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Completed

NCT Number: NCT06358417

CHW Intervention to Improve Nutrition Security of 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.

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Key information

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrition-enhanced CHW

Behavioral

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

Basic CHW

Behavioral

CHW provide usual care for hypertension management.

Primary outcomes

  1. Feasiblity

    Time frame: Baseline

    Proportion of eligible participants enrolled in study

  2. Feasibility of CHW nutrition intervention (intervention arm only)

    Time frame: 4 months

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

  3. Acceptability (intervention arm only)

    Time frame: 4 months

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

Secondary outcomes

  1. Diet quality

    Time frame: 4 months

    Change in Healthy Eating Index-20 score

  2. Blood pressure

    Time frame: 4 months

    Change in systolic and diastolic blood presure

  3. Secondary feasibility (intervention arm only)

    Time frame: 4 months

    At least 70% participants complete 3 of 6 nutrition worksheets

  4. Secondary feasibility (intervention arm only)

    Time frame: 4 months

    At least 70% participants have a CHW assessment of their home cooking environment

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Acronym: HeartWell

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 10, 2024
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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