participants will receive gift cards totaling $150 for completing baseline ($75) and four-month post 
intervention data collection ($75). Additionally, index adults will receive an additional $25 if they complete all 16 
of the weekly process evaluations. Children will be compensated with a small toy (ages 3-10) or $20 gift card 
(ages 11-17) for completing BMI, Veggie Meter, and survey data collection. 
In order to meet our recruitment goal and account for retention, we aim to recruit 440 adults. We plan to offer 
additional compensation for enrolled participants who refer adults to enroll in the ISA study. Adults will be 
compensated $10 for each adult who is eligible and enrolls in the “Go Healthy” study, and will be compensated 
up to $50. 
 
Primary Outcomes. Study outcomes are shown in Table 1. The National Cancer Institute’s Automated Self-
Administered 24-hour Recall (ASA-24) 2022 will be used to assess diet. This self-report instrument generates a 
“healthy eating index” (HEI), with scores ranging from 0 (least healthy) to 100 (healthiest). We will use the most 
recent version, the HEI-2015 with adult participants, which has been updated to reflect recent US dietary 
guidelines and has been demonstrated to have good validity and reliability. The HEI has been widely used in 
public health research with diverse populations, including one analysis that used the previous version (HEI-2010) 

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to assess diet of the FDPIR recipients administered by the US federal government. Continuous values of the 
overall HEI score will constitute our primary outcome, but we will also evaluate subscores for diet adequacy and 
moderation, and an ordinal categorical outcome that reflects conventional letter grades ranging from “A” (score 
= 90-100) to “F” (score = 0-59). Blood pressure will be measured using a rigorous standardized protocol 
previously developed for similar intervention projects. All research staff will be trained to measure blood pressure 
for adult participants. A total of three measurements, separated by 30 seconds, will be obtained on participants’ 
right arm, using a cuff of appropriate size, after they rest quietly in the seated position for at least five minutes. 
Blood lipid panels for adult participants will be assayed from a finger stick sample that is collected and 
processed using a point of care testing (POCT) machine, CardioCheck PA analyzer. Staff will be trained on 
proper finger stick and POCT procedures to collect instant blood lipid results.  
 
Secondary Outcomes. We will measure food insecurity among adults using the Household Food Security 
Survey Module. This instrument contains 18 items to capture the qualitative and quantitative dimensions of 
household food supply, including psychological and behavioral responses of household members. To compute 
levels of food security and insecurity, we will total the number of affirmative responses to these items, counting 
“Often” and “Sometimes” as affirmative. Consistent with USDA guidelines, 0-2 affirmatives indicate food security, 
and 3 or more affirmatives indicate food insecurity. BMI will be evaluated on adults and children by measuring 
height with a portable stadiometer (Hopkins) to the nearest 0.1 centimeter. Height will be taken twice and 
averaged. We will measure weight to the nearest 0.1 kilogram on an electric digital scale (Health Morbius Health 
Meter). Weight will be taken with clothing on and without shoes. Scales will be calibrated monthly. We will 
calculate adult BMI as a continuous variable by dividing weight in kilograms by height in meters squared and 
categorize participants according to CDC guidelines: 1) underweight (BMI < 18.5); 2) healthy weight (BMI = 18.5-
24.9); 3) overweight (BMI = 25.0-29.9); 4) obese (BMI = 30.0-39.9), and 5) morbidly obese (BMI ≥ 40.0). Note 
that all index participants will have BMI ≥ 25 kg/m2 at baseline. Child BMI will be calculated as a continuous 
variable using the CDC Child and Teen BMI Calculator. HbA1c will only be collected for adult participants. The 
Osage Nation Health System estimates that approximately 20% of their total population may have undiagnosed 
diabetes. Using a CardioChek PA analyzer, we will collect a blood sample by finger stick to assess HbA1c at 
baseline and four months. Values reflect the percentage of red blood cells with attached glucose molecules and 
will be recorded both as a continuous value (%) to the tenths digit and as a binary indicator of HbA1c < 8%. Adult 
Health status will be assessed using a general overall health question from the Short Form-36 (SF-36), which 
participants rate their overall health as excellent, very good, good, fair, or poor. The SF-36 has been widely used 
and validated with AIs. In addition, we will also administer the EuroQuol 5 Dimension – 5 Level Questionnaire 
(EQ-5D-5L). The EQ-5D-5L is a self-assessment of overall health and quality of life, measuring five dimensions 
of participant’s health today, including mobility, self-care, usual activities, pain/discomfort, and 
anxiety/depression. Skin carotenoids will be measured in adult and child participants using a Veggie Meter 
machine. The Veggie Meter uses a LED light to measure carotenoids. Three scans will be taken with the average 
entered into the database. 
 
Table 1 Randomized controlled trial measures 
Variables  
Role  
Diet  
Primary outcome  
Blood pressure  
Primary outcome  
Blood lipids  
Primary outcome  
Food insecurity  
Secondary outcome  
Body mass index  
Secondary outcome  
Hemoglobin A1c 
Secondary outcome  
Health status  
Secondary outcome  
Skin carotenoids 
Secondary outcome 
Self-efficacy  
Mediator  
Social support 
Mediator 
Cultural connection  
Mediator  

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Community efficacy  
Mediator  
Food environment 
Mediator 
Mindful eating 
Mediator 
Age  
Covariate  
Sex  
Covariate  
Education  
Covariate  
Marital status  
Covariate  
Household income  
Covariate  
Employment status  
Covariate  
Smoking and alcohol use  
Covariate  
Comorbidities* 
Covariate  
Healthcare access 
Covariate  
Healthcare utilization 
Covariate 
Physical activity 
Covariate 
Public assistance programs  
Covariate  
Health economics†  
Specific Aim 2  
*Chronic kidney disease, cardiovascular disease, diabetes, prediabetes, depression, anxiety, hypertension at baseline  
†Financial and non-financial costs and outcomes measured at the level of individual, organization, and community (see Section 4.F).  
 
Mediators. We will assess the following mediators among adults to facilitate a comprehensive analysis of the 
ability of diet-related food system intervention to improve AI health. Self-efficacy will be measured using the 
Healthy Eating and Weight Self Efficacy scale. This scale measures the consumption of healthy foods on a five-
point Likert scale, with a higher score indicating a higher healthy eating and weight self-efficacy. Social support 
will be measured using the Social Support for a Healthy Diet survey. This survey evaluates how a participant’s 
family supports and either encourages or discourages healthy diet maintenance using a five-point Likert scale. 
A higher score indicates higher levels of social support from family. Cultural connection will be measured using 
an Osage Traditional Food Frequency questionnaire and a Cultural Identity Scale. Questions include the 
frequency of following tribal ways of life, importance of Indigenous values and practices, and involvement in 
traditional and cultural events and practices. Community efficacy will be measured using the Community Health 
and Climate Survey and a Food Sovereignty and Health survey. These questions are adapted to the Osage 
Nation community and include interest, involvement and importance of cultural practices and climate change. 
These items have both been used with AIs. Food environment will be measured using the First Nations Food 
Nutrition and Environment Survey, which evaluates traditional Indigenous foods, and the Perceived Nutrition 
Environment Survey (NEMS-P). The NEMS-P will assess home food environment, food shopping, and thoughts 
and habits about food. Mindful eating will be measured using the Mindful Eating Behavior Scale (MEBS). MEBS 
measures the attention element of mindful eating. We will also assess exposure to the intervention by assessing 
log-in sheets during the ISA pick-ups and website metrics for logging on to the study site for weekly recipes and 
video narratives as well as intervention participation questions on a six-month post-intervention survey.   
 
Covariates. Additional covariates assessed via study questionnaires will include age, sex, education, marital 
status, household composition and income, employment status, cigarette and alcohol use (coded current, former, 
and never), comorbidities (e.g., chronic kidney disease, cardiovascular disease, diabetes, pre-diabetes, 
depression, anxiety), healthcare access and utilization, and physical activity. We will also ask about participation 
in public assistance programs such as Temporary Assistance for Needy Families, SNAP, Women, Infants, and 
Children, and Supplemental Security Income.  
 
