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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014