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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Eating Index
• Intervention / Treatment: Behavioral: Multilevel restaurant intervention to improve the food environment

• Study Type: Interventional
• Enrollment (Estimated): 756
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joel Gittlesohn, PhD; Phone Number: (410)955-3927; Email: jgittel1@jhu.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • Johns Hopkins Bloomberg School of Public Health
      • Contact: Joel Gittelsohn, PhD; Email: jgittel1@jh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Restaurants receiving FRESH intervention; Restaurants enrolled in the experimental arm of will FRESH undergo activities aimed to improve their healthy food offerings at their restaurants.	Behavioral: Multilevel restaurant intervention to improve the food environment; FRESH is a restaurant-based intervention in low-income neighborhoods in Baltimore, MD and the Washington, District of Columbia metro area that aims to improve the healthy prepared-food environment for consumers, informed by community members and other stakeholders. FRESH intervention components include food preparation, food access and procurement, and consumer nutrition environment. Activities will take place over 16 months, and include training restaurant chefs to use healthier cooking methods, partnering with restaurant suppliers to offer healthier ingredients, and offering point-of-purchase promotions to educate customers on the healthier promoted food options. Intervention staff will form strong relationships with restaurant owners and chefs via in-person visits at least twice a month. Data from the intervention trial will inform the development of a system dynamics simulation model that will allow stakeholders to test new policy ideas prior to implementation.
No Intervention: Restaurants not receiving FRESH intervention; Restaurants will be enrolled in the study, but not receive the FRESH intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Customer Dietary Quality	Regular customer diet quality in the last 30 days will be assessed using the 2014 semi-quantitative Block Food Frequency Questionnaire (FFQ). The FFQ provides the data that allows for calculating the Healthy Eating Index. We will use the 2015 index rules. Healthy Eating Index (HEI) 2015 Score and individual component scores will be calculated from the FFQ according to the HEI-2015 guidelines to assess changes in overall diet quality and changes within each component. The range of scores for the Healthy Eating Index 2015 is 0-100. A higher score is considered better and represents meeting more of the recommended dietary guidelines.	1 hour, 24 months apart

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); George Washington University
• Investigators: Principal Investigator: Joel Gittlesohn, PhD, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

General Publications

• Colon-Ramos U, Lewis EC, Tucker AC, Poirier L, Pathiravasan CH, Estrade M, Igusa T, Wolfson JA, Mui Y, Velez-Burgess V, Thomas AE, Hua S, Cheskin LJ, Trujillo AJ, Oladimeji AT, Williamson S, Romero R, Hernandez PS, Gittelsohn J. 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. Front Public Health. 2025 Jan 7;12:1427792. doi: 10.3389/fpubh.2024.1427792. eCollection 2024.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 5R01MD018022-02 (U.S. NIH Grant/Contract); IRB00024491 (Other Identifier: JHSPH IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No