Emory Midtown Clinic
Atlanta, Georgia, 30329, United States
NCT Number: NCT06695533
The goals of this study are to:
1. Co-develop a user-friendly word game-based workbook format for patients with diabetes to understand how to manage their diabetes. For this study, the first section of the workbook will be developed to teach carbohydrate management. 2. Assess the feasibility and acceptability of the workbook. 3. Understand the implementation challenges that will be important for improving the workbook and preparing it for larger-scale effectiveness research.
Participants will be asked to:
* Complete the workbook during their waiting time in the clinic or at home. * Engage in word games designed to teach diabetes management vocabulary and concepts. * Attend follow-up sessions to assess changes in self-efficacy and glycemic control.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Atlanta, Georgia, 30329, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Focus group inclusion:
Focus group exclusion:
Aim 2 inclusion criteria:
Aim 2 exclusion criteria:
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.
Time frame: Pre test, post test (3months)
Measures the confidence of patients with diabetes regarding diet, exercise and medical treatment)
Time frame: Pre test, post test (3months)
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.
Time frame: Pre test, post test (3months)
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
Time frame: Pre test, post test (3months)
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.
Time frame: Pre test, post test (3months)
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
Time frame: Pre test, post test (3months)
Change in Weight over the course of study.
Time frame: Pre test, post test (3months)
Change in Blood Pressure over the course of study.
Emory University
Other
"I Can Do This! Managing My Diabetes: A Pilot Project Using a Novel Word Game-based Workbook Intervention to Allow People Living With Diabetes to Increase Their Diabetes Self-efficacy"
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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