Changing Physical Activity Behavior in Individuals With Type 2 Diabetes Using Counceling and Information From Continuous Glucose Monitoring

Study Overview
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Brief Summary
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The purpose of this study was to develop a nurse counseling intervention to increase physical activity behavior in people with type 2 diabetes and to improve their health

Detailed Description
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Diabetes affects 20.8 million Americans and is the fifth leading cause of death in the United States. Although physical activity is a cornerstone in the treatment of diabetes, it is difficult to change physical activity behaviors and up to 60% of individuals with diabetes do not participate in regular physical activity. The use of a nurse counseling intervention based on established behavior change theory with technology-derived graphical representations of glucose information created a unique opportunity to test the feasibility of motivating people with type 2 diabetes to change physical activity behaviors. The consent form described the study protocol, participant expectations, benefits, risks, and the process of maintaining participant confidentiality.

Official Title
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Changing Activity Behavior With Glucose Sensor Feedback

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Effect of Physical Activity on Type II Diabetes Mellitus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Type 2 Diabetes Mellitus Three month blood sugar test (HbA1c) > 7.5% Not receiving insulin to manage diabetes Not engaged in a physical activity program more than 2 days per week Able to read and speak English Exclusion Criteria: Not able to walk ¼ mile in 10 minutes Taking glucocoricoids Serious health problems, such as heart problems, found on examination.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Control group uses 90 minutes of standard diabetes education/ 7 days using the International Diabetes Center curriculum & update phone call at 4 weeks. | |
| Experimental: Intervention<br>Interventional group received standard diabetes education, CGMS monitor, and extra educational topics including CGMS counceling. | Behavioral: Effect of Physical Activity on Type II Diabetes Mellitus<br>* Reviewing participants and a role model's continuous glucose monitor graphs, discussing benefits of physical activity and setting physical activity goals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increased physical activity |  | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BP, BMI, & HgA1c (a long term measure of blood glucose) |  | 8 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Glucose Monitor graphs, Physical Activity