Type 2 Diabetes Self-management Intervention for Low-income Women
A Comprehensive Approach to Type 2 Diabetes Self-management for Low-income Women
研究概览
详细说明
In recent years, the prevalence of diabetes has significantly increased among women and because of the expected fast growth rate of minority populations, the number of women in these groups who will be diagnosed with diabetes is also expected to increase significantly over the coming years. Among women from minority groups diabetes is the fourth leading cause of death while it is the seventh among non-Hispanic White females. Non-compliance to diabetes self-care is a major concern for type 2 diabetic women of racial/ethnic groups because of the existing socio-economic and environmental barriers. Often, these women live in poverty; have less than a high school education as well as language barriers and inadequate health literacy, which further place them at risk for complications, and the daily activities of diabetes self-care are implemented within the context of family responsibilities and patient's priorities.
This study is a 12-month randomized controlled trial designed to compare a lifestyle intervention group (combination group) and a control group (education only group). Participants assigned to either group will receive three group education sessions (baseline, 3 and 6 months) with an emphasis on self-management.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Tennessee
-
Nashville、Tennessee、美国、37208
- Meharry Medical College
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Low-income women ages 21 and older; With type 2 diabetes ( fasting plasma glucose > 126 mg/dl);
At risk of developing diabetes related complications (treatments goals from The American Diabetes Association Standards of medical care) as defined by:
- HbA1c >8.0 %
- Any of the metabolic clusters such as Pre-prandial plasma glucose > 130 mg/dl; Obesity (BMI >25 kg/m2, or waist circumference >88 cm (>35 in); Hypertension (Systolic >130 and Diastolic > 80 mmHg); Hyperlipidemia (Triglycerides >150 mg/dL; HDL<50 mg/dL; LDL >100 mg/dL)
Exclusion Criteria:
- Participants will be excluded if they are currently pregnant, have conditions (i.e., end stage diagnosis) or behaviors likely to affect conduct of the trial, and unwilling to accept treatment assignment by randomization.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Intervention group
Education and patient liaison combination
|
Group education sessions with Patient liaison using ecological momentary assessment principles
其他名称:
|
|
实验性的:Control group
Education only
|
Group education sessions at baseline, 3 and 6 months
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
HbA1c
大体时间:baseline, 6 and 12 months
|
glycosylated hemoglobin
|
baseline, 6 and 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Risk factors for co-morbidity and daily self-management behaviors
大体时间:baseline, 3, 6, 9 and 12 months
|
|
baseline, 3, 6, 9 and 12 months
|
合作者和调查者
调查人员
- 首席研究员:Sylvie A Akohoue, PhD、Meharry Medical College
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 081204AAH231 26
- U54RR026140-01 (美国 NIH 拨款/合同)
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