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| ID | Type | Description | Link |
|---|---|---|---|
| SBIR-PHASE2 | Other Identifier | Kamin Consulting Inc |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Tech | Behavioral | Access to technological platform and weekly health coaching |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Management | Measured using HbA1c | 24 weeks |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29567642 | Background | 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. | |
| 14501578 | Background | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Low-Tech | Behavioral | Weekly email with educational content and weekly health coaching |
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| Attention Control | Behavioral | No technology access or health coaching |
|
| 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 |
| 19447843 | Background | 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. |
| 41002071 | Derived | 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. |
| D004700 | Endocrine System Diseases |