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Study for Uncontrolled High Blood Pressure and Food Insecurity

This study is looking at different ways to help people with uncontrolled high blood pressure (hypertension) who also have trouble getting enough food (food insecurity). You might be able to join if you are 18 or older, speak English or Spanish, have high blood pressure, take blood pressure medicine, and your last two blood pressure readings were 130/80mmHg or higher. The study will test three approaches: providing information about community resources, getting help from a Community Health Worker, or receiving medically-tailored meals delivered to your home. The main goals are to see if these interventions help lower your systolic and diastolic blood pressure and improve your adherence to a healthy diet (DASH diet) after 9 months.

Study design
This is an interventional study with 224 participants. It uses a special design called a Sequential Multiple Assignment Randomized Trial to compare different approaches.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your blood pressure and diet adherence will be measured at Month 9 after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07031739

Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity

Recruiting
NAAges 18+InterventionalTreatment
Wake Forest University Health Sciences
~224 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Resource informationCommunity Health Worker (CHW) assistanceMedically-tailored Meals (MTM)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Systolic blood pressure value
Measured over Month 9
+4 more outcomes measured

Conditions

Uncontrolled Hypertension

Explore related trials

Food InsecurityHypertension

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

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

Who to contact

Rebecca Stone, MPH
[email protected]
336-713-5544
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Systolic blood pressure valueMonth 9

    Systolic blood pressure measured as mmHg

  • Diastolic blood pressure valueMonth 9

    Diastolic blood pressure measured as mmHg

  • Dietary Approaches to Stop Hypertension (DASH) diet adherence ScoreMonth 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 ScoreMonth 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 ScoreMonth 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.