Clinical trial NCT06868056: Validation of Restaurant App
Official title: Pilot Randomized Controlled Trial of Food Policies to Promote Healthier Choices at Restaurants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Disease
Keywords: chronic disease
sugar-sweetened beverages
warning labels
beverage tax
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Average total kcals purchased
timeFrame: Assessed weekly at completion of restaurant order over 3 weeks
measure: Average total sodium purchased
timeFrame: Assessed weekly at completion of restaurant order over 3 weeks
measure: Average total added sugars purchased
timeFrame: Assessed weekly at completion of restaurant order over 3 weeks
measure: Average total saturated fat purchased
timeFrame: Assessed weekly at completion of restaurant order over 3 weeks
Secondary outcomes:
measure: Assessing acceptability and realism of online restaurant app
timeFrame: Assessed at study completion, average of 3 weeks.
measure: Average total dollars spent
timeFrame: Assessed weekly at completion of restaurant order over 3 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Christina Roberto, PhD
role: PRINCIPAL_INVESTIGATOR
References: