Fresh Food Boxes for Food Insecurity

Recruiting at 1 trial location

Overseen By Rubayat Qadeer, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Not a BHC patient, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Fresh Takes!, which provides fresh food boxes and nutrition education to help individuals with prediabetes and diabetes manage their condition. The goal is to improve blood sugar control and reduce food insecurity by offering free bimonthly fresh food boxes and support over six months. Participants will serve as their own control group, with researchers examining changes in blood sugar, food security, and diet before and after the program. Individuals with diabetes or prediabetes who have experienced food insecurity in the past year may be well-suited for this trial. As an unphased trial, this study offers participants a unique opportunity to benefit directly from fresh food support while contributing to valuable research.

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 to focus on providing fresh food and nutrition education rather than changing medication routines.

What prior data suggests that the Fresh Takes! program is safe?

Research has shown that food distribution programs like Fresh Takes! are safe and helpful. In past studies, participants had better access to food and healthier diets, with no reported safety issues. One study found significant improvements in food access and eating habits, with no negative effects. This indicates that receiving nutritious food boxes and education can be safe and beneficial for people with diabetes or prediabetes who struggle to get enough food. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Fresh Takes! because it offers a novel approach to managing diabetes and prediabetes for those experiencing food insecurity. Unlike traditional treatments that focus solely on medication and regular glucose monitoring, Fresh Takes! provides free bimonthly fresh food boxes, coupled with nutrition education and personalized support. This holistic method addresses dietary needs directly and could improve both glucose control and food security simultaneously. Additionally, by empowering individuals with knowledge and resources, this program has the potential to foster long-term healthy eating habits and enhance overall well-being.

What evidence suggests that the Fresh Takes! program could be effective for reducing food insecurity and improving diabetic control?

Research has shown that providing fresh food boxes and nutrition education can improve health for people with diabetes or prediabetes. In one study, the number of people with enough food increased to 40% among those who received these supports. Another study found that receiving fresh produce and diabetes-friendly food packages helped adults with diabetes have enough food and eat healthier. In this trial, participants in the various cohorts will receive support through the Fresh Takes! program, which aims to prevent diabetes from worsening and help those with diabetes manage their condition better. Overall, these efforts show promise in helping people eat better and control their blood sugar levels. ^{1 2 3 5 6}

Who Is on the Research Team?

Barbara Hackley, PhD

Principal Investigator

Montefiore Medical Center

Rubayat Qadeer, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 who are patients at BHC, have experienced food insecurity in the past year, and have been identified with prediabetes or diabetes through specific diagnostic codes or HbA1c levels.

Inclusion Criteria

You had trouble getting enough food to eat in the past year.

I have diabetes or my HbA1c level was over 6.4% in the last year.

I have been diagnosed with prediabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bimonthly fresh food boxes, nutrition education, and individualized support over a 6-month program

6 months

Bimonthly visits for food box pickup and education

Follow-up

Participants are monitored for changes in dietary intake, food security, and diabetic control after program completion

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Fresh Takes!

Trial Overview The 'Fresh Takes!' program provides participants with fresh food boxes every two weeks and nutritional education to help those with prediabetes avoid developing diabetes and assist diabetic individuals in better managing their condition over six months.

How Is the Trial Designed?

Group I: Cohort 4 Receipt of Food Box Active Control 1 Intervention

Up to 80 individuals with diabetes or prediabetes with a history of food insecurity enrolled in a 6 month program offering free bimonthly fresh food boxes, nutrition education, and individualized support. Each enrolled individual will serve as their own control. The study will evaluate pre and post program changes in reported self-obtained home glucose levels, food security, and dietary intake.

Group II: Cohort 1 Receipt of Food Box Active Control 1 Intervention

Up to 80 individuals with diabetes or prediabetes with a history of food insecurity enrolled in a 6 month program offering free bimonthly fresh food boxes, nutrition education, and individualized support. Each enrolled individual will serve as their own control. The study will evaluate pre and post program changes in reported self-obtained home glucose levels, food security, and dietary intake.

Group III: Cohort 2 Receipt of Food Box Active Control 1 Intervention

Up to 80 individuals with diabetes or prediabetes with a history of food insecurity enrolled in a 6 month program offering free bimonthly fresh food boxes, nutrition education, and individualized support. Each enrolled individual will serve as their own control. The study will evaluate pre and post program changes in reported self-obtained home glucose levels, food security, and dietary intake.

