Clinical trial NCT06358417: CHW Intervention to Improve Nutrition Security of Patients with Hypertension
Official title: CHW Intervention to Improve Nutrition Security of Primary Care Patients with Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Nutrition, Healthy
Food Insecurity
Community Health Worker
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Feasiblity
timeFrame: Baseline
measure: Feasibility of CHW nutrition intervention (intervention arm only)
timeFrame: 4 months
measure: Acceptability (intervention arm only)
timeFrame: 4 months
Secondary outcomes:
measure: Diet quality
timeFrame: 4 months
measure: Blood pressure
timeFrame: 4 months
measure: Secondary feasibility (intervention arm only)
timeFrame: 4 months
measure: Secondary feasibility (intervention arm only)
timeFrame: 4 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Anne N Thorndike, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: