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Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity
Sponsor: Wake Forest University Health Sciences
Summary
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.
Official title: Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity and Improve Adherence in Patients With Hypertension
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
224
Start Date
2025-08-18
Completion Date
2030-02
Last Updated
2025-09-16
Healthy Volunteers
No
Conditions
Interventions
Resource information
Participants randomized to this arm will receive a tailored list of information about community resources.
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.
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.
Locations (1)
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States