NCT05877898

Brief Summary

The overall objective of this project is to assess the feasibility, acceptability, and appropriateness of adapted community health worker (CHW)-led implementation strategies designed to improve intake of fruits and vegetables and reduce BP among patients with hypertension experience food insecurity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
1.7 years until next milestone

Study Start

First participant enrolled

February 3, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2025

Completed
Last Updated

December 17, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

May 17, 2023

Last Update Submit

December 11, 2025

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

  • Blood pressure

    Change in measure of participant systolic and diastolic blood pressure

    4 weeks

  • carotenoid levels

    Change in carotenoid levels as measured by the Veggie Meter

    4 weeks

Study Arms (3)

No strategy

NO INTERVENTION

Individuals assigned to this arm with receive a publicly available color copy of the NIH's Healthy Blood Pressure for Healthy Hearts: Small Steps to Take Control Flyer available

Community health worker provided education

EXPERIMENTAL

Participants will be invited to meet with the CHW to learn about eating healthier to reduce blood pressure and enhance quantity and quality of life. The CHW will register individuals for SNAP benefits and educate them on how to use their benefits locally. As other resources exist, including food pantries, food distribution events, and Fresh Access Bucks (a federal program to double SNAP if spent on local produce at eligible farmers markets), the CHW will provide information on these services. The CHW will also provide a brief motivational educational session about eating healthier to reduce BP and enhance quality and quantity of life. The CHW will meet once for up to one hour with each participant.

Behavioral: CHW Education

Community health worker provided education and Navigation

EXPERIMENTAL

Participants will be invited to complete all the CHW education arm material and be offered a menu of optional services for personalization including: (1) transportation to the grocery store (weekly for 4 weeks), (2) culturally adapted hypertension-tailored cooking recipes, (3) a virtual cooking class with food delivered to their door led by community partner, (4) access to UF IFAS's online library of healthy food cooking videos, and (5) in-store education on food labels, grocery shopping, and food resource management skills through the Cooking Matters at the Store curricula.

Behavioral: CHW Education and Navigation

Interventions

CHW EducationBEHAVIORAL

Participants will be invited to meet with the CHW to learn about eating healthier to reduce blood pressure and enhance quantity and quality of life.

Community health worker provided education
CHW Education and NavigationBEHAVIORAL

Participants will be invited to complete all the CHW education arm material and be offered a menu of optional services for personalization including: (1) transportation to the grocery store (weekly for 4 weeks), (2) culturally adapted hypertension-tailored cooking recipes, (3) a virtual cooking class with food delivered to their door led by community partner, (4) access to UF IFAS's online library of healthy food cooking videos, and (5) in-store education on food labels, grocery shopping, and food resource management skills through the Cooking Matters at the Store curricula.

Community health worker provided education and Navigation

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • self-reported diagnosed hypertension
  • BP between 130 to 179 mm Hg systolic and 80 to 119 mm Hg diastolic
  • experience food insecurity
  • live in 32609, 32601, or 32641 zip codes
  • eligible for SNAP

You may not qualify if:

  • Participated in a focus group to develop the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Stephanie Staras, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

  • Carla Fisher, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2023

First Posted

May 26, 2023

Study Start

February 3, 2025

Primary Completion

May 27, 2025

Study Completion

May 27, 2025

Last Updated

December 17, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)