NCT07422922

Brief Summary

Unhealthy diets significantly contribute to major preventable chronic diseases including type 2 diabetes, obesity, heart disease and stroke, which disproportionally impact racial/ethnic minority groups and those with lower income \[1-3\]. Although taxes and warning labels targeting sugar-sweetened beverages (SSB) have been successful at shifting behavior \[4-7\], there are many other ultra-processed food products that contribute to unhealthy diets \[8\]. What is less well-known is whether a suite of healthy food policies that are expanded to target a range of ultra-processed foods can shift dietary choices and intake in meaningful ways. Our research team's long-term goal is to identify and understand the degree to which combinations of healthy food policies can improve nutrition security and reduce nutrition-related diseases.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Feb 2026Apr 2028

First Submitted

Initial submission to the registry

February 12, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

February 25, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2028

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

2.2 years

First QC Date

February 12, 2026

Last Update Submit

May 15, 2026

Conditions

Keywords

chronic diseasebehavioral economicswarning labelnutritionultra-processed foodunhealthy foodsugar-sweetened beverageadvertisement restrictionnutrition policy

Outcome Measures

Primary Outcomes (1)

  • Average kcals purchased per participant per day from unhealthy ultra-processed food products that are targeted by our suite of healthy food policies

    We will sum the number of kcals from ultra-processed food products purchased in the online grocery store and divide that by the number of people in the household and 7 days per week. We will then add that to the number of kcals from ultra-processed foods purchased from the online restaurant to calculate total kcals from ultra-processed foods purchased per study participant per day. We will also examine these outcomes separately in the grocery store and restaurant context.

    Change between baseline and Weeks 2-4 (Aim 1) and Weeks 5-6 (Aim 3)

Secondary Outcomes (12)

  • Average sodium, saturated fat, and added sugars purchased per participant per day from unhealthy ultra-processed food products that are targeted by our suite of policies

    Change between baseline and Weeks 2-4 (Aim 1) and Weeks 5-6 (Aim 3)

  • Average overall kcals, sodium, saturated fat, and added sugars from all foods purchased in the online grocery store and restaurant per participant per day

    Change between baseline and Weeks 2-4 (Aim 1) and Weeks 5-6 (Aim 3)

  • Percentage of total dollars per order spent on products targeted by our suite of healthy food policies

    Change between baseline and Weeks 2-4 (Aim 1) and Weeks 5-6 (Aim 3)

  • Total dollars spent on food and beverage products purchased outside of the study grocery store and restaurant

    Baseline to Week 6

  • Total dollars spent on sugar sweetened beverages, candy, and fast food purchased outside of the study grocery store and restaurant

    Baseline to Week 6

  • +7 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Intervention

EXPERIMENTAL
Behavioral: Suite of healthy food policies

Interventions

A suite of healthy food policies in an online restaurant and grocery store including 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 pages.

Intervention

Eligibility Criteria

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

You may qualify if:

  • ≥18 years old
  • Not currently eligible for or participating in SNAP or another government program that automatically qualifies the person for SNAP (e.g., WIC, TANF)
  • Meets the following income eligibility requirements:
  • For participants living in the Houston or San Antonio areas, their household income must be greater than 165% of the federal poverty level, but less than the Texas state median household income (based on the 2023 American Community Survey) for their household size \[11\].
  • For participants living in the Philadelphia area, their income must be greater than 200% of the federal poverty level, but less than the Pennsylvania state median household income (based on the 2023 American Community Survey) for their household size \[11\].
  • Reports consuming food from McDonald's or a similar fast-food chain at least once a month
  • Does most of the grocery shopping for the household
  • Can adhere to the study schedule (e.g., receive a lunch on a Wednesday)
  • Has regular internet access
  • Has a smart phone that can take pictures
  • Resident of Houston, TX, San Antonio, TX or Philadelphia, PA or the surrounding areas and plans to be there for the next six weeks
  • Household size of six or fewer people
  • Have an address eligible for receiving Grubhub+ and Walmart+ deliveries

You may not qualify if:

  • Cognitive impairment; per PIs discretion
  • Participant is under 18 years old
  • Does not speak English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (11)

