Changing Physical Activity Behavior in Individuals With Type 2 Diabetes Using Counceling and Information From Continuous Glucose Monitoring
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Behavioral: Effect of Physical Activity on Type II Diabetes Mellitus |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Changing Activity Behavior With Glucose Sensor Feedback |
- increased physical activity [ Time Frame: 8 Weeks ]
- BP, BMI, & HgA1c (a long term measure of blood glucose) [ Time Frame: 8 Weeks ]
| Enrollment: | 52 |
| Study Start Date: | July 2004 |
| Study Completion Date: | December 2005 |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control
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
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
Reviewing participants and a role model's continuous glucose monitor graphs, discussing benefits of physical activity and setting physical activity goals.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| United States, Massachusetts | |
| Berkshire Health System | |
| Pittsfield, Massachusetts, United States, 01201 | |
| Baystate Health System | |
| Springfield, Massachusetts, United States, 01199 | |
| Principal Investigator: | Nancy A Allen, Ph.D. | University of Massachusetts Worcester Medical School |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00542698 History of Changes |
| Other Study ID Numbers: | 00004009, NIH: F31 NR008818-01A1 |
| Study First Received: | October 10, 2007 |
| Last Updated: | October 10, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Nursing Research (NINR):
|
Type 2 Diabetes Mellitus Glucose Monitor graphs Physical Activity |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013