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

90 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this project is to develop, and pilot test an accessible and inclusive medical nutrition therapy and diabetes self-management education program for people with Type 2 Diabetes and physical disabilities.

Eligibility Criteria

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.

I live with a permanent physical disability like SCI or MS.

Timeline

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

Treatment Details

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.

Participant Groups

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+