Validation of Restaurant App (VRA)

July 15, 2025 updated by: University of Pennsylvania

Pilot Randomized Controlled Trial of Food Policies to Promote Healthier Choices at Restaurants

Unhealthy diets significantly contribute to preventable chronic diseases among older adults. To advance the investigator's understanding of policies needed to support healthy diets, the objectives are: 1) to develop and validate an online fast food restaurant ordering application; and 2) to conduct a feasibility study for a larger randomized, controlled trial that will test healthy food policies in restaurant settings.

Study Overview

Status

Completed

Conditions

Detailed Description

To advance the investigator's understanding of policies needed to support healthy diets and nutrition security, the overall objectives are: 1) to develop and validate an online restaurant ordering application that will mimic a real fast-food restaurant; 2) to conduct a feasibility study for a larger randomized, controlled trial that will examine the extent to which healthy food policies like ultra-processed food and beverage taxes and warning labels as well as restrictions on checkout aisle marketing influence restaurant purchases. The development of this restaurant application will enable the investigator's to conduct rigorous experiments that can test policy changes to the online restaurant ordering environment. In the feasibility study, participants will be randomized to either: 1) control (no taxes, warning labels, or healthy checkout regulations on any products); or 2) 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). The investigators propose recruiting 60 adults with low income who live in the Philadelphia, PA region. Participants will be recruited for a 3-week study. During week 1, they will be asked to make a purchase in person at a physical McDonald's location and text the research staff a picture of their receipt (a procedure that has have successfully used in the past). During weeks 2 and 3, they will be asked to shop once per week on the restaurant platform, which will be modeled after McDonald's online ordering site. Week 2 will be a baseline (control) week without interventions followed by Week 3, when the healthy food policy interventions will be introduced into the restaurant ordering interface. During each of the 3 weeks, participants will be given money to spend on their restaurant purchases. A restaurant delivery service (e.g., GrubHub) will be used to send participants the food they order. Participants will also complete a baseline and post-intervention survey. To begin to establish the validity of the online restaurant ordering app, investigators will examine the correlation between the total calories and sugars purchased as well as dollars spent when purchasing food in person vs. on the app. The rationale underlying the proposed research is based on the investigator's work showing that beverage taxes and warning labels greatly reduce SSB purchases. The research team's long-term goal is to understand the independent and combined effects of promising food policies to improve nutrition security and reduce nutrition-related diseases. The specific aims are:

Aim 1: To develop and validate an online restaurant ordering app that can be used to experimentally test the effects of food policies on restaurant purchases.

Aim 2: To conduct a pilot study on the feasibility of implementing healthy eating interventions and policies such as ultra-processed food and beverage taxes, warning labels, and checkout restrictions through the restaurant app.

Because the pilot study is a small-scale feasibility trial, it will generate descriptive statistics for outcomes, but they will not be formally analzyed.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years old.

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

Has regular internet access.

Has a smart phone that can take pictures.

Can travel to a McDonald's location to buy a meal with the study debit card

Exclusion Criteria:

Does not meet all of the inclusion criteria

Unable to provide consent non-English speaker

Cognitive impairment; per PIs discretion

Participant is under 18 years old

Doesn't in the greater Philadelphia area.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No ultra-processed food and beverage taxes, warning labels, or healthy checkout regulations
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
Experimental: Intervention (Suite of healthy food policies)
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average total kcals purchased
Time Frame: Assessed weekly at completion of restaurant order over 3 weeks
Our primary outcome at the person-week level will be the correlation between the mean number of calories purchased overall and from taxed/labeled products per person during the in-person restaurant shopping trip (Week 1) and their online restaurant order (Week 2) prior to the implementation of the healthy food policy interventions.
Assessed weekly at completion of restaurant order over 3 weeks
Average total sodium purchased
Time Frame: Assessed weekly at completion of restaurant order over 3 weeks
Our primary outcome at the person-week level will be the correlation between the mean amount of sodium (mg) purchased overall and from taxed/labeled products per person during the in-person restaurant shopping trip (Week 1) and their online restaurant order (Week 2) prior to the implementation of the healthy food policy interventions
Assessed weekly at completion of restaurant order over 3 weeks
Average total added sugars purchased
Time Frame: Assessed weekly at completion of restaurant order over 3 weeks
Our primary outcome at the person-week level will be the correlation between the mean amount of sodium (mg) purchased overall and from taxed/labeled products per person during the in-person restaurant shopping trip (Week 1) and their online restaurant order (Week 2) prior to the implementation of the healthy food policy interventions
Assessed weekly at completion of restaurant order over 3 weeks
Average total saturated fat purchased
Time Frame: Assessed weekly at completion of restaurant order over 3 weeks
Our primary outcome at the person-week level will be the correlation between the mean amount of sodium (mg) purchased overall and from taxed/labeled products per person during the in-person restaurant shopping trip (Week 1) and their online restaurant order (Week 2) prior to the implementation of the healthy food policy interventions
Assessed weekly at completion of restaurant order over 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing acceptability and realism of online restaurant app
Time Frame: Assessed at study completion, average of 3 weeks.
We will also assess the acceptability of the online restaurant (e.g., overall experience using the restaurant, ease of use) and realism of the restaurant (e.g., extent to which participants' selections are similar to usual purchases, extent to which it felt real).
Assessed at study completion, average of 3 weeks.
Average total dollars spent
Time Frame: Assessed weekly at completion of restaurant order over 3 weeks
Our primary outcome at the person-week level will be the correlation between the mean amount of dollars spent overall and from taxed/labeled products per person during the in-person restaurant shopping trip (Week 1) and their online restaurant order (Week 2) prior to the implementation of the healthy food policy interventions
Assessed weekly at completion of restaurant order over 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christina Roberto, PhD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2025

Primary Completion (Actual)

May 20, 2025

Study Completion (Actual)

May 20, 2025

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Actual)

July 16, 2025

Last Update Submitted That Met QC Criteria

July 15, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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