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Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity

RecruitingNAAges 18 Years - anyAllWake Forest University Health Sciences
NCT07031739 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Resource information
  • Community Health Worker (CHW) assistance
  • Medically-tailored Meals (MTM)
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Where

1 site
Wake Forest University Health Sciences
Winston-Salem, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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