RightFit
RecruitingNot applicable

Integrating Free-choice Marketplace, dieTitian coacHing, cultuRally Tailored messagIng to improVE Blood Pressure

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years to 70 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a digital FARMacy program, personal coaching from a dietitian (food and nutrition expert), prescriptions for fruits and vegetables, and home blood pressure checks improve blood pressure. It is for 100 adults with high blood pressure who live in certain Maryland areas where healthy food is hard to get.

iTHRIVE intervention is a 2-arm randomized controlled trial testing the effects of digital FARMacy, personalized dietitian coaching with produce prescriptions, and home blood pressure measurement in 100 hypertensive adults living in high food priority areas in counties in Maryland.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 21–70 years old.
  • Identify as Black/African American or Hispanic/Latino.
  • Have a top blood pressure number of 130 or higher at screening, plus at least one condition listed in the next bullet.
  • Have diagnosed high blood pressure; prediabetes (HbA1c 5.7–6.4%) or type 2 diabetes (HbA1c 6.5% or higher), based on average blood sugar; or stage 3 long-term kidney disease (kidney filtering rate of 30–59).
  • Live in a designated high food priority area in Montgomery County, Prince George’s County, or Baltimore City.
  • The area must meet the listed food access rules: low healthy food availability score (0–9.5), middle household income at or below 185% of the federal poverty level, 30% of households without a vehicle, and a supermarket more than ¼ mile away.
  • Have a refrigerator, cooking appliances such as a microwave or stove, and a cell phone for the app.

Who can't join

  • Be younger than 21.
  • Have end-stage kidney disease (kidney failure) or receive dialysis, a treatment that filters the blood.
  • Have a serious illness, such as cancer, that limits how long you may live or needs active treatment.
  • Have food allergies, food preferences, intolerances, or special diet needs that would prevent following the study diet.
  • Have an active alcohol or drug use disorder and have not stopped using for at least 30 days.
  • Have problems with memory or thinking, or another condition that prevents taking part.
  • Be pregnant, breastfeeding, or planning to become pregnant.
  • Be in a health management program or another clinical trial that could interfere with this study, or plan to move out of the area within 12 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 21-70 years * Self-identify as Black/African American or Hispanic/Latino * Have Stage 2 CKM defined as: * Systolic BP ≥130mmHg (measured at screening) AND at least one of: * Hypertension (ICD-10: I10-I16) * Prediabetes (HbA1c 5.7-6.4%) or Type 2 Diabetes (HbA1c ≥6.5%) * Stage 3 chronic kidney disease (CKD) (eGFR 30-59 mL/min/1.73m²) * Live in census tracts identified by the Montgomery/ Prince George's/Baltimore City County Departments of Planning as HFPA: * Healthy Food Availability Index score is low (0-9.5), * Median household income ≤185% of Federal Poverty Level * 30% of households have no vehicle, * Distance to supermarket \>1/4 mile. 5. Have refrigeration, food preparation appliances (microwave, stove), and cell phones for the App Exclusion Criteria: * Age \<21 years * Diagnosis of end-stage renal disease (ESRD), dialysis * Serious medical condition that either limits life expectancy or requires active management (e.g., cancer) * Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence * Active alcohol or substance use disorder (i.e., not sober/abstinent for ≥ 30 days) * Patients with cognitive impairment or other condition preventing their participation in the intervention * Pregnant, breastfeeding, or planning pregnancy * Current participation in a care management program related to health conditions (e.g., weight reduction, smoking cessation) or another clinical trial that could interfere with the study protocol * Planning to move out of the geographic area in 12 months

Study sites (3)

MD