Medical Nutrition Therapy and Diabetes Self-Management Education for People With Disabilities
2 other identifiers
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Jun 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2023
CompletedFirst Posted
Study publicly available on registry
September 22, 2023
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedDecember 18, 2025
December 1, 2025
1.2 years
August 24, 2023
December 11, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Glycemic Management
24 weeks
Other Outcomes (4)
Physical Activity
24 weeks
Dietary intake
24 weeks
Medication Adherence
24 weeks
- +1 more other outcomes
Study Arms (3)
Experimental: High-Tech Intervention Group
EXPERIMENTALThose 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.
Experimental: Low-Tech Intervention Group
EXPERIMENTALThose in low-tech group will receive 6 months of one weekly coaching calls (last up to 60 minutes) and one weekly email
Active Comparator: Attention Control Group
ACTIVE COMPARATORThe 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.
Interventions
Access to technological platform and weekly health coaching
Weekly email with educational content and weekly health coaching
No technology access or health coaching
Eligibility Criteria
You may qualify if:
- Diagnosis of T2DM
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Related Publications (4)
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.
PMID: 29567642BACKGROUNDHall 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.
PMID: 14501578BACKGROUNDKayes 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.
PMID: 19447843BACKGROUNDAboagye 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.
PMID: 41002071DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 24, 2023
First Posted
September 22, 2023
Study Start
June 1, 2024
Primary Completion
July 31, 2025
Study Completion
September 1, 2025
Last Updated
December 18, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share