Food Insecurity, Food as Medicine, Hypertension

Alison Gustafson

Status: Completed

Conditions: Hypertension; Food Insecurity

Treatments: Other: Survey; Behavioral: Food as Medicine Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07011251

24FIM1255467 (Other Grant/Funding Number)

93234

Details and patient eligibility

About

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.

Enrollment: 159 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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159 participants in 1 patient group

Food is Medicine Program Type

Other group

Description:

Patients were screened for food insecurity either face to face or automated based on standard of care practice at their respective healthcare site. Patients were referred to the study team to utilize a screening decision tool to allocate them to receive either Medically tailored meals or a grocery voucher program. Participants then received their program for 12-weeks. Participants then completed post intervention survey.

Treatment:

Behavioral: Food as Medicine Program

Other: Survey