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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00542698
Recruitment Status : Completed
First Posted : October 11, 2007
Last Update Posted : October 11, 2007
Information provided by:
National Institute of Nursing Research (NINR)

Brief 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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: Effect of Physical Activity on Type II Diabetes Mellitus Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Changing Activity Behavior With Glucose Sensor Feedback
Study Start Date : July 2004
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. increased physical activity [ Time Frame: 8 Weeks ]

Secondary Outcome Measures :
  1. BP, BMI, & HgA1c (a long term measure of blood glucose) [ Time Frame: 8 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00542698

United States, Massachusetts
Berkshire Health System
Pittsfield, Massachusetts, United States, 01201
Baystate Health System
Springfield, Massachusetts, United States, 01199
Sponsors and Collaborators
National Institute of Nursing Research (NINR)
Principal Investigator: Nancy A Allen, Ph.D. University of Massachusetts Worcester Medical School

Publications of Results:
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 Identifier: NCT00542698     History of Changes
Other Study ID Numbers: 00004009
NIH: F31 NR008818-01A1
First Posted: October 11, 2007    Key Record Dates
Last Update Posted: October 11, 2007
Last Verified: October 2007

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