Group IV: Cohort 3 Receipt of Food Box Active Control 1 Intervention

Up to 80 individuals with diabetes or prediabetes with a history of food insecurity enrolled in a 6 month program offering free bimonthly fresh food boxes, nutrition education, and individualized support. Each enrolled individual will serve as their own control. The study will evaluate pre and post program changes in reported self-obtained home glucose levels, food security, and dietary intake.

Fresh Takes! is already approved in United States for the following indications:

Approved in United States as Fresh Takes! for:

• Prediabetes
• Diabetes Management

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

United States Department of Agriculture (USDA)

Collaborator

Trials

103

Recruited

287,000+

Published Research Related to This Trial

Focus groups with food pantry users in Washington State revealed high rates of household food insecurity, highlighting the urgent need for targeted support and resources for families with children.

Participants expressed a strong desire for nutrition education on how to stretch food dollars, indicating that educational programs should address practical coping strategies and the emotional challenges of food insecurity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping strategies and nutrition education needs among food pantry users. Hoisington, A., Shultz, JA., Butkus, S.[2019]

Participation in a six-month produce prescription program significantly improved food security and reduced diastolic blood pressure among participants, with 122 graduates primarily from underserved communities in Georgia.

The program combined nutrition education with subsidies for fresh produce, demonstrating its potential effectiveness in enhancing health outcomes for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food Security and Clinical Outcomes of the 2017 Georgia Fruit and Vegetable Prescription Program. Cook, M., Ward, R., Newman, T., et al.[2021]

A systematic review of 10 studies on food provision programs for patients with type 2 diabetes or prediabetes showed that those including nutrition education consistently reduced HbA1c levels, indicating improved diabetes management.

Programs varied widely in their design and implementation, but those that incorporated nutrition education—covering topics like general nutrition and fruit/vegetable consumption—tended to yield better dietary quality and health outcomes compared to those without such education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A narrative review of clinic-community food provision interventions aimed at improving diabetes outcomes among food-insecure adults: examining the role of nutrition education. Schier, HE., Chetty, KS., Garrity, K., et al.[2023]

The Supporting Wellness at Pantries (SWAP) system was successfully implemented in two large food pantries in New Haven, Connecticut, reaching over 12,200 individuals annually, and led to an increase in the percentage of healthy 'Green' foods offered.

Despite challenges posed by the COVID-19 pandemic, the pantries adapted the SWAP implementation, demonstrating its flexibility and effectiveness as a nutritional intervention to improve food quality for those experiencing food insecurity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Implementation of a Nutrition Intervention in Food Pantries: The Spirit of SWAP. Morales, SI., Vicente, G., LaMonaca, K., et al.[2023]

The UnProcessed Pantry Project (UP3) significantly improved dietary quality among 43 participants over 16 weeks, as indicated by better Healthy Eating Index-2015 scores, particularly in whole grains and reduced added sugars.

Participants also experienced significant health improvements, including reductions in BMI, total cholesterol, and waist circumference, suggesting that interventions in the emergency food system can effectively address food insecurity and related health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The UnProcessed Pantry Project (UP3): A Community-Based Intervention Aimed to Reduce Ultra-Processed Food Intake Among Food Pantry Clients. Byker Shanks, C., Vanderwood, K., Grocke, M., et al.[2023]

A study involving 50 participants with food insecurity showed that using a prefilled, nutritionally balanced online grocery shopping cart led to significantly healthier purchases compared to just reviewing nutrition information.

Participants using the default shopping cart bought more whole grains, fruits, and vegetables, while also selecting foods lower in sodium, cholesterol, and unhealthy fats, indicating that this approach can effectively promote better nutrition in financially constrained individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nudging while online grocery shopping: A randomized feasibility trial to enhance nutrition in individuals with food insecurity. Coffino, JA., Udo, T., Hormes, JM.[2021]

Freshplace, a community-based food pantry program in Hartford, Connecticut, significantly improved food security and diet quality among its members compared to those using traditional food pantries, with notable increases in food security scores and fruit and vegetable intake over three months.

