NCT07031739 · Wake Forest University Health Sciences
Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity
(SMART)
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
Systolic blood pressure value
Time frame: Month 9
Systolic blood pressure measured as mmHg
Diastolic blood pressure value
Time frame: Month 9
Diastolic blood pressure measured as mmHg
Dietary Approaches to Stop Hypertension (DASH) diet adherence Score
Time frame: Month 9
Change in DASH diet adherence over time, based on the Mellen DASH diet adherence index - The Mellen DASH diet index is a nutrient-based method for assessing adherence to the Dietary Approaches to Stop Hypertension (DASH) diet. It uses nine key nutrients to determine a score ranging from 0 to 9, with 9 indicating the most adherence - Food items on the FFQ are assigned to 7 DASH food groups and 3 components using the Harvard nutrient database. Servings in each component are scored 0, 0.5, and 1. The DASH diet adherence score ranges from 0 to 10 and is the sum of the 10 component scores. Higher scores indicate greater diet concordance.
Medication adherence Score
Time frame: Month 9
Change in medication adherence based on the 12-item Adherence to Refills and Medications Scale - The 12-item Adherence to Refills and Medications Scale (ARMS) is a self-report questionnaire designed to measure a patient's adherence to medication regimens - Each scale comprises five items that are scored on a Likert-type scale, where 1 = strongly disagree, 2 = disagree, 3 = uncertain, 4 = agree and 5 = strongly agree. Higher scores indicate stronger beliefs in the necessity of medication and greater concerns about taking it.
Food Security Score
Time frame: Month 9
Change in food security over time based on the 10-item USDA Food Security Survey Module with a 30-day reference period - The USDA Food Security Survey Module (HFSSM) uses a 10-item adult-referenced module to assess food security status. A raw score is calculated based on affirmative responses to these 10 questions, and this score is then used to classify households into food security categories: high, marginal, low, or very low. High Food Security (Raw Score 0): No affirmative responses. Marginal Food Security (Raw Score 1-2): One or two affirmative responses. Low Food Security (Raw Score 3-5): Three to five affirmative responses. Very Low Food Security (Raw Score 6-10): Six to ten affirmative responses.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Systolic Blood Pressure \> 210mmHg or a diastolic blood pressure \> 120mmHg
- have a severe cognitive impairment or major psychiatric illness that prevents consent or serious medical condition which either limits life expectancy or requires active management (e.g. certain cancers)
- pregnant, breastfeeding, or planning to become pregnant in the next 6 months
- planning on moving out of the area within 6 months
- lack safe stable housing
- do not have the ability to store meals
- lack of a telephone
Where
- Winston-Salem, North Carolina
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations