Family Model of Diabetes Self-Management Education in the Marshallese Community
Phase: NA
Conditions: Diabetes
Sponsor: University of Arkansas

Title: Family Model of DSME in the Marshallese Community 
PI: Kohler, P.O. 
Version #: 8 
IRB#: 203482 
Date: 20170825 
Page 1 
Study Title: 
Family Model of DSME in the Marshallese Community 
 
Principal Investigator: 
Peter O. Kohler 
University of Arkansas for Medical Sciences 
Northwest Arkansas Campus 
1125 North College Avenue 
Fayetteville, AR 72703 
Telephone: (479) 684-5124 
Email: pkohler@uams.edu 
 
Co- Principal Investigator: Peter Goulden 
University of Arkansas for Medical Sciences 
4301 West Markham 
Little Rock, AR 72205 
Telephone: (501) 686-5130 
Email: pagoulden@uams.edu 
 
Co- Principal Investigator Pearl McElfish 
and Study Director: 
University of Arkansas for Medical Sciences 
Northwest Arkansas Campus 
1125 North College Avenue 
Fayetteville, AR 72703 
Telephone: (479) 713-8680 
Email: pamcelfish@uams.edu 
 
Co- Investigator: 
Jonell Hudson 
University of Arkansas for Medical Sciences 
Northwest Arkansas Campus 
1125 North College Avenue 
Fayetteville, AR 72703 
Telephone: (479) 713-8000 
Email: JSHudson@uams.edu 
 
Study location: 
University of Arkansas for Medical Sciences 
Northwest Arkansas Campus 
1125 North College Avenue 
Fayetteville, AR 72703 

Title: Family Model of DSME in the Marshallese Community 
PI: Kohler, P.O. 
Version #: 8 
IRB#: 203482 
Date: 20170825 
Page 2 
 
Background and Rationale 
 
The Marshallese population suffers from a significant and disproportionate burden of 
type 2 diabetes. The rate of type 2 diabetes among the Marshallese is one of the 
highest of any population group in the world—at least 400% higher than the general 
US population.1-7 Our systematic review of local, national, and international data found 
estimates of diabetes in the Marshallese (populations living both in the US and 
Marshall Islands) ranging from 30% to 50% compared to 8.3% for the US population 
and 4% worldwide.4-7 Causes for this disparity have not been completely unraveled 
and are partially embedded in the history of the Marshall Islands. Between 1946 and 
1958, the US military tested nuclear weapons on several of the Marshall Islands. 
People who inhabited the bombed islands and atolls were relocated, but Marshallese 
living on nearby atolls that were not evacuated experienced nuclear fallout during and 
after nuclear tests. Because of the nuclear testing, the Atomic Energy Commission 
lists the Marshall Islands as one of the most contaminated places in the world, and 
several studies demonstrate ongoing health effects from the nuclear testing.8 The 
nuclear contamination resulted in significant and long-term changes in diet and 
lifestyle of the Marshallese.9-12 These changes in diet and lifestyle have contributed to 
an increased rate of type 2 diabetes.2-5,16-19 The Compact of Free Association between 
the Republic of the Marshall Islands (RMI) and the US, signed in 1986, permits the US 
to conduct military activities in the Marshall Islands and also allows Marshallese 
individuals to come to the US without a visa. The Marshallese population living in the 
US tripled between 2000 and 2010, with Arkansas having the largest population of 
Marshallese living outside of the RMI. 
 
Diabetes self-management education (DSME) is an evidence-based model that has been 
shown to improve glycemic control, reduce diabetic complications, and reduce the cost of 
managing diabetes. Traditional implementation approaches of DSME have not been 
effective in Marshallese populations, indicating that a unique approach tailored to this 
population is needed.2-3 Because of the disproportionate burden of diabetes and related 
complications experienced by this high-risk population, a novel adaptation of the 
evidence-based DSME model and subsequent testing in a community-based setting are 
needed. 
 
