Viewing Study NCT06868056


Ignite Creation Date: 2025-12-24 @ 11:28 PM
Ignite Modification Date: 2025-12-29 @ 8:21 PM
Study NCT ID: NCT06868056
Status: COMPLETED
Last Update Posted: 2025-07-16
First Post: 2025-02-13
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Validation of Restaurant App
Sponsor: University of Pennsylvania
Organization:

Study Overview

Official Title: Pilot Randomized Controlled Trial of Food Policies to Promote Healthier Choices at Restaurants
Status: COMPLETED
Status Verified Date: 2025-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: VRA
Brief Summary: 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.
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: