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

NCT05869149 | Recruiting

• 2 other identifiers: 5R01MD018022-02IRB00024491
• Study Type: interventional
• Target: 756
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Eating Index

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Restaurants receiving FRESH intervention

EXPERIMENTAL

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

Restaurants not receiving FRESH intervention

NO INTERVENTION

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

Interventions

Multilevel restaurant intervention to improve the food environment BEHAVIORAL

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.

Restaurants receiving FRESH intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• George Washington University: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 39845656 DERIVED

Study Officials

• Joel Gittlesohn, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joel Gittlesohn, PhD

CONTACT

(410)955-3927; jgittel1@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 22, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)