Healthy Eating IndexFRESHNCT05869149
Systems Science Approaches to Improve Access to Healthier Foods: The FRESH Trial
A study testing Multilevel restaurant intervention to improve the food environment in people with Healthy Eating Index, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Eating Index
- What is being tested?
- Multilevel restaurant intervention to improve the food environment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 756 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
Joel Gittelsohn, PhD, jgittel1@jh.edu
About this study
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
- Being tested
- Multilevel restaurant intervention to improve the food environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multilevel restaurant intervention to improve the food environmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Restaurants receiving FRESH intervention | Experimental | Restaurants enrolled in the experimental arm of will FRESH undergo activities aimed to improve their healthy food offerings at their restaurants. Receives: Behavioral: Multilevel restaurant intervention to improve the food environment |
| Restaurants not receiving FRESH intervention | No intervention | Restaurants will be enrolled in the study, but not receive the FRESH intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour, 24 months apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Jun 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Eating IndexStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 756 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- George Washington University, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Joel Gittlesohn, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869149
- Sponsor's protocol ID
- 5R01MD018022-02
- Other IDs
- IRB00024491
- Acronym
- FRESH
- Status last verified
- Oct 2026
- First submitted
- 9 May 2023
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 to and promotion of healthful foods. Front Public Health. 2025 Jan 7;12:1427792. doi: 10.3389/fpubh.2024.1427792. eCollection 2024.
PubMed 39845656
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Science Approaches to Improve Access to Healthier Foods: The FRESH Trial
- ClinicalTrials.gov ID
- NCT05869149
- Acronym / sponsor ID
- FRESH / 5R01MD018022-02
- Conditions
- Healthy Eating Index
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 756 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- George Washington University, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restaurants receiving FRESH intervention | Experimental | Behavioral: Multilevel restaurant intervention to improve the food environmentRestaurants enrolled in the experimental arm of will FRESH undergo activities aimed to improve their healthy food offerings at their restaurants. |
| Restaurants not receiving FRESH intervention | No intervention | –Restaurants will be enrolled in the study, but not receive the FRESH intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multilevel restaurant intervention to improve the food environmentFRESH 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. | Behavioural | Restaurants receiving FRESH intervention |
Primary outcome
Change in Customer Dietary Quality
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Derived from this study: PubMed 39845656Colon-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 to and promotion of healthful foods. Front Public Health. 2025 Jan 7;12:1427792. doi: 10.3389/fpubh.2024.1427792. eCollection 2024.
- Individual participant dataSharing planned: No
Related trials for Healthy Eating Index
Recruiting
Environmental Harm Menu Labels and Overall Dietary Quality
Food Choices
Active, not recruiting
The Effect of Lifestyle Program Women With PCOS
Polycystic Ovary Syndrome
Active, not recruiting
Guys/Girls Opt for Activities for Life Trial (GOAL) to Increase Young Adolescents' Physical Activity and Healthy Eating
Obesity, Adolescent
Not yet recruitingObservational study
Teaching Kitchens Intervention for Older Adults in a Senior Center in New England
Dietary Quality
Recruiting
Pulses: Optimizing Pulse Consumption for Cardiometabolic Health
Cardiovascular (CV) Risk, Healthy Eating Index
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joel Gittlesohn, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multilevel restaurant intervention to improve the food environment in people with Healthy Eating Index, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joel Gittlesohn, PhD ((410)955-3927, jgittel1@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Customer Dietary Quality (time frame: 1 hour, 24 months apart). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05869149, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.