CHW Intervention to Improve Nutrition Security of Patients With Hypertension

NCT06358417 | Completed

• 1 other identifier: 2024P000873
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; Nutrition, Healthy; Food Insecurity; Community Health Worker

Outcome Measures

Primary Outcomes (3)

• Feasiblity

  Proportion of eligible participants enrolled in study

  Baseline

• Feasibility of CHW nutrition intervention (intervention arm only)

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

  4 months

• Acceptability (intervention arm only)

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

  4 months

Secondary Outcomes (4)

• Diet quality

  4 months

• Blood pressure

  4 months

• Secondary feasibility (intervention arm only)

  4 months

• Secondary feasibility (intervention arm only)

  4 months

Study Arms (2)

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.

Behavioral: Nutrition-enhanced CHW

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.

Behavioral: Basic CHW

Interventions

Nutrition-enhanced CHW BEHAVIORAL

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

Nutrition-enhanced CHW intervention

Basic CHW BEHAVIORAL

CHW provide usual care for hypertension management.

Basic CHW intervention

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 41610938 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Anne N Thorndike, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 10, 2024
• Study Start: September 1, 2024
• Primary Completion: September 26, 2025
• Study Completion: February 28, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

US (1)