Type 2 DiabetesNCT06049225
Medical Nutrition Therapy and Diabetes Self-Management Education for People With Disabilities
A study testing High-Tech and Low-Tech in people with Type 2 Diabetes and Physical Disability, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes, Physical Disability
- What is being tested?
- High-Tech and Low-Tech
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes, Physical Disability
- Being tested
- High-Tech, Low-Tech, Attention Control
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-TechBehavioural
Access to technological platform and weekly health coaching
Low-TechBehavioural
Weekly email with educational content and weekly health coaching
Attention ControlBehavioural
No technology access or health coaching
| Study group | Role | What they receive |
|---|---|---|
| Experimental: High-Tech Intervention Group | Experimental | 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. Receives: Behavioral: High-Tech |
| Experimental: Low-Tech Intervention Group | Experimental | Those in low-tech group will receive 6 months of one weekly coaching calls (last up to 60 minutes) and one weekly email Receives: Behavioral: Low-Tech |
| Active Comparator: Attention Control Group | Active comparator | 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. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 weeks
Psychological Distress
Measured using Diabetes Distress Scale (DDS); Minimum score = 1, maximum score = 6; Higher score represents worse outcome
Measured: 234 weeks
Self-efficacy
Measured using Diabetes Empowerment Scale; Minimum score = 1; maximum score = 5; Higher score represents better outcome
Measured: 24 weeks
Secondary outcomes (1)
Glycemic Management
Measured using HbA1c
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Jun 2024
- Primary completion31 Jul 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohanraj Thirumalai, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049225
- Sponsor's protocol ID
- IRB-300010728
- Other IDs
- SBIR-PHASE2
- Status last verified
- Dec 2025
- First submitted
- 24 Aug 2023
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29567642Hall 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.
PubMed 14501578Kayes 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.
PubMed 19447843Aboagye 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.
PubMed 41002071
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Nutrition Therapy and Diabetes Self-Management Education for People With Disabilities
- ClinicalTrials.gov ID
- NCT06049225
- Acronym / sponsor ID
- IRB-300010728
- Conditions
- Type 2 Diabetes, Physical Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: High-Tech Intervention Group | Experimental | Behavioral: High-TechThose 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 | Experimental | Behavioral: Low-TechThose 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 comparator | Behavioral: Attention ControlThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-TechAccess to technological platform and weekly health coaching | Behavioural | Experimental: High-Tech Intervention Group |
| Low-TechWeekly email with educational content and weekly health coaching | Behavioural | Experimental: Low-Tech Intervention Group |
| Attention ControlNo technology access or health coaching | Behavioural | Active Comparator: Attention Control Group |
Primary 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
Psychological Distress
Time frame: 234 weeks
Measured using Diabetes Distress Scale (DDS); Minimum score = 1, maximum score = 6; 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
1 secondary outcome
Glycemic Management
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Background: PubMed 29567642American 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.
- Background: PubMed 14501578Hall 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.
- Background: PubMed 19447843Kayes 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.
- Derived from this study: PubMed 41002071Aboagye 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Tech and Low-Tech in people with Type 2 Diabetes and Physical Disability, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Quality of Life (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06049225, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.