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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001427 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHW Education | Behavioral | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Change in measure of participant systolic and diastolic blood pressure | 4 weeks |
| Veggie Meter Skin Carotenoid Score Change | 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. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Staras, PhD | University of Florida | Principal Investigator |
| Carla Fisher, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Flyer Only | Participants received a publicly available color copy of the National Institutes of Health's "Healthy Blood Pressure for Healthy Hearts: Small Steps to Take Control" flyer. |
| FG001 | Community Health Worker Education | Participants were invited to attend a one-hour meeting with a CHW to receive education on healthy eating to reduce blood pressure. Educational materials included: (1) assistance in SNAP enrollment, (2) a list of community food resources, and (3) a brief motivational educational session focused on healthy eating for blood pressure control. |
| FG002 | Community Health Worker Education and Navigation | Participants were invited to complete all components of the CHW education arm and were offered a menu of personalized support services, including: (1) transportation assistance to the grocery store (weekly rides or a one-time gas gift card), (2) culturally adapted, hypertension-tailored cooking recipes, and (3) access to the UF IFAS online library of healthy cooking videos. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Flyer Only | Participants received a publicly available color copy of the National Institutes of Health's "Healthy Blood Pressure for Healthy Hearts: Small Steps to Take Control" flyer. |
| BG001 | CHW Education |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Pressure | Change in measure of participant systolic and diastolic blood pressure | Posted | Mean | Standard Deviation | mmHg | 4 weeks |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Strategy | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Staras | University of Florida | 352-294-8299 | sstaras@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2025 | Apr 20, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 21, 2025 | Jul 1, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| CHW Education and Navigation | Behavioral | 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 were invited to attend a one-hour meeting with a CHW to receive education on healthy eating to reduce blood pressure. Educational materials included: (1) assistance in SNAP enrollment, (2) a list of community food resources, and (3) a brief motivational educational session focused on healthy eating for blood pressure control.
| BG002 | CHW Education and Navigation | Participants were invited to complete all components of the CHW education arm and were offered a menu of personalized support services, including: (1) transportation assistance to the grocery store (weekly rides or a one-time gas gift card), (2) culturally adapted, hypertension-tailored cooking recipes, and (3) access to the UF IFAS online library of healthy cooking videos. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Community Health Worker Provided Education and Navigation | Participants were invited to complete all components of the CHW education arm and were offered a menu of personalized support services, including: (1) transportation assistance to the grocery store (weekly rides or a one-time gas gift card), (2) culturally adapted, hypertension-tailored cooking recipes, and (3) access to the UF IFAS online library of healthy cooking videos. |
|
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| Primary | Veggie Meter Skin Carotenoid Score Change | 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. | Posted | Mean | Standard Deviation | Units on scale | 4 weeks |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Community Health Worker Provided 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. 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. CHW 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. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Community Health Worker Provided 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. CHW 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. | 0 | 25 | 0 | 25 | 0 | 25 |
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