Systems Science Approaches to Improve Access to Healthier Foods: The FRESH Trial

Johns Hopkins Bloomberg School of Public Health

Status: Enrolling

Conditions: Healthy Eating Index

Treatments: Behavioral: Multilevel restaurant intervention to improve the food environment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05869149

IRB00024491 (Other Identifier)

5R01MD018022-02

Details and patient eligibility

About

Working with independently owned restaurants, a common source of calorie-rich, nutrient-poor foods in predominantly minority, low-income urban neighborhoods, has the potential to improve dietary quality, and contribute to cancer prevention. This study uses systems science approaches to improve access to healthier foods in independently owned restaurants by: 1) testing the effects of a novel intervention called FRESH (Focus on Restaurant Engagement to Strengthen Health) on dietary quality, health indicators and other outcomes in African American and Latin communities, and 2) developing a system dynamics model to allow stakeholders to virtually test FRESH strategies in their own communities. The resulting restaurant intervention simulation model offers potential cost savings from avoided trial-and-error testing, and will support community-based cancer prevention.

Enrollment: 756 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult (18-75 years)
• Regular restaurant customer (e.g., visits the specified restaurant at least 1x/week)
• Live in a household of at least 2 persons (criterion intended to provide a more stable sample, and to reduce loss to follow-up)
• Current resident of study neighborhood

Exclusion criteria

• Anticipate moving out of Baltimore or District of Columbia metropolitan area in the next 18 months
• Pregnant (due to changes in diet, weight and body composition)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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756 participants in 2 patient groups

Restaurants receiving FRESH intervention

Experimental group

Description:

Restaurants enrolled in the experimental arm of will FRESH undergo activities aimed to improve their healthy food offerings at their restaurants.

Treatment:

Behavioral: Multilevel restaurant intervention to improve the food environment

Restaurants not receiving FRESH intervention

No Intervention group

Description:

Restaurants will be enrolled in the study, but not receive the FRESH intervention.