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

Not Applicable

Active, not recruiting

• Conditions: Type 2 Diabetes; Physical Disability
• Interventions: Behavioral: High-Tech; Behavioral: Attention Control; Behavioral: Low-Tech

• Registration Number: NCT06049225
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-08-24
• Study First Submitted QC: 2023-09-14
• Study First Posted: 2023-09-22
• Status Verified: 2024-06
• Study Start: 2024-06-01
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-26
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: High-Tech Intervention Group	High-Tech	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.
Active Comparator: Attention Control Group	Attention Control	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.
Experimental: Low-Tech Intervention Group	Low-Tech	Those in low-tech group will receive 6 months of one weekly coaching calls (last up to 60 minutes) and one weekly email

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Glycemic Management	24 weeks	Measured using HbA1c

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States