Diabetes Education + Food Assistance for Type 2 Diabetes

(LIFT-DM Trial)

Recruiting at 1 trial location

Overseen By Elise Mosley-Johnson, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: Dementia, Other trials, Substance abuse, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

300 Participants Needed

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. ^{1 2 3 4 5}

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. ^{5 6 7 8 9}

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. ^{1 5 10 11 12}

Who Is on the Research Team?

Rebekah J Walker, PhD

Principal Investigator

State University of New York at Buffalo

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.

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.

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?

Group I: Group 4 -- Diabetes Education Plus Combination of Monthly Food Experimental Treatment 1 Intervention

Individuals assigned to this group will receive diabetes education and skills training, monthly food vouchers for use at local Farmer's markets mailed to their home, and monthly stock boxes with diabetes appropriate food items mailed to their home.

Group II: Group 3 - Diabetes Education Plus Monthly Stock Boxes Experimental Treatment 1 Intervention

Individuals assigned to this group will receive diabetes education and skills training and monthly stock boxes with diabetes appropriate food items mailed to their home.

Group III: Group 2 - Diabetes Education Plus Monthly Food Vouchers Experimental Treatment 1 Intervention

Individuals assigned to this group will receive diabetes education and skills training and monthly food vouchers for use at local Farmer's markets mailed to their home.

Group IV: Group 1- Diabetes Education Only Active Control 1 Intervention

Individuals assigned to this group will receive diabetes education and skills training but will not receive food supplementation.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting educational therapy for type 2 diabetes: identification of predictors of therapeutic success. da Vico, L., Monami, M., Biffi, B., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Nutrition education and social learning interventions for type II diabetes. [2019]

2. Italy pubmed.ncbi.nlm.nih.gov

[Experience in educational information for diabetics and their families]. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Potential Effect of Vouchers on the Completion of Self-management Education Among Patients With Diabetes. [2021]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

Educating patients with diabetes: comparison of nutrient-based and exchange group methods. [2015]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

A survey of diabetic educators and patients for the revision of korean food exchange lists. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Reducing the burden of diabetes. The National Diabetes Education Program. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

National Diabetes Education Program: opportunities and challenges. The National Diabetes Education Program Strategic Planning Committee. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

The healthy diabetes plate. [2022]

10. Iran pubmed.ncbi.nlm.nih.gov

The effect of intervention using the PRECEDE-PROCEED model based on quality of life in diabetic patients. [2020]

11. France pubmed.ncbi.nlm.nih.gov

Evaluation of a structured educational programme for type 2 diabetes patients seen in private practice. [2008]

12. Germany pubmed.ncbi.nlm.nih.gov

Targeting educational therapy for type 2 diabetes: identification of predictors of therapeutic success. [2022]