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ObesityNCT06283394

Penn Medicine Food Market Study

A study testing Storefront Choice Architecture, Fresh Funds and Loss Framing in people with Obesity and Diabetes, run by University of Pennsylvania at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this interventional study is to test ways to improve the effectiveness of a healthy foods prescription program in increasing the purchase of healthy foods for patients who have both obesity (BMI >or= 30) and diabetes (last A1C>8 in the 90 days from data pull). Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Obesity, Diabetes
What is being tested?
Storefront Choice Architecture, Fresh Funds and Loss Framing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
214 participants
Where
1 siteUnited States
Study dates
1 Aug 2024to 21 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Between the ages of 30 and 70
  • Patients in the Penn Medicine system who have obesity (BMI>or=30) and diabetes (last A1C>8 in the 90 days prior to data pull)
  • Self-report being comfortable online shopping
  • Have a backup payment option available to use in registering for Instacart

Who cannot join

  • Not fluent in English
  • Opted out of research
  • The patient does not have a Primary care provider assigned
  • The patient is part of a Penn primary care practice engaged with the Healthy Heart Program

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: AHA (American Heart Association) Health Care x Food Penn Medicine Food Market Study

The goal of this interventional study is to test ways to improve the effectiveness of a healthy foods prescription program in increasing the purchase of healthy foods for patients who have both obesity (BMI >or= 30) and diabetes (last A1C>8 in the 90 days from data pull). The main questions it aims to answer are:

Aim 1: Examine feasibility and engagement among participants by assessing percent enrollment among those identified as eligible, rates of Instacart platform use, amount of the subsidy used each week, and amounts of healthy foods ordered.

Read more

Aim 2: Examine strategies to optimize the user experience of trial participation, including communication strategies and on-boarding, to increase uptake and engagement in this and subsequent studies.

Usual Care (Control): Participants in the usual care arm will not receive weekly subsidies on Instacart, and they will not receive any modifications to the virtual storefront on Instacart. They will have access to the standard Instacart platform and Instacart + memberships with $5 per week to cover service and delivery fees and delivery tips for 3 months.

Intervention Arms: The four treatment groups will also each receive a $160 subsidy per month for 3 months to be used on produce (fruits and vegetables).

Read the detailed description

Patients who have both obesity (BMI >or= 30) and diabetes (last A1C>8 in the 90 days from time of data pull) will be recruited from specific Penn Medicine primary care practices. This patient list is curated based on the inclusion/exclusion criteria.

Participants in the control group will receive usual care (defined as access to the the virtual storefront without the choice architecture manipulation) but all study participants will receive a free Instacart+ membership for the 3 months they are a study participant and be given $20 per month to help cover the cost of additional delivery and service fees as well as tips for delivery drivers on Instacart. Participants in the intervention groups will in addition receive $160 per month in subsidies on Instacart. All arms will receive text messages and/or email messages from W2H 1x per week with a link to Instacart and different messaging depending on the study arm.

The main difference between the pilot intervention and the main RCT is the length (2 weeks for the pilot, 3 months for the main RCT); otherwise, they will receive the same experience. The pilot phase intends to test out a mini version of the full intervention and get participant feedback so that the study team can improve the user experience before conducting the main intervention study.

Participants in 4 of the 5 study arms will be given vouchers for use on Instacart to buy fruit and vegetables ($160 a month). They will be given an individualized link to a special study website that is an Instacart virtual store where they can order food items to be delivered. Weekly, Instacart will send us data on how much is left in terms of unexpended vouchers and what food is purchased for each study ID each month.

Initial Feasibility Test (2 Weeks): Before enrolling participants in this phase of the study, the study team will examine strategies for uptake and engagement through one rapid 10-person studies followed by semi-structured interviews to gather feedback on ways to improve the user experience. There will be a cohort of 10 participants randomized 2 in each of the 5 study arms. Each interview will be audio-recorded with permission from the participant and subsequently transcribed for analysis. Interviews will take place over the phone or on Zoom and will be recorded using an audio recorder. Audio files will be uploaded to a third-party professional transcription service, which will transcribe the recordings and send us the transcripts for analysis. Participants that sign up for their Instacart account within 48 hours will receive a $25 Instacart gift card. All participants in the intervention arms during this phase will receive $40 per week for two weeks to be used to subsidize the purchase of foods on the healthy foods list (denoted by Instacart on the virtual storefront). Participants in the control arm will receive $5 per week for two weeks to cover additional service fees, delivery fees, and driver tips. This will be done twice to reach high rates of initial enrollment and ongoing engagement. This will also test the integration of our trial platform (W2H), connection to Instacart, and receipt of data from Instacart at the individual level. These iterative studies will be used to get participant input into the user experience and to streamline our on-boarding processes. Participants will also receive $50 to debrief with the study team on their experience.

Randomized Controlled Trial (3 Months): The study team then plans to test modifying choice architecture and different ways of presenting incentives to affect the degree to which these strategies change healthy food purchasing behavior.

All participants will start in the study at the beginning of the month. If they do not complete their enrollment by the 5th day of the month, they will be paused until the 1st business day of the following month.

In the RCT phase, participants will be reached out to by text and sent to a Way to Health study link where they will be asked to first complete a brief eligibility survey via text message. Eligibility questions include whether the participant is comfortable online shopping and if they have a backup payment method for foods they purchase over and above the value of the subsidies.

