Trial to Address Food Insecurity in Patients With Hypertension (SMART-FI)
- Conditions
- Hypertension
- Interventions
- Behavioral: medically tailored mealsBehavioral: community health worker (CHW)Behavioral: Resource information Supplemental Nutrition Assistance Program (SNAP)
- Registration Number
- NCT05800145
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
In the US, 47% of adults have hypertension (HTN), and HTN accounts for more cardiovascular disease (CVD) deaths than any other CVD risk factor. Thus, the lack of an adaptive, stepped-care intervention to address FI in patients with HTN is a critical problem affecting a large, vulnerable population.
- Detailed Description
Despite advances in prevention and treatment, barriers to adherence are common and HTN disparities remain pervasive. Populations that have been socially and economically disadvantaged have a greater prevalence of HTN, worse blood pressure control, and are at higher risk of developing CVD from HTN. Food insecurity (FI), the lack of consistent access to nutritionally adequate foods, is an important social need that affects 30 million people in the US, impacts adherence to treatment, and contributes to HTN disparities. Increasingly, health systems are investing in interventions to address FI as part of routine care, including lower-cost, low intensity (e.g. providing information about community resources) and higher-cost, high intensity (e.g. using community health workers (CHWs), delivery of medical tailored meals (MTM)) interventions
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 94
- Adult patients (≥18 years of age)
- diagnosis of Hypertension (HTN) (defined by ICD-10 code) or have been prescribed at least one blood pressure medication (including thiazide diuretic, calcium channel blocker, beta-blocker, angiotensin-converting enzyme inhibitors, or angiotensin receptor blocker)
- blood pressures at their primary care office was >130/80
- experience Food Insecurity (FI) based on the 2-item Hunger Vital Sign
- live in Winston-Salem or Forsyth County
- unable to speak English or Spanish
- have severe cognitive impairment or major psychiatric illness that prevents consent and participation
- lack of safe, stable residence and ability to store meals
- pregnant, breastfeeding, or planning to become pregnant in the next year
- advance kidney disease (estimated creatine clearance < 30 mL/min)
- serious medical condition which either limits life expectancy or requires active management
- those planning on moving out of the geographic area within 12 months
- lack of a telephone
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description medically tailored meals (MTM) medically tailored meals Participants will receive 10 medically tailored meals delivery to their home weekly for 3 months community health worker (CHW) intervention community health worker (CHW) assist participants in addressing FI and supporting them in their blood pressure management resource referral Resource information Supplemental Nutrition Assistance Program (SNAP) will receive a tailored list of information about community resources. The list will include information about local emergency food resources (e.g. local food pantries) and government programs to address Food Insecurities (FI) Supplemental Nutrition Assistance Program (SNAP).
- Primary Outcome Measures
Name Time Method Blood Pressure Readings Month 6 assess blood pressure (using ambulatory blood pressure cuffs)
Feasibility of recruitment Percentage Month 6 Feasibility will be measured based on the proportion of patients screened who consented to be part of the study
Feasibility of retention Percentage Month 6 Feasibility will be measured at the proportion of participants who completed 3 and 6 month follow ups
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States