- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06868056
Validation of Restaurant App (VRA)
Pilot Randomized Controlled Trial of Food Policies to Promote Healthier Choices at Restaurants
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Christina Roberto, PhD, University of Pennsylvania
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 855149
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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