Child Measures. BMI and dietary intake will be assessed in households with up to four children, aged 3-17. 
Dietary intake will be measured using the Veggie Meter and the Pediatric-Adapted Liking Survey (PALS). PALS 
assesses a child’s level of liking or disliking a list of 33-items, shown in both words and pictures, using a visual 
scale from -100 to 100 with seven different faces corresponding with the level of liking of the item. Additional 
demographic questions including age and sex will also be asked.  
 

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Data Security. All databases and computers will be password-protected in accordance with OSU-CHS IRB 
requirements, and all data will be stored on a secure server operated by OSU-CHS and WSU. Nightly 
incremental backups and weekly full backups will ensure optimal recovery of data in the event of a disaster. On 
all data files, individuals will be identified only by a unique participant identification code. Similarly, paper records 
will identify the participant only by identification code and will be kept in a locked filing cabinet at OSU-CHS. A 
key associating the participant identification codes with the participants’ names and contact information will be 
kept separately in a locked drawer. All audit and survey data collected on iPads using REDCap will be 
automatically uploaded to a secure server when an Internet connection is available. Identification codes will be 
used to merge datasets for statistical analysis. All personal identifiers will be redacted before data transmission.   
 
Statistical Analysis. Dr. Muller will attend team meetings, oversee methods-related implementation and 
potential changes to study design, and work with the research team during data analysis. Quantitative analyses 
will be conducted using R (version 3.3 or later) or Stata (version 14 or later) software packages. All analyses will 
use the intent-to-treat principle, with results reported as point estimates with 95% confidence intervals. For 
descriptive statistics, we will describe all variables by using counts and frequencies for categorical factors, and 
means, medians, standard deviations, and ranges for continuous factors. We will use chi-square and t tests to 
compare baseline distributions across the two treatment groups to identify factors that might be unbalanced by 
chance. We will plot primary and secondary outcomes during follow-up in the intervention and wait-list control 
groups and calculate descriptive statistics for primary outcomes stratified by potential mediators (Table 1). For 
inferential analysis we will conduct the following:  
 
Intervention Effectiveness. We will use linear mixed models to test the effect of the ISA intervention on 
within-person change in primary and secondary outcomes. For each outcome, the initial model will include a 
fixed effect for group assignment, a random intercept for individual participant, and a fixed effect for time 
(baseline and four-month follow-up). We will run models with and without a participant-level random effect for 
slope associated with the intervention and will include the effect if it provides a better fit to the data. Next, we will 
add a term for the intervention × time interaction to determine whether the intervention is associated with 
divergence between the two treatment groups during the four-month follow-up period. Separate models will be 
fit where time is considered a continuous variable vs. indicator variables. A likelihood ratio test will be used to 
determine the best-fitting model. This analysis will be the primary test of the effectiveness and will be 
interpreted as estimating the average within-person change for the intervention group, beyond any change that 
participants would have experienced without the ISA program. If necessary, we will conduct sensitivity analyses 
in which models are adjusted for covariates that showed imbalance between treatment groups at baseline. We 
will also conduct exploratory analyses to examine if the intervention has a differential effect according to 
biological group. These analyses will follow the same approach described above except analyses will be 
stratified by biological group.   
 
Mediation Analysis. First, we will estimate the effect of the ISA intervention on the potential mediating factors 
at four-month follow-up to establish whether a temporal effect exists as would be necessary for a mediating 
influence. Second, we will evaluate whether baseline levels of the mediators predict the outcome at four-month 
follow-up among control participants only, adjusting for baseline outcome values. Although this analysis will not 
establish causality, it will address whether associations are present in the control group consistent with 
mediation. Third, we will evaluate whether the magnitude of association between treatment group and outcome 
attenuates after adjusting for the potential mediating factors. This model estimates the controlled direct effect of 
the ISA intervention and will include adjustment for potential confounders of the association between the 
mediators and the outcome. Given well-established limitations in causal inference from mediation analysis, we 
will emphasize a qualitative interpretation in which we evaluate whether the results of these models are 
consistent with a mediating influence of the interim factor on the effect of the intervention on outcome variables, 
rather than attempting to quantify the precise percentage of the overall effect that is “explained by” the mediators.  
 
