Healthy Body Healthy Souls: A Weight Loss Intervention Using Diabetes Prevention Program Lifestyle Intervention (DPP-LI) With Church Level Systems Change in the Marshallese Population
Phase: NA
Conditions: Weight Loss, Pre Diabetes, Overweight and Obesity
Sponsor: University of Arkansas

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Study Title: 
Healthy Body Healthy Souls: A weight loss intervention using 
Diabetes Prevention Program Lifestyle Intervention (DPP-LI) 
with Church Level Systems Change in the Marshallese 
Population. 
 
 
 
 
Principal Investigator: 
Pearl McElfish, PhD 
College of Medicine 
University of Arkansas for Medical Sciences 
1125 North College Avenue 
Fayetteville, AR 72703 
Phone: 479.713.8680 
E-mail: pamcelfish@uams.edu 
 
 
 
 
Study location: 
University of Arkansas for Medical Sciences 
Northwest Arkansas Campus 
1125 North College Avenue 
Fayetteville, AR 72703 
 

Title: Healthy Bodies Healthy Souls in the Marshallese Population 
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Background and Rationale 
Disparities in type 2 diabetes, pre-diabetes, and obesity among the Marshallese and Pacific 
Islanders. This study focuses on the Marshallese living in Arkansas. The Marshallese are a 
Pacific Islander population experiencing significant health disparities, with some of the highest 
documented rates of type 2 diabetes of any population group in the world.1-3, 4, 5-7 Our review of 
local, national, and international data sources found estimates of diabetes in the Marshallese 
population (in the US and the Republic of the Marshall Islands) ranging from 20% to 50%, 
compared to 8% for the US population and 4% worldwide (Table 1).1-3, 5 
 
While national prevalence data are limited, 23.7% 
of Pacific Islanders surveyed by the Centers for 
Disease Control and Prevention (CDC) in 2010 
reported a diagnosis of type 2 diabetes – more than all 
other racial/ethnic groups.8 Our preliminary research, 
which included health screenings with the Marshallese 
community in Northwest Arkansas (n = 401), 
documented extremely high incidence of diabetes 
(38.2%) and pre-diabetes (32.4%). Our pilot data also 
revealed similar disparities in obesity, one of the 
strongest risk factors for diabetes; 90% of Marshallese 
participants were classified as overweight or obese.9, 10 Further compounding these significant 
disparities, Pacific Islanders living in the US are less likely than other racial/ethnic groups to 
receive preventive or diagnostic treatment or diabetes education.11, 12, 13, 14, 15 
 
This study addresses an urgent need for interventions to reduce obesity and diabetes disparities 
in the Marshallese community and will employ a culturally appropriate, multilevel approach. The 
scientific premise of our study includes four main points. First, the Arkansas Marshallese suffer 
from a significant and disproportionate burden of type 2 diabetes and lack access to effective 
prevention and treatment due to a dearth of research with Pacific Islanders.16-19, 20, 21,22,13 Second, 
the association between weight gain and risk for type 2 diabetes is strong. Overweight/obesity is 
considered the strongest modifiable risk factor for type 2 diabetes,23 and even a modest reduction 
in weight (5-10%) is clinically meaningful.24-26 Third, research demonstrates the effectiveness of 
multi-level lifestyle interventions in reducing weight and the onset and impact of diabetes.27-33 
Fourth, to be effective among Pacific Islanders, interventions must be developed to address 
influences at multiple levels34-36, 37-39, 40 and should be culturally adapted to incorporate Pacific 
Islanders’ worldviews and cultural values.20,41-49 Prior research indicates the importance of using 
a Community Based Participatory Research (CBPR) approach to understand and integrate 
cultural nuances during the cultural adaptation process and implementation of multilevel 
interventions.34-39, 50-61 A CBPR approach is also essential to conducting ethical, valid health 
research in populations whose health beliefs and behaviors have been shaped by historical 
trauma.59, 62, 63 Finally, churches are primary social institutions of Pacific Islander health.64-68 
Faith-based interventions are effective at improving behavioral and anthropometric outcomes 
within collectivistic communities and therefore hold great promise for Marshallese and other 
Pacific Islanders.42,43,69-73 
Table 1. Diabetes rates 
Documented rates of diabetes 
in Marshallese population 
% 
US (IDF) 
8 
World Wide (IDF) 
4 
Marshallese (Yamada) 
20 
Marshallese (Minegishi) 
31 
Marshallese age 15+ (LeDoux) 28 
Marshallese age 35+ (LeDoux) 
50 
Marshallese (Woodall) 
30 

