300 Participants Needed

Diabetes Education + Food Assistance for Type 2 Diabetes

(LIFT-DM Trial)

Recruiting at 1 trial location
EM
Overseen ByElise Mosley-Johnson, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: State University of New York at Buffalo
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing different ways to help low-income African Americans with Type 2 Diabetes manage their blood sugar. It combines diabetes education with either food vouchers, mailed food boxes, or both. The goal is to see if these methods improve blood sugar control better than education alone.

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 food assistance and education for managing diabetes.

Is the combination of diabetes education and food assistance safe for humans?

The research articles reviewed do not provide specific safety data for the combination of diabetes education and food assistance. However, diabetes education programs are generally considered safe as they focus on improving dietary habits and managing diabetes effectively.12345

How does the Diabetes Education + Food Assistance treatment differ from other treatments for type 2 diabetes?

This treatment is unique because it combines diabetes education with food assistance, providing monthly food vouchers and stock boxes to help manage diabetes through better nutrition, which is not a standard component of most diabetes treatments.56789

What data supports the effectiveness of the treatment Diabetes Education + Food Assistance for Type 2 Diabetes?

Research shows that diabetes education programs can improve dietary habits, such as reducing calorie and fat intake, which are important for managing Type 2 diabetes. Additionally, offering vouchers for healthy food has been suggested to increase the completion of diabetes self-management education, potentially enhancing the effectiveness of the treatment.15101112

Who Is on the Research Team?

RJ

Rebekah J Walker, PhD

Principal Investigator

State University of New York at Buffalo

LE

Leonard E Egede, MD

Principal Investigator

State University of New York at Buffalo

Are You a Good Fit for This Trial?

This trial is for African American adults with Type 2 Diabetes who are experiencing food insecurity, have an income at or below 133% of the federal poverty level or are Medicaid eligible, and can communicate in English. Participants must be over 21 years old with a clinical diagnosis of diabetes and HbA1c levels >=8%. Those with drug/alcohol dependency, short life expectancy, significant dementia, active psychosis, or involvement in other diabetes trials cannot join.

Inclusion Criteria

Income <=133% of federal poverty level based on household income and size of household or Medicaid eligible
Able to communicate in English
You must be 21 years old or older.
See 3 more

Exclusion Criteria

You have a problem with drinking too much alcohol or using drugs.
You are expected to live less than 12 months.
You have significant memory problems or confusion during the interview.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive diabetes education and food supplementation (vouchers and/or stock boxes) for 12 months

12 months
Monthly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Diabetes Education Only
  • Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes
  • Diabetes Education Plus Monthly Food Vouchers
  • Diabetes Education Plus Monthly Stock Boxes
Trial Overview The LIFT-DM study is testing whether monthly mailed stock boxes of food or monthly food vouchers improve blood sugar control better than just diabetes education alone. It's also checking if combining both stock boxes and vouchers has a superior effect. Participants will be randomly assigned to one of four groups: only education; education plus stock boxes; education plus vouchers; or all three combined.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: Group 4 -- Diabetes Education Plus Combination of Monthly FoodExperimental Treatment1 Intervention
Group II: Group 3 - Diabetes Education Plus Monthly Stock BoxesExperimental Treatment1 Intervention
Group III: Group 2 - Diabetes Education Plus Monthly Food VouchersExperimental Treatment1 Intervention
Group IV: Group 1- Diabetes Education OnlyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials
279
Recruited
52,600+

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+

Published Research Related to This Trial

In a study involving 78 type II diabetic outpatients, both nutrition education programs led to significant improvements in dietary goals compared to a control group, indicating their effectiveness in managing diabetes through dietary changes.
However, the addition of a social learning component did not provide any additional benefits over the standard nutrition education program, and there were minimal differences in long-term outcomes like weight or blood sugar levels.
Nutrition education and social learning interventions for type II diabetes.Glasgow, RE., Toobert, DJ., Mitchell, DL., et al.[2019]
The nutrient-based diet guide method was found to be as easy to use as the food-group exchange lists method for menu planning in individuals with noninsulin-dependent diabetes, with 97 out of 105 participants completing the workshops and 83 attending the 6-month follow-up.
Participants using the diet guide method showed significantly greater improvements in nutrition knowledge retention compared to those using the exchange lists method, with a 24% increase in knowledge at 3 months versus 15% for the exchange group.
Educating patients with diabetes: comparison of nutrient-based and exchange group methods.Kendall, PA., Jansen, GR.[2015]
A structured interactive group education program for 150 patients with type 2 diabetes led to significant reductions in HbA1c levels at 12 and 24 months, indicating improved blood sugar control.
Patients with a shorter duration of diabetes were more likely to benefit from the education program, suggesting that early intervention is crucial for maximizing the effectiveness of diabetes education.
Targeting educational therapy for type 2 diabetes: identification of predictors of therapeutic success.da Vico, L., Monami, M., Biffi, B., et al.[2022]

Citations

Nutrition education and social learning interventions for type II diabetes. [2019]
[Experience in educational information for diabetics and their families]. [2015]
Potential Effect of Vouchers on the Completion of Self-management Education Among Patients With Diabetes. [2021]
Does an advanced insulin education programme improve outcomes and health service use for people with Type 2 diabetes? A 5-year follow-up of the Newcastle Empowerment course. [2022]
Educating patients with diabetes: comparison of nutrient-based and exchange group methods. [2015]
A survey of diabetic educators and patients for the revision of korean food exchange lists. [2021]
Reducing the burden of diabetes. The National Diabetes Education Program. [2019]
National Diabetes Education Program: opportunities and challenges. The National Diabetes Education Program Strategic Planning Committee. [2019]
The healthy diabetes plate. [2022]
The effect of intervention using the PRECEDE-PROCEED model based on quality of life in diabetic patients. [2020]
Evaluation of a structured educational programme for type 2 diabetes patients seen in private practice. [2008]
Targeting educational therapy for type 2 diabetes: identification of predictors of therapeutic success. [2022]
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