Community Partnered Medical Nutrition Intervention for Native Americans Living with Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Change in A1c (from baseline to 90 days and 180 days)
研究概览
简要总结
This research study is for American Indian and Alaska Native (AIAN) people with diabetes in Los Angeles County, California. Participants (people who join the study) are signed up for a program that includes healthy meals, online diabetes classes, and social support.
This study aims to answer the following question:
Can this program (the meals, classes, and social support) have health and well-being benefits for participants, like lower blood sugar levels and less social isolation?
Participants are asked to fill out surveys and go to three clinic visits. Participants do not have to pay for the clinic visits or any other parts of the study.
详细描述
Diabetes in the American Indian and Alaska Native (AIAN) population is a public health crisis. AIAN have the highest diabetes prevalence rates when compared to other racial and ethnic populations in the United States. According to the Centers for Disease Control and Prevention, 14.7% of AIAN adults compared to 7.5% of non-Hispanic Whites have been diagnosed with diabetes. In California (CA), those who self-identify as having CA Tribal heritage are twice as likely than individuals from tribes outside of CA to be diagnosed with diabetes (31% versus 16%). Significant disparities also exist in diabetes-related outcomes. Compared to the general population, AIANs are 2.3 times more likely to die from diabetes, and the incidence of diabetes-related kidney failure among AIANs is 2.0 times higher. Cardiovascular disease among AIANs with diabetes may be 3-8 times higher than those AIAN without diabetes.
The diabetes crisis among AIAN is best addressed using a holistic approach. Aside from addressing the impact of diabetes on several physical health outcomes, best practices also include addressing the impact of trauma and mental and emotional health, providing robust patient education, and addressing structural barriers such as food insecurity, lack of access to healthy food, living in poverty, limited social support, and lack of access to health care, especially that which is culturally responsive.
Given the disproportionate rates of diabetes and diabetes-related outcomes among AIANs, this is the perfect opportunity to provide a culturally tailored health promotion intervention among the largest urban AIAN population in the U.S.; approximately 171,163 AIANs reside in Los Angeles County.
The goal of this pilot study was originally to reach up to 312 Native Americans with diabetes (later reduced, aiming for 150) to participate in an intervention to lower blood sugar and feelings of social isolation. The intervention will include 12 weeks of diabetes-friendly, medically tailored meals, and four weeks of virtual diabetes wellness classes. Each participant will be part of a 180-day cohort, during which participants will complete surveys and attend three clinic visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Reside in Los Angeles County,
- •18 years and older,
- •Identify as American Indian or Alaska Native,
- •Have freezer space for 14 meals (about the size of two shoe boxes),
- •Ability to attend virtual classes via Zoom,
- •Ability to complete electronic surveys distributed by email,
- •Ability to commit to attending at least five of the six initial classes and meetings,
- •Ability to commit to making personal arrangements to attend three study clinic visits during weekday, daytime hours, and
- •Ability to consent to study activities, attend classes, and complete surveys all in English.
排除标准
- •Food allergies,
- •Serious non-allergic reactions to foods, and
- •Unable or unwilling to eat study meals (considering the limited accommodations available).
结局指标
主要结局
Change in A1c (from baseline to 90 days and 180 days)
时间窗: Baseline, 90 days, and 180 days
次要结局
- Change in blood pressure (from baseline to 90 days and 180 days)(Baseline, 90 days, and 180 days)
- Change in BMI (using weight and height) (from baseline to 90 days and 180 days)(Baseline, 90 days, and 180 days)
- Change in social isolation (using loneliness measure survey questions) (from baseline to 90 days and 180 days)(Baseline, 90 days, and 180 days)
- Change in level of diabetes distress (using diabetes distress scale survey responses) (from baseline to 90 days and 180 days)(Baseline, 90 days, and 180 days)
- Change in identity and level of cultural connectedness (using part of Multigroup Ethnic Identity Measure survey questions) (from baseline to 90 days and 180 days)(Baseline, 90 days, and 180 days)
研究者
Claradina Soto
Assistant Professor
University of Southern California