Medical Nutrition Therapy and Diabetes Self-Management Education for People With Disabilities

The University of Alabama at Birmingham

Status: Completed

Conditions: Physical Disability; Type 2 Diabetes

Treatments: Behavioral: High-Tech; Behavioral: Low-Tech; Behavioral: Attention Control

Study type: Interventional

Funder types: Other

Identifiers

NCT06049225

IRB-300010728

SBIR-PHASE2 (Other Identifier)

Details and patient eligibility

About

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.

Full description

This study will use a three-arm randomized control trial design. Eligible and consented participants will be assigned to one of three groups: (1) intervention with high-tech support, (2) intervention with low-tech support, and (3) attention-control group. The active intervention period will include six months of weekly health coaching calls and technology access. The low-tech support group will receive six months of weekly coaching calls and weekly email containing related materials in PDF format but no video and technology content.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of T2DM
2. 18 to 65 years of age
3. Living with a permanent physical disability such as SCI, spina bifida, multiple sclerosis, stroke
4. Ability to converse in and read English
5. Availability of a smartphone or computer that can run apps
6. Have internet connection capabilities

Exclusion criteria

1. Current enrollment in any diabetes related intervention
2. Present or soon-planned pregnancy
3. Major heart attack or heart surgery in the past 12 months
4. Have undergone a dialysis, kidney transplant or a kidney surgery in the past 12 months
5. Severe cognitive impairment
6. Severe untreated depression in the past 6 months

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Experimental: High-Tech Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: High-Tech

Experimental: Low-Tech Intervention Group

Experimental group

Description:

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

Treatment:

Behavioral: Low-Tech

Active Comparator: Attention Control Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Attention Control