Healthy Food First

Summary

Socioeconomic barriers to healthy eating, particularly food insecurity, are a major reason for poor blood pressure control and hypertension complications. Healthy diet patterns have been shown to improve health. Unfortunately, food insecurity makes it difficult for individuals to maintain healthy diet patterns. This pragmatic randomized trial will compare two food insecurity interventions (a healthy food subsidy versus a delivered food box), with or without lifestyle support delivered by community health workers, for 6 versus 12 months duration. Key outcomes include blood pressure, food insecurity, and other patient reported outcomes.

Conditions

• Hypertension
• Food Insecurity
• Diet, Mediterranean

Interventions

OTHER

Food Subsidy, 6 months

Food subsidy for 6 months

OTHER

Food Subsidy, 12 months

Food subsidy for 12 months

BEHAVIORAL

Lifestyle Support, 6 months

lifestyle support intervention delivered by community health workers for 6 months

BEHAVIORAL

Lifestyle Support, 12 months

lifestyle support intervention delivered by community health workers for 6 months

OTHER

Food Delivery, 6 months

Twice monthly delivery of healthy food for 6 months

OTHER

Food Delivery, 12 months

Twice monthly delivery of healthy food for 12 months

Sponsors & Collaborators

• Blue Cross Blue Shield of North Carolina

  collaborator UNKNOWN

• UNC Health Alliance

  collaborator UNKNOWN

• Duke University

  collaborator OTHER

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Darren DeWalt, MD, MPH · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-07

Primary Completion

2024-08-12

Completion

2024-08-12

Countries

• United States

Study Locations