Missing Data. We will carefully check for non-random patterns of missing data and determine whether 
analytic methods are necessary to adjust for informative missingness. Our preferred method is multiple 
imputation, in which participants with complete data are sampled repeatedly to generate probability distributions, 
allowing unbiased parameter estimates with appropriate standard errors. Multiple imputation assumes that data 
are missing at random, but is robust to violation of this assumption and performs well even with large amounts 

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of missing data (> 50%). Dr. Muller has the necessary expertise to consider other methods, such as the full 
maximum likelihood estimator, which does not require the assumption of missing at random.   
 
Power. A sample size of 200 households will provide at least 80% power to detect between-group 
differences (e.g., intra-individual change compared between the two treatment groups) as small as 2.6 for the 
HEI score, 3.7 mmHg for systolic blood pressure, and 8.6 mg/dL for low density lipoproteins. These calculations 
assume three data collection points per person, 15% attrition over four months, an alpha error rate of 0.05, within-
person correlation of 0.6, and standard deviation estimates obtained from prior studies. These minimum 
detectable differences correspond to standardized effect sizes of 0.2, which are conventionally considered 
indicative of strong statistical power.    
 
Aim 2. Perform an economic evaluation to estimate the ISA’s cost-effectiveness and cost-benefit. We will 
conduct a health economics analysis for individual (e.g., health-related quality of life), organizational (e.g., 
healthcare utilization costs), and community-level (e.g., prevention of cardiometabolic diseases) outcomes.  
 
For the health economics analysis, we will use measures collected at baseline and four months follow-up to 
estimate the cost benefit of the ISA intervention in improving expected quality adjusted life years (QALYs), 
reducing direct medical costs associated with overweight/obesity, hypertension, and dyslipidemia, and a cost-
effectiveness analysis of clinical improvements based on glycemic control, QALYs, and other secondary 
outcomes.   
 
Measures and Analysis. The costs of the RCT include both programmatic costs and the costs for participants. 
Programmatic costs include the ISA subsidy, the cost of education materials, videos and workshops, kitchen 
starter kit, and administration. The ISA subsidy is easily available as the direct costs paid by the study to Harvest 
Land and Go Fresh. The personnel time and material costs for education, videos, and research will be collected 
by direct interaction between Dr. Rosenman and the research staff.  Administrative costs will be assessed 
similarly. Participant costs primarily consist of time and effort spent to obtain the ISA boxes and learn new 
recipes, offset by any reduction in grocery costs since the ISA provides food which may displace the participants’ 
normal diets. At each data collection point, participants will be asked to report their time spent and any indirect 
costs (e.g., taking time off from work or extra childcare) associated with obtaining the ISA boxes. Participants 
will also be asked to monitor their time spent on educational activities. The value of time will be either the 
participant’s actual hourly wage or, if not working, the prevailing minimum wage.  Finally, participants will be 
asked to estimate any change in their spending on foods (offset or augmentation instigated by receiving the ISA 
boxes). At the participant-level, cost-benefit analyses (CBA) and cost-effectiveness analyses (CEA) will be 
conducted. The CBA will compare the direct and indirect costs the participants incur to any change in food 
spending that results from receiving the ISA boxes, as well as reduction in out-of-pocket healthcare costs, and 
gains is QALYs from health improvements.  The CEA will compare the costs per unit improvement in the primary 
outcomes: diet, blood pressure, blood lipids, and QALYs (as measured by the EQ5D, a six-item instrument that 
has been widely used internationally for this purpose) and three of the four secondary outcomes (excluding 
health status because of any lack of comparison outside the study). This analysis assesses the economic value 
of the intervention to the participants. Economics at the organizational level will be assessed with CBA and CEA 
similarly by adding the programmatic costs to the participant costs and performing the same analytics that will 
be done at the participant level.  This analysis assesses the economic value of the intervention to Osage Nation. 
Finally, at the community-level, the economic analysis will forecast savings in healthcare expenditures due to 
improved health. Using changes in adult participants’ blood pressure, blood lipids, HbA1c, and BMI, Dr. 
Rosenman will predict changes in cardiovascular events.  He will conduct a CEA on these outcomes and will 
also translate these health status changes into healthcare resources saved through a CBA.  
 
