Project Dulce for Arab Americans With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Understanding Health Implications of Genomics at 3 months
研究概览
简要总结
Arab Americans (AA) face many challenges in diabetes self-management due to the limited educational resources and support available for them. The cultural and linguistic barriers between patients and health care providers lead to poor diabetes management and outcomes. This study (Project Dulce Arabic) is adapted from the Project Dulce, an American Diabetes Association (ADA)-recognized Diabetes Self-Management Education Support (DSMES) program. Project Dulce Arabic comprises both peer-led diabetes education in Arabic and a 3-month text messaging program (Dulce Digital). The main aim of the study is to examine the effectiveness of a more culturally and linguistically appropriate diabetes education program in improving diabetes knowledge, beliefs, and self-management as well as hemoglobin A1C.
详细描述
Although the Arab American (AA) population is at a higher risk of pre-diabetes and type 2 diabetes (T2D) compared to the white non-Hispanic population, there are hardly any culturally appropriate diabetes self-management resources available for Arab Americans.
Project Dulce Arabic is a pilot study addressing both the linguistic and cultural barriers faced by the AA community in diabetes self-management while exploring the genetic background of type 2 diabetes in Arab Americans. To overcome the linguistic barriers, we adapt educational materials from the Project Dulce diabetes self-management study of Mexican Americans (A. Philis-Tsimikas et al., 2011). This 5-week peer-led educational program in Arabic aims to enhance type 2 diabetes knowledge, beliefs, and self-management behaviors as well as improving diabetes management measured by hemoglobin A1C after 3 months and 6 months in the study.
Project Dulce Arabic is incorporating genetic education as a part of its curriculum to raise the community awareness of the role of genetics in T2D development as well as the importance of early genetic risk detection for T2D prevention. We are also asking our Project Dulce Arabic participants to participate in the Scripps Bio-Repository (https://www.scripps.org/research/bio-repository). The specimens obtained from our study cohort will be used for genetic sequencing. Obtaining this genetic information will enable us to gain more insights into the genetic basis of type 2 diabetes in Arab Americans. Comparing the genetic risk of T2D, available from different biobanks, in other ethnic groups with that in Arab Americans would highlight the disease risk faced by the community and draw more attention towards the importance of early disease detection and prevention through tailored screening recommendations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Are a participant of Metro Caring
- •Self-identified Arab
- •Diagnosed with type 2 diabetes mellitus (T2DM)
- •HbA1c ≥7.5% in the last 30 days
- •Able to speak, read, write, and comprehend in English and Arabic
- •Have access to a cell phone that can receive/send text messages throughout the study
排除标准
- •Are currently participating in another diabetes-related study
研究组 & 干预措施
Project Dulce + Dulce Digital
Participants will participate in a peer-led group diabetes self-management education and support program and receive ongoing support via text messages designed to improve knowledge, health beliefs, self-management behaviors and clinical outcomes.
干预措施: Project Dulce + Dulce Digital (Behavioral)
结局指标
主要结局
Understanding Health Implications of Genomics at 3 months
时间窗: 3 months
To assess the genetic knowledge, a 12-items questionnaire. Response options are 'agree', 'disagree', or 'don't know'. Similarly, a 13-items questionnaire with response options of 'agree' or 'disagree' will be used to assess the attitudes toward genetics research and testing.
Change in Baseline Self-Efficacy for Diabetes Scale at 3 months
时间窗: 3 months
Stanford Self-Efficacy for Diabetes Scale (Lorig, Stewart, Ritter, et al., 1996) is comprised of 8 items that measure the confidence of a participant in performing self-care activities such as eating meals every 4 to 5 hours, following a healthful diet, exercising, and blood glucose monitoring. Response options range from 1=not at all confident to 10=totally confident, with higher scores indicating greater self-efficacy.
Understanding Health Implications of Genomics at 6 months
时间窗: 6 months
To assess the genetic knowledge, a 12-item questionnaire. Response options are 'agree', 'disagree', or 'don't know'. Similarly, a 13-item questionnaire with response options of 'agree' or 'disagree' will be used to assess the attitudes toward genetics research and testing.
Change from Baseline Health Belief Model Scale at 3 months
时间窗: 3 months
Health Belief Model scale (Tan, 2004) is comprised of 36 items that evaluate the health beliefs and attitudes about complications prevention behaviors and active health related behaviors in individuals with diabetes. Responses are on a 5-point Likert-type scale (1=strongly disagree, 5=strongly agree), with lower scores indicating greater negative beliefs.
Change from Baseline Diabetes Knowledge at 3 months
时间窗: 3 months
Diabetes Knowledge Test (Diabetes Research and Training Center, University of Michigan, 2015) is a 23-item measure of diabetes knowledge, with general questions related to symptoms, self-management (e.g., diet, exercise, foot care, blood glucose monitoring, insulin), and complications (e.g., low, and high blood sugar). Greater scores indicate greater diabetes knowledge.
Change from Baseline Health Belief Model Scale at 6 months
时间窗: 6 months
Health Belief Model scale (Tan, 2004) is comprised of 36 items that evaluate the health beliefs and attitudes about complications prevention behaviors and active health related behaviors in individuals with diabetes. Responses are on a 5-point Likert-type scale (1=strongly disagree, 5=strongly agree), with lower scores indicating greater negative beliefs.
Change from Baseline Diabetes Knowledge at 6 months
时间窗: 6 months
Diabetes Knowledge Test (Diabetes Research and Training Center, University of Michigan, 2015) is a 23-item measure of diabetes knowledge, with general questions related to symptoms, self-management (e.g., diet, exercise, foot care, blood glucose monitoring, insulin), and complications (e.g., low, and high blood sugar). Greater scores indicate greater diabetes knowledge.
Change in Baseline Self-Efficacy for Diabetes Scale at 6 months
时间窗: 6 months
Stanford Self-Efficacy for Diabetes Scale (Lorig, Stewart, Ritter, et al., 1996) is comprised of 8 items that measure the confidence of a participant in performing self-care activities such as eating meals every 4 to 5 hours, following a healthful diet, exercising, and blood glucose monitoring. Response options range from 1=not at all confident to 10=totally confident, with higher scores indicating greater self-efficacy.
次要结局
- Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 6 months(6 months)
- Change in Baseline Summary of Diabetes Self-Care Activities at 3 months(3 months)
- Change in Baseline International Physical Activity Questionnaire-Short Form at 3 months(3 months)
- Change in Baseline International Physical Activity Questionnaire-Short Form at 6 months(6 months)
- Change in Baseline Food Frequency Questionnaire at 3 months(3 months)
- Change in Baseline Summary of Diabetes Self-Care Activities at 6 months(6 months)
- Change in Baseline Food Frequency Questionnaire at 6 months(6 months)
- Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months(3 months)