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

Not Applicable

Recruiting

• Conditions: Hypertension
• Interventions: Behavioral: THRIVE Intervention; Behavioral: Active Comparator

• Registration Number: NCT06257550
• Lead Sponsor: Johns Hopkins University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-05
• Study First Posted: 2024-02-14
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-05
• Study Start: 2024-06-30
• Primary Completion: 2025-01-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
THRIVE Intervention Arm	THRIVE Intervention	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.

Primary Outcome Measures

Name	Time	Method
DASH Adherence as assessed by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)	0, 12 weeks and 24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Cost of the intervention	0, 12 weeks, 24 weeks	Intervention cost/person will be estimated based on the cost of the intervention
Weight in pounds	0, 12 weeks and 24 weeks	Weight will be measured
Recruitment rate	0, 12 weeks, 24 weeks	Recruitment yield per time
Participant Accrual	0, 12 weeks and 24 weeks	Referrals, participation rates, and recruitment yields.
Number of referrals to health and social need resources	0, 12 weeks and 24 weeks	Social needs as assessed by the number of participants connected to health services and services for social needs.
Diastolic Blood pressure	0, 12 and 24 weeks	Blood pressure measured in millimeters of mercury (mmHg)
Systolic Blood pressure	0, 12 and 24 weeks	Blood pressure measured in millimeters of mercury (mmHg)
Hemoglobin A1c	0, 12 and 24 weeks	Hemoglobin A1c (percent)
Height in inches	0, 12 and 24 weeks	Height will be measured

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States