Using a CBPR approach, we have conducted four focus groups and individual interviews 
with the Marshallese community to better understand how to best address the well-
established need for diabetes education. Through interviews and focus groups, 
Marshallese participants pointed out that the delivery method and the concept of self-
management as an individual experience are problematic components. DSME was 
designed with a very Western societal approach, which is highly individualistic. The 
Marshallese have a highly collectivist culture and the idea of self-management is counter 
to their cultural values. As stakeholders described, we eat together from one pot. For one 
person to refuse the food from that one pot is not just inconvenient, it is shameful. It 
shames the person and the person’s family. It is not an acceptable option. We will not do 
it. The interviewees stated that any changes must be a family change. Incorporating 

Title: Family Model of DSME in the Marshallese Community 
PI: Kohler, P.O. 
Version #: 8 
IRB#: 203482 
Date: 20170825 
Page 3 
collectivist and family concepts into the delivery mechanism is imperative. Through the 
interviews and focus groups, the Marshallese community suggested that DSME be 
implemented within a family model with a family group receiving DSME so that the entire 
family can benefit and the patient can be supported in their effort to make lifestyle 
changes. Because ~30-50% of the Marshallese community have type 2 diabetes, this 
approach could be even more beneficial. 
 
Hypothesis and/or Specific Aims or Objectives 
 
We hypothesize that a culturally adapted DSME implemented in a family model 
will result in better diabetes management outcomes compared to traditional DSME 
for the Marshallese. 
 
In the family delivery model, a participant is encouraged to invite his/her family 
members to the diabetes educational sessions. As outlined by stakeholders, the 
model has several potential benefits. First, patients are empowered to invite the 
people they define as family and as appropriate for taking part in the sessions with 
them. Second, the education will engage the patient-defined support unit. Third, given 
the high rate of diabetes within the community, it is highly probable that others within 
the group will have Type 2 diabetes or pre-diabetes and may benefit from the 
intervention as well. 
 
Our aim is to test a Family Model of DSME using a mixed-methods approach. 
Marshallese participants with type 2 diabetes will be recruited. Those who are assigned to 
the family model will be asked to invite one to ten adult members of their families to 
participate in the DSME. Given that ~30-50% of adults in the Marshallese community 
have type 2 diabetes, and the Marshallese typically have large families, recruitment for 
this nontraditional model is plausible. Furthermore, the method was designed from 
input from our CBPR partnership with the Marshallese. 
 
This research is highly translational. It will help bridge the gap between knowledge of an 
effective DSME intervention and actual implementation of the intervention among a 
Pacific Islander population with especially high rates of type 2 diabetes and significant 
health disparities. 
 
Study Design and Procedures 
 
We will conduct a comparative effectiveness evaluation using a randomized control trial 
design of the adapted Family Model of DSME, and compare results of the Family Model 
of DSME with traditional DSME within the Marshallese population. The family model will 
cover the same concepts as the traditional format. However, the family model will 
incorporate culturally-adapted education and recommendations aimed at engaging family 
members in the management of the primary participant’s diabetes, and family members 
will be invited to fully participate in the study. By contrast, the traditional model provides 
diabetes self- management education to the diabetic participant only, and the 
participant’s family members do not participate in the classes or any other part of the 

Title: Family Model of DSME in the Marshallese Community 
PI: Kohler, P.O. 
Version #: 8 
IRB#: 203482 
Date: 20170825 
Page 4 
study. Biometric and survey data will be collected pre-intervention, post-intervention, 6 
months post-intervention, and 12 months post-intervention. In the event missing data is 
identified, participants will be contacted to collect the missing data. A qualitative debriefing 
session will be held for each family between the final DSME session and the 6 month 
post-intervention to obtain qualitative data regarding the participant’s perceptions of the 
intervention and implementation process. Participants will be offered a $20 gift card as 
compensation for their time for each biometric data collection event and the qualitative 
debriefing session. 
 
Randomized participant assignment. Six cohorts will be recruited, approximately 
three months apart. Each cohort will be comprised of 75 participants with diabetes, with 
50% being assigned to the Family Model arm and 50% being assigned to the traditional 
DSME control group. The study sample size will be the total of each cohort; thus a total 
of 300 diabetics and up to 2000 family members (only those in the family model arm will 
be inviting family members). We initially chose an unequal group design (70/30), but 
after assessing Cycle 1 attrition, we needed to adjust the ratio in order to have sufficient 
control group numbers for analysis. Discussion with stakeholders resulted in support for 
this modification. Each participant will be randomly assigned to a group after consent. 
 
