AdapTive Personalized Dietitian coacHing, Messaging and pRoduce prescrIption to improVE Healthy Dietary Behaviors

Hypertension Clinical Trial

— THRIVE  

Official title:

THRIVE: AdapTive Personalized Dietitian coacHing, Messaging and pRoduce prescrIption to improVE Healthy Dietary Behaviors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06257550
• Other study ID #: IRB00427492
• Secondary ID: 24FIM1264121
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: Johns Hopkins University
• Contact: Oluwabunmi Ogungbe, PhD, MPH, RN
• Phone: 4106141519
• Email: oogungb3[@]jh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 60 Black adults with hypertension.

Description:

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 60 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

1. 18 years or older

2. Self-identify as Black/African American

3. 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)

4. Live in census tracts identified by Montgomery County Department of Planning52 as HFPA:

1. Healthy Food Availability Index score is low (0-9.5),

2. Median household income =185% of Federal Poverty Level

3. >30% households have no vehicle, Distance to supermarket >1/4 mile.

5. Participants must have refrigeration, food appliances (microwave, stove),

6. Cell phone to receive messages

Exclusion Criteria:

1. Age <18 years

2. Type 1 or Type 2 Diabetes defined as a hemoglobin A1c =6.5% or diabetes treatment

3. Diagnosis of end-stage renal disease (ESRD)

4. Condition which interferes with outcome measurement (e.g., dialysis)

5. Serious medical condition which either limits life expectancy or requires active management (e.g. cancer)

6. Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence

7. Patients with cognitive impairment or other condition preventing their participation in the intervention

8. Current participation in a care management program related to health conditions (e.g., weight reduction, smoking cessation)

9. Current participation in another clinical trial that could interfere with the study protocol

10. Those planning to move out of the geographic area in 12 months

11. Unwillingness to provide informed consent

12. Other conditions or situations at the discretion of the Investigative team

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• THRIVE Intervention
THRIVE Intervention includes: Weekly Pulse Surveys Adaptive culturally tailored messages Personalized Dietitian Coaching Produce Prescription "FARMacy" Mobile Market Linkages to Social Services
• Active Comparator
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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Recruitment rate	Recruitment yield per time	0, 12 weeks, 24 weeks
Secondary	Cost of the intervention	Intervention cost/person will be estimated based on the cost of the intervention	0, 12 weeks, 24 weeks
Secondary	Participant Accrual	Referrals, participation rates, and recruitment yields.	0, 12 weeks and 24 weeks
Secondary	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
Secondary	Systolic Blood pressure	Blood pressure measured in millimeters of mercury (mmHg)	0, 12 and 24 weeks
Secondary	Diastolic Blood pressure	Blood pressure measured in millimeters of mercury (mmHg)	0, 12 and 24 weeks
Secondary	Hemoglobin A1c	Hemoglobin A1c (percent)	0, 12 and 24 weeks
Secondary	Height in inches	Height will be measured	0, 12 and 24 weeks
Secondary	Weight in pounds	Weight will be measured	0, 12 weeks and 24 weeks