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

224 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the Healthy Foods Program for Diabetes and Obesity treatment?

Research shows that programs combining healthy food access and education, like the Fruit and Vegetable Prescription Program, can improve dietary habits and food purchasing practices among low-income adults. Additionally, interventions that improve the availability and marketing of healthy foods in stores have been shown to increase the purchase of healthier food items. ^{1 2 3 4 5}

Is the Healthy Foods Program for Diabetes and Obesity safe for humans?

The studies reviewed focus on the effectiveness and feasibility of healthy food marketing and financial incentive programs, but they do not report any safety concerns for humans participating in these types of interventions. ^{2 6 7 8 9}

How does the Healthy Foods Program for Diabetes and Obesity treatment differ from other treatments?

The Healthy Foods Program for Diabetes and Obesity is unique because it combines financial incentives, like Fresh Funds, with strategies such as loss framing and storefront choice architecture to encourage healthier food purchases. This approach focuses on changing shopping behaviors in supermarkets, which is different from traditional medical treatments that often focus on medication or direct dietary advice. ^{2 9 10 11 12}

What is the purpose of this trial?

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).

Research Team

Kevin Volpp, MD PhD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

1. Switzerland 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The healthy food marketing strategies study: design, baseline characteristics, and supermarket compliance. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Linking the Flint Food Store Survey: Is Objective or Perceived Access to Healthy Foods Associated with Glycemic Control in Patients with Type 2 Diabetes? [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A farmers' market at a federally qualified health center improves fruit and vegetable intake among low-income diabetics. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of a Fruit and Vegetable Prescription Program With Expanded Education for Low-Income Adults. [2022]

6. England pubmed.ncbi.nlm.nih.gov

U.S. county "food swamp" severity and hospitalization rates among adults with diabetes: A nonlinear relationship. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Nationwide expansion of a financial incentive program on fruit and vegetable purchases among Supplemental Nutrition Assistance Program participants: A cost-effectiveness analysis. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Health and Economic Impacts of Implementing Produce Prescription Programs for Diabetes in the United States: A Microsimulation Study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluating A USDA Program That Gives SNAP Participants Financial Incentives To Buy Fresh Produce In Supermarkets. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

SNAP Participants Improved Food Security And Diet After A Full-Service Supermarket Opened In An Urban Food Desert. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

A Traffic-Light Label Intervention and Dietary Choices in College Cafeterias. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Supermarket and grocery store-based interventions to promote healthful food choices and eating practices: a systematic review. [2022]