Randomization will occur at the family level rather than the individual level. Prior to 
randomization, consented participants will be grouped according to family unit to prevent 
two diabetics in the same family being randomly assigned to different groups, creating 
cross-contamination. Once an entire cohort is recruited and assigned a family identification 
number, each number (family) will be randomly assigned to a study arm. Randomization 
will be conducted utilizing the Excel random number generation function. Randomization 
will be conducted by an investigator who will have no interactions with potential participants 
and has no supervisory role with program staff responsible for recruitment consent, or 
intervention delivery. Designated study staff will send the investigator a list of consented 
participants prior to the start of each new DSME cycle. The investigator will deliver the 
study arm assignments to a designated study staff member at the project site. Participants 
will be notified of their group assignment at least one week prior to commencement of 
study activities. 
 
Study arms description. The standard care group will receive traditional DSME in a 
group format. However, those in the standard group will attend classes with other un-
related participants, unless two or more diabetics within the same family get assigned 
to the control group. The intervention group will receive the adapted Family Model of 
DSME in a family format, as described above. Participants in the Family Model will be 
encouraged to invite one to ten family members to participate in the DSME sessions as 
well as all other study events. 
 
Intervention: Both the Family Model and the traditional DSME will include 10 hours of 
content comprised of 8 modules. The classes will be delivered over a 6-10 week period 
and each class will be approximately 75 minutes in length. To ensure fidelity, the DSME 
programs in both study groups will be facilitated by a Certified Diabetes Educator (CDE) 
or other licensed healthcare professional with expertise in the content areas. A 
translator/interpreter fluent in both English and Marshallese will be present for every 

Title: Family Model of DSME in the Marshallese Community 
PI: Kohler, P.O. 
Version #: 8 
IRB#: 203482 
Date: 20170825 
Page 5 
session. The family model intervention will be co-facilitated by a Certified Diabetes 
Educator or other licensed healthcare professional and a Marshallese staff person 
fluent in both English and Marshallese. The core elements of DSME intervention are: 
healthy eating, being active, monitoring, understanding blood glucose and taking 
medication, problem solving, reducing risks and healthy coping, mitigating 
complications of diabetes, and goal setting. These core elements will be maintained 
across both groups and are consistent with the American Association of Diabetes 
Educators’ AADE seven self-care behaviors. Sessions will be provided at the 
Springdale AHEC clinic, the Jones Center, or at a location of the participant’s choice. 
 
Biometric Data 
The primary study outcome will be glycemic control as measured by HbA1c. Secondary 
biometric measures include: fasting glucose, waist and hip circumference, weight, height, 
BMI, blood pressure, and fasting lipids: total cholesterol, LDL, HDL, and triglycerides. 
HbA1c, fasting glucose, and fasting lipids will be collected via finger prick, measured using 
portable equipment, and immediately discarded after results are recorded. The biometric 
collection will be completed by qualified, trained research staff. A translator/interpreter will 
be present for each biometric collection. 
 
Survey Data 
We have developed a survey instrument that includes modules from the Diabetes 
Care Profile (DCP), the Behavioral Risk Factor Surveillance Survey (BRFSS), and 
internally developed modules pertaining to diet and physical activity. We will also 
collect demographics, contact information, and a medication inventory using study 
specific forms. The documents will be translated into Marshallese and field tested by 
the study’s Marshallese Community Advisory Board. These surveys/forms will be 
administered at the pre-intervention data collection events and all post- intervention 
data collection events. All surveys will be either self-administered or interviewer-
administered, depending on the preference and/or literacy of the participant. A 
Marshallese translator/interpreter will be present for all DSME sessions and data 
collection events. 
 

