CHW Intervention to Improve Nutrition Security of Patients With Hypertension (HeartWell)

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Food Insecurity; Nutrition, Healthy; Community Health Worker
• Intervention / Treatment: Behavioral: Nutrition-enhanced CHW; Behavioral: Basic CHW

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Nutrition-enhanced CHW; CHW provides nutrition education and skills training in addition to the usual care (Basic CHW) hypertension management.
Active Comparator: 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.	Behavioral: Basic CHW; CHW provide usual care for hypertension management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasiblity	Proportion of eligible participants enrolled in study	Baseline
Acceptability (intervention arm only)	Average of participants' ratings of intervention components on a 10-point scale.	4 months
Feasibility of CHW nutrition intervention (intervention arm only)	At least 70% participants complete at least 3 of 4 CHW nutrition education modules	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diet quality	Change in Healthy Eating Index-20 score	4 months
Blood pressure	Change in systolic and diastolic blood presure	4 months
Secondary feasibility (intervention arm only)	At least 70% participants complete 3 of 6 nutrition worksheets	4 months
Secondary feasibility (intervention arm only)	At least 70% participants have a CHW assessment of their home cooking environment	4 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Anne N Thorndike, MD, MPH, Massachusetts General Hospital

Publications and helpful links

General Publications

• Gu KD, Cheng J, Bejarano O, Gelsomin E, Malone A, Faulkner KC, Thorndike AN. Design of Heart Well: A randomized pilot study of a community health worker-delivered nutrition intervention for low-income adults with hypertension. Contemp Clin Trials. 2026 Mar;162:108244. doi: 10.1016/j.cct.2026.108244. Epub 2026 Jan 28.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): September 26, 2025
• Study Completion (Actual): February 28, 2026

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: 2024P000873

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified feasiblity, acceptability, diet quality, and blood pressure data will be shared. The data and details related to the analytic plan and study measures will be deposited in a publicly accessible data repository, such as the Harvard Dataverse, a NIH-approved Scientific Generalist Data Repository free to researchers inside and outside the Harvard community.
• IPD Sharing Time Frame: Analytic plans and details will be made available no later than the official publication date of a peer-reviewed article that includes the study results, and these will be available for at least 5 years after the study period ends. De-identified data from the study will be made publicly available through the data repository within 90 days of the closeout of the project and made available according to the Harvard Dataverse's data retention policy.
• IPD Sharing Access Criteria: In accordance with the data repository methods, completion of a data use agreement form, that stipulates data sharing under an IRB-approved protocol, will be required for accessing the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No