Title: Healthy Bodies Healthy Souls in the Marshallese Population 
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Reducing disparities by reducing weight. Overweight/obesity is considered the strongest 
modifiable risk factor for type 2 diabetes,74 and even a modest reduction in weight (5-10%) can 
be clinically meaningful.75-77 
 
Specific Aim. Our aim is to pilot test a weight-loss intervention referred to throughout the 
proposal as Healthy Bodies Healthy Souls (HBHS) in a single arm study. The intervention 
includes the Diabetes Prevention Program Lifestyle Intervention (DPP-LI) with the additional 
enhancement of working with Marshallese churches to implement organizational/institutional 
level changes to support the individual behavioral intervention of the DPP-LI. Because the DPP-
LI intervention and data collection are the same as the approved UAMS IRB #207034, the study 
team may compare the outcomes of this pilot study to the outcomes of the DPP-LI. 
 
Study design 
Up to four Marshallese churches will be recruited. 
 
The primary outcome is percentage of body weight loss. Secondary variables include: 1) HbA1c, 
2) blood pressure, 3) changes in food and physical activity related behaviors, and 4) changes in 
self-efficacy and perceived social and environmental support for healthy lifestyle changes. 
 
Recruitment and Consent 
Participants will be recruited through churches from Arkansas, Kansas, Missouri, and/or 
Oklahoma. The recruitment goal for the church level intervention is up to 40 participants per 
church for up to four churches for a total of 160 participants through the duration of the study. 
The recruitment goal for the DPP-LI is up to 18 participants per church for up to four churches 
for a total of up to 72 participants through the duration of the study. 
 
During recruitment, Marshallese study staff will give presentations and distribute study 
information in English and Marshallese within churches. All persons in attendance will be offered 
the opportunity to participate in the health screening. Those who express interest in participation 
in the DPP-LI will complete a screening instrument to determine eligibility – see 
Inclusion/Exclusion criteria. The eligibility screener will include systolic and diastolic blood 
pressure and height and weight measurements to calculate BMI. 
 
Church-based recruitment is specified by stakeholders as culturally appropriate and the 
community’s preferred recruitment method. 
 
Inclusion Criteria 
Participant inclusion criteria: 
1) Self-reported Marshallese 
2) 18 years of age or older 
3) To participate in the DPP-LI, have a body mass index (BMI) of ≥25 kg/m2 

Title: Healthy Bodies Healthy Souls in the Marshallese Population 
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Exclusion Criteria 
Participant exclusion criteria for the DPP-LI: 
1) A clinically significant medical condition likely to impact weight (cancer, HIV/AIDS, 
etc.) 
2) Currently pregnant or breastfeeding an infant who is 6 months old or younger. 
3) Have any condition that makes it unlikely that the participant will be able to follow the 
protocol, such as terminal illness, plans to move out of the area within 6 months, and 
inability to finish the intervention, etc. 
 
Two physicians, a Marshallese family practice doctor and an endocrinologist, make up the data 
safety monitoring team, and will review the Eligibility Screener forms to determine if persons 
screened have clinically significant medical conditions that will exclude them from the DPP-LI 
component of the study. 
 
All study information and consent materials will be provided in English and/or Marshallese 
based upon the participants’ preferences. Eligible participants will be provided a copy of the 
consent to review, and participants will have the opportunity to ask questions, consent, and enroll 
in the study. The consent process will include providing information to the potential participants 
and the opportunity to have bilingual Marshallese staff answer questions regarding study 
participation. The consent document will be given to the participant, and the informed consent 
process will be documented in the participant’s research record. The consent document will be 
reviewed with the group and questions will be answered by research staff. Experience working 
with the Marshallese population and input from both advisory groups and Marshallese staff 
support providing consent information to potential participants in a group setting. This is 
consistent with Marshallese cultural practices and does not preclude the provision of the 
opportunity for all potential participants for individual, private discussion of the study and the 
consent document before they sign the consent. All members of the research team will be trained 
and certified in participant consent procedures, the study protocol, human subjects protection, 
and HIPAA regulations. After the consent process, a participant contact information form will be 
completed. 
 