Title: Family Model of DSME in the Marshallese Community 
PI: Kohler, P.O. 
Version #: 8 
IRB#: 203482 
Date: 20170825 
Page 6 
 
Table 1. Data Collection and Survey Instrument Description 
Biometric 
Measures 
Biometric measures will include: HbA1c, fasting glucose, waist and hip 
circumference, weight, height, blood pressure, and fasting lipids: total 
cholesterol, LDL, HDL, triglycerides. Standardized protocols will be utilized for 
biometric measures. Waist and hip circumference will be measured to the 
nearest quarter inch utilizing a standard measuring tape. Waist to hip ratio will 
be calculated. Weight will be measured without shoes on a digital scale. Height 
will be measured without shoes to the nearest quarter inch. BMI will be 
calculated using weight and height measurements. Systolic and diastolic blood 
pressure will be measured with participant seated and arm elevated using a 
Sphygmomanometer and stethoscope or digital blood pressure monitor. 
Participants will be asked to fast for 8 hours prior to data collection. Point of 
Care tests will be used to test HbA1c, fasting glucose, and fasting lipids: total 
cholesterol, LDL, HDL, and triglycerides. Through a finger prick blood 
collection, we will test: 1) HbA1c using a Siemens DCA Vantage Analyzer. 2) 
Fasting glucose using the Cholestech LDX, 3) Fasting lipids using a 
commercial lipid panel kit and Cholestech LDX. 
PCORI DSME 
Survey 
Instrument 
A 43 item questionnaire that contains a total of seven modules: demographics, 
health status, health behavior, BRFSS diabetes, understanding, support, and 
health care access. 
Participant 
Contact 
Form 
This form is completed at consent to collect all relevant contact and address 
information as well as contact permissions, in order to schedule and administer 
study activities. Form will be updated as necessary. 
Medication 
Inventory 
A list of current diabetes medications will be collected at each data collection 
event so that we can control for variations in medications during the analytical 
phase and be better able to attribute changes in glycemic control to the DSME 
rather than confounding factors. 
 
 

Title: Family Model of DSME in the Marshallese Community 
PI: Kohler, P.O. 
Version #: 8 
IRB#: 203482 
Date: 20170825 
Page 7 
Estimated Study Calendar 
Table 2: Milestones 
YEAR 1 
Milestones 
Description 
Approximate Dates 
Recruitment and random 
assignment of 
participants 
Recruitment and random assignment will begin 
during the second quarter of year one and 
continue throughout the year. 
04/30/2015 
Intervention sessions and 
data collection events 
completed 
The intervention sessions will begin during the 
second half of year one, with approximately 53 
participants from the intervention (plus family 
participants) and 22 control participants will 
complete the intervention and pre-post-data 
collection events. 
04/30/2015 
YEAR 2 
Recruitment and random 
assignment of 
participants. 
Recruitment and random assignment will 
continue through the first half of year two. 
10/31/2015 
Intervention sessions and 
data collection events 
completed 
The intervention sessions will continue 
throughout year two, approximately110 primary
participants (plus family participants) and 50 
control participants will complete the 
intervention and pre-post-data collection 
events. 6 and 12 month data collection events 
will be completed for year one participants. 
04/30/2016 
YEAR 3 
Data analysis 
Collaborative analysis of data with 
stakeholders. 
04/30/2017 
Collaborative 
Dissemination 
Collaborative dissemination of results back to 
the community. 
04/30/2017 
 
Study Population 
 
Recruitment and Consent: There are ~11,000 Marshallese living in Springdale, 
Arkansas. Using conservative estimates, 3,000 of the Marshallese living in Springdale, 
Arkansas have type 2 diabetes, providing a sufficient participant pool for recruitment.1-5,37 
Participants will be recruited through the three primary clinics that care for the 
Marshallese—the Community Clinic (a Federally Qualified Health Center), the Springdale 
Family Medical Center, and the Dr. Bates Outreach Clinic in Springdale. In addition, 
participants will be recruited through local Marshallese churches, community leaders, 
and Yokwe.net, the primary social media site for the Marshallese community. A more 
detailed recruitment plan is outlined in the following section. Potential participants will be 
provided information about the study and given the opportunity to take a brief eligibility 
screener that determines and documents study eligibility. Up to 300 participants with 
diabetes (initial participants) will be recruited and enrolled, and each participant in the 

Title: Family Model of DSME in the Marshallese Community 
PI: Kohler, P.O. 
Version #: 8 
IRB#: 203482 
Date: 20170825 
Page 8 
treatment group will be asked to invite between one and ten family members to attend the 
diabetes education sessions and potentially join the study. All members of the research 
team will be trained and certified in participant consent procedures, the study protocol, 
human subjects protection, and HIPAA regulations. During the presentation/discussion 
of the study, potential participants will be screened for eligibility. Inclusion/exclusion 
criteria are as follows: 
 
Initial Participant Inclusion Criteria 
 
 18 years and older 
 Self-reported Marshallese ethnicity or descent 
 Self-reported Diabetes Mellitus Type 2 diagnosis by a health care provider 
 
Initial Participant Exclusion Criteria 
 
 Younger than 18 years of age 
 Not Marshallese ethnicity or descent 
 No reported Diabetes Mellitus Type 2 diagnosis 
 
Family Member Inclusion Criteria 
 
 18 years and older 
 
Family Member Exclusion Criteria 
 
 Younger than 18 years of age 
 
Potential participants who are interested in joining the study will be provided the 
opportunity to ask questions, consent and enroll in the study. At enrollment, a participant 
contact information form will be completed and include participant contact information 
(phone numbers, address, e-mail), preferred method of contact (i.e. text, phone, mail, e-
mail), and demographic information. 
Recruitment Plan. Identified, recruited, and enrolled: Marshallese recruitment staff will be 
employed to conduct the study. Participants will be recruited through provider referrals 
from the three primary clinics that care for the Marshallese: Community Clinic (a Federally 
Qualified Health Center), the Springdale Family Medical Center, and the Dr. Bates 
Outreach Clinic in Springdale. In addition, participants will be recruited through local 
Marshallese churches, community leaders, our Community Advisory Board, community 
health events, and Yokwe.net. 
In the clinical setting, potential participants who meet the enrollment criteria will be 
identified by their healthcare provider. All potential participants meeting the inclusion 
criteria will be systematically provided information about the study and given the 
opportunity to discuss the study with a Marshallese research staff member. To reduce 
selection bias and ensure we reach persons who may not have a primary care provider 

Title: Family Model of DSME in the Marshallese Community 
PI: Kohler, P.O. 
Version #: 8 
IRB#: 203482 
Date: 20170825 
Page 9 
(there is a low rate of insurance and medical homes among the target population), we will 
also recruit from local Marshallese churches. 
For recruitment in the churches, we will distribute recruitment information, which will include 
the purpose of the study, the PI, sponsor, and inclusion criteria. Study information will be 
distributed in both English and Marshallese. Marshallese recruitment staff will also give a 
presentation about the study at churches after religious services. While this method of 
recruitment may seem unconventional, we have successfully used it to engage the 
Marshallese community, and our CBPR group believes it is the most culturally appropriate 
way to recruit. 
At targeted community and health events, we will set up a booth and provide informational 
materials as well as be available to discuss the study in more detail. If potential participants 
are interested in enrolling in the study, they will complete a form that captures contact 
information and a meeting will be set up so that the consent process can take place in 
private. 
We will also provide a dedicated e-mail address and phone lines for any interested 
community members who hear about this study through community leaders, Marshallese 
Community Advisory Board members, and Yokwe.net to learn about and participate in the 
study. 
Participants and family member measures. As discussed above, the participants 
assigned to the treatment group will be asked to invite between one and ten family 
members to join them for the education sessions. Family members may or may not 
have Type 2 diabetes. Family members will be provided the opportunity to consent 
after the initial participants have invited them to take part in the study. Primary analysis 
will be based on the participants with diabetes. In addition, we will collect and analyze 
the outcomes of the family participants who have consented and report any value 
added by including outcomes of family members. We will collect biometric and survey 
instrument data on family members who consent and participate. If family members are 
found to have elevated HbA1c during the data collection but have not previously been 
diagnosed with diabetes, we will refer them to a health care provider. 
 
Primary participant’s diabetes status will be confirmed by their HbA1c at the time of 
initial data collection. Primary participants who do not have HbA1c results indicative of 
diabetes, 6.5 or above, will be unenrolled from the study as primary participants. If they 
were randomized into the family arm of the study and another family member does 
have HbA1c results indicative of diabetes, participation of the entire family unit 
(including with an HbA1c less than 6.5) will continue. 
 
