Diabetes Education + Food Assistance for Type 2 Diabetes

(LIFT-DM Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if different types of food assistance, alongside diabetes education, can help people with type 2 diabetes better manage their blood sugar levels. Participants will receive either diabetes education alone or education with monthly food vouchers, stock boxes, or both. The goal is to identify which combination most effectively improves health outcomes. This trial suits African American adults with type 2 diabetes who struggle with food insecurity and meet certain income criteria.

As an unphased trial, this study offers participants the opportunity to contribute to research that could lead to improved support strategies for managing diabetes.

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.

What prior data suggests that this protocol is safe?

Research has shown that food assistance programs, such as food vouchers and stock boxes, can be safely used to help manage Type 2 Diabetes. Although studies primarily focus on the effectiveness of these programs rather than their safety, no serious side effects have been reported from using food vouchers or stock boxes.

One study on food vouchers found they did not improve diabetes control, but it also did not report any negative health effects from their use. Similarly, research on stock boxes, which are packages of food sent by mail, did not mention any harmful effects, suggesting they are safe to use.

Overall, these programs aim to support better nutrition and diabetes management, and current evidence does not indicate any safety concerns for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for type 2 diabetes because they combine diabetes education with practical food assistance, offering a holistic approach. Unlike the usual focus on medications and insulin, this approach emphasizes lifestyle and dietary changes by providing monthly food vouchers and stock boxes tailored to diabetes-friendly diets. This method not only aims to improve blood sugar control but also makes healthy eating more accessible, potentially leading to better long-term management and quality of life for individuals with diabetes.

What evidence suggests that this trial's treatments could be effective for Type 2 Diabetes?

Research has shown that teaching people about diabetes and providing food assistance can help control blood sugar in those with Type 2 diabetes. In this trial, participants will be assigned to different groups to evaluate these approaches. One group will receive only diabetes education. Another group will receive diabetes education plus monthly stock boxes of diabetes-friendly food, which studies have found can effectively manage blood sugar levels. A separate group will receive diabetes education plus monthly food vouchers. Other studies discovered that this approach didn't greatly improve diabetes control but did lead to eating more healthy foods like fruits and vegetables. The final group will receive a combination of food vouchers and food boxes along with diabetes education, which might offer the best support by making nutritious foods more accessible and improving eating habits. Overall, the mix of education and food assistance seems promising in helping people with diabetes manage their blood sugar better. ^{1 2 3 6 7}

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33166622/

Lowering the impact of food insecurity in African American ... We describe a 4-year ongoing randomized controlled trial, which will test the separate and combined efficacy of monthly food vouchers and monthly food stock ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7726093/

Lowering the Impact of Food Insecurity in African American ... The primary aim of this study is to test the separate and combined efficacy of monthly food vouchers to farmers market and monthly mailed food stock boxes ...

3. researchgate.net researchgate.net/publication/347573867_Lowering_the_impact_of_food_insecurity_in_African_American_adults_with_type_2_diabetes_mellitus_LIFT-DM_-_Study_protocol_for_a_randomized_controlled_trial

Lowering the impact of food insecurity in African American ... An ongoing RCT is evaluating the individual and combined effectiveness of food vouchers and food boxes, with and without diabetes education, ...

4. chcs.org chcs.org/media/Improving-Diabetes-Outcomes-Through-Home-Delivery-Healthy-Foods-and-Education.pdf

Improving Diabetes Outcomes Through Home-Delivered ... The pilot program aimed to improve diabetes-related outcomes among Medicaid enrollees by providing consistent access to healthy foods, education, and engagement.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12538504/

Voucher for Healthy Foods and Diabetes Control The voucher improved self-reported vegetable consumption (44.7% vs 21.5% 2 or more times per day), fruit consumption (42.6% vs 22.7% 2 or more ...

6. europepmc.org europepmc.org/article/med/33166622

Lowering the impact of food insecurity in African American ... The primary aim of this study is to test the separate and combined efficacy of monthly food vouchers to farmers market and monthly mailed food ...

7. cdc.gov cdc.gov/pcd/issues/2020/19_0210.htm

Food Bank–Based Diabetes Prevention Intervention to ... This intervention demonstrated that food banks can effectively screen clients at high risk for diabetes and improve household food security and other risk ...