Systems Science Approaches to Improve Access to Healthier Foods: The FRESH Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multilevel restaurant intervention to improve the food environment.
- Who it may be relevant to
- Registry conditions: Healthy Eating Index. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Change in Customer Dietary Quality [Time frame: 1 hour, 24 months apart]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Johns Hopkins Bloomberg School of Public Health — Baltimore
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 PMID 39845656
Identifiers
NCT: NCT05869149 · 5R01MD018022-02 · IRB00024491