Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

About this trial

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

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

224 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Wake Forest University Health Sciences

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator