Clinical trial NCT03377244: Healthy Body Healthy Souls in the Marshallese Population
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Pre Diabetes
Overweight and Obesity
Keywords: Marshallese
Pacific Islanders
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Percent Body Weight (Pounds) Change
timeFrame: Baseline, 6 months post-intervention
Secondary outcomes:
measure: Change in Mean HbA1c (%)
timeFrame: Baseline, 6 months post-intervention
measure: Change in Mean Systolic Blood Pressure (mmHg)
timeFrame: Baseline, 6 months post-intervention
measure: Change in Mean Diastolic Blood Pressure (mmHg)
timeFrame: Baseline, 6 months post-intervention
measure: Change in Eating Habits Self-Efficacy
timeFrame: Baseline, 6 months post-intervention
measure: Change in Physical Activity Self-Efficacy
timeFrame: Baseline, 6 months post-intervention
measure: Change in Percentage of Participants Engaging in Sufficient Levels of Physical Activity Over the Past Month
timeFrame: Baseline, 6 months post-intervention
measure: Change in Sugar-Sweetened Beverage Consumption
timeFrame: Baseline, 6 months post-intervention
measure: Change in Fruit and Vegetable Consumption
timeFrame: Baseline, 6 months post-intervention
measure: Change in Perceived Family Support for Exercise and Dietary Habits
timeFrame: Baseline, 6 months post-intervention
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas for Medical Sciences Northwest
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Pearl McElfish, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
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