Risks and Benefits 
 
Potential risks to study participants are minimal and no greater than usual care or 
standard health screenings. There is a potential risk for loss of confidentiality. Measures 
to protect the confidentiality of study participants will be implemented as described in the 
Data Handling and Recordkeeping section below. 

Title: Family Model of DSME in the Marshallese Community 
PI: Kohler, P.O. 
Version #: 8 
IRB#: 203482 
Date: 20170825 
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The DSME has the potential to benefit participants by fostering better disease 
management activities and improving health and quality of life. In addition, knowledge 
gained from the study could impact future delivery of DSME to minorities and 
underserved populations. 
 
Data Capture 
 
The study team will utilize an electronic database to capture study data. Survey 
instrument responses will be captured with paper and pencil instruments (PAPI). All 
surveys will be available in English or Marshallese and then entered into the database. A 
translator/interpreter will be available to assist participants. Biometric data will be 
collected and recorded in the database. Upon entry into the study, each participant will 
be assigned a participant identification number and registered to the study. 
 
Data Handling and Recordkeeping 
 
The Principal Investigator will carefully monitor study procedures to protect the safety of 
research subjects, the quality of the data and the integrity of the study. All study subject 
material will be assigned a unique identifying code or number. Only study investigators 
and analytical and quality assurance staff will have access to the code and information 
that identifies the subject in this study. All hard copies of study materials will be kept in a 
locked file and the key to the participant codes and any electronic data will be stored on a 
secure, encrypted server. 
 
Data Analysis 
 
Sample size and power considerations 
All of the power and sample size calculations and estimations were performed using 
PASS 2008 (NCSS, LLC. Kaysville, Utah.  www.ncss.com). Our study design is a 
randomized two-group construct with 4 repeated time points (baseline, post intervention, 
6 months, and 12 months). So at its core, the study is a two-factor design with repeated 
measures, which can be expanded into a general linear regression model, with main 
covariates being group assignment, time, their interaction, and adjustment for other 
covariates. The sample sizes will achieve 80% power to detect a medium effect of 0.3 in 
a design with 4 repeated measurements having a compound symmetry covariance 
structure. The correlation between observations on the same subject is assumed to be of 
moderate magnitude at 0.5, and the alpha level is 0.05.38-39 This hypothesized detectable 
effect is of the same magnitude as a study that reported approximately 0.5% change in 
HbA1c with the standard deviation of the change being 1.5%. 
 
Statistical Analysis 
All of the analyses are going to be conducted using SAS v9.3 (SAS Institute Inc. Cary, 
NC. www.sas.com). Preliminary analyses will include the generation of descriptive 
statistics and assessment of group differences at baseline, as well as examination of 
distributions, treatment drop-out, and missing data patterns’ impact on treatment effects. 

Title: Family Model of DSME in the Marshallese Community 
PI: Kohler, P.O. 
Version #: 8 
IRB#: 203482 
Date: 20170825 
Page 11 
Comparison of baseline characteristics between the two groups are going to be 
performed using two sample techniques such as a two-sample t-test and chi-square test; 
however, if the distributional or other assumptions have been violated we are going to use 
non-parametric alternatives, like Wilcoxon Rank Sum test, and/or Fishers exact test. 
Additional statistical analyses and considerations follow. 
 
Analysis of primary outcome 
The primary outcome is change in HbA1c between baseline, post intervention, 6 months 
post-intervention, and 12 months post-intervention. Repeated measures of these 
outcomes will be obtained at four visits as described. Our primary analytic approach will 
use general linear models (GLM) and mixed models for continuous repeated measures to 
model the mean outcome differences and covariance structures between the groups. 
Using these models, group effects will be estimated and tested by comparing group- 
specific means at post intervention, 6 months, and 12 months, while conservatively 
adjusting for the baseline differences in ANCOVA like mixed regression models. 
 
Analysis of secondary outcomes 
Analytic strategies similar to those used to evaluate our primary outcome will be 
employed to examine the proposed secondary measures. We will examine group effects, 
time effects and the interaction between them on other measures (fasting glucose, % 
weight loss, BMI, waist-hip ratio, lipids, and survey instrument data) using mixed and 
general/generalized linear ANCOVA like mixed models or general estimating equations 
(GEE), depending on the measurement scale of the outcome. Additional analyses would 
expand the existing multivariate models to include several other covariates for 
adjustments as well as to examine their associations with the outcomes. 
Demographics and socioeconomic factors will be included for conservative adjustment if 
not comparable between conditions. 
 
