Hypertension
Conditions
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
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.
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 4 weeks | Change in measure of participant systolic and diastolic blood pressure |
| Veggie Meter Skin Carotenoid Score Change | 4 weeks | Veggie 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
University of Florida
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, Continuous | 51.7 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 type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 |