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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier:
NCT00542698
First received: October 10, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  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

Resource links provided by NLM:


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
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
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
Berkshire Health System
Pittsfield, Massachusetts, United States, 01201
Baystate Health System
Springfield, Massachusetts, United States, 01199
Sponsors and Collaborators
Investigators
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 April 16, 2014