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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Type 2 Diabetes, Physical Disability

Intervention / Treatment
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* Behavioral: High-Tech
* Behavioral: Low-Tech
* Behavioral: Attention Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of T2DM 18 to 65 years of age Living with a permanent physical disability such as SCI, spina bifida, multiple sclerosis, stroke Ability to converse in and read English Availability of a smartphone or computer that can run apps Have internet connection capabilities Exclusion Criteria: Current enrollment in any diabetes related intervention Present or soon-planned pregnancy Major heart attack or heart surgery in the past 12 months Have undergone a dialysis, kidney transplant or a kidney surgery in the past 12 months Severe cognitive impairment Severe untreated depression in the past 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: High-Tech Intervention Group<br>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. | Behavioral: High-Tech<br>* Access to technological platform and weekly health coaching<br>|
| Experimental: Experimental: Low-Tech Intervention Group<br>Those in low-tech group will receive 6 months of one weekly coaching calls (last up to 60 minutes) and one weekly email | Behavioral: Low-Tech<br>* Weekly email with educational content and weekly health coaching<br>|
| Active Comparator: Active Comparator: Attention Control Group<br>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. | Behavioral: Attention Control<br>* No technology access or health coaching<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes Quality of Life | Measured using the DQoL (Diabetes Quality of Life Measure) Questionnaire; Minimum score =1; maximum score = 5; Higher score represents worse outcome | 24 weeks | 
| Psychological Distress | Measured using Diabetes Distress Scale (DDS); Minimum score = 1, maximum score = 6; Higher score represents worse outcome | 234 weeks | 
| Self-efficacy | Measured using Diabetes Empowerment Scale; Minimum score = 1; maximum score = 5; Higher score represents better outcome | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Management | Measured using HbA1c | 24 weeks |