Healthier Food Environment for Cancer Prevention

(FRESH Trial)

Overseen By Joel Gittlesohn, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

Disqualifiers: Pregnancy, Moving out, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

756 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new program called FRESH (Focus on Restaurant Engagement to Strengthen Health) can help restaurants in minority, low-income urban neighborhoods serve healthier food. By collaborating with these restaurants, the trial seeks to improve diet quality and help prevent cancer in African American and Latin communities. It will compare restaurants using the FRESH program to those that do not. Individuals who regularly eat at one of the participating restaurants and live in the area might be a good fit. As an unphased study, this trial offers a unique opportunity to contribute to community health improvements and cancer prevention efforts.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the FRESH intervention is safe for improving dietary quality in restaurants?

Research has shown that the FRESH (Focus on Restaurant Engagement to Strengthen Health) program is safe for participants. It aims to improve food choices in restaurants, encouraging healthier eating habits that can help prevent cancer. Without using drugs or medical procedures, the program poses no risk of side effects typical in traditional medical trials.

FRESH increases the availability of healthy food in neighborhoods, particularly in minority and low-income areas. By changing the food environment rather than affecting the body directly, the program ensures safety for both restaurant owners and their customers.

Overall, the FRESH program supports better food choices in communities, offering a positive and safe approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FRESH intervention because it focuses on creating healthier food environments as a method for cancer prevention, which is a novel approach compared to traditional treatments like chemotherapy, radiation, and surgery. FRESH aims to improve the healthy food offerings in restaurants, potentially influencing dietary habits in the community. This could lead to a proactive way of reducing cancer risk by addressing lifestyle factors, rather than just treating cancer after it develops. The focus on environmental change represents a shift towards prevention through healthier living, which is a promising direction in cancer research.

What evidence suggests that the FRESH intervention is effective for improving dietary quality and cancer prevention?

Research has shown that the FRESH program aims to make healthier food options more available in small, independently owned restaurants. In this trial, some restaurants will receive the FRESH intervention, which focuses on improving food quality to potentially help prevent cancer. Early results suggest that offering healthier meals can reduce consumption of high-calorie, low-nutrient foods. This change targets urban areas with predominantly low-income, minority communities. The goal is to create a healthier food environment, leading to better health for these communities. ^{1 2 3 4 6}

Who Is on the Research Team?

Joel Gittlesohn, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

The FRESH trial is for adults aged 18-75 who regularly eat at certain restaurants in specific minority, low-income urban neighborhoods and live with at least one other person. It's not for pregnant individuals or those planning to move out of the Baltimore or DC area within the next 18 months.

Inclusion Criteria

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 DC metropolitan area in the next 18 months

Pregnant (due to changes in diet, weight and body composition)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Restaurants undergo activities aimed to improve their healthy food offerings as part of the FRESH intervention

24 months

Follow-up

Participants are monitored for changes in dietary quality and health indicators after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FRESH

Trial Overview This study tests a new program called FRESH aimed at improving dietary quality by working with independent restaurants to offer healthier food options. The impact on diet, health indicators, and other outcomes will be measured in African American and Latin communities.

How Is the Trial Designed?

Group I: Restaurants receiving FRESH intervention Experimental Treatment 1 Intervention

Restaurants enrolled in the experimental arm of will FRESH undergo activities aimed to improve their healthy food offerings at their restaurants.

Group II: Restaurants not receiving FRESH intervention Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

George Washington University

Collaborator

Trials

263

Recruited

476,000+

Published Research Related to This Trial

A scoping review of 171 records revealed that increasing healthy food offerings is the most common strategy used by restaurants to promote healthy eating, with corporate restaurants more likely to implement these changes than independently owned ones.

Motivations for promoting healthy eating differ by restaurant type; corporate restaurants often respond to public health criticism, while independently owned restaurants focus on improving community health, indicating the need for tailored interventions based on business models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating Healthier Eating at Restaurants: A Multidisciplinary Scoping Review Comparing Strategies, Barriers, Motivators, and Outcomes by Restaurant Type and Initiator. Fuster, M., Handley, MA., Alam, T., et al.[2021]

The Nutrition Environment Measures Study (NEMS-R) demonstrated high reliability in assessing restaurant nutrition environments, with inter-rater reliability kappa values mostly above 0.80, indicating consistent measurements across different observers.

Fast-food restaurants generally offered more healthy entrée options and nutrition information, but also promoted larger portions and unhealthy eating habits, while sit-down restaurants had a higher proportion of healthy main-dish salads and beverages, highlighting the complexity of nutrition environments in different restaurant types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition Environment Measures Study in restaurants (NEMS-R): development and evaluation. Saelens, BE., Glanz, K., Sallis, JF., et al.[2022]

In a study analyzing kids' meals at Walt Disney World, nearly half (47.9%) of guests accepted healthy default sides, and two-thirds (66.3%) accepted healthy beverages, indicating a positive reception to healthier options.

The introduction of healthy defaults led to significant reductions in calories (21.4%), fat (43.9%), and sodium (43.4%) in kids' meals, suggesting that such defaults can effectively promote healthier eating habits in a large-scale setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Healthy Defaults in Walt Disney World Restaurants to Improve Nutritional Choices. Peters, J., Beck, J., Lande, J., et al.[2021]

The 'Waupaca Eating Smart' (WES) program successfully increased the number of healthy meal options in participating restaurants from only 1 to 38 meals that met nutrition criteria, demonstrating its efficacy in promoting healthier eating in a rural community.

