Nutrition and Education for Type 2 Diabetes with Disabilities

Overseen By Mohanraj Thirumalai

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Pregnancy, Heart issues, Kidney issues, others

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

Compensation: Varies

Number of Visits: 24

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program designed to assist individuals with Type 2 Diabetes who also have physical disabilities. The program emphasizes medical nutrition therapy (a dietary approach to manage diabetes) and diabetes self-management education to enhance daily health management. Participants will be divided into groups: some will receive weekly coaching calls and tech support, while others will serve as a comparison group without these interventions. Ideal candidates have Type 2 Diabetes, a physical disability such as spinal cord injury or multiple sclerosis, and access to a smartphone or computer with internet.

As an unphased trial, this study provides participants the chance to contribute to innovative diabetes care approaches tailored for those with physical disabilities.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this medical nutrition therapy and diabetes self-management education program is safe?

Research has shown that diabetes self-management education (DSME) and medical nutrition therapy (MNT) are safe and effective for individuals with Type 2 Diabetes. These methods improve blood sugar levels and reduce the risk of other diabetes-related health issues. The programs teach individuals to manage their diabetes through diet and lifestyle changes.

Importantly, DSME and MNT are well-tolerated, with no major reports of negative effects. They are designed to promote healthier choices without causing harm.

Overall, DSME and MNT are considered safe and beneficial for managing Type 2 Diabetes, especially when provided by trained professionals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they focus on combining Medical Nutrition Therapy (MNT) and Diabetes Self-Management Education (DSME) in innovative ways to help individuals with Type 2 Diabetes and disabilities. Unlike standard treatments that often rely heavily on medication or insulin therapy, these interventions emphasize education and personalized nutrition coaching. The low-tech group offers weekly coaching calls and emails, making support accessible without advanced technology. Meanwhile, the high-tech group integrates digital tools with health coaching, potentially enhancing engagement and personalized care. These strategies aim to empower patients with knowledge and skills, addressing both dietary and self-management aspects in a comprehensive manner.

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

Research has shown that both Medical Nutrition Therapy (MNT) and Diabetes Self-Management Education (DSME) can effectively help people manage Type 2 Diabetes. Studies have found that DSME helps control blood sugar levels and lowers the risk of complications. This trial will compare different methods of delivering these programs. Participants in the high-tech intervention group will receive technology access alongside weekly health coaching calls, while those in the low-tech intervention group will receive weekly coaching calls and emails. Previous findings suggest that individuals using these educational and nutritional strategies improve their diabetes management. Overall, strong evidence supports these therapies in managing Type 2 Diabetes. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with Type 2 Diabetes who also have a permanent physical disability like spinal cord injury, spina bifida, multiple sclerosis, or stroke. Participants must be able to communicate and read in English and have access to a smartphone or computer with internet for app use.

Inclusion Criteria

I have been diagnosed with type 2 diabetes.

You possess the capacity to both converse and read English.

You possess a smartphone or computer capable of running applications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly health coaching calls and content delivery for 6 months

24 weeks

24 weekly calls (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term Follow-up

Participants are monitored for psychological distress and diabetes quality of life

234 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Medical Nutrition Therapy and Diabetes Self-Management Education

Trial Overview The study aims to test an accessible medical nutrition therapy and diabetes self-management education program tailored for people with Type 2 Diabetes and physical disabilities. It compares high-tech (app-based), low-tech (non-app-based), and attention control methods.

How Is the Trial Designed?

Group I: Experimental: Low-Tech Intervention Group Experimental Treatment 1 Intervention

Those in low-tech group will receive 6 months of one weekly coaching calls (last up to 60 minutes) and one weekly email

Group II: Experimental: High-Tech Intervention Group Experimental Treatment 1 Intervention

Those in the high-tech intervention group will receive 6 months of active intervention (up to 60 minutes weekly health coaching calls and content delivery) and technology access.

Group III: Active Comparator: Attention Control Group Active Control 1 Intervention

The control group will be used to provide an untreated comparison for the intervention groups and will not receive MNT or technology support. Participants in the control arm will only get a baseline and post-intervention testing.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41002071/

A Technology-Enhanced Medical Nutrition Therapy and ... Conclusions: Effective self-management in DM is important to reduce complications. Using technology to deliver MNT and DSME could serve as an ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06049225

Medical Nutrition Therapy and Diabetes Self-Management ... The purpose of this project is to develop, and pilot test an accessible and inclusive medical nutrition therapy and diabetes self-management education program ...

3. researchprotocols.org researchprotocols.org/2025/1/e71495

A Technology-Enhanced Medical Nutrition Therapy and ... Objective: This study aims to evaluate the impact of different levels of technology on the delivery of MNT and DSME among persons with ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2212267218313133

Diabetes Self-Management Education and Medical ... Diabetes self-management education (DSME) and medical nutrition therapy (MNT) improve glycemic control and reduce risk of chronic comorbid disease. Objective.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8129774/

Effectiveness of diabetes self-management education (DSME ... In conclusion, diabetes self-management education intervention has been shown to be effective in dealing with type 2 diabetes mellitus. Furthermore, DSME has a ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30219311/

Diabetes Self-Management Education and Medical ... Diabetes self-management education (DSME) and medical nutrition therapy (MNT) improve glycemic control and reduce risk of chronic comorbid disease.

7. diabetesjournals.org diabetesjournals.org/care/article/45/2/484/140905/2022-National-Standards-for-Diabetes-Self

2022 National Standards for Diabetes Self-Management ... Numerous studies have proven the benefits of DSMES, which include improved clinical outcomes and quality of life, while reducing ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1751991819301445

The health effects of medical nutrition therapy by dietitians ... This systematic review and meta-analysis found evidence to support incorporating medical nutrition therapy as a central component of the management of diabetes ...