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美国非洲移民中的虚拟心脏代谢健康项目:一项试点整群随机临床试验。

A Virtual Cardiometabolic Health Program Among African Immigrants in the US: A Pilot Cluster-Randomized Clinical Trial.

作者信息

Ogungbe Oluwabunmi, Hinneh Thomas, Turkson-Ocran Ruth-Alma N, Owusu Loretta, Kumbe Baridosia, Spaulding Erin M, Gbaba Serina, Assani-Uva Adeline, Mensah Jasmine, Yeboah-Kordieh Yvette, Sinyan Aminata, Ampofo Margaret, Oyedepo Faith, Commodore-Mensah Yvonne

机构信息

Johns Hopkins University School of Nursing, Baltimore, Maryland.

Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.

出版信息

JAMA Netw Open. 2025 Mar 3;8(3):e2462559. doi: 10.1001/jamanetworkopen.2024.62559.

Abstract

IMPORTANCE

Black persons, including immigrants, in the US disparately experience poor cardiometabolic health (CMH). Limited research on the effect of lifestyle interventions that improve CMH among African immigrant populations is available.

OBJECTIVE

To test the effectiveness of a culturally adapted, virtual lifestyle intervention on control of blood pressure (BP) and hemoglobin A1c (HbA1c) levels among African immigrants with CMH risk factors.

DESIGN, SETTING, AND PARTICIPANTS: Afro-DPP (Diabetes Prevention Program), a pilot cluster-randomized clinical trial, evaluated the effectiveness of a multicomponent CMH intervention. The study took place in 2 churches with predominantly African immigrant congregations in the Baltimore-Washington, DC, metropolitan area from January 1, 2022, to July 31, 2023. Participants were adults aged 25 to 75 years with at least 2 CMH risk factors who self-identified as African immigrants and belonged to the participating churches. Analyses followed the intention-to-treat principle.

INTERVENTION

Participants received a 6-month culturally adapted lifestyle intervention based on the National DPP curriculum, delivered via virtual group sessions by a lifestyle coach of African origin. The delayed intervention began 6 months later with a follow-up time of 6 months. The intervention also included remote BP and weight monitoring.

MAIN OUTCOME AND MEASURES

Primary outcomes were changes in systolic and diastolic BP and HbA1c levels from baseline to 6 months. Secondary outcomes included reduced body weight and body mass index (BMI; calculated as weight in kilograms divided by height in meters squared).

RESULTS

The analytic population included 60 participants (mean [SD] age, 50.6 [11.9] years; 40 [66.7%] women). In the first intervention group (n = 30), systolic BP decreased by 9.2 (95% CI, 2.5-15.9) mm Hg, diastolic BP by 6.1 (95% CI, 2.1-10.0) mm Hg, body weight by 4.9 (95% CI, 1.0-8.7) kg, and BMI by 1.1 (95% CI, 0.4-1.7) at 6 months. In the delayed intervention group (n = 30), systolic BP decreased by 11.4 (95% CI, 2.4-20.5) mm Hg, diastolic BP by 10.3 (95% CI, 5.4-15.2) mm Hg, and body weight by 3.3 (95% CI, 0.01-6.5) kg, while BMI increased by 0.3 (95% CI, -1.5 to 2.0).

CONCLUSIONS AND RELEVANCE

Trial findings indicate that interventions incorporating cultural adaptation and virtual components could help address CMH disparities in this population.

TRIAL REGISTRATION

ClincalTrials.gov Identifier NCT05144737.

摘要

重要性

在美国,包括移民在内的黑人在心脏代谢健康(CMH)方面存在明显差异,健康状况较差。关于改善非洲移民群体心脏代谢健康的生活方式干预措施效果的研究有限。

目的

测试一种经过文化调适的虚拟生活方式干预措施对有CMH风险因素的非洲移民控制血压(BP)和糖化血红蛋白(HbA1c)水平的有效性。

设计、地点和参与者:非裔糖尿病预防计划(Afro-DPP)是一项试点整群随机临床试验,评估了多成分CMH干预措施的有效性。该研究于2022年1月1日至2023年7月31日在华盛顿特区巴尔的摩大都市区的2所主要由非洲移民会众组成的教堂进行。参与者为年龄在25至75岁之间、自我认定为非洲移民且属于参与教堂的成年人,至少有2种CMH风险因素。分析遵循意向性分析原则。

干预措施

参与者接受了一项基于国家糖尿病预防计划课程的为期6个月的经过文化调适的生活方式干预,由一名非洲裔生活方式教练通过虚拟小组会议进行授课。延迟干预在6个月后开始,随访时间为6个月。干预措施还包括远程血压和体重监测。

主要结局和指标

主要结局是从基线到6个月时收缩压和舒张压以及HbA1c水平的变化。次要结局包括体重减轻和体重指数(BMI;计算方法为体重(千克)除以身高(米)的平方)降低。

结果

分析人群包括60名参与者(平均[标准差]年龄为50.6[11.9]岁;40名[66.7%]为女性)。在第一个干预组(n = 30)中,6个月时收缩压下降了9.2(95%置信区间,2.5 - 15.9)毫米汞柱,舒张压下降了6.1(95%置信区间,2.1 - 10.0)毫米汞柱,体重下降了4,9(95%置信区间,1.0 - 8.7)千克,BMI下降了1.1(95%置信区间,0.4 - 1.7)。在延迟干预组(n = 30)中,收缩压下降了11.4(95%置信区间,2.4 - 20.5)毫米汞柱,舒张压下降了10.3(95%置信区间,5.4 - 15.2)毫米汞柱,体重下降了3.3(95%置信区间,0.01 - 6.5)千克,而BMI增加了0.3(95%置信区间,-1.5至2.0)。

结论与意义

试验结果表明,结合文化调适和虚拟成分的干预措施有助于解决该人群中的CMH差异问题。

试验注册

ClinicalTrials.gov标识符NCT05144737。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e9b7/11880947/4cc4e17b52c4/jamanetwopen-e2462559-g001.jpg

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