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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Must Speak English or Spanish

• have a diagnosis of Hypertension (HTN)

• prescribed at least one blood pressure lowering medication (including thiazide diuretic, calcium channel blocker, beta-blocker, angiotensin-converting enzyme inhibitors, or angiotensin receptor blocker)

• past 2 blood pressures at their primary care doctor were greater than or equal to130/80mmHg (millimeters of Mercury)

• seen by their primary care doctor in the past 6 months

• experience Food Insecurities (FI) based on the 2-item Hunger Vital Sign

Locations
United States
North Carolina
Wake Forest University Health Sciences
RECRUITING
Winston-salem
Contact Information
Primary
Rebecca Stone, MPH
rjstone@wakehealth.edu
336-713-5544
Time Frame
Start Date: 2025-08-18
Estimated Completion Date: 2030-02
Participants
Target number of participants: 224
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Wake Forest University Health Sciences
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov