CHW Intervention to Improve Nutrition Security of Patients with Hypertension

Not Applicable

Recruiting

• Conditions: Community Health Worker; Food Insecurity; Hypertension; Nutrition, Healthy
• Interventions: Behavioral: Nutrition-enhanced CHW; Behavioral: Basic CHW

• Registration Number: NCT06358417
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2024-04-05
• Study First Submitted QC: 2024-04-05
• Study First Posted: 2024-04-10
• Study Start: 2024-09-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Primary Completion: 2027-04-01
• Study Completion: 2028-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrition-enhanced CHW intervention	Nutrition-enhanced CHW	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.
Basic CHW intervention	Basic CHW	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Diet quality	4 months	Change in Healthy Eating Index-20 score
Blood pressure	4 months	Change in systolic and diastolic blood presure
Secondary feasibility (intervention arm only)	4 months	At least 70% participants have a CHW assessment of their home cooking environment

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States