CHW Intervention to Improve Nutrition Security of Patients With Hypertension

Hypertension Clinical Trial

— HeartWell  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06358417
• Other study ID #: 2024P000873
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: August 1, 2024
• Est. completion date: May 1, 2027

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: Anne N Thorndike, MD, MPH
• Phone: 6177244608
• Email: athorndike[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 1, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Community Health Worker
• Food Insecurity
• Hypertension

Intervention

Behavioral:
• Nutrition-enhanced CHW
CHW provides nutrition education and skills training in addition to the usual care (Basic CHW) hypertension management.
• Basic CHW
CHW provide usual care for hypertension management.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasiblity	Proportion of eligible participants enrolled in study	Baseline
Primary	Feasibility of CHW nutrition intervention (intervention arm only)	At least 70% participants complete at least 3 of 4 CHW nutrition education modules	4 months
Primary	Acceptability (intervention arm only)	Average of participants' ratings of intervention components on a 10-point scale.	4 months
Secondary	Diet quality	Change in Healthy Eating Index-20 score	4 months
Secondary	Blood pressure	Change in systolic and diastolic blood presure	4 months
Secondary	Secondary feasibility (intervention arm only)	At least 70% participants complete 3 of 6 nutrition worksheets	4 months
Secondary	Secondary feasibility (intervention arm only)	At least 70% participants have a CHW assessment of their home cooking environment	4 months