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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Physical Disability
• Intervention / Treatment: Behavioral: High-Tech; Behavioral: Low-Tech; Behavioral: Attention Control

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: High-Tech Intervention Group; 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; Access to technological platform and weekly health coaching
Experimental: Experimental: Low-Tech Intervention Group; 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; Weekly email with educational content and weekly health coaching
Active Comparator: Active Comparator: Attention Control Group; 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; No technology access or health coaching

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity	Measured using Godin leisure-time exercise questionnaire; Minimum score = 0; Maximum score = unknown; Higher score represents better outcome	24 weeks
Dietary intake	Measured using The US version of the Diabetes and Diet Questionnaire	24 weeks
Medication Adherence	Measured using the Medication Adherence Rating Scale	24 weeks
Health Dashboard Usability	Measured using the System Usability Scale; Maximum item score (Strongly agree) = 5, minimum item score (Strongly disagree) = 1; Higher scores represent better outcomes	24 weeks

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Publications and helpful links

General Publications

• American Diabetes Association. Economic Costs of Diabetes in the U.S. in 2017. Diabetes Care. 2018 May;41(5):917-928. doi: 10.2337/dci18-0007. Epub 2018 Mar 22.
• Hall L, Colantonio A, Yoshida K. Barriers to nutrition as a health promotion practice for women with disabilities. Int J Rehabil Res. 2003 Sep;26(3):245-7. doi: 10.1097/00004356-200309000-00013.
• Kayes NM, Schluter PJ, McPherson KM, Taylor D, Kolt GS. The Physical Activity and Disability Survey -- Revised (PADS-R): an evaluation of a measure of physical activity in people with chronic neurological conditions. Clin Rehabil. 2009 Jun;23(6):534-43. doi: 10.1177/0269215508101750. Epub 2009 May 15.
• Aboagye A, Peckham J, Hearld KR, Abdullah S, Thirumalai M. A Technology-Enhanced Medical Nutrition Therapy and Diabetes Self-Management Education for Adults With Disability and Type 2 Diabetes: Protocol for a Pilot and Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 26;14:e71495. doi: 10.2196/71495.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: IRB-300010728; SBIR-PHASE2 (Other Identifier: Kamin Consulting Inc)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No