Aim 3. Document and disseminate study processes and findings using participatory video methods and 
compile a web-based toolkit for other AI communities to use CBPR to improve tribal food systems.  
 
We will document and disseminate study processes and findings using participatory video methods and compile 
a web-based toolkit for other AI communities to use participatory research to improve tribal food systems. Once 
the web-based toolkit is complete, we will partner with local and national groups, including the NCAI Tribal Food 

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Sovereignty Advancement Initiative (TFSAI), to broadly disseminate the toolkit to Indigenous communities across 
the US and assess its appropriateness and potential for supporting tribes to improve their food systems and 
positively impact health. The TFSAI supports the development and strengthening of tribal nations’ efforts to build 
and protect Indigenous food systems. The TFSAI currently provides the broadest forum and network in the US 
to share best practices for advancing Indigenous food sovereignty and assisting tribal governments with 
developing food sovereignty and related policies that improve the health of tribal citizens.  
 
Toolkit Development. The toolkit and dissemination process will be guided by the Social Impact Model for 
Creative Media, which begins with a culturally-appropriate and compelling story and uses awareness raising, 
engagement methods and best practices for dissemination from our previous work, such as video voice, 
photovoice, and digital storytelling. Dr. Jacob will lead our study partnership in creating the toolkit, which will 
include a documentary-style film and multimedia manual of intervention materials including study processes, 
measures, and findings. We will use video footage and materials developed in Specific Aims 1 and 2 (e.g., 
cooking demonstrations and community gatherings) to create culturally-relevant and engaging material that will 
raise awareness about food systems and health with the goal to increase tribal communities’ readiness and 
capacity to assess and improve their food systems. In addition, community members who are enrolled in the 
study and participating in the intervention component of the study will be invited to share their stories as part of 
the toolkit and documentary. Dr. Jacob will interview interested participants prior to and after each of the healthy 
eating and traditional Indigenous foods cooking workshops, as well as during ISA pick-ups, and at other times 
of convenience for study participants, to include participant perspectives within the toolkit. In addition, 
participants will be invited to submit video narratives via the study website, to which they will be given an 
individual link. They will be provided with guidelines, including release forms to complete for themselves and all 
individuals included within their videos. To assist in creating engaging video narratives, participants will be 
prompted with questions that pertain to their experiences in the different components of the intervention and 
their perspectives on Indigenous food sovereignty. The documentary will share the story of Osage Nation’s 
Harvest Land Farm, our research and ISA intervention, and the ways in which working to improve the food 
system impacted Osage Nation. We successfully used these participatory video methods in previous studies 
which were featured in the PBS documentary Blood Sugar Rising and in the online associated learning 
materials. In the proposed study, we will implement similar methods with NCAI TFSAI to disseminate our study 
processes and findings.   
 
Assessment of Community Engagement and Impact. Upon completion of the web-based toolkit and 
documentary, we will work in close partnership with NCAI TFSAI to disseminate the toolkit to Indigenous 
communities across the US via community events, conferences, listservs, and websites, screen the documentary 
film, and assess its impact via surveys, focus groups, and interviews with tribal citizens and leaders. We will 
evaluate the usefulness, appropriateness, and potential impact of the toolkit in partnership with the TFSAI. 
Specifically, we will use website metrics to track the number of downloads of the toolkit and offer a small incentive 
($10 gift card) for completing a brief online survey. We aim to survey 500 Indigenous adults from diverse 
Indigenous communities to assess the broad feasibility and readiness of tribal communities to implement ISAs 
and food system interventions across diverse Indigenous communities, including both rural and urban 
communities. In addition, we will distribute toolkit materials and host small screenings (approximately 10 
participants per screening) of the documentary film at Indigenous conferences and national meetings. After the 
screenings, we will facilitate talking circles to evaluate usefulness, appropriateness, and feasibility of the toolkit 
within participants’ communities.  We will host approximately six screenings with diverse tribal community 
members including tribal citizens, health planners, and leaders, and offer a $100 gift card to each participant. 
We will also follow-up with organizations that have used the toolkit to obtain feedback about how these materials 
were used and what impact they had on improving the tribe’s food system and health. We will use the study 
website and the TFSAI networks to share success stories.  
Timeline   
Study activities in six-month intervals are shown in Table 2.  
Table 2 Study timeline in six-month intervals (red signifies changes from the original table) 
Project Phase 
Year 1 
Year 2 
Year 3 
Year 4 
Year 5 
Development 
Obtain regulatory approvals 
 
 
 
 
 
 
 
 
 
 
Finalize study protocols 
 
 
 
 
 
 
 
 
 
 

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Assemble intervention materials 
 
 
 
 
 
 
 
 
 
 
Train research staff 
 
 
 
 
 
 
 
 
 
 
Randomized Controlled Trial 
Recruit and randomized participants 
 
 
 
 
 
 
 
 
 
 
Baseline data collection 
 
 
 
 
 
 
 
 
 
 
Pilot intervention ISA 
 
 
 
 
 
 
 
 
 
 
Intervention group ISA 
 
 
 
 
 
 
 
 
 
 
Wait-list control group ISA equivalent 
 
 
 
 
 
 
 
 
 
 
Four-month follow-up data collection 
 
 
 
 
 
 
 
 
 
 
Process evaluation 
 
 
 
 
 
 
 
 
 
 
Data Analysis and Dissemination 
Data cleaning and management 
 
 
 
 
 
 
 
 
 
 
Data analysis 
 
 
 
 
 
 
 
 
 
 
Documentary and dissemination 
 
 
 
 
 
 
 
 
 
 
 
 
4. PROTECTION AGAINST RISKS 
 
All university and tribal research staff will be required to complete the CITI (Collaborative Institutional Training 
Initiative) program in ethical use of human participants in research. All research protocols and activities will be 
co-developed by the tribal/university study partnership and reviewed and approved by the OSU-CHS IRB. It will 
also be reviewed and approved by the Osage Nation Historic Preservation Department prior to implementation. 
This Department serves as a research review body for the Osage Nation. No research will take place without 
both the OSU-CHS IRB review and approval and the Osage Nation Preservation Department review and 
approval. 
 
Adequacy of Protection Against 
 
Risks Informed Consent and Assent. Standard language in our consent and assent procedures assures the 
participants understand the nature of the study. Trained university/tribal research staff members will obtain 
informed consent during the first research encounter and prior to any data collection. Eligible child participants 
17 or younger will have a guardian complete the Child Consent Form on their behalf. For children between the 
ages of 7 and 17, the child participant will sign an Assent Form. The informed consent and assent documents 
will be clearly written in accordance with the OSU-CHS IRB guidelines. If subjects being enrolled cannot read 
the consent form or HIPAA form due to low literacy levels or age, consent materials will be presented orally. 
Sufficient time will be allowed for questions to be asked and answered both by the subject and the person 
obtaining the consent to ensure the subject comprehends the consent information. Research staff will verbally 
review the consent forms including voluntary participation, confidentiality, ability to withdraw from the study or 
videotaping at any time. The consent form will be orally reviewed with each participant and they will be given a 
copy of the signed consent form. The original signed consent forms will be maintained by Dr. Jernigan, study PI, 
for documentation. Consent forms will be stored separately from participant data and contact information 
 
Protections Against Risk. All surveys and data collection from study participants will be identified by an 
identification code only, and will be stored in password protected databases, maintained on a secure server for 
which only research staff have access. Passwords will be changed in the event of a staff member leaving the 
research team and/or bi-yearly, whichever occurs earlier. Published results will be presented as group data, 
without identifiers. The Osage Nation Congress will review all presentations and manuscripts prior to 
dissemination or submission. 
 
