Medical Nutrition Therapy and Diabetes Self-Management Education for People With Disabilities
NCT ID: NCT06049225
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
90 participants
INTERVENTIONAL
2024-06-01
2025-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
High-Tech
Access to technological platform and weekly health coaching
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
Low-Tech
Weekly email with educational content and weekly health coaching
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.
Attention Control
No technology access or health coaching
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
High-Tech
Access to technological platform and weekly health coaching
Low-Tech
Weekly email with educational content and weekly health coaching
Attention Control
No technology access or health coaching
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Alabama at Birmingham
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mohanraj Thirumalai
Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SBIR-PHASE2
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-300010728
Identifier Type: -
Identifier Source: org_study_id