Missing data 
Analyses of our primary outcome variable (mean differences in HbA1c between groups) 
will be done in accordance with the intent-to-treat principle. That is, data from all 
randomized participants will be analyzed regardless of compliance with study protocol or 
failure to complete the study. For this reason, we propose to impute the missing data 
using SAS PROC MI and its inbuilt MCMC algorithm, which is the most appropriate 
imputation method for the arbitrary missing data mechanism.40-41 If the data are missing 
according to non-ignorable mechanism, alternative imputation mechanisms will be 
considered. Imputed data will be combined and analyzed using SAS PROC MIANALYZE 
in order to generate appropriate estimates and their standard errors. 
 
Ethical Considerations 
 
This study will be conducted in accordance with all applicable government regulations 
and University of Arkansas for Medical Sciences research policies and procedures. This 
protocol and any amendments will be submitted and approved by the UAMS 
Institutional Review Board (IRB) to conduct the study. 
 

Title: Family Model of DSME in the Marshallese Community 
PI: Kohler, P.O. 
Version #: 8 
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Date: 20170825 
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The formal consent of each subject, using the IRB-approved consent form, will be obtained 
before that subject is submitted to any study procedure. All subjects for this study will be 
provided a consent form describing this study and providing sufficient information in 
language suitable for subjects to make an informed decision about their participation in this 
study. A translator/interpreter will be available for the consent process. The person 
obtaining consent will thoroughly explain each element of the document and outline the 
risks and benefits, alternate treatment(s), and requirements of the study. The consent 
process will take place in a private setting (e.g. participant’s home, the UAMS office at the 
JTL Shops in Springdale, or the UAMS offices in Fayetteville) of the participant’s choice 
and subjects may take as much time as needed to make a decision about their 
participation. Participation privacy will be maintained and questions regarding participation 
will be answered. No coercion or undue influence will be used in the consent process. This 
consent form must be signed by the subject and the individual obtaining the consent. A 
copy of the consent will be given to the participant, and the informed consent process will 
be documented in each subject’s research record. 
 
Dissemination of Data 
 
The data gained from the proposed research will help providers offer effective diabetes 
self-management programs, and care plans for the Marshallese and further research on 
diabetes among the Marshallese. Our first priority will be to disseminate results back to 
participants. Through our CBPR collaborative, we will also provide a summary of the 
results back to the Marshallese community, ensuring that participant confidentiality is 
maintained. Additionally, results of this study may be used for presentations, posters, or 
publications. The publications will not contain any identifiable information that could be 
linked to a participant. 
 
References 
 
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International Diabetes Federation; 2011. 
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Community-Based Diabetic Health Improvement Project. Californian Journal of 
Health Promotion. 2005;3(4):36-47. 
3. Ravi Reddy, Richard Trinidad, Johannes Seremai, Nasa J. Marshallese Diabetic 
Health Improvement Pilot Project in Ebeye. Californian Journal of Health 
Promotion. 2009;7(Special Issue: Obesity Prevention):125-30. 
4. S Yamada, A Dodd, T Soe, TH Chen, Bauman K. Diabetes Mellitus Prevalence in 
Out-Patient Marshallese Adults on Ebeye Island, Republic of the Marshall 
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Arkansas Assessment Initiative; 2009. 

Title: Family Model of DSME in the Marshallese Community 
PI: Kohler, P.O. 
Version #: 8 
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Date: 20170825 
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7. Patricia Woodall, David Scollard, Rajan L. Hansen Disease among Micronesian and 
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Aspirin Therapy, Blood Pressure, Cholesterol and Diabetes. Am J Pharm Ed. 
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9. Jimeno RA. A Profile of the Marshallese Community in Arkansas, Volume 3. Little 
Rock, AR and Fayetteville, AR: University of Arkansas; 2013. 
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12. McElfish P. Unpublished preliminary planning interviews with local Marshallese 
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Date: 20170825 
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