Healthy Body Healthy Souls in the Marshallese Population

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-30

Study Completion Date

2019-10-31

Brief Summary

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The primary aim is to pilot test a weight-loss intervention for Marshallese adults, referred to throughout as Healthy Bodies Healthy Souls (HBHS). The HBHS intervention includes the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) implemented at the individual level, with the additional enhancement of working with Marshallese churches to implement church-level changes to support the individual behavioral intervention of the WORD DPP. We will then compare changes in outcomes with participants in the churches who were exposed to the policy changes but did not participate in the WORD DPP, and with those enrolled in a separate DPP trial who participated in the WORD DPP but were not exposed to church-level policy changes.

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Detailed Description

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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. 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.

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 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. 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.

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 Marshallese in Arkansas 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.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, and even a modest reduction in weight (5-10%) is clinically meaningful. Third, research demonstrates the effectiveness of multi-level lifestyle interventions in reducing weight and the onset and impact of diabetes. Fourth, to be effective among Pacific Islanders, interventions must be developed to address influences at multiple levels and should be culturally adapted to incorporate Pacific Islanders' worldviews and cultural values. 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. 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. Finally, churches are primary social institutions of Pacific Islander health. 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.

Conditions

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Weight Loss Pre Diabetes Overweight and Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Our aim is to pilot test a multi-level weight-loss intervention in the Marshallese community. Changes in outcomes were examined from baseline to 6 months post-intervention (12 months post-initiation of the intervention).

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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HBHS

Participants in the Healthy Bodies Healthy Souls (HBHS) arm received the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) with the addition of church-level policy changes to support the individual behavioral intervention of the WORD DPP. The 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. Church-level 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.

Group Type EXPERIMENTAL

HBHS

Intervention Type BEHAVIORAL

Faith based diabetes curriculum that teaches participants to connect faith and health plus church-level policy changes that encourages participants to engage in healthy behaviors.

HBHS Policy

Participants in the HBHS Policy arm included members of churches enrolled in the HBHS study who did not receive the WORD DPP intervention (ie, these participants were exposed to only the church-level policy changes). Church-level 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.

Group Type ACTIVE_COMPARATOR

HBHS Policy

Intervention Type BEHAVIORAL

Church-level policy changes that encourages participants to engage in healthy behaviors.

WORD DPP

Participants in the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) arm included participants enrolled in a separate DPP study without the church-level policy changes (ie, these participants received only the WORD DPP intervention). The 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-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length.

Group Type OTHER

WORD DPP

Intervention Type BEHAVIORAL

Faith based diabetes curriculum that teaches participants to connect faith and health.

Interventions

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HBHS

Faith based diabetes curriculum that teaches participants to connect faith and health plus church-level policy changes that encourages participants to engage in healthy behaviors.

Intervention Type BEHAVIORAL

HBHS Policy

Church-level policy changes that encourages participants to engage in healthy behaviors.

Intervention Type BEHAVIORAL

WORD DPP

Faith based diabetes curriculum that teaches participants to connect faith and health.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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/m\^2

Exclusion Criteria

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes