Healthy Body Healthy Souls in the Marshallese Population

Study Overview
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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.

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.

Official Title
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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

Conditions
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Weight Loss, Pre Diabetes, Overweight and Obesity

Intervention / Treatment
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* Behavioral: HBHS
* Behavioral: HBHS Policy
* Behavioral: WORD DPP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-reported Marshallese 18 years of age or older To participate in the DPP-LI, have a body mass index (BMI) of ≥25 kg/m^2 Exclusion Criteria: A clinically significant medical condition likely to impact weight (cancer, HIV/AIDS, etc.) 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, and inability to finish the intervention, etc.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HBHS<br>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. | Behavioral: HBHS<br>* 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.<br>|
| Active Comparator: HBHS Policy<br>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. | Behavioral: HBHS Policy<br>* Church-level policy changes that encourages participants to engage in healthy behaviors.<br>|
| Other: WORD DPP<br>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. | Behavioral: WORD DPP<br>* Faith based diabetes curriculum that teaches participants to connect faith and health.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Body Weight (Pounds) Change | Mean percent body weight (pounds) change from baseline to 6 months post-intervention (12 months post-initiation of the intervention). Participant weight (without shoes) was measured in light clothing to the nearest 0.5 lb using a calibrated digital scale. | Baseline, 6 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sugar-Sweetened Beverage Consumption | Change in participants' sugar-sweetened beverage consumption from baseline to 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' sugar-sweetened beverage consumption over the past 30 days using two questions from 'Module 14: Sugar Sweetened Beverages' of the CDC's Behavioral Risk Factor Surveillance System (BRFSS). Participants could respond in number of times per day, per week, or per month. Responses for each question were converted to number of times per day (i.e., self-reported times per week divided by 7 or self-reported times per month divided by 30), resulting in two measures: number times soda was consumed per day and number of times sugar-sweetened fruit drinks, sweet tea, and sports drinks were consumed per day. Per BRFSS guidelines, these two measures were added together to create a total daily SSB consumption rate. | Baseline, 6 months post-intervention | 
| Change in Fruit and Vegetable Consumption | Change in participants' fruit and vegetable consumption from baseline to 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' fruit and vegetable consumption over the past three months using three questions adapted from: Shannon et al (1997) (reference provided in the References in the Protocol Section). Each of the three items was scored as Often=2; Sometimes=1; Never=0. Items were summed to create a scale score, giving a possible range of scores of 0-6, with higher scores indicating more frequent consumption of fruit and vegetables. | Baseline, 6 months post-intervention | 
| Change in Perceived Family Support for Exercise and Dietary Habits | Change in perceived family support for exercise and dietary habits from baseline to 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure was adapted to examine changes in perceived family support for engaging in healthy exercise and dietary habits. This measure consists of a 6-item scale adapted from: Gruber (2008) (reference provided in the References in the Protocol Section). Each of the 6 items are measured via 3 response options (Often=2; Sometimes=1; and Never=0), giving a possible range of scores of 0-12, with higher scores indicating higher perceived family support for exercising and eating healthier. | Baseline, 6 months post-intervention | 
| Change in Mean HbA1c (%) | Change in mean HbA1c (NGSP %) from baseline to 6 months post-intervention (12 months post-initiation of the intervention). A Siemens analyzer (point of care) was utilized to calculate HbA1c levels for each participant. | Baseline, 6 months post-intervention | 
| Change in Mean Systolic Blood Pressure (mmHg) | Change in mean systolic blood pressure (mmHg) from baseline to 6 months post-intervention (12 months post-initiation of the intervention). Blood pressure was measured with a sphygmomanometer, with participants seated. | Baseline, 6 months post-intervention | 
| Change in Mean Diastolic Blood Pressure (mmHg) | Change in mean diastolic blood pressure (mmHg) from baseline to 6 months post-intervention (12 months post-initiation of the intervention). Blood pressure was measured with a sphygmomanometer, with participants seated. | Baseline, 6 months post-intervention | 
| Change in Eating Habits Self-Efficacy | Change in eating habits self-efficacy from baseline to 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' self-efficacy related to their ability to make healthy eating decisions in the face of real or perceived barriers (e.g. while at social events, while watching TV, etc.). This 7-item measure was adapted from items in the original Weight Efficacy Life-Style Questionnaire by Clark et al (1991) (reference provided in the References in the Protocol Section). Each of the 7 items are measured via 3 response options (Yes/Completely Sure=2; Maybe/Not Sure=1; and No/Not Sure at All=0), giving a possible range of scores of 0-14, with higher scores indicating higher self-efficacy for making healthy eating decisions in spite of barriers. | Baseline, 6 months post-intervention | 
| Change in Physical Activity Self-Efficacy | Change in physical activity self-efficacy from baseline to 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' self-efficacy for exercising in the face of real or perceived barriers (e.g., bad weather, exercising alone, etc.). This 9-item measure was adapted from the Self-Efficacy for Exercise Scale by Resnick & Jenkins (2000) and Resnick et al (2004) (references provided in the References in the Protocol Section). Each of the 9 items are measured via 3 response options (Yes/Completely Sure=2; Maybe/Not Sure=1; and No/Not Sure at All=0), giving a possible range of scores of 0-18, with higher scores indicating higher self-efficacy for exercising despite barriers. | Baseline, 6 months post-intervention | 
| Change in Percentage of Participants Engaging in Sufficient Levels of Physical Activity Over the Past Month | Change in percentage of participants engaging in sufficient levels of physical activity (PA) from baseline to 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' frequency of engaging in both moderate and vigorous levels of physical activity over the past month with two items. Both items used a 4-point response scale: 1) Rarely or Never; 2) Once a week; 3) 2-4 times a week; and 4) More than 4 times a week. Each 4-point scale for moderate PA and vigorous PA was weighted: 0=Rarely or Never; 1=Once a week; 2=2-4 times a week; and 4=More than 4 times a week. The weights were then summed and dichotomized as follows: ≥4 = sufficient PA and <4 = insufficient PA. Items were adapted to include relevant cultural examples of physical activity from the DASH 2 Brief Physical Activity Questionnaire (link to original items provided in the References in the Protocol Section). | Baseline, 6 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Marshallese, Pacific Islanders