Diabetes Prevention Program Lifestyle Intervention in the Marshallese Population
NCT ID: NCT03270436
Last Updated: 2020-12-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
380 participants
INTERVENTIONAL
2018-01-08
2020-05-14
Brief Summary
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Detailed Description
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Disparities in type 2 diabetes, pre-diabetes, and obesity among the Marshallese and Pacific Islanders.
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. Our review of local, national, and international data sources found estimates of diabetes in the Marshallese population (those living in the US and in the Republic of the Marshall Islands) ranging from 20% to 50%, compared to 8.3% for the US population and 4% worldwide. 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. Our pilot research, which includes health screenings with the Marshallese community in northwest Arkansas (n=398), documented extremely high incidence of diabetes (38.4%) and pre-diabetes (32.6%). Our pilot data also revealed similar disparities in one of the strongest risk factors for diabetes-obesity-with 90% of Marshallese participants classified as overweight or obese. Thirty-two percent of those who had pre-diabetes were also overweight or obese. Further compounding these significant disparities in diabetes prevalence and related risk factors, research indicates that Pacific Islanders living in the US are less likely than other racial/ethnic groups to receive preventative or diagnostic treatment, or diabetes education.
Reducing disparities by reducing weight. Overweight/obesity is considered the strongest modifiable risk factor for type 2 diabetes, and even a modest reduction in weight (5-10%) can be clinically meaningful.
Specific aim. Our aim is to compare the effectiveness of achieving weight loss between two Diabetes Prevention Program (DPP) Lifestyle Interventions - the faith-based Wholeness, Oneness, Righteousness, Deliverance (WORD) DPP, and the Pacific Islander culturally-adapted Partnership for Improving Lifestyle Interventions (PILI) DPP - in the Marshallese population using a cluster randomized controlled trial (cRCT).
Study design. The study design is a comparative effectiveness cRCT conducted in church settings or other community setting convenient to the participant group. Churches were selected as the primary setting based on Marshallese stakeholder input.
Randomized participant assignment. Randomization will occur at the church cluster level, with 1:1 assignment of churches to each arm. Churches and community based participant groups will be blocked (i.e., grouped into similar units) according to geographic region and approximate number of adult church members. Randomization will be conducted by a biostatistician or designated investigator, who will have no interactions with potential participants and has no supervisory role with study staff responsible for recruiting, consent, and intervention process.
Recruitment and Consent
Church-based recruitment is specified by stakeholders as culturally appropriate and the community's preferred recruitment method. During recruitment, Marshallese study staff will give presentations and distribute study information in English and Marshallese. Those who express interest will complete an eligibility screener, to determine eligibility. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program
The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (WORD DPP) is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.
Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program
Faith based diabetes curriculum that teaches participants to connect faith and health.
Partnership for Improving Lifestyle Intervention Diabetes Prevention Program
The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.
Partnership for Improving Lifestyle Intervention Diabetes Prevention Program
Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.
Interventions
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Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program
Faith based diabetes curriculum that teaches participants to connect faith and health.
Partnership for Improving Lifestyle Intervention Diabetes Prevention Program
Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.
Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older
* BMI greater than or equal to 25
Exclusion Criteria
* Currently pregnant or breastfeeding an infant who is 6 months old or younger
* 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, an inability to finish the intervention, etc.
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of Arkansas
OTHER
Responsible Party
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Principal Investigators
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Pearl McElfish, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas
Locations
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University of Arkansas for Medical Sciences Northwest
Fayetteville, Arkansas, United States
Countries
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References
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McElfish PA, Felix HC, Bursac Z, Rowland B, Yeary KHK, Long CR, Selig JP, Kaholokula JK, Riklon S. A Cluster Randomized Controlled Trial Comparing Diabetes Prevention Program Interventions for Overweight/Obese Marshallese Adults. Inquiry. 2023 Jan-Dec;60:469580231152051. doi: 10.1177/00469580231152051.
McElfish PA, Long CR, Kaholokula JK, Aitaoto N, Bursac Z, Capelle L, Laelan M, Bing WI, Riklon S, Rowland B, Ayers BL, Wilmoth RO, Langston KN, Schootman M, Selig JP, Yeary KHK. Design of a comparative effectiveness randomized controlled trial testing a faith-based Diabetes Prevention Program (WORD DPP) vs. a Pacific culturally adapted Diabetes Prevention Program (PILI DPP) for Marshallese in the United States. Medicine (Baltimore). 2018 May;97(19):e0677. doi: 10.1097/MD.0000000000010677.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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207034
Identifier Type: -
Identifier Source: org_study_id