Recruiting

Observational Study

Sponsor:

Johns Hopkins Bloomberg School of Public Health

Code:

NCT05869149

Conditions

Healthy Eating Index

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Multilevel restaurant intervention to improve the food environment

Study Details

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

Study ID

NCT05869149

Start date

Jun 1, 2023

Status verified date

May, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

756 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

no intervention: Restaurants not receiving FRESH intervention

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

Interventions

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.

Primary outcome measure

  • Change in Customer Dietary Quality [ Time Frame: 1 hour, 24 months apart ]

Central Contacts and Locations

Central contacts

Joel Gittlesohn, PhD

(410)955-3927jgittel1@jhu.edu

Locations

Johns Hopkins Bloomberg School of Public Health

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Joel Gittelsohn, PhD

jgittel1@jh.edu

More Information

Sponsor

Johns Hopkins Bloomberg School of Public Health

Last update posted

May 27, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins Bloomberg School of Public Health on 2026-05-27.