Data Collection Instruments and Procedures 
Biometric and survey data will be collected during pre-intervention, post-intervention, and 
twelve months post-initiation on both persons who only participate in the health screening and 
those who participate in the DPP-LI. The data collection window is up to six weeks on each side 
of the data collection date to accommodate participant availability. In the event missing data is 
identified, participants will be contacted to collect the missing data. 
 
Participants may be invited to participate in a qualitative interview to understand participants’ 
perceptions of the intervention and implementation process. Participants may refuse any data 
collection or any questions within a data collection event. 
 

Title: Healthy Bodies Healthy Souls in the Marshallese Population 
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Biometric Data 
Biometric measures include: HbA1c, weight, height, BMI (calculated by height and weight), 
waist measurement, and blood pressure. Participants’ weight will be measured in clothing to the 
nearest 0.5 lb. (0.2 kg) using a calibrated scale. Height (without shoes) will be measured to the 
nearest 0.25 inches using a stadiometer. Weight and height will be used to compute a continuous 
measure of BMI using the Quetelet Index (kg/m2).78 Systolic and diastolic blood pressure will be 
measured using a sphygmomanometer and stethoscope or digital blood pressure device with the 
participant seated and arm elevated. Finger stick blood collection will be used to test HbA1c 
using a Rapid A1c test kit and Siemens DCA Vantage Analyzer. The biometric data collection 
will be completed by qualified, trained research staff. Bilingual study staff will be present for 
each biometric collection. 
 
Survey Data 
The survey data collection instruments include: 
 
Data 
collection 
measures 
Description of outcomes measured and validated scales/instruments 
Eligibility 
Screener 
Name, phone number, identification as Marshallese, date of birth, age, weight, 
height, calculated BMI, interest in participation, physical limitations, dietary 
restrictions, related co-morbidities, and a brief suitability for physical activity 
screener.79-80 
Biometric 
measures 
HbA1c, weight, height (only at pre-intervention), calculated BMI, waist 
measurement, and blood pressure. 
Demographic 
Age, sex, marital status, pregnancy status, number of persons in home, 
education, employment, health status, select co-morbidities, insurance status, 
and ability to access health care will be captured. 
Diabetes 
related 
behaviors 
Diabetes related behaviors will be collected based on measures from the DPP-
LI81-83, Behavioral Risk Factor Surveillance System (BRFSS)69, and National 
Health and Nutrition Examination Survey (NHANES)84. 
 
The survey data collection includes 57 items adapted from valid and reliable scales, which will 
take participants approximately 20 minutes to complete. Family support for exercise and healthy 
diet is measured by items from Gruber (2008).85 Weight locus of control is measured using the 
Weight Locus of Control scale.86 Exercise self-efficacy is measured using the self-efficacy for 
exercise and outcome expectations scale Resnick (2004).87 Eating habits are measured by self-
efficacy scales for health related diet and exercise behaviors from Clark et al (1991). Fruit and 
vegetable consumption is measured by Shannon et al., (1997).89 Food insecurity is measured 
using questions from National Health and Nutrition Examination Survey (NHANES).84 
Questions about sugar sweetened beverage consumption and sleep quality and quantity are taken 
from the Behavioral Risk Factor Surveillance System (BRFSS).69 There is one item about church 
attendance from the Koenig & Büssing (2010), and items regarding how often participants 
receive health messages at church adapted from Ayers et al.88 
 

Title: Healthy Bodies Healthy Souls in the Marshallese Population 
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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 and post-intervention data collection events. All surveys will be 
administered by a qualified study staff who have completed all required trainings (see 
protections against risk). A bilingual Marshallese staff will be present for all sessions and 
data collection events. 
 
Remuneration: Participants who only participate in the church health screening will be offered 
a $20 Walmart gift card for each data collection event and an additional $20 gift card if they 
participate in the qualitative interview. Participants who participate in all three data collection 
events and a qualitative interview will receive a total of $80 in gift cards. Participants will only 
receive gift cards for the health screenings they complete. 
 
Participants that are in the DPP-LI classes will be offered a $20 Walmart gift card as 
remuneration for their time for their pre-intervention data collection event, a $30 Walmart gift 
card as remuneration for their post-intervention data collection event, and a $40 Walmart gift 
card as remuneration for their 12 month post-initiation event. Participants will only receive gift 
cards for the data collection events they complete. Each participant will be eligible to collect 
three gift cards, for a total of $90 for those who participate in all three data collection events. 
 
