Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying ways to help people with high blood pressure (hypertension) who also struggle with food insecurity, meaning they don’t always have reliable access to enough healthy food. Since food insecurity can make it harder to take medicines properly and control blood pressure, this study aims to find out which types of food support work best to improve both medication use and blood pressure levels. The study will try different approaches and adjust the support based on how well participants respond over time.

People who might be eligible to join are adults aged 65 to 74 who speak English or Spanish, have been diagnosed with high blood pressure, are taking at least one blood pressure medicine, and have had blood pressure readings above the recommended level at recent doctor visits. They must also be experiencing food insecurity. Participants will receive food-related support tailored to their needs, and if the first approach doesn’t help enough, additional support will be offered. It’s important that participants have stable housing, a way to store food, and a phone to stay in contact with the study team. This study is not yet recruiting but aims to find better ways to support people with hypertension who face food challenges.

Gender

ALL

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 130/80mmHg (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