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临床试验/NCT06358417
NCT06358417已完成不适用

CHW Intervention to Improve Nutrition Security of Primary Care Patients With Hypertension

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Feasiblity

研究概览

简要总结

The goal of this study is to implement and evaluate a randomized pilot study of a 4-month Nutrition-enhanced community health worker (CHW) intervention for primary care patients with nutrition insecurity and poorly controlled hypertension. The nutrition intervention will be added to the pre-existing Massachusetts General Hospital CHW hypertension (Basic CHW) program that provides hypertension education, coaching about adherence to medications and primary care visits, and home BP cuffs and promotion of BP self-monitoring over the course of approximately 4 months.

详细描述

The goal of this study is to implement and evaluate a randomized pilot study of a 4-month Nutrition-enhanced CHW intervention in primary care patients with nutrition insecurity and poorly controlled hypertension. The nutrition intervention will be added to the pre-existing Massachusetts General Hospital CHW hypertension (Basic CHW) that provides basic hypertension education, coaching about adherence to medications and primary care visits, and home BP cuffs and promotion of BP self-monitoring over the course of approximately 4 months. The CHW nutrition intervention curriculum is tailored to the needs and preferences of a food-insecure population with limited resources. Nutrition education materials will be provided to participants, including a booklet of nutrition information and a summarized version of key points on a brochure that they can use as a quick reference when grocery shopping. Nutrition education will focus on reducing sodium, saturated fats, and added sugars and increasing fruits, vegetables, and whole grains. Much of the educational material is based on a traffic-light system. These topics are organized into four modules: nutrition label reading, grocery shopping, meal-planning, and healthy cooking.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible to participate in the Massachusetts General Hospital CHW hypertension program (age 21 years or older, uncontrolled hypertension, patient at one of 5 participating primary care clinics; either identifies as a minoritized race/ethnicty or is low-income); speaks English or Spanish

排除标准

  • declines participation in CHW hypertension program; does not speak English or Spanish

研究组 & 干预措施

Nutrition-enhanced CHW intervention

Experimental

This intervention integrates a nutrition component into the Basic CHW hypertension intervention to address gaps in patients' knowledge, skills, and resources for consuming and sustaining a healthful diet. CHWs will administer a 4-part nutrition curriculum that is tailored to the needs and preferences of a food-insecure population with limited resources. The nutrition education materials provided to participants will include a booklet of nutrition information that will serve as the primary educational resource for CHW use with participants.

干预措施: Nutrition-enhanced CHW (Behavioral)

Basic CHW intervention

Active Comparator

The CHW provides basic hypertension education, coaching about adherence to medications and primary care visits, and home BP cuffs and promotion of BP self-monitoring. All participants are provided home BP cuffs and remote monitoring free of charge.

干预措施: Basic CHW (Behavioral)

结局指标

主要结局

Feasiblity

时间窗: Baseline

Proportion of eligible participants enrolled in study

Feasibility of CHW nutrition intervention (intervention arm only)

时间窗: 4 months

At least 70% participants complete at least 3 of 4 CHW nutrition education modules

Acceptability (intervention arm only)

时间窗: 4 months

Average of participants' ratings of intervention components on a 10-point scale.

次要结局

  • Blood pressure(4 months)
  • Diet quality(4 months)
  • Secondary feasibility (intervention arm only)(4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne N. Thorndike, MD, MPH

Associate Professor of Medicine

Massachusetts General Hospital

研究点 (2)

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