N/A N=159 Supportive Care

Food Insecurity, Food as Medicine, Hypertension

Food Insecurity · Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT07011251 ↗

Enrolled (actual)

159

Serious AEs

0.0%

Results posted

Apr 2026

Primary outcome: Primary: Change Systolic Blood Pressure — 9.39; .25 mmHg

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Food as Medicine Program (Behavioral); Survey (Other)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Alison Gustafson
Primary completion: Jan 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Change Systolic Blood Pressure	9.39; .25	—
PRIMARY Change Diastolic Blood Pressure	5.45; 1.26	—
SECONDARY Change in Dietary Intake	.49; .24; .24; .22	—
SECONDARY Number of Participants Who Answered Never/Rarely, Sometimes, Often/Always, and Don't Know to the Nutrition Security Question	9; 34; 3; 38; 18; 30	—
SECONDARY Number of Participants Reporting Food Insecurity	5; 1; 0; 17; 28; 93	—
SECONDARY Number of Participants Reporting Food Insecurity	5; 1; 0; 17; 28; 93	—
SECONDARY Number of Participants Who Answered Never/Rarely, Sometimes, Often/Always, and Don't Know to the Nutrition Security Question	9; 34; 3; 38; 18; 30	—

Summary

Development of a user centered design to understand how a tailored food is medicine program based on user preferences and needs improves engagement and clinical outcomes. The study will examine how patients, screened either face to face or through automated for food insecurity, engage in a food is medicine program over 12-weeks.

Eligibility Criteria

Inclusion Criteria

Diagnosis of Hypertension in last 12 months
Experiencing food insecurity as indicated by 2-item Hunger Vital Sign
English or Spanish speaking
No plans to move from the area for at least 1 year
Willing and able to accept text messages
Free living to the extent that participant has control over dietary intake
Willing and able to provide written informed consent and participate in all study activities.

Exclusion Criteria

Participant in weight research intervention in last 12 months
Considering bariatric surgery in the next year or prior bariatric surgery
Lack of safe, stable residence and ability to store meals
Lack of telephone which can receive text messages
Pregnancy/breastfeeding or intended pregnancy in the next year
Known drug or alcohol misuse in the past 2 years

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT07011251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.