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Behavioural Intervention

Eat Well Produce Benefit for Diabetes

N/A
Recruiting
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are at risk for food insecurity as defined by one of the following: 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), 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), has Medicaid as insurance payer, lives in Area Deprivation Index (ADI) zip code of 7th decile or harder
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months pre program, during program enrollment, and up to 18 months post program
Awards & highlights

Study Summary

This trial tests if a food program can help diabetes patients manage their health & reduce emergency visits. Participants get gift/debit cards & nutrition materials. Researchers compare their outcomes with those only receiving materials.

Who is the study for?
This trial is for diabetes patients who struggle with getting enough food (food insecurity). They must have been active in the Duke Diabetes Registry within the past year and had at least one outpatient A1c measurement. There are no specific exclusion criteria, so a wide range of individuals facing these challenges may qualify.Check my eligibility
What is being tested?
The 'Eat Well' program provides participants with gift/debit cards to buy fruits and vegetables plus educational nutrition materials. The study compares these participants against those only receiving education to see if there's an improvement in blood sugar control (Hb A1c levels) and fewer emergency visits up to 18 months after finishing the program.See study design
What are the potential side effects?
Since this intervention involves dietary changes through increased access to healthy foods rather than medication, typical drug side effects aren't expected. However, changes in diet can sometimes lead to digestive adjustments or food sensitivities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am at risk of not having enough food due to financial issues or where I live.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months pre program, during program enrollment, and up to 18 months post program
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months pre program, during program enrollment, and up to 18 months post program for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in HbA1C
Change in number of ED Visits
Secondary outcome measures
Change in blood pressure
Change in body mass index (BMI)
Change in cholesterol
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Eat WellExperimental Treatment1 Intervention
The experimental group will participate in the Eat Well Produce Prescription program, receiving an $80 monthly benefit for eligible produce for 12 months and diabetes education materials through email, including curated nutrition and diet information from the Diabetes Resource Page, consistent with standard of care at Duke University Health System.
Group II: ControlActive Control1 Intervention
The control group will receive usual care (including diabetes educational materials) without the prescription benefit.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,417,069 Total Patients Enrolled
14 Trials studying Diabetes
35,560 Patients Enrolled for Diabetes

Media Library

Eat Well (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05896644 — N/A
Diabetes Research Study Groups: Control, Eat Well
Diabetes Clinical Trial 2023: Eat Well Highlights & Side Effects. Trial Name: NCT05896644 — N/A
Eat Well (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05896644 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current expected size of this clinical research program?

"Confirmed. According to the information hosted on clinicaltrials.gov, this medical study is presently recruiting participants and was initially posted in June 20th 2023 with a recent update on 6/23/2023. 3000 patients are needed from 1 location for the trial to be successful."

Answered by AI

Is this investigation currently recruiting participants?

"Data hosted on clinicaltrials.gov confirms that this is an ongoing study, which was initially posted on June 20th of 2021 and recently edited on the 23rd. Candidates are currently being sought for participation."

Answered by AI
~273 spots leftby Jun 2024