Clinical trial NCT06257550: AdapTive Personalized Dietitian coacHing, Messaging and pRoduce prescrIption to improVE Healthy Dietary Behaviors
Official title: THRIVE: AdapTive Personalized Dietitian coacHing, Messaging and pRoduce prescrIption to improVE Healthy Dietary Behaviors
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hypertension
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2024-02-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: DASH Adherence as assessed by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)
timeFrame: 0, 12 weeks and 24 weeks
Secondary outcomes:
measure: Recruitment rate
timeFrame: 0, 12 weeks, 24 weeks
measure: Cost of the intervention
timeFrame: 0, 12 weeks, 24 weeks
measure: Participant Accrual
timeFrame: 0, 12 weeks and 24 weeks
measure: Number of referrals to health and social need resources
timeFrame: 0, 12 weeks and 24 weeks
measure: Systolic Blood pressure
timeFrame: 0, 12 and 24 weeks
measure: Diastolic Blood pressure
timeFrame: 0, 12 and 24 weeks
measure: Hemoglobin A1c
timeFrame: 0, 12 and 24 weeks
measure: Height in inches
timeFrame: 0, 12 and 24 weeks
measure: Weight in pounds
timeFrame: 0, 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: JHU School Of Nursing
name: Oluwabunmi Ogungbe, PhD, MPH, RN
role: PRINCIPAL_INVESTIGATOR
References: