RecruitingNot ApplicableNCT07031739

Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity

Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity and Improve Adherence in Patients With Hypertension

Sponsor

Wake Forest University Health Sciences

Enrollment

224 participants

Start Date

Aug 18, 2025

Study Type

INTERVENTIONAL

Conditions

Uncontrolled Hypertension

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests different ways to help people manage both food insecurity (not having reliable access to enough food) and high blood pressure at the same time, using a step-by-step treatment approach. **You may be eligible if...** - You speak English or Spanish - You have been diagnosed with high blood pressure (hypertension) - You are currently taking at least one blood pressure medication - Your last two blood pressure readings at your doctor's office were 130/80 mmHg or higher - You have seen your primary care doctor in the past 6 months - You are currently experiencing food insecurity **You may NOT be eligible if...** - Your blood pressure is well-controlled - You do not experience food insecurity - You do not speak English or Spanish Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALResource information

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

BEHAVIORALCommunity 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.

BEHAVIORALMedically-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.