Using the FRESH Intervention to Improve Healthy Food Access in Baltimore and Washington, DC Neighborhoods
Led by Johns Hopkins Bloomberg School of Public Health · Updated on 2026-05-27
756
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a novel intervention called FRESH Focus on Restaurant Engagement to Strengthen Health to improve access to healthier foods in independently owned restaurants located in predominantly minority, low-income urban neighborhoods. This study aims to improve dietary quality and health indicators in African American and Latin communities while contributing to cancer prevention. The study also involves developing a system dynamics model to help stakeholders virtually test FRESH strategies in their own communities, potentially saving costs and supporting community-based cancer prevention efforts.
The FRESH intervention is delivered over 16 months and includes activities such as training restaurant chefs in healthier cooking methods, partnering with suppliers to offer healthier ingredients, and providing point-of-purchase promotions to educate customers about healthier food options. Intervention staff will visit restaurants in person at least twice a month to build strong relationships with restaurant owners and chefs. Participating restaurants are randomly assigned to either receive the FRESH intervention or serve as a comparison group without the intervention.
Participants in this study are regular customers of the enrolled restaurants who live in the study neighborhoods. They will be assessed for changes in dietary quality, measured by the Healthy Eating Index, with evaluations occurring 24 months apart. The study collects data on dietary habits and health indicators, and uses findings to inform the system dynamics simulation model. Participants involvement lasts up to two years, with ongoing monitoring and data collection to understand the interventions impact on healthy eating behaviors and related outcomes.
CONDITIONS
Brief Title
Systems Science Approaches to Improve Access to Healthier Foods: The FRESH Trial
Research Team
J
Joel Gittlesohn, PhD
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
FRESH Intervention
No Intervention (Control)
Usual Food Environment
What it is
A multilevel, restaurant‑based intervention called FRESH tested in independently owned restaurants, including chef training, healthier ingredients sourcing, point‑of‑purchase promotions, and stakeholder engagement over a 16‑month period
Restaurants that did not receive any FRESH activities, serving as control arm
Restaurants in low‑income urban neighborhoods typically operate without coordinated healthy food promotion or systems science intervention
Role in trial
Test arm implementing the FRESH systems science intervention
Control arm with no intervention activities
Reflects usual practice outside of intervention settings
Primary use
To improve the healthy prepared‑food environment by enhancing menu offerings, preparation methods, and promotions
Standard operation without deliberate efforts to promote healthier choices
Usual restaurant service without structured promotion of healthier options
How it is delivered
Delivered via in‑person visits at least twice monthly to train chefs, partner with suppliers, and support promotions, over 16 months
Restaurants continued usual operations without external support
Operate without system‑guided chef training, supplier coordination, or promotional support
Broader evidence context
Effectiveness remains unproven; trial is ongoing and designed to detect a meaningful 5‑point increase in healthy eating score
No additional evidence beyond serving as control arm; effects will be measured through contrast with intervention
Past evidence shows limited positive impact from restaurant‑based interventions in similar contexts
Important limitations
Evidence on effectiveness of restaurant‑level interventions is limited and mostly low quality, so success is uncertain
As a control arm, it provides contrast but does not inform broader effectiveness outside trial context
Findings may not generalize if typical restaurant environments vary substantially or change over time
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Years - 75Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
Adult aged 18 to 75 years
Regular customer of the specified restaurant, visiting at least once per week
Lives in a household with at least two persons
Current resident of the study neighborhood
You will not qualify if you...
Plans to move out of Baltimore or District of Columbia metropolitan area within the next 18 months
Pregnant due to changes in diet, weight, and body composition
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 16 months
Participants who are regular customers of enrolled restaurants experience intervention activities aimed at improving healthy food offerings, including healthier cooking methods, ingredient sourcing, and educational promotions.
Biweekly visits to participating restaurants by intervention staff
Follow-up
Duration - Up to 24 months from baseline
Participants are assessed for changes in dietary quality over a 24-month period.
2 visits, 24 months apart
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Using the FRESH Intervention to Improve Healthy Food Access in Baltimore and Washington, DC Neighborhoods
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Published Research Related To This Trial
Design of the Focus on Restaurant Engagement to Strengthen Health (FRESH) study: leveraging systems science to work with independently-owned restaurants to increase access to and promotion of healthful foods.
Uriyoán Colón-Ramos, Emma C Lewis, Anna Claire Tucker...