CompletedNot Applicable

Eat Well Produce Benefit for Diabetes and Food Insecurity

United States2,177 participantsStarted 2023-06-20

Plain-language summary

The goal of this clinical trial is to assess the impact of participation in Eat Well for diabetes patients who are at risk of food insecurity. The main questions it aims to answer are: * whether there is a difference in Haemoglobin (Hb) A1c measurements and emergency department (ED) utilization between the Eat Well and control groups up to 18 months post-program completion. * whether there are differences in cardiometabolic health-related outcomes for Eat Well participants. Participants in the program will receive gift/debit cards for fruits and vegetables and educational nutrition materials. Researchers will compare Eat Well participants with those only receiving educational materials to see if there are differences in cardiometabolic health outcomes.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. answered often true or sometimes true on one or both of the food insecurity questions as part of the electronic health record social history section (Maestro Care/ Epic of Verona WI) OR
. answered hard or very hard to the financial stress question as part of the electronic health record social history section (Maestro Care/ Epic of Verona WI) OR
. has Medicaid as insurance payer OR
. lives in Area Deprivation Index (ADI) zip code of 7th decile or harder

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in HbA1C

Timeframe: 18 months pre program, during program enrollment, up to 12 months

Change in number of ED Visits

Timeframe: up to 18 months pre program, during program enrollment, up to 12 months

Trial details

NCT IDNCT05896644

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-16

View on ClinicalTrials.gov More Diabetes Mellitus trials