Adaptive program to reduce food insecurity for people with uncontrolled high blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study uses a Sequential Multiple Assignment Randomized Trial (SMART) design to identify which food-security interventions work best for adults with uncontrolled hypertension. Eligible participants who screen positive for food insecurity and are on at least one blood-pressure medication with recent readings ≥130/80 mmHg will be randomized to receive resource information, community health worker assistance, or medically-tailored meals. People who do not respond to the initial intervention will be re-randomized to receive intensified or alternative supports, with primary outcomes including medication and dietary adherence and changes in blood pressure. The study is conducted at Wake Forest University Health Sciences and includes English- and Spanish-speaking adults who can attend follow-up visits.

Why it matters

Who can join: the full rules

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

Where it's running

• Wake Forest University Health Sciences
  Winston-Salem, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Deepak Palakshappa, MD, MSHP — Wake Forest University Health Sciences
• Study coordinator: Rebecca Stone, MPH
• Email: Rebecca.J.Stone@Advocatehealth.org
• Phone: 336-713-5544

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.