NCT06868056

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

February 24, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

February 13, 2025

Last Update Submit

July 15, 2025

Conditions

Keywords

chronic diseasesugar-sweetened beverageswarning labelsbeverage tax

Outcome Measures

Primary Outcomes (4)

  • Average total kcals purchased

    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

    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

    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

    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 Outcomes (2)

  • Assessing acceptability and realism of online restaurant app

    Assessed at study completion, average of 3 weeks.

  • Average total dollars spent

    Assessed weekly at completion of restaurant order over 3 weeks

Study Arms (2)

No ultra-processed food and beverage taxes, warning labels, or healthy checkout regulations

NO 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

Intervention (Suite of healthy food policies)

EXPERIMENTAL

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

Behavioral: Suite of healthy food policies

Interventions

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

Intervention (Suite of healthy food policies)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christina Roberto, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not be aware of their group assignment initially. It will be necessary to omit these details so that participants will shop for restaurant food as they would do in the real-world. We hope this minimizes the chances that the participant will purchase foods that they think the research team wants them to purchase. To conceal the study's purpose, participants will be told that we are conducting consumer market research about online shopping experiences, but will not be told that we are specifically interested in understanding the effects of food and beverage taxes, nutrition labels, and marketing restrictions.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2025

First Posted

March 10, 2025

Study Start

February 24, 2025

Primary Completion

May 20, 2025

Study Completion

May 20, 2025

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations