What side effects are associated with this type of intervention?

Dietary interventions for diabetes, such as those involving increased intake of fruits and vegetables, generally have minimal side effects but may include gastrointestinal discomfort like bloating or gas due to increased fiber intake. Educational programs aimed at improving dietary habits and knowledge typically do not have direct side effects but require patient engagement and adherence to be effective. Pharmacological treatments, such as metformin, can cause gastrointestinal issues like nausea and diarrhea, while insulin therapy may lead to hypoglycemia and weight gain. Overall, lifestyle interventions are considered safe and beneficial for managing diabetes.

What prior FDA approvals exist?

The FDA has approved various medications for the treatment of diabetes, including insulin, metformin, GLP-1 receptor agonists, and SGLT2 inhibitors. However, specific FDA approvals for programs similar to the Eat Well Program, which focuses on dietary improvements and educational interventions, are not well-documented. Broadly, dietary management and patient education are recognized as essential components of diabetes care. Programs that provide nutritional guidance and support, such as the Diabetes Prevention Program (DPP), have shown effectiveness in managing and preventing diabetes through lifestyle changes, including diet and exercise.

What other types of research exist?

Promising alternatives to the Eat Well Program for diabetes patients include: 1) The Women's Health Initiative dietary intervention, which focuses on behavioral and nutritional modifications to decrease fat and increase vegetable, fruit, and grain intake. 2) The Fruit and Vegetable Prescription (FVRx) Program, which combines produce prescriptions, nutrition education, and health screenings. 3) The FQHC-based farmers' market intervention, which provides financial incentives to improve fruit and vegetable intake. 4) The EatSmart program, a web-based and mobile-delivered healthy eating behavior change program designed for disadvantaged individuals with Type 2 Diabetes.

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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

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

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months pre program, during program enrollment, and up to 18 months post program

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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for diabetes, particularly those focusing on dietary interventions, include the provision of healthy foods and educational materials to improve dietary habits and knowledge. The mechanism of action involves increasing the intake of fruits and vegetables, which are high in fiber and low in glycemic index, thereby helping to regulate blood sugar levels. Educational materials enhance patients' understanding of nutrition, empowering them to make healthier food choices. This approach is crucial for diabetes patients as it directly impacts glycemic control, reduces the risk of complications, and improves overall health outcomes.

Effectiveness of Health Coaching in Diabetes Control and Lifestyle Improvement: A Randomized-Controlled Trial.Multicomponent approaches to promoting healthy behaviours in people with Type 2 diabetes: an integrative review.Effectiveness of a self-management support program for type 2 diabetes patients in the first years of illness: Results from a randomized controlled trial.

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Who is running the clinical trial?

Duke UniversityLead Sponsor

2,394 Previous Clinical Trials

3,056,486 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

~1440 spots leftby Jul 2025

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