Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 24FIM1264121 | Other Grant/Funding Number | American Heart Association |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Heart Association | OTHER |
Not provided
Not provided
Not provided
Not provided
THRIVE intervention is a 2-arm randomized pilot trial testing the feasibility and preliminary efficacy of producing prescriptions, tailored dietitian counseling with adaptive messages, and linkages to social resources among 80 Black adults with hypertension.
Nearly 55% of Black adults have hypertension and uncontrolled blood pressure. Dietary Approaches to Stop Hypertension (DASH) promotes a dietary pattern rich in fruits and vegetables (fruits and vegetables), low-fat dairy, lean meats with reduced saturated fat, and sweets, which is effective in lowering blood pressure. The proposed THRIVE intervention will enroll 80 Black adults with hypertension living in Healthy Food Priority Areas (HFPAs) in a 2-arm randomized pilot study. One group will receive Produce prescriptions, personalized dietitian coaching, and adaptive bi-directional messaging; the other group will receive standard produce bags. Both groups will be linked to needed social services.
The investigators will assess changes in overall DASH adherence, acceptability, and feasibility at 3- and 6-months post-randomization. The investigators will: 1) Develop and beta test THRIVE among Black adults with hypertension living in HFPAs; 2) Test feasibility and preliminary efficacy of THRIVE at 6 & 12 weeks; 3) Determine short-term sustainability of THRIVE at 6 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THRIVE Intervention Arm | Experimental | The THRIVE intervention arm will receive produce prescription, personalized dietitian coaching, adaptive bi-directional messaging; and linkages to social services. |
|
| Comparator Arm | Active Comparator | The comparator arm will receive standard produce bags; and linkages to social services. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THRIVE Intervention | Behavioral | THRIVE Intervention includes:
|
| Measure | Description | Time Frame |
|---|---|---|
| DASH Adherence as assessed by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) | Adherence will be assessed by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24). The scores range from 0 to 100, with higher scores reflecting greater adherence. | 0, 12 weeks and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Recruitment yield per time | 0, 12 weeks, 24 weeks |
| Cost of the intervention | Intervention cost/person will be estimated based on the cost of the intervention |
Not provided
Inclusion Criteria:
18 years or older
Self-identify as Black/African American
Have diagnosed hypertension stages 1 (130-139/80-89 mm Hg) OR 2 (>140/90 mm Hg), determined via self-report and/or Electronic Medical Records (EMR)
Live in census tracts identified by Montgomery County Department of Planning as HFPA:
Participants must have refrigeration, food appliances (microwave, stove),
Cell phone to receive messages
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Oluwabunmi Ogungbe, PhD, MPH, RN | JHU School Of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Outcomes assessors and data analysts will be masked to treatment allocation.
| Active Comparator | Behavioral | The Active Comparator arm will receive standard produce bags through our food is medicine partner, and will receive the linkages to needed social and health resources intervention components. |
|
| 0, 12 weeks, 24 weeks |
| Participant Accrual | Referrals, participation rates, and recruitment yields. | 0, 12 weeks and 24 weeks |
| Number of referrals to health and social need resources | Social needs as assessed by the number of participants connected to health services and services for social needs. | 0, 12 weeks and 24 weeks |
| Systolic Blood pressure | Blood pressure measured in millimeters of mercury (mmHg) | 0, 12 and 24 weeks |
| Diastolic Blood pressure | Blood pressure measured in millimeters of mercury (mmHg) | 0, 12 and 24 weeks |
| Hemoglobin A1c | Hemoglobin A1c (percent) | 0, 12 and 24 weeks |
| Height in inches | Height will be measured | 0, 12 and 24 weeks |
| Weight in pounds | Weight will be measured | 0, 12 weeks and 24 weeks |