Design of Heart Well: A randomized pilot study of a community health worker-delivered nutrition intervention for low-income adults with hypertension

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2026-03-01 Epub Date: 2026-01-28 DOI:10.1016/j.cct.2026.108244

Kristine D. Gu , Jessica Cheng , Oldy Bejarano , Emily Gelsomin , Ashlie Malone , Katherine C. Faulkner , Anne N. Thorndike

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引用次数: 0

Abstract

Background

Suboptimal diet and food insecurity contribute to hypertension disparities experienced by individuals with low-income. Clinic-based nutrition counseling is limited by time constraints and low access to dietitians. Integrating community health workers (CHWs) with basic nutrition training into care teams may be an effective strategy to promote sustainable dietary modifications.

Objective

Describe the design of Heart Well, a study to determine whether adding nutrition counseling to a primary care-based CHW hypertension program is feasible and acceptable and improves diet and blood pressure (BP).

Methods

Heart Well is a 4-month randomized controlled study of low-income adults (N = 60) who have uncontrolled hypertension and are enrolled in a CHW hypertension coaching program. The control group receives usual care in the existing hypertension program. The intervention group additionally receives nutrition counseling on label reading, healthy eating on a budget, and simplified nutrition education (e.g., traffic light categories, green = healthy). Intervention CHWs are trained by a registered dietitian, who also provides ongoing CHW support. Primary outcomes are feasibility (i.e., proportion of participants enrolled, percent completion of nutrition modules) and acceptability (i.e., participant ratings of nutrition components). Secondary outcomes are changes over 4 months in Healthy Eating Index-2020 scores (calculated from dietary recalls) and in BP.

Conclusions

Heart Well tests a novel strategy integrating nutrition counseling tailored to low-income adults into an existing CHW hypertension program. Results will inform a larger trial to evaluate the intervention's impact on cardiovascular health and may have implications for CHW interventions for other diet-sensitive chronic diseases. Trial Registration: ClinicalTrials.gov NCT06358417

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心脏井的设计：一项社区卫生工作者为低收入高血压成年人提供营养干预的随机试点研究

背景：次优饮食和粮食不安全导致了低收入人群的高血压差异。以诊所为基础的营养咨询受到时间限制和难以接触到营养师的限制。将接受过基本营养培训的社区卫生工作者（CHWs）纳入护理团队可能是促进可持续饮食改变的有效策略。目的描述Heart Well的设计，这是一项研究，旨在确定在以初级保健为基础的CHW高血压项目中加入营养咨询是否可行和可接受，并能改善饮食和血压（BP）。方法：heart Well是一项为期4个月的随机对照研究，研究对象为低收入成年人（N = 60），他们患有未控制的高血压，并参加了CHW高血压指导计划。对照组在现有高血压方案中接受常规护理。干预组还接受有关标签阅读、预算内健康饮食和简化营养教育（例如，交通信号灯类别，绿色=健康）的营养咨询。干预护理生由注册营养师培训，并提供持续的护理生支援。主要结果是可行性（即参与者注册的比例，营养模块完成的百分比）和可接受性（即参与者对营养成分的评分）。次要结果是4个月内健康饮食指数-2020评分（根据饮食召回计算）和血压的变化。heart Well测试了一种将针对低收入成年人的营养咨询整合到现有CHW高血压项目中的新策略。结果将为更大规模的试验提供信息，以评估干预措施对心血管健康的影响，并可能对其他饮食敏感型慢性病的CHW干预措施产生影响。试验注册：ClinicalTrials.gov NCT06358417

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.