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NCT06358417 | Not yet recruiting | Hypertension


CHW Intervention to Improve Nutrition Security of Patients With Hypertension
Sponsor:

Massachusetts General Hospital

Information provided by (Responsible Party):

Anne N. Thorndike, MD, MPH

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.

Condition or disease

Hypertension

Nutrition, Healthy

Food Insecurity

Community Health Worker

Intervention/treatment

Nutrition-enhanced CHW

Basic CHW

Phase

Phase 2

Phase 3

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
Estimated Enrollment : 60 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : CHW Intervention to Improve Nutrition Security of Primary Care Patients With Hypertension
Actual Study Start Date : August 1, 2024
Estimated Primary Completion Date : January 31, 2027
Estimated Study Completion Date : May 1, 2027
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

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

Ages Eligible for Study: 21 Years to 99 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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

CHW Intervention to Improve Nutrition Security of Patients With Hypertension

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CHW Intervention to Improve Nutrition Security of Patients With Hypertension

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