Healthy Foods Program for Diabetes and Obesity

Overseen By Jenna White, M.S.W.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Not fluent in English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to encourage people with obesity and diabetes to purchase healthier foods. Participants will receive a monthly subsidy to spend on fruits, vegetables, and other nutritious options through Instacart. The study aims to determine which strategies, such as changing how foods are displayed online (Storefront Choice Architecture) or sending reminder messages (Loss Framing), most effectively increase healthy food purchases. Individuals diagnosed with obesity and diabetes, who shop online comfortably and have a backup payment method for Instacart, may be well-suited for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance healthy eating habits for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on dietary changes rather than medication adjustments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that giving vouchers for healthy foods increased fruit and vegetable consumption, demonstrating the safety of this approach. Another study found that discounts on healthy foods led to more purchases and consumption, supporting the idea that financial incentives can safely encourage healthier eating habits.

Research has also shown that messages highlighting the negative effects of inaction can effectively change behaviors without safety risks. Additionally, organizing the environment to make healthy choices easier has helped people eat better without any negative effects. Together, these findings suggest that the strategies in this study are well-tolerated and pose minimal safety risks for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to encourage healthier eating habits using digital platforms, which could transform how we manage diabetes and obesity. Unlike traditional treatments focusing on medication or dietary advice, this trial investigates the impact of financial incentives and behavioral nudges. The study's unique features include "Fresh Funds," which provide a financial subsidy for healthy food purchases, and "Choice Architecture," which rearranges online grocery options to highlight healthier choices. Additionally, "Loss Framing" uses motivational text messages to remind participants of their remaining subsidy, aiming to boost engagement and enhance healthy food purchasing. These approaches could offer new, practical strategies for supporting healthier lifestyles in a digitally-driven world.

What evidence suggests that this trial's treatments could be effective for diabetes and obesity?

Research has shown that programs offering healthy food prescriptions can improve diets and reduce risks related to heart and metabolic health. For example, providing discounts on healthy foods has led to increased consumption of fruits and vegetables, which can help manage diabetes and improve body weight. In this trial, participants in different arms will receive various interventions to support healthier eating habits.

One approach being tested is "loss framing," where participants in certain arms receive text messages highlighting potential losses from inaction, motivating healthier eating habits. Additionally, some participants will experience choice architecture manipulation, where healthy foods are made more visible in the virtual storefront, encouraging better eating choices. Together, these strategies offer promising ways to support healthier eating habits in people with obesity and diabetes. ^{4 6 7 8 9}

Who Is on the Research Team?

Kevin Volpp, MD PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for Penn Medicine patients aged 30-70 with obesity (BMI > 30) and diabetes (last A1C > 8 in the last 90 days). Participants must have internet access, experience with online shopping at least three times in the past year, and a backup payment method for Instacart registration.

Inclusion Criteria

I am 30-70 years old, have obesity and diabetes, use online shopping, and have a backup payment for Instacart.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (virtual)

Initial Feasibility Test

Pilot phase to test strategies for uptake and engagement with a cohort of 10 participants

2 weeks

Interviews conducted via phone or Zoom

Randomized Controlled Trial

Participants receive subsidies and interventions to test the impact on healthy food purchasing behavior

3 months

Weekly virtual check-ins and dietary assessments at 0 and 3 months

Follow-up

Participants are monitored for changes in dietary habits and health outcomes post-intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fresh Funds
• Loss Framing
• Storefront Choice Architecture

Trial Overview The study tests how to boost healthy food purchases through a prescription program. It compares usual care—access to standard Instacart without subsidies—to four treatment groups that get monthly produce subsidies ($160 for fruits and vegetables) plus various incentives and storefront changes.

How Is the Trial Designed?

Group I: Non Choice Architecture + Loss Framing (Arm C) Experimental Treatment 2 Interventions

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.

Group II: Non Choice Architecture (Arm A) Experimental Treatment 1 Intervention

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.

Group III: Choice Architecture + Loss Framing (Arm D) Experimental Treatment 3 Interventions

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.

Group IV: Choice Architecture (Arm B) Experimental Treatment 2 Interventions

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.

Group V: Usual Care Active Control 1 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.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

A review of 58 articles identified 33 interventions in supermarkets and grocery stores aimed at promoting healthful food choices, with the most effective strategy being a combination of point-of-purchase promotions and advertising.

