Skip to main content
Clinical Trials/NCT06049225
NCT06049225
Completed
Not Applicable

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

University of Alabama at Birmingham1 site in 1 country90 target enrollmentJune 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
University of Alabama at Birmingham
Enrollment
90
Locations
1
Primary Endpoint
Psychological Distress
Status
Completed
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2024
End Date
September 1, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohanraj Thirumalai

Assistant Professor

University of Alabama at Birmingham

Eligibility Criteria

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

Outcomes

Primary Outcomes

Psychological Distress

Time Frame: 234 weeks

Measured using Diabetes Distress Scale (DDS); Minimum score = 1, maximum score = 6; Higher score represents worse outcome

Diabetes Quality of Life

Time Frame: 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

Time Frame: 24 weeks

Measured using Diabetes Empowerment Scale; Minimum score = 1; maximum score = 5; Higher score represents better outcome

Secondary Outcomes

  • Glycemic Management(24 weeks)

Study Sites (1)

Loading locations...

Similar Trials