  • US Burden of Disease Collaborators; Mokdad AH, Ballestros K, Echko M, Glenn S, Olsen HE, Mullany E, Lee A, Khan AR, Ahmadi A, Ferrari AJ, Kasaeian A, Werdecker A, Carter A, Zipkin B, Sartorius B, Serdar B, Sykes BL, Troeger C, Fitzmaurice C, Rehm CD, Santomauro D, Kim D, Colombara D, Schwebel DC, Tsoi D, Kolte D, Nsoesie E, Nichols E, Oren E, Charlson FJ, Patton GC, Roth GA, Hosgood HD, Whiteford HA, Kyu H, Erskine HE, Huang H, Martopullo I, Singh JA, Nachega JB, Sanabria JR, Abbas K, Ong K, Tabb K, Krohn KJ, Cornaby L, Degenhardt L, Moses M, Farvid M, Griswold M, Criqui M, Bell M, Nguyen M, Wallin M, Mirarefin M, Qorbani M, Younis M, Fullman N, Liu P, Briant P, Gona P, Havmoller R, Leung R, Kimokoti R, Bazargan-Hejazi S, Hay SI, Yadgir S, Biryukov S, Vollset SE, Alam T, Frank T, Farid T, Miller T, Vos T, Barnighausen T, Gebrehiwot TT, Yano Y, Al-Aly Z, Mehari A, Handal A, Kandel A, Anderson B, Biroscak B, Mozaffarian D, Dorsey ER, Ding EL, Park EK, Wagner G, Hu G, Chen H, Sunshine JE, Khubchandani J, Leasher J, Leung J, Salomon J, Unutzer J, Cahill L, Cooper L, Horino M, Brauer M, Breitborde N, Hotez P, Topor-Madry R, Soneji S, Stranges S, James S, Amrock S, Jayaraman S, Patel T, Akinyemiju T, Skirbekk V, Kinfu Y, Bhutta Z, Jonas JB, Murray CJL. The State of US Health, 1990-2016: Burden of Diseases, Injuries, and Risk Factors Among US States. JAMA. 2018 Apr 10;319(14):1444-1472. doi: 10.1001/jama.2018.0158.

    PMID: 29634829BACKGROUND
  • Centers for Disease Control. Type 2 Diabetes. Centers for Disease Control. Published December 16, 2021. Accessed September 30, 2022. https://www.cdc.gov/diabetes/basics/type2.html#:~:text=Healthy%20eating%20is%20your%20recipe,them%20have%20type%202%20diabetes.

    BACKGROUND
  • Centers for Disease Control. Adult obesity facts. Centers for Disease Control. Published May 17, 2022. Accessed September 30, 2022. https://www.cdc.gov/obesity/data/adult.html

    BACKGROUND
  • Andreyeva T, Marple K, Marinello S, Moore TE, Powell LM. Outcomes Following Taxation of Sugar-Sweetened Beverages: A Systematic Review and Meta-analysis. JAMA Netw Open. 2022 Jun 1;5(6):e2215276. doi: 10.1001/jamanetworkopen.2022.15276.

    PMID: 35648398BACKGROUND
  • An R, Liu J, Liu R, Barker AR, Figueroa RB, McBride TD. Impact of Sugar-Sweetened Beverage Warning Labels on Consumer Behaviors: A Systematic Review and Meta-Analysis. Am J Prev Med. 2021 Jan;60(1):115-126. doi: 10.1016/j.amepre.2020.07.003. Epub 2020 Oct 12.

    PMID: 33059917BACKGROUND
  • Clarke N, Pechey E, Kosite D, Konig LM, Mantzari E, Blackwell AKM, Marteau TM, Hollands GJ. Impact of health warning labels on selection and consumption of food and alcohol products: systematic review with meta-analysis. Health Psychol Rev. 2021 Sep;15(3):430-453. doi: 10.1080/17437199.2020.1780147. Epub 2020 Jul 2.

    PMID: 32515697BACKGROUND
  • Grummon AH, Hall MG. Sugary drink warnings: A meta-analysis of experimental studies. PLoS Med. 2020 May 20;17(5):e1003120. doi: 10.1371/journal.pmed.1003120. eCollection 2020 May.

    PMID: 32433660BACKGROUND
  • Dong D, Bilger M, van Dam RM, Finkelstein EA. Consumption Of Specific Foods And Beverages And Excess Weight Gain Among Children And Adolescents. Health Aff (Millwood). 2015 Nov;34(11):1940-8. doi: 10.1377/hlthaff.2015.0434.

    PMID: 26526253BACKGROUND
  • How the HEI is scored. Food and Nutrition Service U.S. Department of Agriculture. (n.d.). https://www.fns.usda.gov/cnpp/how-hei-scored

    BACKGROUND
  • University of Minnesota Nutrition Coordinating Center (NCC). NDSR Software. Nutrition Coordinating Center (NCC). Published July 25, 2025. Accessed August 6, 2025. https://www.ncc.umn.edu/products/

    BACKGROUND
  • U.S. Census Bureau (2023). Median Household Income in the Past 12 Months (In 2023 Inflation-adjusted Dollars) by Household Size American Community Survey 1-year estimates. Retrieved from <https://censusreporter.org>

    BACKGROUND

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
  • Pasquale Rummo, PhD, MPH

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 20, 2026

Study Start

February 25, 2026

Primary Completion (Estimated)

April 21, 2028

Study Completion (Estimated)

April 21, 2028

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

De-identified data available for public use and associated documentation will be available to the research community free of charge through the Data Sharing for Demographic Research (DSDR) data repository hosted at ICPSR. Data and datasets will be kept and available to share for at least three years following completion of the project, in accordance with NIH regulations. Datasets in DSDR will be findable and identifiable through a study digital object identifier (DOI) minted by ICPSR.

Locations