Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity

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

Sponsor
Wake Forest University Health Sciences
Study ID
NCT07031739
Status
Recruiting
Apply to this trial

Conditions

  • Uncontrolled Hypertension

Eligibility Criteria

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

Interventions

  • Resource information — BEHAVIORAL
    Participants randomized to this arm will receive a tailored list of information about community resources.
  • Community Health Worker (CHW) assistance — BEHAVIORAL
    The CHW will meet with the participant at the baseline visit and will follow up with participants at least every other week. The CHW will also work directly with the patient's care team.
  • Medically-tailored Meals (MTM) — BEHAVIORAL
    MTM will consist of weekly home meal delivery. During the 3 months, participants will receive 10 medically tailored refrigerated or frozen meals (5 lunches and 5 dinners) delivered to their home weekly.

Study Details

Food insecurity affects 20% of the 116 million people in the US with hypertension and is associated with poor adherence to evidence-based treatments and disparities in hypertension outcomes. Interventions are being used to address food insecurity in clinical care settings, but people differ in the support they need to reduce food insecurity and little is known about which food insecurity interventions work best, or for whom. The goal of this study is to develop and test an adaptive food insecurity intervention using a Sequential Multiple Assignment Randomized Trial to determine which initial food insecurity intervention is more effective in improving adherence and blood pressure in patients with hypertension and for those who do not respond to the initial intervention, evaluate how to best provide additional support.

Key Dates

Start date
Aug 18, 2025
Status verified
May 2026
Primary completion
Sep 30, 2029
Completion
Feb 28, 2030

Study Design

Enrollment
224 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Resource information
    Participants randomized to this arm will receive a tailored list of information about community resources. The list will include information about local food resources (e.g. local food pantries) and government programs (e.g. Supplemental Nutrition Assistance Program) to address Food Insecurities (FI).
  • Experimental: Community Health Worker (CHW) assistance
    The CHW will meet with the participant at the baseline visit and will follow up with participants at least every other week. The CHW will also work directly with the patient's care team. As health advisors, CHW will help them overcome commonly experienced barriers in blood pressure management.
  • Experimental: Medically-tailored Meals (MTM)
    MTM will consist of weekly home meal delivery. During the 3 months, participants will receive 10 medically tailored refrigerated or frozen meals (5 lunches and 5 dinners) delivered to their home weekly. All meals are planned by a registered dietician and based on the Dietary Approaches to Stop Hypertension (DASH) diet.

Primary Outcome Measure

Systolic blood pressure value [ Time Frame: Month 9 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Rebecca Stone, MPH
[email protected]
336-713-5544
Deepak Palakshappa, MD, MSHP (PRINCIPAL_INVESTIGATOR)

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