Adaptive program to reduce food insecurity for people with uncontrolled high blood pressure
Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity and Improve Adherence in Patients With Hypertension
This study will test whether different food-support approaches—resource information, community health worker help, or medically-tailored meals—help adults with uncontrolled hypertension who face food insecurity stick to diet and medication plans and lower their blood pressure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT07031739 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are English- or Spanish-speaking adults with a diagnosis of hypertension, prescribed at least one blood-pressure medication, with their last two clinic blood pressures ≥130/80 mmHg, who screen positive for food insecurity and have seen their primary care doctor within the past six months.
Not a fit: Patients unlikely to benefit include those with dangerously high blood pressure (systolic >210 mmHg or diastolic >120 mmHg), severe cognitive or major psychiatric illness or other serious medical conditions limiting life expectancy, pregnant or planning pregnancy within six months, planning to move away, or those who do not actually have food insecurity.
Why it matters
Potential benefit: If successful, this program could help patients with hypertension who lack reliable access to healthy food better follow treatment plans and improve blood pressure control.
How similar studies have performed: Programs like the DASH diet and medically-tailored meals have improved blood pressure and adherence and community health worker interventions have shown promise, but applying a SMART adaptive approach to match food-insecurity interventions to individual patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Winston-Salem, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.