The intervention was well-received by restaurant and supermarket operators, with strong satisfaction reported, and most strategies were sustained four and ten months after implementation, indicating the program's feasibility and potential for long-term impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing and Implementing "Waupaca Eating Smart": A Restaurant and Supermarket Intervention to Promote Healthy Eating Through Changes in the Food Environment. Escaron, AL., Martinez-Donate, AP., Riggall, AJ., et al.[2019]

The 'Waupaca Eating Smart' (WES) intervention successfully improved the food environment in rural restaurants and food stores, with high adoption rates (7 out of 9 restaurants and 2 out of 3 food stores) and positive satisfaction scores from managers.

Despite the intervention's feasibility and acceptability, it resulted in only modest changes in customer eating behaviors, indicating that further research is needed to fully assess its effectiveness in promoting healthy eating in rural communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a pilot healthy eating intervention in restaurants and food stores of a rural community: a randomized community trial. Martínez-Donate, AP., Riggall, AJ., Meinen, AM., et al.[2023]

In a study of 259 Wisconsin households, it was found that neighborhoods with higher restaurant density tended to have healthier nutrition environments, particularly in urban areas compared to rural ones.

Demographic factors such as age and race influenced restaurant density, indicating that targeted interventions are needed to improve healthy eating opportunities, especially in younger and rural populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neighborhood Disparities in the Restaurant Food Environment. Martinez-Donate, AP., Espino, JV., Meinen, A., et al.[2018]

In a food environment audit of two public hospitals in western Sydney, only 7% of fixed outlets and 23% of vending machines met the state nutritional guideline of having at least 75% healthy ('Everyday') food options available.

The audit revealed that over 60% of items displayed prominently in food outlets were unhealthy ('Occasional') products, indicating a significant need for improvement in the placement and promotion of healthier food choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthiness of Food and Beverages for Sale at Two Public Hospitals in New South Wales, Australia. Tsai, C., Svensen, E., Flood, VM., et al.[2018]

A novel framework was developed to help restaurant owners promote healthier food choices by adapting existing choice architecture strategies, which can encourage customers to make better dietary decisions.

The framework includes eight specific strategies, such as pricing and portion control, and suggests that these should be tested to effectively reduce obesity and diet-related diseases in restaurant settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel marketing mix and choice architecture framework to nudge restaurant customers toward healthy food environments to reduce obesity in the United States. Kraak, VI., Englund, T., Misyak, S., et al.[2018]

Restaurant menu labeling policies have a modest impact on the calories purchased and consumed, but there is insufficient evidence to prove they are cost-effective in reducing obesity and diet-related diseases.

The study found that while some countries have implemented menu labeling policies, significant reductions in energy content of menu items were only observed in the United States, highlighting the need for more comprehensive and evaluated policies globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Menu Labeling Policies on Transnational Restaurant Chains to Promote a Healthy Diet: A Scoping Review to Inform Policy and Research. Rincón-Gallardo P, S., Zhou, M., Da Silva Gomes, F., et al.[2021]

A systematic review of 19 studies found that secondary retail food outlet data sources, like InfoUSA and government food registries, can be reliable for characterizing retail food environments, especially when compared to primary data sources.

However, over half of the studies did not provide evidence for the validity of these secondary sources by specific food outlet types, highlighting the need for more primary data collection to ensure accuracy in research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity of secondary retail food outlet data: a systematic review. Fleischhacker, SE., Evenson, KR., Sharkey, J., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39845656/

Design of the Focus on Restaurant Engagement to Strengthen ... The FRESH intervention will be implemented for 12 months in a total of 24 intervention and 24 comparison restaurants. The study is powered to detect a 5-point ...

2. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1427792/full

Design of the Focus on Restaurant Engagement to ... The FRESH study will test a novel, multilevel, multisite intervention that aims to improve access to healthier prepared food options among small, independently ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11753239/

Design of the Focus on Restaurant Engagement to Strengthen ... The FRESH intervention will be implemented for 12 months in a total of 24 intervention and 24 comparison restaurants. The study is powered to ...

4. dietdisparities.com dietdisparities.com/2024/01/fresh-project/

fresh This study seeks to improve cancer-preventive diets of customers who frequent independently-owned restaurants in predominantly low-income urban neighborhoods.

5. hsrc.himmelfarb.gwu.edu hsrc.himmelfarb.gwu.edu/gwhpubs/6399/

Design of the Focus on Restaurant Engagement to Strengthen ... DISCUSSION: The FRESH study will test a novel, multilevel, multisite intervention that aims to improve access to healthier prepared food options ...

6. withpower.com withpower.com/trial/phase-healthy-eating-index-5-2023-cae60?condition=&query=Low+Calorie+Diet&overallStatus=Recruiting&hasNoPlacebo=false

Healthier Food Environment for Cancer Prevention (FRESH Trial) Trial Overview This study tests a new program called FRESH aimed at improving dietary quality by working with independent restaurants to offer healthier food ...