In the event of unanticipated adverse events or reactions, Dr. Jernigan, the study PI, will attempt to contact the 
participant and ascertain the need for services (e.g., psychological reassurance). A full report will be made to 
the OSU-CHS IRB, Osage Nation, and to the NIH program officer (PO). Participants will be informed that, should 
they pose a potential threat to themselves, (e.g., suicide), they will be given a mental health referral number and 
are encouraged to make contact immediately. Serious adverse events will be reported to the OSU-CHS IRB 

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within 24 hours and to the appropriate NIH PO within 48 hours. Non-serious adverse events will be reported to 
the NIH PO within 15 days. 
 
Loss of Privacy. All university and tribal staff will complete CITI training and will be trained in all participant 
consent processes, such as informing community members of the potential risks of participation (e.g., loss of 
privacy) and benefits (e.g., opportunity to share experiences and ideas). They will also be trained in how to 
identify and report potential human subjects’ issues and/or concerns. 
 
For the video data collected, Dr. Jacob, and other staff who assist him, will be trained in the participant consent 
process to inform community members of the risks of participating in the video recordings, such as loss of 
privacy, and benefits, such as an opportunity to share experiences and ideas. They will explain to potential 
interviewees that footage, if they provide consent, may appear on the study and tribal websites, in the web-based 
toolkit, and in the documentary film about the study. The footage and the products in which it may be used may 
be shared at community and online screenings. All participants who are video recorded will sign consent forms. 
At the start of each video recording, and otherwise when necessary, we will explain to participants that they have 
the right to stop participating at any time. To date, in our five previous research studies that have used video in 
a similar manner, we have never experienced an incident that resulted in participants asking us to stop 
videotaping or that needed to be reported to tribal authorities or to the IRB. The likelihood of such an incident is 
extremely low. In the rare and unlikely event that such an incident is observed during video recording, the study 
PI will work with the Osage Nation Historic Preservation Department to report it to appropriate tribal officials. She 
will also report the incident to the OSU-CHS IRB. 
 
Embarrassment. Though unlikely, participants may feel embarrassed or uncomfortable in responding to 
some of the survey questions or from participating in research activities, such as getting weighed. At the start of 
each survey session, and otherwise when necessary, we will explain to participants that they have the right to 
withdraw from the study at any time, and that they can refuse to answer any question or to decide not to 
participate in a study activity, but still continue their participation. Likewise, participants who are video recorded 
may also feel embarrassment, though unlikely. They will be informed that they can refuse to be video recorded 
at any time or can ask for the camera to be turned off at any time. 
 
Disclosing Psychopathology. Though highly unlikely, participants may disclose psychopathology or 
distress, and may request help for their distress. At the conclusion of each survey, all telephone survey 
participants will be provided with contact information for the tribal health clinics that offer food assistance and 
mental health services, independent of any expression of concern on their parts. Disclosing information that 
requires intervention by research staff (e.g., statements of intent to commit suicide) is unlikely, because we do 
not ask about mental health or suicide. Nevertheless, if this should happen, the study PI will be on-call during all 
data collection times. She will assess and make appropriate referrals if needed. All of the research staff are or 
will be fully trained in relevant ethical principles and procedures, including confidentiality. We will report all 
situations or potential situations to the OSU-CHS IRB.  
 
Out-of-range results that might indicate uncontrolled or previously undiagnosed pathology will be flagged and 
explained in lay terms to emphasize the need for immediate medical attention. For urgent levels of HbA1c (≥ 
10.5%) or blood pressure (≥ 200/120 mmHg) participants will be referred immediately to their physician during 
clinic hours or to a hospital emergency department. These individuals will still be eligible for participation in the 
randomized controlled trial, with the consent of their physician.