Trial to Address Food Insecurity in Patients With Hypertension (SMART-FI)

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT05800145
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Resource information Supplemental Nutrition Assistance Program (SNAP) — BEHAVIORAL
    Participants randomized to the resource referral arm 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 FI (e.g. SNAP).
  • community health worker (CHW) — BEHAVIORAL
    Participants randomized to the CHW intervention will have an initial baseline visit scheduled at a mutually convenient location.
  • medically tailored meals — BEHAVIORAL
    Participants will receive 10 medically tailored meals delivery to their home weekly for 3 months

Study Details

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.

Key Dates

Start date
May 16, 2023
Status verified
Sep 2024
Primary completion
Sep 3, 2024
Completion
Sep 3, 2024

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: resource referral
    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).
  • Active Comparator: community health worker (CHW) intervention
    assist participants in addressing FI and supporting them in their blood pressure management
  • Active Comparator: medically tailored meals (MTM)
    Participants will receive 10 medically tailored meals delivery to their home weekly for 3 months

Primary Outcome Measure

Systolic Blood Pressure Readings [ Time Frame: Baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-

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