Healthy Food Policies for Chronic Disease

(VRA Trial)

Overseen By Aaliyah Randall, M.A.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Non-English speaker, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how various healthy food policies can improve diets and reduce chronic diseases among older adults. An online app simulating fast food ordering will test the impact of policies such as taxes on unhealthy foods and improved nutrition labels. Participants will be divided into groups: one with no new policies and one with these healthy changes. The trial suits individuals living near Philadelphia who eat fast food at least once a month and have internet access. As an unphased trial, it offers a unique opportunity to contribute to research that could shape future health policies and enhance public health.

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 this suite of healthy food policies is safe for older adults?

Research has shown that healthy food policies can be implemented safely without causing harm. Policies like taxing sugary drinks and improving food labels encourage healthier choices. Studies indicate that these measures help prevent diet-related diseases and improve public health. As these policies do not involve medication or direct physical procedures, they are generally considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how a suite of healthy food policies could impact chronic disease management. Unlike traditional approaches that focus on medication or lifestyle changes alone, this intervention combines strategies like taxes on ultra-processed foods, nutrition labels, and healthy checkout regulations to potentially alter consumer behavior. By targeting the environment where food choices are made, this trial could reveal new ways to reduce the consumption of unhealthy foods and improve public health outcomes on a broader scale.

What evidence suggests that this suite of healthy food policies is effective for supporting healthy diets?

Research has shown that healthy food policies can improve diets and lower the risk of long-term diseases. This trial will compare two approaches: one arm will implement a suite of healthy food policies, including taxing sugary drinks, using clear food labels, and enforcing healthy checkout regulations. Studies suggest these strategies can reduce diseases linked to poor diets. The other arm will not include these interventions, allowing for a comparison of their effectiveness. Implementing these policies may greatly improve overall health by reducing diet-related chronic diseases. ^{1 2 3 6 7}

Who Is on the Research Team?

Christina Roberto, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults over 18 who eat at McDonald's or similar fast-food chains monthly, have a low household income (<200% of federal poverty level), can access the internet regularly, own a smartphone with camera, and can travel to buy meals in Philadelphia.

Inclusion Criteria

Can adhere to the study schedule (e.g., receive a lunch on a Wednesday, Thursday, or Friday)

Household income approximately <200% of the federal poverty level (the same eligibility criterion as SNAP)

Reports consuming food from McDonald's or a similar fast-food chain at least once a month

Exclusion Criteria

Does not meet all of the inclusion criteria

Cognitive impairment at PI's discretion

Does not reside in the greater Philadelphia area

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants make a purchase in person at a physical McDonald's location and text the research staff a picture of their receipt

1 week

1 visit (in-person)

Control

Participants shop on the restaurant platform modeled after McDonald's online ordering site without interventions

1 week

1 visit (virtual)

Intervention

Healthy food policy interventions are introduced into the restaurant ordering interface

1 week

1 visit (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Suite of healthy food policies

Trial Overview

The study aims to develop an online ordering app for healthier food choices at fast-food restaurants and prepare for a larger test of healthy food policies. Participants will use this app to order meals as part of the feasibility study.

How Is the Trial Designed?

Group I: Intervention (Suite of healthy food policies) Experimental Treatment 1 Intervention

An online application with a suite of healthy food policies, ultra-processed food and beverage taxes, front-of-pack nutrition labeling, and healthy check out regulations that restrict the promotion of ultra-processed products on the checkout page

Group II: No ultra-processed food and beverage taxes, warning labels, or healthy checkout regulations Active Control 1 Intervention

An online application that will mimic real-world restaurant ordering with no ultra-processed food and beverage taxes, warning labels, or healthy checkout regulations on any products

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

The EuroFIR Document and Data Repositories are being created to provide easy access to food composition data and source documents, which will help food database compilers select accurate nutritional information.

The implementation of a searchable Document Repository in Europe PubMed Central and the establishment of data management requirements will streamline data access and improve the quality of food composition databases, reducing duplication of efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing the EuroFIR Document and Data Repositories as accessible resources of food composition information. Unwin, I., Jansen-van der Vliet, M., Westenbrink, S., et al.[2018]

Unhealthy diets are the leading modifiable cause of ill health and death worldwide, largely due to the prevalence of unhealthy food options in our daily environments.

To effectively improve population nutrition, a comprehensive approach involving policy changes at multiple levels—from national to local—is necessary, and clinicians can play a key role in advocating for healthy food policies even without government initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity and the future of food policies that promote healthy diets. Peeters, A.[2019]

Unhealthy dietary patterns and physical inactivity are major contributors to the global obesity crisis, leading to preventable deaths and disabilities.

There is a need for innovative public health policies, such as economic incentives and marketing restrictions, to promote healthier eating habits and improve diet quality at the population level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Public health policies to encourage healthy eating habits: recent perspectives. Gorski, MT., Roberto, CA.[2020]

A new nutrition classification scheme was developed to assess food healthiness based on processing levels and nutrient content, which was validated using a dataset of 7,322 food and beverage items from Australia.

