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

Sponsored by:	National Institute of Nursing Research (NINR)
Information provided by:	National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier:	NCT00542698

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 I

MedlinePlus related topics: Diabetes

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Changing Activity Behavior With Glucose Sensor Feedback

Further study details as provided by National Institute of Nursing Research (NINR):

Primary Outcome Measures:

increased physical activity [ Time Frame: 8 Weeks ]

Secondary Outcome Measures:

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
Control: No Intervention Control group uses 90 minutes of standard diabetes education/ 7 days using the International Diabetes Center curriculum & update phone call at 4 weeks.
Intervention: Experimental 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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542698

Locations

United States, Massachusetts
Baystate Health System
Springfield, Massachusetts, United States, 01199
Berkshire Health System
Pittsfield, Massachusetts, United States, 01201

Sponsors and Collaborators

National Institute of Nursing Research (NINR)

Investigators

Principal Investigator:

Nancy A Allen, Ph.D.

University of Massachusetts Worcester Medical School

More Information

Study ID Numbers:	00004009, NIH: F31 NR008818-01A1
Study First Received:	October 10, 2007
Last Updated:	October 10, 2007
ClinicalTrials.gov Identifier:	NCT00542698
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Nursing Research (NINR):

Type 2 Diabetes Mellitus
Glucose Monitor graphs
Physical Activity

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 15, 2009