Diabetes Prevention Program Lifestyle Intervention in the Marshallese Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 2
- 主要终点
- Change in Mean Body Weight (kg)
研究概览
简要总结
The investigators will conduct a comparative effectiveness cluster-randomized controlled trial (cRCT) of two Diabetes Prevention Program (DPP) lifestyle interventions: a faith-based intervention (Wholeness, Oneness, Righteousness, Deliverance [WORD] DPP); and a Pacific Islander adapted intervention (Partnership for Improving Lifestyle Interventions [PILI] DPP. Each intervention lasted 24 weeks and focused on the importance of healthy eating, being physically active, and maintaining a healthy weight. Eligible participants included overweight and obese Marshallese adults living in Arkansas and Oklahoma. The unit of randomization is at the church level. The primary outcome measure is body weight loss (from baseline weight). As selected by stakeholders, HbA1c, blood pressure, physical activity, and dietary intake will be evaluated as secondary outcome measures. Data collection will take place at baseline (pre-intervention), immediate post-intervention (6 months post-initiation of the intervention), and 6 months post-intervention (12 months post-initiation of the intervention).
详细描述
Background and Rationale
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 否
入选标准
- •Self reported Marshallese
- •18 years of age or older
- •BMI greater than or equal to 25
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, an inability to finish the intervention, etc.
结局指标
主要结局
Change in Mean Body Weight (kg)
时间窗: Baseline, immediate post-intervention, 6 months post-intervention
Change in mean body weight (kg) from baseline to immediate post intervention and 6 months post-intervention. Participant weight (without shoes) was measured in light clothing using a calibrated digital scale at each time point.
次要结局
- Change in Mean Diastolic Blood Pressure (mmHg)(Baseline, immediate post-intervention, 6 months post-intervention)
- Change in Mean HbA1c (%)(Baseline, immediate post-intervention, 6 months post-intervention)
- Change in Mean Systolic Blood Pressure (mmHg)(Baseline, immediate post-intervention, 6 months post-intervention)
- Change in Sugar-sweetened Beverage Consumption(Baseline, immediate post-intervention, 6 months post-intervention)
- Change in Fruit and Vegetable Consumption(Baseline, immediate post-intervention, 6 months post-intervention)
- Change in Proportion of Participants Engaging in Sufficient Levels of Physical Activity(Baseline, immediate post-intervention, 6 months post-intervention)