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Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity

NCT07031739 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Deepak Palakshappa, MD, MSHP · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-18
Primary Completion
2029-09-30
Completion
2030-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07031739 on ClinicalTrials.gov