Participants that are in the DPP-LI classes and who participate in the qualitative interview will be 
provided a $20 Walmart gift card for their participation. A DPP-LI class participant who 
completes all three data collection events and the interview will receive a total of $110 in gift 
cards. 
 
Intervention Description. Participant groups will receive the DPP-LI. The intervention modules 
will be delivered at a church group setting and participation in discussion will be encouraged. 
The interventions’ core curricula emphasize increasing physical activity, eating healthy, and 
sustaining motivation. Participants will be invited to join a private Facebook group to facilitate 
providing reminders and sharing information between educational sessions. The private 
Facebook group will be created and managed by study staff. Participation will not be a required 
component of the study. The intervention includes 16 modules that are delivered over a 24 week 
period, each class will last about 90 minutes and may include up to 30 minutes of physical 
activity. The first 8 modules are delivered weekly and the last 8 modules are intended to be 
delivered every other week. Participants will be encouraged to maintain a daily weight, nutrition, 
physical activity, and prayer log. Persons who do not want to participate in the study or choose to 
stop participating in the study can still attend the classes. 
 
Each group will be led by bilingual (Marshallese and English) DPP-LI lay educators who will 
each receive no less than 40 hours of DPP-LI lifestyle coach training provided by Dr. Karen 
Yeary, an expert in DPP. The lay educators have also receive 24 hours of training as Community 
Health Workers. Each of these lay educators have at least two years’ experience delivering 
health education interventions. The intervention will offer materials and survey instruments in 
English and Marshallese. Makeup sessions for missed modules will be offered. 
 

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Within three months of the conclusion of the educational modules, participants may be invited to 
participate in a qualitative interview to collect information regarding their experience. 
Qualitative data will be collected from participants in focus groups or individual interviews. A 
semi-structured interview guide will be used to allow participants to speak in-depth about their 
experiences, yet also ensure that all focus groups or individual interviews cover the same topics. 
Each focus group or individual interview will have an anticipated duration of one hour. 
 
In addition to the DPP-LI provided to the church members, organizational/institutional change 
level support will be provided to the church. The organizational/institutional intervention will 
include meeting with church leadership and church health committee members approximately 
monthly to identify what organizational changes they want to make. The facilitated meetings to 
identify changes that the church wants to make will last approximately 2-3 hours. The 
organizational/institutional systems, policies, and environmental changes will be developed 
collaboratively with church leaders/members. Organizational/instructional changes to support 
healthier behaviors include improvements in food purchasing and preparation for events, 
physical activity programs, and increased congregational engagement in health promotion 
activities.91, 92 Example changes could include: starting a walking club, implementing a policy to 
not included sugary beverages at church meals, implementing a healthy potluck policy. The 
number of church leaders and health members who will attend per church will be determined by 
each church. Process notes will document changes made by each church. Church leaders and 
health committee member will not be consented unless they take part in the DPP-LI and/or they 
take part in the focus groups. 
 
Risks and Benefits 
Potential risks to study participants are minimal and no greater than usual care or standard health 
screenings. The physical activity may result in fatigue or soreness. 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. The alternative to 
participating in the interventions is to not participate in the interventions. Further, any participant 
can choose to leave the study at any time. 
 
Protections against risk. All data collectors involved in the interventions will have received 
training on: participant consent procedures, the study protocol, human subjects protection, 
HIPAA regulations, survey administration, biomedical data collection (including finger stick 
blood collection), maintaining confidentiality of study participants, mandatory reporting, and 
appropriate treatment of participant data. Collection, transport, and storage of data, and 
subsequent access will be limited to only those personnel who need it to complete relevant job 
duties. All data, regardless of whether it is identifiable or not, will be stored in a locked file 
cabinet in a locked room, or on a secure UAMS server that requires two-factor authentication. 
 
Medical related risks identified by study staff or reported by participants will be referred to Dr. 
Sheldon Riklon for consultation and response. 
 

