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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05869149
Acronym
FRESH
Enrollment
756
Registered
2023-05-22
Start date
2023-06-01
Completion date
2026-10-31
Last updated
2026-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Eating Index

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.

Interventions

BEHAVIORALMultilevel 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.

Sponsors

Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER
George Washington University
CollaboratorOTHER
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in Customer Dietary Quality1 hour, 24 months apartRegular 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.

Countries

United States

Contacts

CONTACTJoel Gittlesohn, PhD
jgittel1@jhu.edu(410)955-3927
PRINCIPAL_INVESTIGATORJoel Gittlesohn, PhD

Johns Hopkins Bloomberg School of Public Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026