Integrating Free-choice Marketplace, dieTitian coacHing, cultuRally Tailored messagIng to improVE Blood Pressure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Systolic blood pressure (mmHg)
研究概览
简要总结
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.
详细描述
Cardiovascular-kidney-metabolic (CKM) syndrome is a devastating public health crisis that affects nearly 90% of US adults. CKM accounts for >30% of all US deaths and >5 million hospitalizations annually and imposes an annual economic burden of ≥$1 trillion, with a disproportionate impact on Black, Hispanic adults. Inequitable access to care, high-quality food, culturally tailored dietitian support, and living in "food deserts" (also known as Healthy Food Priority Areas (HFPAs) exacerbate CKM disparities. Innovative approaches are urgently needed to sustainably improve food access and CKM health of Black and Hispanic adults.
More than three times as many Black adults (31%) in Baltimore City live in HFPAs compared to White adults (9%). About 45% of households in Montgomery County earn less than the self-sufficiency standard, 64% of Supplemental Nutrition Assistance Program (SNAP)-eligible adults are unenrolled, the highest rate in MD. In 2022, 48% of Prince George's County residents lived in HFPAs. Reasons for these disparities are complex and comprise factors at the individual, provider, community, and systemic levels.
Evidence-based interventions that improve CKM health include personalized dietitian coaching, home blood pressure monitoring (HBPM), and culturally tailored messages. Digital interventions could improve access to dietitians and fruits/vegetables (f/v) through digital "FARMacy" (akin to a virtual farmers market). Implementation strategies for the delivery of these digital interventions are critical gaps, and clinic integration remains unclear. Digital FARMacy platforms offer potential for increased reach and engagement-relative effectiveness and implementation approach have not been explored.
The investigators propose to test the effects of iTHRIVE using a randomized controlled trial among 100 adult participants living in HFPAs in MD counties with uncontrolled BP defined as systolic blood pressure (SBP) ≥130 milimiters of mercury (mmHg) and diabetes or moderate risk chronic renal disease. Participants will be randomized to either iTHRIVE (digital FARMacy, personalized dietitian coaching with produce prescription [PRx], and HBPM) or enhanced usual care (EUC, general dietary advice, standard food bags). The investigators will assess the effectiveness of iTHRIVE in improving systolic blood pressure at 6 months and evaluate the reach, adoption, implementation, maintenance, and budget impact of iTHRIVE
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •Have refrigeration, food preparation appliances (microwave, stove), and cell phones for the App
排除标准
- •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
研究组 & 干预措施
iTHRIVE intervention arm
iTHRIVE intervention will include access to a digital produce prescription platform, virtual dietitian coaching, a Home blood pressure monitor with App integration, and produce
干预措施: iTHRIVE intervention (Behavioral)
Comparator Arm
The active comparator arm will receive enhanced usual care, standard produce bags, general dietary advice, and a home blood pressure monitor
干预措施: Active comparator (Behavioral)
结局指标
主要结局
Systolic blood pressure (mmHg)
时间窗: Baseline, 3, 6 and 12 months
Systolic blood pressure measured in millimeters of mercury (mmHg) by the home blood pressure device and in the electronic medical record (EMR)
次要结局
- Hemoglobin A1c (percent)(Baseline, 3, and 6 months)
- Weight in pounds(Baseline, 3, 6, and 12 months)
- Change in Dietary Patterns assessed by 24 hour dietary recall(Baseline and 6 months)
- Cost effectiveness(Baseline and 12 weeks)
- Cultural appropriateness and acceptability assessed by Cultural Sensitivity Assessment Tool(Baseline, 6 and 12 months)
- Height in inches(Baseline, 3,6 and 12months)