NCT07031739 Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity
| NCT ID | NCT07031739 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Uncontrolled Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 224 participants |
| Start Date | 2025-08-18 |
| Primary Completion | 2029-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 224 participants in total. It began in 2025-08-18 with a primary completion date of 2029-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Deepak Palakshappa, MD, MSHP
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT07031739 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Uncontrolled Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07031739 currently recruiting?
Yes, NCT07031739 is actively recruiting participants. Contact the research team at Rebecca.J.Stone@Advocatehealth.org for enrollment information.
Where is the NCT07031739 trial being conducted?
This trial is being conducted at Winston-Salem, United States.
Who is sponsoring the NCT07031739 clinical trial?
NCT07031739 is sponsored by Wake Forest University Health Sciences. The principal investigator is Deepak Palakshappa, MD, MSHP at Wake Forest University Health Sciences. The trial plans to enroll 224 participants.