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

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the treatment FRESH for creating a healthier food environment for cancer prevention?

Research shows that promoting healthier food options in restaurants can lead to positive outcomes, such as increased availability of healthy foods and revenue benefits. Strategies like increasing healthy offerings and using marketing techniques to encourage healthy choices have been effective in similar settings, suggesting potential for FRESH to improve food environments and support cancer prevention. ^{1 2 3 4 5}

Is the Healthier Food Environment for Cancer Prevention treatment safe for humans?

The research on creating healthier food environments in restaurants, like the FRESH program, focuses on promoting healthy eating habits and does not indicate any safety concerns for humans. ^{2 5 6 7 8}

How does the 'Healthier Food Environment for Cancer Prevention' treatment differ from other treatments for cancer prevention?

This treatment is unique because it focuses on changing the food environment, particularly in restaurants, to promote healthier eating habits as a way to prevent cancer. Unlike traditional treatments that might involve medication or medical procedures, this approach aims to increase the availability and promotion of healthy food options in dining establishments, making it a community-based preventive strategy. ^{1 2 3 9 10}

Research Team

Joel Gittlesohn, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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) 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]

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]

References

1. Switzerland 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. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Nutrition Environment Measures Study in restaurants (NEMS-R): development and evaluation. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Neighborhood Disparities in the Restaurant Food Environment. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Healthiness of Food and Beverages for Sale at Two Public Hospitals in New South Wales, Australia. [2018]

5. England 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. [2018]

6. Switzerland 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. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Validity of secondary retail food outlet data: a systematic review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Using Healthy Defaults in Walt Disney World Restaurants to Improve Nutritional Choices. [2021]

9. England 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. [2023]

10. United States 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. [2019]