跳至主要内容
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2024年9月1日

概览

阶段
不适用
干预措施
Nutrition-enhanced CHW
疾病 / 适应症
Hypertension
发起方
Massachusetts General Hospital
入组人数
60
试验地点
2
主要终点
Feasiblity
状态
已完成
最后更新
11天前

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.

注册库
clinicaltrials.gov
开始日期
2024年9月1日
结束日期
2026年2月28日
最后更新
11天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Anne N. Thorndike, MD, MPH

Associate Professor of Medicine

Massachusetts General Hospital

入排标准

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

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

Basic CHW intervention

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

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)

研究点 (2)

Loading locations...

相似试验