The model showed substantial agreement with existing classification systems, effectively identifying healthy foods like fruits and vegetables, while classifying unhealthy options like snacks and confectionery, suggesting it could guide effective dietary policy actions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel food processing-based nutrition classification scheme for guiding policy actions applied to the Australian food supply. Dickie, S., Woods, J., Machado, P., et al.[2023]

Recent federal dietary policies in the US, such as trans-fat elimination and financial incentives for fruits and vegetables in SNAP and WIC programs, aim to improve cardiometabolic health, but the adoption of state and local proposals like sugar-sweetened beverage taxes has been limited.

Key elements for effective dietary policy design include clearly defined dietary targets (like fruits, vegetables, and sodium), implementation mechanisms, and alignment with evidence-based guidelines, which are often inconsistently characterized in government documents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adoption and Design of Emerging Dietary Policies to Improve Cardiometabolic Health in the US. Huang, Y., Pomeranz, J., Wilde, P., et al.[2023]

Poor nutrition and foodborne diseases significantly contribute to health issues and mortality in the WHO European Region, indicating a need for improved food safety and access to nutritious food.

Effective food and nutrition policies must involve multiple sectors beyond health, such as agriculture and trade, to ensure public health is prioritized and to promote sustainable, safe, and nutritious food for all.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food and health in Europe: a new basis for action. Robertson, A., Tirado, C., Lobstein, T., et al.[2022]

The UK National Diet and Nutrition Survey updated its food database from 5933 food codes to a more efficient 2481 codes, improving data management for dietary assessments.

Using the new rationalised database showed only small differences in nutrient intake estimates, indicating that it remains reliable for ongoing nutritional surveillance in the UK.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationalisation of the UK Nutrient Databank for Incorporation in a Web-Based Dietary Recall for Implementation in the UK National Diet and Nutrition Survey Rolling Programme. Amoutzopoulos, B., Steer, T., Roberts, C., et al.[2022]

The systematic review identified that among various food-related policies aimed at preventing obesity and diabetes, only menu labeling and taxes on unhealthy foods showed significant positive effects in over 50% of studies evaluated.

Despite an increase in published studies over 11 years, the overall quality of research did not improve, highlighting the need for better evaluation methods to inform effective policy-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The State of Evaluation Research on Food Policies to Reduce Obesity and Diabetes Among Adults in the United States, 2000-2011. Freudenberg, N., Franzosa, E., Sohler, N., et al.[2018]

A new policy formulation tool was developed to help create effective food and nutrition policies that promote healthy and sustainable diets, addressing the complex challenges of the food system.

The tool includes a conceptual framework that analyzes the relationship between the environment and public health nutrition, and a schema that identifies different approaches to changing food systems, making it easier to navigate political realities in policy-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Formulating policy activities to promote healthy and sustainable diets. Lawrence, MA., Friel, S., Wingrove, K., et al.[2023]

Nova Scotia Health implemented a healthy eating policy aimed at creating a supportive food environment, which serves as a benchmark for continuous quality improvement in healthcare.

The policy not only sets nutritional standards but also incorporates cultural aspects of healthy eating, fostering collaboration among practitioners to enhance health outcomes across the organization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Setting the standard for healthy eating: Continuous quality improvement for health promotion at Nova Scotia Health. Kennedy, LJ., Taylor, NGA., Nicholson, T., et al.[2021]

Food consumption data are crucial for managing agricultural and nutrition policies, but there are significant gaps in data collection, especially regarding specific food product consumption among high-risk groups.

Current sampling methods often fail to accurately capture food consumed away-from-home, which represents about half of consumer food spending, highlighting the need for improved survey designs and standardized data collection methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food consumption data needs for food and agricultural policy. Myers, LH.[2018]

The FDA has shifted its focus from solely ensuring food safety to also addressing the connection between dietary practices and chronic diseases, highlighting the importance of nutrition in public health.

To support better nutrition, the FDA now mandates detailed Nutrition Facts labels on food packages and promotes public education on diet-health relationships, aiming to improve consumer awareness and dietary practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evolution of national nutrition policy. Kessler, DA.[2004]

Combining nutrition education with policy, systems, and environmental (PSE) changes is more effective in improving dietary habits than using either strategy alone, which is crucial for addressing the obesity epidemic and diet-related health issues in the U.S.

The article outlines a framework for understanding dietary influences and provides examples of successful integration of nutrition education with PSE strategies in areas like federal nutrition programs and food labeling, suggesting this approach could enhance public health and reduce health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting Healthy Eating: Synergistic Effects of Nutrition Education Paired with Policy, Systems, and Environmental Changes. Story, MT., Duffy, E.[2020]

Food environment (FE) policies, such as pricing strategies and food provision in schools, have been shown to effectively improve population diets by altering the intake and purchase of targeted foods and beverages, based on a review of 12 systematic reviews.

Despite the positive findings, the review highlights a need for more high-quality evidence to further support the effectiveness of various FE policies in enhancing dietary habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of food environment policies in improving population diets: a review of systematic reviews. Hansen, KL., Golubovic, S., Eriksen, CU., et al.[2022]

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Implementing policies improving American nutrition will significantly impact public health by reducing rates of diet-related chronic diseases, ...

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