HypertensionNCT05877898
Improving Blood Pressure Control Among Food Insecure Hypertensive Adults
A study testing CHW Education and CHW Education and Navigation in people with Hypertension, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Hypertension
- What is being tested?
- CHW Education and CHW Education and Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2025to 27 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participated in a focus group to develop the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ReCLaiMeD: Using Community Healthcare Workers to Improve Blood Pressure Control Among Food Insecure Hypertensive Adults: Aim 2
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- CHW Education, CHW Education and Navigation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHW EducationBehavioural
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.
CHW Education and NavigationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: CHW Education and Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Change in measure of participant systolic and diastolic blood pressure
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start3 Feb 2025
- Primary completion27 May 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Stephanie Staras, PhD, Principal investigator, University of FloridaCarla Fisher, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877898
- Sponsor's protocol ID
- IRB202300592
- Other IDs
- UL1TR001427
- Status last verified
- Jun 2025
- First submitted
- 17 May 2023
- Last updated
- 15 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReCLaiMeD: Using Community Healthcare Workers to Improve Blood Pressure Control Among Food Insecure Hypertensive Adults: Aim 2
- ClinicalTrials.gov ID
- NCT05877898
- Acronym / sponsor ID
- IRB202300592
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 26 May 2023 (actual)
- Results
- Posted 15 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: CHW EducationParticipants 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. |
| Community health worker provided education and Navigation | Experimental | Behavioral: CHW Education and NavigationParticipants 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. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Participated in a focus group to develop the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHW EducationParticipants will be invited to meet with the CHW to learn about eating healthier to reduce blood pressure and enhance quantity and quality of life. | Behavioural | Community health worker provided education |
| CHW Education and NavigationParticipants 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. | Behavioural | Community health worker provided education and Navigation |
Primary outcome
Blood Pressure
Time frame: 4 weeks
Change in measure of participant systolic and diastolic blood pressure
Veggie Meter Skin Carotenoid Score Change
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Staras, PhD principal investigator
University of Florida
Carla Fisher, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHW Education and CHW Education and Navigation in people with Hypertension, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.