Health Literacy Enhanced Intervention for Inner-city African Americans With Uncontrolled Diabetes: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Change in Health literacy as assessed by the Newest Vital Sign
研究概览
简要总结
Disparities in diagnosis and control of type 2 diabetes mellitus are most evident in African Americans (AAs) with lower socioeconomic status. Health literacy is an important predictor of adequate self-management and control of diabetes. The purpose of this pilot study was to test the feasibility and preliminary efficacy of a health literacy-enhanced diabetes intervention -Prevention through Lifestyle intervention And Numeracy (PLAN) 4 Success-Diabetes, in inner-city, low-income AAs with uncontrolled diabetes. To evaluate the feasibility, acceptability, and preliminary efficacy of the intervention, the investigators conducted a pilot study with 24-week follow-up. The investigators that participation in the PLAN 4 Success-diabetes intervention would be associated with a reduction in glucose outcomes and improvements in psychosocial variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •African Americans residing in Baltimore, Maryland
- •had uncontrolled diabetes (defined as HbA1C>7%)
排除标准
- •Unable to give informed consent
- •Physical or mental health conditions that could limit active participation in the study (e.g., blindness in both eyes, severe immobility, psychiatric diseases)
- •Hematological condition that would affect HbA1C assay, e.g., hemolytic anemia, sickle cell anemia
研究组 & 干预措施
Intervention
This is a one arm study with all participants enrolled into this arm.
干预措施: PLAN 4 Success-Diabetes (Behavioral)
结局指标
主要结局
Change in Health literacy as assessed by the Newest Vital Sign
时间窗: baseline; 12 and 24 weeks
The Newest Vital Sign consists of four items and measures numeracy. After reviewing a nutrition label, participants are asked to answer questions based on some calculation of the nutritional information (e.g., fat, sodium) presented on the label. Total possible scores range from 0 to 4, with one point assigned for each correct response.
Change in Health literacy as assessed by Literacy Assessment in Diabetes (LAD).
时间窗: baseline; 12 and 24 weeks
The Literacy Assessment in Diabetes (LAD) has high reliability and validity indices. The items on the LAD are scored as correct/incorrect, with total possible scores ranging from 0 to 60. Higher scores indicated higher health literacy levels.
次要结局
- Change in Diabetes knowledge measured with the validated Diabetes Knowledge Test(baseline; 12 and 24 weeks)
- Change in Diabetes self-efficacy measured with Stanford Diabetes Self-Efficacy scale(baseline; 12 and 24 weeks)