Adaptation and Implementation of a Cherokee-based Participatory Research Project to Reduce CVD Risk
Phase: NA
Conditions: Blood Pressure
Sponsor: University of Missouri-Columbia

 
 
OFFICIAL TITLE: 
Adaptation and Implementation of a Cherokee-based Participatory Research Project to Reduce 
CVD Risk 
 
NCT NUMBER: 
NCT06671652 
 
DOCUMENT DATE: 
July 13, 2025 
 

STUDY PROTOCOL 
Overview. The goal of this study is to develop and then test the feasibility and acceptability 
of a culturally grounded intervention of CVD in CN citizens. Based on community-based 
participatory research methods, a program developed by and for Cherokee people will best 
address the unique values, expectations, and needs of this population for CVD prevention. This 
proposal builds on over 3 years of well-established, trusting, and collaborative partnership 
between the PI and the CN. Aim 1 of the proposed project will lead to the development of the 
intervention while Aim 2 will test the intervention for feasibility and acceptability.  
 
Eligibility, 
recruitment 
and informed consent. To 
participant 
in 
JOC, 
participants must be at least 
18 
years 
old, 
enrolled 
members of the CN, and 
express 
an 
interest 
in 
participating in the JOC. 
Participants will be recruited 
through 
a 
number 
of 
channels via 1) follow-up contact information from the online survey; 2) flyers at key CN buildings, 
including health centers and tribal complex buildings, recruitment at community center meetings; 
and 3) Online recruiting. Participants can contact PI by phone or email. If they meet eligibility 
criteria, she will complete the informed consent process with potential participants by appointment. 
Baseline data collection. Baseline data will be obtained after each eligible person enrolls in 
the study and provides informed consent. PI will administer an online survey to all eligible 
participants to collect self-report data within the Cherokee Nation, Tahlequah, OK. The 
questionnaire will include information that will be used to contact participants when the cohort is 
assembled and ready to begin. Research staff will measure height, weight, and blood pressure 
using the same equipment for all participants (see C.8.1). We anticipate baseline data collection 
will require 60 minutes for each participant. After data collection is completed, participants will 
receive a gift card worth $50 as compensation for their time. They will be provided with a packet 
of study information, including information they can use to contact PI with questions. 
Intervention. Participants will be given a schedule of events at the time of recruitment to 
determine if they can attend all sessions. There will be approximately one scheduled meeting with 
a facilitator a month, as well as one meeting a month that the group scheduled. There will also be 
assignments between group meetings that include reading and homework. Participants must 
agree to the schedule at the time of recruitment, including group and individual activities, to be 
eligible to participate. Note that although participants will agree up front to attend all sessions, we 
recognize that obstacles come up and that not everyone can have perfect attendance. Therefore, 
the intervention will be designed so that benefits can be experienced even if 1 or 2 of the sessions 
are missed; dose and attendance will be assessed as part of the feasibility study. Participants will 
be asked to meet at the Cherokee Nation, Tahlequah, Oklahoma for start of the group intervention. 
Participants (n=50) will be assorted into groups of ten and each will have a leader for primary 
contact. All participants will meet for key learning sessions, such as lectures, but will break out for 
experiential activities. This will allow for increased team building and peer relationships to develop, 
as well as ensuring safety for groups as they complete their group activities. 
Follow-up data collection. For all participants, follow-up data collection will occur within two-
four weeks of the final JOC session—approximately five months after the first session—in a 
computer lab at the CN, Tahlequah, OK. Follow-up will re-assess all measures collected at 
baseline that have the potential to change over time. After completing follow-up data collection, 
all participants will receive a $50 gift card and a meal as compensation.  
 
Table 4. Steps for fulfilling Aim 2 goals (Years 2-4) 
 
1. Recruit, determine eligibility, and enroll JOC participants 
2. Initiate intervention 
3. Complete data collection 
3a. Pre- and post-surveys; health information, satisfaction with 
program 
4. Data Analysis 

Measures. Study measures (Table 5) were selected based on the results of a pilot test and 
focus groups with RTR participants and alumni 
and feedback from our CN partners. The purpose 
of data collection is to establish if the measures 
we have chosen are acceptable to this population. 
Compared to the original program, we are adding 
additional demographic and CVD risk factor 
measures including blood pressure, and we plan 
to assess if these additions are acceptable to this 
community. 
 
 
 
Statistical Analysis 
First, descriptive analyses will be conducted for all study variables, including means with ranges 
and standard deviations for continuous variables, and frequencies and proportions for 
categorical variables. Second, in order to assess change in participant outcomes between 
the two data collection periods (pre, post), paired sample t-tests will be utilized. Paired t-tests 
work well when the underlying distribution is symmetric, unimodal, and continuous. If the values 
are highly skewed or the sample is smaller than anticipated, it might be more appropriate to use 
a non-parametric procedure such as the Wilcoxon signed-rank test. All statistical analyses will 
be conducted using SAS 9.4 for Windows (SAS Institute Inc., Cary, NC.). 
 
 
 
Table 5. Measures and collection times 
Variable construct 
Collection times 
Demographics 
Baseline 
Anthropometrics 
Baseline, follow-up 
Physical health 
Baseline, follow-up 
Emotional health 
Baseline, follow-up 
Social well-being 
Baseline, follow-up 
Stress 
Baseline, follow-up 
Cherokee culture 
Baseline, follow-up 
Program satisfaction 
Follow-up