The study involved 233 participants and utilized a randomized controlled design, marking Freshplace as the first food pantry intervention to be rigorously evaluated, with promising preliminary results indicating its effectiveness in promoting long-term food security and self-sufficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing the conversation about hunger: the process of developing Freshplace. Martin, K., Shuckerow, M., O'Rourke, C., et al.[2012]

Over half of the food pantry clients studied (50.5%) experienced very low food security, which was linked to lower consumption of fruits, vegetables, and fiber, indicating a significant impact on diet quality.

Despite a mean BMI of 29.5 kg/m² and women being four times more likely to be obese than men, food insecurity did not show a direct association with obesity in this group, suggesting other factors may influence weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food insecurity, poor diet quality, and obesity among food pantry participants in Hartford, CT. Robaina, KA., Martin, KS.[2022]

The FoodMate® program, an 8-week nutrition education initiative, was well-received by participants and led to long-term improvements in their cooking skills, dietary habits, and overall life satisfaction over a follow-up period of up to 2 years.

Participants reported enhanced confidence in cooking and trying new foods, indicating that such programs can effectively promote healthy eating and food independence among individuals facing food insecurity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of SecondBite® 's FoodMate® , a nutrition education and skill-building program aimed at reducing food insecurity. Stephens, LD., Smith, G., Olstad, DL., et al.[2021]

Participants in a food box program showed increased fruit and vegetable consumption, while those who left the program experienced a decline in their intake, highlighting the program's positive impact on dietary habits.

Food insecurity was linked to lower fruit and vegetable consumption, suggesting that ongoing participation in the food box program could help improve food security and nutrition for those in need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of a food box program in fruit and vegetable consumption and food security. Miewald, C., Holben, D., Hall, P.[2016]

In a study conducted at Student-run Free Clinics in San Diego, 92.5% of patients were screened for food insecurity, revealing that 74% were food insecure, including 30.7% with very low food security.

The implementation of a food insecurity screening and referral program successfully connected patients to resources, with 201 participants receiving monthly food boxes and others accessing food pantries and SNAP, highlighting the importance of addressing food insecurity in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a food insecurity screening and referral program in student-run free clinics in San Diego, California. Smith, S., Malinak, D., Chang, J., et al.[2020]

A new screening process for food insecurity was successfully implemented in a hospital setting, increasing the screening rate from just 2.2% to 61.5% over 28 weeks, demonstrating the effectiveness of integrating a validated screening tool into the nursing workflow.

Out of the patients screened, 5.8% were identified as food insecure, highlighting the importance of such screenings in connecting vulnerable patients with necessary food resources, even amidst challenges like staff turnover and the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a Process for Screening Hospitalized Adults for Food Insecurity at a Tertiary Care Center. Gore, E., DiTursi, J., Rambuss, R., et al.[2023]

Citations

1. 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 ... Rates of high food security increased to 40%. Of the 60 participants who completed both pre and post food insecurity surveys, participants in Fresh Takes ...

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

Food Insecurity and Diabetes: Overview of Intersections ... Studies show that the provision of produce and/or diabetes-appropriate packages to adults with diabetes results in improved food security, dietary intake, ...

3. cdc.gov cdc.gov/pcd/issues/2020/19_0210.htm

Food Bank–Based Diabetes Prevention Intervention to ... This intervention demonstrated that food banks can effectively screen clients at high risk for diabetes and improve household food security and other risk ...

4. trials-api.montefioreeinstein.org trials-api.montefioreeinstein.org/node/392996

An Evaluation of the Impact of Receiving Fresh Food Boxes The goal of Fresh Takes! is to help reduce food insecurity and prevent progressions to overt diabetes in patients with prediabetes and to help patients with ...

5. feedingamerica.org feedingamerica.org/sites/default/files/2024-09/HCP%20Evidence%20Review%20-%20Key%20Drivers%20to%20Improve%20Food%20Security%20and%20Health%20Outcomes_FINAL.pdf

Key Drivers to Improve Food Security and Health Outcomes Effectiveness of the Fresh Rx Program in Food Bank Clients with Chronic Disease. Journal of. Nutrition Education and Behavior, 49(7), S36-S37. doi:10.1016/j ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9790279/

The nutritional quality of food parcels provided by food banks ... Research indicates that food parcels provided by food banks are nutritionally poor. Food insecurity and the use of food banks are both rising.