Actively Recruiting
Led by Wake Forest University Health Sciences · Updated on 2026-05-06
224
Participants Needed
1
Research Sites
21 weeks
Total Duration
W
Wake Forest University Health Sciences
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
This research aims to develop and test an adaptive intervention to reduce food insecurity and improve treatment adherence and blood pressure control in people with uncontrolled hypertension. Food insecurity affects many individuals with hypertension and is linked to poor adherence to treatments like diet and medications, contributing to health disparities. The study uses a Sequential Multiple Assignment Randomized Trial (SMART) design to find out which food insecurity intervention works best initially and how to provide additional support for those who do not respond. Participants will be randomly assigned to one of two first-stage interventions for three months: receiving tailored information about community food resources or support from a community health worker (CHW). Those who do not show a significant improvement in blood pressure after three months will be re-randomized to receive either CHW support or home delivery of medically tailored meals (MTM) for another three months. MTM includes weekly delivery of meals based on the DASH diet, designed to support blood pressure control. Participants will be involved for a total of nine months, including six months of intervention and three additional months of follow-up. Assessments will include measuring blood pressure, adherence to the DASH diet and medications, food security status, health-related quality of life, and use of community resources. Researchers will also conduct interviews to understand how and why the interventions affect participants. Safety monitoring and adherence to treatments will be tracked throughout the study.
CONDITIONS
Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants are randomized to receive either tailored information about community food resources or in-person support from a community health worker to help manage blood pressure and food insecurity.
Baseline visit and follow-up visits every other week for participants receiving community health worker support
Duration - 3 months
Participants who do not show sufficient improvement in blood pressure after the first 3 months are re-randomized to receive either continued community health worker support or home delivery of medically tailored meals based on the DASH diet.
Weekly home meal deliveries for participants receiving medically tailored meals; follow-up visits every other week for those continuing community health worker support
Duration - 3 months
Participants are followed for additional 3 months after interventions to monitor blood pressure, adherence to diet and medication, food security, and quality of life.
Periodic assessments during follow-up period
Total: 1 location
1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
R
Rebecca Stone, MPH
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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Deepak Palakshappa, Rebecca J Stone, Jesus Betancourt Torres...
https://pubmed.ncbi.nlm.nih.gov/42061553