针对黑人的“FAITH（基于信仰的高血压治疗方法）”整群随机临床试验

Cluster Randomized Clinical Trial of FAITH (Faith-Based Approaches in the Treatment of Hypertension) in Blacks.

作者信息

Schoenthaler Antoinette M, Lancaster Kristie J, Chaplin William, Butler Mark, Forsyth Jessica, Ogedegbe Gbenga

机构信息

Department of Population Health, Center for Healthful Behavior Change, New York University School of Medicine (A.M.S., M.B., J.F., G.O.).

Department of Nutrition and Food Studies, Steinhardt School of Culture, Education, and Human Development, New York University (K.J.L.).

出版信息

Circ Cardiovasc Qual Outcomes. 2018 Oct;11(10):e004691. doi: 10.1161/CIRCOUTCOMES.118.004691.

DOI:10.1161/CIRCOUTCOMES.118.004691

PMID:30354579

Abstract

BACKGROUND

Therapeutic lifestyle change (TLC) is a recommended treatment for patients with hypertension, but its effectiveness in community-based settings remains untested, particularly in black churches-an influential institution for health promotion in black communities.

METHODS AND RESULTS

The FAITH study (Faith-Based Approaches in the Treatment of Hypertension) evaluated the comparative effectiveness of a TLC intervention plus motivational interviewing (MINT) sessions versus health education (HE) alone, on blood pressure (BP) reduction among blacks with uncontrolled hypertension. Data were collected on 373 participants meeting eligibility criteria (self-identification as black, age ≥18 years, self-reported diagnosis of hypertension, and uncontrolled BP [BP ≥140/90 or ≥130/80 mm Hg with diabetes mellitus or chronic kidney disease]) from 32 New York City churches. The MINT-TLC intervention plus motivational interviewing treatment comprised 11 weekly group sessions on TLC plus 3 MINT sessions delivered monthly by lay health advisors. The HE control group received 1 TLC session plus 10 sessions on health topics delivered by local experts. The outcomes were BP reduction at 6 months (primary) and BP control and BP reduction at 9 months (secondary). The sample mean age was 63 years; 76% women, with mean BP of 153/87 mm Hg. Using linear mixed-effects regression models, the MINT-TLC intervention plus motivational interviewing group had a significantly greater systolic BP reduction of 5.79 mm Hg compared with the HE group at 6 months ( P=0.029). The treatment effect on systolic BP persisted at 9 months but had reduced significance (5.21 mm Hg; P=0.068). The between-group differences in diastolic BP reduction (0.41 mm Hg) and mean arterial pressure (2.24 mm Hg) at 6 months were not significant. Although the MINT-TLC intervention plus motivational interviewing group had greater BP control than the HE group at 9 months, the difference was not statistically significant (57.0% versus 48.8%; odds ratio, 1.43; 95% CI, 0.90-2.28).

CONCLUSIONS

A community-based lifestyle intervention delivered in churches led to significantly greater reduction in systolic BP in hypertensive blacks compared with HE alone.

CLINICAL TRIAL REGISTRATION

URL: https://www.clinicaltrials.gov . Unique identifier: NCT01065831.

摘要

背景

治疗性生活方式改变（TLC）是推荐用于高血压患者的治疗方法，但其在社区环境中的有效性仍未得到验证，尤其是在黑人教会——黑人社区中促进健康的一个有影响力的机构。

方法与结果

FAITH研究（基于信仰的高血压治疗方法）评估了TLC干预加动机性访谈（MINT）课程与单纯健康教育（HE）相比，对血压未得到控制的黑人患者降低血压的比较效果。从纽约市的32个教会收集了373名符合资格标准（自我认定为黑人、年龄≥18岁、自我报告有高血压诊断且血压未得到控制[血压≥140/90或糖尿病或慢性肾脏病患者血压≥130/80 mmHg]）参与者的数据。MINT-TLC干预加动机性访谈治疗包括由非专业健康顾问每月进行3次MINT课程以及关于TLC的11次每周小组课程。HE对照组接受1次TLC课程以及由当地专家进行的10次关于健康主题的课程。结局指标为6个月时的血压降低（主要指标）以及9个月时的血压控制和血压降低（次要指标）。样本的平均年龄为63岁；76%为女性，平均血压为153/87 mmHg。使用线性混合效应回归模型，MINT-TLC干预加动机性访谈组在6个月时收缩压降低幅度比HE组显著大5.79 mmHg（P = 0.029）。对收缩压的治疗效果在9个月时持续存在，但显著性降低（5.21 mmHg；P = 0.068）。6个月时两组间舒张压降低幅度（0.41 mmHg）和平均动脉压（2.24 mmHg）的差异不显著。尽管MINT-TLC干预加动机性访谈组在9个月时血压控制情况比HE组更好，但差异无统计学意义（57.0%对48.8%；比值比，1.43；95%可信区间，0.90 - 2.28）。