While some intervention categories showed sufficient evidence for effectiveness, overall, none of the strategies demonstrated strong evidence, highlighting the need for more rigorous testing to assess their impact on dietary and health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supermarket and grocery store-based interventions to promote healthful food choices and eating practices: a systematic review. Escaron, AL., Meinen, AM., Nitzke, SA., et al.[2022]

The B'more Healthy Communities for Kids (BHCK) intervention successfully improved the availability and purchasing of healthier foods in low-income neighborhoods, with significant increases in sales of promoted products at wholesalers and improved stocking in corner stores.

Children exposed to the intervention showed an increased frequency of purchasing healthier foods, indicating that multilevel community interventions can positively influence food choices among children in urban food deserts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of a Multi-Level Multi-Component Childhood Obesity Prevention Intervention on Healthy Food Availability, Sales, and Purchasing in a Low-Income Urban Area. Gittelsohn, J., Trude, AC., Poirier, L., et al.[2022]

A randomized trial involving 33 supermarkets in low-income, high-minority neighborhoods tested healthy food marketing strategies over 18 months, showing high compliance (76.5%) with these strategies.

The study aimed to promote healthier food purchases, but pre-intervention sales of healthier items were similar in both intervention and control stores, indicating that simply increasing healthy food availability may not be enough to change purchasing habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The healthy food marketing strategies study: design, baseline characteristics, and supermarket compliance. Glanz, K., Chung, A., Morales, KH., et al.[2022]

The Fruit and Vegetable Prescription (FVRx) program significantly increased the consumption of dark green vegetables among participants compared to those in the Ad hoc Nutrition Education and Control groups, indicating its effectiveness in promoting healthier eating habits.

Participants in the FVRx program also showed improved food purchasing practices and financial management, suggesting that combining nutrition education with produce prescriptions can enhance food security and resource management for low-income adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Fruit and Vegetable Prescription Program With Expanded Education for Low-Income Adults. Slagel, N., Newman, T., Sanville, L., et al.[2022]

The intervention, which included a farmers' market and financial incentives, led to a marginally significant increase of 1.6 servings of fruits and vegetables consumed per day among 41 low-income diabetics over 22 weeks.

Diabetics who used financial incentives and visited the farmers' market more frequently had significantly higher odds of improving their fruit and vegetable consumption, highlighting the importance of addressing economic barriers to healthy food access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A farmers' market at a federally qualified health center improves fruit and vegetable intake among low-income diabetics. Freedman, DA., Choi, SK., Hurley, T., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12538504/

Voucher for Healthy Foods and Diabetes Control The primary outcome was change in HbA1c levels from baseline to 6 months. Secondary outcomes included levels of β-carotene and ascorbic acid, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5743436/

Veggie Rx: an outcome evaluation of a healthy food ... Greater improvement in BMI was found among Veggie Rx programme participants. This information will guide programme changes and inform the field on the ...

3. thelancet.com thelancet.com/journals/lanplh/article/PIIS2542-5196(24)00004-4/fulltext

Impact of price reductions, subsidies, or financial incentives ... 10% and 25% discounts on healthy food purchases were associated with an increase in fruit and vegetable consumption by 0·38 (95% CI 0·37 to 0·39) and 0·64 (0·62 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S216183132200480X

Healthy Food Prescription Programs and their Impact on ... The primary outcomes were changes in dietary behavior and cardiometabolic risk factors due to healthy food prescription programs, standardized as percent ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2792845

Evaluation of Economic and Health Outcomes Associated ... For example, a 10% discount on healthy food purchases was associated with higher consumption of fruits and vegetables by 0.382 daily servings, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10465985/

Food Insecurity and Diabetes: Overview of Intersections ... Among people experiencing food insecurity, SNAP participation is associated with improved glucose control and (among older adults) a moderate decrease in cost- ...

7. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2840467

Voucher for Healthy Foods and Diabetes Control The 95% CIs excluded a large effect on HbA1c. The voucher improved patient-reported vegetable consumption, fruit consumption, food security, and ...

8. portal.nifa.usda.gov portal.nifa.usda.gov/web/crisprojectpages/1029491-fresh-takes-addressing-health-outcomes-for-patients-with-diabetes-and-prediabetes-by-combating-food-insecurity.html

Fresh Takes!: Addressing health outcomes for patients with ... Fresh Takes!, aims to improve health outcomes for those with prediabetes or overt diabetes by increasing consistent access to high quality fruits and vegetables ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3898771/

Effectiveness of subsidies in promoting healthy food ... All but one study found subsidies on healthier foods to significantly increase the purchase and consumption of promoted products.