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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Changing Activity Behavior With Glucose Sensor Feedback

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542698
• Other study ID #: 00004009
• Secondary ID: NIH: F31 NR00881
• Status: Completed
• Phase: Phase 1
• First received: October 10, 2007
• Last updated: October 10, 2007
• Start date: July 2004
• Est. completion date: December 2005

Study information

• Verified date: October 2007
• Source: National Institute of Nursing Research (NINR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	Berkshire Health System	Pittsfield	Massachusetts
United States	Baystate Health System	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Abstract -OR 27: Effect of Counseling with Continuous Glucose Monitoring on Physical Activity Behaviors June 2006, Oral Presentation for American Diabetes Association 66th Scientific Session, Washington D.C

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	increased physical activity		8 Weeks
Secondary	BP, BMI, & HgA1c (a long term measure of blood glucose)		8 Weeks