- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07422922
Click & Pick Study
A Longitudinal, Randomized-Controlled Experiment of Healthy Food Policies in Online Retail Settings
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
To advance our understanding of policies needed to support nutrition security and health, our overall objective is to examine the degree to which a suite of healthy food policies in online food retailers can increase the purchase and intake of healthy foods and beverages while reducing the purchase and intake of unhealthy ultra-processed foods and beverages.
To accomplish this objective, we will use an innovative online grocery store and restaurant platforms to randomize participants 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). We will recruit 300 adults with lower income across Houston and San Antonio, TX, and Philadelphia, PA to shop once per week for six weeks in both our online grocery store and restaurant. Week 1 will be a baseline (control) week without interventions, followed by three weeks of the interventions. In the last two study weeks, we will introduce unhealthy food marketing (e.g., banner ads) into the online platforms to mimic what we expect industry will do to counter public health policy efforts.
A key aim of the study is to simulate how food companies will respond to healthy eating policies if they were to be implemented in the real world. For that reason, we will increase the intensity of non-checkout advertisements for unhealthy foods during the last two weeks of the intervention period because this is likely how industry would respond in the real-world if the U.S. adopted any of the policies we are testing. Therefore, we are trying to measure the extent to which that advertising would undermine the policy effects. This is a critical component of our study because many nutrition policy experiments look at the impact of a policy in a static situation that does not account for a likely industry response. The advertisements we are using will mimic what's normally seen in delivery/grocery apps such as ads for sugar-sweetened beverages like Coke or Pepsi.
Participants will be given money to spend in these online platforms and purchases will be delivered to them via a real food retail store and restaurant. Participants will complete surveys at baseline and after 6 weeks of shopping and will complete two dietary recalls administered over the phone during the baseline week and during the fourth week (4 recalls total). The rationale underlying the proposed research is based on our work showing that beverage taxes and warning labels greatly reduce SSB purchases.
The specific aims of the study are:
- Aims 1: To evaluate the effects of three healthy food policies (ultra-processed food and beverage taxes, front-of-pack nutrition warning labels, and healthy checkout regulations) on purchases across online grocery store and restaurant settings.
- Aim 2: To evaluate the effects of three healthy food policies (ultra-processed food taxes, front-of-pack nutrition warning labels, and healthy checkout regulations) on dietary quality.
- Aim 3: To understand the degree to which unhealthy food marketing counters the effects of a suite of healthy food policies.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eva Fabian, MPH
- Email: Eva.Fabian@Pennmedicine.upenn.edu
Study Contact Backup
- Name: Julianna Catania, MPH
- Phone Number: (215) 839-9689
- Email: julianna.catania@pennmedicine.upenn.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- University of Pennsylvania
-
Contact:
- Eva Fabian, MPH
- Email: Eva.Fabian@Pennmedicine.upenn.edu
-
Contact:
- Julianna Catania, MPH
- Phone Number: 609-385-8219
- Email: julianna.catania@pennmedicine.upenn.edu
-
Principal Investigator:
- Christina Roberto, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥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
Exclusion Criteria:
- Does not meet all of the inclusion criteria
- Cognitive impairment; per PIs discretion
- Participant is under 18 years old
- Does not speak English or Spanish
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
|
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.
|
|
No Intervention: Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average kcals purchased per participant per day from unhealthy ultra-processed food products that are targeted by our suite of healthy food policies
Time Frame: Change between baseline and Weeks 2-4 (Aim 1) and Weeks 5-6 (Aim 3)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
Time Frame: Change between baseline and Weeks 2-4 (Aim 1) and Weeks 5-6 (Aim 3)
|
Using the same approach as our primary outcome, our secondary behavioral outcomes will be the average sodium, saturated fat, and added sugars purchased per 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)
|
|
Average overall kcals, sodium, saturated fat, and added sugars from all foods purchased in the online grocery store and restaurant per participant per day
Time Frame: Change between baseline and Weeks 2-4 (Aim 1) and Weeks 5-6 (Aim 3)
|
We will create this outcome using the same approach as our primary outcome, except we will look at all foods and beverages purchased, not just ultra-processed foods and beverages.
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)
|
|
Percentage of total dollars per order spent on products targeted by our suite of healthy food policies
Time Frame: Change between baseline and Weeks 2-4 (Aim 1) and Weeks 5-6 (Aim 3)
|
To create this outcome for each week of the study, we will divide the number of dollars spent on targeted ultra-processed products by the total dollars spent and multiply by 100.
|
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
Time Frame: Baseline to Week 6
|
We will sum together the total amount of dollars spent on food and beverages purchased outside the study using outside receipts submitted by the participants.
|
Baseline to Week 6
|
|
Total dollars spent on sugar sweetened beverages, candy, and fast food purchased outside of the study grocery store and restaurant
Time Frame: Baseline to Week 6
|
Total dollars spent on sugar sweetened beverages, candy, and fast food purchased outside the study using outside receipts submitted by the participants.
|
Baseline to Week 6
|
|
Healthy Eating Index Score (HEI-2020)
Time Frame: Change between baseline and Week 4
|
The HEI is a tool to assess how well a participant's diet aligns with the 2015-2020 Dietary Guidelines for Americans and can be used to measure the efficacy of nutrition interventions [9].
We will average intake estimates from the two 24-hour dietary recall interviews conducted at baseline and again at follow up (Week 4).
|
Change between baseline and Week 4
|
|
Change in usual intake for: energy (kcals), discretionary calories, SSB servings per day, total fruit servings/day, total vegetable servings/day, daily intake of key macronutrients, and daily intake of whole grains
Time Frame: Change between baseline and Week 4
|
We will average intake estimates from the two NDSR 24-hour dietary recall interviews conducted at baseline and again at follow up (Week 4) [10].
|
Change between baseline and Week 4
|
|
Food and beverage product perceptions
Time Frame: Final survey (administered Week 7)
|
During the final survey (Week 7), participants will view four ultra-processed products.
Those in the intervention group will see those products with any applicable warning labels and those in the control group will see the same products without any warning labels.
Participants will then rate how healthy or unhealthy they believe the product to be.
|
Final survey (administered Week 7)
|
|
Nutrient content knowledge
Time Frame: Final survey (administered Week 7)
|
During the final survey (Week 7), participants will also be asked about their knowledge of different nutrients of concern, and we will determine whether they provide the correct answer or not.
They will view the same four ultra-processed products as the food and beverage product perceptions questions and be asked whether or not the product has low, medium, or high amounts of calories, sodium, saturated fats, and added sugars.
|
Final survey (administered Week 7)
|
|
Warning label perceptions
Time Frame: Final survey (administered Week 7)
|
At the end of the final study survey (Week 7), participants will be shown the warning labels used in the study and asked about perceived message effectiveness.
|
Final survey (administered Week 7)
|
|
Policy opinions
Time Frame: Final survey (administered Week 7)
|
During the final survey (Week 7), participants will also answer four questions about their support or opposition for the suite of healthy food policies.
|
Final survey (administered Week 7)
|
|
Online store perceptions
Time Frame: Final survey (administered Week 7)
|
We will assess the acceptability of the online grocery store and restaurant (e.g., overall difficulty of using the grocery store/restaurant, satisfaction with number of options) and realism of the online grocery store and restaurant (e.g., extent to which participants' selections are similar to usual purchases, extent to which it felt real).
|
Final survey (administered Week 7)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christina Roberto, PhD, University of Pennsylvania
- Principal Investigator: Pasquale Rummo, PhD, MPH, NYU Langone Health
Publications and helpful links
General Publications
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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/
- 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>
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 855856
- 1R01DK136779-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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