Skip to content

Improving Blood Pressure Control Among Food Insecure Hypertensive Adults

ReCLaiMeD: Using Community Healthcare Workers to Improve Blood Pressure Control Among Food Insecure Hypertensive Adults: Aim 2

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05877898
Enrollment
75
Registered
2023-05-26
Start date
2025-02-03
Completion date
2025-05-27
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Detailed description

We will recruit community members at food distribution events. Community members who have self-reported diagnosed hypertension, BP between 130 to 179 mm Hg systolic and 80 to 119 mm Hg diastolic, experience food insecurity (defined by the 10-question US Adult Food Security Survey Module), live in 32609, 32601, or 32641, are eligible for Supplemental Nutrition Assistance Program (SNAP), are between 18 and 69 years old, and did not participate in our developmental focus groups are eligible for this study. Participants, will be invited to complete the baseline data collection, randomly assigned to a study group, and receive instructions on the next steps. The baseline data collection includes a brief behavior survey and baseline biometrics. After the completion of the baseline data, participants will randomly be assigned to one of the three arms: (1) no strategy (n=25 participants), (2) Community Health Worker (CHW) education (n=25 participants), (3) CHW Education and Navigation (n=25 participants). Each participant will be in the study for the following 4 weeks. The implementation strategies will be conducted by a trained and certified CHW from within the East Gainesville community. The participants assigned to no strategy will be provided a color copy of the NIH's Healthy Blood Pressure for Healthy Hearts: Small Steps to Take Control Flyer. The CHW Education arm 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 Education and Navigation arm 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 University of Florida Institute of Food and Agricultural Sciences' 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. We will produce descriptive statistics of baseline characteristics for study participants in each arm and test for balanced randomization. We will perform regression analyses, ANOVA estimations, and non-parametric statistical tests for pre-post differences in BP and carotenoid levels within and between treatment arms. Assuming a baseline systolic mean of 140 mmHg, standard deviation of 10, 25 participants/arm, and alpha 0.05, we will have 82% power to detect a 8 mmHg difference in both active arms vs. control, similar to prior dietary studies (≥71% power if one arm achieves only 4 mmHg difference). Average scores of ≥3 on the 0-5 scale for AIM, FIM, and IAM will indicate success.

Interventions

BEHAVIORALCHW Education and Navigation

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.

BEHAVIORALCHW Education

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.

Sponsors

University of Florida
Lead SponsorOTHER
National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Participated in a focus group to develop the intervention

Design outcomes

Primary

MeasureTime frameDescription
Blood Pressure4 weeksChange in measure of participant systolic and diastolic blood pressure
Veggie Meter Skin Carotenoid Score Change4 weeksVeggie Meter Skin Carotenoid Score Change Skin Carotenoid Scores were measured with the Veggie Meter, a noninvasive reflection spectroscopy device that measures skin carotenoid concentration as an objective biomarker of fruit and vegetable intake. Veggie Meter Skin Carotenoid Scores are highly correlated with serum carotenoid. Score range: 0-800 (device-generated score) with higher scores indicating greater fruit and vegetable consumption. Lower scores reflect lower fruit and vegetable consumption. Skin Carotenoid Score is generated directly by the Veggie Meter; no sub-scales are used and no composite score calculation is required. The outcome measure presented is the group average change in Veggie Meter score from baseline to the 4-week outcome. Positive changes indicate increased fruit and vegetable intake while negative changes indicate decreased intake.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORStephanie Staras, PhD

University of Florida

PRINCIPAL_INVESTIGATORCarla Fisher, PhD

University of Florida

Participant flow

Recruitment details

We recruited 75 participants at events held at a community food distribution center between February and May 2025. Participants were randomized equally to 3 arms.

Baseline characteristics

Characteristic
Age, Continuous51.7 years
STANDARD_DEVIATION 10.6
Race/Ethnicity, Customized
Non-Hispanic Black
20 Participants
Race/Ethnicity, Customized
Non-Hispanic White
7 Participants
Race/Ethnicity, Customized
Other
5 Participants
Region of Enrollment
United States
25 participants
Sex/Gender, Customized
Female
13 Participants
Sex/Gender, Customized
Male
8 Participants
Sex/Gender, Customized
Other
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 250 / 250 / 25
other
Total, other adverse events
0 / 250 / 250 / 25
serious
Total, serious adverse events
0 / 250 / 250 / 25

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026