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Potential Benefits of the Proposed Research to Human Subjects and Others 
Individuals may experience positive health benefits throughout the period of the study. The 
intervention has the potential to improve healthy behaviors and facilitate weight loss that can 
reduce the risk of diabetes. However, these benefits are not guaranteed. It cannot be predicted 
how each participant will respond to intervention education and activities. By following each 
individual participant, the study will acquire new information regarding effective methods to 
influence risk factors for diabetes among Marshallese community members. Results of the study 
will inform future interventions and can provide benefits to future participants and the broader 
community. The opportunities for improved health, coupled with the fact that this is minimal risk 
behavior-modification research, creates an ideal benefit-to-risk ratio. 
 
Data Capture 
Survey, biometric, and other instrument responses will be captured with paper and pencil 
instruments or through a computerized data collection tool. All survey data collection 
instruments will include English and Marshallese versions. A computer database will be used to 
manage study data after it is collected. 
 
Data Handling and Recordkeeping 
The Principal Investigator and study team will carefully monitor study procedures to protect the 
safety of research subjects, the quality of the data, and the integrity of the study. Collection, 
transport, and storage of data, and subsequent access will be limited to only those personnel who 
require it to complete relevant job duties and who have completed all required trainings for study 
activities and in maintaining confidentiality. Detailed procedures will be developed for data 
collection, transfer, and storage, but will at minimum require that data is always in a locked 
transfer case, in a locked storage unit, or on a secure, password-protected server. Participant 
identification numbers will be used to track study forms. Access to files will be limited to select 
study personnel as designated in the delegation log. All records will be retained consistent with 
the UAMS Administrative Guide (seven years after final reporting or publication of a project). 
Data collected from participants who indicate on the consent form that their information may be 
used for future diabetes related research will be retained indefinitely. 
 
Data analysis. The proposed study is a pilot, so the focus is not on testing hypotheses;93 the 
focus is on culturally adapting the HBHS intervention and evaluating its feasibility, acceptability, 
and preliminary effectiveness of the adapted intervention. In addressing the question of 
preliminary effectiveness, the pilot study data will be used to estimate parameters and effect 
sizes needed to better plan a larger study.94 Using pilot data, the results will be compared to the 
results of protocol #207034 testing DPP-LI in the Marshallese community without the 
organizational/institutional level intervention. Focus will be on point estimates and confidence 
intervals instead of p-values from hypothesis tests. Judgment of the preliminary effectiveness of 
the intervention will be based on the estimated mean difference between the groups and the 
range of plausible values for that parameter from confidence interval. Attention will be on 
looking to see if the effect is in the right direction (consistent with the intervention being 
effective) and whether the estimate would be clinically meaningful. To assess feasibility of the 
analysis plan for the larger study and the preliminary effectiveness of the intervention, pilot data 

Title: Healthy Bodies Healthy Souls in the Marshallese Population 
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will be analyzed with SASv9.495 following the plan for a larger study. This will include 
screening for outliers and violations of model assumptions. Using linear mixed-effects models to 
test the effect of the HBHS intervention, controlling for demographics and relevant covariates. 
These analyses will provide information about possible problems with measures and data 
collection procedures. The pilot data will also be used to estimate within- and between-cluster 
variability and the intraclass correlation (using protocol #207034 data as a comparator). Based 
only on review of the relevant literature, a 2.5 kg (SD = 7 kg; Cohen’s d = 0.36) difference in 
weight loss between the groups is anticipated.96 For context, the proposed pilot study would have 
80% power to detect an effect size of 0.68 (calculated with PASS12; two-sided alpha = .05; ICC 
= .01). Although the pilot study is not adequately powered as a full scale RCT to evaluate the 
effectiveness of the intervention, we will have an adequate sample size to estimate means, 
standard deviations, effect sizes, and confidence intervals that will provide preliminary 
information and prove invaluable in planning the full scale evaluation of the intervention. 
 
 
Qualitative data analysis. The 10 post-intervention interviews will be recorded and transcribed, 
and then imported into MAXQDA qualitative software.97 Transcripts will be analyzed using 
content analysis related to the feasibility and acceptability of the intervention. 
 
 
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. 
 
The formal consent of each subject, using the IRB-approved consent form, will be obtained 
before that subject is involved in 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. Subjects may take as much time as needed to make a 
decision about their participation. 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. 
 
 
Data and Safety Monitoring Plan. This is no more than a minimum risk study however, a Data 
and Safety Monitoring Plan has been submitted as a separate document. 
 
 
Dissemination of Data. The data gained from the proposed research will help providers offer 
effective diabetes prevention programs and further research on diabetes among the Marshallese. 

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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. 
 

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