NCT06283394

Brief 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). 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. 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).

Trial Health

75
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P75+ for not_applicable obesity

Timeline
8mo left

Started Aug 2024

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
active not 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 Progress74%
Aug 2024Dec 2026

First Submitted

Initial submission to the registry

February 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2026

Expected
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

February 21, 2024

Last Update Submit

April 27, 2026

Conditions

Outcome Measures

Primary Outcomes (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)

    At the end of the 3 month intervention

Secondary Outcomes (3)

  • Mean percentage of the $160 subsidy used each month in the intervention arms.

    At the end of the 3 month intervention

  • Change in hemoglobin A1c

    At the end of the 3 month intervention

  • Percentage of expenditures spent on eligible fruits and vegetables

    At the end of the 3 month intervention

Study Arms (5)

Usual Care

NO INTERVENTION

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 a $5 per week to cover service and delivery fees and coverage of delivery tips for 3 months.

Non Choice Architecture (Arm A)

EXPERIMENTAL

Arm 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.

Behavioral: Fresh Funds

Choice Architecture (Arm B)

EXPERIMENTAL

Arm 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.

Behavioral: Storefront Choice ArchitectureBehavioral: Fresh Funds

Non Choice Architecture + Loss Framing (Arm C)

EXPERIMENTAL

Arm 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.

Behavioral: Fresh FundsBehavioral: Loss Framing

Choice Architecture + Loss Framing (Arm D)

EXPERIMENTAL

Arm 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.

Behavioral: Storefront Choice ArchitectureBehavioral: Fresh FundsBehavioral: Loss Framing

Interventions

Fresh FundsBEHAVIORAL

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

Choice Architecture (Arm B)Choice Architecture + Loss Framing (Arm D)Non Choice Architecture (Arm A)Non Choice Architecture + Loss Framing (Arm C)

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

Choice Architecture (Arm B)Choice Architecture + Loss Framing (Arm D)
Loss FramingBEHAVIORAL

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).

Choice Architecture + Loss Framing (Arm D)Non Choice Architecture + Loss Framing (Arm C)

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

ObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Kevin Volpp, MD,PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2024

First Posted

February 28, 2024

Study Start

August 1, 2024

Primary Completion

May 1, 2025

Study Completion (Estimated)

December 21, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations