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CHW Intervention to Improve Nutrition Security of Patients With Hypertension

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06358417
Acronym
HeartWell
Enrollment
60
Registered
2024-04-10
Start date
2024-09-01
Completion date
2026-02-28
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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.

Interventions

BEHAVIORALNutrition-enhanced CHW

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

BEHAVIORALBasic CHW

CHW provide usual care for hypertension management.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
FeasiblityBaselineProportion of eligible participants enrolled in study
Feasibility of CHW nutrition intervention (intervention arm only)4 monthsAt least 70% participants complete at least 3 of 4 CHW nutrition education modules
Acceptability (intervention arm only)4 monthsAverage of participants' ratings of intervention components on a 10-point scale.

Secondary

MeasureTime frameDescription
Diet quality4 monthsChange in Healthy Eating Index-20 score
Blood pressure4 monthsChange in systolic and diastolic blood presure
Secondary feasibility (intervention arm only)4 monthsAt least 70% participants complete 3 of 6 nutrition worksheets

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAnne N Thorndike, MD, MPH

Massachusetts General Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026