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

Not Applicable

Recruiting

• Conditions: Healthy Eating Index
• Interventions: Behavioral: Multilevel restaurant intervention to improve the food environment

• Registration Number: NCT05869149
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-05-11
• Study First Posted: 2023-05-22
• Study Start: 2023-06-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-20
• Primary Completion: 2026-10-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 756

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restaurants receiving FRESH intervention	Multilevel restaurant intervention to improve the food environment	Restaurants enrolled in the experimental arm of will FRESH undergo activities aimed to improve their healthy food offerings at their restaurants.

Primary Outcome Measures

Name	Time	Method
Change in Customer Dietary Quality	1 hour, 24 months apart	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.

Trial Locations

Locations (1)

Johns Hopkins Bloomberg School of Public Health; 🇺🇸 Baltimore, Maryland, United States