Participants will complete dietary recall questionnaires at 0 and 3 months via W2H. The study team will use the Diet.ID validated a two-minute dietary assessment tool (https://www.dietid.com/). As part of the 3-month assessment, participants will be asked questions about their study experience. Participants will be compensated $25 for completing instacart sign up within 48 hours, $25 for the baseline dietary survey and $25 for completing the 3-month dietary survey and exit survey and $50 for completing a hemoglobin A1c lab after 3 months.

At the completion of the 3-month study period, a subset of participants (total of 42, selecting those with highest and lowest % of fruit and vegetable voucher use each month) will be invited to complete semi-structured exit interviews conducted by a trained research coordinator over the phone or through Zoom. Participants will receive an extra $50 for completing these interviews.

Conditions
Obesity, Diabetes
Being tested
Storefront Choice Architecture, Fresh Funds, Loss Framing
Medical subject headings
Obesity, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Storefront Choice ArchitectureBehavioural

    An Instacart storefront with choice architecture manipulation (healthy items for diabetics appear first and less healthy items are less visible)

  • Fresh FundsBehavioural

    The treatment groups will each receive a $160 subsidy per month for 3 months to be used on produce through Instacart.

  • Loss FramingBehavioural

    They will receive text messages detailing how much of their $160 subsidy is left (beginning of weeks 1, 2, 3, and 4 and following end of the month).

Study groups in NCT06283394
Study groupRoleWhat they receive
Usual CareNo interventionParticipants in the usual care arm will not receive weekly subsidies on Instacart, and they will not receive any modifications to the virtual storefront on Instacart. They will have access to the standard Instacart platform and Instacart + memberships with a $5 per week to cover service and delivery fees and coverage of delivery tips for 3 months.
Non Choice Architecture (Arm A)ExperimentalArm A will receive a $160 subsidy per month for 3 months to be used on healthy foods (fruits and vegetables, whole grains, etc.). They will see the Instacart storefront without choice architecture manipulation and will see the discount applied at checkout. They will have Instacart + memberships for 3 months.
Receives: Behavioral: Fresh Funds
Choice Architecture (Arm B)ExperimentalArm B will receive a $160 subsidy per month for 3 months to be used on healthy foods (fruits and vegetables, whole grains, etc.). They will see a storefront with choice architecture manipulation (healthy items for diabetics appear first and less healthy items are less visible) and will see the discount applied at checkout. They will have Instacart + memberships for 3 months.
Receives: Behavioral: Storefront Choice Architecture; Behavioral: Fresh Funds
Non Choice Architecture + Loss Framing (Arm C)ExperimentalArm C will receive a $160 subsidy per month for 3 months to be used on produce.They will see the usual Instacart storefront and will see the discount applied at checkout. They will also receive text messages detailing how much of their $160 subsidy is left (beginning of weeks 1, 2, 3, and 4 and following the end of the month). They will have Instacart + memberships.
Receives: Behavioral: Fresh Funds; Behavioral: Loss Framing
Choice Architecture + Loss Framing (Arm D)ExperimentalArm D will receive a $160 subsidy per month for 3 months to be used on produce. They will see a storefront with choice architecture manipulation (healthy items for diabetics appear first and less healthy items are less visible) and will see the discount applied at checkout. They will also receive text messages detailing how much of their $160 subsidy is left (as in arm C). They will have Instacart + memberships.
Receives: Behavioral: Storefront Choice Architecture; Behavioral: Fresh Funds; Behavioral: Loss Framing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary outcome will be the total expenditures spent on fruits and vegetables (dollars spent inclusive of application of subsidies)

    The primary outcome will be the total expenditures spent on fruits and vegetables (dollars spent inclusive of application of subsidies)

    Measured: At the end of the 3 month intervention

Secondary outcomes (3)
  1. Mean percentage of the $160 subsidy used each month in the intervention arms.

    Secondary outcome include the mean percentage of the $160 subsidy used each month in the intervention arms.

    Measured: At the end of the 3 month intervention

  2. Change in hemoglobin A1c

    Secondary outcome include change from baseline in hemoglobin A1c.

    Measured: At the end of the 3 month intervention

  3. Percentage of expenditures spent on eligible fruits and vegetables

    percentage of expenditures spent on eligible fruits and vegetables (i.e., total spent on fruits and vegetables/total spent)

    Measured: At the end of the 3 month intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start1 Aug 2024
  3. Primary completion1 May 2025
  4. Study completion21 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
214 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06283394
Sponsor's protocol ID
854803
Status last verified
Apr 2026
First submitted
21 Feb 2024
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hua SV, Klaiman T, Coratti S, White J, John A, Putt ME, Dixon E, Posner H, Volpp KG. Using a human-centered design framework and behavioral economic interventions to increase fruit and vegetable purchases in an online grocery store: Study design and methodologies. Contemp Clin Trials. 2025 Jun;153:107921. doi: 10.1016/j.cct.2025.107921. Epub 2025 Apr 17.

    PubMed 40252826

Questions about this trial

What is this clinical trial studying?

A study testing Storefront Choice Architecture, Fresh Funds and Loss Framing in people with Obesity and Diabetes, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome will be the total expenditures spent on fruits and vegetables (dollars spent inclusive of application of subsidies) (time frame: At the end of the 3 month intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06283394, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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