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Completed

NCT Number: NCT06049225

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Physical Disability

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-Tech

Behavioral

Access to technological platform and weekly health coaching

Low-Tech

Behavioral

Weekly email with educational content and weekly health coaching

Attention Control

Behavioral

No technology access or health coaching

Primary outcomes

  1. 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

  2. Psychological Distress

    Time frame: 234 weeks

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

  3. Self-efficacy

    Time frame: 24 weeks

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

Secondary outcomes

  1. Glycemic Management

    Time frame: 24 weeks

    Measured using HbA1c

Other outcomes

  1. Physical Activity

    Time frame: 24 weeks

    Measured using Godin leisure-time exercise questionnaire; Minimum score = 0; Maximum score = unknown; Higher score represents better outcome

  2. Dietary intake

    Time frame: 24 weeks

    Measured using The US version of the Diabetes and Diet Questionnaire

  3. Medication Adherence

    Time frame: 24 weeks

    Measured using the Medication Adherence Rating Scale

  4. Health Dashboard Usability

    Time frame: 24 weeks

    Measured using the System Usability Scale; Maximum item score (Strongly agree) = 5, minimum item score (Strongly disagree) = 1; Higher scores represent better outcomes

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2023
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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