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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Mean Percent Body Weight (Pounds) Change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Mean Percent Body Weight (Pounds) Change
时间窗: Baseline, 6 months post-intervention
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.
次要结局
- Change in Mean Systolic Blood Pressure (mmHg)(Baseline, 6 months post-intervention)
- Change in Mean Diastolic Blood Pressure (mmHg)(Baseline, 6 months post-intervention)
- Change in Percentage of Participants Engaging in Sufficient Levels of Physical Activity Over the Past Month(Baseline, 6 months post-intervention)
- Change in Sugar-Sweetened Beverage Consumption(Baseline, 6 months post-intervention)
- Change in Fruit and Vegetable Consumption(Baseline, 6 months post-intervention)
- Change in Eating Habits Self-Efficacy(Baseline, 6 months post-intervention)
- Change in Physical Activity Self-Efficacy(Baseline, 6 months post-intervention)
- Change in Perceived Family Support for Exercise and Dietary Habits(Baseline, 6 months post-intervention)
- Change in Mean HbA1c (%)(Baseline, 6 months post-intervention)