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一项针对城市低收入非裔美国 2 型糖尿病患者的生活方式干预的随机试验。

Randomized Trial of a Lifestyle Intervention for Urban Low-Income African Americans with Type 2 Diabetes.

机构信息

Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL, 60625, USA.

Department of Behavioral Sciences, Rush University Medical Center, Chicago, IL, 60625, USA.

出版信息

J Gen Intern Med. 2019 Jul;34(7):1174-1183. doi: 10.1007/s11606-019-04894-y. Epub 2019 Apr 8.

DOI:10.1007/s11606-019-04894-y
PMID:30963440
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6614233/
Abstract

BACKGROUND

African Americans suffer more than non-Hispanic whites from type 2 diabetes, but diabetes self-management education (DSME) has been less effective at improving glycemic control for African Americans. Our objective was to determine whether a novel, culturally tailored DSME intervention would result in sustained improvements in glycemic control in low-income African-American patients of public hospital clinics.

RESEARCH DESIGN AND METHODS

This randomized controlled trial (n = 211) compared changes in hemoglobin A1c (A1c) at 6, 12, and 18 months between two arms: (1) Lifestyle Improvement through Food and Exercise (LIFE), a culturally tailored, 28-session community-based intervention, focused on diet and physical activity, and (2) a standard of care comparison group receiving two group DSME classes. Cluster-adjusted ANCOVA modeling was used to assess A1c changes from baseline to 6, 12, and 18 months, respectively, between arms.

RESULTS

At 6 months, A1c decreased significantly more in the intervention group than the control group (- 0.76 vs - 0.21%, p = 0.03). However, by 12 and 18 months, the difference was no longer significant (12 months - 0.63 intervention vs - 0.45 control, p = 0.52). There was a decrease in A1c over 18 months in both the intervention (β = - 0.026, p = 0.003) and the comparison arm (β = - 0.018, p = 0.048) but no difference in trend (p = 0.472) between arms. The intervention group had greater improvements in nutrition knowledge (11.1 vs 6.0 point change, p = 0.002) and diet quality (4.0 vs - 0.5 point change, p = 0.018) while the comparison group had more participants with improved medication adherence (24% vs 10%, p < 0.05) at 12 months.

CONCLUSIONS

The LIFE intervention resulted in improved nutrition knowledge and diet quality and the comparison intervention resulted in improved medication adherence. LIFE participants showed greater A1c reduction than standard of care at 6 months but the difference between groups was no longer significant at 12 and 18 months.

NIH TRIAL REGISTRY NUMBER

NCT01901952.

摘要

背景

非裔美国人比非西班牙裔白人更容易患 2 型糖尿病,但糖尿病自我管理教育(DSME)在改善非裔美国人的血糖控制方面效果较差。我们的目的是确定一种新的、文化适应性的 DSME 干预措施是否会持续改善低收入非裔美国公共医院诊所患者的血糖控制。

研究设计和方法

这项随机对照试验(n=211)比较了两种治疗组在 6、12 和 18 个月时血红蛋白 A1c(A1c)的变化:(1)生活方式改善通过食物和运动(LIFE),一种文化适应性的、28 节社区为基础的干预措施,侧重于饮食和身体活动,以及(2)接受两组 DSME 课程的标准护理对照组。使用聚类调整的 ANCOVA 模型分别评估两组从基线到 6、12 和 18 个月时 A1c 的变化。

结果

在 6 个月时,干预组的 A1c 下降幅度明显大于对照组(-0.76%比-0.21%,p=0.03)。然而,到 12 和 18 个月时,差异不再显著(12 个月干预组-0.63%,对照组-0.45%,p=0.52)。在干预组(β=-0.026,p=0.003)和对照组(β=-0.018,p=0.048)中,A1c 在 18 个月内均有下降,但两组之间的趋势没有差异(p=0.472)。干预组在营养知识方面有更大的改善(11.1 分比 6.0 分的变化,p=0.002)和饮食质量(4.0 分比-0.5 分的变化,p=0.018),而对照组在改善药物依从性方面有更多的参与者(24%比 10%,p<0.05)在 12 个月时。

结论

LIFE 干预措施导致营养知识和饮食质量的改善,而对照干预措施导致药物依从性的改善。LIFE 组参与者在 6 个月时的 A1c 降低幅度大于标准护理组,但在 12 个月和 18 个月时,两组之间的差异不再显著。

美国国立卫生研究院临床试验注册号

NCT01901952。

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