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| ID | Type | Description | Link |
|---|---|---|---|
| 2025P011698 | Other Identifier | Emory IRB | |
| P30DK111024 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Georgia Center for Diabetes Translation Research | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The goals of this study are to:
Participants will be asked to:
Diabetes poses a significant public health challenge in the U.S., affecting approximately 37 million people, or 11% of the population. The prevalence is rising, particularly among youth, with a forecasted 700% increase in type 2 diabetes cases by 2060. Diabetes leads to severe health complications, including increased risks of heart attacks, strokes, and kidney failure, and affects nearly 1 million people worldwide with vision loss. Many individuals struggle to manage their diabetes effectively; only about 50% achieve proper glycemic control.
Diabetes self-management education is crucial for improving self-efficacy and adherence to treatment, yet only 5-7% of eligible patients receive this education. The American Diabetes Association advocates for individualized nutrition therapy, but access remains limited, especially for uninsured populations, exacerbating health disparities.
To address this gap, a novel word game-based workbook is proposed to enhance diabetes self-efficacy. This workbook can be used in waiting rooms or at home, offering an engaging way to learn about diabetes management through word games and puzzles. It aims to provide accessible education for underserved communities, improve glycemic control, and ultimately reduce diabetes-related disparities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes self management | Experimental | Eligible participants will utilize the workbook for a span of 3 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes self management workbook | Behavioral | The diabetes self-management workbook section used in this pilot study will focus on diet management, specifically carbohydrates, following ADA guidelines. It will include exercises based on the ADA diabetes plate method, aimed at helping subjects understand meal planning, food categories, portion sizes, goal setting, and the impact of foods on blood glucose levels. Activities will include word searches, crosswords, and goal-setting exercises. Subjects will begin the first section during a clinic visit. They can complete the workbook at home over three months, with input from subjects and Certified Diabetes Care and Education Specialists to refine the content. |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes self-efficacy score (Diabetes management self-efficacy (DMSE) | Measures the confidence of patients with diabetes regarding diet, exercise and medical treatment) | Pre test, post test (3months) |
| Knowledge of American Diabetes Association (ADA) diabetes plate method | The ADA diabetes plate method is a meal planning tool that divides a plate into three sections: half for non-starchy vegetables, one-quarter for lean protein, and one-quarter for whole grains or starchy foods. It helps individuals with diabetes control portions and manage carbohydrate intake for better blood glucose control. | Pre test, post test (3months) |
| Acceptability of Intervention Measure (AIM) | The Acceptability of Intervention Measure (AIM) is a tool used to assess how acceptable an intervention is to participants. The AIM is a 4-item instrument that uses a 5-point Likert scale | Pre test, post test (3months) |
| Feasibility of Intervention Measure (FIM) | The Feasibility of Intervention Measure (FIM) is a tool used to assess the perceived feasibility of an intervention. The FIM is a 4-item instrument that uses a 5-point Likert scale. | Pre test, post test (3months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c | HbA1c, or glycated hemoglobin, measures average blood glucose levels over the past two to three months. It's expressed as a percentage, with higher values indicating poorer blood sugar control | Pre test, post test (3months) |
| Change in Weight |
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Inclusion Criteria:
Focus group inclusion:
Focus group exclusion:
Aim 2 inclusion criteria:
Aim 2 exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Park, MD | Emory University | Principal Investigator |
| Saria Hassan, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Midtown Clinic | Atlanta | Georgia | 30329 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 10, 2025 | Dec 22, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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The workbook will be designed with the help of 5 focus group discussions. Five focus groups will include participants from one of the following categories: patients, caregivers, providers, and diabetes educators. Each focus group will have 6-10 participants.
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Change in Weight over the course of study. |
| Pre test, post test (3months) |
| Change in Blood Pressure | Change in Blood Pressure over the course of study. | Pre test, post test (3months) |