CHW Intervention to Improve Nutrition Security of Patients With Hypertension

NCT ID: NCT06358417

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypertension Nutrition, Healthy Food Insecurity Community Health Worker

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Nutrition-enhanced CHW

Intervention Type BEHAVIORAL

CHW provides nutrition education and skills training in addition to the usual care (Basic CHW) hypertension management.

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.

Group Type ACTIVE_COMPARATOR

Basic CHW

Intervention Type BEHAVIORAL

CHW provide usual care for hypertension management.

Interventions

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Nutrition-enhanced CHW

CHW provides nutrition education and skills training in addition to the usual care (Basic CHW) hypertension management.

Intervention Type BEHAVIORAL

Basic CHW

CHW provide usual care for hypertension management.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* declines participation in CHW hypertension program; does not speak English or Spanish
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anne N. Thorndike, MD, MPH

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne N Thorndike, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2024P000873

Identifier Type: -

Identifier Source: org_study_id

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