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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJohns Hopkins Bloomberg School of Public Health

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

756 Participants
are divided into 2 treatment groups
Group A: Restaurants receiving FRESH interventionExperimental treatment 1 intervention
Group B: Restaurants not receiving FRESH interventionNo intervention 0 interventions

Trial outcomes

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.

Time frame
1 hour, 24 months apart

Secondary outcomes

Other outcomes

Sponsors and contacts

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Johns Hopkins Bloomberg School of Public Health

Lead sponsor

George Washington University

Collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator