Trial Outcomes & Findings for Improving Blood Pressure Control Among Food Insecure Hypertensive Adults (NCT NCT05877898)
NCT ID: NCT05877898
Last Updated: 2026-06-15
Results Overview
Change in measure of participant systolic and diastolic blood pressure
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
4 weeks
Results posted on
2026-06-15
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
23
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
1
|
Baseline Characteristics
Improving Blood Pressure Control Among Food Insecure Hypertensive Adults
Baseline characteristics by cohort
| Measure |
Flyer Only
n=25 Participants
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.
|
CHW Education
n=25 Participants
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.
|
CHW Education and Navigation
n=25 Participants
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.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.9 years
STANDARD_DEVIATION 11 • n=20 Participants
|
52.3 years
STANDARD_DEVIATION 8.8 • n=20 Participants
|
51 years
STANDARD_DEVIATION 12 • n=40 Participants
|
51.7 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
8 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
25 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
16 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
49 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
3 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
20 Participants
n=20 Participants
|
22 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
63 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=20 Participants
|
25 participants
n=20 Participants
|
25 participants
n=40 Participants
|
75 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksChange in measure of participant systolic and diastolic blood pressure
Outcome measures
| Measure |
Flyer Only
n=23 Participants
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.
|
Community Health Worker Provided Education
n=25 Participants
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.
|
Community Health Worker Provided Education and Navigation
n=24 Participants
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.
|
|---|---|---|---|
|
Blood Pressure
Systolic Blood Pressure
|
-1.1 mmHg
Standard Deviation 18.1
|
-2.5 mmHg
Standard Deviation 18.7
|
-4.6 mmHg
Standard Deviation 21.3
|
|
Blood Pressure
Diastolic Blood Pressure
|
-2.6 mmHg
Standard Deviation 11.1
|
-0.7 mmHg
Standard Deviation 12.5
|
-5.2 mmHg
Standard Deviation 15.1
|
PRIMARY outcome
Timeframe: 4 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.
Outcome measures
| Measure |
Flyer Only
n=23 Participants
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.
|
Community Health Worker Provided Education
n=25 Participants
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.
|
Community Health Worker Provided Education and Navigation
n=24 Participants
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.
|
|---|---|---|---|
|
Veggie Meter Skin Carotenoid Score Change
|
1.1 Units on scale
Standard Deviation 49.6
|
0.7 Units on scale
Standard Deviation 62
|
3 Units on scale
Standard Deviation 59
|
Adverse Events
No Strategy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Community Health Worker Provided Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Community Health Worker Provided Education and Navigation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place