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RECRUITING
NCT07031739
NA

Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

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

Interventions

BEHAVIORAL

Resource information

Participants randomized to this arm will receive a tailored list of information about community resources.

BEHAVIORAL

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.

BEHAVIORAL

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